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

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 BreenIn 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.

Preventive Controls – A New Ballgame for Food Safety Compliance

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

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

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

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 have 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

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 have 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

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

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

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

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

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

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.