A. Growing Interest in Food Safety Policy Reform
The largest food recall in U.S. history, triggered by salmonella contamination discovered in certain peanut products, began to unfold in late 2008, just as the new administration was preparing to take office. To date, the implicated peanut products have been linked to nine deaths and over 700 cases of foodborne illness, and have required the recall of thousands of peanut-containing products. This widescale recall of peanut products is the latest in a succession of high profile episodes implicating the safety of commonly consumed food products, including fresh produce, meat, seafood, candy, and even pet food products.
Despite the demands of the serious economic challenges and ambitious policy reform agenda confronting the new administration, the continuing succession of food safety episodes has strengthened the resolve of policymakers to renew the food safety policy reforms advanced during the 110th Congress, and enact far-reaching legislation in the near term. These actions are all part of a longer term effort to bolster public confidence in federal regulatory programs to safeguard the safety and security of the nation's food supply.
Lawmakers have responded by bringing forth myriad legislative proposals for reforming the nation's food safety net. Recently, President Obama highlighted his administration's support for food safety legislation. During his March 15, 2009 radio address, the President singled out the need to increase the effectiveness of the nation's food safety measures and announced a Food Safety Working Group to examine problems with the food safety system and sort out the various proposals for reworking that system: "[the] Working Group will bring together cabinet secretaries and senior officials to advise me on how we can upgrade our food safety laws for the 21st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them."1
B. The Straining U.S. Food Safety Net
Despite the significant expansion of federal food safety and security regulatory authority accomplished under the post-9/11 "Bioterrorism Act" amendments to the Federal Food Drug & Cosmetic Act ("FFDCA"), these policy changes have been inadequate to assuage public concerns in the face of the recent succession of widespread food recall incidents, and the rising tide of food imports from countries with lesser developed food regulatory systems.2
Lawmakers and various stakeholders have questioned the adequacy of current federal programs to meet the challenges of an increasingly globalized U.S. food supply, particularly in view of the limited capacity of the Food and Drug Administration ("FDA") and other federal agencies to enforce U.S. food safety standards against foreign food suppliers, and the limited funding that can be provided through appropriations. In addition, lawmakers have questioned the cost effectiveness of current federal programs, which operate under a complex organizational structure involving no less than 15 federal agencies, with areas of overlapping jurisdiction, and administering at least 30 different federal statutes.3
The Government Accountability Office ("GAO") has questioned the adequacy of federal food regulatory programs in its reports evaluating these programs in recent years. In 2007, at the start of the 110th Congress, GAO issued its bi-annual "High Risk Series" report, and for the first time, placed federal food safety programs on its list of "high risk" programs warranting the attention of Congress in the near future, citing its earlier reports evaluating federal food safety programs.4
During the 110th Congress, a number of Congressional committees in both the House and Senate held hearings on food regulatory programs. The House Committee on Energy and Commerce conducted a series of oversight hearings concerning FDA food safety programs and investigated incidents involving intentional melamine contamination in food imports and related concerns. Lawmakers in the House and Senate introduced more than 20 bills proposing to reform federal food regulatory programs administered by the FDA and other federal agencies. In addition, FDA issued a new "Food Protection Plan," launching food safety policy reforms under its existing FFDCA authority. At the same time, FDA advocated legislation that would further expand its regulatory and enforcement authorities, and provide greater funding for food regulatory programs.5
In its recent "High Risk Series" report issued at the start of the 111th Congress, GAO again included federal food safety programs on its list of "high risk" programs warranting prompt Congressional attention.6
Although the 111th Congress has been in session for less than three months, already there have been Congressional hearings to address food safety issues, and numerous bills have been introduced in the House and Senate that propose to reform federal food regulatory programs administered by FDA and other federal agencies. The most significant bills are the same as or similar to bills that were previously introduced during the 110th Congress.
Most pending bills propose to shore up the straining U.S. food safety net by expanding FDA's regulatory and enforcement authority with respect to both domestically produced and imported foods. Other bills propose to expand the regulatory and enforcement authority of the Food Safety and Inspection Service ("FSIS") with respect to meat, poultry, and processed egg products. In addition, there appears to be some growing interest in legislative proposals aimed at reorganizing and consolidating federal food regulatory programs in a new "single food agency," as part of a longer term strategy for strengthening and streamlining federal programs, although the feasibility of launching such a reorganization in the current environment has been questioned by some Members of Congress.
This briefing paper addresses the leading bills in the House and Senate that propose to expand FDA regulatory and enforcement authority through amendments to the FFDCA: The FDA Globalization Act of 2009 (H.R. 759) and the FDA Food Safety Modernization Act of 2009 (S. 510),7
and highlights other key bills proposing potential alternative and/or supplemental changes in food regulatory programs.
II. Review of Leading Bills
A. FDA Globalization Act of 2009 and FDA Food Safety Modernization Act of 2009
The FDA Globalization Act of 2009 (H.R. 759) was introduced by Representatives John Dingell (D-MI), Frank Pallone (D-NJ), and Bart Stupak (D-MI). This bill represents a further evolution of the food safety bills that were championed by Representative Dingell and others during the 110th Congress.8
Among other things, it proposes to amend the FFDCA in order to create a dedicated revenue stream for FDA food safety activities through registration and user fees, expand FDA's capacity and authority to conduct inspections of foreign facilities, require facilities to maintain detailed food safety plans, and establish new traceability and recall requirements.
The FDA Food Safety Modernization Act (S. 510) was introduced by Senators Richard Durbin (D-IL), Judd Gregg (R-NH), Ted Kennedy (D-MA), and Richard Burr (R-NC).9
The bill would make far-reaching amendments to the FFDCA to, among other things, increase the frequency of food facility inspections, give the FDA expanded access to company records and testing results, and authorize FDA to mandate food recalls under certain conditions.
The two bills are similar in purpose and reach, and H.R. 759 and S. 510 both would substantially increase the regulatory burdens and costs, as well as liability risks, for companies that are involved in the manufacturing, processing, packing, transporting, holding, importing, and marketing of food and food ingredients. At the same time, the specific nature of the amendments the two bills would make to existing law are significantly different, and the amendments that would be made by H.R. 759 could amplify liability and business risks for companies to a greater extent than the FDA Food Safety Modernization Act amendments.
In general, S. 510 would establish new requirements by adding new provisions of law that are coupled with amendments to FFDCA section 301, which define the noncompliance with these new provisions to be "prohibited acts" that are punishable through both existing and additional new remedies established under the FFDCA. In addition to amendments of this general type, H.R. 759 would amend FFDCA section 403, expanding the conditions under which the sale of safe food products could be prohibited under the FFDCA. For example, under H.R. 759, companies would be prohibited from causing the delivery or receipt in interstate commerce of the following "misbranded" foods:
- Food that is manufactured, processed, packed, or held in a facility that has not been properly re-registered;
- Food that is part of a raw agricultural commodity shipment for which the grower name, lot number, the harvesting and packing dates of the product, and other pertinent information is not properly identified;
- Food that is part of an imported shipment for which a proper certification of compliance with FFDCA requirements has not been provided;
- Processed food for which country of origin labeling fails to properly identify the country of final processing or for which the manufacturer's website fails to disclose the country of origin for each ingredient; and
- Non-processed food for which labeling fails to properly identify the country of origin, or for which the original packer's website fails to identify the country of origin.
Other key features of H.R. 759 and S. 510 are highlighted below.
- Re-registration of Food Facilities: Both H.R. 759 and S. 510 would require facilities that manufacture, process, pack, or hold food to re-register on a periodic basis. Under H.R. 759 re-registration would be required annually, and under S. 510 re-registration would be required bi-annually.
- Written HACCP-Type Plans: Both H.R. 759 and S. 510 would prohibit under Section 301 of the FFDCA the operation of a food facility except in compliance with written Hazard Analysis and Critical Control Points ("HACCP")-type plans and related requirements, and would give FDA access to those plans and other relevant company records.
- Fresh Produce Safety: Both H.R. 759 and S. 510 would prohibit under Section 301 of the FFDCA the production or harvesting of produce except in compliance with standards that would be established by FDA.
- Intentional Adulteration of Food: Unlike H.R. 759, S. 510 would prohibit under Section 301 of the FFDCA the failure to comply with the requirements that FDA would establish by regulation to safeguard food from intentional adulteration.
- Traceability of Food: Both bills would enhance the traceback requirements for identifying raw agricultural commodities.
- Third-Party Certification: Both bills would create third-party certification programs but the programs would differ in certain respects. S. 510 would permit FDA to require certifications only when there is a food safety problem with imported food, but otherwise would make the certification voluntary. In contrast, H.R. 759 would require foreign food facilities to certify that their imports meet all U.S. food safety standards. Both bills would mandate the testing of food for certain compliance purposes to be done by a federal laboratory or certified laboratory, and would require FDA to establish and implement a certification program for qualifying third parties to certify certain types of food facilities as meeting the requirements of the FFDCA.
- Food-Borne Illness Surveillance: Both bills would expand federal food-borne illness surveillance programs to improve the quality of data collection, analyses, and reporting activities concerning food-borne illnesses.
- Access to Company Records: H.R. 759 would expand FDA's authority by permitting the agency to access and copy records to determine if an article of food is adulterated, misbranded, or otherwise in violation of the Act. FDA would no longer need to have a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death. In contrast, S. 510 would grant FDA authority to access and copy records only when it has a reasonable belief that an article of food presents a threat of serious adverse health consequences or death. This authority under S. 510 would extend to any other article of food that is likely to be affected in a similar manner. S. 510 would also prohibit under Section 301 of the FFDCA the introduction into interstate commerce of food in violation of this provision.
- Mandatory Food Recalls: Both bills would prohibit under Section 301 of the FFDCA the failure to follow a recall order issued by FDA.
- Suspension of Facility Registration: Both bills would authorize FDA to suspend a food facility's registration if there is a reasonable probability that food from the facility will cause serious adverse health consequences or death.
- Administrative Detention: Both bills would eliminate the requirement that FDA inspectors need credible evidence or information indicating that a product presents a threat of serious adverse health consequences or death to humans or animals before the inspector can detain the food. Both bills would permit inspectors to detain food when the inspector has "reason to believe" that the food "is adulterated or misbranded."
- Notification of a Violation: Unlike S. 510, H.R. 759 would require any person (other than the consumer) to immediately notify FDA if that person has reason to believe that a food product is adulterated or misbranded in a manner that, if consumed, may result in illness or injury. FDA would prescribe the manner in which the notification would be made. Failure to do so would be prohibited under Section 301 of the FFDCA.
- Civil Penalties: H.R. 759 would permit FDA to assess a civil penalty of up to $100,000 (for an individual) and up to $500,000 (for any other person) for each violation of Section 301. Each prohibited act and each day the violation persists would be considered a separate offense. S. 510 does not have a similar provision. In contrast, S. 510 would permit FDA to assess a civil penalty of up to $50,000 (for an individual) and up to $250,000 (for any other person) not to exceed $500,000 for all violations in a single proceeding.
- False Certifications Made to the Government: S. 510 would subject an importer, or foreign entities that certify exported food or that elect to be certified by a third-party agent, to a fine or imprisonment of 5 years or less, under 18 U.S.C. § 1001, for any false statements or misrepresentations relating to the food.
- Expanded Reporting Obligations: Under both bills, audit reports and records related to the compliance or certification of a foreign food facility would need to be provided at FDA's request. In addition, both bills would require the results of certain food safety testing conducted by certified laboratories to be transmitted directly to FDA. Both bills also would authorize FDA to require companies engaged in food recalls to make progress reports to FDA.
- User Fees: S. 510 would expand FDA authority to collect user fees to defray certain costs to the government associated with company noncompliance, including costs associated with facilities reinspection, food recalls, and certain imported food compliance activities. H.R. 759 would establish a broader range of user fees to defray certain costs associated with FDA programs concerning facilities registration, facilities reinspection, accreditation programs for agents certifying food facilities and laboratories, and issuance of export certificates.
- Foreign Supplier Verification Program: Unlike H.R. 759, S. 510 would prohibit under Section 301 of the FFDCA the importation of food if the importer does not have a foreign supplier verification program in place, which may include monitoring records for shipment, lot-by-lot certification compliance, annual inspections, checking hazard analysis and risk-based preventive control plan of foreign supplier, and sampling shipments.
- Expedited Imports: As mentioned above, both bills would require FDA to implement a certification program to expedite the importation of food that has only been manufactured, produced, processed, packaged, and held in facilities that were certified and the facility has agreed to abide by and has been deemed by FDA to be in compliance with the food safety and security guidelines. This would require FDA to develop safety and security guidelines by taking into account a number of factors. Unlike H.R. 759, S. 510 would require FDA to establish this program in consultation with the Department of Homeland Security.
- Other Import Provisions: S. 510 and H.R. 759 would add other new sections to FFDCA with regard to imports and foreign governments. Both would authorize FDA to review the regulatory capacity of foreign governments. S. 510 would make further amendments to: add to prior notice requirements the inclusion of information about any country that has refused a food seeking entry to the United States; allow FDA to enter into agreements with foreign governments to inspect foreign food facilities; and mandate the creation of a third-party accreditation regime. H.R. 759 would not allow imported food to enter the United States from a facility that has failed to consent to an inspection, or has delayed or refused inspection.
- Performance Standards: Both bills would require FDA to review, evaluate, and identify the most significant food-borne contaminants and resulting hazards, and then issue guidance or regulations with science-based performance standards to assist the regulated industry in minimizing, preventing, and eliminating the occurrence of hazards.
- The National Agriculture and Food Defense Strategy: S. 510 would require the Secretaries of Health and Human Services and the Department of Agriculture, in coordination with the Secretary of Homeland Security, to submit to Congress and make publicly available on the Internet:
- "The National Agriculture and Food Defense Strategy," which would seek to enhance preparedness, improve detection capabilities, ensure an efficient emergency response, and implement recovery plans; and
- A report on the activities of the Food and Agriculture Sector Coordinating Council relating to goals of trying to help unify and enhance the protection of the agriculture and food system of the United States.
- Food Emergency Response Network: S. 510 would require the Secretary of Health and Human Services, in coordination with the Secretaries of the Department of Agriculture and Homeland Security, and state, local, and tribal governments, to issue a report to the relevant Committees of Congress and to make publicly available on the Department of Health and Human Services' website an update on the progress in implementing a national food emergency response laboratory network.
- Research: H.R. 759 would require the Secretary of Health and Human Services to conduct research to assist in the implementation of the Globalization Act and would be authorized to enter into contracts and agreements with any state, university, government agency, or other person to carry out this section.
- Carbon Monoxide as a Color Additive: Unlike S. 510, H.R. 759 proposes to expand the definition of color additive to include carbon monoxide added to meat, poultry, or seafood that imparts, maintains, preserves, stabilizes, fixes, or otherwise affects the color of the product unless a disclosure statement is included on the label.
- GRAS: H.R. 759 proposes to require FDA to publish in the Federal Register any requests that a food substance be determined by FDA to be generally recognized as safe ("GRAS").
- Cosmetics Requirements: H.R. 759 would require cosmetic establishments to (1) submit to FDA a cosmetic and ingredient statement for each cosmetic; (2) report any serious and unexpected adverse event in the United States associated with the use of the cosmetic; and (3) conform with good manufacturing practices. S. 510 does not have a comparable provision concerning cosmetics.
B. Review of Other Pending Legislation
1. Safe Food Enforcement, Assessment Standards, and Targeting Act of 2009
As mentioned above, many other bills are currently pending that would amend the FFDCA with regard to food oversight. Since several of those could be incorporated into, or could otherwise impact final legislation, they should be considered.
First, Reps. Costa (D-CA) and Putnam (R-FL) have reintroduced their Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009 (H.R. 1332). It has the same general purpose and scope as H.R. 759 and S. 510, and is similar to each bill in some respects. For example, H.R. 1332 includes the same recall provisions as S. 510. It also includes similar provisions with regard to enhancing FDA's detention authority, expanding FDA's authority to access records during food emergencies, and crafting a National Agriculture and Food Defense Strategy.
Further, like both H.R. 759 and S. 510, H.R. 1332 proposes prohibiting facilities from operating if a hazard analysis has not been conducted or if the facility has not implemented science-based preventive controls. Like the other two bills, it also would allow FDA to set produce standards and performance standards, and would provide for increased inspection resources and the development of a food-borne illness surveillance system. However, H.R. 1332 does not mandate new traceability and related record keeping standards, opting instead for a pilot project to review traceback methods. After such a pilot project is completed, FDA would offer regulations based on the results of the project.
H.R. 1332 increases registration requirements by requiring bi-annual re-registration and allows for suspension of that registration if FDA has a reasonable belief that food from the facility could cause harm. Notably, H.R. 1332 does not have any provisions regarding civil penalties, though it does allow FDA to collect user fees for compliance failures and certain services rendered. Like S. 510, it also does not include any provisions related to cosmetics.
Finally, with regard to import issues, like S. 510, H.R. 1332 puts the responsibility of safe imports on U.S. importers by requiring that they adopt a verification program for foreign imported foods. It is also similar to Senator Durbin's S. 510 in that it provides for a voluntary qualified importer program, expansion of FDA authority to require import certifications in certain circumstances, expansion of prior notice requirements for imported food, inspection of foreign food facilities, and creation of a system to accredit third-parties to certify foreign food. Like both the other bills discussed above, H.R. 1332 would authorize FDA to review the regulatory systems of foreign governments. And like S. 510, but unlike H.R. 759, it would require FDA to develop a plan to help foreign governments expand their regulatory capacity.
2. Tracing and Recalling Agricultural Contamination Everywhere Act of 2009 & Safe And Fair Enforcement and Recall for Meat, Poultry, and Food Act of 2009
Representative DeGette (D-CO) has introduced two food safety bills that would amend the statutes administered both by FDA (i.e., FFDCA), and the USDA's Food Safety and Inspection Service (i.e., the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act) to establish comparable FDA and FSIS standards with respect to food traceability and recalls. The first bill, the Tracing and Recalling Agricultural Contamination Everywhere Act of 2009 (H.R. 814), would establish FDA and FSIS traceability requirements for food facilities and related record keeping requirements. The second bill, the Safe And Fair Enforcement and Recall for Meat, Poultry, and Food Act of 2009 (H.R. 815) would establish FDA and FSIS standards and procedures governing voluntary and mandatory food recalls. The bill also would establish civil penalties for violations of the new requirements. Senator Sherrod Brown (D-OH) has introduced similar legislation in the Senate, the Food Safety and Tracking Improvement Act (S. 425). It combines the issues addressed in Representative DeGette's bills. In one bill it seeks to detail a food tracing system under the FFDCA, while also creating new recall authorities and notification requirements under the FFDCA, and the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act.
3. Food Safety Modernization Act of 2009
Finally, Representative DeLauro (D-CT) has reintroduced the Food Safety Modernization Act of 2009 (H.R. 875).10
In contrast to other bills that have been introduced so far in the 111th Congress, the central objective of H.R. 875 is to establish a new food regulatory agency within the Department of Health and Human Services' Public Health Service, in addition to expanding federal authority to regulate the safety and marketing of food products. The bill would transfer FDA's current authority to regulate food, dietary supplements, cosmetics, pet food, animal feed, and veterinary drugs under the FFDCA, to a new agency that would be named the "Food Safety Administration" ("FSA").
The head of the new FSA, the Administrator of Food Safety, would assume responsibility for regulatory programs that currently are administered by the FDA's Center for Foods Safety and Applied Nutrition, the Center for Veterinary Medicine, the National Center for Toxicological Research, and related programs administered by the FDA Office of Regulatory Affairs, the Office of the FDA Commissioner, and seafood safety programs currently administered by the National Marine Fisheries Service of the National Oceanic and Atmosphere Administration (currently under the Department of Commerce). This would be accomplished through a transfer of program functions, personnel, and assets (including facilities and financial resources) of those components (including all related functions of any officer or employee of the component) that relate to administration or enforcement of the food safety law, as determined by the President. The legislation does not propose any conforming amendments to the FFDCA that would be needed to make the transfer of FDA authorities to two separate regulatory agencies successful in the long term. Instead, the legislation would require the President to undertake an evaluation of the conforming amendments needed, and submit an appropriate legislative proposal within 60 days of enactment.
Under the Food Safety Modernization Act, responsibilities for regulating human drugs, biologics, radiological health products, and medical device products would remain with FDA, but the name of the agency would be changed to the "Federal Drug and Device Administration," reflecting the reduced scope of the agency's regulatory jurisdiction under the FFDCA. This bill also would endeavor to address many of the issues tackled in the Durbin and Dingell bills. However, it diverges, in some cases dramatically, from those bills on the details. As just one example, it proposes a significantly different annual registration system that categorizes facilities based on the type of activity conducted at that facility. That categorization also impacts the frequency of inspections.
III. Outlook and Next Steps for Food Companies
Representative Dingell's FDA Globalization Act is expected to be marked up in the House Energy and Commerce Committee in the coming weeks. A hearing has already been held to examine that legislation, and it is likely to be the first piece of food-related legislation to begin the path towards enactment. Still, several other committees, including the House and Senate Agriculture Committees, will want to provide their input on these issues. Considering the range of proposals, differences over the scope of any eventual effort, and jurisdictional competition among congressional committees and executive agencies, it is important for companies to be engaged in the legislative process.
Further, any food-related legislation likely will have a significant impact on the business operations and products of nearly every company involved in the production, distribution, importation, and marketing of food and food ingredients. Such legislation could significantly expand regulatory requirements. The specific nature of those requirements combined with potential aggressive timelines for implementation are likely to significantly increase the burdens associated with regulatory compliance, the penalties for noncompliance, and amplify enforcement risks and related commercial liability risks.
Food providers and other facilities can work to educate members of Congress on these issues and describe the anticipated impacts to Members' constituent businesses. It is particularly important to highlight for those Members the substantial liability that law abiding companies may face if some of the proposals are adopted in their current form, and the need to thoroughly vet legislative language before enactment. Legal counsel and government relations professionals can both help navigate the legislative landscape and begin developing measures to ensure compliance with the final reforms.
The above analysis addresses only some of the aspects of the legislation proposed to date. Other details of the bills may be applicable to your business, and additional legislation may be filed. If you are interested in more information about this Issue Brief, please contact:
Chair, Food and Drug Law
Dana S. Wood
Director, Government Relations and Public Policy
"Weekly Address: President Barack Obama Announces Key FDA Appointments and Tougher Food Safety Measures": http://www.whitehouse.gov/the_press_office/Weekly-Address-President-Barack-Obama-Announces-Key-FDA-Appointments-and-Tougher-F/.
See Sarah Roller, "More Penalties, Fewer Rewards: Righting the Balance in FDA's Food Safety Net," FDLI Update, Jan./Feb. 2008, at 6-11.
GAO "High-Risk Series: An Update," January 2007: www.gao.gov/new.items/d07310.pdf
FDA "Food Protection Plan, One Year Progress Summary, December 2008".
GAO "High Risk Series: An Update," January 2009: www.gao.gov/new.items/d09271.pdf
. Also of note is the fact that GAO added medical product imports as an high risk area in its 2009 update.
All of the comprehensive proposals offer many changes to the current food safety system. Not all of those proposed changes are reviewed here.
In April of 2008, Representative Dingell circulated the FDA Globalization Act of 2008 as a "discussion draft" (the "Discussion Draft"). That effort built on other legislation previously prepared by leading food safety members of the 110th Congress: H.R. 3610 (Rep. Dingell), H.R. 3624 (Rep. Pallone), H.R. 3115 (Rep. Stupak), and H.R. 3484 (Rep. DeGette). The Discussion Draft incorporated findings from an Energy and Commerce Oversight Subcommittee investigation, the report of the FDA Science Board, and the Bush Administration's Food Protection Plan and Import Safety Plan, as well as input from key stakeholders, like the Center for Science in the Public Interest. After the bill's release, the House Energy and Commerce Committee held a series of hearings to review the bill.
The FDA Food Safety Modernization Act was also introduced during the 110th Congress.
As with the FDA Globalization Act of 2009, the Food Safety Modernization Act of 2009 follows several related efforts in earlier Congressional sessions. In September 2008, during the 110th Congress, Ms. DeLauro introduced H.R. 7143, the Food Safety Modernization Act of 2008. It was an updated version of a bill with the same title introduced in 2007.