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Creating a Single Federal Food Safety Agency - Progress or Regress?

June 1, 2005

A. Introduction of the Safe Food Act of 2005

While the concept is not new, creation of a single federal food safety agency has received new vigor in light of bioterrorism and renewed concern that the U.S. food supply is not as safe and secure as it could be. Both houses of Congress are currently considering legislation that would consolidate all food safety responsibility into one agency, a newly created Food Safety Administration. The "Safe Food Act of 2005," S. 729 introduced by Senator Richard Durbin (D-IL) on April 6, 2005 and its companion bill H.R. 1507, introduced by Representative Rosa DeLauro (D-CT), call for an "integrated, system-wide approach" to food safety.[1] In particular, the bills criticize outdated laws and a fragmented federal food safety system as a serious impediment to efficient deployment of food safety resources and effective prevention of foodborne illness.[2]

Under the proposed regulatory scheme, all food safety, labeling, inspection, and enforcement functions currently exercised by federal agencies would be transferred to the Food Safety Administration. [3] This would include: (1) the Food Safety and Inspection Service (FSIS) of the Department of Agriculture (USDA); (2) the part of the Agriculture Marketing Service that administers shell egg surveillance; (3) the Animal and Plant Health Inspection Service of the USDA; (4) the part of the Research, Education, and Economics mission area of the USDA related to food safety and animal feed research; (5) the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA); (6) the Center for Veterinary Medicine of the FDA; (7) the resources and facilities of the Office of Regulatory Affairs of the FDA that administer and conduct inspections of food establishments and imports; (8) the resources and facilities of the Office of the Commissioner of the FDA that support CFSAN, the Center for Veterinary Medicine, and the Office of Regulatory Affairs; (9) the resources and facilities of the Environmental Protection Agency (EPA) that control and regulate pesticide residues in food; and (10) the part of the National Marine Fisheries Service (NMFS) of the National Oceanic Atmospheric Administration of the Department of Commerce that administers the seafood inspection program.[4]

Under the Safe Food Act of 2005, the Administrator of the new agency would: (1) administer a national food safety program based on actual risks associated with different foods and food processing; (2) adopt science-based safety standards for food processors and food establishments; (3) establish a certification system for foreign governments or food establishments seeking to import food to the U.S.; (4) establish requirements for tracing food and food producing animals from point of origin to retail sale; (5) maintain an active surveillance system of food, food products, and epidemiological evidence; (6) establish a sampling system to monitor contaminants in food; (7) rank and analyze hazards in the food supply; (8) establish a national public education campaign; and (9) conduct integrated food safety research. The Administrator also would serve as the national and international leader for food safety.

The Safe Food Act of 2005 would require any food establishment or foreign food establishment engaged in the processing of food in the U.S. to register with the Administrator.[5] As part of the national food safety program and in contrast to the current food safety inspection system administered by USDA and FDA, the comprehensive inspection program would be based on five categories of food establishments that correspond to different timeframes for inspection.[6] Food Establishments are categorized as follows: (1) a Category one food establishment means a food establishment that slaughters animals for food; (2) a Category two food establishment includes food establishments that process raw meat, poultry, and seafood products and animal feed and other products that are determined to be at high risk of contamination and whose processes include a step validated to destroy contaminants; (3) a Category three food establishment refers to a food establishment that processes meat, poultry, seafood products, and other products determined to be at high risk of contamination and whose processes include a step validated to destroy contaminants; (4) a Category four food establishment means a food establishment that processes all other categories of food products; and (5) a Category five food establishment corresponds to food establishments that store, hold, or transport food products prior to delivery for retail sale. The frequency of inspection would follow a spectrum starting with continuous, daily inspections for Category 1 establishments, random daily inspections for Category 2 establishments, random monthly inspections for Category 3 establishments, random quarterly inspections for Category 4 establishments, and ending with random annual inspections for Category 5 establishments. Food establishments categorized as 2 through 5 may be eligible for a decreased (or increased) inspection frequency according to the relative risks associated with foodborne illness.[7]

To address the rising volume of food imports, foreign governments or foreign food establishments seeking to import food into the U.S. would first be required to obtain certification, which would be granted only after demonstration that the foreign-produced food meets U.S. equivalent safety standards.[8] Certification would be based on onsite inspection and renewed every five years to ensure continued compliance with U.S. food safety and labeling standards.[9] In addition, imported foods would be subject to routine physical inspection.[10]

Senator Durbin asserts that only an agency independent from both the USDA and FDA may adequately focus on food safety without being conflicted by the dual tasks of marketing and promotion on the one hand and safety regulation on the other.[11] Notably, while the food safety functions of USDA and FDA would be transferred to the new Food Safety Administration, all other responsibilities of USDA and FDA would remain within their agency's jurisdiction. Senator Durbin's persistent reform efforts[12] are motivated by a number of factors which he believes highlight the need for streamlining the current regulatory scheme including emerging pathogens, an aging population more susceptible to foodborne illness, and a greater number of food imports.[13]

Creation of a single, independent federal food safety agency is backed by a National Academy of Sciences (NAS) report[14] recommending a unified framework for food safety management, congressional testimony by the National Commission on the Public Service[15] that unacceptable gaps in safety protection emerge when regulation is distributed among several agencies, and numerous Government Accountability Office (GAO) reports calling for consolidation of food safety functions.

B. How GAO Weighs in on Food Safety Regulation

GAO believes "that creating a single food safety agency to administer a uniform, risk-based inspection system is the most effective way for the federal government to resolve long-standing problems, address emerging food safety issues, and better ensure the safety of the nation's food supply."[16] GAO reasons that a single food safety agency could better prevent food contamination by comprehensively addressing safety issues throughout the entire food cycle, from farm to table.[17] In its most recent report before the House of Representatives, GAO asserted that the fragmented nature of the federal food safety system leads to overlapping and duplicative inspection and training activities, wasting resources that could be spent more efficiently to ensure food safety across the nation.[18]

Under the current regulatory scheme, thirty principal food safety laws are administered by fifteen federal agencies.[19] According to GAO, the result is that the agencies are expending resources on similar activities in a piecemeal fashion which overlooks food safety risks. In particular, the GAO stressed that USDA and FDA conduct similar inspections at 1,451 dual jurisdiction establishments.[20] Specifically, USDA, under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, is responsible for the safety of meat, poultry, and certain egg products while FDA regulates all other foods under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act including shell eggs, seafood, milk, grain products, and fruits and vegetables. GAO believes that the dual inspections conducted by USDA and FDA of the same food-processing facilities represent an inefficient use of scarce government resources.[21] (FDA and USDA generally proclaim that their inspectors coordinate to avoid duplication.)

Secondly, GAO emphasized that USDA and FDA expenditures on inspection activities do not track either the volume of foods regulated by the agencies or the risk of foodborne illness.[22] While the majority of federal expenditures for food safety inspections are directed towards USDA programs, USDA is only responsible for regulating 20% of the food supply; the other 80% of the food supply is FDA-regulated, accounting for 24% of federal expenditures on food safety inspections.[23] Based on fiscal year 2003 figures, FDA's budget represented 40% ($508 million) of the approximately $1.3 billion spent on food safety oversight while FSIS, which inspects approximately 21% of the foods Americans consume annually, represented 60% ($756 million) of the federal expenditures for food safety.[24] Furthermore, GAO pointed to the disproportionate percentage of the risk of foodborne illness to the degree of regulation for certain foods. According to Centers for Disease Control and Prevention (CDC) data, even though USDA food safety expenditures exceed FDA's by about half (49% more), USDA regulated foods accounts for only about 32% of reported foodborne outbreaks with known sources, as opposed to the 68% of outbreaks associated with FDA-regulated foods.[25]

Furthermore, GAO noted that the applicable regulations impose differing inspection and approval requirements, as food products regulated by FDA may be marketed without prior approval and inspections are generally conducted once every one to five years; whereas, food products regulated by USDA require pre-market approval based on daily inspections.[26] According to GAO, some representatives from individual food companies find the overlapping inspections burdensome and confusing, and at times, even contradictory.[27]

Lastly, in addition to inspection activities, GAO identified the following as duplicative among the USDA, FDA, EPA, and NMFS: (1) research, (2) risk assessment, (3) education and outreach, (4) surveillance and monitoring, and (5) rulemaking and standard setting.[28] As such, GAO maintains its position that the benefits of establishing a single national system for food safety regulation outweigh the costs.[29]

Agency Perspective

CFSAN director Robert E. Brackett, Ph.D., disagrees with GAO's unequivocal position in favor of creating a single food safety agency and accused GAO of mischaracterizing the existence of overlap in food safety responsibilities. [30] He stresses that: (1) the USDA's and FDA's inspection activities are fundamentally different, requiring different scientific knowledge and training to understand and regulate certain food products and related processing techniques; and (2) the dual jurisdiction establishments (DJEs) emphasized by GAO as a prime example of overlap are misleading.[31] In fact, Brackett states that DJEs only comprise 2% of the total food processing or manufacturing facilities in the U.S. and declares that GAO failed to take into account that the majority of such facilities are low risk, thus, not requiring a high frequency of inspection by either agency.[32]

Brackett intimates that creation of a single food safety agency is unnecessary as the current system of interagency coordination is helping to improve the safety of the food supply.[33] In fact, he notes that since the advent of increased agency coordination, foodborne infections due to common pathogens in 2004, in comparison to 1996 through 1998, have declined.[34] According to Brackett the agencies are already effectively working together in areas of inspection, surveillance, and research, as well as cooperative information sharing.[35]

C. The Case for Consolidating Food Safety Responsibilities

Other proponents of consolidation, like GAO, allege that the current system is ineffectual, inefficient, and inadequate. More specifically, proponents claim that the current system (1) permits gaps in food safety, thereby increasing the incidence of foodborne illness, (2) depletes resources by allowing overlapping and duplicative activities by multiple agencies, and (3) fails to provide for unified leadership with which to communicate promptly and cohesively within the U.S. and to act as a single voice to the international community.

The National Academy of Science (NAS) found that current food safety regulators operate within an out-of-date framework poorly designed to accomplish food safety goals in today's world where food production is more global and complex.[36] Specifically, NAS believes that archaic food statutes inhibit science-based decision making in food safety activities.[37] Accordingly it is claimed that the lack of scientific risk assessment fails to allocate resources to the areas of greatest need.[38]

The Food Marketing Institute (FMI) takes GAO findings a step further, asserting that "it is not just that the current complex and fragmented system creates gaps and overlaps . . . [but] that each one of these agencies uses a very different approach . . . to address the very same issues depending on jurisdiction."[39] FMI stressed the hazards associated with food imports, authority over which is split by FDA and USDA, noting the inconsistency in requirements for the foods regulated by the respective agencies.[40] USDA requires certification by exporting countries that their domestic control systems are equivalent to that of the U.S. and relies on one satisfactory on-site visit to establish certification of equivalence to be followed by limited, random inspection of individual shipments.[41] Thus, every foreign meat plant producing food for the U.S. must accord with U.S. standards.[42] FDA, on the other hand, depends almost exclusively on border inspections that comprise only 1% to 2% of import shipments.[43] In contrast to USDA, FDA's physical inspections rely on a standardized sampling procedure to detect after-the-fact contamination.[44]

Differing procedures also have been emphasized in the context of inspections of U.S. facilities. In particular, USDA inspects every poultry carcass in the U.S. even though NAS has discredited the program as ineffective at detecting safety hazards, while FDA on the other hand struggles to inspect high-risk seafood plants once a year.[45] Also, some food safety problems are alleged to fall through the cracks of both agencies.[46] It is posited that such regulatory gaps are responsible for the CDC estimated 5,000 food-related illness deaths and 325,000 hospitalizations that occur each year.[47]

D. Following the Lead Abroad

Proponents of consolidation also have posited that, even though the U.S. may enjoy a superior food regulation system today, maintaining the regulatory status quo will eventually result in the U.S. trailing behind its International counterparts when it comes to food safety. Canada, Denmark, Ireland, Germany, the Netherlands, New Zealand, and the United Kingdom have already taken steps to consolidate food safety functions for better food safety management and enforcement. Benefits reported to GAO include: (1) reduced overlap in inspections; (2) more risk-based inspections; (3) more consistent and timely enforcement of food safety laws and regulations; and (4) increased cost savings.[48]

Importantly, however, none of the countries which reorganized their food safety activities have conducted a comparative analysis to assess the actual benefits of restructuring in terms of increased food safety or efficiency.[49] Also, the countries have faced many challenges which cannot be easily overlooked, including: (1) the need to separate food safety responsibilities from food industry promotion; (2) agency autonomy; (3) employee assimilation to a new agency culture and priorities; and (4) the significant start-up costs of reorganization.[50] In fact, some countries reported an initial reduction in food safety activities.[51]

Dr. Merle Pierson, Ph.D., of USDA's Food Safety and Inspection Service (FSIS) testified before Congress that data from countries that have consolidated their food safety agencies do not indicate a change in foodborne illness trends.[52] Dr. Pierson stressed that a radical overhaul to the U.S. food safety system should be undertaken only if a measurable benefit to public health will result.[53] FSIS is not convinced that creation of a single U.S. food safety agency, based on the financial and human costs, would best utilize funding for food safety.[54]

E. Why a Single Food Safety Agency Would Not Work

Many feel that while a single food agency with jurisdiction over the full range of regulated food products has its advantages, starting from scratch after almost a century of combined regulatory history is not feasible, as the costs of reorganizing and consolidating such large and complex federal agencies would outweigh any potential benefit.

1. Consolidation Would Compromise Food Safety

First and foremost, an overhaul of U.S. food regulation would compromise food safety and leave the food supply vulnerable to intentional contamination. Opponents of creating a single food safety agency emphasize the jurisdictional confusion and regulatory gaps that would arise during the transition period.[55] While the Safe Food Act of 2005 defines its "transition period" as a twelve month period following the Act's effective date, the period of time required to ensure the Food Safety Administration is up to speed and operating at the same level of safety and security as the combined FDA and USDA would almost certainly take considerably longer.

The Safe Food Act of 2005 calls for the gradual integration of a number of agencies as well as the integration of a number of new and different programs to be implemented over a number of years. In particular, the bill establishes a one year time period for the new agency to promulgate regulations that require all food establishments to adopt preventative process controls, set standards for sanitation, and require sampling and testing to ensure compliance with regulatory standards.[56] Over the course of six months to three years, the agency must identify major foodborne contaminants and foods contributing to the risk of foodborne illness as well as set performance standards to protect against the identified contaminants.[57] In addition, one year after the promulgation of performance standards, the agency is tasked with implementing a sampling program to ensure compliance.[58] Furthermore, the inspection transition will be as follows: (1) for Category 1 and 2 establishments, to continue to follow the inspection mandates of the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act until promulgation of implementing regulations for the new inspection scheme and implementation of performance standards for one year; (2) for category 3 food establishments, the current inspection scheme will remain in place until implementation regulations are promulgated and the first resource plan has been submitted;[59] and (3) for category 4 and 5 food establishments, inspection requirements will be implemented after promulgation of implementation regulations and publication of the first resource plan.[60]

Lessons Learned from Creation of the Department of Homeland Security

The proposed reorganization carries some of the same risks associated with creation of the Department of Homeland Security (DHS).[61] Specifically, GAO identified the creation of DHS as high risk because of the size and complexity of consolidating so many agencies and integrating their different employees and disciplines.[62] Further, the agency functions to be merged already faced existing challenges.[63] Finally, a failure to effectively carry out the agency's mission would expose the nation to potentially very serious consequences.[64] Creating a cohesive organization from the integration of disparate agencies and activities posed a monumental and long-term challenge to achieving the efficacy and efficiency contemplated for DHS. The twenty-two agencies which were to make up the DHS comprised multiple missions, values, and cultures; thus, unsuccessful implementation of DHS would put the nation at significant risk.[65]

Although GAO has yet to issue a report on this issue, the same would likely hold true for consolidating the food safety functions currently exercised by fifteen different agencies.[66] The proposed Food Safety Administration would have to simultaneously establish itself and continue to ensure the safety and security of the nation's food supply. GAO estimates that successful consolidations of large organizations can take from five to seven years.[67] The proposed scheme for food safety is vulnerable because of the inevitable lost productivity and inefficiency during the long transition to complete consolidation of the agencies involved. In a time of heightened concern regarding intentional contamination of food, consolidation would detract from the core missions of the respective agencies. In fact, the creation of a single food safety agency may have the opposite effect, decreasing the effectiveness of food safety regulation and jeopardizing the security of the food supply.[68]

2. Consolidation Would Result in Lost Expertise and Knowledge

As it stands now, each agency possesses established relationships with states and foreign governments and is a relative expert in its jurisdictional and statutory authority.[69] FDA and USDA have accumulated a great deal of expertise and knowledge, some of which could be lost in the shuffle of transferring the functions of so many large, complex federal agencies, even with a strategic and detailed reorganization plan.[70] Given the differing missions of the agencies, a merger of food safety functions may prove unworkable.

Employees within the respective agencies are not necessarily interchangeable. Rather, the employees of the different agencies possess varied knowledge and have undergone specialized training for their respective areas of expertise.[71] In fact, GAO recognizes that USDA inspectors do not have the training necessary to conduct inspections on FDA-regulated foods.[72] Thus, it will be difficult to create a new, common culture while maintaining the current level of food safety and security.

The Safe Food Act of 2005 also provides for cooperation with the States to continue, strengthen, or establish State food safety and inspection programs.[73] Notably, however, relationships between the current agencies and the States are already well established.[74] It would be costly to lose the history and understanding developed by those relationships over time.

3. Consolidation Would Detract From Safety and Security Successes

Importantly, America's food supply is one of the safest in the world.[75] One factor is the collaborative strides that have been made in the area of food safety. The Foodborne Diseases Active Surveillance Network (FoodNet), jointly operated by CDC, FDA, FSIS, and emerging infections program sites among the states, has played a major role in preventing foodborne illness.[76] According to CFSAN Director, Robert E. Brackett, Ph.D., such collaborations address emerging challenges to the nation's food supply by drawing on and applying the unique expertise of the respective agencies.[77]

GAO identifies as a regulatory flaw the need for multiple agencies to respond when faced with serious food safety challenges.[78] Proponents of consolidation agree and claim that the current regulatory structure results in delayed initiation of a coordinated response during a food safety crisis, which has a negative effect on consumer confidence.[79] FSIS, on the other hand, disagrees. In particular, FSIS notes that the 2003 incidence of Bovine Spongiform Encephalopathy (BSE) is a good example of the food safety agencies coming together to address an issue promptly and with one voice to ensure that prevention and response measures are of optimal effectiveness.[80]

Also, FDA and USDA already have in place initiatives to address food security, which would be disrupted rather than improved by creation of a single food agency.[81] Specifically, the FDA created the Office of Crisis Management to coordinate emergency and crisis response activities, as well as interagency crisis management and emergency preparedness and response.[82] In addition, FDA also created a ten-point program to ensure the safety and security of the food supply.[83] Likewise, USDA created a new Office of Crisis Planning and Management and a FSIS Office of Food Security and Emergency Preparedness, as well as strengthened their inspection activities.[84] Thus, a fundamental overhaul of food safety regulation would disrupt already implemented food security programs and expose the food supply to dangerous regulatory gaps.[85]

F. Prospects for Passage

At least eight bills in the past seven years have been introduced to consolidate food safety functions within a single government agency. Nevertheless, not one bill has ever been voted out of committee. The Safe Food Act of 2005 is identical to its predecessor, the Safe Food Act of 2004, which was never acted upon after its referral to the appropriate committees.[86] The Safe Food Act of 2005 also is very similar to three other bills introduced in the House and Senate - the Safe Food Act of 2001, the Safe Food Act of 1999, and the Safe Food Act of 1997 - all attempting to establish a single Food Safety Administration.[87] Based on the fate of previous legislation proposing consolidation of food safety activities, prospects for passage of the Safe Food Act of 2005 look grim.

However, even though the Federal Food Safety Act of 2005 introduced in the Senate only has one cosponsor, Senator Hillary Rodham Clinton (D-NY), and the House bill only has two cosponsors, Representative George Miller (D-CA) and Representative Lucille Roybal-Allard (D-CA), additional congressional support exists. Representative Jon Porter (R-NV) expressed views in favor of food safety consolidation during a House Government Reform subcommittee hearing on May 17, where he slammed FDA and USDA for duplication and inefficiency in carrying out their food safety responsibilities. Representative Porter, focused on streamlining government and eliminating wasted resources, indicated that enhanced cooperation and coordination among the agencies is insufficient without more specific reforms.[88]

Congress' inaction on this issue is a strong indicator that the current system is not broken and does not need the proposed legislative fix. Notably, creation of a single food safety agency would not eliminate a layer of bureaucracy; rather, it would add one by creating a new federal agency. As already outlined, the current agencies are working together to implement safety and security programs and more effectively prevent contamination of the food supply and foodborne illness. The regulatory scheme in place now is complex; however, on issues of food safety, the complicated system that we do know may be better than the simple one that we do not, especially in light of the cost and uncertainty involved. As it stands now, the respective agencies, with their relative expertise and knowledge as to the actual risks posed by different foods and food processing, can engage in a targeted approach to the broad array of food safety issues that could potentially arise.

Ultimately, food safety and security concerns may be better addressed in a less radical manner of reform. Examples include: (1) increased funding for FDA inspections more commensurate with that of meat, poultry and egg products;89 (2) greater interagency coordination among FDA, USDA, EPA, and NMFS; and (3) steps to ensure food security initiatives are fully implemented and improved. This approach is likely to face less congressional opposition since it eliminates the risk of a lengthy transition period where the food supply is vulnerable and does not tinker with an agency structure of food safety regulation, which has clearly worked with great success for some time and continues in that tradition.

 

FOOTNOTES

1 See Safe Food Act of 2005, S. 729, 109th Cong. § 2(b)(C) (2005); Safe Food Act of 2005, H.R. 1507, 109th Cong. § 2(b)(C) (2005).

2 See Id. at § 2(a)(7).

3 "Food," as defined in the Safe Food Act of 2005, does not encompass dietary supplements.

4 See Id. at § 102(b).

5 See Id. at § 202(a).

6 See Id. at § 205.

7 Alternative inspection frequencies are permissible only so long as Category 2 food establishments are inspected at least monthly and Category 3, 4, and 5 food establishments are inspected at least annually. See Id. at 205(d).

8 See Id. at § 208(a) and (b).

9 See Id. at § 208(c) and (f).

10 See Id. at § 208(g).

11 Richard J. Durbin, Food Safety Oversight for the 21st Century: The Creation of a Single, Independent Federal Food Safety Agency, 59 Food Drug L.J. 383, 384 (2004).

12 Senator Durbin has introduced four bills since 1997 to establish an independent Food Safety Administration.

13 See Id.

14 See Nat'l Inst. of Medicine and Nat'l Research Council, Ensuring Safe Food from Production to Consumption (Nat'l Acad. Press, Wash., D.C. 1998).

15 See Nat'l Comm'n on the Pub. Serv., Urgent Business for America: Revitalizing the Federal Government For the 21st Century (The Brookings Inst., Wash., D.C. 2003) available at http://www.uscourts.gov/newsroom/VolckerRpt.pdf.

16 See Government Accounting Office (GAO) Federal Food Safety And Security System: Fundamental Restructuring is Needed to Address Fragmentation and Overlap 19 (GAO-04-588T) (March 30, 2004) (statement of Lawrence J. Dyckman, Director Natural Resources and the Environment before the House Subcommittee on Civil Service and Agency Organization, Committee on Government Reform) available at http://www.gao.gov/new.items/d04588t.pdf.

17 See Id.

18 See Government Accounting Office (GAO) Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities (GAO-05-549T) (May 17, 2005) (statement of Robert A. Robinson, Managing Director Natural Resources and the Environment before the House Subcommittee on the Federal Workforce and Agency Organization, Committee on Government Reform) available at http://www.gao.gov/new.items/d05549t.pdf.

19 Responsible agencies include: (1) under the Department of Health and Human Services, the Food and Drug Administration and the Centers for Disease Control and Prevention; (2) under the United States Department of Agriculture, the Food Safety and Inspection Service, the Animal and Plant Health Inspection Service, the Grain Inspection, Packers and Stockyards Administration, the Agricultural Marketing Service, the Agricultural Research Service, the Economic Research Service, the Cooperative State Research, Education, and Extension Service, and the National Agricultural Statistics Service; (3) under the Department of Commerce, the National Marine Fisheries Service; (4) under the Department of Homeland Security, the US Customs and Border Protection; (5) under the Department of the Treasury, the Bureau of Alcohol, Tobacco and Firearms; (6) the Environmental Protection Agency; and (7) the Federal Trade Commission.

20 See Government Accounting Office (GAO) Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities at 9.

21 See Id.

22 See Government Accounting Office (GAO) Federal Food Safety And Security System: Fundamental Restructuring is Needed to Address Fragmentation and Overlap at 8.

23 See Government Accounting Office (GAO) Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities at 8.

24 See Government Accounting Office (GAO) Federal Food Safety And Security System: Fundamental Restructuring is Needed to Address Fragmentation and Overlap at 8-9.

25 See Id. at 9.

26 See Government Accounting Office (GAO) Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities at 3-4.

27 See Id. at 14.

28 See Id. at 6.

29 See Id. at 19.

30 See Oversight Hearing on the Federal Food Inspection Programs Before the Subcommittee on the Federal Workforce and Agency Organization Committee on Government Reform, 109th Cong. (May 17, 2005) (statement of Robert E. Brackett, Ph.D., Director CFSAN) available at http://www.fda.gov/NewsEvents/Testimony/ucm112947.htm.

31 See Id.

32 See Id.

33 See Id.

34 See Id.

35 See Id.

36 See Timothy M. Hammonds, Ph.D., It Is Time to Designate a Single Food Safety Agency, 59 Food Drug L.J. 427, 428 (2004) (citing the National Institute of Medicine and National Research Council, Ensuring Safe Food from Production to Consumption (1998)).

37 See Id.

38 See Id.

39 Id. at 430.

40 See Id. at 431.

41 See Id.

42 See Michael R. Taylor, Lead or React? A Game Plan for Modernizing the Food Safety System in the United States, 59 Food Drug L.J. 399, 400 (2004).

43 See Id.

44 See Id.

45 See Id.

46 One example cited in Michael R. Taylor's Article, Lead or React? A Game Plan for Modernizing the Food Safety System in the United States, was that the USDA addresses the pathogen Escherichia coli O157:H7 at the meat slaughter and processing stage, while FDA is responsible for the bacteria in fresh produce; however, neither agency possesses a congressional mandate to address the problem where it originates, on the farm where preventive measures are more likely to be effective.

47 See Id.

48 See Government Accounting Office (GAO) Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities at 17.

49 See Id.

50 See Id. at 16-17.

51 See Id. at 17.

52 See Hearing before the Subcommittee on Civil Service and Agency Organization of the House Government Reform Committee, 108th Cong. (March 30, 2004) (statement of Dr. Merle Pierson, Deputy Under Secretary for Food Safety, FSIS of the USDA) available at http://www.fsis.usda.gov/OA/congress/2004/pierson033004.htm.

53 See Id.

54 See Id.

55 See Stuart M. Pape, Paul D. Rubin, Heili Kim, Food Security Would Be Compromised by Combining the Food and Drug Administration and the U.S. Department of Agriculture Into a Single Food Agency, 59 Food Drug L.J. 405, 406 (2004).

56 See Safe Food Act of 2005, S. 729, 109th Cong. § 203(b) (2005); Safe Food Act of 2005, H.R. 1507, 109th Cong. § 203(b) (2005).

57 See Id. at § 204(b).

58 The sampling program, to determine food establishments' compliance with new performance standards, is supposed to be at least as stringent as the Hazard Analysis and Critical Control Point System. See Id. at § 204(d)(1).

59 The administrator is required to prepare a resource plan, to be updated annually, which describes the resources required for full implementation of the national food safety program including personnel, facilities, equipment, and financial resources. The resource plan would be submitted annually to the Senate and House Appropriations Committees.

60 See Id. at § 204(b).

61 See Government Accounting Office (GAO) Major Management Challenges and Program Risks: Department of Homeland Security (GAO-03-102) (January 2003) (a report to Congress included as part of GAO's Performance and Accountability Series) available at http://www.gao.gov/pas/2003/d03102.pdf .

62 See Id.

63 See Id.

64 See Id.

65 See Id. at 3-4.

66 See Stuart M. Pape, Paul D. Rubin, Heili Kim, Food Security Would Be Compromised by Combining the Food and Drug Administration and the U.S. Department of Agriculture Into a Single Food Agency, 59 Food Drug L.J. at 413.

67 See Government Accounting Office (GAO) Major Management Challenges and Program Risks: Department of Homeland Security at 4.

68 See Stuart M. Pape, Paul D. Rubin, Heili Kim, Food Security Would Be Compromised by Combining the Food and Drug Administration and the U.S. Department of Agriculture Into a Single Food Agency, 59 Food Drug L.J. at 406.

69 See Id.

70 See Id. at 414.

71 See Id.

72 See Government Accounting Office (GAO) Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities at 10.

73 See S. 729 and H.R. 1507 Section 207.

74 In his written testimony before the Subcommittee on the Federal Workforce and Agency Organization Committee on Government Reform on May 17, 2005, Robert E. Brackett, Ph.D., Director CFSAN, stated that FDA has thirty-nine contract and thirty-seven partnership agreements with states to assist with domestic inspection activities, as well as working closely with food safety officials on both the state and local level on retail food safety inspections.

75 See Oversight Hearing on the Federal Food Inspection Programs Before the Subcommittee on the Federal Workforce and Agency Organization Committee on Government Reform, 109th Cong. (May 17, 2005) (statement of Robert E. Brackett, Ph.D., Director CFSAN) available at http://www.fda.gov/NewsEvents/Testimony/ucm112947.htm.

76 See Id.

77 See Id.

78 See Government Accounting Office (GAO) Federal Food Safety And Security System: Fundamental Restructuring is Needed to Address Fragmentation and Overlap at 12.

79 See Timothy M. Hammonds, Ph.D., It Is Time to Designate a Single Food Safety Agency, 59 Food Drug L.J. 427, 428 (2004).

80 See Hearing before the Subcommittee on Civil Service and Agency Organization of the House Government Reform Committee, 108th Cong. (March 30, 2004) (statement of Dr. Merle Pierson, Deputy Under Secretary for Food Safety, FSIS of the USDA) available at http://www.fsis.usda.gov/OA/congress/2004/pierson033004.htm.

81 See Stuart M. Pape, Paul D. Rubin, Heili Kim, Food Security Would Be Compromised by Combining the Food and Drug Administration and the U.S. Department of Agriculture Into a Single Food Agency, 59 Food Drug L.J. at 406.

82 See Id. at 408-410.

83 See Id. at 410-411.

84 See Id. at 411-412.

85 See Id. at 413.

86 S. 2910, was introduced by Senator Durbin on October 7, 2004 and its companion bill, H.R. 5259 was introduced by Representative DeLauro.

87 In 1997, S. 1465 was introduced by Senator Durbin and referred to the Senate Committee on Governmental Affairs Subcommittee on Oversight of Government Management. Its companion bill, H.R. 2801, was introduced by Representative Fazio (D-CA) and referred to the House Agriculture Subcommittee on Livestock, Dairy and Poultry and the Subcommittee on Department Operations, Nutrition and Foreign Agriculture as well as the House Commerce Subcommittee on Health and Environment. In 1999, S. 1281 was introduced by Senator Durbin and referred to the Senate Governmental Affairs Subcommittee on Oversight of Government Management, the Federal Workforce and the District of Columbia. H.R. 2345 was introduced by Representative DeLauro and referred to the House Commerce Subcommittee on Health and Environment and two subcommittees of the House Agricultural Committee, the Subcommittee on Livestock and Horticulture and the Subcommittee on Department Operations, Oversight, Nutrition and Forestry. In 2001, S. 1501 was introduced by Senator Durbin and referred to the Senate Governmental Affairs Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia. H.R. 1671 was introduced by Representative DeLauro and referred to the House Agriculture Subcommittee on Department Operations, Oversight, Nutrition and Forestry and the Subcommittee on Livestock and Horticulture as well as the House Energy and Commerce Subcommittee on Health.

88 See Congressman blasts USDA, FDA for not consolidating food safety tasks, 47 Food Chemical News 15 (May 23, 2005).

89 Fiscal year 2004 budget summaries indicate USDA was allocated more than twice as much food safety funding as FDA (i.e., $899 million for USDA's food inspection program versus $413 million for FDA). See Caroline Smith DeWaal, J.D., Rising Imports, Bioterrorism, and the Food Supply, 59 Food Drug L.J. 433 (2004).