Description
The FDA Food Safety Modernization Act (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On May 27, 2016, FDA published in the Federal Register a final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule) (81 FR 34165), that creates new requirements for the production of food by registered food facilities to protect the food supply against intentional adulteration. The final rule became effective on July 26, 2016.
Scope & Applicability
Stakeholders
5Target audience for the compliance guide
A business averaging less than $1,000,000 in annual sales of human food; Definition based on average annual sales plus market value; Business averaging less than $2,500,000 in annual sales of animal food
Entity type with specific compliance dates
One of the roles authorized to manage facility registration.
Person qualified to prepare translations
Identified Hazards
Hazards
4Risks addressed by food defense systems
substances like Salmonella or lead found in food supply
Vulnerability that could cause wide scale public health harm if exploited; A vulnerability that, if exploited, could cause wide scale public health harm.; Identified during the vulnerability assessment process.; A point in the process susceptible to intentional adulteration; identify and implement the most appropriate mitigation strategy(ies) necessary to address the significant vulnerability(ies) present at the actionable process step.; minimize the significant vulnerability associated with the
A specific threat that must be considered during vulnerability assessments.
Related CFR Sections (15)
- 21CFR1.227§ 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
- 21CFR121.3§ 121.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:Read full regulation →
- 21CFR121.4§ 121.4 Qualifications of individuals who perform activities under subpart C of this part .
(a) Applicability. You must ensure that each individual who performs activities required under subpart C of this part is a qualified individual as that term is defined in § 121.3 .Read full regulation →
- 21CFR121.5§ 121.5 Exemptions.
(a) This part does not apply to a very small business, except that a very small business must, upon request, provide for official review documentation sufficient to show that the facility meets this exemption. Such documentation must be retained for 2 years.Read full regulation →
- 21CFR121.126§ 121.126 Food defense plan.
(a) Requirement for a food defense plan. You must prepare, or have prepared, and implement a written food defense plan.Read full regulation →
- 21CFR121.157§ 121.157 Reanalysis.
(a) You must conduct a reanalysis of the food defense plan, as a whole at least once every 3 years;Read full regulation →
- 21CFR121.1§ 121.1 Applicability.
This part applies to the owner, operator or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, unless one of the exempRead full regulation →
- 21CFR121.130§ 121.130 Vulnerability assessment to identify significant vulnerabilities and actionable process steps.
(a) Requirement for a vulnerability assessment. You must conduct or have conducted a vulnerability assessment for each type of food manufactured, processed, packed, or held at your facility using appropriate methods to evaluate each point, step, or procedure in your food operation to identify signifRead full regulation →
- 21CFR121.135§ 121.135 Mitigation strategies for actionable process steps.
(a) You must identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated Read full regulation →
- 21CFR121.138§ 121.138 Mitigation strategies management components.
Mitigation strategies required under § 121.135 are subject to the following mitigation strategies management components as appropriate to ensure the proper implementation of the mitigation strategies, taking into account the nature of each such mitigation strategy and its role in the facility's foodRead full regulation →
- 21CFR121.310§ 121.310 Additional requirements applying to the food defense plan.
The owner, operator, or agent in charge of the facility must sign and date the food defense plan:Read full regulation →
- 21CFR121.140§ 121.140 Food defense monitoring.
As appropriate to the nature of the mitigation strategy and its role in the facility's food defense system:Read full regulation →
- 21CFR121.145§ 121.145 Food defense corrective actions.
(a) Food defense corrective action procedures. As appropriate to the nature of the actionable process step and the nature of the mitigation strategy:Read full regulation →
- 21CFR121.150§ 121.150 Food defense verification.
(a) Food defense verification activities. Food defense verification activities must include, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system:Read full regulation →
- 21CFR121.305§ 121.305 General requirements applying to records.
Records must:Read full regulation →
Related Warning Letters (3)
- 2023-03-07
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Arrow Reliance Inc.
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (Status: Final)
- CPG Sec 100.250 Food Facility Registration (Human and Animal Food) (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Determination of Status as a Qualified Facility (Status: Final)
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (Status: Draft)
- Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)