Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Released: 2016-12-16T00:00:00

C ongress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353 ), which was signed into law on January 4, 2011. FSMA represented the largest expansion and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight authority at the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS), but did not alter oversight authorities within other federal agencies responsible for food safety, such as the U.S. Department of Agriculture.

Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. These included several "foundational" rules required to fully implement FSMA covering preventive controls for human food and for animal food, produce safety, sanitary transportation, intentional adulteration, and development of a Foreign Supplier Verification Program along with a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. These regulations become final in 2016. This report documents the scheduled timeline for action on selected FSMA provisions, as specified in the enacted law, and FDA-reported actions taken to date.

Overview of FSMA Provisions

FSMA focused on FDA-regulated foods and amended FDA's existing structure and authorities, in particular the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). Among its many provisions, FSMA expanded FDA's authority to conduct a mandatory recall of contaminated food products; enhanced surveillance systems to investigate foodborne illness outbreaks; established new preventive controls and food safety plans at some food processing facilities and farms; enhanced FDA's traceability capacity within the nation's food distribution channels; increased inspection frequencies of high-risk food facilities (both domestic and foreign facilities); and expanded FDA's authority and oversight capabilities regarding foreign companies that supply food imports to the United States. FSMA does not directly address meat and poultry products under the jurisdiction of USDA.

When the law was enacted, FDA has identified five key elements of FSMA:

Preventive controls —FSMA provides FDA with a legislative mandate to require comprehensive, prevention-based controls across the food supply. As examples, the act requires mandatory preventive controls for food facilities and mandatory produce safety standards, and also gives FDA the authority to prevent intentional contamination. Inspection and Compliance —FSMA provides FDA with the ability to conduct oversight and ensure compliance with new requirements and to respond when problems emerge. Examples include establishing a mandated inspection frequency (based on risk); giving FDA access to industry records and food safety plans; and requiring certain testing to be conducted by accredited labs. Response —FSMA provides FDA with the ability to respond to problems when they emerge. Examples include giving FDA mandatory recall authority for all food products; expanding FDA's authority to administratively detain products that are in violation of the law; giving FDA the authority to suspend a facility's registration, effectively prohibiting the company from selling any products within the United States; establishing pilot projects so FDA can enhance its product tracing capabilities; and requiring additional recordkeeping by facilities that "manufacture, process, pack or hold" foods designated as "high-risk." Imported Food Safety —FSMA provides FDA with the ability to help ensure that food imports meet U.S. food safety standards. Examples include requiring importers to verify that their foreign suppliers have adequate preventive controls; establishing a third-party verification system; requiring certification by a credible third party for high-risk foods as a condition for entry into the United States; establishing a voluntary qualified importer program for expedited review and entry from participating importers; and giving FDA the right to refuse entry into the United States of food from a foreign facility if FDA is denied access to the facility or the country where the facility is located. Enhanced Partnerships —FSMA provides FDA with the authority to improve training of state, local, territorial, and tribal food safety officials. Examples include requiring FDA to develop and implement strategies to enhance the food safety capacities of state and local agencies through multi-year grants, as well as strategies to enhance the capacities of foreign governments and their industries; and giving FDA the authority to rely on inspections of other federal, state, and local agencies in meeting its increased inspection mandate for domestic facilities.

FSMA authorized additional appropriations and staff for FDA's future food safety activities. The Congressional Budget Office (CBO) estimated that implementing the newly enacted law could increase net federal spending subject to appropriations by $1.4 billion over a five-year period (FY2011-FY2015). FSMA authorizes an increase in FDA staff, to reach 5,000 in FY2014.

During the regulatory development phase of FSMA, seven "foundational" rules were identified as required to fully implement FSMA (see listing in text box below). These regulations were to have been proposed or, in some cases, finalized within one to two years of enactment (roughly January 2012 and January 2013); other rules were to have been submitted within 18 months of enactment (roughly mid-2012). However, FDA's regulations were not finalized until 2016. Some other FDA actions under FSMA were also delayed. Table 3 documents the scheduled timeline for actions on selected FSMA provisions, as specified in the law, and FDA-reported actions taken to date, based on available FDA press releases and publicly available progress reports. For more information about each of these provisions, see Appendix B in CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353) .

Delays in FSMA's Implementation Schedule

FDA began to release proposed rules for some of the foundational regulations that constitute the food safety framework under FSMA in 2013. However, there were continued delays in the agency's release of other FSMA rules, industry guidance, and reports, well beyond the dates required under the law. These delays were exacerbated by FDA's decision to extend the public comment and response period for most FSMA proposed regulations as well as the agency's decision to re-propose key provisions of some regulations. Other factors also contributed to delays in FSMA implementation, including oftentimes a lengthy review process by the Office of Management and Budget's (OMB) and—according to FDA—limited agency resources and the lack of availability of discretionary appropriations. Delays in FDA's rulemaking process resulted in many FSMA regulations being released according to a court-ordered schedule under a federal lawsuit brought by the Center for Food Safety.

Delayed Publication of FDA's Proposed Rules

Publication of FDA proposed regulation often took place well after FSMA's mandated rulemaking schedule. Most of the law's key regulations were not proposed until 2013, with some proposals being delayed until later that same year. For example, proposed rules regarding Preventive Controls for Human Food (FSMA §103) and Produce Safety Standards (FSMA §105) were both released in January 2013. Two other related rules regarding imported foods—Foreign Supplier Verification Program (FSMA §301) and Standards for Third-Party Auditors (FSMA §307)—were not released until July 2013. Proposed requirements for Preventive Controls for Food for Animals (FSMA §103) were not released until October 2013, followed by proposed requirements for Intentional Adulteration (FSMA §106) in December 2013. FDA's Sanitary Transportation of Human and Animal Food proposal (FSMA §111) was released in February 2014.

For some proposed rules, press reports indicated that several proposals were held up, often for many months, by OMB's review process. It was also reported that OMB made changes to several proposed rules while in review.

Extensions in Public Comment and Response Period

Some FSMA proposed rules were granted multiple extensions for public comment and review. For example, FDA's first two proposed foundational rules—Preventive Controls for Human Food (FSMA §103) and Produce Safety Standards (FSMA §105)—were released in January 2013 but later granted a series of extensions, eventually closing on November 15, 2013. These extensions were requested by a wide range of stakeholders, given the complexity of the regulations as well as FDA's delayed release of other related FSMA rules that some groups argued needed to be considered together as a full regulatory package.

FDA's Decision to Re-Propose Certain Key Provisions

Further delay in FDA's implementation of FSMA is attributable to FDA's announcement that would re-propose key provisions in some of its proposed regulations. In the agency's December 2013 announcement, it acknowledged that "significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers," namely regulations implementing Preventive Controls for Human Food (FSMA §103) and also Produce Safety Standards (FSMA §105). Provisions that FDA plans to change "include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms." Some stakeholders expect further changes to other provisions in these proposed rules. In March 2014, FDA announced it would also re-propose regulations implementing a second preventive controls regulation, namely the Preventive Controls for Food for Animals (FSMA §103).

FDA had suggested that they would likely publish the re-proposed sections of these rules at or very near to the same time. The agency also indicated that it will accept "additional comments only on those sections of the proposed rules that have been revised," recognizing the "court order regarding the timelines for finalizing these rules." In September 2014, FDA re-proposed certain aspects of four major proposed rules, including preventive controls for both human food and animal food (FSMA §103(a) and (c)), produce safety (FSMA §105(a)), and the Foreign Supplier Verification Program (FSMA §301(a)).

Congress pushed FDA to consider rewriting these proposed regulations. Several Members of Congress have submitted a series of letters to FDA requesting that the agency release a second set of proposed rules and solicit public comment before going final. Within Congress, two letters were sent to FDA on November 22, 2013, including a House-Senate letter from Senators Shaheen and Blunt and Representatives Courtney and Gibson, and a letter from members of the House Organic Caucus, each expressing concerns about the proposed requirements in FDA's produce rule, among other concerns. A third letter was sent to FDA on November 13, 2013, by Senators Tester and Hagan expressing concerns about the effects of the proposed rules on small farms and facilities. Another letter was sent on November 15, 2013, from Members from Vermont (Senators Leahy and Sanders, and Representative Welch), urging FDA to re-propose these rules. A wide range of stakeholders have also expressed similar concerns and are supporting FDA's reexamination of some of its proposed regulations.

Other congressional actions taken regarding FSMA include the addition of a provision in the enacted 2014 farm bill ( P.L. 113-79 , §12311) requiring FDA to provide Congress with a scientific and economic analysis of FSMA, including an analysis of how the law affects farm businesses of all sizes, prior to implementing final regulations under the law. Recent appropriations bills also have addressed certain aspects of FDA's implementation of regulations under FSMA. As part of the enacted FY2014 appropriations, Congress directed FDA to implement a "comprehensive training program" for federal and state inspectors and commended FDA for its decision to revise its proposed rules affecting farmers. As part of the enacted FY2015 and FY2016 Agriculture appropriations, both the House and Senate Appropriations Committees made a number of recommendations in their respective bills regarding FDA's ongoing efforts to develop FSMA-related regulations and guidance. Both committees have addressed FSMA's re-proposal of certain key regulations regarding food safety preventive controls for both human and animal food, and standards for produce, and have also expressed a range of concerns as FDA has developed regulations under FSMA, including concerns about extensive delays in FDA's rulemaking and implementation of FSMA.

Budgetary and Staff Resources

Limited resources and the availability of discretionary appropriations might also have affected FDA's rollout and full implementation of FSMA. Although the law authorized appropriations, it did not provide the actual funding needed for FDA to perform these activities. When the law was being debated in Congress, CBO had estimated that implementing the law could increase net federal spending subject to appropriation by about $1.4 billion over a five-year period (FY2011-FY2015). The Obama Administration has repeatedly requested that additional user fees be implemented to cover some of these costs, which Congress has not approved. Increases in appropriated funding for FDA's Food Program have not matched the Administration's additional requested user fees. Staff levels at FDA also have remained below levels authorized in FSMA, with an estimated 3,700 FDA staff working on food-related activities in FY2014. As part of the agency's implementation of FSMA, FDA has conducted stakeholder outreach, hosted public meetings, and released web videos and other written materials and presentations.

During the past six years (FY2011-FY2016), enacted budgetary changes for food safety and FSMA implementation (as reported by congressional appropriators) have totaled nearly $300 million. This amount includes the enacted FY2016 Agriculture appropriation for FDA food safety activities, which provided for a $104.5 million increase in budget authority to "assist the FDA in preparation for the implementation of FSMA prior to the effective dates of the seven foundational proposed rules." Previously, FDA reported that an additional $400 million to $450 million per year above the FY2012 base is needed to fully implement FSMA. Available FDA funding for FSMA implementation and other food safety activities has been lower than what FDA has said it needs to fully implement the law.

Lawsuit and Court-Order Deadlines for Final Rules

In August 2012, the Center for Food Safety (CFS) filed suit in federal court against FDA and OMB, citing the government's failure to implement seven food safety regulations required by FSMA (see box below). CFS argues that, by not meeting statutory deadlines for rulemaking, FDA is breaking the law and needs to protect the public.

FDA filed a motion to dismiss the complaint against the agency in November 2012, which was denied by the court in April 2013. As part of a June 2013 agreement, FDA was ordered to complete the regulations as follows: by November 30, 2013, publish all remaining proposed regulations; by March 31, 2014, close any comment period on these proposed regulations; and by June 30, 2015, finalize all regulations.

In July 2013, FDA filed a motion to reconsider, asking the court to extend the implementation timeline for two FSMA-required rules: Sanitary Transport of Food and Feed (FSMA §111) and Intentional Contamination (FSMA §106). This motion was also denied in August 2013.

The Center for Food Safety accepted a 60-day extension of the deadline for publication of the sanitary transport proposed rule (until January 31, 2014), provided that the comment period end date not be extended beyond April 30, 2014, and that the final rule date remain June 30, 2015. The rule timeline for the intentional contamination proposal was not extended, although in November 2013 FDA was later granted a 20-day extension, until December 20, 2013, to publish the proposed rule on intentional contamination due to setbacks that were likely caused by the federal government shutdown in October 2013. Under a February 2014 agreement between FDA and the Center for Food Safety, the agency agreed to a new court-ordered schedule requiring that final FSMA regulations be issued by mid-2016. This schedule further pushed back the implementation dates for final FSMA regulations beyond the dates originally mandated by Congress in the enacted law.

In late 2014, an FDA official indicated that full implementation of FSMA would likely take another 10 years, the amount of time needed to "reasonably expect all the rules to be working."

Expected Compliance Post Rulemaking

FDA's Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA) was released in May 2014 and describes "the next phase of FSMA implementation by outlining broadly the drivers of change in FDA's approach to food safety and the operational strategy for implementing that change, as mandated and empowered by FSMA."

Full implementation of the most FSMA regulations will be phased in over the next several years, mostly to provide flexibility to farms and food businesses to comply with the new requirements, as provided for in the enacted law. In addition, in September 2016, FDA further extended the compliance dates for many regulated facilities, especially small and very small businesses, within the main core regulations including Preventive Controls for Human and Animal Food, Produce Safety Standards, and the Foreign Supplier Verification Program (FSVP) for food imports.

Table 1 provides summary information on FSMA phased-in general compliance schedule. Table 2 compares the compliance schedule for small and very small business compliance periods.