4 Dec 2015
FDA Issues Final Rules on Foreign Supplier Verification Programme, Produce Safety Standards and Accreditation of Third-Party Auditors
The Food and Drug Administration has issued three separate final rules implementing key sections of the Food Safety Modernization Act in an effort to improve the safety of domestically-produced and imported human and animal food by shifting the focus to preventing food safety problems rather than responding to problems after the fact. These rules involve (i) standards for the growing, harvesting, packing and holding of produce for human consumption; (ii) foreign supplier verification programmes for importers of food for humans and animals; and (iii) accreditation of third-party certification bodies to conduct food safety audits and to issue certifications. These rules will be effective as of 26 January 2016. The FDA has now issued five of the seven major rules required to implement the core of the FSMA. The previous two, setting forth preventive controls for human and animal food, were published in September and will start taking effect next autumn.
To minimise the risk of serious adverse health consequences or death from consumption of contaminated produce, the FDA is establishing enforceable science- and risk-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables on foreign and domestic farms. This rule covers all fruits and vegetables except those rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule.
The rule sets forth procedures, processes and practices that minimise the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. These standards include requirements for water quality, employee health and hygiene, wild and domesticated animals, biological soil amendments of animal origin (such as compost and manure), and equipment, tools and buildings. The new requirements are expected to reduce food-borne illness associated with the consumption of contaminated produce.
Foreign Supplier Verification Programmes for Food Importers
This rule requires importers of food for humans or animals, with some exceptions, to verify that the food they import is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug and Cosmetic Act, is not adulterated, and is not misbranded with respect to food allergen labelling. The FDA states that this rule is designed to be flexible based on risk and that the requirements vary based on the type of food product (e.g., processed foods, produce and dietary supplements) and category of importer.
The U.S. owner or consignee of a food offered for import into the United States, or if there is no U.S. owner or consignee the U.S. agency or representative of the foreign owner at the time of entry, will be responsible for (i) determining known or reasonably foreseeable hazards with each food; (ii) evaluating the risk posed by a food based on the hazard analysis and the foreign supplier’s performance; (iii) using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities; (iv) conducting supplier verification activities; and (v) conducting corrective actions.
Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported. Importers are also required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if (i) they are in compliance with the supply-chain programme requirements under the preventive controls rules; (ii) they implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or (iii) they are not required to implement preventive controls under those rules in certain specified circumstances. Examples of such circumstances include when the type of food (e.g., coffee beans) could not be consumed without application of a preventive control, or when the customer will be significantly minimising or preventing identified hazards and they comply with requirements for disclosures and written assurances.
The evaluation of the risk posed by the imported food and the supplier’s performance must be re-evaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance. Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements. Importers must also disclose in documents accompanying the food that the food is not processed to control the identified hazard.
The final rule includes elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. For example, importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation.
Accreditation of Third-Party Certification Bodies
The last rule establishes a programme for the accreditation of third-party certification bodies (auditors) to conduct food safety audits of foreign food entities, including registered foreign food facilities, and certify that they and the food they produce meet applicable food safety requirements. These certifications will be required for participation in the FDA’s voluntary qualified importer programme, which offers participants expedited review and entry of food that is part of the VQIP. In addition, in certain circumstances the FDA will require as a condition of entry a certification issued by either a third-party certification body accredited under this rule or an agency or representative of the government of the country from which the food originated.
Requirements that third-party certification bodies must comply with cover legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. In limited circumstances the FDA may directly accredit third-party certification bodies. For example, the agency could directly accredit a body if it has not identified and recognised an accreditation body within two years after establishing this programme. To promote international consistency and utilise an existing framework that is familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with ISO/IEC standards, supplemented as necessary, in meeting programme requirements under this rule. The FDA will closely monitor participants in the programme and may revoke an accreditation body’s recognition and withdraw a certification body’s accreditation if there is cause.