The Food and Drug Administration (FDA) has released three more major final rules implementing the FDA Food Safety Modernization Act (FSMA). The final rules are:
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule);
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule);
- Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party Certification rule).
FDA also has published an Environmental Impact Statement for the Produce Safety rule. The final rules will be published in the Federal Register on November 27, 2015, the Friday after Thanksgiving.
FDA has posted fact sheets and other materials explaining the final rules on its website (see generally FDA’s FSMA webpage) and announced that it will host two webinars on November 17th (Produce Safety rule) and 23rd (FSVP and Third-Party Certification rules) explaining the final rules in greater detail.
As explained by FDA Deputy Commissioner Mike Taylor today, these regulations apply a preventive approach to two areas where FDA regulation has previously tread lightly, farms and food imports.
This posting provides a brief summary of the highlights of the three final rules released today. More detailed analyses of these lengthy and complex regulations will follow in later blog posts and OFW Law memoranda.
The final rule establishes minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables by farms. It includes the following key provisions:
- The expanded definition of “farm” in the final rule on Preventive Controls for Human Food is adopted in the Produce Safety rule. The definition of “farm” now includes both “primary production farms” and “secondary activities farms,” the latter being off-farm operations engaged in harvesting, packing or holding raw agricultural commodities, provided that the primary production farm that provides most of the raw agricultural commodities owns a majority interest in the secondary activities farm.
- For operations that meet the definition of “farm,” the rule imposes requirements in the following five areas: (a) agricultural water quality; (b) biological soil amendments; (c) domesticated and wild animals; (d) worker training and worker health and hygiene; and (e) equipment, tools, and buildings.
- The final rule includes separate and highly prescriptive requirements applicable to sprouts.
- There are exemptions or modified requirements, including for the following:
- Produce that is not a “raw agricultural commodity”;
- Produce that FDA identifies as rarely consumed raw (e.g., sweet corn, cocoa beans, eggplant, peanuts, potatoes);
- Food grains and oilseeds;
- Produce that is used for personal or on-farm consumption;
- Produce that receives commercial processing that adequately controls microorganisms of public health significance; and
- Farms that have average annual sales of produce of $25,000 or less.
- States, tribes, and foreign countries only may petition FDA for variances from one or more of the rule’s requirements.
- Covered activities, except for those involving sprouts, must comply with the final rule by the following dates:
- For very small businesses (i.e., those with more than $25,000 but not more than $250,000 in average annual sales of produce), four years after the effective date of the final rule;
- For small businesses (i.e., those with more than $250,000 but not more than $500,000 in average annual sales of produce), three years after the effective date of the final rule;
- For other farms, two years after the effective date of the final rule; and
- For certain water quality standards and related testing and recordkeeping requirements, an additional two years beyond the above compliance dates.
- FDA plans to issue several guidance documents, including a general guidance on the rule, a Small Entity Compliance Guide, and guidance on sprouts.
- FDA asserts that the water quality standards for agricultural water will be more flexible than those proposed. The final rule will have to be carefully parsed to understand whether this purported flexibility will, in fact, be workable in agricultural production.
- FDA is developing a comprehensive training strategy in cooperation with the Produce Safety Alliance, the Sprout Safety Alliance, the National Institute of Food and Agriculture, and other partners. FDA also hopes to create a network of institutions (including cooperative extension units, land grant universities, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), trade associations, and foreign partners) that can provide technical assistance to farmers.
The FSVP final rule requires importers of human food and animal food to develop and implement a Foreign Supplier Verification Program for each food they import into the United States and each foreign supplier of that food. If an importer imports the same food from multiple foreign suppliers, a separate FSVP is required for each foreign supplier.
Key provisions of the final rule include the following:
- The FSVP “importer” is the U.S. owner or consignee of a food offered for import. If there is no U.S. owner or consignee, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.
- The importer is responsible for the following actions:
- Conducting a hazard analysis of the imported food;
- Conducting a risk evaluation for the imported food and the foreign supplier;
- Using the risk evaluation to determine appropriate foreign supplier verification activities;
- Conducting foreign supplier verification activities;
- Taking corrective actions as appropriate; and
- Establishing and following written procedures to ensure that it imports food only from approved foreign suppliers (or, when necessary on a temporary basis, from unapproved foreign suppliers whose food has been subjected to adequate verification activities before being imported).
- The importer may rely on another entity to perform many of the above actions (e.g., conduct a hazard analysis, conduct a risk evaluation, select and perform foreign supplier verification activities), provided the importer reviews and assesses the relevant documentation. The other entity performing these activities generally may not be the foreign supplier. However, the importer may rely on a hazard analysis performed by the foreign supplier, provided the importer reviews and assesses it.
- If the importer is also a manufacturer/processor and is in compliance with the supply-chain control requirements of the relevant preventive controls rule, it is deemed to be in compliance with the FSVP rule.
- Foreign supplier verification activities may include: (a) annual onsite audits of the foreign supplier performed by a qualified auditor; (b) sampling and testing of food; (c) review of the foreign supplier’s food safety records; and/or (d) other appropriate activities. However, where there is a reasonable probability that an identified hazard would cause serious adverse health consequences, annual onsite audits is the “default” foreign supplier verification activity required.
- There are a number of exemptions or modified requirements for the following:
- Very small importers (i.e., importers with average annual sales of human food of less than $1 million, importers with average annual sales of animal food of less than $2.5 million);
- Importers of food from certain small foreign suppliers (i.e., qualified facilities, farms with average annual produce sales of $25,000 or less, shell egg producers with fewer than 3,000 laying hens);
- Importers of dietary supplements; and
- Certain categories of imported foods (e.g., juice products, seafood products, low-acid canned foods, alcoholic beverages, meat and poultry products regulated by the U.S. Department of Agriculture at time of importation, food for research or evaluation, food imported for export, food for personal consumption).
- Covered importers must comply 18 months after publication of the final rule (i.e., July 2017). However, where the imported food is from a foreign supplier subject to the Produce Safety rule or one of the preventive controls rules, the importer must comply 6 months after the foreign supplier is required to comply with the relevant rule.
- FDA plans to issue several guidance documents, including a general guidance on the FSVP rule and a guidance on “how to obtain the necessary expertise to be a qualified auditor.”
- The Food Safety Preventive Controls Alliance (FSPCA) intends to issue a training course for importers. Its training curriculum for food processors will also include a module on the FSVP rule for processors that import food.
This rule establishes the framework, procedures, and requirements for accreditation bodies to be recognized by FDA, and for third-party certification bodies to be accredited by accreditation bodies. It also includes requirements for audits and issuance of food safety certifications by accredited third-party certification bodies.
Food and facility certifications issued by accredited third-party certification bodies are intended to be used for the following purposes:
- Food and facility certifications issued by accredited third-party certification bodies can be used by importers to establish eligibility for the Voluntary Qualified Importer Program (VQIP). VQIP offers participating importers expedited review and entry of the foods they import. One condition of participation is importation of food from facilities audited and certified by accredited third-party certification bodies.
- FDA may make a risk-based determination to require that a food imported or offered for import into the U.S. be accompanied by a certification or other assurance that the food meets the applicable requirements of the FD&C Act. When FDA has determined that a food import is subject to such certification, FDA will require, as a condition of entry, a certification issued either by an accredited third-party certification body or by an agency or representative of the government of the country from which the food originated.
Key provisions of the final rule include the following:
- Accreditation bodies and third-party certification bodies may use documentation of their compliance with ISO/IEC standards to meet the program requirements under this rule, supplemented as necessary. The final rule does not, however, incorporate those standards by reference.
- The final rule does not incorporate by reference Global Food Safety Initiative (GFSI) benchmarked schemes, but does discuss the work of the GFSI with regard to provisions addressing audit quality, auditor competency, and auditor capacity.
- FDA will prioritize applications for accreditation of third-party certification bodies based on food safety needs, rather than following a “first come, first served” approach as had been proposed.
- The final rule clarifies that the requirement to notify FDA, if a serious risk to public health is discovered during an audit, only applies to (a) an unannounced regulatory audit requested to obtain certification, or (b) an unannounced consultative audit requested in preparation for a regulatory audit. Consultative audits that are arranged in advance and announced will not trigger the notification and reporting requirements.
During a conference call with industry today, an FDA official said that the agency plants to implement the new accreditation system as soon as possible after the agency finalizes its draft guidance on Model Accreditation Standards (Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards) and its proposed rule on user fees for accreditation bodies and third-party certification bodies.