/>iThe FDA Food Safety Modernization Act (FSMA), enacted in 2011, shifted the focus of the Food and Drug Administration (FDA) from responding to food contamination incidents to preventing contamination from occurring.[1] FSMA amends the Federal Food, Drug, and Cosmetic Act (FFDCA) as it applies to the food supply, and provides FDA with new authority to regulate food. This alert outlines the major provisions of FSMA applicable to industry and FDA’s efforts to implement these provisions.
Title I of FSMA contains requirements relating to the prevention of food safety problems, including hazard analysis and risk-based preventive controls, standards for produce safety, and protecting against intentional adulteration. Title II contains requirements relating to detecting and responding to food safety issues, including FDA’s mandatory recall authority, its authority to administratively detain food, and the Reportable Food Registry. Title III contains requirements relating to improving the safety of imported food, including the Foreign Supplier Verification Program and accreditation of third-party auditors of foreign facilities. A table summarizing FDA’s activity under FSMA is provided.
TITLE I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS
Expanding Access to Records
Section 101 of FSMA provides FDA with access to facilities’ records relating to articles of food likely to cause serious adverse health effects or death. Prior to FSMA’s enactment, FDA had access only to records relating to an article of food that it reasonably believed to be adulterated and presented a threat of serious adverse health consequences or death. Now, FDA also has access to records relating to any other article of food that it believes likely may be affected in a similar manner. FDA’s records access authority extends to both domestic and foreign entities that manufacture, process, pack, transport, distribute, receive, hold, or import articles of food, except for farms and restaurants. FDA issued a final rule regarding records access in April 2014.[2]
FDA issued guidance in April 2014 stating that it will have access to records relating to manufacturing, raw materials (ingredients and packaging), product distribution, product inventory, testing, recalls, customer distribution, complaints, and adverse events.[3] However, FDA will not have access to recipes, financial and pricing information, personnel data, research data, and sales data (other than shipment data).
Registration of Food Facilities
Under section 102 of FSMA, food facilities previously required to register with FDA under section 415 of the FFDCA are required to renew their registrations every other year. Section 102 of FSMA also requires domestic and foreign facilities that manufacture, process, pack, or store food to submit additional registration information to FDA, including an assurance that the agency will be permitted to inspect the facility in accordance with its delegated authority. It also authorizes FDA to suspend registration of a facility if it determines that a food manufactured, processed, packed, received, or held by the facility poses a reasonable probability of causing serious adverse health consequences or death, and the facility either was responsible for the danger or had actual or constructive knowledge of the danger. A suspended facility is prohibited from importing or exporting food into the United States, or introducing food into interstate or intrastate commerce.
Reducing the Risk of Adulteration
Section 103 requires facilities to evaluate hazards that could affect the food manufactured, processed, or packaged, and take preventive measures to minimize or eliminate the risk of harm from these hazards.
In 2013, FDA issued a proposed rule that would require hazard analysis and risk-based preventive control requirements to implement section 103 of FSMA as it pertains to human food.[4] The proposed rule would apply to foreign and domestic facilities that manufacture, process, pack, or hold human food. Facilities would be required to submit written plans that include the following:
(1) Hazard analyses that identify known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility;
(2) Preventive controls, including, as appropriate, process controls, allergen controls, sanitation controls, and a recall plan, to ensure that foreseeable hazards would be significantly minimized or prevented;
(3) Monitoring procedures to ensure the preventive controls are being properly implemented;
(4) Corrective actions that would be taken if preventive controls are not properly implemented; and
(5) Verification measures to ensure that the preventive controls are effective.
The proposed rule would also modify existing Current Good Manufacturing Practice (CGMP) regulations to protect against cross-contact of food by allergens, and requested comment on several other CGMP issues. CGMPs apply to a broader range of facilities than the hazard analysis and risk-based preventive control requirements outlined above. FDA predicts that it will issue the final rule for human food in August 2015.
Standards for Produce Safety
Section 105 requires FDA to set scientific standards for the production and harvesting of fruits and vegetables. In 2013, FDA issued a proposed rule for science-based standards for produce on domestic and foreign farms.[5] The proposed rule would focus on specific sources of microbial contamination of produce, such as agricultural water, biological soil amendments of animal origin, bacteria, viruses and parasites, animal feces, and equipment, tools and buildings.
The proposed rule would cover most unprocessed fruits and vegetables but would not apply to produce that is rarely consumed raw or food destined for commercial processing, such as canning.
Intentional Adulteration
Section 106 requires FDA to conduct a vulnerability assessment of the food system and determine how to guard against intentional adulteration of food at vulnerable points. FDA issued a proposed rule in 2013 that would require large facilities to develop written food defense plans that address vulnerabilities in their processes to intentional acts to adulterate food.[6] The proposed rule would apply to domestic and foreign facilities that manufacture, process, pack, or hold food, and are required to register as a food facility. FDA identified four activities that are most vulnerable to adulteration: bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Facilities would be required to identify their most vulnerable processes and develop focused mitigation strategies for each of these processes to reduce the risk of intentional adulteration. FDA predicts that it will issue the final rule in May 2016.
Re-inspection and Recall Fees
Section 107 provides FDA with authority to collect re-inspection fees from importers and domestic and foreign facilities subject to a re-inspection, and to recover expenses for recall activities from domestic facilities and importers that do not comply with recall orders. In September 2011, FDA published a guidance document addressing fee collection.[7] In its guidance, FDA states that examples of non-compliance that might warrant re-inspection include foodborne pathogens in ready-to-eat products, pesticide residues above tolerance levels, and failure to declare the presence of a major food allergen in product labeling.
Sanitary Transportation of Food
Section 111 requires FDA to promulgate rules to ensure the safe transportation of human and animal food. FDA published a proposed rule in January 2014 that addresses common practices that create food risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transport.[8] The proposed rule would apply to shippers, receivers, and carriers that transport food in the U.S. by motor or rail vehicle, whether or not the food enters interstate commerce. Specifically, the proposed rule would establish requirements for vehicles and transportation equipment, transportation operations (such as temperature controls and separation of food items and non-food items), training of carrier personnel in sanitary transportation practices, exchanging information about prior cargos, and maintenance of written procedures and records. FDA predicts that it will issue the final rule in March 2016.
New Dietary Ingredients
Section 113 requires FDA to publish guidance clarifying when a dietary supplement ingredient is a new dietary ingredient (NDI), the evidence needed to document the safety of a NDI, the methods to establish the identity of a NDI, and when a manufacturer should submit a NDI notification to FDA. FDA issued comprehensive draft guidance in July 2011.[9]
TITLE II - IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS
Improving the Tracking and Tracing of Food
Section 204 requires FDA, in consultation with the Department of Agriculture (USDA), to establish pilot projects to evaluate effective methods of tracking and tracing of foods. The program's goal is to increase the number of qualified laboratories, and both domestic and foreign laboratories are eligible for participation.
FDA released a report detailing two pilot projects conducted by the Institute of Food Technologists (IFT) in 2012.[10] One project was for produce and the other was for processed foods. IFT conferred with USDA, state agencies, and consumer groups for proposed foods and product-tracing technologies. The report contains IFT’s recommendations to FDA for improving the tracking and tracing of food.
Mandatory Recall Authority
Section 206 states that if FDA determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded, and exposure to the food will cause serious adverse health consequences or death, FDA must provide the responsible party with an opportunity to cease distribution and recall the article. If the responsible party does not cease distribution or recall the article within the time allotted, FDA may order the party to cease distribution immediately and notify the public.
From fiscal year 2011 to 2013, FDA has exercised its mandatory recall authority only once, when it issued a Notification of Opportunity to Initiate a Voluntary Recall letter to Kasel Associates Industries, Inc. for certain lots of the company’s pet treats.[11]
Administrative Detention of Food
Section 207 provides FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. Under the previous standard, FDA required credible evidence of a threat of serious adverse health consequences or death to order administrative detention. In February 2013, FDA issued a final rule implementing this new standard as required by section 207.[12]
FDA issued guidance in March 2013 to facilitate compliance with the requirements of section 207.[13] According to this guidance, FDA may detain an article of food for a reasonable period, not to exceed 20 calendar days, after a detention order is issued. However, an article of food may be detained for 10 additional calendar days if a greater period of time is required to institute a seizure or injunction action. The entire detention period may not exceed 30 calendar days. The guidance further provides that FDA will have factual information that a food is adulterated or misbranded when it orders administrative detention.
Improving the Reportable Food Registry
Section 211 provides FDA with authority to require a responsible party to submit to FDA easily understandable “consumer oriented” information about reportable foods. A reportable food is a food for which there is a reasonable probability of serious adverse health consequences or death. Section 211 further directs FDA to use this information to create summaries on its website to notify consumers about the food, and grocery chains with at least fifteen locations are required to prominently display these summaries.
In March 2014, FDA published an advance notice of proposed rulemaking which seeks input on a number of issues, including information that should be required in consumer notifications, the format in which the information should be presented, the types of retail establishments FDA should consider grocery stores, and the manner in which grocery stores should be notified that information has been posted on FDA's website.[14]
TITLE III - IMPROVING THE SAFETY OF IMPORTED FOOD
Foreign Supplier Verification Program
Section 301 increases FDA’s authority to oversee foods imported into the U.S. Under the Foreign Supplier Verification Program (FSVP), importers are required to verify that food imported to the U.S. has been produced in a manner that provides the same level of public health protections as food produced domestically.
In 2013, FDA issued a proposed rule regarding the FSVP that focuses on foreseeable food-safety risks.[15] The proposed FSVP regulations would require importers to review the compliance status of food, including whether the food is the subject of a FDA warning letter or import alert, determine the hazards reasonably likely to occur with each food, conduct activities that ensure identified hazards are adequately controlled, and review complaints and take corrective actions in the event of supplier noncompliance. In general, an importer would be required to comply with FSVP regulations within six months after its foreign supplier is required to comply with FSMA preventive controls regulations. FDA predicts that it will issue the final rule in October 2015.
Accreditation of Third Party Auditors
Section 307 details the requirements for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities. FDA published a proposed rule in 2013 that would establish requirements for accreditation, including standards for legal authority, impartiality and objectivity, quality assurance, and competency.[16]
CONCLUSION
FDA has been extremely busy implementing the provisions of FSMA, but still has work to do to complete implementation of FSMA. With its new authority, FDA will be able to more effectively ensure the safety of the U.S. food supply.
[1] Public Law 111-353 (Jan. 4, 2011), http://www.gpo.gov/fdsys/pkg/PLAW-111publ353/pdf/PLAW-111publ353.pdf.
[2] Final Rule: Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements, 79 Fed. Reg. 18800 (Apr. 4, 2014), http://www.gpo.gov/fdsys/pkg/FR-2014-04-04/pdf/2014-07550.pdf.
[3] Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug and Cosmetic Act,http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM292797.pdf.
[4] Proposed Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, 78 Fed. Reg. 3646 (Jan. 16, 2013),http://www.gpo.gov/fdsys/pkg/FR-2013-01-16/pdf/2013-00125.pdf.
[5] Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 78 Fed. Reg. 3503 (Jan. 16, 2013), http://www.gpo.gov/fdsys/pkg/FR-2013-01-16/pdf/2013-00123.pdf.
[6] Proposed Rule: Focused Mitigation Strategies To Protect Food Against Intentional Adulteration, 78 Fed. Reg. 78014 (Dec. 24, 2013), http://www.gpo.gov/fdsys/pkg/FR-2013-12-24/pdf/2013-30373.pdf.
[7] Guidance for Industry on Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act,http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/fooddefense/ucm274176.htm.
[8] Proposed Rule: Sanitary Transportation of Human and Animal Food, 79 Fed. Reg. 7005 (Feb. 5, 2014), http://www.gpo.gov/fdsys/pkg/FR-2014-02-05/pdf/2014-02188.pdf.
[9] Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues,http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm257563.htm.
[10] IFT, Pilot Projects for Improving Product Tracing along the Food Supply System-Final Report(Aug. 12, 2012), http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM341810.pdf.
[11] U.S. Food and Drug Administration, Annual Report to Congress on the Use of Mandatory Recall Authority (Dec. 2013), http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm382490.htm.
[12] Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption, 78 Fed. Reg. 7994 (Feb. 5, 2013), http://www.gpo.gov/fdsys/pkg/FR-2013-02-05/pdf/2013-02497.pdf.
[13] Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide,http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM342591.pdf.
[14] Advance Notice of Proposed Rulemaking: Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act, 79 Fed. Reg. 16698 (Mar. 26, 2014),http://www.gpo.gov/fdsys/pkg/FR-2014-03-26/pdf/2014-06614.pdf.
[15] Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, 78 Fed. Reg. 45729 (Jul. 29, 2013), http://www.gpo.gov/fdsys/pkg/FR-2013-07-29/pdf/2013-17993.pdf.
[16] Proposed Rule: Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, 78 Fed. Reg. 45782 (Jul. 29, 2013),http://www.gpo.gov/fdsys/pkg/FR-2013-07-29/pdf/2013-17994.pdf.
