Abstract
The FDA Food Safety Modernization Act (FSMA ) is the most sweeping reform to the US food safety laws in more than 70 years. The legislation, signed into law by President Obama on January 4, 2011, amended the Food, Drug, and Cosmetic Act in three principal ways. First, it provided the Food and Drug Administration (FDA) new enforcement powers and lower threshold for administrative actions. Second, it required the FDA to promulgate seven foundational rules. These rules fundamentally reshape the food safety landscape. Finally, FSMA integrated the relationships up and down the supply chain requiring supplier verification which can ensure compliance through cooperation and also compel it through the enhanced risk of private litigation. This chapter will explore the roots of FSMA, delve into the new provisions of the legislation and foundational rules, and also analyze the early progress enforcing FSMA as of 2017.
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- 1.
Public Law 111–353 (2011).
- 2.
78 FR 79994 (2011).
- 3.
Codified as 21 U.S. Code § 350d(b).
- 4.
80 FR 55907 (2015).
- 5.
21 CFR 117.126.
- 6.
21 CFR 117.130(a).
- 7.
21 CFR 117.170(a).
- 8.
21 CFR 117.170(b)(1)–(4).
- 9.
21 CFR 117.130(b)(I)(1)–(3) and (b)(ii)(1)–(3).
- 10.
Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis , and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide.
- 11.
21 CFR 117.130(c).
- 12.
21 CFR 117.135(2)(a)(1).
- 13.
21 CFR 117.405.
- 14.
21 CFR 117.4.
- 15.
21 CFR 117.4(b).
- 16.
21 CFR 1.227(1).
- 17.
21 CFR 1.227(1) and (1)(iii).
- 18.
21 CFR 1.227(1)(iii)(A).
- 19.
21 CFR 1.227(1)(iii)(B)(1)–(3).
- 20.
21 CFR 1.227(2).
- 21.
21 CFR 117.5(g)(2)(i)–(x).
- 22.
21 CFR 117.3.
- 23.
21 CFR 117.3.
- 24.
21 CFR 117.201(a)(2)(i)–(ii).
- 25.
21 CFR 117.7.
- 26.
Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (August 2017); Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (August 2017).
- 27.
Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (August 2017).
- 28.
21 CFR 117.5(j).
- 29.
21 CFR 117.5(f) and (i).
- 30.
21 CFR 117.95(a).
- 31.
80 FR 56173 (2016).
- 32.
Melamine Pet Food Recall – Frequently Asked Questions (October, 2009).
- 33.
Id.
- 34.
Id.
- 35.
80 FR 74226.
- 36.
21 CFR 1.500.
- 37.
21 CFR 1.501(f), (d), and (e).
- 38.
21 CFR 1.501(b) and (c) and 21 CFR 1.502(b).
- 39.
21 CFR 1.504–1.514.
- 40.
21 CFR 1.505(a)(ii).
- 41.
21 CFR 1.505(a)(iii).
- 42.
21 CFR 1.506.
- 43.
21 CFR 1.506(d)(2).
- 44.
21 CFR 1.503(a).
- 45.
21 CFR 1.503(a).
- 46.
21 CFR 1.511(a) and (b).
- 47.
21 CFR 1.507.
- 48.
21 CFR 1.507(a)(2)(i), (a)(3)(i), and (a)(4)(i).
- 49.
21 CFR 1.509.
- 50.
80 FR 74354 (2015).
- 51.
21 CFR 112.4(a).
- 52.
21 CFR 112.1(a)(1)–(2).
- 53.
21 CFR 112.41.
- 54.
21 CFR 112.44(a)(1)–(4).
- 55.
21 CFR 112.45(b).
- 56.
21 CFR 112.3.
- 57.
21 CFR 112.42.
- 58.
21 CFR 112.42.
- 59.
21 CFR 112. (b)(1) and (2).
- 60.
21 CFR 112.46 (b)(1)(i)(A).
- 61.
21 CFR 112.46 (b)(1)(i)(B).
- 62.
21 CFR 112.3.
- 63.
21 CFR 112.51(a).
- 64.
21 CFR 112.51(b).
- 65.
21 CFR 112.56(a)(1).
- 66.
21 CFR 112.60(b)(1)(i) and (b)(1)(ii).
- 67.
21 CFR 112.56(a)(2).
- 68.
21 CFR 112.141.
- 69.
Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide (September 2017).
- 70.
21 CFR 112.143.
- 71.
21 CFR 112.44.
- 72.
21 CFR 112.44.
- 73.
21 CFR 112.83.
- 74.
21 CFR 112.84.
- 75.
21 CFR 112.83.
- 76.
21 CFR 112.21(a) and (b).
- 77.
21 CFR 112.21(c).
- 78.
21 CFR 112.22(a).
- 79.
21 CFR 112.31.
- 80.
21 CFR 112.31(b).
- 81.
21 CFR 112.122 and 121.
- 82.
21 CFR 112.123(a) and (b).
- 83.
21 CFR 112.126–112.128.
- 84.
21 CFR 112.129 and 112.130.
- 85.
21 CFR 112.2(b).
- 86.
21 CFR 112.2(b)(2).
- 87.
21 CFR 112.2(b)(3)(i) and (ii).
- 88.
21 CFR 112.2(b)(3)(ii)(B).
- 89.
21 CFR 112.3.
- 90.
21 CFR 112.5(a)(1)–(2).
- 91.
21 CFR 112.6(a).
- 92.
80 FR 74569 (2015).
- 93.
21 CFR 1.503(b).
- 94.
Id.
- 95.
21 CFR 1.610.
- 96.
21 CFR 1.640.
- 97.
21 CFR 1.652.
- 98.
81 FR 20091.
- 99.
21 CFR 1.900.
- 100.
21 CFR 1.904.
- 101.
Id.
- 102.
21 CFR 1.906.
- 103.
Key Requirements: Final rule on sanitary transportation of human and animal food (April 2016).
- 104.
81 FR 34165 (2016).
- 105.
21 CFR 121.1.
- 106.
21 CFR 121.126(b) and 121.310.
- 107.
21 CFR 121.3.
- 108.
Id.
- 109.
21 CFR 121.157(a).
- 110.
21 CFR 121.157(b)(1)–(4).
- 111.
21 U.S.C. 384b.
References
CFR Part 1 (Subparts L, M, and O), 112, 117, 121 and 507
FDA’s Voluntary Qualified Importer Program Guidance for Industry
Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration – What You Need to Know About the FDA Regulation: Small Entity Compliance Guide (August 2017)
Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation – Small Entity Compliance Guide
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Sanchez, M.C. (2018). The Food Safety Modernization Act. In: Food Law and Regulation for Non-Lawyers. Food Science Text Series. Springer, Cham. https://doi.org/10.1007/978-3-319-71703-6_6
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DOI: https://doi.org/10.1007/978-3-319-71703-6_6
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