2019 Produce Compliance Dates for FSMA

By Charles Breen, EAS Independent Advisor for FSMA Consulting Services

January 28, 2019, marks the compliance date for four categories of produce growers:

  • Sprouts from Very Small Farms (with certain exemptions), 
  • Sprouts from Very Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7, 
  • Other small farms, (except those with certain water requirements), and 
  • Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7

must come into compliance.

FSMA’s Final Rule on Produce Safety, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and FDA’s helpful Small Entity Compliance Guide concerning determination of business size (based on annual monetary value of the food farms sell directly to qualified end users) are two important resources for farms growing and harvesting produce for consumption without further processing.

Recent foodborne illness outbreaks from romaine lettuce illustrate why it is prudent to take a fresh look at some specific areas where the introduction and harboring of pathogens can wreak havoc and cause devastating public health and economic consequences.

FDA’s recently announced that the list of possible growing areas identified as the source of the E. coli outbreak in romaine lettuce has been narrowed to three California counties, and one farm in particular. However, FDA concedes that this does not explain all of the illnesses. As of December 13, 2018, traceback information from five restaurants in four states have identified 11 different distributors, nine different growers, and eight different farms as potential sources of the contaminated lettuce, so it is likely that the outbreak cannot be explained by a single farm, grower, harvester, or distributor. FDA continues to investigate.

It’s also not only E. coli causing produce industry woes. Listeria monocytogenes prompted recent recalls of pre-packaged salad products and asparagus, as did a summer outbreak of Cyclospora in melons and lettuce. 

Why are these events continuing to happen? FSMA’s many requirements were designed to prevent just such occurrences. Are growers not complying with the regulations because they are too difficult to understand, or too difficult to follow? Or are these outbreaks examples of Murphy’s law, that no matter the risk mitigation strategy, if something can go wrong, it will?

The answer, in my view, is yes to all three – and I’ll add that sometimes downstream consequences are not fully understood until it is too late. 

Take for instance, this past summer’s E. coli outbreak in romaine lettuce. The fact that after so many months FDA still cannot pinpoint the exact source of the outbreak suggests these companies and areas under investigation appear (at least on the surface) to be largely in compliance. As of this writing, Whole Genome Sequencing testing has identified only one result where an agricultural water reservoir sediment contains the same E. coli O157:H7 strand implicated in the outbreak. However, the agency says it isn’t clear how the water became contaminated and that additional illnesses demonstrate that this reservoir cannot be the only cause of such a widespread outbreak. 

As compliance dates for various sized produce and sprout farms arrive, FDA will continue to transition from an educational to a regulatory approach for FSMA and supplier enforcement. Prudent companies will take a step back and review their supplier, manufacturing, agricultural and transportation protocols to ensure that all conceivable entry points for microbiological, chemical and physical hazards are controlled, and, when problems do occur, quickly testing entry points to identify and reduce impacts.

Just because something hasn’t yet happened at your facility doesn’t mean it won’t, and don’t assume that just because something happens at one of your suppliers or distributors, that your company won’t see negative repercussions. Food safety is everyone’s business.

EAS stands ready to help you with all aspects of FSMA compliance. Contact us or more information end-users and we invite you to view our many industry information sheets to learn more about our services with regards to foods, FSMA and other FDA requirements for all product areas.

New Report on the Sources of Foodborne Illnesses Highlights Urgency of FSMA Compliance

By Charles Breen, Independent Advisor for FSMA

The Interagency Food Safety Analytics Collaboration (IFSAC) report, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, highlights why FSMA is so important a tool in driving the food industry to do more to prevent foodborne outbreaks. Each year in the U.S., an estimated 9 million people get sick, 56,000 are hospitalized, and 1,300 die of foodborne disease caused by known pathogens. IFSAC identified four priority pathogens, Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter that together cause 1.9 million foodborne illnesses each year. In addition to their frequency, these pathogens are also well-known for the severity of the illnesses they can cause, and the fact that targeted interventions can significantly reduce their incidence.

The IFSAC statistical analysis showed 1,255 outbreaks between the years 1998 and 2016 (3,553 in raw data) in which a confirmed or suspected food or foods could be assigned to a single food category: 762 caused or suspected to be caused by Salmonella, 235 by E. coli O157, 37 by Listeria, and 221 by Campylobacter. Using outbreak data, the report estimates:

  • Salmonella: Illnesses came from a wide variety of foods, of which more than 75% of illnesses were attributed to seven food categories: Seeded Vegetables (such as tomatoes), Chicken, Pork, Fruits, Other Produce (such as nuts), Eggs, and Beef.
  • E. coli O157: Nearly 75% of illnesses were linked to Vegetable Row Crops and Beef.
  • Listeria monocytogenes: Illnesses were most often linked to Dairy products and Fruits.
  • Campylobacter: Over 80% of non-Dairy foodborne illnesses were attributed to Chicken, Other Seafood (such as shellfish), Turkey, Other Meat/Poultry (such as lamb or duck), and Vegetable Row Crops, with the majority of illnesses most often linked to Chicken.

Since FSMA’s passage in January 2011, FDA has worked hard to educate stakeholders on the many new food safety requirements covering all foods (with limited exceptions) under FDA’s purview. The message of the newly released IFSAC report strongly suggests that manufacturers and processors of implicated food categories should take special care. If not FDA coming to look, it will be FSIS to check on food safety measures and controls.

For example, the Produce Safety Rule and more recent Guidance for Industry establish science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Specific requirements include agricultural water (pending further research), biological soil amendments, worker hygiene, building and equipment requirements. Growing sprouts is given special attention because of the inherent risk.

After the largest E. coli O157 outbreak in a decade, the Agency confirmed in early November that three samples of irrigation canal water were found to be contaminated with the H7 strain that sickened so many and killed five. Shortly before this announcement, the Agency released a Draft Guidance for Industry on minimizing food safety hazards for cut produce that discusses how to comply with new Good Manufacturing Practices as well as hazard analysis and risk-based preventive controls.

You may have also want to read EAS Senior Director for Food Consulting Services, Allen Sayler’s recent article in Dairy Foods Magazine on how FDA’s enforcement of Appendix T in the 2017 Pasteurized Milk Ordinance is focusing on FSMA-like requirements. I expect this to be a game changer for the Dairy industry.

Reports such as IFSAC’s find that the majority of severe foodborne illnesses can be mitigated through better controls, and more diligent efforts at safety. We can only be encouraged as FSMA compliance dates tick forward and we learn more of the “whats” and “hows” of preventive controls and better implementation methods. Unfortunately, we also learn much from cases where preventive controls did not work. When that happens, all of the industry should take note, assess their own procedures and make adjustments as needed so that we can collectively continue to create a safer food supply.

FDA Proposes Releasing Retailer Names in Most Serious Recalls

Charles BreenBy Charles Breen, Independent Advisor for FSMA

In an effort at greater transparency as well as consumer safety, FDA issued Draft Guidance this month proposing how and when FDA would publicize the identities of retail consignees that may have received recalled human or animal foods. This release of retailer information would only occur in cases where a food recall presents a serious adverse health consequence or death to humans or animals (SAHCODA), i.e., Class I recalls. The intention is to provide information to consumers to take a closer look at their purchases should they recognize that they shop at a particular location.

There is typically no single source that FDA can access to readily obtain a list of retail consignees of a recalled food product, therefore the decision to list retail consignees requires information obtained from multiple entities throughout a supply chain, including the recalling firm and its intermediate distributors – no small task. In addition, FDA may not be able to fully verify the accuracy or completeness of the information it receives from recalling firms or distributors so its available information may be over and under-inclusive In other words, FDA may not identify every retailer who received recalled product, and might inadvertently identify retailers who, in fact, did not receive the recalled item.

Currently, FDA routinely provides labeling information, product descriptions, lot numbers, and photographs, and if available to FDA – geographic or retail-related distribution information. It also lists all FDA-regulated recalls in the FDA Enforcement Report.

As noted in the Draft Guidance, the release of retailer information is authorized under Section 206 of the 2011 FDA Food Safety Modernization Act, ‘which directs the Agency, in conducting recalls under the section to “consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public,” when FDA considers the release to be appropriate (21 U.S.C. § 350l(g)(2)). The Department of Agriculture (USDA) policy is to make publicly available the names and locations of retail consignees of recalled meat or poultry products that USDA compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death (Class I recalls). 9 CFR 390.10.’

FDA will consider two specific criteria that may warrant the release of retail consignee information, including when a recalled food is related to a foodborne illness outbreak, and where the information would be most useful to consumers. Examples of such foods are fruits, nuts, vegetables, and rawhide chews sold in bulk bins with no UPC or barcode, raw meat or deli products, or when the food product lacks a lot number, or other identifiers, which consumers can use to readily identify the product as one being recalled.

While there is some understandable concern regarding the publication of consignees and suppliers due to possible disclosure of confidential information, the Agency assures all that it will consider carefully the release of any additional retailer information, weighing risks to consumer health and safety. While FSMA has many facets that aim to proactively improve our food safety, no system is completely fool-proof. In cases where FDA and food manufacturer efforts at preventive controls fail, the additional release, as necessary of retailer information included in a recall will help to ensure the public has a greater awareness of contamination and can avoid the consumption of such products.

FDA Announces Export Certifications and Fees for Certain Food Products

By Charles Breen, Independent Advisor for FSMA

On August 31, 2018, FDA announced a new voluntary export certification option for certain foods as authorized under FSMA, similar to that available for qualified pharmaceuticals and medical devices. This new export certification program and its associated fees will allow the agency to collect up to $175 for export certifications for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The issuance and collection of these fees begin October 1, 2018, and are in effect for two new types of food certificates, the “Certificate to a Foreign Government” and “Certificate of Exportability.”

Prior to this announcement, CFSAN issued only a “Certificate of Export” for seafood, food additives, and food contact substances and a “Certificate of Free Sale” for foods other than seafood, dietary supplements, infant formula, medical foods, and foods for special dietary use.

Per the FDA’s Constituent Update, the “Certificate to a Foreign Government” will be available for products that meet the applicable requirements of the FD&C Act and will certify that a product (or products) may be marketed in and legally exported from the United States. The “Certificate of Exportability” will be available for export only products and will certify that a product or products meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. FDA anticipates that the new certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by FDA of FDA-regulated food products.

Requests for written export certification for FDA regulated products are common from foreign customers or foreign governments. In the case of food products, FDA provides, though does not require, written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Those U.S. companies which export foods are required to follow U.S. laws and regulations as well as those specific to the countries the products are being exported to. It is important to note that laws vary across countries and FDA does not provide any guidance for laws outside of the U.S. that companies must follow.

Most CFSAN export certificates may be obtained by completing an online application through the FDA Unified Registration and Listing Systems (FURLS) Certificate Application Process (CAP). These take several weeks to process with no expedited review option. Some foreign governments require the additional step of verifying the export certificate via apostille or authentication from the U.S. Department of State or, in cases where the certificate was issued after April 2016, a unique Certificate ID, printed in the top left corner of every certificate, may be used to independently verify whether the export certificate was issued by FDA.

EAS offers U.S. import assistance as well as assistance for companies exporting product to foreign countries via the application of a certificate of export as well as obtaining apostille from the U.S. Department of State. Contact us for more information.

Preventive Controls – A New Ballgame for Food Safety Compliance

By Charles Breen, Independent Advisor for FSMA

With the recent issuance of a Warning Letter citing violations of Part 117 subpart C (preventive controls), implementation of FDA’s Preventive Controls rule takes its next step – FDA will cite food facilities for preventive control failures. Everyone paying any attention to FSMA knew this would happen, and as long as it happens to someone else, it can be a low pain, high gain learning opportunity.

For example, we now know FDA objects to food facilities that make a ready to eat products, have multiple positive Salmonella results from an environmental sampling program, and yet do not consider Salmonella a hazard in need of one or more controls as part of a food safety plan. Equally, FDA objects to having corrective actions that are not implemented when a problem arises for which the corrective action was planned. And failing to verify that sanitation procedures are properly performed is worthy of citation in a Warning Letter.

No matter how much FDA educates, theoretical agency definitions of unacceptable conditions or practices are no substitute for concrete examples. These first few are obvious, but we can expect more, and more finely detailed, citations in the future.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods and Animal Foods lays out expectations for the prevention of contaminated foods in all areas of processing, packing, holding and transporting. Food facilities must have plans in place that address hazards reasonably likely to occur in the absence of one or more controls.

As noted in the recent Warning Letter, implementation of controls, verification, and monitoring can be lacking. This challenges many companies because writing written procedures is one thing, properly implementing them is another. Practicing accountability from start to completion is often overlooked, leaving many facility managers ill prepared just when and where they need it most. Performing practiced implementation for when things go awry is one critical way of preparing for the inevitable and doing so with measured success.

Firms are busy and time is money. When a production line is down, a product is not being made, customer demand is not met and earnings suffer. In maximizing efficiency, the devil in the details can get lost and we miss steps. Some missed steps may even seem innocuous at the time, after all – we are in a hurry, but they compound each other leading to a failure.

Let’s take the case of the requirement for pathogen swabbing, (shameless plug – EAS is offering a complimentary webinar on swabbing for environmental pathogens September 21). FDA requires that facilities producing foods that have been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for that does not include a kill step after packaging, establish environmental sampling programs.

When there is an identified environmental pathogen hazard requiring a preventive control, environmental monitoring is required at regular intervals. At some point, there will be a positive result. If you never find any positives, FDA may suggest your sampling program is not robust enough. As you have read before in this column, no matter how comprehensive your sanitizing procedures, at some point you’ll have a result that requires further assessment, cleaning, evaluation of the previous production, and whether your food safety plan needs revision. When that positive result first comes to light – what next?

This is when copies of Wanting Letters are useful. Comparing what you have to what FDA found inadequate can reassure you, or point to things that need attention.

Another resource that is becoming more useful is FDA’s Technical Assistance Network (TAN). Begun in September 2015, the TAN responds to inquiries related to all FSMA rules. As of May 2018. they have received 9,030 inquiries, indicating at least two things. First, this is an industry that largely wants to do the right thing, and second, it is an industry that needs specific answers to many varied specific questions.

The TAN recently published answers to 172 frequently asked questions (https://www.fda.gov/food/guidanceregulation/fsma/ucm247559.htm). There are insights into FDA thinking to be found among the answers.

Be mindful that a similar question does not mean FDA would give a similar answer. Details matter. Each food facility must tailor its plan to individual facility operations. The expectations behind FSMA and Preventive Controls are laid out in great detail and the Preventive Controls requirements are the hallmark of food safety. Look broadly at first, then focus in. Flow-charts can be helpful with “if-then” scenarios. If a positive result is found, then what? Which zones of the production area should be included in these tests and once the positive result is confirmed, then what? Product recall? Who should the results be reported to? FSMA spells out that these scenarios must be developed and documented so that when disaster strikes a haphazard plan isn’t created in a moment of panic.

Now comes the often overlooked part: Once the plan is made, the real work begins. Practice. It’s easy to spell things out on paper (or digitally) but how practical are the steps? Does everyone understand the process or is there room for interpretation which can lead to confusion and those missteps we spoke of earlier? Much like the requirement for FSMA training which must be in a language that each employee can understand, the same true for PC steps. Make sure all, no matter who is in charge at every step of the process, understands and can perform those activities expected of them.

Lastly, ask for help when needed. Whether it is through the FDA and their TAN, FSMA training videos and fact sheets or through reputable consulting firms such as EAS, your ability to follow PC rules depend on your complete understanding of detailed, documented steps and practicing these steps so that they are seamlessly executed when needed.

Produce Safety Rule’s July Compliance Dates

By Charles Breen, Independent Advisor for FSMA

Those closely watching FSMA compliance dates will note that July 26, 2018 marks a significant date for FSVP and the Produce Safety Rule. Specifically,

  • importers with Small Business Foreign Suppliers will now be required to comply with sprout requirements of Produce Safety Rule;
  • importers with Small Business Foreign Suppliers that are farms producing sprouts are eligible for a Qualified Exemption under the Produce Safety Rule; and
  • importers with Large Foreign Suppliers are required to comply with Produce Safety Rule;

with an exception for importers of food contact substances who now have an additional two years to comply with the FSVP requirements.

FDA is postponing an enforcement regarding written assurances in certain cases when a manufacturer/processor does not control a hazard requiring a preventive control. Originally, an additional two years to comply with the above specific requirements were to be granted based on written assurances from their customer that they will either manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so. Sellers must notify commercial customers that hazards are not controlled, but sellers do not now need to obtain written assurances from customers as a condition of sale. FDA says in this context, “customer” does not mean “consumer.”

FDA provided a decision tree to assist affected firms in their understanding of the details for enforcement discretion of the written assurances provisions.

What does all this mean for your business? Plenty – particularly in light of the recent food safety outbreaks of Listeria monocytogenes which illustrate that even when preventive controls are applied, food emergencies can still occur. Managing a safe food supply requires serious vigilance at all times. Unfortunately, even the most diligent will likely see, at some point, some type of food safety event requiring immediate action, whether it is an unsanitary method of transportation, storage or production, worker hygiene, use of contaminated water or a large number of additional factors.

As part of the Produce Safety Requirement, you may recall our January 2018 FSMA Perspective which discussed the agricultural water testing and safety requirements. After much industry feedback that the numerical criteria for microbial water quality in the final rule are too complex, FDA issued a proposed rule to extend the compliance dates for the agricultural water requirements for produce other than sprouts. If finalized, the earliest compliance date for most agricultural water provisions would be January 2022 for the largest farms. Once finalized the specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to water testing data history for their own assessments of safety. Of course, prior to finalization, agricultural entities would be wise to begin or continue documented monitoring to gain a complete understanding of water quality used for irrigation and worker hygiene in order to provide FDA required data at the time of an inspection. Even though enforcement of FDA’s agricultural water provisions has been pushed back, they should still be considered a suitable benchmark for testing purposes. Any results found to be out-of-specification (OOS) should be retested followed by an assessment and correction of procedures leading to those OOS results.

Firms should also take a look at their entire organization’s policies and procedures, including the very important, and required by FSMA, training. Employees must understand what is required of them and why, and it is management’s responsibility to ensure that all required training is conducted in a language and manner that employees understand. This may mean conducting various types of training in a variety of languages.

Look closely at operations to assess whether they are meeting the requirements of the Produce Safety Rule. Start thinking: What training do we need? What may we have to adjust in our work processes to meet FDA’s standards?

An audit of all practices is a good idea in order to get an accurate picture of how current operating procedures match FSMA requirements allowing for the identification of needed improvements, planning, and execution. Additionally, some buyers require private audits (which may or may not have the same standards as FSMA requirements) so being able to demonstrate results from internal and/or third-party audits or mock-FDA inspections can only enhance one’s demonstration of efforts to meet or exceed standards.

In short, the compliance date for the Produce Safety Rule is right around the corner for importers with large business foreign suppliers as well as some small. It is always the right time to assess one’s current status and plan for improvements, though as FSMA continues to take shape and enforcement dates move forward, the urgency has never been greater.

New Brewers Need to Know GMPs

By Charles Breen, Independent Advisor for FSMA

The explosion in the numbers of new breweries is a blessing for beer drinkers and their communities. In FDA’s eye, beer is food, and while exempt from preventive control requirements, brewers must comply with good manufacturing practice regulations, GMPs.

The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system into one that is based on the prevention of foodborne illnesses by putting into place measures that will effectively prevent contamination. As any responsible grower, manufacturer, packer, and transporter know, keeping food safe to eat is paramount, no matter where it is produced, whether conventional or organic, whether the operation is small, medium or large, or whether it’s produce or process. Good Manufacturing Practices are critical to FSMA’s success.

A major new GMP component is the appropriate training of all employees to comply with GMPs. From managers to line staff, no matter the job and no matter the spoken language – everyone must understand and be able to apply those requirements that apply to their role in producing food. In FDA’s view, without this training, education and related experience, an employee is not qualified to act in their role or perform assigned duties. FSMA training encompasses everyone involved in the food industry, including domestic and foreign food producers and domestic importers.

Because the food industry, including brewers, is so varied, it is plain that a one size approach to training does not fit all. The most important goal for FDA is safe food, and the agency expects training programs to contribute to its accomplishment — that training advances knowledge in the food industry to meet FSMA requirements. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene as appropriate to the food, the facility, and the individual’s assigned duties.

There are a variety of FSMA training options available. FDA has a detailed webpage for many of the options including standardized trainings designed by the Food Safety Preventive Controls Alliance (FSPCA) and coordinated by Illinois Institute of Technology’s Institute for Food Safety and Health which offers technical information to help the domestic and foreign food industry comply with the requirements of the Preventive Controls rules for human and animal food, as well as the rule on Foreign Supplier Verification Programs (FSVP).

Those looking for FSMA compliance training need look no further than EAS. Many EAS Independent Consultants are Lead Instructors and we offer FDA recognized training programs as part of our FSMA educational curriculum.

EAS also hosts and participates in many industry webinars discussing the various aspects of FSMA, specifics of compliance and practical steps to bring facilities and operations into compliance.

Additionally, EAS is often an invited speaker as part of technical sessions at industry events such as the upcoming IFT Annual Meeting (where EAS will be moderating two sessions on FSMA) and the recent Dietary Supplement Regulatory Summit, (where Senior Director for Food Consulting Services, Allen Sayler, spoke on which parts and how FSMA applies to the dietary supplement industry).

EAS Consulting Group is a one-stop shop when it comes to education, assessing readiness, updating GMPs and other SOPs to bring processes into FSMA compliance and more. Our FSMA team takes great pride in the breadth and depth of services we offer.

Should you and your employees seeking FSMA training, look no further than EAS as we have a number of upcoming training seminars and on-demand informative sessions from which to choose.

And numerous On-Demand Webinars including:

Implementing a robust training program as part of your company’s FSMA compliance is a must and EAS Consulting Group offers many tools to help you get there.

Dietary Supplements vs. Foods — A FSMA Regulatory Challenge

By Tara Lin Couch, Ph.D., EAS Senior Director of Dietary Supplement and Tobacco Services and Allen Sayler, EAS Senior Director for Food Consulting Services

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary supplements; however, DSHEA carved out unique regulatory exemptions and requirements for dietary supplements. Achieving a correct and complete understanding of the FDA regulatory requirements applicable to dietary supplements versus other general foods can be challenging and confusing.

Foods are defined in the FD&C as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. Dietary supplements are defined as a product taken by mouth that contain a dietary ingredient intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites; or extracts or concentrates of any of these. Dietary supplements can be in many dosage forms such as tablets, capsules, softgels, gelcaps, gummies, liquids, powders, and bars if they do not represent the product as a conventional food or sole item of a meal or diet.

The primary method for identifying a product as a dietary supplement versus a general food is to ensure it meets the definition above and for the product label to declare that the product is a “dietary supplement.” It is also required dietary supplement labels include a Supplement Facts panel, rather than a Nutrition Facts panel, which is required for almost all FDA-regulated foods. Both general foods and dietary supplements must comply with similar and also different labeling requirements, all found in 21 CFR 101, Food Labeling. Both general foods and dietary supplements could be identified by FDA as misbranded when they fail to meet applicable label claims or labeling requirements provided in the 21 CFR 101 regulation. If used, structure/function claims for dietary supplements and general foods must be truthful and not misleading. Specific to dietary supplements, the following disclosure statement is required to ensure that the dietary supplement product also does not represent itself as a pharmaceutical drug.

  • “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Although dietary supplement labels are not required to be pre-approved by FDA, the product owner of a dietary supplement must provide FDA, a notification with the text of the structure/function claim no later than 30 days after marketing the product. General foods have no such FDA notification requirement for product labeling.

DSHEA also requires FDA to promulgate GMPs (good manufacturing practices) for the dietary supplement industry. This resulted in the issuance of 21 CFR 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in 2007. Note: FDA issued the “Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in December 2010, which also has important information on FDA’s regulatory and enforcement expectations.

The DSHEA regulation itself addresses aspects of the manufacturing, packaging and distribution of a dietary supplement product for distribution to the consumer. The comparable general food regulations are found in the relatively new FDA “Preventive Controls for Human Foods” regulation found in 21 CFR 117.

Comparison of Dietary supplement (21 CFR 111) and General Food Good Manufacturing (21 CFR 117) Requirements

21 CFR 111

Subpart

Description Summary 21 CFR 117 Subpart
B Personnel B – 117.10
C Physical Plant and Grounds B – 117.2, 117.20, 117.35, 117.37, 117.140 a‐d
D Equipment and Utensils B – 117.40, 117.35a, 117.37d,e, 117.40 a‐e
E Production and Process Controls – Specifications B – 117.80; C; G
F Quality Control B – 117.80
G Components, Packaging, and Label Controls B – 117.80
H Master Manufacturing Records B – 117.80 & F
I Batch Production Records B – 117.80 & F
J Laboratory Operations B – 117.40
K Manufacturing Operations B – 117.80
L Packaging and Labeling Operations B – throughout this Subsection
M Holding and Distribution Operations B – throughout this Subsection
N Returned Products NA
O Product Complaints Part of 117.155 but not specifically mentioned –
P Recordkeeping F

Shortly after the beginning of enforcement of 21 CFR 111 by the Center for Food Safety and Applied Nutrition (CSFAN), in 2010, the Food Safety Modernization Act (FSMA) was passed by the United States Congress in 2011. FSMA has been referred to as the most sweeping and significant legislation for the protection of public health regarding safety, efficiency and security of foods, drugs and cosmetics (the mandate of the FDA) since the first set of laws were passed with FD&C in 1938. It was in reaction to numerous cases of food-borne illness and product recalls, particularly for pathogens (undesirable microorganisms) and allergen cross-contact and contamination issues in general foods. Pathogenic microorganisms of most notable concern are Escherichia Coli, Salmonella, Staphylococcus aureusand Listeria monocytogenes. Allergens are foreign substances that, in some consumers, can cause an abnormal immune system response that, at its most dangerous extreme, can result in death. In the United States, by law, eight food allergens must be identified; these are known as the “big eight”, i.e., milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Seven major regulations have been issued by FDA to support enforcement of FSMA. The most important of these being 21 CFR 117, “cGMP and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF).” Interestingly, dietary supplements are exempt from many of the requirements in these seven FSMA-based regulations, but not all.

The challenge: in late 2018, FDA is committed to full enforcement of all provisions of FSMA-based PCHF and by mid-2019, of the Foreign Supplier Verification Program (FSVP). Both have parts applicable and enforceable on the dietary supplement industry. Which new parts of the PCHF and FSVP regulations will impact the dietary supplement industry? Unfortunately, simply reading both regulations may not provide the insight and understanding necessary for dietary supplement manufacturers to adjust their regulatory programs for these new challenges.

The PCHF regulation, in accordance with 21 CFR 117.5(e), does not apply to any facility with regard to the manufacturing, processing, packaging or holding of a dietary supplement that is in compliance with the requirements in 21 CFR 111. For example, for general foods, Subpart C of 21 CFR 117 states that a hazard analysis must be conducted to identify and evaluate microbiological, chemical and physical hazards. Preventative controls must then be developed and implemented to ensure that these hazards will be significantly minimized or prevented, and the food will not be adulterated or misbranded. Subpart G of 117, also applicable to general foods, requires a written, risk-based supply chain program to ensure control of these same hazards in incoming raw material and other ingredients. Since these are already addressed in the dietary supplement regulations (21 CFR 111, particularly Subpart E), Subparts C and G of 117 are not applicable to dietary supplement manufacturers. Subpart B of 21 CFR 117 is the cGMP for general foods has its counterpart in 21 CFR 111 for dietary supplement manufacturers; however, the cGMPs are enforced by FDA for dietary supplement manufacturers as well as the dietary supplement GMPs found in 11. Allergen control is discussed at length in 21 CFR 117, but 21 CFR 111 never specifically dictates the need for allergen control or testing, however, all components must be demonstrated to meet established limits of potential contaminants, and the big eight food allergens certainly qualify as potential contaminants.

The other FSMA-based regulation, FSVP is also applicable to dietary supplement manufacturers, in some cases. The rule provides several exceptions to the standard FSVP requirements for certain types of importers. First, for dietary supplements and dietary supplement components/ingredients, importers that establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) under the dietary supplement cGMP regulations will not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. The same exception would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements. In contrast, importers of other dietary supplements would be required to comply with most of the standard FSVP requirements, but would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier follows the dietary supplement cGMP regulation, rather than verifying that hazards requiring a control are significantly minimized or prevented, as required under the standard supplier verification activity provisions. For foreign suppliers exporting a food ingredient to the United States that could be used as a dietary supplement, all the FSVP requirements apply. If this same supplier exported the same component/ingredients for use only as a dietary component/ingredient, then few of the FSVP requirements apply. However, if FDA discovers that the component/ingredient imported as a dietary ingredient, is being used by general food manufacturers, then it is likely that FDA will take regulatory action against the FSVP Importer and could potentially declare the food that the dietary component/ingredient was used in “adulterated,” which could trigger recalls as well as other FDA regulatory actions.

In addition, the FSVP regulation has a requirement of using a “qualified individual” for general foods also applies to dietary supplement manufacturers conducting the following operations:

  • 506(a)—procedures to ensure the importation of food from approved suppliers
  • 509—identification of the importer at entry
  • 510—recordkeeping
  • 511(c)(2)—procedures to ensure the importation of dietary supplements from approved suppliers
  • 512(b)(5) —recordkeeping by very small importers

A few years into the future we will all have “muscle memory” related to which parts of the FSMA-based regulations apply to dietary supplement manufacturers and understand the regulatory requirement differences between dietary supplements and general foods. Until then, it is important to rely on knowledgeable, experienced people in the industry, FDA and the consulting world as the enforcement threshold is “now,” and any uncertainty could result in noncompliance and FDA actions against dietary supplement manufacturers.

Tara Lin Couch, Ph.D., is an analytical/organic chemist with more than 20 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a senior consultant with EAS Consulting Group.

Allen Sayler is the senior director for food consulting services at EAS. Sayler’s expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF). Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other half as a state and federal government employee.

This article was reprinted with permission from Natural Products Insider.

GMPs and Preventive Controls in Animal Foods – New Rules, New Animal Foods, New Problems in Compliance

By Charles Breen, Independent Advisor for FSMA

Although six months have passed since the compliance date for large animal food facilities to meet Good Manufacturing Practices (GMPs) and Preventive Controls requirements, and for small animal food facilities with fewer than 500 full-time equivalent employees, to meet the GMPs, the pet food industry in particular continues to struggle with the FSMA Final Rule for Preventive Controls for Animal Foods. Despite FDA having indicated that the industry should expect greater inspection activity for GMP compliance after September 18, 2017, numerous recent recalls suggest an excess of complacency on the parts of some, and a challenge in understanding and meeting the requirements of others.

Recent popular trends for raw meat diets in pet food have led to a spike in the frequency of recalls for pathogen contamination. Contamination in pet food and animal food, much like human food, can cause ill effects and even death. In the case of pet food, cross-contamination also has the potential to cause harm to humans.

The final rule requires animal food facilities to have a written food safety plan, including GMPs, and controls in place for any hazards identified as part of a required hazard analysis. In addition, risk-based preventive controls must be in place for processes, as required, to reduce or eliminate the risk of additional contaminations. FDA’s staggered compliance dates are based on the size of a business, with the next compliance date for small businesses to meet preventive controls requirements in September 2018, at which time very small businesses will need to meet CGMPs. Large firms were expected to have preventive controls in place effective September 2017. However, FDA will not begin conducting routine inspections of preventive controls until the fall of 2018, allowing time to ensure companies understand and are able to meet those expectations. FDA also just released draft guidance to help firms determine whether they meet the definition of a small business, which of course directly impacts whether the company is exempt from the human food preventive controls requirements and the animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Also, small businesses have later compliance dates for parts 117 and 507 than larger businesses.

What is the difference between GMPs and Preventive Controls? Jenny Murphy, a consumer safety officer with FDA’s Center for Veterinary Medicine says in a Q&A that GMPs are more basic, including items one would do in the normal course of business to establish a base to prevent contamination. Preventive controls focus prevention of harm by controlling risks to public health. “Once you have CGMPs in place,” she says, “you can see where you need extra layers of protection. Preventive controls require a food safety plan that includes an analysis of potential biological, chemical or physical hazards and the steps needed to reduce or minimize that risk.”

The written food safety plan is required to have a hazard analysis. Hazards identified as needing preventive controls, such as process controls, sanitation controls, and others, require firms to implement controls to ensure those hazards are reduced or eliminated in all foods the facility manufactures, processes, packs, or holds, and when applicable, supply-chain programs. A recall plan is also required. Preventive Control plans must be prepared by or the preparation overseen by a “preventive controls qualified individual” for animal food.

I’ll bring to your attention a recent webinar hosted by EAS independent consultant, Dr. Omar Oyarzabal, an expert of acidified foods, who recently hosted a webinar on FSMA impacts on Acidified Foods along with Priya Rantham, an FDA Consumer Safety Officer. The process controls of acidifying foods are complex. Dr. Oyarzabal does an excellent job of simplifying the understanding both in this free on-demand webinar and in a Q&A based on the webinar recently published in Food Safety Tech.

In addition, regarding sanitary controls, EAS Independent Consultant Dr. Kathy Glass and Senior Director for Food Consulting Services, Allen Sayler, answered many questions on contamination and control of Listeria monocytogenes. While this information was directed at RTE human foods, much of the information is also applicable to animal foods.

On the subject of EAS resources, you may also be interested in an EAS produced FSMA pocket guide, which contains the 21 CFR Part 117 regulation. This pocket guide is also available digitally as a free download from our website.

The FSMA Final Rule for Preventive Controls for Animal Foods is just one of FDA’s many efforts at requiring and enabling greater control and oversight of safety for all manufacturing, processing and holding facilities of human and animal foods and animal feed. Through a combination of GMPs, hazard analysis and risk-based preventive controls, we can expect greater food safety for all.

Please reach out to EAS if you have any questions on this or other FSMA rules. We offer comprehensive services in this area and would be glad to discuss your firm’s readiness and compliance with FSMA requirements.

Dietary Supplements vs. Foods — A FSMA Regulatory Challenge

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary supplements; however, DSHEA carved out unique regulatory exemptions and requirements for dietary supplements. Achieving a correct and complete understanding of the FDA regulatory requirements applicable to dietary supplements versus other general foods can be challenging and confusing.

Foods are defined in the FD&C as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. Dietary supplements are defined as a product taken by mouth that contains a dietary ingredient intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites; or extracts or concentrates of any of these. Dietary supplements can be in many dosage forms such as tablets, capsules, soft gels, gel caps, gummies, liquids, powders, and bars if they do not represent the product as a conventional food or sole item of a meal or diet.

The primary method for identifying a product as a dietary supplement versus a general food is to ensure it meets the definition above and for the product label to declare that the product is a “dietary supplement.” It is also required dietary supplement labels include a Supplement Facts panel, rather than a Nutrition Facts panel, which is required for almost all FDA-regulated foods. Both general foods and dietary supplements must comply with similar and also different labeling requirements, all found in 21 CFR 101, Food Labeling. Both general foods and dietary supplements could be identified by FDA as misbranded when they fail to meet applicable label claims or labeling requirements provided in the 21 CFR 101 regulation. If used, structure/function claims for dietary supplements and general foods must be truthful and not misleading. Specific to dietary supplements, the following disclosure statement is required to ensure that the dietary supplement product also does not represent itself as a pharmaceutical drug.

  • “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Although dietary supplement labels are not required to be pre-approved by FDA, the product owner of a dietary supplement must provide FDA, a notification with the text of the structure/function claim no later than 30 days after marketing the product. General foods have no such FDA notification requirement for product labeling.

DSHEA also requires FDA to promulgate GMPs (good manufacturing practices) for the dietary supplement industry. This resulted in the issuance of 21 CFR 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in 2007. Note: FDA issued the “Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements” in December 2010, which also has important information on FDA’s regulatory and enforcement expectations.

The DSHEA regulation itself addresses aspects of the manufacturing, packaging, and distribution of a dietary supplement product for distribution to the consumer. The comparable general food regulations are found in the relatively new FDA “Preventive Controls for Human Foods” regulation found in 21 CFR 117.

Comparison of Dietary supplement (21 CFR 111) and General Food Good Manufacturing (21 CFR 117) Requirements

21 CFR 111

Subpart

Description Summary 21 CFR 117 Subpart
B Personnel B – 117.10
C Physical Plant and Grounds B – 117.2, 117.20, 117.35, 117.37, 117.140 a‐d
D Equipment and Utensils B – 117.40, 117.35a, 117.37d,e, 117.40 a‐e
E Production and Process Controls – Specifications B – 117.80; C; G
F Quality Control B – 117.80
G Components, Packaging, and Label Controls B – 117.80
H Master Manufacturing Records B – 117.80 & F
I Batch Production Records B – 117.80 & F
J Laboratory Operations B – 117.40
K Manufacturing Operations B – 117.80
L Packaging and Labeling Operations B – throughout this Subsection
M Holding and Distribution Operations B – throughout this Subsection
N Returned Products NA
O Product Complaints Part of 117.155 but not specifically mentioned –
P Recordkeeping F

Shortly after the beginning of enforcement of 21 CFR 111 by the Center for Food Safety and Applied Nutrition (CSFAN), in 2010, the Food Safety Modernization Act (FSMA) was passed by the United States Congress in 2011. FSMA has been referred to as the most sweeping and significant legislation for the protection of public health regarding safety, efficiency and security of foods, drugs, and cosmetics (the mandate of the FDA) since the first set of laws were passed with FD&C in 1938. It was in reaction to numerous cases of food-borne illness and product recalls, particularly for pathogens (undesirable microorganisms) and allergen cross-contact and contamination issues in general foods. Pathogenic microorganisms of most notable concern are Escherichia Coli, Salmonella, Staphylococcus aureus and Listeria monocytogenes. Allergens are foreign substances that, in some consumers, can cause an abnormal immune system response that, at its most dangerous extreme, can result in death. In the United States, by law, eight food allergens must be identified; these are known as the “big eight”, i.e., milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Seven major regulations have been issued by FDA to support enforcement of FSMA. The most important of these being 21 CFR 117, “cGMP and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF).” Interestingly, dietary supplements are exempt from many of the requirements in these seven FSMA-based regulations, but not all.

The challenge: in late 2018, FDA is committed to full enforcement of all provisions of FSMA-based PCHF and by mid-2019, of the Foreign Supplier Verification Program (FSVP). Both have parts applicable and enforceable on the dietary supplement industry. Which new parts of the PCHF and FSVP regulations will impact the dietary supplement industry? Unfortunately, simply reading both regulations may not provide the insight and understanding necessary for dietary supplement manufacturers to adjust their regulatory programs for these new challenges.

The PCHF regulation, in accordance with 21 CFR 117.5(e), does not apply to any facility with regard to the manufacturing, processing, packaging or holding of a dietary supplement that is in compliance with the requirements in 21 CFR 111. For example, for general foods, Subpart C of 21 CFR 117 states that a hazard analysis must be conducted to identify and evaluate microbiological, chemical and physical hazards. Preventative controls must then be developed and implemented to ensure that these hazards will be significantly minimized or prevented, and the food will not be adulterated or misbranded. Subpart G of 117, also applicable to general foods, requires a written, risk-based supply chain program to ensure control of these same hazards in incoming raw material and other ingredients. Since these are already addressed in the dietary supplement regulations (21 CFR 111, particularly Subpart E), Subparts C and G of 117 are not applicable to dietary supplement manufacturers. Subpart B of 21 CFR 117 is the cGMP for general foods has its counterpart in 21 CFR 111 for dietary supplement manufacturers; however, the cGMPs are enforced by FDA for dietary supplement manufacturers as well as the dietary supplement GMPs found in 11. Allergen control is discussed at length in 21 CFR 117, but 21 CFR 111 never specifically dictates the need for allergen control or testing, however, all components must be demonstrated to meet established limits of potential contaminants, and the big eight food allergens certainly qualify as potential contaminants.

The other FSMA-based regulation, FSVP is also applicable to dietary supplement manufacturers, in some cases. The rule provides several exceptions to the standard FSVP requirements for certain types of importers. First, for dietary supplements and dietary supplement components/ingredients, importers that establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) under the dietary supplement cGMP regulations will not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. The same exception would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements. In contrast, importers of other dietary supplements would be required to comply with most of the standard FSVP requirements, but would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier follows the dietary supplement cGMP regulation, rather than verifying that hazards requiring a control are significantly minimized or prevented, as required under the standard supplier verification activity provisions. For foreign suppliers exporting a food ingredient to the United States that could be used as a dietary supplement, all the FSVP requirements apply. If this same supplier exported the same component/ingredients for use only as a dietary component/ingredient, then few of the FSVP requirements apply. However, if FDA discovers that the component/ingredient imported as a dietary ingredient, is being used by general food manufacturers, then it is likely that FDA will take regulatory action against the FSVP Importer and could potentially declare the food that the dietary component/ingredient was used in “adulterated,” which could trigger recalls as well as other FDA regulatory actions.

In addition, the FSVP regulation has a requirement of using a “qualified individual” for general foods also applies to dietary supplement manufacturers conducting the following operations:

  • 506(a)—procedures to ensure the importation of food from approved suppliers
  • 509—identification of the importer at entry
  • 510—recordkeeping
  • 511(c)(2)—procedures to ensure the importation of dietary supplements from approved suppliers
  • 512(b)(5) —recordkeeping by very small importers

A few years into the future we will all have “muscle memory” related to which parts of the FSMA-based regulations apply to dietary supplement manufacturers and understand the regulatory requirement differences between dietary supplements and general foods. Until then, it is important to rely on knowledgeable, experienced people in the industry, FDA and the consulting world as the enforcement threshold is “now,” and any uncertainty could result in noncompliance and FDA actions against dietary supplement manufacturers.

Tara Lin Couch, Ph.D., is an analytical/organic chemist with more than 20 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a senior consultant with EAS Consulting Group.

Allen Sayler is the senior director for food consulting services at EAS. Sayler’s expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products, and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF). Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other half as a state and federal government employee.

This article was reprinted with permission from Natural Products Insider.

FSVP – Next Compliance Dates for Some Importers of Human and Animal Foods

By Charles Breen, Independent Advisor for FSMA

The next FSMA/FSVP compliance date is March 19, 2018. FDA enforcement activities begin with:

  • Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF);
  • Importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in PCAF, but not to CGMP requirements;
  • Importers of animal food whose Small Business Foreign Supplier is subject to PCAF cGMP requirements

Importers are already being inspected for the adequacy of their FSVP. A quick look at the most recent FDA inspection citations with data through January 15, 2018, shows nearly 100 Foreign Supplier Verification Program (FSVP) violations since FDA started inspecting importers last year. The citations made show that in many cases there is a clear lack of understanding, not only of the requirements but the implications for lack of compliance. FDA can stop an importer from importing food for which there is no evidence that the food complies with FDA requirements.

For anyone keeping score, March 19th marks the compliance date for 30th, 31st and 32nd FSMA rules, and the seventh, eighth and ninth for FSVP-specific rules so far.

It is important to also note that even though seafood, juice beverages, infant formula, dietary supplements, and Low Acid Canned Foods (LACF) foods may not be subject to significant parts of the FSMA preventive controls regulation, USDA regulated products are completely exempt, no FDA-regulated food has a complete exemption. When companies are producing foods that combine USDA and FDA regulated foods, whichever agency regulates the final food product may not be the only one regulating some of the ingredients of this final food. These companies need to check to be sure their food safety programs meet the requirements of either USDA, FDA or in a few cases, both. EAS has the expertise and regulatory knowledge to assist companies in navigating these sometimes-murky regulatory waters.

USDA’s various inspection Acts, (poultry products, egg products, the Federal Meat Inspection Act) have jurisdiction over these imported products at the time of U.S. entry. While USDA and FDA requirements are gradually coming into closer alignment, each agency’s requirements are still quite different. Understanding both sets of requirements is warranted for those whom this applies.

So, back to the March 19th deadline and what it means for you. First – does your company even need to comply with FSVP? Is your foreign food supplier aware that in order to comply fully with FSVP, they must first comply with the FSMA Preventive Controls regulations (human food and animal foods as applicable)? FDA has developed a handy flow-chart to help you make that determination. Even so, it’s not always so simple to understand the correct regulatory path to compliance – particularly in the case of seafood, juice beverages, infant formula, dietary supplements, and LACF foods – when and what FSVP rules must be followed, comply with FSVP.

The size of a business is a factor in whether companies need to comply, as is the case with those that meet the definition of a “very small businesses” (i.e., earned less than $1 million per year on average in the preceding three calendar years, adjusted for inflation from 2011, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale; or in the case of Animal Food – $2.5 million per year for three years in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee)). FDA provides a useful tool to help calculate inflation. For example, $1 million in 2011 is adjusted to $1,078,242 in 2016.

There are other exemptions in addition to those mentioned above. Imported food from Canada, New Zealand and Australia are still required to meet FSVP requirements. However, those who import foods from these countries may document FSVP compliance by relying on inspections by officially recognized food safety inspections in those countries. Their food safety systems are deemed to be comparable to that of FDA. Companies must clarify that imported food is within the scope of that official recognition or equivalency determination. For example, baked goods are food by definition, but are regulated by Health Canada. The mutual recognition with Canada is between FDA and CFIA, not HC. The details of this FDA recognition are still being worked out and food companies from Canada, New Zealand and Australia should consult with their US customs agents or EAS for the latest information on this moving target.

The many components of FSMA Preventive Controls regulations and the detailed technical aspects of FSVP alone are challenging to understand and implement. Addressing those challenges from two interwoven US regulations may sometimes require the assistance of outside experts, such as those at EAS, who can help you navigate the requirements and determine a course of action.

EAS offers FSMA services in all areas of food – from Dairy to Juice to Produce, Seafood, LACF, Infant Formula and dietary supplement manufacturers who fall under FSMA and FSVP requirements, workings with manufacturers, processors, holders and packers and transporters of products as well as their retailers.

EAS services in the area of FSMA and FSVP can save time and eliminate confusion. Understanding what rules apply to whom and how to develop compliant procedures can make all the difference when FDA inspectors arrive at your door. Don’t let your company be part of the next FDA inspection citations list or find your company on the FDA Import Alert list. Whether with the help of EAS or working independently with your own internal staff, make sure your FSVP compliance documentation is in good working order.

FDA Responds to GAO’s Report on Insufficient Agency Oversight of Recalls

By Charles Breen, Independent Advisor for FSMA

The December 2017 Department of the Inspector General report on FDA’s food recall process included some particularly harsh criticisms of the agency including inadequate authority, oversight and follow-up on voluntary food recalls. These criticisms came as little surprise as a number of issues surrounding agency oversight of recalls has been identified in recent years. A 2012 GAO report indicated that both FDA’s food advisory and recall processes need strengthening and a 2015 report again showed FDA is not keeping pace with foreign inspections.

The 2012 report findings prompted the agency to undertake significant steps in an effort to strengthen recall processes, including a revision of recall procedures published in the Regulatory Procedures Manual to better define recall categories in FDA’s database and to improve information sharing between federal and state agencies that also have oversight of food safety. Other improvement areas identified by GAO remain open, such as final guidance based on public comments on mandatory food recalls, and others that the agency said were impractical to implement.

Based on preliminary findings of the 2017 GAO report, which had been provided to FDA in 2016, the agency responded with the creation of a new management unit, the Strategic Coordinated Oversight of Recall Execution, (SCORE). It is intended to help the agency better investigate those reports of food illness that could pose a significant health hazard to consumers. Though a good start, the GAO recommends taking SCORE a step further to establish measurable performance expectations, such as timeframes, expedited decision-making, and improved electronic recall data. In other words, GAO wants to see scoring for SCORE.

One area of debate is the GAO’s review of 30 of the 1,557 voluntary FDA recalls between the years 2012 and 2015 where GAO determined in many cases FDA did not assess the hazards in a timely manner, nor did it communicate recall and safety concerns effectively. GAO cited, for instance, an extreme example where an affected product was not removed from commerce until 303 days after receipt of FDA’s warning letter prompting a recall. On average, says GAO, companies took 57 days to remove their recalled products. As well, GAO found the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES) to be deficient. The report noted “Our review found that FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls. This means that dangerous food products may have remained in our nation’s food supply for weeks after FDA was aware of the contamination.”

FDA takes some exception with how the 30 voluntary recalls reviewed were chosen, as GAO self-describes them as “judgementally selected.” In FDA’s view, these companies represent “extreme outliers” and says their own data show that during this 2012-2015 period when FDA “found out about a product problem that eventually resulted in a recall, the recall initiation took place, on average, in less than four days. In the highest risk recalls, when there was a reasonable probability that the use of or exposure to a product would cause serious adverse health consequences or death, recall initiation took place, on average, in less than three days.”

That being said, the agency stresses that it understands the urgency of getting recalls right and is reviewing selected recalls to identify gaps and improve procedures. FDA Commissioner, Scott Gottlieb said in a statement responding to the report, “Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities — and how we deploy them — are a cornerstone of our vital, consumer protection mission.”

HHS Office of the Inspector General rejects the agency’s claim that the 30 selected recalls were “extreme outliers” and says that FDA lacks a reliable tracking system. The current system makes it difficult to capture the recall initiation date and the date FDA became aware of potentially hazardous food products.

Regardless of the back and forth, the importance and urgency of identifying a food safety issue and its subsequent follow-throughs cannot be overstated. Recalls are a unique challenge as a consumer may have already purchased the recalled product.

It is imperative that companies have a robust and well-documented recall plan as part of their standard operating procedures (SOP) and that those plans are routinely practiced, drilling through the process with various scenarios – from a product in the warehouse, in-transit, already on consumer shelves and the type of threat identified.

  • How will your company respond?
  • Who is the internal point of contact/liaison with FDA?
  • How will parties who may be in possession of the product be identified and contacted?
  • How will the return and destruction of a product be identified and tracked?
  • How and by whom will the media be addressed?

There are many aspects to consider, many contingencies to plan for, and only one opportunity to get this right the first time. The safety of the public and the long-term viability of your company may depend on it.

The Food Safety Modernization Act (FSMA) granted FDA the authority to initiate mandatory food recalls. While the agency is working through their requirements to do so and simultaneously monitor voluntary recalls effectively, so should you. EAS offers assistance in preparing recall strategies as part of our holistic regulatory compliance planning services under FSMA. Take steps now and be prepared.

Produce Safety Requirements for Large Firms

By Charles Breen, Independent Advisor for FSMA

The coming year will be a busy one for food firms as the compliance date for 14 components of the FSMA Final Rule come into effect. FDA has published a helpful tool, Key Dates for Compliance, which runs through 2024 and this quick, color-coded reference offers a handy visual for determining when the compliance date for each area of FSMA goes into effect.

Of particular note is the compliance date of January 26, 2018 for the Produce Safety Requirement for large firms, (except certain water requirements) which applies to growers of fruits and vegetables that are consumed raw, with a few exclusions – specific types of produce that are rarely consumed raw (such as asparagus, coffee beans and pumpkins); those which would undergo further processing reducing the likelihood of contamination by microorganisms that could harm public health; produce which is grown for personal use; farms which have a three year annual sales totaling less than $25,000 and produce which is not a RAC.

A brief review of the water requirements makes clear why the agency is taking more time to find a way to protect consumers that is also practical and efficient for producers. Right now, the Produce Safety requirements and benchmarks for water testing are designed to be flexible, depending on the agricultural use and whether the water is received from municipal sources or other systems that have acceptable established standards, such as valid certificates of compliance that the water meets relevant requirements, or if the water is treated in compliance with the rule. Its very flexibility is leaving many producers wondering what would work best, if at all, in their own particular case.

Agricultural water is estimated to be the most significant pathway of E. coli contamination. So, it is unacceptable for water used in hand washing during and after harvest, water used on food contact surfaces, that comes in direct contact with produce (including ice) during or after harvest, or that is used for sprout irrigation to have any trace of E. coli.

Untreated surface water that is directly applied to growing produce (other than spouts) is considered to be the most vulnerable to external influences. FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. After that, an annual survey of a minimum of five samples per year is required. Those five newest samples in combination with 15 of the most recent samples will create a “rolling dataset” of 20 samples for use in confirming the safety of the water in use.

For untreated groundwater that is directly applied to growing produce (excluding sprouts) farms must take a minimum of four samples, again collected as close as is practicable to harvest, during the growing season or over a period of one year. After that, a minimum of one sample should be taken annually and that latest sample, combined with three of the previous samples will create the rolling dataset of four samples confirming that the water is appropriate for use.

The water’s safety is calculated using these samples through a complex statistical process with two sets of criteria for microbial water quality called the geometric mean (the average amount of generic E. coli in a water source) and statistical threshold (the amount of variability in the water quality). The sample’s generic mean must be 126 or less CFU of generic E. coli per 100 mL of water and the statistical threshold must be 410 CFU or less of generic E. coli in 100 mL of water. The determination of these statistical analyses may be confusing and FDA is considering the creation of a usable online tool to help make sense of individual data.

In the many US produce growing areas, the only available water for irrigation is untreated surface water that does not and cannot practically be treated to meet the microbiological criteria in the current rule. There is scant evidence of harm to consumers from the use of these water sources in some areas. At the same time, there is ample evidence of the risk that untreated surface water does cause illnesses in human. FDA is taking more time to sort out why what seems to be equally unacceptable agricultural water does cause illness in some situations but not in others.

There are numerous other components to the Produce Safety Rule such as a Biological Soil Amendment, which is somewhat in flux as the agency continues to assess the number of days needed between the applications of raw manure as a soil amendment and crop harvesting in an effort to minimize the risk of contamination. Currently, FDA thinking states that untreated biological soil amendments of animal origin must be applied in a manner so that it does not contact covered produce during application and minimizes the potential for contact with covered produce after application. FDA also feels that the USDA’s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil to be a prudent approach while it continues its own risk assessment.

There is also a provision for working and grazing animals, whereby farmers that allow animal grazing on land where produce is also grown should take every reasonable step to not harvest produce that is likely to be contaminated and should consider (but are not required) to implement waiting periods between grazing and harvesting.

Workers and visitors to the farm or facilities must be educated on and use good hygiene practices such as washing hands, and workers who handle covered produce and food contact substances must have must have training, education, and experience to perform their responsibilities and have adequate tools, equipment and buildings to do so in a manner that prevents contamination such as appropriate storage, maintenance, clean equipment, and tools.

Lastly, sprouts have received much attention as they are particularly susceptible to microbes causing foodborne illness and there are numerous testing requirements under the Produce Safety Requirement, many of which pertain to water usage. Among other requirements, farms must test spent sprout irrigation water from each production batch or in-process sprouts for certain pathogens. In addition, sprouts cannot be allowed to enter commerce until these pathogen test results are confirmed to be negative.

In an agency Q&A on Water Safety Requirements it was noted that the Produce Safety Requirement is anticipated to bring about a reduction of over 60 percent in the risk of contamination from agricultural water, and a reduction of about 20 percent in the total number of foodborne illnesses associated with produce with an expected overall reduction in costs related to foodborne illnesses of $477 million.

What does all this mean? For one, FDA now has enforceable regulations for both domestic and international produce growers for the safe growing, harvesting, packing and holding of fresh produce. The specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to that data history for their own assessments of safety. As with any compliance requirement, accurate and complete documentation is necessary to satisfy FDA requirements. Under § 112.161(a)(1), all records required must include, as applicable, the name and farm location, actual values, and observations obtained during monitoring, an adequate description of covered produce applicable to the record, the location of the growing area or other areas applicable to the record, and the date and time of the activity documented, signed and dated. These records must be kept in a safe location, whether electronic or paper storage for a period of time. That time, however, is currently undetermined as FDA has not yet addressed issues related to traceability and additional record keeping of high-risk foods as mandated under FSMA section 204.

Visit FDA’s FSMA Final Rule on Produce Safety for more details on the components of the Produce Safety Rule including Draft Guidance for Industry for the Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption of Sprout Operations.

After January, the next FSMA compliance date will be March 19, 2018, with new requirements for importers of human and animal foods. Stay tuned…

FDA Allows Co-Manufacturers More Time to Comply With Supply-Chain Program Requirements

In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal foods, and also under the Foreign Supplier Verification Program (FSVP).

The agency defines “co-manufacturing” as a contractual arrangement whereby a brand owner arranges for a co-manufacturer to manufacture or process food on its behalf. The enforcement delay will give brand owners time to develop new supplier contracts allowing them to share information on ingredient suppliers, such as audits, with their co-manufacturers.

In co-manufacturing, a supply-chain program can be implemented by the brand owner, the co-manufacturer, or both. The agency said it will not take enforcement action against a co-manufacturer that is out of compliance if supplier approval and verification activities are divided between the brand owner and the co-manufacturer.

Co-manufacturers subject to FSMA preventive control requirements and that manufacture or process a raw material or other ingredient received from a supplier are defined as “receiving facilities” under 21 CFR Parts 117 and 507. Receiving facilities that find a hazard in a raw material or ingredients requiring an applied control are required to approve their suppliers for those raw materials or ingredients. But the supply-chain provisions allow an entity other than the receiving facility — such as the brand owner — to conduct supplier verification activities, provided the receiving facility documents its review and assessment of the other entity’s documentation.

When contract prevents a co-manufacturer from being able to review a brand owner’s documentation of supplier verification activities, the co-manufacturer would not be able to verify suppliers based on a review of the brand owner’s documentation. In this situation, the co-manufacturer would need to conduct its own supplier verification activities that might otherwise not be required. The net result would be unnecessary costs to both the co-manufacturer and supplier. If the brand-owner’s supplier approval process is adequate, the co-manufacturers verification activities would not add any greater assurance of safe human or animal food.

In its Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, the agency said it will not take enforcement action if:

  • A brand owner conducts supplier approval activities;
  • The co-manufacturer describes these activities in its food safety plan; and
  • The co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner.

Similarly, the agency will not take enforcement action if:

  • A brand owner determines and/or conducts supplier verification activities for its co-manufacturer;
  • The co-manufacturer describes these activities in its food safety plan; and
  • The co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner — for example, sampling and testing of the raw material or other ingredient.

The agency said it was exercising enforcement discretion “because the guidance represents a less burdensome policy consistent with the public health,” and is immediately in effect. Implicit in all FDA guidance is that the agency has the authority to take an enforcement action under other regulations should it become necessary to protect public health.

Brand owners and co-manufacturers have until November 6, 2019 to be in compliance with supply chain and FSVP requirements.

FDA Issues Guidance on Facilities Exempt from CGMP and Preventive Controls

One of the first steps for assessing a facility’s compliance status under the rules implementing the Food Safety Modernization Act is to consider whether the facility is required to comply or if it may qualify for an exemption, however narrow it may be.

As a simple rule of thumb, if a food establishment is required to register with the agency, it is required to comply with FMSA rules. But some registered facilities may qualify for exemptions from some requirements. The FDA released draft guidance last month on exemptions for “solely engaged” facilities from the current good manufacturing practice (CGMP) and preventive controls requirements in 21 CFR Part 117 or Part 507.

For example, an establishment that exclusively holds raw agricultural commodities (RACs) — other than fruits and vegetables — for human and animal food use, hulls or shells nuts, and does not engage in any other activities covered by the CGMP requirements in Parts 117 and 507 is exempt from the CGMP requirements.

Similarly, if all activities performed by a facility are exempt under one or more preventive controls exemptions, the facility is not subject to the Part 117 and/or Part 507 preventive controls requirements. But if any part of a facility is engaged in an activity subject to the CGMP or preventive controls requirements, the entire facility is then subject to CGMPs, the preventive control requirements, or both, the agency said.

A facility that stores unexposed, packaged human and animal food that does not require time/temperature control, stores grain RACs intended for further processing and distribution, and does not engage in any additional activities covered by the preventive controls requirements is exempt from the preventive controls requirements. However, a facility that stores unexposed packaged human food that does not require time/temperature control but also cuts vegetables – that is, manufactures/processes food – is not “solely engaged” in activities exempt from the preventive controls requirements, so it must comply with the preventive controls requirements in Part 117.

The agency also issued final guidance in October on Current Good Manufacturing Practice Requirements for Food for Animals. The guidance emphasizes the “flexible” nature of the CGMP requirements, and says there may be significant differences in how CGMPs are implemented in facilities where undesirable microorganisms are a food safety concern for the type of animal food produced compared to facilities producing an animal food for animals that are not as likely to be affected by undesirable microorganisms.

This means animal food companies must implement appropriate CGMPs for their unique facility, the type of animal food, and the animal(s) for which they are producing.

There are a number of FSMA initiatives coming out of FDA, the requirements of which can be confusing, particularly in the case of those companies which are authorized an exemption. Greater details on exemptions can be found on FDA’s website. Those companies wishing to discuss their particular circumstances may wish to contact a consulting firm such as EAS to learn more about which rules of FSMA apply.

FDA Proposes Four-Year Compliance Delay for Produce Rule’s Water Standard

FDA issued a proposed rule September 13, 2017, that would extend the compliance dates for agricultural water requirements in the Produce Safety Rule, giving the agency four years to reconsider the water standards to ensure that they are feasible.

FDA Commissioner Scott Gottlieb hinted at a possible “course correction” in relation to the water standards, in a presentation last month at the National Association of State Departments of Agriculture annual meeting in New Orleans.

The agency has gotten the message from stakeholders that the microbial quality standards for agricultural water are “too complicated, and in some cases too costly, to be effectively implemented,” he said.

Under the proposed rule, the earliest non-sprout compliance date for the water standards won’t be until January 2022.

In another announcement, Gottlieb said the planned 2018 produce inspections by states under agency-funded cooperative agreements will not begin until spring 2019. He urged the states to use the 2018 cooperative agreement funding for On-Farm Readiness Reviews — voluntary farm visits by a team of state officials, cooperative extension agents, and FDA produce experts, to give farmers an assessment of their “readiness” to meet the new requirements.

NASDA and FDA have already pilot-tested On-Farm Readiness Reviews in six states, and they are planning to roll out the program nationally this fall.

A NASDA-FDA working group formed to work on plans for training state and federal inspectors recently piloted a regulator training course. The agency has four regulator training courses planned for 2018, Gottlieb said. “We’re committed to offering more training courses before the start of inspections to ensure we train inspectors to meet these needs,” he said.

The agency is also growing its Produce Safety Network of FDA produce safety experts located across the country.

FDA is still working on “a rather large guidance document” on the Produce Safety Rule and Gottlieb said he is aware there is “some frustration that this guidance has not come out yet.” He said the agency now expects to publish the draft guidance early next year.

Gottlieb also noted concerns raised regarding the use of traditional Form 483 reports to document regulatory issues during produce inspections. The agency is “planning to explore additional ways of communicating our concerns about what we observe during produce inspections,” he said.

In response to requests from stakeholders, the agency also has listed eight additional water testing methodsas equivalent to the method incorporated by reference (Method 1603) in the Produce Safety Rule and it and intends to add other methods to the list as they are identified, he said.

Finding the correct balance between food safety and real-world irrigation practices when growing produce, domestic and foreign, has presented FDA with significant regulatory challenges. The extension in the dates for compliance with agricultural water requirements gives the agency more time to accomplish internal produce rule preparations, and allows produce growers more time to adjust irrigation practices if they prove to be needed.

FDA Issues New Food Defense Guide, Food Safety Software

FDA released two useful tools last month to advise and assist companies in complying with new FSMA rules.

The agency issued a Small Entity Compliance Guide(SECG) to help small food businesses comply with the FSMA final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration.

“We encourage you to comply with the [intentional adulteration] rule as soon as possible,” the agency said. The mandatory compliance dates depend on the size of the business. Businesses that do not qualify for exemptions must comply by July 26, 2019. Small businesses – with fewer than 500 full time equivalent employees — have until July 27, 2020 to comply. Very small businesses are exempt from the rule, except for a documentation requirement which has a compliance date of July 26, 2021. A very small business is defined as a business (including any subsidiaries and affiliates) averaging less than $10 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food, plus the market value of human food manufactured, processed, packed, or held without sales.

The intentional adulteration rule requires a written food defense plan that must include:

  • A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations;
  • Mitigation strategies and associated explanations;
  • Procedures for food defense monitoring;
  • Procedures for food defense corrective actions; and
  • Procedures for food defense verification.

The rule applies to all food facilities, foreign or domestic, that are required to register because they manufacture, process, pack, or hold human food for consumption in the U.S.

Although this new FDA guidance is for small entities, it includes useful advice for any size of business thinking about ways to minimize the risk of intentional adulteration — such as how to prepare a food defense plan, the required contents, who must sign the document, what ongoing records are required, who is qualified to create the plan, where and for how long records must be held, and so on. Perhaps equally useful is the guide reflects current FDA thinking, and offers some reason for confidence that following the guidance will probably be acceptable to FDA.

As a FSMA consultant, I should note that the qualified individual who creates the food defense plan may be, but is not required to be, an employee of the facility.

The agency also unveiled a new software program called the Food Safety Plan Builderto help owners and operators develop food safety plans. The program was modeled after the Food Defense Plan Builder, created to help food facilities create food defense plans.

The new tool asks a series of questions to help identify potential hazards and the preventive controls needed to address the hazards. The FSP Builder, much like the SECG for Mitigation Strategies, is current agency thinking. Using the tool correctly to design a facility specific FSP should satisfy FDA, at least initially, that a good faith effort is being made by a regulated firm to follow food good manufacturing practices, and identify hazards in need of controls(s). It may also help firms distinguish between safety hazards that FDA will review, and quality characteristics unrelated to food safety that are present in many operating SOPs.

The agency won’t have access to any documents developed using the software, Jenny Scott, senior advisor in FDA’s Office of Food Safety, emphasized in an agency blog. However, during an inspection, FDA will review the FSP.

FDA Funds States’ Efforts to Implement FSMA Produce Rule

FDA awarded almost $31 million in funding last month to help states implement FSMA produce safety programs — on top of the almost $22 million the agency awarded last fall for that purpose. The year-two funding underscores the importance of state partnerships as the agency moves forward with prevention-based oversight of U.S. food safety.

Commissioner Scott Gottlieb said the agency’s partnerships with states are especially critical for fresh fruits and vegetables. Transformation of the U.S. food safety system “can’t happen without the support of state partners who are helping food producers and growers understand and achieve the new requirements promulgated at Congress’ direction,” he said, in announcingthe new funding.

The states applied for funding under two tracks – one covering infrastructure, education, technical assistance, and inventory, and the other also including inspection, compliance and enforcement activities. The level of funding was based on the number of farms growing covered produce within the jurisdiction. So, for example, California ($1.9 million), Pennsylvania ($1.3 million) and Washington state ($1.3 million) were among the top recipients of the 43 total states to receive funds.

Using the new funding, states will, among other activities:

  • Establish a process to develop and maintain a produce farm inventory.
  • Formulate a multi-year plan to implement a produce safety system.
  • Develop a performance measurement system, plan, and/or process to measure progress towards the goals of the cooperative agreement.
  • Evaluate legislative or regulatory authority for produce safety.
  • Provide education, outreach, and technical assistance, prioritizing farming operations covered by the rule.
  • Implement a compliance program for applicable produce safety regulations at the state level.

The funding will help awardees provide education, outreach and technical assistance, Gottlieb said. The agency will also continue its own outreach. “We want to hear from farmers and other food producers to understand what challenges remain and how the FDA can best support their efforts to enhance produce safety,” Gottlieb said.

The agency also recently announced plans to extend the compliance dates for agricultural water standards under the produce rule, and it is considering simplifying those standards.

There are no certainties for future funding, but broad support from states will be a major influence on upcoming appropriations.

FDA Unveils Accredited Third-Party Certification Site

In one more step toward improved oversight of imported foods, FDA unveiled a new section of the FDA Industry Systems (FIS) websiteon June 21, 2017, to allow organizations – including foreign governments and agencies or private third-parties – to apply for recognition as third-party accreditation bodies under the FSMA voluntary Accredited Third-Party Certification program.

The accredited bodies will accredit third-party auditors, who can then conduct food safety audits of foreign food entities and issue certifications that qualify them for the Voluntary Qualified Importer Program (VQIP). Under VQIP, U.S. importers can use the certifications by foreign entities to secure expedited entry of food shipments.

The accreditation bodies will monitor the performance of the third-party auditors and submit reports to FDA. Third-party auditors accredited under the program must conduct unannounced facility audits, notify FDA of any serious public health risk, and must ensure that their agents are competent and objective.

The VQIP allows for two kinds of audits, regulatory and consultative, but only a regulatory audit can be used for certification. For regulatory audits, the auditor must submit an audit report to the FDA within 45 days of the audit.

Under fee-based VQIP, FDA may grant recognition to an accreditation body for up to five years.

Water Standards Delay

In another significant move last month, FDA announced that it plans to extend the compliance dates for agricultural water standards under the FSMA Produce Safety Rule, except in the case of sprouts. The agency is considering simplifying the standards, which have proved to be some of the most challenging to develop in the entire FSMA rulemaking process.

The agency said it remains committed to protecting public health while implementing rules that are “workable.” FDA said it will extend the compliance dates “using appropriate procedures at a later time.” It has not decided how long the extension will be. So, at least for now, that’s an indefinite delay.

First FSVP Compliance Deadline Arrives

In a significant FSMA milestone, May 30, 2017 was the initial deadline for U.S. food importers to implement a foreign supplier verification program (FSVP).

Beginning May 30, the U.S. Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system is requiring filers to enter at least one additional code for their food shipments, noted Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine, in an interview posted on the agency’s website just days ahead of the deadline.

Importers covered by the deadline should enter the code “FSV” to indicate that the entry is subject to the FSVP regulation. When it sees that code, ACE will ask for the importer’s name, email address, and unique facility identifier (UFI) – and FDA has formally recognized the Data Universal Numbering System (DUNS) for this purpose.

If a food is exempt or not yet subject to the FSVP, the filer should enter “FSX,” to indicate that the food is exempt from FSVP or that compliance with FSVP is not yet required — or “RNE,” to indicate that the food is exempt because it will be used for research or evaluation.

For a limited time, Mayl said, importers can enter “UNK” – indicating unknown — for the DUNS number if they don’t have one. But this option is temporary and they will need to get a DUNS number to come into full compliance. Importers without DUNS numbers should use this link to obtain a free DUNS number: fdadunslookup.com.

FSVP verification by importers should be based on an evaluation of the risk of the food and the supplier’s performance, so verification could include a review of the supplier’s food safety records, sampling and testing, as well as onsite auditing.

FSVP compliance dates are based on the size of the foreign supplier and the regulations that apply to the supplier. Importers generally must comply six months after their foreign supplier must be in compliance with the FSMA preventive controls or produce safety rules.

For companies unsure of whether they are covered by the FSVP, the agency has created a useful chart titled Am I Subject to FSVP?

FDA Combines Old and New Inspection Tools for Imported Foods

The Food and Drug Administration is using a combination of old and new tools to improve the safety of imports and a quick look at the numbers explains why.

We’ve seen the familiar statistics: Almost 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood is imported. The U.S. imports from more than 200 countries and from about 125,000 firms, so a risk-based approach to inspection is really the only kind of oversight that makes sense.

FDA’s Don Prater, in his new role as acting assistant commissioner for food safety – which makes him the agency’s new point person for FSMA – discussed this in an FDA Constituent Alert last month.

FDA activities related to imported foods are undergoing big changes, largely due to FSMA, he said.

Overseas inspections are very resource intensive because of the need for coordination with national and local authorities, visa requirements, logistical arrangements, language (need for interpreters), and other challenges, he said. So the agency will keep focusing on facilities that pose the highest risk.

The agency currently uses the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to electronically screen all regulated shipments imported or offered for import into the U.S. In addition, it is now using data analytics to get a deeper understanding of the global inventory of regulated entities, he said. This will help the agency target its resources.

Traditional inspection will continue, Prater said, so facility inspections and examination at the port of entry will continue to be important tools. The challenge is integrating the old and new tools. The agency currently has several FSMA implementation groups working on this issue.

One challenge involves using information from third parties for oversight activities. A big question is how the agency can use this information in planning its work, he said.

Integrating open source material, such as new reports and social media, has great potential, but is challenging to evaluate and confirm. FDA historically has been very conservative in using unofficial and unconfirmed information to direct its focus. Data analytics may offer some degree of confidence as FDA gains experience.

The agency has recognized just three countries as providing the same level of public health protection – New Zealand, Canada and, just last month, Australia. It is still too early to know when and what will be a recognizable difference in FDA surveillance activities compared to those prior to recognition.

A Good Time for Stakeholder Comment on FSMA Guidance

FDA has published and continues to prepare more draft guidances. As they become available, it’s important for companies to know how and what FDA expects to see during inspections. Now is the time to study the relevant draft documents and submit comments on agency expectations that will impose a high financial burden. In a very real sense, FDA relies on the regulated industry to help the agency understand the real-world implications of its policies as it begins enforcing the new FSMA rules.

The agency has said it will strive to achieve a balance between its public health mission and easing regulatory burdens, and the new administration is committed to continuing that approach.

A case in point is the water quality standards in the produce safety rule. In response to comments from stakeholders, the agency issued a March 20, 2017 notice acknowledging that parts of the FSMA produce rule setting numerical criteria for pre-harvest microbial water quality may be too complex to translate, understand, and implement. The agency is considering ways to simplify the water standards in a fashion that protects public health across the great diversity of circumstance for growing food.

Another issue with many moving parts and implications for industry is the use of third-party audits. The FDA has invited comments on its guidance on the Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards. There is no deadline for comment on this guidance.

The VQIP guidance document, FDA’s Voluntary Qualified Importer Program, is closely tied to Third-Party certification and it too needs advice and input from affected industry.

Another key FSMA document, FDA’s Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods, is open for public comment through July 17, 2017.

Remember that even finalized guidance just represents the FDA’s “current thinking” on a topic and is not binding. Companies can “use an alternative approach if it satisfies the requirements of the applicable statutes and regulations,” the agency says. FDA suggests you contact its Technical Assistance Network (TAN) to discuss any alternative approaches. Although (necessarily) slow to answer policy questions, the TAN’s goal is to be an authoritative source for scientific and technical answers.

FDA Urges Industry Groups to Develop FSMA Guidance

By Charles Breen, EAS Independent Advisor, FSMA Consulting Services

The Food and Drug Administration is encouraging industry groups and trade associations to develop their own guidance to help their members comply with new requirements under the Food Safety Modernization Act.

FDA laid out steps for developing guidance in a January 31 constituent update and said the agency would help by providing technical advice and by checking for any potential conflicts with federal regulations.

FDA would prefer the scope of the industry guidance be kept broad to increase its usefulness for any future FDA guidance. The agency is especially interested in guidance on topics not covered by existing or planned FDA guidances.

The recommended steps are:

  • Define the scope of the guidance – produce grown in a greenhouse, for example – and decide how much of the process will be included, whether just a single process or the entire supply chain, and whether the guidance is for regional, national or international use;
  • Establish a work group of experts from industry and academia – and invite both state and federal government;
  • Develop draft guidance;
  • Finalize the document and circulate it to stakeholders for comment – including state and federal regulators.

The agency said it may place links to final industry guidance on its website.

FSMA extended FDA’s authority to include produce all the way to the farm level. The agency issued a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption on November 27, 2015. That rule went into effect on January 26, 2016, with staggered enforcement dates depending mostly on size. Certain sprout growers were required to comply by January 2017 – because sprouts are considered to pose a higher food safety risk.

In January, the agency issued draft guidance for compliance of sprout operations with the produce safety rule. But there is plenty of room for additional guidance for other products.

FDA has said it will rely heavily on partnerships during the implementation phase of FSMA. Realistically, it has no other option. The call for industry-developed guidance is part of this strategy and it will certainly help both the agency to leverage its limited resources, and for industry groups to share best practices for safer food.

FDA’s Revised Draft Guidance on Listeria Controls

By Stephen Sundlof, D.V.M., Ph.D., EAS Independent Advisor, Animal and Human Food Safety

FDA released updated draft guidance on preventive controls for Listeria monocytogenes in ready-to-eat foods last month, adopting the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service.

Facilities that produce ready-to-eat foods that are regulated by both FDA and USDA will benefit from a uniform federal approach, the agency says.

As every food facility manager knows, the persistence of Lm in processing facilities – in hard-to-reach locations such as drains and ducts – presents a serious challenge for food safety personnel. The hardy pathogen can find its way onto food contact surfaces and can then contaminate the food products. To make matters worse, it survives refrigeration temperatures, so the only effective preventive measure is to keep Lm away from ready-to-eat foods.

The updated guidance includes recommended procedures for environmental sampling and schedules for routine cleaning and sanitizing. Generally, the agency recommends that food contact surfaces should be cleaned and sanitized at least once every 24 hours. But the schedule for any surface needs to be based on the characteristics of the products and processes, the agency says.

If you clean and sanitize less frequently than every 24 hours, you should validate the frequency of your cleaning and sanitizing by microbial testing and not allow the reduced frequency to impact the microbiological condition of the production equipment, it says. And if the results of environmental monitoring or product testing indicate a problem, you should consider increasing the frequency of cleaning and sanitizing as part of an overall corrective action procedure.

The updated guidance suggests that non-food-contact surfaces such as drains, floors, waste containers, cleaning tools — and any surfaces that have a greater potential to become a source of Lm contamination – should be cleaned and sanitized every day. This would include surfaces likely to be touched by personnel who touch the food products or food contact surfaces, or areas where there could be a build-up of moisture or product residues.

Other non-food-contact surfaces such as condensate drip pans, overhead piping, ceilings and walls, coolers, and HVAC systems should be cleaned and sanitized weekly or monthly, the agency says. Motor housings and external surfaces of enclosed processing systems should be cleaned and sanitized weekly. Freezers containing exposed ready-to-eat foods and the interiors of ice makers should be cleaned and sanitized semi-annually, the guidance recommends.

I believe that effective implementation of this Lm draft guidance in RTE facilities would go a long way to address one of the toughest food safety challenges. And the careful documentation of all these activities would show FDA inspectors the facilities are implementing all the necessary preventive measures.

Third-Party Certification Will be Critical for Import Safety

By Stephen Sundlof, D.V.M., Ph.D., EAS Independent Advisor, Animal and Human Food Safety

The Food and Drug Administration released an amended final rule last month establishing user fees so the agency can administer the FSMA program for accreditation of third-party certification bodies to conduct food safety audits.

The fees apply to accreditation bodies seeking FDA recognition as well as to third-party certification bodies that seek direct accreditation from FDA. In addition to application fees, the agency will also seek annual user fees and renewal fees.

Third-party certification is an important component of FSMA’s preventive approach. The landmark food safety legislation gave FDA the authority to require risk-based import certification of food. And importers can use facility certifications to qualify for other programs such as the Voluntary Qualified Importer Program (VQIP), which offers expedited review of import entries of food.

In a separate December 14 notice, FDA issued a fee schedule for fiscal year 2017, effective from January 13 through September 30, 2017. The hourly fee for review work by FDA staff will be $204 excluding travel costs — or $285 per hour if travel is involved, the agency says.

The estimated application fee, including travel, for an accreditation body seeking direct accreditation from FDA in FY 2017 will be $35,100. The agency estimates it will take 60 “person-hours” to review an accreditation body’s application, 48 person-hours for an onsite performance evaluation of the applicant, and 45 person-hours to prepare a written report documenting the onsite assessment.

In its justification of the fees, the agency offered some insights into its typical costs for overseas travel. In fiscal year 2015, for example, FDA’s Office of Regulatory Affairs spent more than $2.5 million on 269 foreign inspection trips for programs related to the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The average cost was $9,373 per foreign inspection trip and the trips averaged 3 weeks or 120 paid hours.

Because this user fee program is just getting under way, renewals and annual fees will not be collected in 2017, but the agency has set the following estimated fees for planning purposes:

  • Annual fee for a recognized accreditation body — $1,579.
  • Annual fee for an accredited certification body — $1,974.
  • Annual fee for a certification body directly-accredited by FDA — $20,208.
  • Renewal application fee for a recognized accreditation body — $18,855.
  • Renewal application fee for a certification body directly-accredited by FDA — $26,460.

FDA says there will be no exemptions or reduced fees for participation in the program by small businesses or entities or for public-sector entities. It notes that the cost to the agency for performing the application review and monitoring “will not vary greatly regardless of the entity’s size or public versus private status.”

I believe the third-party certification program provides FDA a way to extend its reach and leverage its resources to improve the safety of food imported into the United States. And although fee-based programs are unpopular among the regulated community, they do allow the agency to reliably fund programs that are scalable and sustainable.

On FDA’s Latest FSMA Guidance

The Food and Drug Administration recently issued three new guidance documents to help simplify compliance with Food Safety Modernization Act (FSMA) regulations and programs.

On November 7, the agency released new draft guidance on registration of food facilities. The expanded registration introduced by FSMA is a key change that underpins all other FSMA requirements and I would encourage you to read the new draft as it includes substantive information in a useful question-and-answer format, including details on the timing of the biennial registration renewals and other new information. For example, it is not necessary to wait until after October 1 to renew registration.

On November 10, FDA released final guidance on compliance with the Voluntary Qualified Importer Program (VQIP). The eligibility criteria for taking part in this voluntary, fee-based program include compliance with the Foreign Supplier Verification Program (FSVP). But the VQIP importer may be located either inside or outside the U.S., whereas the designated importer under the FSVP must be U.S.-based, the agency says.

In addition, the VQIP importer may be, but need not be, the importer of record listed with U.S. Customs and Border Protection (CBP). CBP defines the importer of record for a food as the person or firm responsible for making entry and payment of import duties, fees, and taxes for the food. So there is some potential for confusion of the various roles. Willingness to participate in the VQIP program may depend on such practical issues of eligibility and compliance, as well as on the bottom line analysis of the program’s costs and benefits.

On October 31, the agency released final guidance for small entities on compliance with the Preventive Controls for Human Foods (PCHF) rule. Because the guidance is designed for companies that may not have in-house expertise in the fundamentals of hazard analysis and current good manufacturing practices (cGMPs) it takes nothing for granted and is a useful introduction to the rule’s requirements, whether or not a company is a “small entity.”

One PCHF requirement that is likely to be a challenge for all sizes of companies is the required risk-based supply chain program for raw materials and other ingredients for which a hazard has been controlled before receipt.

If a registered facility identifies a hazard that requires a control and that control is applied in the supply chain before receipt, the facility must have a supply-chain program, FDA explains. Food facilities covered by the regulation must ensure raw materials and other ingredients for their products are received “only from approved suppliers, or — if received on a temporary basis from unapproved suppliers — ensuring those materials are subject to verification activities before being accepted for use,” the agency says.

If an applied control is applied by an entity other than the receiving facility’s supplier, the receiving facility must either verify the applied control or obtain verification documentation from another entity, the agency explains. Supplier verification activities can include onsite audits, testing of raw materials and other ingredients, review of the supplier’s food safety records, as well as other appropriate supplier verification activities. What’s appropriate will depend on the risk associated with the raw material or ingredient and on the supplier’s performance, the agency says.

The compliance dates for the supply chain program will depend on the size of the receiving facility and the status of the supplier. For example, if a facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the FSMA produce safety rule, the compliance date is March 17, 2017. If the receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule, compliance is required by September 18, 2017.

If the supplier will be subject to the human preventive controls rule or the produce safety rule, the compliance date will be six months after the supplier is required to comply with the applicable rule.

So many registered facilities covered by the PCHF and produce rules have another round of compliance deadlines to look forward to in 2017.

FDA Invites Comment on Two Draft CGMP Guidances

FDA is inviting public comments by November 23 on two draft guidances — on current good manufacturing practices (CGMP) requirements for food for animals and on CGMPs for human food by-products for use as animal food.

The two guidances are essential reading if your company is required to implement CGMPs for animal foods, especially as FDA is allowing flexibility in compliance depending on the nature of the products and the facilities.

As with all FDA draft guidances, the contents are non-binding and some elements in the final versions may be amended based on stakeholder comments. Nonetheless, the drafts provide useful examples and offer insights into the agency’s latest thinking.

Human food by-products used for animal food must be generally recognized as safe (GRAS) or approved as a food additive. But a substance that is considered GRAS or approved as a food additive for human use “may not always be suitable for use in animal food,” the agency says. Propylene glycol, for example, is considered GRAS as an anti-caking agent for human food but is prohibited in or on cat food.

The agency says it will be reviewing the list of animal food ingredient definitions in the Official Publication of the Association of American Feed Control Officials (AAFCO). Until that review is completed, FDA will accept ingredients in the AAFCO list “provided there are no food safety concerns about the use or composition of the ingredient that would render the food adulterated.”

In guidance on the use of shipping containers and bulk vehicles, the agency says it would expect a facility to know the previous use of a shipping container and whether it needed to be cleaned prior to containing a human food by-product for use as animal food. However, “this does not mean that the shipping container must be cleaned prior to each use in all situations,” the agency adds. But it would be “good practice for the facility to examine the customer’s shipping container or bulk vehicle to confirm that the shipping container or bulk vehicle will not lead to contamination of the human food by-products for use as animal food,” the agency says.

The two guidance documents list exemptions from the CGMP requirements. Generally, if a facility is not required to register with FDA under the Food, Drug and Cosmetic Act (FDCA), it does not have to comply with the CGMP requirements. This includes: farms; facilities regulated exclusively by the U.S. Department of Agriculture (under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act); retail food establishments; restaurants (including pet shelters, kennels and veterinary facilities that provide food to animals are considered restaurants); and foreign facilities – if the food undergoes further processing by another facility outside the United States.

In situations where a facility is required to follow both the human food CGMPs and the animal food CGMPs, FDA will allow them to choose either compliance with the CGMPs in CFR part 117 for its human and animal food or following the CGMPs in part 117 for the human food and the CGMPs in 21 CFR part 507 for the animal food.

Some facilities manufacture, process, pack, or hold food for both humans and animals, FDA notes. For example, a facility that manufactures salt may process some salt meeting certain specifications for human use and other salt meeting certain specifications for animal use.

To decide which CGMPs to follow, the agency suggests that facilities consider how they are manufacturing, processing, packing, or holding the human and animal food. For example, if they have separate employees, production lines, and holding areas for human food and animal food, they might follow 21 CFR part 117 for the human food and 21 CFR part 507 for the animal food. If not, they it might prefer to follow 21 CFR part 117 for both the human and animal food, the agency says.

“We recognize that in many instances animal food facilities will be using the same building, grounds, employees, supervisors, management, equipment, and utensils to perform operations under 21 CFR part 507, subpart B, and part 225. In instances where the facility is subject to both 21 CFR parts 225 and 507 and the CGMPs overlap, the facility must follow the more specific requirements found in 21 CFR part 507, the agency says.

The CGMPs in 21 CFR part 507 are “umbrella” CGMPs that apply broadly to animal foods, but some animal foods, such as low acid canned food and medicated feed, also require specialized CGMPs, FDA explains.

September 19, 2016 was the compliance deadline for larger animal food facilities to comply with new CGMP requirements under FSMA. Small businesses have until September 18, 2017 and very small businesses have an extra year to comply.

As FDA begins to implement the new FSMA rules, the agency is committed to outreach and education rather than enforcement. So I think it would be entirely appropriate to consult with your local FDA district office if you are not clear about anything in the guidance.

What Now for FSMA Compliance?

The sky did not fall on September 19, 2016, the compliance date for larger human food facilities to meet FSMA preventive controls and Current Good Manufacturing Practice (CGMP) requirements, and for larger animal food facilities to comply with CGMPs.

In a September 19 poston the agency’s website, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, gave some good insights about what agency oversight of compliance might look like in the next few months for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.

“We know that this is new territory for food companies; it’s new territory for us too,” she said. But the agency’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.

She cited the agency’s recently issued draft guidanceon implementation of preventive controls and CGMP requirements and promised there are more guidances to come, “about two dozen planned over the next few years.”

She advised that the best thing companies can do at this time is to “take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system.” This should include promptly responding to problems, “even if they aren’t yet violations,” to prevent them becoming food safety issues.

She also emphasized the need for “a thorough system” for companies to document what they do. “If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?”

It is up to the management of a company to make sure everyone in the production chain understands what is expected and has the training and education they need to get the job done, she said.

Speaking of guidance, I suggest you mark your calendar to attend FDA’s October 14, 2016webinarin which agency staff will discuss the draft guidances for current good manufacturing practices requirements for food for animalsand the human food by-products for use as animal food. The webinar will offer an overview of the two draft guidances and will also include a question and answer session. These Q&A sessions often provide key insights into the agency’s thinking on specific issues, so I encourage you to listen in.

FDA Issues Draft Guidance on FSMA Rules, Extends Compliance Dates

As the September 19 deadline approaches for compliance by large food facilities with new preventive controls and Current Good Manufacturing Practice (CGMP) requirements under the Food Safety Modernization Act (FSMA), FDA released five chapters of a 14-chapter draft guidance to assist in compliance.

The non-binding draft document is now open for stakeholder comment and the agency promises to consider those in the final guidance and says it will release all 14 draft chapters by early 2018.

The first chapter deals with food safety plans and how a facility will control hazards. Other chapters discuss how to conduct a hazard analysis, common biological, chemical and physical hazards, implementing preventive controls, and monitoring, corrective actions and verification activities.

The agency also released two draft guidances dealing with preventive controls for animal food. One explores ways to comply with the rule’s CGMP requirements for animal food facilities and discusses the training of personnel, among other topics. The other document considers by-products of human food production used as animal food, including grain products and vegetable pulp. These also include foods such as potato chips, baked goods and pasta that are safe but considered the wrong size, shape, color or texture, explained Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, and Tracey Forfa, acting director of FDA’s Center for Veterinary Medicine, in an August 24 FDA Voice blog.

Producers of human food had been concerned that they would have to meet a whole new set of requirements for such by-products sent for use in animal foods. But by-products will only be subject to limited CGMPs to protect against contamination during holding and distribution, provided the human food facility complies with human food safety requirements and is not further processing the by-products for use as animal food, the draft guidance explains.

If the human food facility is further processing the by-products, it may comply with the requirements of either the human or animal food rule, as long as the food safety plan addresses how the facility will prevent or significantly minimize the hazards for the animal food that require a preventive control, the agency says.

“These draft guidances, and the others that we’re working on for the FSMA rules, will be further refined based on input we receive from the public … [W]e want to be sure that we’re all on the same page and these draft guidances will help get us there,” Mayne and Forfa noted.

The agency also issued a separate draft guidance to help businesses to determine whether their activities are covered by the definition of a “farm.”

FDA also released a final rule extending and aligning the compliance dates for certain provisions in four of the seven “foundational” FSMA rules — the CGMP and preventive controls rules for human and animal food, the Foreign Supplier Verification Programs (FSVP) rule, and the produce rule.

Human food companies other than small and very small businesses must be in compliance with the preventive controls and CGMP rule by September 19, 2016. Animal food companies other than small and very small businesses must be in compliance with the CGMP requirements under the animal foods rule by September 19, but they have an extra year to comply with the preventive controls requirements in the animal food rule.

The agency is allowing an extra two years for manufacturers to meet requirements for assurances by their customers who perform some needed food safety step.

The produce safety rule also clarifies the timeframe for agricultural water testing and offers considerable flexibility. Farms covered by the rule have two to four years to fulfill the testing requirement. For example, a farm that is not small or very small must begin sampling and testing untreated surface water no later than January 26, 2018. The relevant compliance date for the related microbial quality criteria is January 27, 2020. But the farm has discretion as to the number of samples included in an initial survey provided that the total is 20 or more samples. The samples must be taken over a period of at least two years and no more than four years, the agency says.

In other produce news, FDA is hiring 40 new consumer safety officers to help implement the FSMA produce safety rule. The safety officers will be working both in the United States and internationally, conducting inspections, investigations and providing technical assistance, the agency says.

Why FDA Views Registration as a FSMA Priority

The Food Safety Modernization Act’s provisions on food facility registration are especially significant from FDA’s perspective because they will enable the agency to know much more about the businesses whose products are covered by the landmark law.

On July 14, 2016, the agency issued a final rule on Amendments to Registration of Food Facilities. The amendments aim to improve the registration, which was first required in December 12, 2003 as part of FDA’s implementation of the Bioterrorism Act of 2002. The expanded registration under Section 102 of FSMA builds on the requirement in Section 415 of the Food Drug & Cosmetic Act (FDCA), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA.

Among other changes, the final rule requires an email address for registration. This may seem to be a small change, but a functioning email contact address will greatly enhance FDA’s ability to contact a registered facility or the registered agent. Similarly, the requirement to renew the registration every two years will help ensure that the on-file information remains reasonably up-to-date. In addition, in order to register, facilities will have to assure the agency that FDA will be allowed to inspect the facility.

FDA believes the changes introduced in the new rule will help it to act more quickly in response to food-related emergencies and will help target its inspection resources more efficiently. Effective July 14, 2016, registrations must specify the type of activity conducted at the facility for each food product category. In addition, all registrations must be submitted electronically starting on January 4, 2020.

The final rule includes a provision allowing a registrant to submit a written request for a waiver explaining why it is “not reasonable to submit the registration, registration renewal, update, or cancellation to FDA electronically or to explain why it is not reasonable to provide the email address of the owner, operator, or agent in charge of the facility.”

Definition of retail establishment expanded 

Currently, retail food establishments are not required to register as food facilities. The final rule broadens the definition of a retail establishment, so operations in the newly expanded category will not be required to register.

Section 102(c) of FSMA directs FDA to amend the definition of the term “retail food establishment” to include: the sale of food products or food directly to consumers at a roadside stand or farmers’ market where the stand or market is located other than where the food was manufactured or processed; the sale and distribution of such food through a community supported agriculture program; and the sale and distribution of such food at any other such direct sales platform.

In addition, the agency is requiring additional data elements in food facility registrations, including a unique facility identifier (UFI) and it is planning to verify information submitted in registrations.

At the proposed rule stage, the agency proposed to amend the regulation to shorten the timeframe for submitting updates and cancellations from 60 calendar days to 30 calendar days. However, in response to comments from stakeholders, it has withdrawn that proposal and the final rule requires updates within 60 days of any change.

FDA Unveils FSMA Final Rule on Intentional Adulteration

FDA has now released its seventh FSMA rule – on intentional adulteration. Published May 27 in the Federal Register, the rule requires registered food facilities to develop a written food defense plan to address intentional adulteration.

In an approach similar to developing a hazard analysis and critical control point (HACCP) plan, facilities must establish food defense monitoring procedures and corrective actions, including a verification step, personnel training and the maintenance of records.

FDA explains that the goal of the rule is to prevent wide-scale public health threats, rather than acts by disgruntled employees or economically motivated adulteration – which is addressed separately in the preventive controls rules for human and animal foods.

The agency knows companies will be working to comply with the other FSMA rules, so it has extended the compliance dates for the intentional adulteration rule. A business that is not defined as “small” or “very small” and does not qualify for exemptions will have three years to comply. A small business employing fewer than 500 employees will have four years to comply, and a very small business will have five years. FDA estimates that the rule will cover 3,400 firms that operate 9,800 food facilities.

In most cases, limiting access to the food product is the key element of an effective food defense plan. But there are other important considerations, such as the volume of food involved and how rapidly the food product is distributed and consumed.

The agency plans to issue guidance on conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions and verification. It is also encouraging stakeholders to look at the existing voluntary food defense program tools at fda.gov/fooddefense.

I believe the process of complying with the FSMA preventive controls requirements should set a lot of the groundwork for the subsequent compliance with the intentional adulteration rule. The vulnerability assessment, risk management, verification and record keeping will be familiar steps for the “qualified individual” who has already mastered the FSMA preventive controls requirements. In addition, EAS consultants can assist in compliance with this additional FSMA rule.

Are You ‘Qualified’ under the Preventative Controls for Human Food Rule?

Who is “qualified” under FDA’s final rule on preventive controls for human food? Why would someone want to be “qualified?” What is the role of someone who is “qualified?” How much of a role does a “qualified” person play to ensure a safe and wholesome food supply?

The Preventative Controls for Human Foods (PCHS) Rule under the Food Safety Modernization Act has several definitions such as Qualified Auditor, Qualified Individual, and Preventive Controls Qualified Individual. I will discuss the definitions and responsibilities for the Preventive Controls Qualified Individual and the Qualified Individual only. As implementation of the PCHS rule begins for some, these individuals will play a vital role in the safety of our food supply.

The PCHS Rule was adopted on September 15, 2015 and applies to facilities that manufacture, process, pack, or hold human food. In general, facilities required to register with FDA under section 415 of the Food, Drug and Cosmetic Act are regulated. The rule sets standards for most wholesale food establishments and updates Good Manufacturing Practices. Most noteworthy is that it requires a food safety plan that identities known or reasonably foreseeable hazards; initiates, monitors, and verifies preventative controls; takes corrective action when needed; and requires documentation to demonstrate that the plan is working. It excludes farms, retail establishments, and those facilities under juice and seafood HACCP. Several other exemptions and limited exemptions within the Rule exist, but are beyond the discussion of this article.

There is some similarity between the definitions of the Qualified Individual and the Preventive Controls Qualified Individual, and thereby, some confusion. However, very distinct responsibilities and background qualifications separate the roles. The regulatory definitions of these two positions appear in bold type below.

Qualified Individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.

This definition casts a broad net that will include many wholesale food facility employees that have at least some food safety responsibilities. The Qualified Individual is expected to be able to demonstrate competence for their assigned job activities as it relates to food safety. Training in the principles of food hygiene and food safety, as appropriate to the food, the facility, and the individual’s assigned duties, must be provided and documented. There are no defined minimum training requirements within the rule for the Qualified Individual.

Preventive Controls Qualified Individual (PCQI) means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

The “standardized curriculum” is offered through the Food Safety Preventive Controls Alliance (FSPCA). The courses, found on the FSPCA website, are 2.5 days in length. The FSPCA also provides a train-the-trainer course for instructors. Courses are being scheduled throughout the nation by the FSPCA and others including food facilities, academia, consultants, and private food safety trainers. Individuals can also meet the PCQI requirements through job experience in lieu of the training requirement.

The rule is very clear in defining tasks that only a PCQI can do. The responsibilities of a PCQI include preparation of the food safety plan, validation of preventive controls, records review, and reanalysis of the plan. The PCQI may be a facility employee, but they can also use outside assistance in developing the plan and for other tasks that must be performed by the PCQI. In many situations, more than one PCQI may be needed to effectively develop and implement the food safety plan.

The mandates under the PCHF Rule establish set requirements and standards for the two positions that are vital for proper implementation. The rule places great responsibilities on the regulated community, so competent and knowledgeable food safety staff are essential. Food safety continues to become more complex and demanding as new and emerging challenges arise. Competent Qualified Individuals and Preventive Controls Qualified Individuals will go a very long way towards ensuring a safe and wholesome food supply.

FSMA Final Rule on Sanitary Transportation of Food Includes Major Revisions

FDA released the FSMA Final Rule on Sanitary Transportation of Human and Animal Food on April 6, 2016.

The final rule, which is part of the agency’s implementation of the 2005 Sanitary Food Transportation Act, contains some significant revisions of the proposed version, including affirming that the use of current sanitary food sanitation best practices will allow industry to meet the rule’s requirements.

The final rule focuses more narrowly on food safety and not on adulteration as a result of spoilage or quality defects. The agency also simplified the definitions for parties covered by the rule to make them activity based.

The final rule places primary responsibility on the shipper for determinations about appropriate transportation operations – for example, whether food needs temperature control for safety and the relevant operating temperature and mode of temperature monitoring, whether particular cleanout procedures are needed, and whether the previous cargo must be identified.

“We believe the shipper is in the best position of the parties covered by this rule to know the appropriate specifications for transport of its food,” the agency says.

Businesses other than small businesses have one year from the date of publication of the final rule to comply with the rule. Small businesses get two years to comply.

FDA hosted an April 25 webinar in which Consumer Safety Officer Mike Kashtock of the Center for Food Safety and Applied Nutrition reviewed the key requirements of the new rule. The agency plans to post the recorded webinar on its FSMA website.

Implementing FSMA for Imports is FDA’s Biggest Challenge

FDA hosted an excellent day-long public meeting on March 21, 2016 to review the import-related elements of the new FSMA regulations. In opening remarks, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor noted that implementing import provisions is the agency’s biggest FSMA challenge.

In a March 21 FDA Voice blog, Taylor called the Foreign Supplier Verification Program (FSVP) “the ‘regulatory linchpin’ of FSMA’s historic paradigm‎ shift for imported food from reaction at the border to accountability for prevention at the point of production.”

Section 301 of FSMA requires importers to have a foreign supplier verification program and the Importer of Record must verify that suppliers have adequate preventive controls to assure the safety of their products. It is the importer’s responsibility to determine the hazards and the best way to verify that preventive controls are being implemented.

A preventive control may not be required for some low-risk products. But this does not mean that low-risk products such as candies, cookies or crackers are exempt from FSVP, just that a hazard analysis may show no significant hazard so no special controls are required.

The FDA does not plan to create a list of high-risk products, but the agency may require special preventive controls in some circumstances.

Food exempted from FSVP requirements include juices and seafood covered by existing HACCP rules, food used for research and development, food for personal consumption, and alcoholic beverages and ingredients (when the importer uses them to make alcoholic beverages). Also exempt are foods transshipped through the U.S., foods imported for processing and export, foods originating in the U.S. that is returned, and meat, poultry and egg products regulated by the U.S. Department of Agriculture.

To the surprise of some stakeholders at the March 21 public meeting, foods imported for distribution as samples at trade shows are not exempt from FSVP requirements.

In some circumstances importers may comply with FSVP requirements if they can establish that there is a system in place to control a hazard at a subsequent stage in the distribution chain. If a hazard is controlled by an importer’s customer or other entity in the distribution system, the importer must have documentation in the form of a disclosure statement and written assurances.

The FSVP preventive control requirements are aligned with those of the FSMA preventive controls and produce rules. The goal is to produce food using the same level of public health protection and to assure that the products are not adulterated or misbranded, especially with regard to allergen labeling. Although the FSVP is not a border program, it will require identification of the importer at the point of entry.

In addition to requiring importers to implement FSVP requirements, FDA plans to conduct more foreign inspections and to work more closely with foreign governments. The agency may determine that some countries have equivalent food safety systems, which should benefit suppliers in those countries. But this will be lengthy process and will likely take years to accomplish for each country. New Zealand was the first country FDA designated as having an equivalent system. Currently, Australia, Canada — and most recently the European Commission — are being considered for this designation.

The final FSVP rule was published on Nov. 27, 2105. Because the compliance dates are aligned with those of the separate preventive controls and produce rules, importers will need to comply with whichever is the latest of the following dates:

  • 18 months after the publication of the FSVP final rule;
  • For the importation of food from a supplier that is subject to the preventive controls regulations for human food or animal food or the produce safety regulation, 6 months after the foreign supplier of the food is required to comply with the relevant regulations; or
  • For an importer that is also subject to the supply-chain program provisions in the preventive controls regulations for human food or animal food, the date the importer, as a receiving facility, is required to comply with the supply-chain program provisions of the relevant regulation.

FDA is currently developing guidance that will give more clarity to the FSVP compliance requirements in specific circumstances, such as in the case of suppliers in countries or regions deemed to have equivalent controls. But the agency says importers should not delay in assessing their products and their suppliers with a view to achieving compliance.

FSMA and Third-Party Auditing

A key piece of the regulatory jigsaw puzzle as FDA moves ahead with implementing the Food Safety Modernization Act (FSMA) is the voluntary, user-fee based program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities and issue food and facility certifications.

When this program is up and running, U.S. importers will be able to use the certifications of foreign entities to secure expedited entry of shipments under the Voluntary Qualified Importer Program (VQIP).

The final rule on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, published in the Federal Register on November 27, 2015, went into effect on January 26, 2016. However, the agency says it will implement the program after it releases separate Model Accreditation Standards guidance and a final user fee rule.

In July 2015, the agency issued Model Accreditation Standards draft guidance containing draft recommendations on the education and experience needed by third-party auditors and their agents. In the same month, the agency issued a separate proposed rule establishing user fees for accreditation bodies and certification bodies.

FDA does not generally plan to directly accredit third-party certification bodies. Instead, it will recognize accreditation bodies to perform that task. An accreditation body could be a foreign government agency or a private third party. The accreditation bodies will have to monitor the performance of the third-party auditors and submit reports to FDA. They must also maintain records and provide FDA access to the records.

Third-party auditors accredited under the program must conduct unannounced facility audits and notify FDA of any serious public health risk and must ensure that their agents are competent and objective.

The voluntary program allows for two kinds of audits – regulatory and consultative. Only a regulatory audit can be used for certification. A consultative audit is for internal use.

For regulatory audits, the auditor must submit an audit report to the FDA within 45 days. No report is required for a consultative audit, but any potential serious risk to public health identified in a consultative audit must be reported to FDA. All reports and notifications required to be submitted to the FDA must be submitted in English, the rule says.

FDA may grant recognition for an accreditation body of up to five years. Four years is the maximum accreditation period for certification bodies.

With many competing demands from other high-profile FSMA regulations and now with the real possibility of reduced funding in fiscal year 2017 and beyond, FDA may find itself in triage mode in terms of the speed of implementation of the various FSMA rules. But this program could play a significant future role in improving the international oversight of food safety.

Produce Final Rule Goes into Effect

The Food Safety Modernization Act (FSMA) extended FDA’s authority to include produce all the way to the farm level, which put the agency in unfamiliar regulatory territory. To avoid burdening covered facilities with unreasonable compliance demands, the agency proceeded with due caution in developing a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, published November 27, 2015.

That rule, which went into effect on January 26, 2016, applies to both domestic and imported produce and has phased implementation dates, beginning in as little as one year for certain sprout growers.

With the exception of sprouts, the implementation dates are two years after the effective date for covered businesses, three for small businesses and four for very small businesses. Again with the exception of sprout operations, the final rule allows an additional two years to comply with some water quality standards, and testing and recordkeeping provisions.

The produce rule includes requirements for agricultural water quality and testing, manure and compost, and the exclusion of animals from growing areas, as well as hygiene and training requirements for farm workers. It also includes standards related to equipment, tools and buildings, and special testing and other requirements for sprouts.

As a first step, produce facilities should determine if they are covered by the rule. In essence, the rule applies to raw agricultural commodities (RACs). But there are numerous exemptions and opportunities for seeking a variance from one or more requirements.

The rule exempts fruits and vegetables that will go through a pathogen-reducing process such as a microbial “kill step” – provided it is appropriately documented — and food that is rarely consumed raw. Items on the rarely consumed raw list include: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.

The new rule does not apply to food grains, including barley, dent-corn or flint-corn (also known as Indian corn), sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds such as cotton seed, flax seed, rapeseed, soybean, and sunflower seed.

The rule contains modified requirements for certain types of facilities, for example a farm with food sales averaging less than $500,000 per year during the previous 3 years that sell mainly to “qualified end-users.” Qualified end-users can be consumers or restaurants or retail food establishments in the same State.

The agency faced significant challenges in crafting the water quality requirements, which involve two sets of criteria for monitoring microbial water quality, depending on the product involved. The rule prohibits the use of untreated surface water in various situations, including for sprout irrigation, handwashing during and after harvest, washing food-contact surfaces, or for directly contacting produce during or after harvest.

The rule includes a second set of numeric criteria for agricultural water applied directly to growing produce other than sprouts.

The agency anticipates developing an online tool for use by farms to input their water sampling data and calculate the statistical values.

Because this is a whole new regulatory area for the agency, working through the complex compliance issues – especially for the water quality and testing requirements – will be a significant challenge.

FDA’s FSMA Funding Boost

FDA’s implementation of the Food Safety Modernization Act (FSMA) is off to a strong start in 2016, with an injection of $104.5 million in additional funding from Congress in the omnibus appropriations bill passed December 18. The substantial increase in funding for fiscal year 2016 will increase the agency’s ability to advance plans for training and outreach relating to the five FSMA final rules released to date and the two additional final rules anticipated this year.

FDA plans to “work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements,” noted Deputy Commissioner for Global Regulatory Operations and Policy, Howard Sklamberg, and Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor, in a December 21 post on the FDA Voice blog site.

But the agency won’t be giving out free passes to bad actors. It is “strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t,” Sklamberg and Taylor said.

Over the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and more than $694 million in fines and restitutions, they noted.

An important first question for any company committed to compliance with the new FSMA regulations is whether its products are covered or exempted. FDA is currently working on numerous guidance documents to help companies find answers to these and other key questions. The agency is preparing guidance for small or very small businesses on the human food and animal food rules, as well as hazard analysis and preventive controls, environmental monitoring, allergen controls, and validation of process controls for human food. It is also preparing guidance on current good manufacturing practices (CGMPs), hazard analysis and preventive controls, and on human food by-products for use as animal food.

Agency officials are still working on some of the thornier questions for these guidance documents. The additional FY2016 funding from Congress should help the agency commit the resources needed to complete these important compliance tools.

FSMA Implementation Enters a New Phase

The Food and Drug Administration hosted a public meeting in Chicago on October 20, 2015 to discuss the recently released final rules on preventive controls for human and animal food, along with plans for the next phase of FSMA implementation. This was a substantive meeting and I encourage you to view the six slide presentations on FDA’s FSMA website.

The first phase of FSMA implementation – the release of final FSMA regulations and related guidance and policies – is moving swiftly forward. FDA released final rules on preventive controls for human and animal foods on September 17 and the agency is now developing numerous guidance documents.

FDA was under a court-imposed October 31, 2015 deadline for releasing three additional final rules – on produce, foreign supplier verification and accreditation of third-party auditors (These are not yet available as I prepare this article). Under the consent decree, FDA must issue final rules on sanitary transportation and on intentional adulteration by May 31, 2016.

The second FSMA implementation phase focuses on “gaining and maintaining industry compliance,” with the final rules and identifying metrics for measuring success. The third phase involves actually using those measuring tools and making any needed adjustments.

Many elements of the complex rules will require further explanation and guidance. In the October 20 meeting, Dan McChesney, director of the Office of Surveillance and Compliance in FDA’s Center for Veterinary Medicine, presented an overview of the animal food final rule and explained, for example, that feed mills may or may not be required to comply.

Mills that are not part of a farm and are required to register as a food facility are subject to the new rule. Examples include an independent feed mill, a feed mill that makes food for contract farms, an on-farm feed mill that makes food for animals under different management than the farm, he said.

Feed mills that are part of a farm are exempt from registering as a food facility and are not subject to the new rule, he explained. For the feed mill to be considered part of the farm, the raising of animals and the feed mill must be under the same management in one general location, and animal food made at the mill must only be fed to animals under the farm’s management, he said.

The agency is currently working on several guidance documents relating to the animal food rule, including guidance on current good manufacturing practices, on human food by-products for use as animal food, and on hazard analysis and preventive controls. It is also developing a compliance guide for small or very small businesses. Under the rule, a very small business is defined as one with an average of less than $2.5 million in annual sales of animal food, plus the market value of animal food held without sale. A small business is defined as one with fewer than 500 full-time equivalent employees.

Provided the three final rules on produce, foreign supplier verification and accreditation of third-party auditors are available, I will offer my perspective on those in the next EAS-e-News issue.

FDA Revises Definition of “Qualified Auditor” in the Preventive Controls Rule

The Food and Drug Administration released two key FSMA-mandated regulations last month — a final rule on current good manufacturing practices (CGMPs) and risk-based preventive controls for food for humans and a related final rule on food for animals. The rules were released on September 10 and formally published September 17 in the Federal Register.

FDA now plans to release numerous guidance documents to help covered companies comply with the new requirements. For human foods, the agency is preparing guidance on hazard analysis and preventive controls, environmental monitoring, allergen controls, validation of process controls, and a compliance guide for small and very small businesses. For the animal food rule, it is developing guidance on CGMPs, hazard analysis and preventive controls, human food by-products for use as animal food, and on compliance for small or very small businesses.

The new preventive controls regulations apply equally to domestic U.S. operations and to international exporters of food to the U.S. market. With this in mind, the agency has translated its fact sheets on the two preventive controls rules into 12 major languages — including Arabic, traditional and simple Chinese, Spanish, French, Italian, Japanese, Korean, Portuguese, Russian, Thai and Hindi. Given the increasing importance of imported food in the U.S. market. Effective outreach to the international community will be a key component of a successful implementation of FSMA’s preventive control principles and I believe it is one of the biggest challenges facing the agency.

For the most part, the final rules reflect the proposed and supplemental rules, but they include some revisions made in response to comments from stakeholders. In a notable revision relating to auditing of facilities covered by the new rules, FDA revised the definition of a “qualified auditor.” The final rules use the term “qualified individual” rather than “preventive controls qualified individual.”

In response to a question about the qualifications needed for a preventive controls qualified auditor, the agency said a qualified auditor might get the necessary auditing expertise in part through education, as well as through training and experience, and it revised the definition of qualified auditor. But it concluded that a person must have some actual experience in auditing to meet the definition of a qualified auditor and that the technical expertise cannot be obtained solely through education and/or training.

Further clarification of the qualifications needed by auditors will be included in a separate Proposed Rule on Accreditation of Third-Party Auditors which has yet to be finalized.

Because the new provision refers to provisions in a future third-party certification rule, FDA plans to publish a document in the Federal Register announcing the effective date of the provision once the third-party certification rule is finalized.

EAS has a network of auditors with both the training and experience needed to conduct audits to assess compliance with the risk-based preventive controls rules. They are also available to conduct a gap-analysis for facilities wishing to ensure that they will be in compliance with the new CGMP and risk-based preventives controls requirements by the appropriate deadline.

A FSMA Milestone 

Stephen Sundlof - D.V.M., Ph.D., Senior Advisor for Animal and Human Food SafetyAs I prepare this FSMA Perspective article, we are anticipating a significant milestone in the implementation of FSMA’s preventive control philosophy – release of a final rule on current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and a separate final rule on cGMPs and preventive controls for animal foods.

Because they were developed with a high degree of transparency and collaboration between the Food and Drug Administration and stakeholders, hopefully neither final rule will contain big surprises.

But there is still a lot more FSMA work to be done. A quick review of FDA’s open dockets relating FSMA provisions indicates the size and scope of this ongoing regulatory undertaking. The open dockets include 12 guidance documents, three draft guidances and one significant proposed rule – on user fees for accreditation of third-party auditors and certification bodies to conduct food safety audits and issue certifications. Comments on that proposal are due by October 7, 2015.

The guidance includes:

  • Draft guidance for industry and FDA staff on Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (FDA-2011-N-0146 Comments due October 7, 2015)
  • Draft guidance for industry on FDA’s Voluntary Qualified Importer Program (FDA-2011-N-0144)
  • Prior Notice of Imported Food Questions and Answers – Edition 3 (FDA-2011-N-0179)
  • Questions and Answers Regarding Food Facility Registration (Sixth Edition) (FDA-2012-D-1002)
  • What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide (FDA-2013-N-1421)
  • FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (FDA-2011-D-0674)
  • What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide (FDA-2011-D-0643)
  • What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide (FDA-2012-D-1003)
  • Questions and Answers Regarding Food Facility Registration (Fifth Edition) (FDA-2012-D-1002)
  • Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (FDA-2012-D-0585)
  • Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food – Edition 5 (FDA-2011-D-0598)
  • What You Need to Know About Administrative Detention of Foods (FDA-2011-D-0643)
  • Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (FDA-2011-D-0721)
  • Fish and Fishery Products Hazards and Controls Guidance (FDA- 2011-D-0287)

In the next FSMA Perspective, I hope to be able to review the new preventive controls rules for human and animal food. In the meantime, I would like to draw your attention to a series of FDA instructional webinars that deal with implementing the preventive controls rules. The agency presented an August 27 session on industry best practices for supplier management. The next webinar in the series, on October 22, 2015, will deal with minimizing allergens.

FDA Seeks Input on Proposed User Fees for Accreditation of Third-Party Auditors

The Food Safety Modernization Act requires the Food and Drug Administration to establish an accreditation program to strengthen foreign food safety audits. The agency issued a proposed rule for an accreditation program on July 29, 2013. In a related July 24, 2015 notice, the agency released a proposed rule that would introduce user fees to pay for the new program.

FDA anticipates issuing a final accreditation rule in October 2015 and it is inviting public comment by October 7, 2015 on the proposed user fees. The agency lists four main groups for the purposes of the “reimbursement” charges:

  • Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program;
  • Recognized accreditation bodies participating in the third-party accreditation program subject to FDA monitoring activities;
  • Certification bodies submitting applications or renewal applications for direct accreditation; and
  • Accredited certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party accreditation program subject to FDA monitoring activities.

Under the agency’s July 24 proposal, accreditation bodies and certification bodies would be subject to application fees for the estimated average cost of the work FDA performs in reviewing and evaluating applications. Alternatively, the agency could charge an hourly rate or could use a combination of those two methods.

FDA estimates that it would take, on average, 60 person-hours to review an accreditation body’s application, 48 person-hours for an onsite performance evaluation of the applicant and 45 person-hours to prepare a written report documenting the onsite audit.

To provide a sense of the proposed fees — which the agency expects to finalize in the fall – it proposes $202 as the base unit fee in determining the hourly fee rate, prior to including domestic or foreign travel costs. With an estimated hourly travel cost of $103, the total fee would be $305 per paid hour for each direct hour of work requiring foreign inspection travel and most applications are likely to involve foreign travel. The agency proposes to set lower hourly rates for domestic travel.

The agency is also considering whether it should establish a flat fee or an hourly rate and is inviting comments on which approach is likely to work best in terms of encouraging high-quality applications.

If it bills using the actual number of hours worked, applications that are faster to review – because they are better-prepared, for example — could result in lower fees, while applications that are slower to review — because they are less organized or require more back-and-forth with the applicant — could result in higher fees, the agency notes.

Similarly, applicants that facilitate the onsite audit process and have higher quality operations would likely have shorter onsite audits than other applicants.

The agency is also considering whether it should have hourly fees for the onsite audit while maintaining a flat fee for other activities, such as the paper application review. This hybrid approach may be most consistent with how accreditation bodies currently charge certification bodies and could “provide a balance of predictability and incentives,” the agency suggests.

Along with the Foreign Supplier Verification Program, the recognition of third parties by FDA to perform audits and inspections is central to FSMA’s goal of achieving parity between domestic and imported food safety programs. By charging user fees, FDA is less reliant on Congressional appropriations, and in the process new jobs will be created in the private sector with the ultimate result of improved food safety. Sounds like a win-win-win to me!

FDA Shares Stakeholder Voices, Issues Guidance for Qualified Importers

In a significant milestone in the Food and Drug Administration’s implementation of FSMA, the agency is expected to issue a final rule next month on preventive controls for human and animal foods.

FDA released a series of videos on FSMA implementation last month featuring comments and insights from stakeholders and agency officials. Many of those speakers expressed the view – and I agree with them – that outreach and education by the agency will be the key to the successful implementation of the new requirements.

Also last month, FDA released draft guidance on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food, for companies that might become participants in the user-fee-funded program. The agency estimates that the annual fee would be approximately $16,400 for participation in the voluntary program.

The program would allow for expedited importation of food from importers who volunteer to participate. The draft guidance describes the eligibility criteria and also reviews what might cause VQIP eligibility to be revoked, as well as criteria for reinstatement. And it describes how the agency plans to set user fees to fund the voluntary program.

FDA says the program will incentivize companies to adopt robust supplier verification programs and will allow the agency to focus its resources on food shipments that pose a higher risk to public health.

The agency estimates it will take an applicant 80 person-hours to compile all the information and complete the application for the VQIP program. FDA expects that it will receive 200 notices of intent to participate in the first year. It also expects to be able to review 200 applications in the first year, depending on the available resources. It anticipates that the program will cost $3.4 million in FY 2018, including the costs of the application review process for 200 applications, the costs of conducting inspections of importers (both foreign and domestic) accepted into the program, the costs of the final determination of eligibility into the program, and annual information technology maintenance costs.

FDA is inviting comments on the draft guidance by August 19, 2015.

FDA Invites Comment on Draft Mandatory Recall Guidance

The Food and Drug Administration issued draft guidance on mandatory recalls in a May 7, 2015 Federal Register notice and is inviting public comment by July 6. The draft document presents the agency’s current thinking on how the food industry can implement the mandatory food recall provisions the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food Safety Modernization Act (FSMA).

In my experience as a former director of FDA’s Center for Food Safety and Applied Nutrition and of FDA’s Center for Veterinary Medicine, the voluntary system of recalls worked well in almost all situations. Nonetheless, the mandatory recall authority is a significant addition to the agency’s enforcement powers for those rare cases in which companies fail to comply with a request.

FDA’s mandatory food recall authority went into effect as soon as the landmark food safety law was enacted on January 4, 2011. The authority added in Section 423 of the FDCA covers all foods (other than infant formula recalls, which are covered separately under Section 412) that are manufactured, processed, packed, or held at a food facility that is required to register with FDA.

The amended FDCA gives FDA the authority to order a “responsible party” to recall food products if there is “a reasonable probability” that the food is adulterated or misbranded and “will cause serious adverse health consequences or death to humans or animals (SAHCODHA).”

The “responsible party” is the person who submits the registration for a food facility at which the food is manufactured, processed, packed, or held, FDA explains. A “person” is defined as including individuals, partnerships, corporations and associations. So the owner, operator, or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring the mandatory recall is performed, the draft guidance says.

The term “food” includes articles used for food or drink for man or other animals, chewing gum, and components of any such article. The term “food” also includes dietary supplements.

Among other topics, the draft guidance describes the process the agency will follow for a mandatory recall. Once it determines that the criteria for a mandatory recall have been met, it will first give the responsible party a chance to voluntarily stop distribution and recall the food. FDA says it will provide the request in writing using “an expeditious method.” If the responsible party won’t comply, the agency may order it to stop distributing the food and it will also give an opportunity for an informal hearing. After these steps, the agency may mandate a recall – and only the FDA Commissioner has the authority to order a recall, the guidance explains.

FDA says it will consider the following factors to assess if a recall is needed:

  • Observations made during inspections of the responsible party or other parties;
  • Results from sample analyses;
  • Epidemiological data;
  • Reportable Food Registry data; and
  • Consumer and trade complaints.

The agency has the authority to collect fees from a responsible party for a domestic facility or importer who does not comply with a food recall order. The fees would cover time spent by FDA conducting the food recall activities, technical assistance, follow-up checks and public notifications. In an August 8, 2014 Federal Register notice, FDA listed its fiscal year 2015 fees for reinspections and for non-compliance with a recall order, which will remain in effect through September 30, 2015 and will be revised annually. For FY 2015, the hourly rate is $215 if domestic travel is involved and $305 if foreign travel is required.

To make consumers and retailers aware of recalls, the agency says it will “ensure that a press release is published regarding the recall,” as well as alerts and public notices, as needed. These will include, at a minimum, the name of the recalled food, a description of the risks associated with the food, and “to the extent practical, information about similar articles of food that are not affected by the recall,” the agency says.

FDA Briefs Stakeholders at FSMA Public Meeting

 

FDA officials discussed their “work in progress” toward implementing the Food Safety Modernization Act at a public meeting hosted by the agency in Washington, D.C. April 23-24, 2015.

The agency is currently considering some new inspection ideas, they explained. For example, they may introduce an inspection system that would separate violations into major and minor, depending on the public health impact. Requirements for major violations would be more stringent, such as shorter response times and increased inspection frequency. The agency is also considering a two-step approach to inspections, beginning with a data check at a company’s corporate offices in advance of an individual facility inspection, they said.

(see more details in Food Chemical News).

Effective training will be an essential component of any successful implementation of FSMA regulations and it is encouraging to see the agency moving forward with several training initiatives. It is working with the Institute for Food Safety and Health (IFSH) — which is led by former CFSAN Director Robert Brackett — on a training curriculum for the Foreign Supplier Verification Program (FSVP). This is still at an early development stage. IFSH, which manages the Food Safety Preventive Controls Alliance (FSPCA), is also developing training programs for preventive controls.

In another initiative, the agency is collaborating with the National Association of State Departments of Agriculture (NASDA) to create voluntary on-farm pre-assessments for use before the new FSMA produce rule is fully implemented.

“We appreciate FDA’s engagement with stakeholders by hosting today’s public meeting,” commented NASDA’s CEO Barbara Glenn. “While we fully support the development of a preventive food safety system, there is still more work needed to get this right,” she said.

“The successful implementation of these rules depends on active partner engagement and education of American farmers, prior to enforcement. We must strike a balance between enhancing public health and not driving American farmers away from growing the fruits and vegetables which are so vital to human health,” Glenn said.

It seems to me that a similar balance is needed for all seven proposed FSMA rules.

Stephen Sundlof, Senior Advisor for Animal and Human Food Safety

 

Dr. Margaret Hamburg, who retired as FDA Commissioner late last month, discussed the agency’s Food Safety Modernization Act (FSMA) budget in her final appearance before a House Appropriations Committee hearing on Capitol Hill, March 4.

Mindful of pressures on the federal budget, the administration focused its budget request for fiscal year 2016 on “the most urgent needs,” she told the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.

The agency’s budget request for FY 2016 seeks an increase of $301 million above the enacted level for FY 2015 for a total of $1.5 billion for food safety. This total includes a $109.5 million increase in budget authority and a $191.8 million increase in user fees. Almost all of the proposed budget authority increase will be dedicated to FSMA implementation, she said.

“With FDA under court order to issue many key FSMA regulations in 2015, FY 2016 is an absolutely crucial year for the investments needed to ensure timely, effective, and non-disruptive implementation,” she said.

As it implements FSMA, the agency will be taking a collaborative approach to inspection and enforcement, focusing on food safety outcomes and encouraging voluntary compliance. The largest single portion of the budget authority will go to states to better integrate, coordinate, and leverage federal and state food safety efforts, Hamburg said.

The agency’s FSMA philosophy of “educate before and while we regulate” calls for investing in guidance, education, and technical assistance for industry to support compliance efforts, especially by smaller scale farmers and manufacturers, she said.

Finally, she said, FDA must make investments in FY 2016 to implement the new import safety system, including the Foreign Supplier Verification Program (FSVP).

“The investments FDA can make with the FY 2016 budget authority request will enable the agency to maintain momentum toward timely and successful implementation of FSMA. Without these investments, implementation will be disrupted and delayed,” she said.

The FDA Center for Food Safety and Applied Nutrition is the only product center that does not receive a substantial portion of its budget from user fees charged to the regulated industries. Of the $4.9 billion requested by the Administration for FDA in 2016, $2.2 billion (45%) comes from user fees, yet the food safety program receives only 1% of its budget from user fees. In early House versions of the FSMA bills, user fees of $1,000 per registered facility were included. This was reduced to $500 per facility in subsequent versions, and eliminated altogether in the final version. With nearly 200,000 registered food facilities, user fees could have generated $200 million per year, increasing the food safety budget by 16%.

I believe the FDA food safety program will never be able to fulfill the promise of FSMA as long as its budget is limited to federal appropriations. Cost recovery user fees would go a long way toward closing the gap, but that opportunity was lost when registration fees were cut from FSMA.

With the first batch of FSMA-implementing regulations on the way this year, it would be prudent for food companies to look ahead and consider budgets for compliance with the new FSMA regulations.

Budgeting for FSMA Implementation

 

Dr. Margaret Hamburg, who retired as FDA Commissioner late last month, discussed the agency’s Food Safety Modernization Act (FSMA) budget in her final appearance before a House Appropriations Committee hearing on Capitol Hill, March 4.

Mindful of pressures on the federal budget, the administration focused its budget request for fiscal year 2016 on “the most urgent needs,” she told the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.

The agency’s budget request for FY 2016 seeks an increase of $301 million above the enacted level for FY 2015 for a total of $1.5 billion for food safety. This total includes a $109.5 million increase in budget authority and a $191.8 million increase in user fees. Almost all of the proposed budget authority increase will be dedicated to FSMA implementation, she said.

“With FDA under court order to issue many key FSMA regulations in 2015, FY 2016 is an absolutely crucial year for the investments needed to ensure timely, effective, and non-disruptive implementation,” she said.

As it implements FSMA, the agency will be taking a collaborative approach to inspection and enforcement, focusing on food safety outcomes and encouraging voluntary compliance. The largest single portion of the budget authority will go to states to better integrate, coordinate, and leverage federal and state food safety efforts, Hamburg said.

The agency’s FSMA philosophy of “educate before and while we regulate” calls for investing in guidance, education, and technical assistance for industry to support compliance efforts, especially by smaller scale farmers and manufacturers, she said.

Finally, she said, FDA must make investments in FY 2016 to implement the new import safety system, including the Foreign Supplier Verification Program (FSVP).

“The investments FDA can make with the FY 2016 budget authority request will enable the agency to maintain momentum toward timely and successful implementation of FSMA. Without these investments, implementation will be disrupted and delayed,” she said.

The FDA Center for Food Safety and Applied Nutrition is the only product center that does not receive a substantial portion of its budget from user fees charged to the regulated industries. Of the $4.9 billion requested by the Administration for FDA in 2016, $2.2 billion (45%) comes from user fees, yet the food safety program receives only 1% of its budget from user fees. In early House versions of the FSMA bills, user fees of $1,000 per registered facility were included. This was reduced to $500 per facility in subsequent versions, and eliminated altogether in the final version. With nearly 200,000 registered food facilities, user fees could have generated $200 million per year, increasing the food safety budget by 16%.

I believe the FDA food safety program will never be able to fulfill the promise of FSMA as long as its budget is limited to federal appropriations. Cost recovery user fees would go a long way toward closing the gap, but that opportunity was lost when registration fees were cut from FSMA.

With the first batch of FSMA-implementing regulations on the way this year, it would be prudent for food companies to look ahead and consider budgets for compliance with the new FSMA regulations.

With FSMA in Mind, GAO Reviews FDA’s Overseas Offices

FDA needs to adequately staff its foreign offices – where 44 percent of positions were vacant as of October 2014 — to fulfill its inspection mandate under the Food Safety Modernization Act (FSMA), according to a newly released report by the Government Accountability Office (GAO).

Under FSMA, FDA was mandated to inspect at least 600 foreign food facilities in 2011 and, for each of the next five years, to inspect at least twice the number of facilities inspected during the previous year. However, GAO explains, the agency is not currently keeping pace with that FSMA requirement. FDA officials told GAO’s researchers they do not plan to meet the FSMA mandate because of funding. The officials also “questioned the usefulness of conducting that many inspections,” GAO says.

GAO conducted an in-depth review of FDA’s foreign office operations in Canada, China, and Mexico. The locations were selected based on an analysis of the volume of food imports, the percentage of food imports refused at the border, and the number of food facility inspections for fiscal year 2013, among other factors. The review included visits to FDA’s offices in Beijing and Guangzhou, China, and in Mexico City.

This is not the first time GAO has looked into FDA’s overseas staffing. In 2010, the oversight arm of the U.S. Congress recommended that FDA develop a strategic workforce plan for its foreign offices to help ensure it recruits staff with the necessary experience and skills. “GAO continues to believe that such a plan for the foreign offices is critical to FDA’s ability to address staffing challenges,” the new report states.

“FDA has not conducted an analysis to determine whether the number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure comparable safety of imported and domestic food. Without such an analysis, FDA is not in a position to know what is a sufficient number of foreign inspections and, if appropriate, request a change in the mandate,” GAO says.

I believe it would be very helpful to fully staff all FDA overseas offices. But as a practical matter, I also believe direct inspection by FDA of overseas food facilities is not the key to improving the safety of food imported into the United States. Certified third party audits, the Foreign Supplier Verification Program, along with outreach and education efforts to stakeholders are likely to play a far more important role. As final regulations begin to roll out this year, FDA’s overseas offices will have their hands full simply explaining those new regulations.

FDA Highlights FSMA Implementation in FY2016 Budget Request

 

President Obama’s ambitious FDA budget request for fiscal year 2016 features an increase in budget authority of more than $109 million for activities implementing the Food Safety Modernization Act.

The agency received an additional $27.5 million for FSMA implementation in FY2015, despite the very difficult budget climate in Washington, D.C., so there is at least a precedent for a significant increase even while lawmakers hunt for ways to trim budgets elsewhere.

FDA says the additional budget authority will allow the agency to “implement fundamental requirements for domestic food and feed safety; acquire the technical staffing needed to support the law, including the training of new inspectors; provide the appropriate guidance to industry about the changes the law will bring; strengthen the role of the states in helping to ensure the safety of the country’s food supply; and build and implement a new import safety system.”

Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, in a February 3 FDA Voice blog, said the agency is “at a critical juncture” as Congress considers the FSMA funding. He explains that a lot of work has to be done now to ensure that the FSMA rules are implemented in late 2016 and 2017. For example, the agency plans to deploy inspectors specialized in specific food commodities. This will involve retraining of more than 2,000 FDA inspectors, compliance officers and other staff involved in food safety activities, he said.

Funds are needed now for the agency to recruit additional experts to help develop guidance and to work with industry, academia, and state extension services to ensure that their concerns are heard, Taylor noted.

The agency plans to provide funding to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance. It has also joined with USDA’s National Institute of Food and Agriculture in providing grants to support food safety training for small, sustainable and organic farm owners and food processors, Taylor said.

The agency plans to provide funds to states for inspector training and to boost information sharing capacity. In addition, it needs to build state partnerships and capacity to provide education and technical assistance to growers, for the produce safety rule.

For imports, the Foreign Supplier Verification Program (FSVP) presents “an enormous challenge for both FDA and food importers,” Taylor said. The program will require an increase in staff and the training of more than 400 investigative and compliance staff within the agency. It will also require extensive training and technical assistance for importers, he said.

“The bottom line is that without investment now, and sustained funding afterwards, there is the risk that the implementation of FSMA will be uneven or even delayed,” Taylor said.

This seems to me to be a fair assessment.

Commenters Say Re-proposed FSMA Animal Food Rule Needs Further Revision

 

The December 15 comment deadline on FDA’s re-proposed rule on Preventive Controls for Animal Food has come and gone. Stakeholders generally welcomed the supplemental proposal as an improvement on the original proposed rule. But further significant changes are needed, according to recent comments submitted to FDA.

Valley Proteins Inc., of Winchester, VA, one of the nation’s largest independent renderers, says in a December 8 comment that the final animal food rule should not include a “blanket requirement” for product testing for rendered products used in food for animals. Product testing has “limited value in confirming that control measures are effective” because testing in and of itself does not protect against hazards occurring in foods, the company suggests. “Rather than focusing on a testing procedure, the focus should be on adherence to the processes and controls that provide the true protection, such as maintaining the appropriate cooking temperature, etc.,” it says.

Similarly, environmental monitoring is not appropriate for many parts of the rendering process, the company contends. The process takes raw materials such as inedible meat parts and used cooking grease and converts them into fats and proteins used as ingredients in animal feeds and in biofuels. “By its nature, rendering takes raw materials that are, in a sense, contaminated and converts them into clean, safe products for use in the food supply,” says Valley Proteins’ President, Gerald F. Smith Jr.

“The final rule should not mandate environmental monitoring for rendering but should allow for the facility to determine whether such monitoring is necessary or appropriate,” he says.

West Central Cooperative of Ralston, IA, a farmer-owned group connecting producers of agricultural products to a network of processors and end-users worldwide – one of the 20 largest grain companies in the U.S. – says in a December 11 comment that the proposed rule should be “revised significantly” to reflect the intent of FSMA and “provide sufficient flexibility to allow facilities to adopt animal feed and pet food safety practices that are practical and effective for their specific, individual operations.”

The proposed rule would for the first time require current Good Manufacturing Practices (cGMPs) for food for animals, along with hazard analysis and risk-based preventive controls. The re-proposed rule also includes a new definition for the phrase “significant hazard.”

“We generally support FDA’s new proposed term ‘significant hazard,’ because it would better define those hazards for which rigorous management control activities may be needed,” says West Central’s President and CEO-elect, Milan Kucerak. “However, we believe the proposed regulation should be further revised to provide firms with appropriate flexibility to manage feed risks in a manner commensurate with the hazard,” he says.

Any product testing or environmental monitoring requirements should only be applied to significant hazards, if any, present in the firm’s operation, Kucerak says. The significant hazard approach should also be applied in the context of hazards that may be intentionally introduced into products for economic gain, as well as for supplier program requirements that the firm relies on its supplier to control, he says.

In a December 9 comment, the Michigan Agri-Business Association says it is particularly concerned that FDA’s proposed cGMPs establish reasonable and practical requirements for animal feed and pet food, and not be based on requirements necessary for human food. Many of the proposed requirements “inappropriately focus on the hygienic design and construction of equipment and facilities, and would establish standards that are required for human food. We strongly believe that FDA must make significant revisions to the proposed cGMPs so that the final regulation does not add unnecessary requirements that would cause animal feed and pet food companies to expend millions of dollars towards attempting to comply with regulatory obligations that are not need to assure the safety of animal feed, says James E. Byrum, the association’s president.

FDA Learns from ‘Listening Sessions’ on the Re-proposed FSMA Rules

 

Senior Food and Drug Administration officials, including Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, traveled to Georgia, North Carolina, Florida, California and Vermont in recent weeks for “listening sessions” with stakeholders to discuss the agency’s re-proposed Food Safety Modernization Act rules. The agency also hosted a public meeting November 13 in College Park, Md. on the supplemental rules.

In a recent FDA Voice blog, Taylor says the emphasis in these sessions has shifted from concerns about the cost of certain measures to “mostly clarifying questions about the content of the rules,” and what has to be done once the rules take effect. “We’re getting down to the nitty gritty of implementation,” he says. However, there appears to be ongoing confusion about the water quality and testing requirement for produce growers. The agency is “committed to providing clear guidance so that expectations are understood,” Taylor says.

In the listening sessions and in their discussions with state representatives, the FDA officials were asked how the agency plans to pay for its FSMA-related activities.

“It is urgent that FDA receive adequate funding for the training, technical assistance, state partnerships and import oversight that is essential for sound implementation of the FSMA rules beginning in late 2016 and 2017,” Taylor says.

The agency will be relying heavily on its state counterparts to provide training, technical assistance and compliance oversight, he said.

He reported separately on the New England listening session in another blog post, noting that many stakeholders are “finding the complexity of the proposed rules daunting, such as the technical underpinnings of the E.coli benchmark for water quality and the various boundary lines and exemptions that determine who is covered.” The agency has opted not to take a “one size fits all” approach, which has contributed to making the rules more complicated.

“This only underscores our responsibility to explain the rules clearly and to provide education, technical assistance and guidance,” Taylor says.

Indeed, these activities are likely to be among the agency’s biggest challenges in achieving a successful implementation of FSMA both for domestic and imported foods.

FDA has declined requests for extensions of the December 15 deadline for public comment on its re-proposed rules, citing its urgent need to move forward because of its court-imposed deadlines for implementing the final rules.

Revised FSMA Proposed Rules Address Stakeholder Concerns

 

The Food and Drug Administration’s supplemental texts for four proposed rules that would implement provisions of the Food Safety Modernization Act (FSMA), published September 29 in the Federal Register, address numerous concerns raised by stakeholders. The agency, for example, changed its thinking on significant issues in response to comments on the proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Under the new proposal, for example, a farm would not be required to register as a food facility just because it packs or holds raw agricultural commodities grown on another farm under a different ownership. In addition, on-farm packing and holding of produce would be subject to the proposed produce safety rule, not the human food preventive controls rule. However, farms that conduct additional processing or manufacturing may be subject to preventive controls rules for those activities, the agency says.

In another policy shift, FDA proposes to exempt distribution centers from the requirement to conduct hazard analyses and supplier verifications.

FDA now proposes to define a “very small business” as one having less than $1 million in total annual sales of human food. Previously, the agency had proposed three options: annual sales of $250,000, $500,000, and $1 million. The new proposed definition would exempt less than 1 percent of the dollar value of food produced in the United States, the agency says.

Under the new proposal, very small businesses would have three years after publication of the final rule to comply. Very small business would be categorized as “qualified facilities,” and would be subject to modified preventive control requirements. Small businesses, defined as those with fewer than 500 persons would have two years after publication of the final rule to comply, unless they qualify for an exemption. All other businesses would have to comply with the final rule one year after its publication.

FDA is seeking comment on whether the preventive controls for human food rule should require a facility, in certain circumstances, to conduct product testing and environmental monitoring to verify preventive controls – if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard, for example.

Supplier controls are proposed when a receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier, the agency says. In such situations, the facility would have the flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing) unless there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, FDA says.

In that instance, an annual onsite audit of the supplier would be required unless the facility can show that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.

In addition, the agency is inviting comment on whether a facility should be required to address, as part of its hazard analysis, hazards that may be intentionally introduced for purposes of economic gain as part of its hazard analysis.

The agency is inviting comment through Dec. 15, 2014 on just the newly proposed changes in the supplemental text and is planning to hold a public meeting on the revised proposals on Thursday, November, 13, 2014 in College Park, Md.

FDA Officials Discuss Phase Two of FSMA Implementation

 

Although still in the phase 1 rulemaking stage of implementing the Food Safety Modernization Act (FSMA), the Food and Drug Administration is planning for moving forward with “phase 2” which will involve training and compliance activities.

FDA Deputy Director for Regulatory Affairs, Roberta Wagner, discussed the agency’s current thinking about how it will tackle the next implementation phase, in an August 26 webinar sponsored by the Food Safety Preventive Controls Alliance (FSPCA). FSPCA is a collaborative program of the Illinois Institute of Technology, industry, academic and government stakeholders which is developing a core curriculum, training and outreach programs for companies producing human and animal food in compliance with FSMA’s preventive control provisions.

A similar presentation, sponsored by the Produce Safety Alliance (PSA), was made in early July by Kathy Gombas, who has the lead role for FSMA change management in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). PSA is a collaborative project between Cornell University, USDA and FDA that will provide training and education on current best practices and guidance, and on the regulatory requirements for produce.

In Phase 2, FDA will be investing in regulatory training to promote consistent inspections. Because not every inspector will be an expert in the products being inspected in every establishment, inspectors will have access to subject matter experts in FDA headquarters who can answer questions that arise. The inspectors will be assessing a company’s “food safety culture” which will determine what approach the agency will take with that facility, using a risk-based approach, the FDA officials explained

FDA plans to facilitate industry implementation of preventive practices by expanding its oversight toolkit to encourage voluntary compliance. This expanded toolkit will include:

  • Commodity and sector-specific guidance;
  • Education, outreach and technical assistance;
  • Regulatory incentives for compliance.

So, a company’s food safety culture will guide FDA’s regulatory approach, using targeted, risk-based inspection models. In addition, the agency will be conducting more sampling, although the sampling will focus on fewer commodities, the agency says.

FDA expects to “educate before regulating,” providing technical assistance and considering work performed by public-private partners. For produce, for example, it plans to conduct targeted on-farm surveys and inspections and to “deploy a cadre of specialized produce safety experts for on-farm activities, to encourage voluntary compliance.”

For Phase 2, the agency has created a steering committee that oversees three workgroups: on Preventive Controls in Food and Feed Facilities, Produce Safety Standards, and Import Oversight. In addition, it plans to set up a Regulator Technical Assistance Call Center, to allow for inquiries and responses while inspectors are at the inspection sites.

The agency also plans to continue stakeholder engagement and to work with multiple partners to foster industry understanding of final rules/guidance and to facilitate high rates of voluntary compliance.

The FSPCA is developing a training curriculum consistent with FSMA. This curriculum will be publicly available when the final preventive controls rule is published. The Produce Safety Alliance is also developing a training curriculum and expects to be in the train-the-trainer phase in the fall or early winter.

Training and education are key to the success of FSMA, not only for the regulated industry but for the FDA regulators who are charged with inspections and enforcement of the sweeping new rules. There is concern within the food industry that the FDA will not be prepared when the final rules take effect leading to inconsistent interpretation and enforcement of the law. Just as the industry is required to employ “qualified individuals” to oversee food safety plans, it has been suggested that the FDA require inspectors to be “qualified” through formal training before performing compliance activities under FSMA.

FDA Announces FSMA Fees for Fiscal Year 2015

 

FDA announced the Food Safety Modernization Act (FSMA) domestic and foreign facility reinspection, recall and importer reinspection fee rates for Fiscal Year (FY) 2015, in an August 1, 2014 Federal Register notice. Section 107 of FSMA added section 743 to the FD&C Act giving FDA the authority to assess and collect fees from the responsible parties of domestic and U.S. Agents of foreign facilities requiring reinspections; domestic facilities and an importer who do not comply with a recall order and importers subject to reinspections. The FSMA Fee Schedule for FY 2015:

  • Hourly rate if domestic travel is required $217 and
  • Hourly rate if foreign travel is required $305

These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.

These fees will be assessed for the reinspection to evaluate if a firm has taken the appropriate corrective actions from the prior inspection in where “Official Action Indicated” (OAI) was indicated. The responsible party for each domestic facility and the U.S. agent for the foreign facility will be required to pay the reinspection fees. The fees will be based on the number of hours spent on the reinspection. This will include time to conduct the physical inspection preparation for the reinspection, travel time, report writing, collecting and analyzing samples, etc. to ensure the facility is compliant.

In addition FDA will be assessing fees for non-compliance with a recall order to cover food recalls. Non-compliance may include: not initiating a recall as ordered by FDA and/or not performing the recall in a manner specified by FDA recall order and/or not providing FDA with requested information regarding the recall order. The responsible parties for a domestic facility and an importer who does not comply with the recall will be responsible for paying the assessed fees. These fees will be assessed on the direct number of hours spent on the FDA taking action in response to the firm’s failure to comply with the recall order.

FDA will be invoicing the responsible parties for paying the fees after the Agency has completed the work for which the invoice is based and payment will be required within 90 days in U.S currency by check, bank draft or U.S. postal money order.

Also, FDA is developing guidance documents to outline the new processes for requesting a reduction of fees for the reinspection and recalls and the agency’s process for assessment and collection of fees from importers.

FDA’s reinspection fees for 2015

 

FDA Sends Revised FSVP Rule to OMB

 

The Food and Drug Administration recently sent a revised rule to the White House Office of Management and Budget (OMB) that will be an important tool in FDA’s future oversight of foods and ingredients imported into the United States.

Under FSMA, FDA has increased regulatory authority over imported foods. For example, it can block a food from entry if the facility has refused inspection by U.S. officials. Of course, resource-related constraints prevent FDA inspection of more than a handful of foreign producers annually. Lawmakers recognized these limitations and included other provisions in section 301 to increase oversight of imports.

On July 26, 2013, FDA released proposed Foreign Supplier Verification Program (FSVP) regulations that would require importers to verify that food imported into the United States is produced in a way that “provides the same level of public health protection as is required for domestic food producers.” The revised rule will not be publicly available until OMB completes its review.

However, many proposed elements will certainly be included in the final document. Under the proposed FSVP, importers must have a foreign supplier verification program; they must review the compliance status of the food, and of the potential foreign supplier, before importing the food. These reviews would take into account any FDA warning letters, import alerts, and certification requirements issued by FDA.

Importers would also be required to identify the hazards associated with each food they import. Among other tasks, they would be required to review any complaints they receive about the foods they import, take corrective actions and revise their FSVPs as needed.

As originally proposed, FDA set out two risk-based options for supplier verification activities. Either foreign suppliers will control the hazards, or will verify that the hazards are being controlled by its raw material or ingredient supplier.

Under Option 1, if the foreign supplier controls the hazard at its establishment and there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required to show documentation of onsite auditing of the foreign supplier. For non-SAHCODHA hazards that the foreign supplier controls, the importer would be required to conduct one of more of the verification activities (onsite auditing, sampling and testing, review of the supplier’s food safety records, or some other appropriate procedure) before using or distributing the food.

Under Option 2, for all hazards that the foreign supplier will either control or verify that its supplier is controlling, importers would need to choose a verification procedure from among onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure.

If the importer’s customer will be controlling a hazard identified by the importer, the importer would need to obtain written assurance, at least annually, that its customer is following procedures (identified in the written assurance) that adequately control the hazard.

The proposed rule also states FDA’s intent is to align the supplier verification provisions in the FSVP regulations with any other supplier verification provisions that may be included in the final rules on preventive controls for human and animal food. This would avoid duplicative requirements for an entity that is both a food importer and a registered food facility.

Under the proposed rule, modified FSVP requirements would apply in certain circumstances, including the following:

  • Importation of a dietary supplement or dietary supplement component;
  • Importation of food by a very small importer or importation of food from a very small foreign supplier; and
  • Importation of food from a foreign supplier in good standing with a food safety system that FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
  • The proposed rule would exempt importation of the following foods from FSVP requirements:
    • Juice and seafood from facilities that are in compliance with the Hazard Analysis & Critical Control Points (HACCP) regulations, which contain their own supplier verification provisions;
    • Food imported for research or evaluation purposes;
    • Food imported for personal consumption;
    • Alcoholic beverages; and
    • Food that is transshipped or imported for further processing and export.

Deciding which food products are high-risk will be an especially difficult part of the implementation of the FSVP. The term “reasonable probability” of exposure to a hazard is imprecise and likely to be contested. Adequate control of hazards will not mean a “high risk” product becomes non-high risk no matter how many safety measures they put in place. The fact that such controls are needed determines the high risk status of a food.

FDA Reopens Comment Period on Reportable Food Registry ANPR

 

On June 18, FDA reopened the comment period on an advance notice of a proposed rule that would introduce certain changes to the Reportable Food Registry (RFR), implementing provisions in Section 211 of the Food Safety Modernization Act (FSMA).

The RFR reporting requirements apply to all FDA-regulated categories of food and feed, except dietary supplements and infant formula. Reporting requirements apply to registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the Food, Drug and Cosmetic Act.

Currently, registered food facilities, as well as federal, state, and local government officials, may voluntarily use the RFR portal to report information about reportable foods. But the agency proposes to extend requirements to food retailers including new requirements for posting consumer notices in stores.

Under the proposed rule, FDA could require a responsible party to submit “consumer-oriented” information to the agency, so consumers could identify whether they were in possession of a reportable food. FDA would publish a one-page online summary of the consumer-oriented information in a format that grocery store chains could print and post where consumers could view them.

Under the proposal, a grocery store with 15 or more physical locations that sold a reportable food identified in an FDA one-page summary, would be required to prominently display the FDA one-page summary, or the information from the summary, within 24 hours after the one-page summary is published on FDA’s website. The agency said it would especially welcome input concerning:

  • What information responsible parties should be required to provide that would enable consumers to accurately identify the foods,
  • Methods and locations used by grocery stores to provide food recall information to consumers, and
  • Potential impacts and costs to chain grocery stores related to posting consumer notifications.

The purpose of an Advanced Notice of Proposed Rulemaking is to obtain public input on specific issues that will form the basis of the proposed rule. By submitting comments in response to the ANPR, the public can help to shape the proposed- and ultimately the final rule.

Another benefit of an ANPR is that the proposed rule will be more closely aligned with public expectations thus reducing the potential that the agency will have to repropose rules as was the case for several key FSMA regulations including human and animal preventive controls and produce safety rules.

Comments on the ANPR may be submitted online at regulations.gov using docket number FDA-2013-N-0590. The new comment deadline is August 18, 2014.

FDA Extends Comment Deadline on Sanitary Transportation Rule

 

In 1990, Congress enacted the Sanitary Food Transportation Act that directed the Department of Transportation to promulgate regulations for the transportation of food to ensure its safety. DOT issued a proposed rule in 1993, but later determined that it lacked the expertise to implement the law. Congress amended the law in 2005 giving FDA the authority to implement it, but with no deadline for rule making. Section 111 of the Food Safety Modernization Act directed FDA to promulgate final regulations no later than 18 months after enactment of the act. FDA published a proposed rule on February 5, 2014.

In response to requests from stakeholders, FDA extended the May 31, 2014 comment deadline on its proposal to establish sanitary transportation requirements for vehicles and transportation equipment. The new deadline for public comment is July 30, 2014. In a May 8 letter, 22 industry groups sought a 90-day extension and said they needed more time to consider several sections of the proposed rule that could have “unintended consequences.” FDA granted a 60-day extension. The agency has a court-ordered deadline of March 31, 2016 for issuing the final rule.

The proposed rule on sanitary transportation of human and animal foods is one of seven regulations mandated by the Food Safety Modernization Act.

As I mentioned in the February issue, this rule is a key component of the implementation of FSMA’s provisions. The sanitary transportation rule deals with requirements for refrigeration of food, cleaning of vehicles between shipments, and protection of food during transportation. The proposed rule would establish requirements for vehicles and transportation equipment and operations, as well as for training, records and procedures for waivers.

With some exceptions, the rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food enters interstate commerce. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container if it will be consumed or distributed in the United States.

Among the exemptions are the transportation of raw agricultural commodities performed by farms. Also exempt are shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. Food that is transshipped and not meant for consumption in the U.S. is also exempt, as well as shelf-stable foods, compressed food gases and live food animals.

According to FDA’s estimates the proposed sanitary transportation rule will impact 83,609 businesses and the average cost is estimated at $1,784 per business in the first year, for a total of $149.1 million. The ongoing annual cost to the regulated companies is estimated at over $30 million.

As you will see elsewhere in this issue, I will be participating in a FSMA panel with CFSAN Director Michael Landa and former CFSAN Director Robert Brackett at the IFT annual meeting in New Orleans in a June 23 1:30 p.m. session. And it’s a safe bet that this proposed transportation rule will feature there among other hot topics.

FDA’s Strategy for Implementing Next Phase of FSMA

FDA offers some insights into its strategy for implementing the next phase of the Food Safety Modernization Act (FSMA) in a guidance document posted on the agency’s website May 2. A key element of the agency’s operational strategy will be to rely heavily on the industry to implement preventive measures.

The agency says the industry needs to work in a continuous improvement mode and to manage operations and supply chains “in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day.”

I would especially draw your attention to the appendix to the guidance, which details some of the ways the agency plans to implement FSMA’s provisions. FDA will vary its strategy for different types of food facilities. For food and animal feed facilities, for example, the agency says it will significantly expand its inspection and surveillance tools to include a wider range of inspection, sampling, testing, and other data collection activities conducted through its own field force and through collaboration with partner agencies and the food industry.

For these facilities, inspection and surveillance will include:

  • Efficiently screening firms for food safety performance to guide risk-based inspection priority, frequency, depth, and approach;
  • Providing firms incentives for compliance through enhanced presence in and targeted scrutiny of high-risk firms and products and reduced scrutiny of firms with records of demonstrated good performance;
  • Assessing the compliance of individual firms through a range of inspection and sampling techniques used in a strategic, risk-based way to maximize coverage of priority sectors and firms;
  • Making in-depth assessments of individual firms when needed to increase the incentive for compliance and determine the need for compliance or enforcement actions
  • Collecting data to inform understanding and analysis of sector-wide hazards, practices, and preventive control deficiencies; and
  • Collecting data on compliance rates to evaluate program performance and plan future efforts

The agency says its primary compliance tools will be administrative actions rather than court enforcement cases. The administrative actions will include:

  • Voluntary correction of problems at the facility level, achieved immediately during the course of an inspection through communication with firm management by investigators and, as needed, Center technical staff;
  • Voluntary correction achieved at the District level through deficiency letters, issued within days after an inspection with Center back up, to document significant safety-related deficiencies and request correction within a specified period, with immediate inspection follow up to verify correction;
  • Administrative detention of product if needed to provide immediate public health protection or for other appropriate purposes;
  • Voluntary and mandatory recalls to remove potentially hazardous food from the market; and
  • Administrative suspension of registration when other administrative compliance measures have failed or are inadequate to achieve correction of significant deficiencies that put consumers at risk.

FDA’s judicial enforcement tools will include:

  • Seizure actions that are needed to back up administrative detentions;
  • Injunction actions when suspension of registration or other measures are inadequate to prevent future non-compliance; and
  • Criminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases.

A Different Approach for Produce

Implementation of FSMA’s produce safety standards will require a different approach, the agency says. Because of the scale and diversity of the produced sector, “there is no reasonable expectation FDA will have the resources to make routine on-farm inspection a major source of accountability for compliance with produce safety standards.”

So, the agency explains, “FDA’s implementation of produce safety standards will entail a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.”

A Strategy for Imports

For imported foods, the agency will rely primarily on “importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems.” The agency plans to build its skills and capacity and to focus on auditing foreign supplier verification programs and on holding importers accountable for managing their supply chains.

Resources

According to the Congressional Budget Office, FDA needed $1.4 billion through 2015 to fulfill FSMA requirements. But the agency’s budget for FSMA received only modest increases since the legislation’s enactment.

As examples, the Foreign Supplier Verification Program will require new staff and skills to audit and verify the adequacy of the importer’s verification plan; conduct more foreign inspections; work more on food safety with foreign governments to leverage their efforts; and improve the agency’s data and import systems to facilitate prompt entry of foods that meet U.S. safety standards.

FDA’s strategy relies on partnerships with state departments of agriculture, other state partners, and local, territorial, and tribal authorities to deliver the education, training and technical assistance, as well as compliance oversight, needed to ensure the rules are implemented properly. However, additional resources are required to build the capacity of these partners and provide the needed assistance to growers, especially small and mid-size operators.

This cannot be done unless FDA finds additional resources to build the capacity of its partners and provide the needed assistance to growers, especially small and mid-size operators. The current appropriations are insufficient to take advantage of these opportunities and meet the objectives of FSMA.

FDA Issues Revised Draft Guidance on Prior Notice of Imported Foods

 

FDA announced the release of new draft guidance on requirements for prior notice of imported food, in a March 31 Federal Register notice. Some of the draft guidance responds to provisions in section 304 of the Food Safety Modernization Act (FSMA). The new draft includes several new questions and answers that help throw light on how the agency would deal with particular scenarios.

The prior notice requirement for imported food originated in the Bioterrorism Act of 2002. The current guidance, the second edition, was issued in May 2004. So the new draft will become the third edition when finalized. The agency issued a final rule on prior notice of food, including animal feed, on November 7, 2008 (73 FR 66294). In May 30, 2013, implementing a provision in section 304 of FSMA, the agency issued a final rule requiring the name of any country to which an article has been refused entry be reported in prior notices (78 FR 32359).

In the draft guidance, the agency says it received many questions about the definition of the term “ultimate consignee” for an imported food. “A significant number of people have asked this question, and there has been a lot of variation in what people have been submitting as the ultimate consignee,” the draft guidance states. “FDA considers the location where the imported food is to be delivered as the ultimate consignee for the purposes of prior notice,” it says.

If the imported food is delivered to the owner, the name and full address of the owner should be given as the ultimate consignee. If the food is owned by a foreign shipping firm and is being delivered to a public storage warehouse in the U.S., FDA considers the public storage warehouse to be the ultimate consignee and its name and address should be submitted in the prior notice, the agency says.

Another new question in the draft deals with the FSMA-related requirement to report the name of any country that has refused entry of the article of food. Specifically, the agency says it is necessary to report refusals of entry of food, including food for animals, based on food safety reasons given by the government of the country that refused entry. This includes a refusal by another U.S. port.

Another new question in the draft guidance deals with the definition of the word “article” and whether it refers only to the food in the specific shipment, or if it also includes food from the same batch or lot numbers that was shipped to other countries. The agency says the term “article” does not refer to food from the same batch or lot numbers that is not being imported or offered for import into the U.S. and for which prior notice will not be submitted at the time of the specific shipment, or food of a similar type that was previously refused entry by a country.

The new draft also clarifies that prior notice is required for meat intended for food for animals, including pet food and treats. “Meat intended for food for animals, such as that fed to zoo animals or meat products intended to be incorporated into food for animals, is not under the jurisdiction of USDA/FSIS and is subject to the prior notice requirements. These meats include meat derived from cattle, swine, goats, sheep, horses, and mules that are destined for food for animals,” the agency says.

As always with such agency guidance, it represents FDA’s current thinking on the subject, but it is not binding upon the agency or the regulated community, so alternative approaches may be used if they satisfy the requirements. The 60-day comment period began March 31, 2014.

 

FDA Issues Proposed Rule on Sanitary Transportation of Food

 

On January 31, 2014, FDA issued a proposed rule on sanitary transportation of human and animal foods — the seventh of seven regulations mandated by the FDA Food Safety Modernization Act. So we now have all the proposed rules that would implement key elements of FSMA.

The other six rules deal with preventive controls for human food, preventive controls for animal food, produce safety, a Foreign Supplier Verification Program, accreditation of third-party auditors, and the prevention of intentional adulteration.

I view this transportation proposal as a valuable and necessary component of the collection of new rules that will introduce a more preventive approach to food safety in the United States. But there is a possible downside to introducing so many regulations at one time – especially for companies that find themselves suddenly required to understand and comply with several new sets of requirements under separate regulations. Animal feed companies, for example, may be unclear about their status relative to all of the FSMA rules. For example, if farmers have their own mills, does the exemption for feeding your own animals also apply to farmers who may feed their own animals that are housed in facilities owned by contract growers?

The sanitary transportation rule deals with requirements for proper refrigeration of food, the cleaning of vehicles between shipments, and the protection of food during transportation. As mandated by the lawmakers who crafted FSMA, the proposed rule would establish requirements for vehicles and transportation equipment and operations, as well as for training, records and procedures for waivers.

With certain exceptions, the proposed rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food enters interstate commerce. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container if it will be consumed or distributed in the United States.

I was interested to see what is not covered by the new requirements. For example, transportation of raw agricultural commodities performed by a farm is exempt. Also exempted are shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. Food that is transshipped and not meant for consumption in the United States is also exempt. In addition, shelf-stable foods, compressed food gases and live food animals are exempt.

According to FDA’s estimates the proposed sanitary transportation rule will impact 83,609 businesses and the average cost is estimated at $1,784 per business in the first year, for a total of $149.1 million. The ongoing annual cost to the regulated companies is estimated at over $30 million.

The agency has scheduled three public meetings on the proposed rule, Feb. 27 in Chicago, IL, March 13 in Anaheim, Calif., and March 20 in College Park, MD.

The deadline for public comments is May 31, 2014.

On FDA’s Proposed Rule on Intentional Adulteration

FDA released its proposed rule on intentional adulteration of food in a December 24 Federal Register notice. The proposed rule, Focused Mitigation Strategies To Protect Food Against Intentional AdulterationFocused Mitigation Strategies To Protect Food Against Intentional Adulteration, would apply to both domestic and foreign facilities that are required to register with the agency and would require those companies to develop and implement a food defense plan.

The proposal introduces some terminology that may initially cause confusion among stakeholders. For example, the term ‘‘actionable process step,’’ is the food defense counterpart of the familiar term ‘‘critical control point’’ (CCP) used in Hazard Analysis and Critical Control Point (HACCP) plans. HACCP per se does not appear in the language of FSMA, which instead allows hazard analysis and preventive controls to be achieved by any means that can be shown to be effective. For the purposes of food defense, we will need to become familiar with the term ‘‘actionable process step,’’ which is a step identified during a vulnerability assessment. A vulnerability assessment, meanwhile, is similar to the hazard analysis conducted in developing a HACCP plan.

Yet another key term, “significant vulnerability,” is the food defense version of the term “reasonably likely to occur” which is used in the preventive controls proposed rules.

In many situations it may be difficult to say what constitutes a significant vulnerability. This is also an issue in the preventive controls rules, where what may or may not be “reasonably likely to occur” is a challenge for the regulators to sharply define. The agency defines a “significant vulnerability” as a vulnerability for which “a prudent person knowledgeable about food defense would employ food defense measures because of the potential for serious adverse health consequences or death and the degree of accessibility to that point in the food process.”

The agency has identified four key activity types as being especially vulnerable to intentional adulteration: bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities. But the agency is open to ideas about what other types of products and facilities may be vulnerable. Judging by the number of questions asked in the proposal, it is clear that even some fundamental elements of the proposal may be open to change before a final rule takes shape.

As proposed, the rule includes numerous exemptions. For example, it would apply to food in liquid storage tanks, but not to the holding of food in general. It would not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact, the agency says. It would not apply to activities of a facility that are subject to produce safety standards. With some exceptions, it would not apply to alcoholic beverages at a facility that meets certain conditions. And it would not apply to the manufacturing, processing, packing, or holding of food for animals.

The proposed rule would not apply to a “qualified” facility. Qualified facilities would include very small businesses, with less than $10 million in annual sales of food. But some companies could be deemed “qualified” if during the preceding 3-year period the average annual value of the food manufactured, processed, packed or held at the facility sold directly to qualified end-users exceeded the average annual monetary value of the food sold by such facility to all other purchasers, and if the average annual monetary value of all food sold during the preceding 3-year period was less than $500,000.

The agency is seeking comments by March 31, 2014 on the proposed exclusions – and, of course, on all other elements of the proposed rule.

FDA Needs Input on Proposed Animal Food Rule

In last month’s FSMA Perspective, I focused on FDA’s release of its proposed rule on Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. I would like to follow up here with issues raised November 21 at a public meeting in College Park, MD — the first of three FDA meetings on the animal feed proposal. The agency held a second session in Chicago, IL, Nov. 25, and has scheduled a third for Sacramento, CA, on December 6.

These meetings are extremely helpful for two-way communication between the agency and stakeholders. The regulated industry learns the agency’s thinking about the proposed rule and FDA staff hears the specific concerns of the stakeholders. I know the agency values these “listening” sessions highly. The first meeting featured public comment and Q&A sessions with senior FDA officials, including: Linda Tollefson, Associate Commissioner in the Office of Foods and Veterinary Medicine; Dan McChesney, director of the Office of Surveillance and Compliance in the Center for Veterinary Medicine (CVM); Kim Young, deputy director of the Division of Compliance in CVM; Eric Nelson, director of the Division of Compliance in CVM; and Jenny Scott, senior advisor in the Office of Food Safety in FDA”s Center for Food safety and Applied Nutrition (CFSAN).

Representatives of the American Feed Industry Association (AFIA) turned out in strength for the first meeting and argued that FDA is proposing to apply tougher preventive controls to animal feed producers than are justified by a risk-based approach. The industry group believes the agency is being overzealous in applying the same rigorous controls to animal feed as it plans for pet foods and for human foods. Instead, the feed industry would like the agency to modify the proposed rule to recognize differences between animal feed and pet food production facilities. The group argues that lawmakers kept animal food separate from human food in FSMA and that the agency needs to do the same. In addition, it wants FDA to apply the same approach to the Federal Food Drug and Cosmetic Act and to separate animal food and human food.

As a former CVM director who is now a consultant to the industry, I can see both sides of this picture. Cleary, there are significant differences between feed mills and pet food processing facilities and these should be taken into account in a final rule. But that does not mean animal feed facilities should get a pass from compliance with FSMA’s preventive approach.

The preventive controls provisions of the proposed rule, would apply to domestic and imported animal food, including pet food, animal feed, and raw materials and ingredients. Facilities producing animal food would be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions would be taken to correct problems that arise. The proposed rule would also establish CGMPs that specifically address animal food. This will be a burden for the feed industry, which will have to comply with CGMP requirements for the first time.

The clock is ticking down toward the court-ordered deadline of June 30, 2015 for publishing this and four other FSMA final rules. So this does not leave much room for additional rounds of comment beyond the current comment deadline of February 26, 2014. For this reason — as I have suggested here before — now is the time for the regulated industry to play an active role in this rulemaking process.

On FDA’s Proposed Rule on Preventive Controls for Animal Food Facilities

FDA unveiled its proposed rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals on October 25 after more than a year and half of waiting for the proposal to emerge from the White House Office of Management and Budget.

This proposed rule is of particular interest to me — as a veterinarian and a former director of FDA’s Center for Veterinary Medicine –and I think it has the potential to make a significant impact on animal health and to improve the safety of the human food supply.

The rule represents the biggest regulatory change the animal feed industry has seen in decades, with many companies becoming subject to new Current Good Manufacturing Practice (CGMP) requirements as well as hazard analysis and preventive controls for the first time. However, there will be added costs for companies required to comply with the new CGMPs and to develop preventive controls. With some exceptions, the proposed rule would apply to facilities that manufacture, process, pack, or hold animal food and are required to register as a food facility. So this will include a large number of companies.

Each facility would be required to have a written food safety plan, including a hazard analysis for each type of animal food manufactured, processed, packed, or held at the facility. The plan would also require preventive controls, monitoring procedures, corrective actions, verification activities and recordkeeping — all terms that are familiar to those of you who have worked with Hazard Analysis and Critical Control Point (HACCP) systems, although the term HACCP is not used in the proposed rule.

The animal food rule will complement FDA’s separate proposed rules on imported foods and on the accreditation of third party auditors for foreign food facilities.

I am often asked if I think the agency will be able to meet its new court-ordered deadline of June 30, 2015 for publishing all five FSMA-related final rules. Because of the complexity of the animal feed proposal and of the other four rules, and because some of the necessary elements are beyond FDA’s control, I believe the agency will find it a major challenge to achieve the deadline. It is always a challenge to develop a new rule that must be properly supported by science and that must address the concerns of all stakeholders. So it would be unfortunate to have to rush through any of the necessary steps in the process.

The proposed animal foods rule, formally released in the October 29 Federal Register, is open for comment through February 26, 2014 and FDA has also scheduled several public meetings, one in College Park, MD on November 21, another in Chicago, IL, on November 25, and a third in Sacramento, CA, on December 6. I would encourage companies in the animal food industry to play an active role in this process because FDA is open to constructive comment on the proposal.

Reporting from Proposed FSMA-related Audits Raises Concerns

Reporting requirements from third-party audits drew many questions from stakeholders at the agency’s public meeting on proposed rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies, held in Washington D.C., September 19-20.

As you may know, the objective of the accreditation proposal is to strengthen foreign food safety audits – although the agency has indicated that it would consider a similar approach for third-party audits conducted in the United States.

The accreditation rule calls for reports to be submitted to FDA on conditions found in an audited facility that might lead to a serious risk to health. Participants in the public meeting sought assurances from the FDA officials — including Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor –that this would only be a requirement for a regulatory audit, and not for a purely consultative audit conducted for the purposes of assessing compliance ahead of time. If FDA requires reports from consultative audits, it could cause companies to avoid this type of audit entirely, with the unintended consequence of reducing the number of audits conducted, stakeholders warned. Or, if FDA-accredited auditors had to report findings from consultative as well as regulatory audits, it would encourage companies to seek consultative audits from non-accredited firms. So there are many possibilities for unintended consequences.

Taylor assured participants at the public meeting that the agency wants to be very clear about reporting requirements and when they will and won’t be required. It doesn’t, for example, want to drive companies away from using FDA-accredited auditors in order to protect themselves from reporting requirements, he said.

Consumer groups are concerned that the agency may extend the third-party accreditation program beyond its intended application to imported food and they point out that this was specifically excluded during the deliberations by lawmakers leading to the enactment of FSMA. They view regulatory audits as the domain of the regulatory authorities and not the business of private auditing firms. This policy issue has been debated for many years – and not just with regard to FDA.

Interestingly, the requirement for inspections conducted by certified third-party auditors is limited to only two situations:

  • Imported food determined to pose a safety risk and requiring certification by FDA as a condition of granting admission into the U.S.
  • Issuing foreign facility certifications that will be used by importers to establish eligibility for the Voluntary Qualified Importer Program.

Importers who rely upon third party audits as part of their Foreign Supplier Verification Program are not required to use accredited third party auditors. However, FDA believes that there will be much broader adoption by the food industry of third-party audits performed by auditors certified by FDA-recognized accreditation bodies.

It seems to me that an effective policy must take account of what is possible in practical terms. By this measure, a preventive approach using third-party audits is the only viable option and it is preferable to the alternative, which is likely to be paralysis and no improvement in food safety measures for imported food.

 

On the Proposed Rules for the Safety of Imported Food

One of FDA’s biggest challenges as it rolls out new regulations to implement the Food Safety Modernization Act will be outreach and education so every impacted business will know what’s expected under the new, prevention-based regulatory approach. As part of its outreach efforts, FDA posted a presentation on its website on August 19, titled Proposed Rules to Help Ensure the Safety of Imported Food, in which it describes the elements of the Proposed Regulations for Foreign Supplier Verification Programs (FSVPs) and the Proposed Rule for Accreditation of Third-Party Auditors.

The agency explains that the new, integrated approach to imports will include the FSVP and the voluntary qualified importer program (VQIP). But it will also include mandatory certification, and enhancements to the existing prior notice system. In addition, the agency wants to help build the capacity of foreign governments, and to expand its own foreign offices. And it has other tools at its disposal, such as stronger enforcement authority under FSMA.

As you may know, a key principle of the import-related rules under FSMA is that the importers will be responsible for ensuring that the food they import to the U.S. complies with FDA safety standards. Unless a product has a specific exemption, the importer will be required to develop an FSVP for each food imported, with varying requirements based on the type of product, the category of importer, the hazard of the specific food, and on who will control the hazard. If there is no U.S. owner of the food at the time of entry, the importer is deemed to be the U.S. consignee. And if there is no consignee or U.S. owner at the time of entry, the importer will be the U.S. agent or representative of the foreign owner or consignee.

The proposed requirements for supplier verification are mainly based on who will control the hazards that are reasonably likely to occur.

The agency is attempting to be fair with regard to exemptions and to avoid duplication of effort by companies already covered by other preventive requirements. So, for example, products from facilities subject to FDA’s low acid canned food requirements will be exempt, but only with regard to the microbiological hazards elements of the rule. In addition, the agency proposes modified FSVP requirement for dietary supplements and for dietary supplement components.

For these and for other reasons, I believe the FSVP will be a complex regulation to implement, with many opportunities for confusion of responsibilities and roles. As a former regulator, I have sympathy with the agency as it gets deep into this huge task that will take many years to complete. I encourage you to speak up if you see elements of the proposed rules that will be unduly burdensome and to present FDA with workable regulatory solutions. Now is the opportune time.

FSMA’s Registration Mandate is the Key

The focus of media attention is currently on FDA’s proposed rules for a Foreign Supplier Verification Program and for Accreditation of Third-Party Auditors. But I would draw your attention to a FSMA provision that is already in force, which, from the agency’s viewpoint, is the most significant new authority under the new law — biennial registration of facilities.

The true significance of the registration mandate is, I believe, being overlooked in the media because of the focus on proposed rules and delays. Under FSMA, facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the agency every two years. There are some exemptions, namely farms, retail food establishments, restaurants, non-profit food establishments, and fishing vessels. But the mandatory registration requirement means that a large number of companies that were not previously very visible to the agency will now be on the radar screen.

Prior to the Bioterrorism Act of 2002, food manufacturers were not required to register with FDA so the agency had to do the best job it could to compile an inventory of food manufacturers so they could be inspected on a regular basis. This was supposed to occur at least once every five years. FDA relied on the states to identify food firms in their state based on tax records and other state requirements for licensing and registration. But this information was often inaccurate or incomplete. Compiling a list of foreign food firms that imported to the U.S. was even more problematic.

On several occasions, outbreaks of foodborne illness were traced to firms that had never been inspected by FDA either because they were considered low on FDA’s priority list or because they were not in FDA’s inventory.

The Bioterrorism Act required all food manufacturers foreign and domestic to register with the FDA thus solving the inventory problem. But the amount of information required by the law was very limited so that FDA often could not tell whether the firm was producing low-risk or high-risk foods. The greatest limitation to the Bioterrorism Act was that companies were only required to register one time. Companies were required to update their registration information if they made changes in the foods they produced and other changes, but many neglected to inform FDA. A 2009 Inspector General’s report indicated that 48 percent of registered facilities gave inaccurate information or failed to update information. Over time the inventory became less and less accurate, which contributed to the disaster that was the Peanut Corporation of America.

PCA’s Blakely, GA plant was registered with FDA as a roaster and blancher of peanuts which was considered fairly low-risk by FDA. By the time of the massive Salmonella outbreak beginning in late 2008, the plant was producing a variety of peanut products including peanut paste. These peanut products were sold to other food companies throughout the U.S. including large companies like Kellogg. When FDA traced the source of the outbreak to the PCA Blakely plant in early 2009, I believe all of the prior inspections were conducted by Georgia state officials under FDA contract. At $500 per inspection under the FDA contract, Georgia inspectors could not do a thorough job and missed many GMP violations that contributed to the establishment and spread of Salmonella throughout the plant. Had PCA bothered to update its registration to reflect its expanded product line, the FDA may have targeted the Blakely plant for an inspection ($10,000 is the cost of an FDA inspection) and prevented the outbreak.

Under FSMA, food facilities are required to reregister every other year and list any changes to the food categories they produce. Furthermore FSMA gives FDA authority to suspend registration if facilities do not comply with the registration requirements. Overall this gives FDA much greater control of its food facility inventory, increases its ability to target high-risk firms, and provides regulatory teeth to encourage compliance.