Barely a week apart, FDA announced the publication of a slew of guidance documents intended to further implement the food supply chain-related provisions of the Food Safety Modernization Act (FSMA). In this posting, we look at the first set of documents, published on January 24. In an upcoming posting, we’ll look at the second set of documents, published on January 31.
The first set of guidance documents – some draft, some not – brings home the extent to which the Agency is leveraging importers and producers to help ensure the safety of food, regardless of its origin. The documents also show the difficulty of trying to weave together the FSMA regulations in a way that is comprehensible and doesn’t result in undue burdens or complexity. Any party involved in the importation and production of food should closely read these documents, which are briefly summarized below.
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry (Draft Guidance) – This 108(!) page draft guidance includes Q&As on a range of topics, including:
- Applicability of the regulation under given circumstances (e.g., importation of food contact substances; return of U.S. goods by a foreign purchaser; importation of live animals)
- Requirements of an FSVP (e.g., single vs. multiple FSVPs depending on types of food imported and the number of suppliers; whether a supplier’s process or procedure provides at least the “same level of public health protection” – a potentially complex analysis that is the subject of its own guidance (see further below); FSVP obligations that apply to receiving facilities under the preventive controls regulation)
- Qualifications of individuals who develop an FSVP and perform FSVP activities, as well as auditors
- Conduct of a hazard analysis (e.g., identification of known or reasonably foreseeable hazards; obligation to address hazards that are intentionally introduced; records that must be maintained)
- Conduct of an evaluation for foreign supplier approval and verification (e.g., scenarios where a foreign supplier relies on its supplier to control a hazard; evaluation of a supplier’s compliance with FDA food safety regulations; circumstances under which the risk posed by a food and a foreign supplier’s performance must be reevaluated)
- Conduct of foreign supplier verification activities (e.g., how to satisfy this obligation when purchasing food from a broker or distributor; factors to consider in selecting appropriate verification activities; conduct of onsite audits; verification activities for hazards related to transportation; mitigation of conflicts of interest)
- Importation of foods that can’t be consumed without a hazard control, or where a hazard is controlled subsequent to importation, including provision of disclosure statements
- Corrective actions, including examples of such actions and assessment of actions taken by a supplier
- Identification of the FSVP importer at entry
- Maintenance of FSVP records (e.g., retention, storage, and availability to FDA; translation of records in a foreign language)
- FSVP requirements applicable to importation of dietary supplements (e.g., rationale for modified requirements and criteria for eligibility; obligations with respect to importation of finished dietary supplements)
- Requirements applicable to very small importers and to importation of certain foods from countries with an officially recognized or equivalent food safety system
- Consequences of failure to comply (e.g., issuance of 483s and warning letters; refusal of admission; import alert; civil and criminal actions; and debarment)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide – This much shorter guidance focuses on modified procedures for importers that qualify as a “very small importer” as that term is defined in the FSVP regulation, as well as importers of food from certain small foreign suppliers (e.g., qualified facilities and farms that grow produce but are not “covered farms” as that term is defined in the produce safety regulation). The guidance also addresses modified requirements applicable to importers of dietary supplements and components, and of food from countries with officially recognized or equivalent food safety systems.
Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507: Guidance for Industry (Draft Guidance) – In FDA’s words, “[t]his guidance describes FDA’s current thinking on considerations for determining whether a measure or procedure used in lieu of an FDA requirement in 21 CFR part 112, 117, or 507 provides the same level of public health protection (SLPHP) as the corresponding FDA requirement.” Ugly as the acronym SLPHP may be, it’s best to get used to it because it represents a core concept integrated into several FSMA regulations. FDA can be expected to closely scrutinize the basis for an SLPHP determination. The guidance sets forth “Points to Consider” that are “intended to provide a general framework for evaluating the adequacy of a measure to provide the necessary level of public health protection that FDA determined is appropriate by establishing the corresponding requirement” – a potentially heavy lift, given the effort ordinarily expended by FDA in establishing food safety requirements. The guidance forthrightly flags FDA’s expectation that “an SLPHP determination should be supported by sound scientific evidence that is analyzed by competent individuals, taking into account any unique measure-specific considerations.” That said, the guidance recognizes that the scope of an SLPHP evaluation can vary widely, and one can reasonably expect that the corresponding burdens will vary accordingly. The Points to Consider included in the draft guidance are listed below:
- Are the relevant data and information in support of the use of a measure sufficient to make a determination that the measure provides the “same level of public health protection” as the corresponding requirement?
- Are there any unique considerations relevant to the level of public health protection provided by that measure?
- Was the evaluation of scientific and technical evidence conducted by competent individuals using an appropriate process?
- Is the determination of “same level of public health protection” properly documented?
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Chapter 15: Supply-Chain Program for Human Food – FDA previously issued the first six chapters of this draft guidance. Issuance of another chapter that focuses on the supply-chain program requirements in part 17, subpart G dovetails with the issuance of the FSVP guidance documents discussed above. Chapter 15 weighs in at a solid 49 pages and addresses numerous topics, including:
- The definition of “receiving facility” (with examples), and the circumstances under which certain activities required of a receiving facility can be conducted by other entities
- The role of a corporate parent in establishing a supply-chain program
- How to deal with situations where a supply-chain-applied control is applied by an entity other than a supplier
- The use of sampling and testing as a supplier verification activity
- What types of records constitute “relevant food safety records”
- Factors to consider in approving a supplier and determining appropriate supplier verification activities (e.g., a supplier’s food safety history)
- Development of written procedures for receiving raw materials, including those received from brokers or distributors
- Alternative supplier verification activities when a supplier is a “qualified facility”
- Qualifications of a “qualified auditor” (including the need for “at least some actual experience in auditing”)
- Summary of several types of records required to document a supply-chain program
- Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry – This guidance states FDA’s intent to exercise enforcement discretion with respect to certain requirements in the regulations on preventive controls for human and animal food, produce safety, and FSVP. The scope of this exercise of enforcement discretion is summarized in a handy fact sheet. As one especially notable example, each of the four regulations includes a requirement that a manufacturer/processor/importer disclose to its customer when a food is not processed to control an identified hazard, and obtain in return a written assurance that the hazard will be controlled. Based on “feedback from industry expressing concern that certain product distribution chains would require vastly more written assurances… than anticipated by FDA during the rulemaking process,” FDA will not enforce the written assurance requirements pending the initiation of amendatory rulemaking.
Comments on the three draft guidance documents discussed above are due by May 25, 2018.