The FDA Food Safety Modernization Act (P.L. 111-353) Page: 4 of 61
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The FDA Food Safety Modernization Act (P.L. 111-353)
Introduction
The combined efforts of the food industry and government regulatory agencies often are credited
with making the U.S. food supply among the safest in the world. Nonetheless, public health
officials have estimated that each year in the United States, many millions of people become sick
and thousands die from foodborne illnesses caused by any of a number of microbial pathogens
and other contaminants.' At issue is whether the current food safety system has the resources,
authority, and structural organization to safeguard the health of American consumers, who spend
more than $1 trillion on food each year.2 Also at issue is whether federal food safety laws, first
enacted in the early 1900s, have kept pace with the significant changes that have occurred in the
food production, processing, and marketing sectors since then.
In 2007 and again in 2009, the Government Accountability Office (GAO) placed food safety on
its biennially published list of high-risk areas, one of 30 needing concerted attention by Congress
and the Administration.3 GAO has identified 15 federal agencies collectively administering at
least 30 laws related to food safety. The majority of both total funding and total staffing, however,
is with the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture
(USDA), which regulates most meat and poultry, and the Food and Drug Administration (FDA) at
the U.S. Department of Health and Human Services (HHS), which regulates virtually all other
foods. FSIS's annual budget in FY2010 was approximately $1.1 billion in appropriated funds,
plus an estimated $131 million in industry-paid user fees. FDA's annual budget in FY2010 for its
human foods program was $784 million, all of it appropriated.4
After discussing several recent food safety incidents and the systemic food safety problems that
they illustrate, this report describes the existing food safety legal and regulatory landscape and
presents an overview of efforts by the 111th Congress to revise federal food safety authorities and
activities, principally at FDA. It then provides a detailed overview of the major provisions in the
newly enacted law-the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). The report
is organized around a number of selected food safety issues, describing how they are addressed in
previously existing law and regulations, and describing their treatment in the newly enacted law.
Finally, appendixes provide a crosswalk of all provisions in FSMA, followed by a side-by-side
comparison of each of these provisions with previously existing law.
1 The Centers for Disease Control and Prevention (CDC) estimates that each year roughly 1 out of 6 Americans (or 48
million people) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. CDC, "Estimates of
Foodborne Illness in the United States," http://www.cdc.gov/foodborneburden/index.html.
2 Nearly half of U.S. food spending is now in restaurants and other places outside the home. Roughly two-thirds of the
$1 trillion is for domestically produced farm foods; imports and seafood account for the balance. Data source: U.S.
Department of Agriculture (USDA), Economic Research Service.
3 GAO, High Risk Series: An Update (GAO-09-271), January 2009.
4 Source: USDA and HHS budget materials for FY2011. The FDA figure does not include some food safety activities
carried out by the Center for Veterinary Medicine and National Center for Toxicological Research. For more
information on current food safety authorities and agencies, with sources, see CRS Report RS22600, The Federal Food
Safety System: A Primer. Also see CRS Report R40721, Agriculture and Related Agencies: FY2010 Appropriations.Congressional Research Service
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Johnson, Renée. The FDA Food Safety Modernization Act (P.L. 111-353), report, February 18, 2011; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc807580/m1/4/: accessed April 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.