Under the Federal Food, Drug and Cosmetic Act, (FFDCA) the Food and Drug Administration
\n(FDA) protects consumers against impure, unsafe, and fraudulently labeled food. The FDA has
\ninspection authority over any food in interstate commerce except for products regulated by the
\nUSDA Food Safety and Inspection Service (FSIS).<\/p>\n
Products that are regulated by the USDA FSIS include meat, poultry, and egg products. Initially,
\nboth FSIS and FDA were part of the US Department of Agriculture. However, in 1940 the FDA
\nwas transferred out of the USDA. It is now part of the Department of Health and Human
\nServices.<\/p>\n
The mission of both the FDA and the FSIS is to ensure national food safety. The FDA requires
\nthat all food come from an \u201capproved source and process.\u201d The most common approved sources
\ninclude licensed food establishments, federally inspected meat plants, and state-inspected meat
\nplants.<\/p>\n
The two agencies share statutory authority in a few instances. They both share authority in regard
\nto egg safety because FSIS is in charge of inspecting plants processing liquid, frozen, and dried
\negg products, while FDA monitors fresh eggs. They both share authority for food additives used
\nin meat, poultry, and egg products. All new additives are initially evaluated for safety by the
\nFDA. However, the FSIS has the authority to enact different regulations than the FDA with
\nregard to the food additives allowed in the products under their jurisdiction. For example,
\nalthough the FDA considers ascorbic acid to be an approved food additive, the FSIS denied
\npermission to use it as an additive in meat salads because of fears that such usage would mask
\nmeat spoilage by organisms causing food borne illnesses.<\/p>\n
In addition, the 1958 Food Additives Amendment to the FFDCA permitted FSIS to continue to
\npermit use of nitrites and nitrates in amenable meat products even though the FDA does not
\npermit their use in other food products. The FDA does not allow the use of nitrite or nitrates in
\nfood products; therefore, all meat food products must be manufactured under USDA FSIS
\ninspection. In March of 2006, FSIS issued notice 15-06 clarifying the use of nitrates in non
\namenable meat products. (More on this in a later section.)<\/p>\n
Meat products for use in pet foods fall under the jurisdiction of the FDA, which is also
\nresponsible for ensuring the safety of medicines, cosmetics, animal feed, and drugs for pets and
\nfarm animals.<\/p>\n
The FDA also ensures that products are labeled truthfully with the information that people need
\nto use them properly.<\/p>\n
The regulations require FDA inspection of the facilities and processes involved in slaughtering
\nof non-amenable species (if not already inspected by another party) and the processing of food,
\nincluding amenable and non-amenable meat and poultry products. According to the FDA the
\nsource and process, not the animal itself, must be inspected and approved. FDA inspections are
\nusually done once a year. If a facility is involved only in processing, then the FDA requires that
\nall ingredients come from an \u201capproved source and process.\u201d Approved sources of meat and
\n38
\npoultry are those that come from a licensed food establishment, a federally inspected meat plant,
\nor a state-inspected meat plant.<\/p>\n
If a company is found violating any of the laws that FDA enforces, then the FDA can encourage
\nthe firm to correct voluntarily the problem or to recall the product from the market. A recall is
\ngenerally the fastest and most effective way to protect the public from an unsafe product. When a
\ncompany can\u2019t or won\u2019t correct a public health problem voluntarily, FDA can enact legal
\nsanctions.<\/p>\n
1. Food Safety Modernization Act<\/p>\n
FDA\u2019s approach to regulating companies in food safety matters was significantly altered by the
\nFood Safety Modernization Act (FSMA), which amended the FFDCA (Federal Food Drug and
\nCosmetic Act) and was enacted in 2011. FSMA\u2019s intent is to significantly increase the food
\nsystem\u2019s focus on preventing contamination as opposed to responding to contamination. After
\nFSMA was enacted, the FDA published several rules in order to implement FSMA. These rules
\nwere then codified as regulations.<\/p>\n
FSMA and the regulations enacted under FSMA do not dramatically affect farmers
\ninvolved in direct marketing their meat and poultry, unless those same farmers are also
\ngrowing produce covered by the legislation. This resource guide will only discuss aspects of
\nFSMA that apply to businesses defined by the FDA as \u201csmall businesses\u201d and \u201cvery small
\nbusinesses.\u201d The FDA defines \u201csmall businesses\u201d as \u201cbusinesses employing fewer than 500 full
\ntime equivalent employees,\u201d and it defines a \u201cvery small business\u201d as \u201cbusiness\u2026that averages
\nless than $1 million per year during the three-year period preceding the applicable calendar year
\nin sales of human food plus the market value of human food manufactured, processed, packed or
\nheld without sale.\u201d58 Information on how FSMA and its regulations apply to small businesses
\nand very small businesses involved in direct marketing meat and poultry is found in the relevant
\nsections in this resource guide.<\/p>\n
For more information on FSMA, see the FDA\u2019s website on the Act. This website contains
\nnumerous helpful links and resources. The website is Food Safety Modernization Act
\n(FSMA), FDA, https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary
\nsupplements\/food-safety-modernization-act-fsma. Note that the FDA\u2019s website also
\ncontains numerous guidances for industry about FSMA. These can be found at FSMA
\nRules & Guidance for Industry, FDA, https:\/\/www.fda.gov\/food\/food-safety
\nmodernization-act-fsma\/fsma-rules-guidance-industry#Guidance.<\/p>\n
For a helpful overview of FSMA and how it applies to meat processors, see Dr. Michele
\nPfannenstiel, Dirigo Food Safety, Food Safety and Modernization Act: How Might It
\nApply to Meat Processors? Fact Sheet Version 2.7.2017,
\nhttp:\/\/www.nichemeatprocessing.org\/wp
\ncontent\/uploads\/2017\/02\/FSMASheetv2.7.17.docx1_.pdf<\/p>\n
Although the Act was enacted in 2011, the Act established compliance dates in the future. The
\ndates by which small businesses and very small businesses need to comply with regulations
\nenacted under FSMA are generally between 2017 and 2020.<\/p>\n
For more information on when businesses need to comply with FSMA regulations, see
\nFSMA Compliance Dates, FDA (last updated May 6, 2019),
\nhttps:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-compliance-dates.<\/p>\n","protected":false},"excerpt":{"rendered":"
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