federal food safety system: a primer

8/14/2019 Federal Food Safety System: A Primer

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Prepared for Members and Committees of Congress


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Numerous federal, state, and local agencies share responsibilities for regulating the safety of theU.S. food supply, which many experts say is among the safest in the world. Nevertheless, critics

view this system as lacking the organization, regulatory tools, and resources to adequately combatfoodborne illnessas evidenced by a series of widely publicized food safety problems, includingconcerns about adulterated food and food ingredient imports, and illnesses linked to various typesof fresh produce, to peanut products, and to some meat and poultry products.

A number of comprehensive food safety proposals aimed at addressing perceived shortcomings inthe U.S. food safety system were introduced but not enacted by the 110 th Congress. Theseincluded measures to reform the Food and Drug Administrations (FDAs) oversight of food andother imports, to create a new independent food safety agency, and to impose a variety of newrequirements on food manufacturers, handlers, and producers (including farms), such asmandated risk-based safety plans, recordkeeping for product tracing purposes, more rigorousregistration requirements, and performance standards. The adequacy of inspection resources also

has been at issue, and appropriators have been ramping up funding for the major agencies,particularly FDA.

Bills with similarly broad goals (such as H.R. 759, H.R. 875, H.R. 1332, S. 510) are re-emergingin the 111 th Congress, where major new legislation is possible although by no means certain. Onthe one hand, food safety reform is a relatively complex, controversial matter competing forattention with a long list of domestic priorities. On the other hand, there has been a growingconsensus that changes are needed; it remains to be seen whether lawmakers will be able to agreeon a measure acceptable to major stakeholders. (For more details see CRS Report R40443, Food Safety: Selected Issues and Bills in the 111th Congress ).


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Background ..................................................................................................................................... 1 The Agencies and Their Roles.......... ................. .................. .................. ................. .................. ....... 1 Food and Drug Administration.............. ................. ................. .................. ................. .................. ... 2 Food Safety and Inspection Service ................. ................. ................. ................. ................. ........... 3 Centers for Disease Control and Prevention (HHS)................. ................. ................. .................. ... 4 National Marine Fisheries Service (DOC) ................ ................. ................. ................. ................. .. 4 Environmental Protection Agency............ ................. ................. ................. ................. ................ ... 4 Other Federal Agencies with Food Safety Responsibilities ................ ................. ................ ........... 5 Congressional Committees.... .................. ................. .................. .................. .................. ................. 5 Selected Issues.............. ................. .................. ................. ................. .................. ................ ............ 5

Table 1. Major Federal Food Safety Agencies ................. ................. ................. ................. ............ 8 Table 2. Selected Comparison of FSIS and FDA Responsibilities.............. ................ ................. . 10

Author Contact Information ................ ................. ................. .................. ................. ................. .....11


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Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools,and other places outside the home. 2 Federal laws give food manufacturers, distributors, and

retailers the basic responsibility for assuring that foods are wholesome, safe, and handled undersanitary conditions. A number of federal agencies, cooperating with state, local, and internationalentities, play a major role in regulating food quality and safety under these laws.

The combined efforts of the food industry and the regulatory agencies often are credited withmaking the U.S. food supply among the safest in the world. Nonetheless, public health officialsestimate that each year 76 million people become sick, 325,000 are hospitalized, and 5,000 diefrom foodborne illnesses caused by contamination from any one of a number of microbialpathogens. 3 In addition, experts have cited numerous other hazards to health, including the use of unapproved veterinary drugs, pesticides, and other dangerous substances in food commodities, of particular concern at a time when an growing share of the U.S. food supply is from overseassources.

At issue is whether the current U.S. regulatory system has the resources and structuralorganization to protect consumers from these dangers. Also at issue is whether the federal foodsafety laws themselves, first enacted in the early 1900s, have kept pace with the significantchanges that have occurred in the food production, processing, and marketing sectors since then.

The Government Accountability Office (GAO) has identified as many as 15 federal agenciescollectively administering at least 30 laws related to food safety. The Food and DrugAdministration (FDA), which is part of the U.S. Department of Health and Human Services

(HHS), and the Food Safety and Inspection Service (FSIS), which is part of the U.S. Departmentof Agriculture (USDA), together comprise the majority of both the total funding and the totalstaffing of the governments food regulatory system. (See Table 1 and 2 at the end of this reportfor a brief comparative look at the agencies responsibilities). 4

FSISs FY2009 budget was approximately $972 million in appropriated funds plus anotherestimated $140 million in industry-paid user fees. FDAs budget for foods was $649 million inFY2009, virtually all of it appropriated (plus an additional $137 million for regulation of animal

1 Background on the agencies is updated information that first appeared in CRS Report 98-91, Food Safety Agenciesand Authorities: A Primer (out of print). Primary sources for that report included various documents and materialsprovided by federal food safety agencies and by the U.S. Government Accountability Office.2 Roughly two-thirds of the $1 trillion is for domestically produced farm foods; imports and seafood account for thebalance. Source: USDA, Economic Research Service, data accessed January 2008 at the Food Sector Web page athttp://www.ers.usda.gov/Browse/FoodSector/.3 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Foodborne Illness:Frequently Asked Questions, accessed at http://www.cdc.gov/foodsafety/. However, this estimate appears to be basedprimarily on 1997 and earlier data in a report by Paul S. Mead et al., Food-related Illness and Death in the UnitedStates, Emerging Infectious Diseases , vol. 5, pp. 607-625, 1999.4 High Risk Series: An Update (GAO-07-310), January 2007.


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drugs and feeds, which includes $20 million in user fees). Thus, FSIS had approximately 65% of the two agencies combined food safety budget, and FDA had the other approximately 35%. 5 Conversely, FSIS is responsible for approximately 20% of the U.S. food supply, but FDA isresponsible for 80%. 6

Among other agencies with smaller but still significant shares of the food safety portfolio are theNational Marine Fisheries Service (NMFS), which is part of the U.S. Department of Commerce(DOC), the Environmental Protection Agency (EPA), and the Centers for Disease Control andPrevention (CDC) in HHS.

The FDA is responsible for ensuring that all domestic and imported food productsexcept formost meats and poultryare safe, nutritious, wholesome, and accurately labeled. Examples of FDA-regulated foods are produce, dairy products, seafood, and processed foods. FDA has

jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of

FSIS. FDA shares responsibility for the safety of eggs with FSIS. FDA has jurisdiction overestablishments that sell or serve eggs or use them as an ingredient in their products. FDA is alsoresponsible for ensuring that most seafood products do not endanger public health (FSIS is tobegin inspecting farmed catfish products under a 2008 farm bill provision). The primary statutesgoverning FDAs activities are the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C.301 et seq.); the Public Health Service Act, as amended (42 U.S.C. 201 et seq.); and the EggProducts Inspection Act, as amended (21 U.S.C. 1031 et seq.).

FDAs food inspection force numbers more than 1,900 in field offices throughout the UnitedStates, plus nearly 900 in the Washington, DC, area. FDA regulates food manufacturers safetypractices by relying on companies self-interest in producing safe products, and by working withthe industry to improve production practices. Overall, FDA has oversight of more than 44,000

U.S. food manufacturers, plus well over 100,000 additional registered food facilities such aswarehouses and grain elevators. According to GAO, unannounced compliance inspections of individual establishments by FDA officials occur roughly once every five years, although otherestimates indicate even less frequency. FDA relies on notifications from within the industry orfrom other federal or state inspection personnel, as well as other sources, to alert it to situationscalling for increased inspection.

In the Washington, DC, area, two FDA offices are the focal point for food safety-relatedactivities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for

5 Data source: various documents of the Agriculture, Rural Development, Food and Drug Administration, and RelatedAgencies Subcommittee of the House Committee on Appropriations.6 Source for the food supply proportions is GAO, Revamping Oversight of Food Safety, urgent issues prepared forthe 2009 Congressional and Presidential Transition, accessed December 2008 at http://www.gao.gov/transition_2009/ urgent/food-safety.php. GAO here does not provide a basis for its calculations, although they appear to representproportions of total spending for food consumed at home. Examined another way, meat and poultry could account foras little as 10% of U.S. per capita food consumption, according to data maintained by USDAs Economic ResearchService (ERS); these per capita data adjust food availability for spoilage, plate waste, and other losses. Source: ERSFood Availability (Per Capita) Data System, accessed December 29, 2008, at http://www.ers.usda.gov/data/ foodconsumption/.


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(1) conducting and supporting food safety research; (2) developing and overseeing enforcementof food safety and quality regulations; (3) coordinating and evaluating FDAs food surveillanceand compliance programs; (4) coordinating and evaluating cooperating states food safetyactivities; and (5) developing and disseminating food safety and regulatory information toconsumers and industry. FDAs Center for Veterinary Medicine (CVM) is responsible for ensuring

that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, areproperly labeled, and produce no human health hazards when used in food-producing animals.

The FDA also cooperates with over 400 state agencies across the nation that carry out a widerange of food safety regulatory activities. However, the state agencies are primarily responsiblefor actual inspection. FDA works with the states to set the safety standards for foodestablishments and commodities and evaluates the states performance in upholding suchstandards as well as any federal standards that may apply. FDA also contracts with states to usetheir food safety agency personnel to carry out certain field inspections in support of FDAs ownstatutory responsibilities.

FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and importedmeat and poultry and their products sold for human consumption. Under the Federal MeatInspection Act of 1906, as amended (21 U.S.C. 601 et seq.), FSIS is required to inspect all cattle,sheep, swine, goats, and equines during slaughtering and processing. Under the Poultry ProductsInspection Act of 1957, as amended (21 U.S.C. 451 et seq.), FSIS is required to inspect anydomesticated bird being processed for human consumption; however, USDA regulationsimplementing this law limit the definition of domesticated birds to chickens, turkeys, ducks,geese, ratites (emus, ostriches, and rheas), and guineas. FDA has jurisdiction over exotic andalternative meats not inspected by FSIS, and shares the responsibility for egg safety with FSIS.The latter is responsible for the safety of liquid, frozen, and dried egg products, domestic and

imported, and for the safe use or disposition of damaged and dirty eggs under the Egg ProductsInspection Act, as amended (21 U.S.C. 1031 et seq.).

FSIS staff numbers around 9,400; roughly 8,000 of them, including about 1,000 veterinarians, arein about 6,300 meat slaughtering and/or processing plants nationwide. FSIS personnel inspect allmeat and poultry animals at slaughter on a continuous basis, and at least one federal inspector ison the line during all hours the plant is operating. Processing inspection does not require an FSISinspector to remain constantly on the production line or to inspect every item. Instead, inspectorsare on site daily to monitor the plants adherence to the standards for sanitary conditions,ingredient levels, and packaging, and to conduct statistical sampling and testing of products.Because all plants are visited daily, processing inspection also is considered to be continuous.

FSIS also is responsible for certifying that foreign meat and poultry plants are operating under aninspection system equivalent to the U.S. system before they can export their product to the UnitedStates. FSIS inspectors located at U.S. ports of entry carry out a statistical sampling program toverify the safety of imported meats from cattle, sheep, swine, goats, and equines and importedpoultry meat from chickens, turkeys, ducks, geese, quail, ratites, and guineas before they arereleased into domestic commerce. FDA is responsible for ensuring the safety of imported meatfrom any other species.


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Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS isstatutorily responsible for ensuring that the states programs are at least equal to the federalprogram. Plants processing meat and poultry under state inspection can market their productsonly within the state. If a state chooses to discontinue its own inspection program, or if FSISdetermines that it does not meet the agencys equivalency standards, FSIS must assume the

responsibility for inspection if the formerly state-inspected plants are to remain in operation. FSISalso has cooperative agreements with more than two dozen states under which state inspectionpersonnel are authorized to carry out federal inspection in meat and/or poultry plants. Productsfrom these plants may travel in interstate commerce. 7

CDC is responsible for (1) monitoring, identifying, and investigating foodborne disease problemsto determine the contributing factors; (2) working with FDA, FSIS, NMFS, state and local publichealth departments, universities, and industry to develop control methods; and (3) evaluating theeffect of control methods. In 1995, CDC launched FoodNet, a collaborative project with theFDA and USDA to improve data collection on foodborne illness outbreaks. FoodNet includesactive surveillance of clinical microbiology laboratories to obtain a more accurate accounting of positive test results for foodborne illness; a physician survey to determine testing and laboratorypractices; population surveys to identify illnesses not reported to doctors; and research studies toobtain new and more precise information about which food items or other exposures may causediseases. FoodNet data allows CDC to have a clearer picture of the incidence and causes of foodborne illness and to establish baseline data against which to measure the success of changesin food safety programs. The Public Health Service Act provides legislative authority for CDCsfood safety related activities.

Although the FDA is the primary agency responsible for ensuring the safety, wholesomeness andproper labeling of domestic and imported seafood products, NMFS conducts, on a fee-for-servicebasis, a voluntary seafood inspection and grading program that focuses on marketing and qualityattributes of U.S. fish and shellfish. The primary legislative authority for NMFSs inspectionprogram is the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.). NMFShas approximately 160 seafood safety and quality inspectors, and inspection services are fundedwith user fees.

EPA has the statutory responsibility for ensuring that the chemicals used on food crops do notendanger public health. EPAs Office of Pesticide Programs is the part of the agency that (1)registers new pesticides and determines residue levels for regulatory purposes; (2) performs

7 The 2008 farm bill (P.L. 110-246) contains new provisions intended to enable more interstate shipment of state-inspected products; USDA must develop regulations to implement these provisions.


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special reviews of pesticides of concern; (3) reviews and evaluates all the health data onpesticides; (4) reviews data on pesticides effects on the environment and on other species; (5)analyzes the costs and benefits of pesticide use; and (6) interacts with EPA regional offices, stateregulatory counterparts, other federal agencies involved in food safety, the public, and others tokeep them informed of EPA regulatory actions. The Federal Insecticide, Fungicide, and

Rodenticide Act, as amended (7 U.S.C. 136 et seq.), and the Federal Food, Drug, and CosmeticAct, as amended (21 U.S.C. 301 et seq.), are the primary authorities for EPAs activities in thisarea.

Among the other agencies that play a role in food safety, USDAs Agricultural Research Service(ARS) performs food safety research in support of FSISs inspection program. It has scientistsworking in animal disease bio-containment laboratories in Plum Island, NY, and Ames, IA.

USDAs Animal and Plant Health Inspection Service (APHIS) indirectly protects the nationsfood supply through programs to protect plant and animal resources from domestic and foreignpests and diseases, such as brucellosis and bovine spongiform encephalopathy (BSE, or madcow disease). The Department of Homeland Security (DHS) is to coordinate many food securityactivities, including at U.S. borders.

In the Senate, food safety issues are considered by the Committees on Agriculture, Nutrition, andForestry; Homeland Security and Governmental Affairs; and Health, Education, Labor, andPensions. In the House, various food safety activities fall under the jurisdiction of the Committeeson Agriculture; Energy and Commerce; Oversight and Government Reform; and Science.Agriculture subcommittees of the House and Senate Appropriations Committees also serveoversight and funding roles in how the major agencies carry out food safety policies.

Food safety-related incidents have tended to heighten congressional scrutiny of the issue and tofuel interest in food safety reform, as a number of developments in recent years have illustrated.Recent incidents have included a major outbreak of Salmonella Typhimurium infections linked tothe consumption of products containing peanut ingredients from a single firm, the PeanutCorporation of America. Between September 1, 2008, and mid-March, 2009, the CDC identifiednearly 700 cases in 46states; the infection may have contributed to the deaths of nine people,according to the CDC. A series of expanding recalls has been announced by FDA in early 2009,involving thousands of products from more than 200 companies (though none have been themajor peanut butter brands). These developments are unfolding two years after a different


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nationwide recall of peanut butter, in February 2007, due to Salmonella contamination, whenhundreds of illnesses, dating back to August 2006, were linked to the bacterium. 8

In April-July 2008, more than 1,300 persons in 43 states, the District of Columbia, and Canadawere found to be infected with the same unusual strain of bacteria ( Salmonella Saintpaul).

Officials first suspected fresh tomatoes as the vehicle, but later genetic tests confirmed thepathogen on samples of a serrano pepper and irrigation water from a farm in Mexico. Throughout2007 and 2008, USDA announced numerous recalls totaling many million pounds of ground beef products due to concerns about E. coli O157:H7 contamination.

Attention also expanded to the safety of food imports in early 2007, when adulterated pet foodingredients imported from China sickened or killed numerous dogs and cats and subsequentlywere found in some hog, chicken, and fish feed. 9 In June 2007, FDA announced that it wasdetaining imports of certain types of farm-raised seafood from China (specifically, shrimp,catfish, basa, dace, and eel) until their shippers could confirm that they are free of unapproveddrug residues. In late 2008, FDA announced that all Chinese dairy products and dairy ingredientswere being detained until importers could prove they were free of melamine (the same adulterant

found earlier in the pet food ingredients). The toxic chemical was being added to milk in China toboost protein readings; seven infants reportedly were killed and approximately 300,000 sickenedthere after consuming tainted infant formula.

These types of incidents have been cited repeatedly in a series of congressional and non-congressional hearings, reports, and studies, issued throughout the 110 th Congress, as evidence of significant shortcomings in the federal food safety system. In the last Congress, a subcommitteeof the House Energy and Commerce Committee alone held eight hearings on food safetyproblems, and various other Senate and House panels held similarly focused hearings. One topicof interest was the Bush Administrations Food Protection Plan, an integrated strategy forprotecting the nations food supply issued in late 2007 by FDA. The plan was simultaneouslyapplauded for recommending a comprehensive three-pronged approach to food safety reform(prevention, intervention, and response) and criticized for offering too few implementing andfunding details. As of late February, Obama Administration officials had yet to weigh in formallywith any specific food safety recommendations, although an outline of the Obama FY2010budget plan, released February 26, 2009, appears to propose a substantial increase for FDA ,including for food safety.

Several dozen bills were introduced in 2007 and 2008 addressing one or more aspects of theissue. Provisions affecting food safety were included in 2007 in P.L. 110-85, the FDAamendments, including a requirement that FDA establish a registry to which companies mustbegin to report events involving potentially adulterated foods. Food safety provisions in the 2008farm bill (P.L. 110-234) include subjecting farmed catfish products to FSIS mandatoryinspections similar to those for red meat and poultry; creating an option for state-inspected meatand poultry plants to ship products across state lines; and requiring meat and poultryestablishments to notify USDA about potentially adulterated or misbranded products.Congressional appropriators also increased funding for food safety activities for FY2008 andFY2009.

8 For sources and updates see the FDA website: http://www.fda.gov/opacom/7alerts.html.9 FDA has the same basic safety standards for human foods and animal feeds, including pet food.


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However, a number of more comprehensive food safety proposals were not enacted by the 110 th Congress, and similar measures are re-emerging in the 111 th Congress, where major newlegislation is possible although by no means certain. On the one hand, food safety reform is arelatively complex, controversial matter competing for attention with a long list of domesticpriorities. On the other hand, there has been a growing consensus for making major changes,

several of them supported not only by consumer advocates but by many in the food industry.

Major bills introduced through early April 2009 include: H.R. 759 (Dingell), a wide-ranging FDAimport safety bill (covering, in addition to foods, other FDA-regulated products such as drugs andmedical devices); H.R. 875 (DeLauro), which seeks to remove food safety from the current FDAand place authorities for all foods (except meat and poultry) in an independent new agency withinHHS; H.R. 1332 (Costa), which like DeLauro focuses on food safety reforms but unlike DeLaurowould do so through amendments to the existing FFDCA as administered by FDA; and S. 510(Durbin), which parallels somewhat the structure and content of the Costa bill, but is by no meansidentical. It was not yet clear (in early April 2009) which legislationamong these bills orothersmight become the primary vehicle for debate, and when that might occur in either theHouse or Senate, although some reports in the trade press were predicting that the House Energy

and Commerce Committee might begin a markup as early as soon after the Easter recess.

Another congressional venue for food safety reform could be the appropriations process. Inaddition to determining annual funding levels for FSIS, FDA, and other agencies with food safetyresponsibilities, the House and Senate Appropriations Committees frequently include directives ineither the appropriation itself, or in accompanying report language, intended to instruct theAdministration in how it is to use that money.

(For additional reports on food safety, where more detailed discussion of selected issues andupdates on legislative and related activities may be found, see the CRS Current Legislative Issueentitled Food Safety, at http://apps.crs.gov/cli/ cli.aspx?PRDS_CLI_ITEM_ID=2621&from=3&fromId=1.)


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T a b l e 1 . M a j o r F e d e r a l F o o d S a f e t y A g e n c i e s

A g e n c y M a j o r R e s p o n s i b i l i t i e s a n d A c t i v i t i e s P r i m a r y A u t h o r i t i e s

D e p a r t m e n t o f H e a l t h a n d

H u m a n S e r v i c e s :

F o o d a n d D r u g

A d m i n i s t r a t i o n a

E n s u r i n g t h a t a l l d o m e s t i c a n d i m p o r t e d f o o d s , e x c e p t

p r o c e s s e d e g g p r o d u c t s a n d m a j o r t y p e s o f m e a t a n d

p o u l t r y , a r e s a f e , w h o l e s o m e , a n d p r o p e r l y l a b e l e d , b y

s e t t i n g s a f e t y a n d s a n i t a t i o n s t a n d a r d s , p e r i o d i c a l l y

i n s p e c t i n g m a n u f a c t u r i n g f a c i l i t i e s , r e v i e w i n g r e c o r d s o f

a n d s p o t - c h e c k i n g i m p o r t s . A l s o o v e r s e e i n g t h e s a f e t y o f

a n i m a l d r u g s a n d f e e d s i n c l u d i n g t h o s e u s e d i n f o o d -

p r o d u c i n g a n i m a l s

F e d e r a l F o o d , D r u g , a n d

C o s m e t i c A c t ( F F D C A ; 2 1

U S C 3 0 1 ) , P u b l i c H e a l t h

S e r v i c e A c t ( 4 2 U S C 2 0 1 ) ,

E g g P r o d u c t s I n s p e c t i o n A c t

( 2 1 U S C 1 0 3 1 ) , P u b l i c

H e a l t h S e c u r i t y a n d

B i o t e r r o r i s m P r e p a r e d n e s s

a n d R e s p o n s e A c t ( 2 1 U S C

3 4 1 ) . a m o n g o t h e r s

C e n t e r s f o r D i s e a s e

C o n t r o l a n d

P r e v e n t i o n

M o n i t o r i n g , i d e n t i f y i n g , a n d i n v e s t i g a t i n g f o o d b o r n e

d i s e a s e s ; d e v e l o p i n g a n d e v a l u a t i n g i m p r o v e d

e p i d e m i o l o g i c a l a n d l a b o r a t o r y m e t h o d s

P u b l i c H e a l t h S e r v i c e A c t

( 4 2 U S C 2 0 1 )

D e p a r t m e n t o f A g r i c u l t u r e :

F o o d S a f e t y

I n s p e c t i o n S e r v i c e a

R e g u l a t i n g t h e s a f e t y , w h o l e s o m e n e s s a n d p r o p e r

l a b e l i n g o f m o s t c o m m e r c i a l t y p e s o f b o t h d o m e s t i c a n d

i m p o r t e d m e a t a n d p o u l t r y , c a t f i s h p r o d u c t s , a n d

p r o c e s s e d e g g p r o d u c t s , b y a p p r o v i n g e s t a b l i s h m e n t

d e s i g n s , s a f e t y p l a n s ; i n s p e c t i n g e v e r y a n i m a l a n d c a r c a s s

i n s l a u g h t e r i n g p l a n t s a n d d a i l y i n s p e c t i n g a l l m e a t a n d

p o u l t r y p r o c e s s i n g p l a n t s ; d e t e r m i n i n g t h e e q u i v a l e n c y o f

i m p o r t i n g c o u n t r i e s m e a t a n d p o u l t r y s a f e t y s y s t e m s

F e d e r a l M e a t I n s p e c t i o n A c t

( 2 1 U S C 6 0 1 ) , P o u l t r y

P r o d u c t s I n s p e c t i o n A c t ( 2 1

U S C 4 5 1 ) , E g g P r o d u c t s

I n s p e c t i o n A c t

A n i m a l a n d P l a n t

H e a l t h I n s p e c t i o n

S e r v i c e

O v e r s e e i n g a n i m a l a n d p l a n t h e a l t h , i n c l u d i n g t h e

p r e v e n t i o n o f f o r e i g n d i s e a s e s a n d p e s t s , e r a d i c a t i o n a n d

c o n t a i n m e n t o f s u c h p r o b l e m s d o m e s t i c a l l y ( i n c l u d i n g

t h o s e t h a t t h r e a t e n p u b l i c h e a l t h )

A n i m a l H e a l t h P r o t e c t i o n

A c t ( 7 U S C 8 3 0 1 ) , P l a n t

H e a l t h P r o t e c t i o n A c t ( 7

U S C 7 7 0 1 )

A g r i c u l t u r a l

M a r k e t i n g S e r v i c e

E s t a b l i s h i n g q u a l i t y a n d m a r k e t i n g g r a d e s a n d s t a n d a r d s

f o r d a i r y p r o d u c t s , f r u i t s a n d v e g e t a b l e s , l i v e s t o c k , m e a t ,

p o u l t r y , s e a f o o d s , a n d e g g p r o d u c t s ; c e r t i f y i n g q u a l i t y

p r o g r a m s ; c o n d u c t i n g q u a l i t y g r a d i n g s e r v i c e s , g e n e r a l l y

u s e r f e e - f u n d e d

A g r i c u l t u r a l M a r k e t i n g A c t

o f 1 9 4 6 ( 7 U . S . C . 1 6 2 1 ) , E g g

P r o d u c t s I n s p e c t i o n A c t ( 2 1

U S C 1 0 3 1 ) , A g r i c u l t u r a l

M a r k e t i n g A g r e e m e n t A c t

( 7 U . S . C . 6 0 1 )

F o o d a n d N u t r i t i o n

S e r v i c e

E n c o u r a g i n g a n d c o o r d i n a t i n g e f f o r t s t o e n s u r e t h e s a f e t y

o f f o o d s i n s c h o o l l u n c h a n d o t h e r d o m e s t i c p r o g r a m s

P r o g r a m s u b s i d i e s

a u t h o r i z e d b y R i c h a r d B .

R u s s e l l N a t i o n a l S c h o o l

L u n c h A c t ( 4 2 U S C

1 7 5 1 ) , C h i l d N u t r i t i o n A c t

( 4 2 U S C 1 7 7 1 ) .

G r a i n I n s p e c t i o n ,

P a c k e r s a n d

S t o c k y a r d s

A d m i n i s t r a t i o n

S e t t i n g q u a l i t y s t a n d a r d s f o r , a n d t e s t i n g , g r a i n s a n d

r e l a t e d c o m m o d i t i e s , p r i m a r i l y f o r m a r k e t i n g p u r p o s e s

U . S . G r a i n S t a n d a r d s A c t ( 7

U S C 7 1 ) , A g r i c u l t u r a l

M a r k e t i n g A c t o f 1 9 4 6


12/14

A g e n c y M a j o r R e s p o n s i b i l i t i e s a n d A c t i v i t i e s P r i m a r y A u t h o r i t i e s

A g r i c u l t u r a l

R e s e a r c h S e r v i c e

C o n d u c t s i n - h o u s e U S D A r e s e a r c h o n a g r i c u l t u r a l a n d

f o o d t o p i c s , o f w h i c h f o o d s a f e t y i s o n e o f m a n y

N u m e r o u s l a w s d a t i n g t o

t h e D e p a r t m e n t o f

A g r i c u l t u r e O r g a n i c A c t o f

1 8 6 2 ( 7 U S C 2 2 0 1 n o t e ) , u p

t h r o u g h a n d i n c l u d i n g

r e c e n t o m n i b u s f a r m l a w s

C o o p e r a t i v e S t a t e

R e s e a r c h , E d u c a t i o n ,

a n d E x t e n s i o n

S e r v i c e

C o o r d i n a t e s a n d a d m i n i s t e r s f e d e r a l f u n d i n g o f l a n d

g r a n t a n d o t h e r i n s t i t u t i o n s t o c o n d u c t a g r i c u l t u r a l a n d

f o o d r e s e a r c h , e d u c a t i o n a n d e x t e n s i o n a c t i v i t i e s ; f o o d

s a f e t y i s o n e o f m a n y s u b j e c t a r e a s

N u m e r o u s l a w s d a t i n g t o

t h e D e p a r t m e n t o f

A g r i c u l t u r e O r g a n i c A c t o f

1 8 6 2 , u p t h r o u g h a n d

i n c l u d i n g r e c e n t o m n i b u s

f a r m l a w s

D e p a r t m e n t o f C o m m e r c e :

N a t i o n a l O c e a n i c

a n d A t m o s p h e r i c

A d m i n i s t r a t i o n

O f f e r i n g a v a r i e t y o f v o l u n t a r y s e a f o o d s a f e t y a n d q u a l i t y

i n s p e c t i o n s e r v i c e s o n a f e e - f o r - s e r v i c e b a s i s

A g r i c u l t u r a l M a r k e t i n g A c t

o f 1 9 4 6 , F i s h a n d W i l d l i f e

A c t o f 1 9 5 6 ( 1 6 U S C 7 4 2 )

E n v i r o n m e n t a l P r o t e c t i o n

A g e n c y

R e g u l a t i n g p e s t i c i d e p r o d u c t s ; s e t t i n g m a x i m u m

a l l o w a b l e t o l e r a n c e s f o r r e s i d u e l e v e l s o n f o o d

c o m m o d i t i e s a n d a n i m a l f e e d s

F e d e r a l I n s e c t i c i d e ,

F u n g i c i d e , a n d R o d e n t i c i d e

A c t ( 7 U S C 1 3 6 ) , F F D C A

F e d e r a l T r a d e

C o m m i s s i o n

E n f o r c i n g f e d e r a l p r o h i b i t i o n s a g a i n s t u n f a i r o r d e c e p t i v e

a c t s o r p r a c t i c e s i n t r a d e , i n c l u d i n g c o n s u m e r d e c e p t i o n

r e g a r d i n g f o o d s

F e d e r a l T r a d e C o m m i s s i o n

A c t ( 1 5 U S C 4 1 )

D e p a r t m e n t o f t h e

T r e a s u r y :

A l c o h o l a n d

T o b a c c o T a x a n d

T r a d e B u r e a u

A d m i n i s t e r i n g a n d e n f o r c i n g l a w s o n t h e p r o d u c t i o n ,

s a f e t y , d i s t r i b u t i o n a n d u s e o f a l c o h o l i c b e v e r a g e s

F e d e r a l A l c o h o l

A d m i n i s t r a t i o n A c t ( 2 7 U S C

2 0 1 ) , I n t e r n a l R e v e n u e

C o d e ( 2 6 U S C C h . 5 1 )

D e p a r t m e n t o f H o m e l a n d

S e c u r i t y :

U . S . C u s t o m s a n d

B o r d e r P r o t e c t i o n

C o o r d i n a t i n g m a n y f o o d s e c u r i t y a c t i v i t i e s , i n c l u d i n g a t

t h e b o r d e r ; n o w c o n d u c t i n g a g r i c u l t u r a l b o r d e r

i n s p e c t i o n a c t i v i t i e s f o r m e r l y d o n e b y A P H I S

H o m e l a n d S e c u r i t y A c t ( 6

U S C 1 0 1 )

S o u r c e : P r e p a r e d b y C R S b a s e d i n p a r t o n v a r i o u s r e p o r t s b y t h e G o v e r n m e n t A c c o u n t a b i l i t y O f f i c e .

a .

T h e s e a g e n c i e s h a v e t h e l e a d i n g f o o d s a f e t y r e g u l a t o r y a u t h o r i t i e s .


13/14

T a b l e 2 . S e l e c t e d C o m p a r i s o n o f F S I S a n d F D A R e s p o n s i b i l i t i e s

A c t i v i t y F o o d S a f e t y a n d I n s p e c t i o n S e r v i c e

F o o d a n d D r u g A d m i n i s t r a t i o n

( F o o d s O n l y )

P r i m a r y

A u t h o r i z a t i o n s

F e d e r a l M e a t I n s p e c t i o n A c t ( 2 1 U S C

6 0 1 ) , P o u l t r y P r o d u c t s I n s p e c t i o n A c t ( 2 1

U S C 4 5 1 ) , E g g P r o d u c t s I n s p e c t i o n A c t

( 2 1 U S C 1 0 3 1 )

F e d e r a l F o o d , D r u g , a n d C o s m e t i c A c t ( F F D C A ;

2 1 U S C 3 0 1 ) , P u b l i c H e a l t h S e r v i c e A c t ( 4 2 U S C

2 0 1 ) , E g g P r o d u c t s I n s p e c t i o n A c t ( 2 1 U S C 1 0 3 1 ) ,

P u b l i c H e a l t h S e c u r i t y a n d B i o t e r r o r i s m

P r e p a r e d n e s s a n d R e s p o n s e A c t ( 2 1 U S C 3 4 1 )

F o o d s R e g u l a t e d M a j o r t y p e s o f d o m e s t i c a n d i m p o r t e d

m e a t a n d p o u l t r y a n d t h e i r p r o d u c t s ;

c a t f i s h p r o d u c t s ; p r o c e s s e d ( d r i e d ,

f r o z e n , l i q u i d ) e g g p r o d u c t s ( 2 0 % o f a t -

h o m e U . S . f o o d s p e n d i n g )

A l l o t h e r d o m e s t i c a n d i m p o r t e d f o o d s , a l s o

a n i m a l d r u g s a n d f e e d s i n c l u d i n g t h o s e u s e d i n

f o o d - p r o d u c i n g a n i m a l s ( 8 0 % o f a t - h o m e U . S . f o o d

s p e n d i n g )

F u n d i n g ( F Y 0 9 ) A p p r o p r i a t e d : $ 9 7 2 m i l l i o n ; u s e r f e e s :

$ 1 4 0 m i l l i o n

A p p r o p r i a t i o n : $ 6 4 9 m i l l i o n ( p l u s $ 1 3 7 m i l l i o n f o r

a n i m a l d r u g s a n d f e e d s i n c l u d i n g $ 2 0 m i l l i o n i n

u s e r f e e s )

S t a f f ( e s t . f i e l d

o n l y )

8 , 0 0 0 1 , 9 0 0

D o m e s t i c f a c i l i t i e s 6 , 3 0 0 s l a u g h t e r a n d / o r p r o c e s s i n g

e s t a b l i s h m e n t s

1 3 6 , 0 0 0 ( i n c l u d e s 4 4 , 0 0 0

m a n u f a c t u r e r s / p r o c e s s o r s )

I n s p e c t i o n

A p p r o a c h

A n t e - a n d p o s t - m o r t e m i n s p e c t i o n o f

e v e r y a n i m a l , c a r c a s s a n d p a r t ;

t r a d i t i o n a l l y o r g a n o l e p t i c ( b u t s e e F o o d

s a f e t y p l a n s b e l o w ) ; o n l y U S D A -

i n s p e c t e d a n d p a s s e d p r o d u c t s m a y e n t e r

c o m m e r c e

P r o h i b i t s a d u l t e r a t i o n o r m i s b r a n d i n g ; r e l i e s o n

f a c i l i t i e s t h a t m a n u f a c t u r e , p r o c e s s , p a c k , o r h o l d

f o o d f o r h u m a n s o r a n i m a l s t o b e m e e t p r e s c r i b e d

s t a n d a r d s ( e . g . , r e g a r d i n g a d d i t i v e s , c o n t a m i n a n t s ,

e t c . ) ; a l l f a c i l i t i e s m u s t r e g i s t e r , r e p o r t c h a n g e s i n

t i m e l y m a n n e r

R e q u i r e d

i n s p e c t i o n

f r e q u e n c y

S l a u g h t e r p l a n t s : a l l t i m e s o f o p e r a t i o n ;

p r o c e s s i n g p l a n t s : a t l e a s t o n c e d a i l y

N o t e x p l i c i t l y r e q u i r e d ; a n n u a l f o r 6 , 0 0 0 h i g h - r i s k

f a c i l i t i e s ; o n c e e v e r y 5 - 1 0 y e a r s f o r r e s t ( e s t s .

v a r y )

F o o d s a f e t y p l a n s R e q u i r e s a l l e s t a b l i s h m e n t t o p r e p a r e a n d

h a v e p r e a p p r o v e d H A C C P ( h a z a r d

a n a l y s i s a n d c r i t i c a l c o n t r o l p o i n t ) p l a n s

d e t e r m i n i n g r i s k s , c o n t r o l l i n g t h e m ( w i t h

d o c u m e n t a t i o n )

F a c i l i t i e s m u s t f o l l o w m o r e g e n e r a l r e g u l a t i o n s o n

g o o d m a n u f a c t u r i n g p r a c t i c e s ( G M P s ) w h i c h

a d d r e s s s a f e h a n d l i n g a n d p l a n t s a n i t a t i o n e x c e p t

a f o r m o f H A C C P r e q u i r e d f o r s e a f o o d , l o w - a c i d

c a n n e d f o o d s , j u i c e s

I m p o r t s S p e c i f i e d p r o d u c t s o n l y f r o m c o u n t r i e s

w h e r e F S I S h a s d e t e r m i n e d e q u i v a l e n c e

o f f o r e i g n s a f e t y s y s t e m , w i t h a n n u a l

v e r i f i c a t i o n ; i m p o r t s e x e m p t f r o m p r i o r

n o t i c e b u t s u b j e c t t o r e i n s p e c t i o n a t 1 5 0

i m p o r t e s t a b l i s h m e n t s ( e s t . 1 0 %

r e i n s p e c t e d )

E q u i v a l e n c e n o t d e t e r m i n e d b e f o r e h a n d ; r e l i a n c e

o n i n s p e c t i o n s a t 3 0 0 p o r t s ; a l l f o r e i g n f a c i l i t i e s

( l i k e d o m e s t i c ) m u s t r e g i s t e r a n d r e p o r t c h a n g e s

i n t i m e l y m a n n e r ; m u s t p r o v i d e p r i o r n o t i c e f o r

e a c h f o o d a r t i c l e i m p o r t e d ( e s t . 1 % o f n o t i f i e d

e n t r i e s i n s p e c t e d )

T h i r d p a r t y

c e r t i f i c a t i o n

P r i v a t e l a b s a c c r e d i t e d f o r c h e m i c a l

t e s t i n g o f m e a t a n d p o u l t r y ( f o r i m p o r t s ,

s e e a b o v e )

N o a c c r e d i t a t i o n f o r f o o d t e s t i n g l a b s o r u s e o f

t h i r d p a r t i e s f o r i m p o r t o v e r s i g h t a d d r e s s e d i n

c u r r e n t l a w

O n - f a r m o v e r s i g h t F S I S i n s p e c t i o n a u t h o r i t y b e g i n s a t

s l a u g h t e r p l a n t

T h o s e e n g a g e d s o l e l y i n h a r v e s t i n g , s t o r i n g o r

d i s t r i b u t i n g r a w a g r i c u l t u r a l c o m m o d i t i e s g e n e r a l l y

e x e m p t f r o m r e g i s t r a t i o n , G M P r e g u l a t i o n s ,

r e c o r d k e e p i n g . a l t h o u g h m a y h a v e a u t h o r i t y t o

r e g u l a t e s o m e o n - f a r m a c t i v i t i e s


14/14

A c t i v i t y F o o d S a f e t y a n d I n s p e c t i o n S e r v i c e

F o o d a n d D r u g A d m i n i s t r a t i o n

( F o o d s O n l y )

L a b e l i n g R e v i e w a n d p r e a p p r o v a l r e q u i r e d f o r a l l

l a b e l s

A l l f o o d s m u s t a d h e r e t o f o o d l a b e l i n g

r e q u i r e m e n t s s u c h a s s t a t e m e n t o f i d e n t i t y ,

d e c l a r a t i o n o f n e t c o n t e n t s , n u t r i t i o n l a b e l i n g ;

l a b e l s c a n n o t b e f a l s e o r m i s l e a d i n g

N o t i f i c a t i o n

R e q u i r e m e n t s

P . L . 1 1 0 - 2 4 6 r e q u i r e s a n e s t a b l i s h m e n t t o

p r o m p t l y n o t i f y U S D A i f i t h a s r e a s o n t o

b e l i e v e t h a t a n a d u l t e r a t e d o r m i s b r a n d e d

p r o d u c t h a s e n t e r e d c o m m e r c e

P . L . 1 1 0 - 8 5 r e q u i r e s r e p o r t a b l e f o o d r e g i s t r y t o

r e p o r t i f a n a r t i c l e o f f o o d p o s e s a r e a s o n a b l e

p r o b a b i l i t y o f c a u s i n g s e r i o u s a d v e r s e h e a l t h

c o n s e q u e n c e s o r d e a t h t o h u m a n s o r a n i m a l s ; n o t

y e t e s t a b l i s h e d b y a g e n c y

R e c a l l A u t h o r i t y N o a u t h o r i t y t o m a n d a t e r e c a l l s ; r e l i e s

o n v o l u n t a r y

N o a u t h o r i t y t o m a n d a t e r e c a l l s ( e x c e p t i n f a n t

f o r m u l a ) ; r e l i e s o n v o l u n t a r y

S o u r c e : P r e p a r e d b y C R S b a s e d o n v a r i o u s C R S r e p o r t s .

Geoffrey S. BeckerSpecialist in Agricultural [email protected], 7-7287

federal food safety system: a primer

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