FDA Issues Draft Guidance on FSMA Rules, Extends Compliance Dates

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Practice (CGMP) requirements under the Food Safety Modernization Act (FSMA), FDA released five chapters of a 14-chapter draft guidance to assist in compliance.

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

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

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

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complies with human food safety requirements and is not further processing the by-products for use as animal food, the draft guidance explains.

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

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

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

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

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

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

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

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

New NDI Guidance – Still a Work in Progress

On August 11, 2016, FDA issued an updated revised draft guidance on new dietary ingredients used in dietary supplements which replaces draft guidance the agency issued in 2011. FDA developed the draft guidance to address confusing issues involving new dietary ingredients, synthetic dietary ingredients, botanicals, and requirements for New Dietary Ingredient Notifications.

In FDA’s own words: “The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications).” FDA is inviting comments on this guidance document. In order for the comments to be considered before FDA begins work on the final version of this guidance, the comments should be submitted no later than October 11, 2016. FDA is specifically requesting comments on three issues as discussed in the Federal Register document announcing the availability of the revised draft guidance document.

While the updated draft is an improvement on the earlier draft, it is still a work in progress. What can be interpreted as improvements are FDA’s intention to establish a “grandfathered” list of dietary ingredients and to establish Master Files for new dietary ingredients. However, judging from comments issued by many stakeholders on this revised draft thus far, this updated draft guidance does not completely answer all of the areas of concern and interpretations regarding dietary ingredients. As such, this is an ongoing and unsettled area. In the meantime, FDA is urging adherence to these guidelines as it best reflects their current thinking in this area.

The major sections of the earlier draft guidance that have been revised are: chemical alteration; manufacturing changes that create an NDI; synthetic substances; NDI definition; list of “grandfathered” dietary ingredients; and structuring NDINs efficiently including how much safety information and types of safety information that should be provided. The revised guidance document also uses a question and answer format to address the pertinent issues involving dietary ingredients along with several examples of what is a dietary ingredient, synthetic ingredient, etc.

There is general agreement that the process involving dietary ingredients has not worked as smoothly as expected… roughly 25% of the NDINs submitted to FDA are accepted while 75% have met with some objection(s) for a variety of reasons.

One area of controversy involving dietary ingredients has been how the interpretation of the legal safety standard is applied. Under DSHEA, dietary ingredients marketed in the U.S. after October 15, 1994, must meet the stated NDI safety standard demonstrating that “… a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.” (21 CFR 190.6(a)) By contrast, the safety standard applied to food additives and GRAS substances must demonstrate that the ingredient meets the safety standard of reasonable certainty of no harm under the intended conditions of use. (21 CFR 170.3(i))

While FDA has published standards as to how to determine safety under the reasonable certainty of no harm under the intended conditions of use safety standard, no such published standards or guidance exists for the reasonably expected to be safe standard. In fact, a comparison of the safety requirements listed under section VI of the revised draft guidance document share a remarkable similarity to the safety requirements for food additives and GRAS substances.

EAS is encouraging clients to offer comments on this draft guidance as this guidance when finalized will reflect FDA’s thinking in this area for years to come. EAS can assist you in this regard by working with you in drafting the comments and serving as a conduit for submission of comments to FDA. In the meantime, it is strongly recommended that clients seek a pre-submission meeting with FDA before submitting an NDIN to answer all questions/concerns beforehand.

GRAS Final Rule: May Result in More Rejects and/or Longer FDA Reviews

On August 17, 2016, FDA published a final rule which formally codifies the requirements for GRAS Notices that originated with the GRAS proposal published in 1997. FDA states that the expressed intent of this final rule is to “… clarify the criteria used to determine whether the use of a substance in human or animal food is generally recognized as safe (GRAS)” and applies to GRAS Notices submitted to the Center for Food Safety and Applied Nutrition (CFSAN) and/or the Center for Veterinary Medicine (CVM). The final rule addresses the scientific evidence that should be used to demonstrate safety, the availability of this data in the public domain, and the criteria for formulating this data into a GRAS Notice that would establish a consensus among experts that the material is safe in food and/or animals for its intended use(s).

Overall, this final rule is welcome. However, based on our reading of this document, there are some areas that will need to be clarified and addressed going forward, in particular, expert panels, conflicts of interest, and independent (self-GRAS) GRAS determinations. This document does not go into much detail regarding independent GRAS determinations as it is made clear that FDA prefers GRAS notices. FDA has indicated that it will issue guidance documents in these areas at a later date. The agency did not provide an option to comment on this final rule aside from requesting comments related to the Paperwork Reduction Act only.

The final rule will also change, and codify, some of the terminology used to describe certain actions. For example, “GRAS determination” in the previous GRAS notices will now refer to “GRAS conclusion” or “conclusion of GRAS status.” The new GRAS notices will refer to “signed statements” as opposed to a “claim” in earlier GRAS notices. FDA has established new sections in 21 CFR 170.203 and 21 CFR 570.203 that list the new definitions and terms to be used in future GRAS notices, for food and animals, respectively.

Notable in this final rule, as compared to the proposed rule, is the use of the word “required” by FDA for the new actions and many of the actions performed in GRAS notices based on the proposed rule and FDA guidance documents (See Table 2 – Summary of the Principal Changes to the Proposed Notification Procedure; 81 FR 54969 – 54970).

The format for future GRAS notices will now be divided into seven parts, all of which must be discussed in the document. FDA describes this format in new sections 21 CFR 170.225 through 170.255 and 21 CFR 570.225 through 570.255, respectively, for human food (CFSAN) and animal food (CVM).

One very troubling aspect of this final rule is that FDA has now expressly given itself the option of extending the targeted 180 day review/completion period for another 90 days “… on an as needed basis.” Most notifiers would prefer a shorter review/completion period rather than a longer one.

One predictable outcome of this final rule is that FDA is likely to receive more GRAS notices to review. As discussed, and implied, in the preamble to the final rule, one way for the agency to keep up with the workload is to refuse to accept submissions during their pre-filing review if, in FDA’s opinion, the document does not meet the requirements for GRAS or conform to the prescribed format. Coupling this with the agency’s ability to extend the review to 9 months could result in longer review times.

The GRAS final rule, which becomes effective on October 17, 2016, will present challenges and difficulties in understanding and making certain that all of the requirements are met. Going forward, EAS stands ready to assist all clients in successfully managing these requirements to secure a successful GRAS notice.