L A W O F F I C E S 7 0 0 T H I R T E E N T H S T R E E T, N. W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5 9 2 9 ( 2 0 2 ) 7 3 7-5 6 0 0 F A C S I M I L E ( 2 0 2 ) 7 3 7-9 3 2 9 w w w. h p m. c o m MEMORANDUM THE FDA FOOD SAFETY MODERNIZATION ACT ENACTED JANUARY 4, 2011 The FDA Food Safety Modernization Act (FSMA), Pub. L. No. 111-353, is divided into titles that correspond roughly to the goals that have been articulated by the federal government for the modernization of food safety laws, namely (1) shifting the emphasis from response to prevention, (2) improving the government s capacity to detect and respond to food safety problems, and (3) addressing the challenge posed by the nation s increased reliance on food imports. Certain provisions of FSMA are already in effect, namely: Mandatory recall authority (FSMA 206). Stronger records access authority (FSMA 101). Whistleblower protection (FSMA 402). Refusal of imported food from a foreign facilities that refuses inspection (FSMA 306). Increased frequency of inspection (FSMA 201). Authority to suspend food facility registration (FSMA 102). Enhanced administrative detention authority (FSMA 207). Enhanced prior notice of imported food (FSMA 304).
Page 2 Significant provisions of FSMA are the subject of ongoing rulemaking and are expected to take effect in the next two to three years. FDA has issued six major final rules and one proposed rule, including: Final rules on Hazard Analysis and Risk-Based Preventive Controls (preventive controls) for human food, and for animal food (FSMA 103). Final rule on establishment of produce safety standards (FSMA 105). Proposed rule on protection against intentional adulteration (FSMA 106). Final rule on sanitary transportation of food (FSMA 111). Final rule on foreign supplier verification program (FSMA 301). Final rule on accreditation of third-party auditors (FSMA 307). FDA fact sheets addressing each of those rules are attached. Below we present a summary of the provisions of FSMA that will have the most direct impact on industry. Title I Improving capacity to prevent food safety problems This title enhances FDA s authority to inspect records under 414 of the Federal Food, Drug, and Cosmetic Act (FDC Act), imposes biennial food facility registration and authorizes suspension of registration, requires industry-wide mandatory hazard analysis and risk-based preventive controls (preventive controls), authorizes FDA to establish contaminant-specific performance standards (including action levels), authorizes FDA to impose requirements to protect against intentional adulteration, and authorizes the collection of reinspection fees, among other things. Section 101 Inspection of records This section amends FDC Act 414 to expand FDA s authority to access records under that section. FDA can be expected to make aggressive use of its expanded authority in instances where a firm is reluctant to provide access to records and FDA believes that there is a potential significant risk to public health. Amended 414 is effective immediately. Section 102 Registration of food facilities This section changes the current one-time facility registration requirement under FDC Act 415 to a biennial registration requirement, effective in the fall of 2012.
Page 3 415(a)(3). More importantly, FDA is granted authority to administratively suspend a registration, which effectively shuts down a facility until FDA reinstates the registration. Section 103 Hazard Analysis and Risk-Based Preventive Controls (Preventive Controls) This section adds new 418 to the FDC Act, which imposes requirements akin to Hazard Analysis and Critical Control Point (HACCP) requirements on all facilities registered under 415 (including foreign facilities), with certain exceptions. The owner, operator, or agent in charge ( owner ) of a facility engaged in manufacturing, processing, packing, or holding food is required to develop a written analysis that identifies and evaluates a wide range of known or reasonably foreseeable hazards that may be associated with the facility, as well as hazards that may be intentionally introduced, including by acts of terrorism. 418(b). The owner must implement preventive controls, including at critical control points, to assure that the identified hazards are significantly minimized or prevented such that food is not adulterated under FDC Act 402 or misbranded under 403(w), which imposes allergen labeling requirements. 418(c). The owner must monitor the effectiveness of the preventive controls and take corrective action as necessary. 418(d), (e). The owner must prepare a written plan that documents the procedures used to comply with 418. 418(h). The owner must also maintain certain records for at least two years. 418(g). All of these records must be made available to FDA upon oral or written request. There are several exemptions in FDC Act 418. First, dietary supplement facilities in compliance with 402(g)(2) (current good manufacturing practices (CGMPs)) and 761 (serious adverse event reporting) are exempt. FSMA 103(g). Second, seafood and juice facilities in compliance with their respective HACCP requirements are exempt, as are low-acid canned food facilities with respect to the microbiological hazards regulated under 21 C.F.R. Part 113. FDC Act 418(j). Third, facilities subject to produce safety standards under new FDC Act 419 are exempt. 418(k). Fourth, FDA may by regulation exempt or modify the requirements for facilities solely engaged in the production of food for animals, the storage of raw agricultural commodities other than fruits and vegetables intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment. 418(m). The preventive controls requirements are modified for qualified facilities, meaning very small businesses as defined by FDA pursuant to regulation, or those facilities that have average annual sales of less than $500,000 and (1) sell primarily to consumers, or (2) to restaurants or retail food establishments located in the same state or
Page 4 within 275 miles. 418(l). Also, FSMA 103(c) directs FDA to issue a regulation clarifying the applicability of the definition of facility to farms that conduct certain onfarm activities, which could affect whether certain farms are subject to registration under FDC Act 415 and, in turn, to preventive controls under 418. FDA issued final rules on preventive controls for human food and animal food on September 17, 2015 (80 Fed. Reg. 55, 908 and 80 Fed. Reg. 56,170 respectively). FDA fact sheets are attached. Section 104 Performance standards FDA is directed to conduct biennial reviews in conjunction with the United States Department of Agriculture (USDA) to determine the most significant foodborne contaminants. [W]hen appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration... or... the spread of communicable disease, FDA is directed to issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. FSMA 104(a), (b). Section 105 Establishment of produce safety standards This section responds to recent outbreaks of foodborne illness associated with fresh produce. Via rulemaking, FDA will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables... that are raw agricultural commodities to minimize the risk of serious adverse health consequences or death. FDC Act 419(a)(1)(A). The content of, and criteria for, the regulation are specified in 419(a)(3) and (c)(1). There is an exemption for direct farm marketing, to which certain conditions attach. 419(f). FDA issued a final rule on November 27, 2015 (80 Fed. Reg. 74,354). An FDA fact sheet is attached. Section 106 Protection against intentional adulteration Currently, the implementation of measures to protect against intentional adulteration is voluntary. FSMA 106 authorizes FDA to make such measures mandatory. FDA issued a proposed rule on December 24, 2013. An FDA fact sheet is attached. Section 107 Authority to collect fees This section adds new 743 to the FDC Act to authorize FDA to assess and collect fees for costs related to reinspection of domestic facilities or of importers. 743(a)(1)(A). The term reinspection is defined to mean one or more inspections
Page 5 conducted subsequent to an inspection under 704 (or one or more examinations conducted subsequent to an examination conducted under 801) which identified noncompliance materially related to a food safety requirement of the FDC Act, and is conducted specifically to determine whether compliance has been achieved to [FDA s] satisfaction. 743(a)(2)(A). FDA is also authorized to assess and collect fees associated with FDA s conduct of a recall where the responsible party for a domestic facility or an importer does not comply with a mandatory recall order. 743(a)(1)(B). Sections 108, 109, and 110 Building domestic capacity in food safety and defense Section 108 directs FDA and USDA, in coordination with the U.S. Department of Homeland Security (DHS), to develop a National Agriculture and Food Defense Strategy to ensure preparedness of the agriculture and food system, improve detection capabilities, ensure efficient response to emergencies, and secure production after an emergency. Section 109 directs DHS, in coordination with FDA and USDA, to submit annual reports to Congress on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council. Section 110 requires FDA, in coordination with USDA and DHS, to submit biennial reports to Congress on programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities, as well as a report on the need for, and feasibility of, requiring registered food facilities and import brokers to have unique identification numbers. FSMA 110(a)(1), (i). Section 111 Sanitary transportation of food This section grants no new authority. Rather, it directs FDA to implement its existing authority by issuing regulations within 18 months of enactment so as to implement the existing FDC Act 416(b), which governs sanitary transportation of food. FDA issued a final rule on April 6, 2016 (81 Fed. Reg. 20,092). An FDA fact sheet is attached. Section 113 New dietary ingredients This section amends FDC Act 413 to require FDA to notify the Drug Enforcement Administration (DEA) of any FDA determination that the information in a new dietary ingredient notification under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid. FDC Act 413(c)(1). In addition, FDA is directed to publish guidance that clarifies when a dietary supplement
Page 6 ingredient is a new dietary ingredient subject to premarket notification. FSMA 113(b). FDA published a draft guidance in July 2011. Section 115 Port shopping FDA is directed to notify DHS of all instances of refusal of an imported food so that Customs and Border Protection (CBP) can prevent port shopping by notifying other ports of entry. The directive is in effect until such time as FDA issues a final rule implementing 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act ), which authorizes FDA to require a food refused admission to bear the statement UNITED STATES: REFUSED ENTRY. Section 116 Alcohol-related facilities This section exempts from some provisions of FSMA (including preventive controls) certain facilities that are required to (1) obtain a permit or register with the Secretary of the Treasury, and (2) register with FDA under FDC Act 415 because they engage in activities relating to the manufacturing, processing, packing, or holding of alcoholic beverages. Title II Improving capacity to detect and respond to food safety problems This title mandates increased frequency of inspections, provides for accreditation of food testing laboratories, mandates the collection of information on food traceability, confers mandatory recall authority on FDA, greatly enhances FDA s administrative detention authority, and amends the Reportable Food Registry to require grocery stores to notify consumers, among other things. Section 201 Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report FDA is directed to allocate its inspection resources according to the known safety risks of the food, the facility s compliance history, the rigor and effectiveness of the facility s HARBPC plan, whether the food is particularly vulnerable to intentional adulteration, and whether the food has been certified under new FDC Act 801(q) or 806 (see discussion of FSMA 303 and 302 further below). FDC Act 421(a). Beginning on the date of enactment, FDA is directed to increase the frequency of inspections of all facilities, domestic and foreign.
Page 7 Section 202 Laboratory accreditation for analysis of foods The section adds new 422 to the FDC Act, which is designed to ensure that food testing laboratories meet federally prescribed standards for quality, that only such laboratories are used for testing for regulatory purposes, and that results of such testing are provided to FDA. This section has yet to be implemented. Section 204 Enhancing tracking and tracing of food and recordkeeping To facilitate rapid and effective identification of recipients of food to prevent or mitigate foodborne illness outbreaks, or to address credible threats of serious adverse health consequences or death, FDA is directed to publish a proposed rule to establish recordkeeping requirements in addition to those required under FDC Act 414 for facilities that manufacture, process, pack, or hold foods that FDA designates as high-risk. FSMA 204(d)(1). A proposed rule has not yet issued. FDA published a draft approach to designating high risk foods in February 2014. Section 205 Surveillance The Centers for Disease Control and Prevention (CDC) is directed to take a number of measures to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses, including augmenting systems to improve attribution of a foodborne illness outbreak to a specific food. FSMA 205(b)(1). Section 206 Mandatory recall authority This section adds new FDC Act 423 to confer mandatory recall authority on FDA, effective immediately. If FDA determines that there is a reasonable probability that a food other than infant formula is adulterated under FDC Act 402 or misbranded under 403(w), and that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals, then FDA must first give the responsible party an opportunity to cease distribution and conduct a voluntary recall. FDC Act 423(a). If the responsible party refuses to cease distribution and conduct the voluntary recall within the time and in the manner prescribed by [FDA], FDA can issue an order to immediately cease distribution of a food and require notification of all parties in the chain of distribution. 423(b). Section 207 Administrative detention of food FDC Act 304(h)(1)(A) is amended to effectively make it easier for FDA to administratively detain food. Instead of needing credible evidence or information indicating that [a food] presents a threat of serious adverse health consequences or
Page 8 death, FDA needs only a reason to believe that [a food] is adulterated or misbranded. FSMA 207(a). Section 211 Improving the reportable food registry This section amends FDC Act 417, which governs the Reportable Food Registry (RFR), to impose a new consumer notification requirement on grocery stores. FDA can require a responsible party to submit consumer-oriented information including the reportable food s description, identification codes, and contact information for the responsible party. FDC Act 417(f). FDA must then prepare that information as a onepage summary to be published on FDA s web page in a format that can be easily printed by a grocery store. 417(g)(1). If a grocery store sold the food and is part of a chain with 15 or more locations, then the store has 24 hours to prominently display the summary or information from the summary in one of several ways to be specified by FDA, and maintain the display for 14 days. 417(h)(1). Title III Improving the safety of imported food This title requires importers to verify that the food they import meets certain legal requirements, gives FDA the authority to require certification that an imported food complies with the FDC Act, directs FDA to implement a voluntary qualified importer program intended to speed the importation process for participating importers, and provides for accreditation of third-party auditors, among other things. Section 301 Foreign supplier verification program This section of FSMA requires importers to take affirmative steps to ensure that the food they import meets certain requirements of the FDC Act. Importers will be required to verify that an imported food complies with the preventive controls or produce standards discussed above, and is not adulterated under FDC Act 402 or misbranded under FDC Act 403(w). FDC Act 805(a)(1); FSMA 301(d). The requirement for verification does not apply to seafood and juice facilities that comply with the existing HACCP requirements for these commodities, or to low acid canned food facilities with respect to the microbiological hazards regulated under 21 C.F.R. Part 113. 805(e). FDA published a final rule on November 27, 2015 (80 Fed. Reg. 74,226). An FDA fact sheet is attached. Section 302 Voluntary qualified importer program This section effectively authorizes FDA to create a fast lane for importers who import food from certified facilities. FDA is directed to establish, in cooperation with DHS, a voluntary qualified importer program that provides for expedited review and
Page 9 importation by participating importers. FDC Act 806(a). Only certified facilities will be eligible for participation. Facility certification will be issued pursuant to a satisfactory regulatory audit performed by an accredited third-party auditor (see discussion of FSMA 307 and FDC Act 808 further below). Section 303 Import certification While FSMA 302 provides for voluntary import certification, this section authorizes FDA to require import certification for foods associated with food safety problems. As a condition of granting admission, FDA is authorized to require that certain imported foods be accompanied by a certification or other assurances that the food complies with the applicable requirements of the FDC Act. 801(q)(1). Section 304 Prior notice of imported food shipments This section amends FDC Act 801(m)(1) to require that a prior notice of imported food shipments include information on any country to which the article has been refused entry. FSMA 304(a). Section 306 Inspection of foreign food facilities This section adds new FDC Act 807, which specifically authorizes FDA to enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities. FDC Act 807(a)(1). FDA is also directed to focus inspections on foreign facilities, suppliers, and food types that present a high risk. 807(a)(2). An imported food will be refused admission if it is from a foreign establishment to which a U.S. inspector is refused entry for the purpose of conducting an inspection. 807(b). In recognition of the risks posed by seafood, FSMA 306(b) explicitly authorizes the Secretary of Commerce to send inspectors to a country or facility that exports seafood to the United States to assess its farming, cultivation, harvesting, preparation, or transportation practices and provide technical assistance. FSMA 306(b)(1). Section 307 Accreditation of third-party auditors This section directs FDA to establish a system for the accreditation of third-party auditors so as to improve the reliability of third-party audits of foreign food facilities and facilitate implementation of the import certification and voluntary qualified importer programs discussed above. Accredited third-party auditors and their audit agents must notify FDA when they discover a condition that could cause or contribute to a serious risk to the public health. 808(c)(4). FDA issued a final rule on November 27, 2015 (80 Fed. Reg. 74,570). An FDA fact sheet is attached.
Page 10 Title IV Miscellaneous provisions Section 402 Whistleblower protection This section adds new FDC Act 1012 protects an employee from retaliation by an employer when that employee (or a person acting pursuant to the employee s request) (1) provides an employer, the U.S. government, or a state attorney general with information relating to any violation of the FDC Act, (2) testifies or is about to testify in a proceeding concerning such a violation, (3) assists, participates, or is about to assist or participate in such a proceeding, or (4) objects to or refuses to participate in any activity, policy, practice, or assigned task that the employee reasonably believes to be a violation (hereinafter referred to as protected activities ). FDC Act 1012(a). Section 403 Jurisdiction; authorities This section makes clear that FSMA is not intended to alter existing jurisdiction between FDA and USDA and the Department of Commerce, or to alter or limit the existing authority of FDA, USDA, or DHS. Section 404 Compliance with international agreements This section makes clear that FSMA is not to be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party. FSMA 404. * * * If you have any questions pertaining to FSMA or its implementation by FDA, please contact Ricardo Carvajal (rcarvajal@hpm.com) or Riette van Laack (rvanlaack@hpm.com).