On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA), which has been touted as the most sweeping legislation of the U.S. food safety law in over 70 years. FSMA makes significant amendments to the Federal Food, Drug & Cosmetic Act (FDCA) which are designed to bolster the regulatory and enforcement authorities of the U.S. Food and Drug Administration (FDA) and impose new regulatory requirements on domestic and foreign companies that supply food for the U.S. market, mandating a more proactive, preventive approach to food safety throughout the food supply chain.
It has now been nearly three years since FSMA was enacted. After sitting quietly the first two years, the FDA made significant progress in 2013. The FDA published five key proposed FSMA implementing regulations, including proposed regulations that would require most food manufacturers to establish “hazard analysis risk-based preventive controls” (“HARPC” proposal) to better prevent food safety problems from occurring, and proposed regulations that would create a new “foreign supplier verification program” to help ensure that food from foreign and domestic suppliers meets equivalent food safety standards. FDA will not begin to enforce these new FSMA requirements until final regulations are issued and take effect. In addition, many more rules remain in the pipeline, such as those related to the prevention of intentional adulteration and sanitary transport of food products.
The regulatory and enforcement policies being developed by the FDA to implement the FSMA requirements will have far-reaching implications for the food industry. Companies need to be well informed about the impact FSMA may have on their businesses and should be actively engaged in the policy development process to ensure that FDA receives the stakeholder input it needs to properly implement FSMA in a manner that promotes its public health objectives without imposing undue hardship on food companies. Although the comment period has closed for two proposed regulations, the FDA has recently extended the comment period for two proposed regulations that would impact food imports by an additional 60 days, so there is still time for companies to submit comments on the regulations.
A summary of the proposed regulations is provided below.
Hazard Analysis & Risk-Based Preventive Controls for Human Food
On January 16, 2013, the FDA published its proposed regulation titled, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” (HARPC proposal). This rule applies to both domestic and foreign facilities that manufacture, process, pack or hold human food. This includes facilities (e.g., manufacturers, processors, warehouses, storage tanks and grain elevators) that are required to register with FDA under FDA’s current food facility registration regulations.
Under the proposed rule, facilities would be required to evaluate food safety hazards, identify and implement preventive controls to address these hazards, verify that preventive controls are adequate, take corrective action when needed, maintain a written hazard control plan, and document the effectiveness of the plan and corrective actions. The proposed rule sets forth how entities would be required to undertake these activities. In drafting the proposed rule, FDA sought to create flexible standards that are science and risk-based, allowing preventive control plans to be tailored on a case-by-case basis to address the food safety hazards that are associated with the particular food.
The rule will become effective 60 days after the final rule is published, and most businesses will have one year to comply. Small businesses will have two years to comply and very small businesses will have three years. The deadline to submit comments on the proposed rule closed on November 22, 2013.
Produce Safety Standards
On January 16, 2013, the FDA also published proposed produce safety regulations titled, “Standards for Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption” (“produce safety” proposal). The proposed regulations would govern farm operations, which historically have been largely excluded from FDA regulation, and would focus on microbiological hazards related to growing, harvesting, packing, and holding produce that is typically consumed raw. Specifically, it would establish safety standards related to worker training, health and hygiene, agricultural water, biological fertilizers and other soil amendments, equipment, tools, and buildings, and special measures for handling sprouts.
Most produce farms would be required to comply with the new produce safety rules, although small farms may be exempt. The proposed rule would apply to both domestic and imported produce, but would not apply to specified produce that is rarely consumed raw or to produce that receives commercial processing that adequately reduces the presence of microorganisms (i.e., a “kill-step” such as pasteurization or irradiation).
Similar to the proposed preventive controls rule, the produce standards will become effective 60 days after the final rule, but FDA will exercise enforcement discretion to give farms more time to comply. The comment period on the proposed produce safety standards closed on November 22, 2013.
Foreign Supplier Verification Programs (FSVPs)
On July 26, 2013, the FDA published proposed regulations relating to the import provisions of FSMA – the proposed “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.”
The FSVP will strengthen the oversight of imported foods for U.S. consumers by shifting the FDA’s historical focus from catching food safety problems at the border to preventing food safety problems before foods arrive on U.S. shores. Under the FSVP regulations, food importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides comparable levels of food safety protection compared to food that is produced domestically. Under the proposed FSVP rule, the “importer” that would be responsible for FSVP compliance would be a U.S. company. The importer would be the U.S. owner or consignee of the food at the time of entry, if one exists. If there is no U.S. owner or consignee at the time of entry, the importer would be the U.S. agent or representative of the foreign supplier or consignee.
Under the FSVP proposed regulations, importers would be required to review the compliance status of the foreign supplier, analyze hazards associated with each food to be imported, verify that hazards reasonably likely to occur are adequately controlled, take appropriate corrective action to address deficiencies, and reassess FSVP activities at least once every three years or in response to a new potential hazard. Importers also would be required to keep certain records regarding verification activities.
Certain importers would be exempt from some FSVP requirements, such as importers of dietary supplements, very small imports, and imports from foreign suppliers in good compliance standing with that country’s food safety system that has officially been recognized as comparable or equivalent to that of the United States (currently only New Zealand).
In addition, the proposed rule exempts certain categories of imported food from the FSVP regulations, such as certain juice, fish, and fishery products, food imported for research or evaluation, food for personal consumption, food that is transshipped or imported for further processing and export, and alcoholic beverages.
To assist importers in developing and following the FSVPs, the FDA plans to publish draft guidance at the time it issues its final regulations. The effective date of the regulations will be 60 days after publication of the final rule, although the compliance date will generally be 18 months after publication.
The deadline to comment on the proposed FSVP regulations is January 27, 2014.
Accreditation of Third-Party Auditors/Certification Bodies
On July 25, 2013, the FDA also published its proposed regulations titled, “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” (“third-party accreditation proposal”). This rule would establish a program to accredit third-party auditors to conduct food safety audits and issue certifications to foreign facilities and the foods for humans and animals they produce. Although importers will not generally be required to obtain certifications, FSMA grants FDA the authority to require certifications of compliance before certain designated high-risk foods can be imported into the United States. In addition, food from foreign facilities that are certified by an accredited third-party generally would be eligible to participate in the Voluntary Qualified Importer Program (VQIP) that currently is being developed by FDA under FSMA. The VQIP is designed to incentivize the certification process by expediting food imports from certified facilities. While certifications are not required under the FSVP, FDA has indicated that certifications could be used on a voluntary basis as a means of complying with FSMA’s FSVP requirements.
FDA’s third-party accreditation proposal contains requirements for the third-party accreditation bodies and auditors, as well as standards for the auditing and certification of foreign food facilities. Among the most controversial provisions of the proposed rule is the requirement that auditors notify the FDA of conditions in a food facility that could cause a serious risk to public health. If this provision is included in the final rule, foreign food facilities audited by accredited third-parties could risk having serious manufacturing violations being reported to the FDA if these violations are not identified and corrected prior to an audit.
The FDA intends to issue draft model accreditation standards to specify what qualifications a certification body must have in order to qualify for accreditation, such as the minimum requirements for education and experience for third-party auditors and their audit agents. The draft model accreditation will be subject to public review and comment prior to finalization. The FDA intends to implement the third-party accreditation program as soon as possible after publication of the final rule and final model accreditation standards.
Comments on the proposed rule are currently due by January 27, 2014.
Hazard Analysis & Risk-Based Preventive Controls for Animal Food
On October 29, 2014, the FDA published proposed regulations to establish requirements for “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” (“HARPC/animal food” proposal). The proposed rule would establish for the first time regulations on current good manufacturing practices that are specifically designed for the manufacturing, processing, packing and holding of animal food. In addition, facilities that process animal food, including pet food products, animal feeds and aquaculture feeds, would be required to establish and follow food safety plans which include preventive controls, comparable to the requirements that would apply to foods for human consumption. Both domestic and foreign facilities that are already required to be registered with FDA under well- established provisions of the FDCA, would be required to comply with the proposed HARPC/animal food requirements. As with the HARPC proposal for human foods, the HARPC/animal food proposal would require covered facilities to establish and maintain extensive records.
The rule will be effective 60 days after the final rule is published. Recognizing that small and very small businesses may need more time to comply with the requirements, FDA has proposed tiered compliance dates based on facility size.
Comments on the proposed rule are due by February 26, 2014.