The FDA Food Safety Modernization Act (P.L. 111-353)
Released: 2011-02-18T00:00:00

Introduction

The combined efforts of the food industry and government regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, public health officials have estimated that each year in the United States, many millions of people become sick and thousands die from foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. At issue is whether the current food safety system has the resources, authority, and structural organization to safeguard the health of American consumers, who spend more than $1 trillion on food each year. Also at issue is whether federal food safety laws, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.

In 2007 and again in 2009, the Government Accountability Office (GAO) placed food safety on its biennially published list of high-risk areas, one of 30 needing concerted attention by Congress and the Administration. GAO has identified 15 federal agencies collectively administering at least 30 laws related to food safety. The majority of both total funding and total staffing, however, is with the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture (USDA), which regulates most meat and poultry, and the Food and Drug Administration (FDA) at the U.S. Department of Health and Human Services (HHS), which regulates virtually all other foods. FSIS's annual budget in FY2010 was approximately $1.1 billion in appropriated funds, plus an estimated $131 million in industry-paid user fees. FDA's annual budget in FY2010 for its human foods program was $784 million, all of it appropriated.

After discussing several recent food safety incidents and the systemic food safety problems that they illustrate, this report describes the existing food safety legal and regulatory landscape and presents an overview of efforts by the 111 th Congress to revise federal food safety authorities and activities, principally at FDA. It then provides a detailed overview of the major provisions in the newly enacted law—the FDA Food Safety Modernization Act (FSMA, P.L. 111-353 ). The report is organized around a number of selected food safety issues, describing how they are addressed in previously existing law and regulations, and describing their treatment in the newly enacted law. Finally, appendixes provide a crosswalk of all provisions in FSMA, followed by a side-by-side comparison of each of these provisions with previously existing law.

Food Safety Incidents

Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food safety system. Large recalls of FSIS-regulated meat and poultry products due to findings of E. coli O157:H7, Listeria , and other problems occur each year. In addition, in recent years, several large multi-state outbreaks have been linked to FDA-regulated foods. For example, in 2006 more than 200 confirmed illnesses and three deaths were linked to bagged fresh spinach grown in California and contaminated with E. coli O157:H7. In 2008, more than 1,400 persons were infected with an unusual strain of bacteria, Salmonella Saintpaul. Officials first suspected fresh tomatoes, but later tests found the pathogen in serrano peppers and irrigation water from a farm in Mexico. These incidents raised public concerns about the safety of all fresh produce and stimulated a number of industry and government initiatives to limit future incidents.

Attention focused on the safety of food imports in 2007, when pet food ingredients imported from China, contaminated with the chemical melamine, sickened or killed an unknown number of dogs and cats and contaminated some livestock feeds. In 2008, melamine contamination of infant formula in China sickened thousands of children and raised concerns about the safety of infant formula in the United States. The melamine incidents highlighted the limited reach of FDA's oversight of imports, the difficulty in tracing the many pathways taken by a common food ingredient, and the frequent confluence of human and animal food ingredients.

In late 2008 and early 2009, a multi-state outbreak of Salmonella Typhimurium was linked to an institutional brand of peanut butter and other peanut-based ingredients from a single firm. The outbreak sickened more than 700 people in 46 states, and may have contributed to the deaths of nine people. A series of expanding recalls was announced by FDA in early 2009, involving thousands of peanut-containing products from more than 200 companies. Again, the incident highlighted the broad reach of a common contaminated ingredient, and the resultant challenges in rapidly tracing products and removing them from commerce.

In July 2010, health officials noticed a spike in cases of infection with Salmonella Enteritidis, a strain commonly associated with shell eggs, which are regulated by FDA. In August, FDA found the same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies of more than 500 million eggs. In July 2009, FDA had published a long-awaited egg safety regulation, which became effective in July 2010 as the outbreak was well underway. Although most observers believe that the rule, if enforced, will help to prevent shell egg contamination and outbreaks in the future, many remain concerned about the apparent lack of coordination between USDA's egg quality inspection activities and FDA's food safety activities, because both agencies have regulatory responsibility for egg products.

Food Safety Legal and Regulatory Landscape

Federal responsibility for food safety rests primarily with FDA and USDA. FDA is responsible for ensuring that most domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood, fish, and shellfish products. USDA's FSIS regulates most meat and poultry and some egg products. State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments.

The division of food safety responsibility between FDA and USDA is rooted in the early history of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the widespread marketing of intentionally adulterated foods, and its implementation was assigned to USDA's Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meatpacking plants, and implementation was assigned to the USDA's Bureau of Animal Industry. This bifurcated system has been perpetuated and split further into additional food safety activities under additional agencies (for example, the Environmental Protection Agency, the National Marine Fisheries Service, and others) by a succession of statutes and executive directives. The separation of the two major food safety agencies was further reinforced when, in 1940, the President moved responsibilities for safe foods and drugs, other than meat and poultry, from USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in USDA. There has been discussion over time regarding whether this dispersal of food safety responsibilities has been problematic, or whether a reorganization would divert time and attention from other fundamental problems in the system.

In the 111 th Congress, major food safety legislation—the subject of this report—was passed, focusing on changes related to FDA, not USDA. The primary law authorizing FDA activities is the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). Some key FFDCA provisions that are discussed throughout this report are presented in the text box on the next page.

Two of the basic statutory components of FFDCA are "adulteration" and "misbranding." FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily prescribed reasons. For example, food may be deemed adulterated if it contains an added poisonous or deleterious substance or an unsafe food additive or if the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated or may have been rendered injurious to health. Persons who violate FFDCA by, for example, introducing an adulterated or misbranded product into interstate commerce, commit what is referred to as a prohibited act under FFDCA § 301 (21 U.S.C. § 331). Persons who commit prohibited acts are subject to criminal and civil penalties.

Administration Views

The George W. Bush Administration issued several reports and studies calling for major changes in the food safety system. Two Bush Administration initiatives were unveiled in November 2007 and were critiqued and debated extensively during the 110 th Congress. They were the FDA's Food Protection Plan: An Integrated Strategy for Protecting the Nation's Food Supply , and the Interagency Working Group on Import Safety's Action Plan for Import Safety: A Roadmap for Continual Improvement , part of which dealt extensively with food product imports. Both reports generally called for a more preventive risk-based approach to food safety oversight, including more attention to imported foods, among numerous other recommendations.

President Barack Obama, in a March 14, 2009, weekly radio address, called the food safety system a "hazard to public health." He announced a Food Safety Working Group (FSWG) of Cabinet secretaries and senior officials "to advise me on how we can upgrade our food safety laws for the 21 st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them." In July 2009, the FSWG announced a number of steps the Obama Administration was taking, under existing authorities, to improve government safeguards. The group released a one-year progress report in July 2010. Also, the Administration announced that it had "taken steps to reduce the prevalence of E. coli, implemented new standards to reduce exposure to Campylobacter, and issued a rule to control Salmonella contamination," and that "FDA has conducted a pilot study on a tracing system, and HHS, in collaboration with USDA, has rolled out an enhanced and updated www.foodsafety.gov site to provide consumers rapid access to information on food recalls."

The Obama Administration weighed in on the principal bills that were considered by the House and Senate during the 111 th Congress (and that are the subject of this report). The Administration declared its support for the primary food safety bill in the House of Representatives, H.R. 2749 , which had been passed in June 2009. Also, in a July 2010 statement, the Administration urged the Senate to complete its work on its principal food safety bill, S. 510 . In November 2010, the Administration expressed its continued support of the Senate's efforts on its bill. In addition, Administration officials testified on aspects of the legislation. Testimony regarding specific provisions of the House bill was given by FDA Commissioner Dr. Margaret Hamburg to the House Energy and Commerce Subcommittee on Health on June 3, 2009, and by FDA Senior Advisor Michael R. Taylor to the House Agriculture Committee on July 16, 2009.

In October 2009 testimony on the Senate bill, FDA Commissioner Hamburg called S. 510 a "major step in the right direction." Provisions in the bill addressed a key policy concern by refocusing FDA's food safety system on prevention, the Commissioner stated. She added that the bill also generally met another key policy concern, the need for adequate FDA legal tools to implement the new requirements, although some additional provisions, such as effective enforcement mechanisms, should be added. Finally, the Commissioner stated, the legislation must provide or anticipate adequate resources, but it "does not provide a guaranteed consistent funding source to help FDA fulfill its new responsibilities." The Commissioner recommended the inclusion of registration fees, flexibility to adjust facility inspection frequencies, and the use of accredited third parties to ensure adequate resources. These issues are among those discussed later in this report.

Congressional Action

Perceived gaps in federal safeguards have been explored at more than two dozen congressional hearings since 2007. The 110 th Congress made several amendments to FDA's food safety authorities, and increased funding for the primary food safety agencies, but more comprehensive food safety legislation was not enacted.

In the 111 th Congress, nearly a dozen food safety bills, several of them comprehensive, were introduced. The major vehicle in the House was H.R. 2749 , introduced by Representative John Dingell. This bill was amended and approved by the Subcommittee on Health of the House Energy and Commerce Committee on June 10, 2009; and by the full committee on June 17, 2009 ( H.Rept. 111-234 , July 29, 2009). After failing to reach the needed two-thirds majority under suspension of the rules on July 29, 2009, the bill passed the House under regular order, with a recorded vote of 283 to 142, on July 30, 2009.

In the Senate, S. 510 was introduced by Senator Richard Durbin. The Senate Committee on Health, Education, Labor, and Pensions (HELP) amended and reported the bill (without a written report) on December 18, 2009. During 2010, a series of substitute amendments to the bill were offered and debated. On November 30, 2010, a substitute version of the bill ( S.Amdt. 4715 ) passed the Senate with a recorded vote of 73-25. However, a procedural issue held up final action on the legislation; it was resolved when the Senate inserted its version of the bill into an earlier House bill ( H.R. 2751 ) that was cleared by the House. This bill was signed by the President in January 2011 as the FDA Food Safety Modernization Act (FSMA, P.L. 111-353 ).

FSMA generally expands or modifies existing FDA authorities under the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). Among its many provisions, the new law increases frequency of inspections at food facilities, tightens record-keeping requirements, extends more oversight to certain farms, and mandates product recalls if a firm fails to institute them voluntarily.

FDA has identified five key elements to the new law.

Preventive Controls . For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. FSMA requires food processing, manufacturing, shipping, and other regulated facilities to conduct an analysis of the most likely food safety hazards and to design and implement risk-based controls to prevent them. This provision is similar conceptually to the so-called hazard analysis and critical control point, or HACCP, plans required of meat and poultry establishments. The new law requires the establishment of science-based "performance standards" for the most significant food contaminants. To aid in determining such risks and hazards, the new law seeks to improve foodborne illness surveillance systems, aiming for better data reporting, analysis, and usefulness, with the CDC playing a lead role. Provisions in FSMA extend safeguards to the farm level, generally calling for new, science-based "performance standards" for safe production mainly of fruits, vegetables, and related products, and expanding enforcement and record-keeping authorities. The new law facilitates the establishment of science-based regulations for the most significant food contaminants. Inspection and Compliance . FSMA reflects the fact that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FSMA seeks to increase the frequency of plant inspections, specifying how often FDA should inspect food producers, while taking into account the risks posed by specific foods or processes. To aid in such inspections, and to improve the ability to rapidly trace food products through the production and marketing chain in the event of a foodborne illness outbreak, suspected contamination, or other problems, the new law generally seeks to strengthen record-keeping requirements and food traceability systems. Food processing, manufacturing, shipping, and other regulated facilities are required to conduct an analysis of the most likely safety hazards and to design and implement risk-based controls to prevent them. FDA has said that it is "committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches." Industry participants will be required to maintain records for certain time periods and in formats to be prescribed by FDA. The importance of adequate records has been demonstrated in recent food safety incidents, particularly in the case of outbreaks eventually linked to fresh produce. Food establishments, which are already subject to a one-time registration requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act, P.L. 107-188 ; 21 U.S.C. § 350d), will need to re-register more frequently than they have previously. The new law also requires that additional registration information be submitted. Imported Food Safety . FSMA increases scrutiny of food imports, which account for a growing share of U.S. consumption; food import shipments must be accompanied by documentation that they can meet safety standards that are at least equivalent to U.S. standards. Such certifications may be provided by foreign governments or other so-called third parties accredited in advance. FSMA also contains provisions for certifying or accrediting laboratories, including private laboratories, to conduct sampling and testing of food, among other provisions. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards. Response . For the first time, FDA has mandatory recall authority for all food products, if a firm with suspect products fails to recall them voluntarily. FDA had lacked such authority for food, except for infant formula. FDA has said that it expects that "it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls." Enhanced Partnerships . FSMA directs FDA to improve training of state, local, territorial, and tribal food safety officials. The law strengthens existing collaboration among all food safety agencies—federal, state, local, territorial, tribal, and foreign—to achieve its public health goals.

Certain food processing operations are exempt from the proposed HACCP requirements, and some farms are also exempt from the new produce standards. Specifically, farms and food facilities that qualify for an exemption are those businesses with an "average annual monetary value" of less than $500,000 for all food sold during the previous three-year period, provided that the food is sold directly to "qualified end users" such as consumers, restaurants, or retail food establishments located in the same state where the facility sold the food or within 275 miles of the facility, among other requirements. In addition, among the types of businesses that are considered to be "retail food establishments" and therefore generally not subject to the facility registration requirements, FSMA also exempts roadside stands, farmers' markets, and foods sold through a community-supported agriculture (CSA) program.

FSMA is explicit in maintaining the separate jurisdictions between FDA and USDA.

The Congressional Budget Office (CBO) has estimated that implementing the new law will increase net federal spending subject to appropriation by about $1.4 billion over a five-year period (FY2011-FY2015). Although the law authorized appropriations when it established the new food safety system, it did not provide the actual funding needed for FDA to perform these activities. The law provides for limited amounts of fees and other offsets; its implementation will depend largely on discretionary appropriations. Some have already questioned whether an expanded investment in this area is appropriate in the current budgetary climate. FDA's deputy commissioner for foods, Michael Taylor, has indicated that FDA has "already done a lot of work in anticipation of the new law," but that funding will continue to be an issue and that building a new preventive system will require new resources and investment.

For a comprehensive listing of all sections and topics addressed in the new law, see the two appendix tables at the end of this report. The first table, Appendix A , provides a snapshot of each section and topic covered by the new law. The second table, Appendix B , contains a side-by-side comparison of FSMA's provisions with previous law.

Selected Issues

The following sections provide a discussion of the key provisions in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353 ). Unless otherwise noted, references to "the Secretary" mean the HHS Secretary.

Facility Registration

Prior to passage of FSMA, the FFDCA required domestic and foreign food facilities to register with FDA. Excepted were farms, restaurants, retailers, and certain types of nonprofit food establishments and fishing vessels. Renewal was not required on any periodic basis, but registrants were required to notify the HHS Secretary in a timely manner of relevant changes in their status. The FFDCA (§ 801(l); 21 U.S.C. § 381(l)) provided that imported food may not be delivered to the importer, owner, or consignee of the article unless the foreign facility is registered.

FSMA Provisions. FSMA (§ 102) amends FFDCA § 415 to require domestic and foreign facilities to register every two years, and to provide some additional types of contact information, with an abbreviated renewal process available to facilities with no change in status. It provides for new procedures for the suspension of registration if the HHS Secretary "determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals." FSMA also provides for procedures for vacating such a suspension. Importing or introducing such food into commerce is prohibited, and subject to possible civil and criminal penalties and other enforcement actions. FSMA does not change existing exemptions from the registration requirement for farms, restaurants, retailers, and certain types of nonprofit food establishments and fishing vessels. It also does not impose new registration fees for food facilities.

FSMA clarifies the types of facilities included as a "retail food establishment" and therefore generally not subject to the registration requirements. It requires the HHS Secretary to amend the definition of "retail food establishment" to include food sold directly to consumers by a roadside stand or farmers' market, food sold through a community-supported agriculture (CSA) program, or sale and distribution of food at any other such direct sales platform as determined by the Secretary (§ 102(c)).

Record-Keeping and Documentation Requirements

Prior to passage of FSMA, the FFDCA authorized the HHS Secretary to impose record-keeping requirements on domestic and foreign food facilities (except farms and restaurants), and to inspect and copy such records "[i]f the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals." The Secretary must take appropriate measures to ensure that unauthorized disclosure of any trade secret or confidential information is prevented. Through rulemaking, the Secretary has required facilities to maintain records that allow for the identification of the immediate previous sources and immediate subsequent recipients of food.

Prior to passage of FSMA, advocates of food safety reform argued that record-keeping requirements needed to be strengthened to help regulators determine whether firms are complying with the law, and to facilitate outbreak investigations and product recalls. Among their concerns has been that records do not have to be maintained in electronic format, which, these advocates assert, delays outbreak response. Related concerns have included the types and level of detail of records to be kept, how long they should be retained, and access to and use of these records by authorities. Concerns about increased record-keeping requirements and access authority often involve concerns about the intrusiveness of government, as well as about privacy and the protection of sensitive commercial information (trade secrets), for example.

FSMA Provisions. FSMA (§ 101) amends FFDCA § 414 to expand the Secretary's authority to inspect and copy relevant records of a food facility in two ways. It requires that access be provided to the HHS Secretary if he or she "has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals," or if the Secretary "believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals." The Secretary has greater flexibility under the second provision, no longer needing a reasonable belief that food is adulterated in order to access records. The Secretary may allow access to records regarding foods likely to be affected in a similar manner, but will need to believe there is at least a risk of harm. Farms and restaurants (as under previous law) remain fully exempt from this provision. For other facilities, written notification is still required to gain access.

(See the subsequent section on " Notification of Contaminated Products and Product Tracing " for additional provisions relating to record-keeping and documentation.)

Hazard Analysis and Risk-Based Preventive Controls

Prior to passage of FSMA, a broad consensus of policymakers agreed that FDA's system of food safety safeguards should be more proactive in addressing the nation's complex food supply. By and large, the agency's statute and regulations spell out the reasons a food article is to be considered adulterated or misbranded and therefore unfit for consumption. In effect, industry players had been expected to abide by the rules; generally it was only when a problem was detected—often after an illness outbreak was reported or testing found a contaminant in a product—that officials would step in to correct it, or order the industry to do so.

A recurring theme in these discussions was the need for prevention. Virtually all stakeholders, including regulators, the regulated industries, consumer advocates, and food safety scientists agreed that the foundations of any new program should be an understanding of what, and how, hazards can enter the food supply, followed by implementation of measures to prevent these hazards. A popular version of this approach is the so-called Hazard Analysis and Critical Control Points (HACCP) system, which was incorporated in the 1990s by FSIS as a regulatory requirement for all meat and poultry slaughtering and processing establishments. Variations of the HACCP system also had been required by FDA in the processing of seafood, juices, and low-acid canned foods, but not other product categories.

In a number of reports, the committees of the National Academy of Sciences' National Research Council (NAS-NRC) recommended the HACCP approach for food safety. The National Advisory Committee on Microbiological Criteria for Foods, established to offer ongoing advice to the FDA and USDA, agreed with the NAS-NRC recommendations, which dated at least to the early 1990s. The advisory committee also noted that HACCP principles should be standardized to provide uniformity in training and applicability, but also must be developed by each food establishment so they can be tailored to individual products, processing, and distribution conditions.

FSMA Provisions. FSMA (§ 103) creates new FFDCA requirements for each owner, operator, or agent of a food facility to evaluate the hazards that could affect food manufactured, processed, packed, transported, or held there; to identify and implement preventive controls to significantly minimize, prevent, or eliminate such hazards; and to monitor and maintain records on these controls once they are in place. It further specifies the types of hazards that should be evaluated, and requires facilities to conduct a re-analysis at specified intervals, and to maintain at least two years of records to document and verify their control measures, among other details. FSMA requires written HACCP-type and/or broader written food safety plans containing certain requirements as part of its so-called Hazard Analysis and Risk-Based Preventive Controls.

FSMA also contains requirements regarding available FDA guidance documents for seafood (see § 114 and § 103; also see section of this report titled " Targeting of Inspections "). Some facilities are exempt from the requirements under certain conditions, as discussed in more detail in the section below titled " Mitigating Effects on Small Business and Farming Operations ."

Performance Standards

Performance standards typically are specific, quantitative measurements of a property of, or a substance in, food that are selected to serve as benchmarks for whether the food is safe in a broader sense. For example, a microbial performance standard could be used to determine whether a product is contaminated with microbes in general, and whether a problem with the product's processing should be investigated and corrected. The NAS-NRC standards committee reported that a common theme of regulatory performance standards is "to provide clear articulation of what is and is not acceptable in the process or system being regulated." The committee added that regulators like FDA, USDA, and the Environmental Protection Agency (EPA) have employed specific standards for diverse reasons and conditions, based on numerous scientific, legal and practical constraints. FFDCA authorizes FDA to promulgate standards for certain hazards, such as tolerances (or legal limits) for pesticide or drug residues in foods, but had not granted explicit authority to develop standards solely as a means to verify that processing is done in a manner that ensures safe food.

FSMA Provisions. FSMA (§ 104) amends FFDCA to require the HHS Secretary to, at least every two years, review and evaluate epidemiological data, health data, or other information to identify the most significant hazards and to issue guidance or regulations on science-based performance standards to significantly minimize, prevent, or eliminate such hazards. Such standards must be specific to products or product classes, not individual facilities. It places conditions on the issuance of standards, requiring them to be "[b]ased on such review and evaluation, and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent the adulteration of food" under FFDCA. It further requires that this review and evaluation of "health data and other relevant information" be conducted in coordination with USDA.

On-Farm Safety Standards; Safety of Produce

Food safety experts agree that an effective, comprehensive food safety system should include consideration of potential hazards at the farm level. Viewpoints diverge on whether this should be mandatory or voluntary. Should farmers and ranchers be subject to mandatory safety standards, enforced through certification of their practices, periodic inspections, and penalties for noncompliance? Or should public policy continue to encourage voluntary strategies for producing safe foods on farms and ranches, through education, cooperation, and market-based incentives? Historically, the federal government and states have largely relied on the latter approach. In addition, numerous existing laws and regulations already impose restrictions, both direct and indirect, on producers of food commodities; these restrictions involve compliance costs and are intended to meet certain food safety objectives. They include requirements on the use of animal drugs, feed additives, and pesticides.

FDA's "current good manufacturing practice" (CGMP) requirements (at 21 C.F.R. Part 110) apply to manufacturing, packing, or holding human food, but establishments engaged solely in harvesting, storing, or distributing raw agricultural commodities generally are excluded. Farms are among those exempted from a requirement that food facilities be registered with FDA, pursuant to the Bioterrorism Act. Further, FFDCA specifically exempts farms (and restaurants) from requirements to maintain records for up to two years for purposes of identifying "immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals," and to permit officials access to these records if a food is suspected of being adulterated and presents a serious health threat.

Historically, FDA's general approach has been not to impose mandatory on-farm safety standards or inspections of agricultural facilities. Rather, the agency has tended to rely on farmers' adoption of so-called good agricultural practices to reduce hazards prior to harvest. Such practices are issued as FDA guidance, not regulations. For example, in July 2009, the Obama Administration released new draft guidances on three specific types of produce: tomatoes, melons, and leafy greens. However, FDA's final rule (effective July 2010) requiring shell egg producers to implement on-farm safety measures to prevent contamination of eggs by Salmonella Enteritidis (SE) is one example of FDA regulatory activity on-farm.

FSMA Provisions. FSMA (§ 105) creates new FFDCA requirements for farms as well as food processors. The provision that could have the most direct effect on on-farm activity—particularly growers of fresh produce—is the establishment of new standards for produce safety. The law requires within one year proposed regulations for the safe production, harvesting, handling, and packing of those fruits and vegetables (that are raw agricultural commodities) for which the HHS Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. Coordination with USDA is encouraged, along with coordination with state agricultural agencies when enforcing standards, as appropriate. Enforcement could be in the form of audit-based verification systems or other inspection methods. FSMA also includes language to enable a state or foreign government to request a variance from HHS if needed to account for local growing conditions. It requires that any standards address growing, harvesting, sorting, and storage; soil amendments; hygiene; packaging; temperature controls; animal encroachment; and water; and that the Secretary convene at least three public meetings to seek input on the proposals.

FSMA exempts some farms from the requirements under certain conditions, as discussed in the next section, " Mitigating Effects on Small Business and Farming Operations ".

Mitigating Effects on Small Business and Farming Operations

Concerns among farm and rural groups about the potential effects of new food safety requirements on farms and food processors surfaced early in the food safety legislative debate. Most vocal were small farms and processors; organizations representing small, organic, direct-to-market, and sustainable farming operations; and small livestock operations. At issue was whether numerous proposed requirements would be more costly and burdensome to small farms and other small businesses than could be justified by the potential public health protections such requirements are intended to provide. For more detailed information, CRS Report RL34612, Food Safety on the Farm .

Among the options considered during the debate were waiving certain requirements, providing additional time for compliance, providing grants and/or technical assistance to aid in compliance, and exempting certain types of businesses from meeting the requirements. FFDCA exempts some types of businesses from certain food safety requirements. For example, farms, restaurants, other retail food establishments, and certain nonprofit food establishments and fishing vessels are exempt from facility registration requirements under FFDCA § 415.

FSMA Provisions. As discussed, some provisions in FSMA will directly affect farms and food processors (§§ 105 and 103, respectively). Other provisions that could potentially affect farms and food processors include facility registration requirements (§ 102); records access and/or inspection requirements (§§ 101 and 204); food traceability requirements (§ 204); and targeting of inspection resources (§ 201). FSMA, however, provides extensive consideration of the needs of small businesses and provides for coordination of enforcement and education activities with others such as USDA and state authorities.

FSMA explicitly exempts certain food processors from the newly enacted HACCP-type requirements and also exempts certain farms from the new produce standards. Food facilities would qualify for an exemption from the HACCP requirements under § 103 if they are either a "very small business" as defined by FDA in rulemaking, or if the facility's "average annual monetary value" of all food sold during the previous three year period was less than $500,000, provided that the food is sold directly to "qualified end users" such as consumers, restaurants, or retail food establishments located in the same state where the facility sold the food or within 275 miles of the facility. Such a facility must demonstrate that it either has "identified potential hazards associated with the food being produced," and is implementing and monitoring these preventive controls, or that it is "in compliance with State, local, county, or other applicable non-Federal food safety law." Foods produced from such a facility will also need to provide the facility's name and address on a food packaging label or at the point of purchase.

Farms that are exempt from the produce standards under § 105 also include those with a three-year average monetary value of the food they sold of less than $500,000, provided that the food is sold directly to the similarly defined "qualified end users" and if the farm provides similar notification to consumers. The exemption for both facilities and farms may be revoked in the event that a foodborne illness outbreak is directly linked to an exempted facility or farm, or based on a determination by the HHS Secretary.

In addition, as discussed in the " Facility Registration " section, FSMA clarifies the types of businesses that should be considered to be "retail food establishments" and specifies that roadside stands, farmers' markets, and foods sold through a community-supported agriculture (CSA) program also are not subject to the requirements.

It is difficult to estimate what share of all food processing operations might be exempt from the new HACCP requirements, how many farms might be exempt from the new produce standards, or how other small business considerations might possibly mitigate the effects of these and other requirements in the new law. In part, this is because the definition of small and very small business would be determined by HHS in future agency rulemaking and subject to other requirements specified in the measures (see, for example, §§ 103, 105, and 204). Even though farms would continue to be exempt from the facility registration requirements, some farms that also engage in food processing might be affected, but data are not available on what share of farms also engage in food processing. In addition, other stipulations in FSMA require that the foods sold from exempted facilities and farms be sold locally and to certain qualified end-users. Data are not available to determine what share of grower-processors might qualify for such an exemption; such a determination will likely be made on a case-by-case basis.

Targeting of Inspections

Reform advocates had long argued that many recent problems leading to illness outbreaks and recalls might have been avoided if inspectors were more frequently present in plants to monitor sanitary conditions and processes. Due to the differing laws and circumstances that apply to FSIS, for example, the agency's inspectors are in meat and poultry slaughter and processing plants every day, where they must organoleptically (by the senses) examine every live animal and every carcass for defects, and must pass every item before it can enter commerce. Prior to FSMA, FFDCA authorized but did not require FDA to inspect food facilities. Therefore, periodic inspection frequencies were not stipulated, although nothing appeared to prohibit FDA from setting an inspection frequency, or prioritizing inspections based on risk.

Leading up to passage of FSMA, some, including former and current FDA officials, argued that the agency lacked sufficient resources to conduct the number of inspections required to ensure the safety of the food supply, particularly in light of the increasing number of registered food facilities. (See Table 1 .) According to FDA budget documents, while the number of registered facilities increased each year from FY2004 to FY2010, the number of food inspectors decreased by about 15% from FY2004 to FY2008. Due in part to the resource arguments, appropriations for the agency's field activities and full-time equivalents (FTEs) rose each fiscal year from FY2007 to FY2010. The number of inspections of food facilities increased each year between FY2008 and FY2010, but remained below FY2004 levels.

A related issue raised during the food safety debate in the 111 th Congress was how FDA could best target its available inspection resources to protect the public health. Different facilities might not merit the same frequency of inspection. For example, facilities that process and package food might create a greater opportunity for contamination than warehouses that merely store foods. Companies and facilities that have a record of meeting all FDA requirements might present less of a risk than those that do not. Foods produced in countries with food processing and handling standards at least as rigorous as those of the United States might present less of a health risk than those with less rigorous standards.

FSMA Provisions. FSMA requires the HHS Secretary to increase the inspection rate for any food facility required to register under FFDCA § 415. In addition, the Secretary is required to identify high-risk facilities and to allocate resources to inspect facilities according to known safety risks. Risks include the type of food, the facility's history of food recalls, the facility's hazard analysis and preventive controls, and others. The new law requires the Secretary to inspect domestic high-risk facilities not less than once in the five-year period following enactment, and not less than once every three years thereafter. The Secretary is required to inspect domestic non-high-risk facilities not less than once in the seven-year period following enactment, and not less than once every five years thereafter. Also, the Secretary is required to inspect at least 600 foreign facilities in the year following enactment, and in each of the subsequent five years to double the number of foreign facilities inspected. In meeting the inspection requirements, the Secretary is authorized to rely on inspections conducted by other federal, state, or local agencies.

For foreign food facilities registered under FFDCA § 415, FSMA permits the Secretary to enter into arrangements and agreements with foreign governments to facilitate the inspection of those facilities. The Secretary is required to direct resources for inspection of such foreign facilities, suppliers, and food types, particularly those identified as high-risk, to help ensure the safety of the U.S. food supply. Notwithstanding any other provision of law, foreign foods are to be refused entry into the United States if inspectors are refused entry to a facility, warehouse, or other establishment by the owner, operator, or agent in charge, or the government of the foreign country. The new law requires the Secretary to allocate resources to identify and inspect imported foods at ports of entry, according to the known safety risks of the article of food, based on certain factors. It requires the Secretary to submit to Congress not later than February 1 of each year, and to make available to the public via FDA's website, a report including certain information about food facilities, food imports, and FDA foreign offices.

With regard to seafood and other fish products, FSMA includes three specific provisions: establishing interagency agreements to improve seafood safety (§ 201); assessing changes to regulations for post-harvest processing of raw oysters (§ 114); and sending inspectors to assess production of seafood imported into the United States (§ 306). The scope of interagency agreements identified in § 201 includes examining and testing seafood; coordinating inspections; standardizing data; modifying existing processes; sharing enforcement and compliance information; and conducting joint training and outreach. Section 114 requires that two reports (one by the Secretary of HHS and one by the GAO) be submitted to Congress and published when the Secretary issues guidance, regulation, or suggested amendments related to post-harvest processing of oysters. The requirement for the Secretary's report is waived if a consensus agreement is reached among federal and state regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference. Section 306 permits the Secretary of Commerce, in coordination with the Secretary of HHS, to send inspector(s) to a country or facility of an exporter of seafood imported into the United States to assess practices and processes used in farming, cultivation, harvesting, preparation for market, and transportation of seafood. Inspectors also may provide technical assistance related to these activities. For each inspection, the Secretary of HHS must prepare and deliver a report to the subject of the inspection, which may then provide a rebuttal or other comments as specified.

Use of Third Parties for Imports and for Laboratory Accreditation

Prior to passage of FSMA, FDA lacked express statutory authority to regulate private laboratories that sample or test imported foods, nor did it have authority to accredit food laboratories or use others to certify the safety of imported foods. Laboratory accreditation was voluntary, and several domestic and international accreditation organizations could accredit laboratories. FDA may conduct voluntary, on-site assessments of private accredited laboratories. FDA's own laboratories are accredited and, according to FDA, "the laboratory industry favors accreditation." Industry participation in third-party certification programs, such as those that help foreign and domestic producers meet FDA requirements through certification, has been voluntary, although FDA has indicated that participation in such programs may "be beneficial." FDA has also indicated that "there is extensive support for certification programs that audit to determine compliance with internationally recognized criteria," and that domestic suppliers use third-party certification programs "in part because of customer demand."

GAO testified in 2008 that private laboratory accreditation "could leverage outside resources while providing FDA greater assurance about the quality of the laboratories importers use to demonstrate that their products are safe." In January 2009, FDA issued draft guidance on accreditation standards for private laboratories and the test data that such labs should submit to the agency for imported FDA-regulated products that were either detained or subject to an FDA Import Alert. The guidance document encouraged importers to notify the FDA in advance of their submission of a sample to an accredited laboratory, so as "to discourage importers from withholding bad test results, re-testing, or re-sampling." In January 2009, FDA also issued a final guidance document on voluntary third-party certification programs for foods and animal feeds, which set forth attributes for third-party certification programs and procedures for preventing conflicts of interest.

The use of third parties has been promoted as a method for helping FDA to carry out its responsibilities and target enforcement and inspections while better using existing personnel. Concerns have been expressed regarding testing and certification by third parties, and there has been criticism regarding the autonomy given to the importers and private laboratories. Such criticism varies from the manner in which the samples are collected for testing, to the reporting of test results by the importers to FDA, to whether test results accurately reflect all information obtained, such as evidence of FFDCA violations, to potential or actual conflicts of interest. Additionally, critics have contended that although third-party certification may be useful as a commercial marketing tool, it does not necessarily ensure safety, as manufacturers involved in recent foodborne illness outbreaks have passed private third-party and state inspections. For example, in two of the most publicized recent recalls—the recall of 380 million eggs by a single company and the recall of over 3,900 peanut products associated with another—both companies had used outside labs and reportedly knew of positive test results for Salmonella in their products prior to the recalls.

FSMA Provisions. FSMA addresses various ways to curb the potential for such problems through laboratory accreditation and third-party certification programs. FSMA (§ 303) creates a system of accreditation of third-party auditors and audit agents, who certify that importing entities are meeting applicable FDA requirements. Foreign governments, foreign agricultural cooperatives, and other third parties can apply to an accreditation body to be a third-party auditor or audit agent, after the accreditation body performs certain reviews. Accreditation bodies cannot accredit a third-party auditor unless it agrees to issue a written food or facility certification to accompany each food shipment for import into the United States from an eligible entity. Accredited third-party auditors or audit agents are required to issue audit reports and to immediately notify the Secretary of discoveries during an audit of "a condition that could cause or contribute to a serious risk to the public health." The new law also contains language regarding revocation of accreditation and avoidance of conflicts of interest. The question remains as to whether industry will opt to use third parties.

FSMA (§ 202) also includes provisions that require the Secretary to establish a program for testing of food by accredited laboratories and to recognize accreditation bodies to accredit laboratories, including state and local government laboratories. It requires the development of model accreditation standards, as well as re-evaluation of accreditation bodies at least every five years, and it requires that laboratory test results be sent to FDA unless the Secretary exempts the submission of test results after making a determination that the results "do not contribute to the protection of public health."

Mandatory Recall Authority

Prior to passage of FSMA, neither FDA nor FSIS had explicit statutory authority to mandate a recall of most adulterated foods, or to impose penalties if recall requirements were violated. FDA could order food recalls only for infant formula. GAO and others contended that these gaps increased the possibility that unsafe food would not be recovered, and would be consumed. Reversing their earlier opposition, many major food industry groups endorsed legislative proposals to grant FDA mandatory recall authority for food.

FSMA Provisions. FSMA (§ 206) requires the HHS Secretary, if he/she has information "that there is a reasonable probability that an article of food (other than infant formula) is adulterated ... or misbranded ... and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals," to provide an opportunity to the responsible party to cease distribution and recall the food. If the party does not do so "within the time and in the manner prescribed by the Secretary," authority is provided to require such person to cease distribution, or to immediately notify everyone involved in handling or receiving the food. The Secretary is required to provide specified notifications to the public of any recall orders, and to establish an incident command or similar operation within the department to assure coordinated communications during a recall. The law provides for the assessment of civil penalties as well as criminal penalties for failure to comply with or follow a recall order. The assessment of civil penalties for failure to comply with a recall order may preclude the assessment of criminal penalties. If the FDA assesses a civil penalty, the agency would not be able to seek seizures or injunctions for the adulterated food.

Notification of Contaminated Products and Product Tracing

Notification and traceability are viewed as tools to make recalls more effective. Some had argued that improved notification and traceability capabilities would enable either FSIS (in the case of meat and poultry products) or FDA (in the case of other foods) to determine more quickly a product's source and whereabouts, in order to prevent or contain foodborne outbreaks. Traceability was also debated in connection with defense against agroterrorism, and for verifying the origin of live animals and their products for marketing, trade, and/or animal health purposes, for example. In some recent highly publicized outbreaks, it appears that food company representatives were aware of a food safety problem for a prolonged period of time before notifying FDA.

The 110 th Congress responded to some of these concerns by including a provision in the Food and Drug Administration Amendments Act of 2007 ( P.L. 110-85 ) requiring the responsible party for a food facility (i.e., one registered under FFDCA § 415) to notify the Secretary of any food "for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals," and requiring the Secretary to establish a Reportable Food Registry of such reports. Also, the enacted 2008 farm bill ( P.L. 110-246 ) amended the meat and poultry laws to require an establishment to notify USDA if it has reason to believe that an adulterated or misbranded product has entered commerce. (See also the earlier discussion of record-keeping requirements under FFDCA § 414.)

FSMA Provisions. FSMA (§ 211) amends current authority for the Reportable Food Registry to allow the Secretary to require the submission by a responsible party of additional types of information about a reportable food in order to improve consumers' ability to identify it. It also requires grocery stores to conspicuously post one-page information sheets about reportable foods, to be developed by FDA and made available for copying on the agency's website. A store's failure to comply would be prohibited.

FSMA (§ 204) also provides for an enhanced food tracing system that requires the Secretary, through rulemaking, to impose enhanced record-keeping requirements (under FFDCA § 414) for foods that the Secretary determines to pose a higher food safety risk. Low-risk foods may be exempted. A number of limitations of such requirements are stipulated, especially with respect to farms and agricultural commodities. Effective dates for the record-keeping requirements are delayed for small businesses. The Secretary is also required to conduct pilot studies and assessments of food tracing systems to inform the rulemaking process.

Foodborne Illness Surveillance and Outbreak Response

Foodborne illness surveillance is carried out by the states, with assistance from CDC. States also investigate foodborne disease outbreaks, in coordination with CDC, either or both FDA or FSIS (depending on implicated or suspected foods), and other federal agencies, if appropriate. A foodborne disease outbreak is not defined in law or in regulations. In practice, a foodborne disease outbreak is "the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food." As a practical matter, particularly for less serious hazards, outbreak investigations are rarely launched when only two people are affected. (There are exceptions for serious illnesses such as botulism.)

The nation's public health capacity for foodborne illness surveillance and outbreak response is a mix of significant strengths and significant gaps. The ability to link seemingly unrelated illnesses through genetic "fingerprinting" has revolutionized the identification of large multistate outbreaks. However, the epidemiological approaches used to identify the food associated with an outbreak can be labor-intensive and time-consuming. Also, especially for FDA-regulated foods, information about common contaminants that may be present in foods during production and in commerce, as well as how to test for them, is limited. As a result, "attribution"—identifying the types of foods that cause foodborne illnesses—remains a significant challenge. The outbreaks of the past few years underscore the problem, but are not the only evidence. Based on data from FoodNet, its active surveillance system, CDC reported that as of 2009, the incidence of several of the foodborne diseases under surveillance had reached a plateau, instead of declining, and that national 2010 health targets for three out of four targeted pathogens— Campylobacter , Listeria , and Salmonella —may not be met.

FSMA Provisions. FSMA (§ 205) contains provisions that, for purposes of surveillance, define a foodborne illness outbreak as two or more cases of a similar illness resulting from the ingestion of a food. The law requires the Secretary, acting through the CDC, to enhance foodborne illness surveillance systems, including coordinating federal, state, and local systems; facilitating timely sharing of agency findings; ensuring early notification of the food industry when a particular food is suspected in an outbreak; developing improved epidemiological tools; and other prescribed methods. It also contains provisions to establish a working group to improve foodborne illness surveillance and outbreak investigations, and to reauthorize food safety capacity-building grants to states and Indian tribes under the PHS Act. It authorizes the appropriation of $24 million for each fiscal year for FY2011-FY2015 for efforts to enhance foodborne illness surveillance.

Criminal Penalties

Under pre-existing law, the concepts of "adulteration" and "misbranding" are two basic statutory components of FFDCA. FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily prescribed reasons. For example, food may be deemed adulterated if it contains an added poisonous or deleterious substance or an unsafe food additive, or if the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated or may have been rendered injurious to health.

Persons who violate FFDCA by, for example, introducing an adulterated or misbranded product into interstate commerce, commit what is referred to as a prohibited act under FFDCA § 301. Persons who commit prohibited acts are subject to criminal and civil penalties. The penalties vary, depending on the offense. Most criminal liability provisions are found in the "Penalties" section of FFDCA, § 303. Injunctions and seizures may also be sought for adulterated or misbranded products. In light of a number of deaths that appear to have resulted from contaminated food, such as nine deaths linked to tainted peanut butter products, some have called for stronger criminal penalties than the current fines and maximum of three years' imprisonment.

Upon conviction for a misdemeanor violation of the prohibited acts section, a person faces the penalties authorized in FFDCA § 303(a). These are presented in Table 2 . The maximum criminal penalty for individuals (as adjusted by 18 U.S.C. §§ 3559 and 3571) is imprisonment for one year and/or either $100,000 if the misdemeanor does not result in death, or $250,000 if the misdemeanor results in death. The maximum criminal penalty for organizations (as adjusted by 18 U.S.C. §§ 3559 and 3571) is $200,000 if the offense does not result in death and $500,000 if the offense results in death. There are exceptions to the misdemeanor penalty provisions in FFDCA § 303(a)(1). A person could avoid being subject to penalties for certain violations of the prohibited acts section under the good faith exception, and persons may also avoid liability for violations of certain prohibited acts if they receive a guaranty from the manufacturer or the person from whom they received the product.

A violation of FFDCA's prohibited acts section is a felony offense if it occurs after a prior conviction for violating FFDCA's prohibited acts section or if it is committed with the intent to defraud or mislead. The maximum criminal penalty for individuals convicted of a felony violation of FFDCA (as adjusted by 18 U.S.C. §§ 3559 and 3571) is imprisonment for not more than three years or a fine of not more than $250,000, or both. The maximum criminal penalty for organizations (as adjusted by 18 U.S.C. §§ 3559 and 3571) is a fine of not more than $500,000.

Criminal liability may also extend to persons who aid and abet criminal violations of FFDCA, or who conspire to violate FFDCA, as federal criminal law generally makes it a separate crime to aid or abet any criminal offense against the United States or to conspire to commit a criminal offense against the United States. The decision to seek criminal sanctions against individuals and corporations suspected of violating FFDCA is within FDA's discretion. Prosecution may be more likely if the case involves "gross, flagrant, or intentional violations, fraud, or danger to health" or "a continuous or repeated course of violative conduct."

FSMA Provisions. FSMA does not alter the criminal or civil penalties under FFDCA. During the food safety debate in Congress, another Senate bill, S. 3767 (the Food Safety Accountability Act of 2010, as introduced by Senator Patrick Leahy), was considered for inclusion in the final Senate version of the food safety bill ( S. 510 ). The provisions of S. 3767 would have amended the penalties provisions of FFDCA § 303(a) to provide for fines and a maximum prison sentence of 10 years, if a person knowingly violated FFDCA's prohibited acts section. However, these provisions were not included in the final enacted law.

FSMA creates a new FFDCA § 1012 prohibiting food businesses from discharging or otherwise discriminating against an employee who provides or causes to be provided information relating to violations of FFDCA. This would include employees who testify, assist, or participate in a proceeding on such a violation, or who refuse to participate in an activity reasonably believed to violate the FFDCA. The new law also contains extensive language on the procedures for treating and protecting whistleblowers.

Dietary Supplements

Survey data show that about half of American consumers report using dietary supplements. Supplements are subject to routine regulations for foods under FFDCA (including new requirements under FSMA, such as mandatory recall authority). Supplements are also subject to an additional set of regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA), as amended. Among other things, DSHEA requires that manufacturers and distributors who wish to market supplements that contain "new dietary ingredients" (those not marketed in the United States in a dietary supplement before October 15, 1994) notify FDA about these ingredients. Since passage of DSHEA, some confusion has existed regarding the criteria for defining new dietary ingredients and evaluating their safety. Also, there is growing concern about the illegal addition of anabolic steroids to certain performance enhancing supplements.

FSMA Provisions. In addition to the general provisions of FSMA that apply to most foods, including supplements, FSMA includes two provisions specifically focused on supplements (both found in FSMA, Section 113). The first provision requires FDA to notify the Drug Enforcement Administration (DEA) if, when reviewing the safety of a new dietary ingredient, FDA determines that the ingredient may contain an anabolic steroid or its analogue. (DEA regulates anabolic steroids as controlled substances. ) The second provision requires that FDA publish guidelines, within 180 days of enactment, to clarify the definition of a new dietary ingredient, and explain how a product so categorized is to be evaluated for safety.

Food Imports

A steady increase in food imports, a result of globalization and consumer desire for a wider variety of foods year-round, has generated growing concerns about whether current federal programs sufficiently ensure the safety of these imports. FDA import alerts in 2007 and 2008 targeting adulterated pet food ingredients, farmed seafood, and dairy products and ingredients, all from China, are among the incidents that have heightened interest in this issue. Most of the recent debate has included extensive discussion about how to improve current import safeguards, within resource constraints, and without unduly restraining free trade.

Before enactment of FSMA, FFDCA (21 U.S.C. § 381(a)) empowered FDA to refuse entry to any food import if it "appears," based on a physical examination or otherwise, to be adulterated, misbranded, or otherwise in violation of the law. In exercising its oversight, under the provisions of the Bioterrorism Act, the agency relied on a system of prior notifications by importers and document reviews at ports of entry. Importers needed an entry bond and had to file a notification for every shipment. An FDA database, the Operational and Administrative System for Import Support (OASIS), helped inspectors to determine a shipment's relative risk and whether it needed closer scrutiny (i.e., a physical examination, and/or testing). In practice, import inspections were relatively infrequent. The agency recorded more than 8.2 million imported food "lines" in FY2007 (compared with fewer than 2.8 million entry lines in FY1997), of which approximately 1% were physically examined and/or tested. Among the cited reasons for this low incidence of inspections were limited and declining resources, including too few inspectors to cover the more than 360 U.S. ports of entry despite ever-increasing import volumes. Prior law did not explicitly authorize, or require, import verification.

FSMA Provisions. FSMA provisions on food imports (Title III) place tighter controls over imports, and use certification or verification systems involving so-called third parties. FSMA (§ 303) authorizes the HHS Secretary, based on public health considerations, including risks associated with food or its place of origin, to require food imports to be accompanied by "certification or such other assurances as the Secretary determines appropriate" that the food complies with some or all requirements of the act. Among other provisions, certifications are to be used for designated food imported from countries where FDA has an agreement for a certification program. Certifying entities include an agency or representative from the originating country or other persons accredited elsewhere (see section titled " Use of Third Parties for Imports and for Laboratory Accreditation ").

FSMA (§ 301) authorizes a "Foreign Supplier Verification Program," generally requiring each importer to perform foreign supplier verification activities in accordance with regulations the Secretary may issue to ensure compliance with relevant FFDCA provisions. Each importer's program will be able to assure that each of its foreign suppliers produces the imported food employing processes and procedures, "including reasonably appropriate risk-based preventive controls," that are documented in a written plan and equivalent in preventing adulteration and reducing hazards to requirements of other relevant provisions of FFDCA. Verification activities include monitoring records, lot-by-lot certification of compliance, annual on-site inspections, checking the preventive control plan of the foreign supplier, and periodically testing and sampling shipments. Importers are required to maintain import verification program records for at least two years and to make them available to the Secretary upon request.

Other FSMA provisions include specific authorizations for the Secretary to review the equivalence of a foreign country's safety standards, regulations, statutes, and controls and to conduct audits to verify their implementation; and to enter into arrangements with foreign countries to facilitate inspection of foreign facilities. The law also requires the establishment of a program to expedite imports from those who voluntarily agree to certain higher safety standards under the "Voluntary Qualified Importer Program" (§ 302).

Some have questioned whether FSMA will provide FDA with so-called "equivalence authority," such as that governing U.S. imports of meat and poultry products under USDA's FSIS jurisdiction. "Equivalency" refers to the requirement that all imported meat and poultry products meet all safety standards applicable to similar products produced in the United States. Foreign meat and poultry food regulatory systems may apply "equivalent sanitary measures to eliminate or abate food safety hazards" if those measures provide the same "level of public health protection" achieved by U.S. measures. Under laws governing meat inspection, no foreign establishment can ship its products to the United States until FSIS has determined that the establishment's country has a meat and/or poultry safety program that provides a level of protection at least equivalent to the U.S. system. FSIS visits the exporting country to review its rules and regulations, meets with foreign officials, and accompanies them on visits to establishments. In addition, FSIS operates a reinspection program at 150 import houses located near approximately 35 border entry points. FDA does not have a program like that of FSIS. Some have suggested that the FDA program should operate more like that of FSIS, although they acknowledge the difficulties and resource demands of attempting to regulate many more different types of foods from many countries of origin. How FDA is able to exercise its new authority under FSMA regarding food imports under the agency's jurisdiction remains to be seen.

Paying for Food Safety with User Fees

Many critics have argued that a fundamental problem has been FDA's lack of sufficient funding and staff to carry out congressionally mandated (and existing) responsibilities to ensure a safe food supply. Responding to a request from Democratic leaders of the House Energy and Commerce Committee, a subcommittee of the FDA Science Board estimated that, in order to address these deficiencies, the food-related portion of FDA's appropriation should be increased. In fact, congressional appropriators increased funding for FDA food activities each year from FY2005 to FY2010. (See Table 3 .)

Proposed increases in program spending raise a variety of policy issues. Requests for higher appropriations compete with other priorities throughout the federal discretionary budget. The programs do not operate as mandatory authorizations, as do farm support programs, for example, and currently are being made during a period of budget deficits.

An alternative approach to direct appropriations is to fill perceived shortfalls through user fees on the regulated industry. For several years before the introduction of FMSA, such user fees related to foods had been proposed in legislation and in budget requests. For example, the President's FY2011 budget request proposed $6.467 million for reinspection fees, $4.307 million for export certification fees, and $182.783 million in inspection and registration fees.

Before FSMA added the authority for FDA to collect food-related user fees, the agency already had the authority to collect user fees related to human and animal prescription drugs and human medical devices (21 U.S.C. 379g - 379j-12); human biologics (42 U.S.C. 262 note); and tobacco products (21 U.S.C. 387s). Some of these user fees are paid annually, and some are paid when submitting certain applications to FDA. The fees collected are intended to fund approval-related activities; with the exception of tobacco fees, they cannot be used to fund enforcement or inspection activities for products on the market, except to a very limited extent. (Unlike foods and some food additives, prescription drugs, medical devices, and animal drugs require FDA's advance permission before they can be legally marketed.) The user fee programs have generally been authorized in five-year increments (except for tobacco fees, which are permanently authorized). Each authorization specifies the fee amounts FDA may collect annually, among other legislative direction.

Since before the FMSA was enacted, FDA has also been explicitly authorized to collect export certification fees for drugs, animal drugs, medical devices, and biological products (21 U.S.C. 381(e)(4)). A person who exports any of these products may request that the Secretary certify in writing that the product meets FFDCA requirements. If the Secretary issues a written export certification, a fee of up to $175 may be charged.

The introduction of user fees for these FDA-regulated products has added to the agency's budget. Fees have provided additional resources for the agency to hire reviewers to conduct premarket reviews; to hire support personnel and field investigators to speed up the application review process for drugs, biological products, and medical devices; and to acquire and support critical information technology infrastructure.

The introduction of fees raises several issues. First, proposals for new user fees typically meet with resistance, both from the companies that would have to absorb such costs and from consumer advocates, who argue that industry funds might cause conflicts of interest by having industry pay the salaries of some of its regulators. To help address the issues that underlie this resistance, clear conflict-of-interest guidelines, as well as certain restrictions on how funds may be expended, have been established.

Second, concerns are sometimes expressed that user fees, once authorized, comprise an ever-increasing proportion of the budget, and may supplant rather than supplement funding for the agency. For that reason, certain fees carry the requirement that direct appropriations meet a certain threshold before user fees can be collected.

Third, the funding generated by some types of fees—those that are periodic and associated with external events such as the submission of marketing applications—can be difficult to predict. However, FDA's highly trained staff cannot easily be increased or trimmed to conform to short-term activity levels and associated available funds. One example of the dilemma of unpredictable fee funding comes from the area of medical device user fees. In FY2002, when they were initially authorized, the fees were all periodic, which led to unpredictable funding for the device program and caused some budgetary shortfalls. In FY2007, in order to make user fee funding more consistent and reliable, certain annual fees (such as annual registration fees) were enacted to help resolve the issue.

A fourth set of concerns has been raised by small businesses. In the area of drugs and devices, small businesses claim to be drivers of innovation, and caution that fees imposed on them have a disproportionate and chilling effect on their work. For that reason, many of the drug- and device-related user fees have reductions for small businesses.

FSMA Provisions. FSMA funds some FDA food safety activities through the collection of user fees. (See Table 4 .) It establishes one annual fee (for participants in the voluntary qualified importer program (VQIP)), and three fees for periodic activities (a reinspection fee, a recall fee, and an export certification fee). Details of these annual and periodic fees are presented in Table 5 , including, where specified, who pays the fee, the fee amount, restrictions on the fee amount, the result of nonpayment, how funds may be used, required reports and meetings, authorizations, appropriations-related restrictions on fee collection, and expiration dates. FSMA does not impose new facility registration fees.

Regarding fees, the Congressional Budget Office (CBO) estimated that over five years, the new requirements would collect $241 million (based on an assessment of the August 2010 manager's amendment of the Senate version of the food safety bill). CBO also estimated that covering the five-year cost of new requirements, including more frequent inspections, would require additional outlays of $1.1 billion.

Appendix A. FDA Food Safety Modernization Act (P.L. 111-353) Provisions

Appendix B. Comparison of Provisions in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353), with Previously Existing Law