---
kind: "section"
citation: "21 U.S.C. § 350g"
title: "21"
title_heading: "Food and Drugs"
number: "350g"
heading: "Hazard analysis and risk-based preventive controls"
release: "119-102"
url: "https://uscodex.org/usc/21/350g"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IV — Food"
---

# §350g. Hazard analysis and risk-based preventive controls

- (a) **In general—** The owner, operator, or agent in charge of a [facility](#o-2) shall, in accordance with this section, evaluate the hazards that could affect [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held by such [facility](#o-2), identify and implement [preventive controls](#o-3) to significantly minimize or prevent the occurrence of such hazards and provide assurances that such [food](/usc/21/321.md?p=f) is not adulterated under [section 342 of this title](/usc/21/342.md) or [misbranded](/usc/21/1033.md?p=l) under [section 343(w) of this title](/usc/21/343.md?p=w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.
- (b) **Hazard analysis—** The owner, operator, or agent in charge of a [facility](#o-2) shall—
  - (1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the [facility](#o-2), including—
    - (A) biological, chemical, physical, and radiological hazards, natural toxins, [pesticides](/usc/21/321.md?p=q-1-A), [drug](/usc/21/321.md?p=g-1) residues, decomposition, parasites, allergens, and unapproved [food](/usc/21/321.md?p=f) and [color additives](/usc/21/321.md?p=t-1); and
    - (B) hazards that occur naturally, or may be unintentionally introduced; and
  - (2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and
  - (3) develop a written analysis of the hazards.
- (c) **Preventive controls—** The owner, operator, or agent in charge of a [facility](#o-2) shall identify and implement [preventive controls](#o-3), including at [critical control points](#o-1), if any, to provide assurances that—
  - (1) hazards identified in the hazard analysis conducted under [subsection (b)(1)](#b-1) will be significantly minimized or prevented;
  - (2) any hazards identified in the hazard analysis conducted under [subsection (b)(2)](#b-2) will be significantly minimized or prevented and addressed, consistent with [section 350i of this title](/usc/21/350i.md), as applicable; and
  - (3) the [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held by such [facility](#o-2) will not be adulterated under [section 342 of this title](/usc/21/342.md) or [misbranded](/usc/21/1033.md?p=l) under [section 343(w) of this title](/usc/21/343.md?p=w).
- (d) **Monitoring of effectiveness—** The owner, operator, or agent in charge of a [facility](#o-2) shall monitor the effectiveness of the [preventive controls](#o-3) implemented under [subsection (c)](#c) to provide assurances that the outcomes described in [subsection (c)](#c) shall be achieved.
- (e) **Corrective actions—** The owner, operator, or agent in charge of a [facility](#o-2) shall establish procedures to ensure that, if the [preventive controls](#o-3) implemented under [subsection (c)](#c) are not properly implemented or are found to be ineffective—
  - (1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure;
  - (2) all affected [food](/usc/21/321.md?p=f) is evaluated for safety; and
  - (3) all affected [food](/usc/21/321.md?p=f) is prevented from entering into commerce if the owner, operator or agent in charge of such [facility](#o-2) cannot ensure that the affected [food](/usc/21/321.md?p=f) is not adulterated under [section 342 of this title](/usc/21/342.md) or [misbranded](/usc/21/1033.md?p=l) under [section 343(w) of this title](/usc/21/343.md?p=w).
- (f) **Verification—** The owner, operator, or agent in charge of a [facility](#o-2) shall [verify](/usc/21/360eee.md?p=28) that—
  - (1) the [preventive controls](#o-3) implemented under [subsection (c)](#c) are adequate to control the hazards identified under [subsection (b)](#b);
  - (2) the owner, operator, or agent is conducting monitoring in accordance with [subsection (d)](#d);
  - (3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under [subsection (e)](#e);
  - (4) the [preventive controls](#o-3) implemented under [subsection (c)](#c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and [product](/usc/21/360eee.md?p=13) testing [programs](/usc/21/1523.md?p=8) and other appropriate means; and
  - (5) there is documented, periodic reanalysis of the plan under [subsection (i)](#i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the [facility](#o-2), and new and emerging threats.
- (g) **Recordkeeping—** The owner, operator, or agent in charge of a [facility](#o-2) shall maintain, for not less than 2 years, records documenting the monitoring of the [preventive controls](#o-3) implemented under [subsection (c)](#c), instances of nonconformance material to [food](/usc/21/321.md?p=f) safety, the results of testing and other appropriate means of [verification](/usc/21/360eee.md?p=28) under [subsection (f)(4)](#f-4), instances when corrective actions were implemented, and the efficacy of [preventive controls](#o-3) and corrective actions.
- (h) **Written plan and documentation—** The owner, operator, or agent in charge of a [facility](#o-2) shall prepare a written plan that documents and describes the procedures used by the [facility](#o-2) to comply with the requirements of this section, including analyzing the hazards under [subsection (b)](#b) and identifying the [preventive controls](#o-3) adopted under [subsection (c)](#c) to address those hazards. Such written plan, together with the documentation described in [subsection (g)](#g), shall be made promptly available to a duly [authorized](/usc/21/360eee–1.md?p=a-6) representative of the [Secretary](/usc/21/321.md?p=d) upon oral or written request.
- (i) **Requirement to reanalyze—** The owner, operator, or agent in charge of a [facility](#o-2) shall conduct a reanalysis under [subsection (b)](#b) whenever a significant change is made in the activities conducted at a [facility](#o-2) operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional [preventive controls](#o-3) needed to address the hazard identified, if any, shall be implemented before the change in activities at the [facility](#o-2) is operative. Such owner, operator, or agent shall revise the written plan required under [subsection (h)](#h) if such a significant change is made or document the basis for the conclusion that no additional or revised [preventive controls](#o-3) are needed. The [Secretary](/usc/21/321.md?p=d) may require a reanalysis under this section to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the [Department](/usc/21/321.md?p=c) of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.
- (j) **Exemption for seafood, juice, and low-acid canned food facilities subject to HACCP—**
  - (1) **In general—** This section shall not apply to a [facility](#o-2) if the owner, operator, or agent in charge of such [facility](#o-2) is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such [facility](#o-2):
    - (A) The Seafood Hazard Analysis [Critical Control Points](#o-1) [Program](/usc/21/1523.md?p=8) of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
    - (B) The Juice Hazard Analysis [Critical Control Points](#o-1) [Program](/usc/21/1523.md?p=8) of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
    - (C) The Thermally Processed Low-Acid [Foods](/usc/21/321.md?p=f) Packaged in Hermetically Sealed Containers standards of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration (or any successor standards).
  - (2) **Applicability—** The exemption under [paragraph (1)(C)](#j-1-C) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid [Foods](/usc/21/321.md?p=f) Packaged in Hermetically Sealed Containers under part 113 of chapter[^1] 21, Code of Federal Regulations (or any successor regulations).
- (k) **Exception for activities of facilities subject to section 350h of this title—** This section shall not apply to activities of a [facility](#o-2) that are subject to [section 350h of this title](/usc/21/350h.md).
- (l) **Modified requirements for qualified facilities—**
  - (1) **Qualified facilities—**
    - (A) **In general—** A [facility](#o-2) is a [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) for purposes of this subsection if the [facility](#o-2) meets the conditions under subparagraph [(B)](#l-1-B) or [(C)](#l-1-C).
    - (B) **Very small business—** A [facility](#o-2) is a [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) under this subparagraph—
      - (i) if the [facility](#o-2), including any [subsidiary](#l-4-D) or [affiliate](#l-4-A) of the [facility](#o-2), is, collectively, a [very small business](#n-1-B) (as defined in the regulations promulgated under [subsection (n)](#n)); and
      - (ii) in the case where the [facility](#o-2) is a [subsidiary](#l-4-D) or [affiliate](#l-4-A) of an entity, if such [subsidiaries](#l-4-D) or [affiliates](#l-4-A), are, collectively, a [very small business](#n-1-B) (as so defined).
    - (C) **Limited annual monetary value of sales—**
      - (i) **In general—** A [facility](#o-2) is a [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) under this subparagraph if [clause (ii)](#l-1-C-ii) applies—
        - (I) to the [facility](#o-2), including any [subsidiary](#l-4-D) or [affiliate](#l-4-A) of the [facility](#o-2), collectively; and
        - (II) to the [subsidiaries](#l-4-D) or [affiliates](#l-4-A), collectively, of any entity of which the [facility](#o-2) is a [subsidiary](#l-4-D) or [affiliate](#l-4-A).
      - (ii) **Average annual monetary value—** This clause applies if—
        - (I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held at such [facility](#o-2) (or the collective average annual monetary value of such [food](/usc/21/321.md?p=f) at any [subsidiary](#l-4-D) or [affiliate](#l-4-A), as described in [clause (i)](#l-1-C-i)) that is sold directly to [qualified end-users](#l-4-B) during such period exceeded the average annual monetary value of the [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held at such [facility](#o-2) (or the collective average annual monetary value of such [food](/usc/21/321.md?p=f) at any [subsidiary](#l-4-D) or [affiliate](#l-4-A), as so described) sold by such [facility](#o-2) (or collectively by any such [subsidiary](#l-4-D) or [affiliate](#l-4-A)) to all other purchasers during such period; and
        - (II) the average annual monetary value of all [food](/usc/21/321.md?p=f) sold by such [facility](#o-2) (or the collective average annual monetary value of such [food](/usc/21/321.md?p=f) sold by any [subsidiary](#l-4-D) or [affiliate](#l-4-A), as described in [clause (i)](#l-1-C-i)) during such period was less than $500,000, adjusted for inflation.
  - (2) **Exemption—** A [qualified](/usc/21/357.md?p=e-7) [facility](#o-2)—
    - (A) shall not be subject to the requirements under [subsections (a) through (i)](#a..i) and [subsection (n)](#n) in an applicable calendar year; and
    - (B) shall submit to the [Secretary](/usc/21/321.md?p=d)—
      - (i)
        - (I) documentation that demonstrates that the owner, operator, or agent in charge of the [facility](#o-2) has identified potential hazards associated with the [food](/usc/21/321.md?p=f) being produced, is implementing [preventive controls](#o-3) to address the hazards, and is monitoring the [preventive controls](#o-3) to ensure that such controls are effective; or
        - (II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the [Secretary](/usc/21/321.md?p=d), that the [facility](#o-2) is in compliance with [State](/usc/21/321.md?p=a-1), local, county, or other applicable non-Federal [food](/usc/21/321.md?p=f) safety law; and
      - (ii) documentation, as specified by the [Secretary](/usc/21/321.md?p=d) in a guidance document issued not later than 1 year after January 4, 2011, that the [facility](#o-2) is a [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) under paragraph [(1)(B)](#l-1-B) or [(1)(C)](#l-1-C).
  - (3) **Withdrawal; rule of construction—**
    - (A) **In general—** In the event of an active investigation of a foodborne illness outbreak that is directly linked to a [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) subject to an exemption under this subsection, or if the [Secretary](/usc/21/321.md?p=d) determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) that are material to the safety of the [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held at such [facility](#o-2), the [Secretary](/usc/21/321.md?p=d) may withdraw the exemption provided to such [facility](#o-2) under this subsection.
    - (B) **Rule of construction—** Nothing in this subsection shall be construed to expand or limit the inspection authority of the [Secretary](/usc/21/321.md?p=d).
  - (4) **Definitions—** In this subsection:
    - (A) **Affiliate—** The term “affiliate” means any [facility](#o-2) that controls, is controlled by, or is under common control with another [facility](#o-2).
    - (B) **Qualified end-user—** The term “qualified end-user”, with respect to a [food](/usc/21/321.md?p=f), means—
      - (i) the [consumer](#l-4-C) of the [food](/usc/21/321.md?p=f); or
      - (ii) a restaurant or retail [food](/usc/21/321.md?p=f) establishment (as those terms are defined by the [Secretary](/usc/21/321.md?p=d) for purposes of [section 350d of this title](/usc/21/350d.md)) that—
        - (I) is located—
          - (aa) in the same [State](/usc/21/321.md?p=a-1) as the [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) that sold the [food](/usc/21/321.md?p=f) to such restaurant or establishment; or
          - (bb) not more than 275 miles from such [facility](#o-2); and
        - (II) is purchasing the [food](/usc/21/321.md?p=f) for sale directly to [consumers](#l-4-C) at such restaurant or retail [food](/usc/21/321.md?p=f) establishment.
    - (C) **Consumer—** For purposes of [subparagraph (B)](#l-4-B), the term “consumer” does not include a business.
    - (D) **Subsidiary—** The term “subsidiary” means any company which is owned or controlled directly or indirectly by another company.
  - (5) **Study—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d), in consultation with the [Secretary](/usc/21/321.md?p=d) of Agriculture, shall conduct a study of the [food](/usc/21/321.md?p=f) processing sector regulated by the [Secretary](/usc/21/321.md?p=d) to determine—
      - (i) the [distribution](/usc/21/360eee.md?p=5) of [food](/usc/21/321.md?p=f) production by type and size of operation, including monetary value of [food](/usc/21/321.md?p=f) sold;
      - (ii) the proportion of [food](/usc/21/321.md?p=f) produced by each type and size of operation;
      - (iii) the number and types of [food](/usc/21/321.md?p=f) [facilities](#o-2) co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity;
      - (iv) the incidence of foodborne illness originating from each size and type of operation and the type of [food](/usc/21/321.md?p=f) [facilities](#o-2) for which no reported or known hazard exists; and
      - (v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing [food](/usc/21/321.md?p=f) and [raw agricultural commodities](/usc/21/321.md?p=r), including differences in risk based on the scale and duration of such activities.
    - (B) **Size—** The results of the study conducted under [subparagraph (A)](#l-5-A) shall include the information necessary to enable the [Secretary](/usc/21/321.md?p=d) to define the terms “[small business](#n-1-B)” and “[very small business](#n-1-B)”, for purposes of promulgating the regulation under [subsection (n)](#n). In defining such terms, the [Secretary](/usc/21/321.md?p=d) shall include consideration of harvestable acres, income, the number of employees, and the volume of [food](/usc/21/321.md?p=f) harvested.
    - (C) **Submission of report—** Not later than 18 months after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall submit to Congress a report that describes the results of the study conducted under [subparagraph (A)](#l-5-A).
  - (6) **No preemption—** Nothing in this subsection preempts [State](/usc/21/321.md?p=a-1), local, county, or other non-Federal law regarding the safe production of [food](/usc/21/321.md?p=f). Compliance with this subsection shall not relieve any [person](/usc/21/321.md?p=e) from liability at common law or under [State](/usc/21/321.md?p=a-1) statutory law.
  - (7) **Notification to consumers—**
    - (A) **In general—** A [qualified](/usc/21/357.md?p=e-7) [facility](#o-2) that is exempt from the requirements under [subsections (a) through (i)](#a..i) and [subsection (n)](#n) and does not prepare documentation under [paragraph (2)(B)(i)(I)](#l-2-B-i-I) shall—
      - (i) with respect to a [food](/usc/21/321.md?p=f) for which a [food](/usc/21/321.md?p=f) packaging [label](/usc/21/321.md?p=k) is required by the [Secretary](/usc/21/321.md?p=d) under any other provision of this chapter, include prominently and conspicuously on such [label](/usc/21/321.md?p=k) the name and business address of the [facility](#o-2) where the [food](/usc/21/321.md?p=f) was manufactured or processed; or
      - (ii) with respect to a [food](/usc/21/321.md?p=f) for which a [food](/usc/21/321.md?p=f) packaging [label](/usc/21/321.md?p=k) is not required by the [Secretary](/usc/21/321.md?p=d) under any other provisions of this chapter, prominently and conspicuously display, at the point of purchase, the name and business address of the [facility](#o-2) where the [food](/usc/21/321.md?p=f) was manufactured or processed, on a [label](/usc/21/321.md?p=k), poster, sign, placard, or documents delivered contemporaneously with the [food](/usc/21/321.md?p=f) in the normal course of business, or, in the case of Internet sales, in an electronic notice.
    - (B) **No additional label—** [Subparagraph (A)](#l-7-A) does not provide authority to the [Secretary](/usc/21/321.md?p=d) to require a [label](/usc/21/321.md?p=k) that is in addition to any [label](/usc/21/321.md?p=k) required under any other provision of this chapter.
- (m) **Authority with respect to certain facilities—** The [Secretary](/usc/21/321.md?p=d) may, by regulation, exempt or modify the requirements for compliance under this section with respect to [facilities](#o-2) that are solely engaged in the production of [food](/usc/21/321.md?p=f) for animals other than man, the storage of [raw agricultural commodities](/usc/21/321.md?p=r) (other than fruits and vegetables) intended for further [distribution](/usc/21/360eee.md?p=5) or processing, or the storage of packaged [foods](/usc/21/321.md?p=f) that are not exposed to the environment.
- (n) **Regulations—**
  - (1) **In general—** Not later than 18 months after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall promulgate regulations—
    - (A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing [preventive controls](#o-3), and documenting the implementation of the [preventive controls](#o-3) under this section; and
    - (B) to define, for purposes of this section, the terms “[small business](#l-5-B)” and “[very small business](#l-5-B)”, taking into consideration the study described in [subsection (l)(5)](#l-5).
  - (2) **Coordination—** In promulgating the regulations under [paragraph (1)(A)](#n-1-A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the [Secretary](/usc/21/321.md?p=d) shall coordinate with the [Secretary](/usc/21/321.md?p=d) of Homeland Security, as appropriate.
  - (3) **Content—** The regulations promulgated under [paragraph (1)(A)](#n-1-A) shall—
    - (A) provide sufficient flexibility to be practicable for all sizes and types of [facilities](#o-2), including [small businesses](#l-5-B) such as a small [food](/usc/21/321.md?p=f) processing [facility](#o-2) co-located on a farm;
    - (B) comply with [chapter 35](/usc/44/ch35.md) of title 44 (commonly known as the “Paperwork Reduction Act”), with special attention to minimizing the burden (as defined in section 3502(2) of such title) on the [facility](#o-2), and collection of information (as defined in section 3502(3) of such title), associated with such regulations;
    - (C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate [foods](/usc/21/321.md?p=f); and
    - (D) not require a [facility](#o-2) to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.
  - (4) **Rule of construction—** Nothing in this subsection shall be construed to provide the [Secretary](/usc/21/321.md?p=d) with the authority to prescribe specific technologies, practices, or critical controls for an individual [facility](#o-2).
  - (5) **Review—** In promulgating the regulations under [paragraph (1)(A)](#n-1-A), the [Secretary](/usc/21/321.md?p=d) shall review regulatory hazard analysis and preventive control [programs](/usc/21/1523.md?p=8) in existence on January 4, 2011, including the Grade “A” Pasteurized [Milk](/usc/21/321c.md) Ordinance to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards in existence on such date.
- (o) **Definitions—** For purposes of this section:
  - (1) **Critical control point—** The term “critical control point” means a point, step, or procedure in a [food](/usc/21/321.md?p=f) process at which control can be applied and is essential to prevent or eliminate a [food](/usc/21/321.md?p=f) safety hazard or reduce such hazard to an acceptable level.
  - (2) **Facility—** The term “facility” means a domestic facility or a foreign facility that is required to register under [section 350d of this title](/usc/21/350d.md).
  - (3) **Preventive controls—** The term “preventive controls” means those risk-based, reasonably appropriate procedures, practices, and processes that a [person](/usc/21/321.md?p=e) knowledgeable about the safe manufacturing, processing, packing, or holding of [food](/usc/21/321.md?p=f) would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under [subsection (b)](#b) and that are consistent with the current scientific understanding of safe [food](/usc/21/321.md?p=f) manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:
    - (A) Sanitation procedures for [food](/usc/21/321.md?p=f) contact surfaces and utensils and [food](/usc/21/321.md?p=f)-contact surfaces of equipment.
    - (B) Supervisor, manager, and employee hygiene training.
    - (C) An environmental monitoring [program](/usc/21/1523.md?p=8) to [verify](/usc/21/360eee.md?p=28) the effectiveness of pathogen controls in processes where a [food](/usc/21/321.md?p=f) is exposed to a potential contaminant in the environment.
    - (D) A [food](/usc/21/321.md?p=f) allergen control [program](/usc/21/1523.md?p=8).
    - (E) A recall plan.
    - (F) Current Good Manufacturing Practices (cGMPs) under [part 110 of title 21, Code of Federal Regulations](/cfr/21/part110.md) (or any successor regulations).
    - (G) Supplier [verification](/usc/21/360eee.md?p=28) activities that relate to the safety of [food](/usc/21/321.md?p=f).

## Footnotes

[^1]: So in original. Probably should be “title”.

## Source credit

(June 25, 1938, ch. 675, § 418, as added Pub. L. 111–353, title I, § 103(a), Jan. 4, 2011, 124 Stat. 3889.)

## Notes

### Statutory Notes and Related Subsidiaries

### Effective Date

Pub. L. 111–353, title I, § 103(i), Jan. 4, 2011, 124 Stat. 3898, provided that: General rule.—The amendments made by this section [enacting this section and amending section 331 of this title] shall take effect 18 months after the date of enactment of this Act [Jan. 4, 2011]. Flexibility for small businesses.—Notwithstanding paragraph (1)— the amendments made by this section shall apply to a small business (as defined in the regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g(n)] (as added by this section)) beginning on the date that is 6 months after the effective date of such regulations; and the amendments made by this section shall apply to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations.”

### Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

### Guidance Document

Pub. L. 111–353, title I, § 103(b), Jan. 4, 2011, 124 Stat. 3896, provided that: “The Secretary shall issue a guidance document related to the regulations promulgated under subsection (b)(1) [probably means 21 U.S.C. 350g(n)(1)] with respect to the hazard analysis and preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g] (as added by subsection (a)).”

### Small Entity Compliance Policy Guide

Pub. L. 111–353, title I, § 103(d), Jan. 4, 2011, 124 Stat. 3898, provided that: “Not later than 180 days after the issuance of the regulations promulgated under subsection (n) of section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g(n)] (as added by subsection (a)), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 418 and this section [enacting this section, amending section 331 of this title, and enacting provisions set out as notes under this section and sections 342 and 350d of this title] to assist small entities in complying with the hazard analysis and other activities required under such section 418 and this section.”

### No Effect on HACCP Authorities

Pub. L. 111–353, title I, § 103(f), Jan. 4, 2011, 124 Stat. 3898, provided that: “Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce Hazard Analysis Critical Control [Points] programs and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards.”

### Dietary Supplements

Pub. L. 111–353, title I, § 103(g), Jan. 4, 2011, 124 Stat. 3898, provided that: “Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa–1).”