FDA Issues Draft Guidance Documents for FSMA Compliance

Grain MillSince the beginning of 2018 FDA has released draft guidance documents relating to FSMA requirements for animal food.  Before we get into the specific documents here is how guidance documents are defined by the FDA. FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Guidance documents are heavily relied upon by those who are responsible for implementing regulations.  In many cases, they provide beneficial examples of what is meant by a specific regulation.  Sometimes a guidance document will follow a question and answer format and in other cases, it simply elaborate in the meaning of a given regulation.

The FDA may release a draft guidance document which it intends to amend after receiving comments.  The comment period will be for an established period of time 120 days for example and the “official” guidance document will be released sometime after comments are evaluated and incorporated as FDA deems appropriate.  After the official guidance document is released, FDA will accept comments at any time.  Following is another important statement routinely issued by FDA relating to guidance documents.

“This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page”.

The three most recent guidance documents released by the FDA that impact animal food manufacturers include:draft guidance andSmall Entity Compliance Guide (SECG), meant to help industry meet the requirements of the Foreign Supplier Verification Programs (FSVP) regulation and draft guidance document #245 to assist firms with the Hazard Analysis and Risk-Based Preventive Controls part of the regulations.

The two documents relating to the Foreign Supplier Verification Program involve both the FSMA human and animal food regulations.

The small entity guidance document is described by FDA as follows: This guide was developed to inform U.S. importers about the FSVP regulation and how to comply with it. It contains important information that may affect your firm. This guide will focus on the modified procedures for very small importers or importers of food from certain small foreign suppliers. The FSVP regulation is binding and has the full force and effect of law.

Key Requirements of the Foreign Supplier Verification Program

The FSVP regulation applies to importers of food into the United States and contains binding requirements for those subject to the rule. For purposes of this rule, an importer is the U.S. owner or consignee of a food offered for import into the United States. (A U.S. owner or consignee of an imported food is defined as a person who, at the time of entry, owns the food, has purchased it, or has agreed in writing to purchase it.) If there’s no U.S. owner or consignee at the time of entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee.

In general, the requirements of the FSVP regulation apply to all food imported or offered for import into the United States, unless an exemption applies under 21 CFR 1.501.

The FSVP regulation establishes requirements relating to:

  • Use of qualified individuals to conduct FSVP activities,
  • Hazard analysis,
  • Food and supplier evaluation,
  • Foreign supplier verification,
  • Corrective actions,
  • Recordkeeping, and
  • Importer identification for a food offered for entry into the United States.


The draft guidance document is described by FDA as follows. The purpose of this document is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.


The draft guidance document #245 Hazard Analysis and Risk-Based Preventive Controls of Animal Food when finalized is being developed to achieve the following as described by the FDA.

The purpose of this guidance is to help you develop a food safety plan that complies with FDA’s PCAF requirements.


Specifically, this document provides guidance on:


  • the biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal  food


  • the components  of a food  safety  plan and  the importance of each component


  • how to conduct a hazard analysis and develop a food safety plan for the animal food that you produce


  • identifying preventive controls for biological, chemical, and physical hazards associated with animal  food and how to apply those preventive controls


  • preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation))


  • the recordkeeping requirements associated with the food safety plan and implementation of the food safety plan


We (the FDA) recommend that you consider how this guidance relates to your operations and tailor your food safety plan to the specific circumstances for the animal food you produce.  We do not provide all the details you might need for all components of your food safety plan and the type of animal food you manufacture, process, pack, or hold. You have the flexibility to identify and implement preventive controls and associated preventive control  management  components from among  all  procedures,  practices,  and processes that  provide  assurances  that  the hazard requiring a preventive  control is  controlled   (i.e., significantly  minimized   or prevented).

The FDA conducted a webinar earlier this year to explain Guidance Document #245.  The webinar was recently posted on the FDA website.  Here is a link to it.

Industry trade associations like the American Feed Industry Association and the National Grain and Feed Association are reviewing the documents and will be submitting comments for changes.  We will keep you up to date with this process.  While there may be some changes to these documents, most of the information will remain intact and presently serves as a resource in your compliance efforts.

Contact us for assistance with conducting your firm’s hazard analysis or any other assistance you need relating to the animal food safety regulations of the FDA.


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