---
kind: "section"
citation: "21 U.S.C. § 2204"
title: "21"
title_heading: "Food and Drugs"
number: "2204"
heading: "Building domestic capacity"
release: "119-102"
url: "https://uscodex.org/usc/21/2204"
units:
  - "Chapter 27 — Food Safety Modernization"
  - "Subchapter I — Improving Capacity to Prevent Food Safety Problems"
---

# §2204. Building domestic capacity

- (a) **In general—**
  - (1) **Initial report—** The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after January 4, 2011, submit to Congress a comprehensive report that identifies [programs](/usc/21/1523.md?p=8) and practices that are intended to promote the safety and supply chain security of [food](/usc/21/346a.md?p=a-1) and to prevent outbreaks of foodborne illness and other [food](/usc/21/346a.md?p=a-1)-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:
    - (A) Analysis of the need for further regulations or guidance to industry.
    - (B) Outreach to [food](/usc/21/346a.md?p=a-1) industry sectors, including through the [Food](/usc/21/346a.md?p=a-1) and Agriculture Coordinating [Councils](/usc/21/2011.md?p=1) referred to in [section 2203 of this title](/usc/21/2203.md), to identify potential sources of emerging threats to the safety and security of the [food](/usc/21/346a.md?p=a-1) supply and preventive [strategies](/usc/21/1701.md?p=12) to address those threats.
    - (C) Systems to ensure the prompt [distribution](/usc/21/360eee.md?p=5) to the [food](/usc/21/346a.md?p=a-1) industry of information and technical assistance concerning preventive [strategies](/usc/21/1701.md?p=12).
    - (D) Communication systems to ensure that information about specific threats to the safety and security of the [food](/usc/21/346a.md?p=a-1) supply are rapidly and effectively disseminated.
    - (E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other [food](/usc/21/346a.md?p=a-1)-related hazards, including how such systems and networks are integrated.
    - (F) Outreach, education, and training provided to [States](/usc/21/321.md?p=a-1) and local governments to build [State](/usc/21/321.md?p=a-1) and local [food](/usc/21/346a.md?p=a-1) safety and [food](/usc/21/346a.md?p=a-1) defense capabilities, including progress implementing [strategies](/usc/21/1701.md?p=12) developed under sections [2202](/usc/21/2202.md) and [2224](/usc/21/2224.md) of this title.
    - (G) The estimated resources needed to effectively implement the [programs](/usc/21/1523.md?p=8) and practices identified in the report developed in this section over a 5-year period.
    - (H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and [facilities](/usc/21/350g.md?p=o-2) (as defined in [section 350d of this title](/usc/21/350d.md).[^1]
    - (I) Specific efforts taken pursuant to the agreements [authorized](/usc/21/360eee–1.md?p=a-6) under [section 350j(c) of this title](/usc/21/350j.md?p=c) (as added by [section 201](/usc/21/201.md)),[^2] together with, as necessary, a description of any additional authorities necessary to improve seafood safety.
  - (2) **Biennial reports—** On a biennial basis following the submission of the report under [paragraph (1)](#a-1), the Secretary shall submit to Congress a report that—
    - (A) [reviews](/usc/21/353.md?p=iii-9-D) previous [food](/usc/21/346a.md?p=a-1) safety [programs](/usc/21/1523.md?p=8) and practices;
    - (B) outlines the success of those [programs](/usc/21/1523.md?p=8) and practices;
    - (C) identifies future [programs](/usc/21/1523.md?p=8) and practices; and
    - (D) includes information related to any matter described in [subparagraphs (A) through (H)](#a-1-A..a-1-H) of paragraph (1), as necessary.
- (b) **Risk-based activities—** The report developed under [subsection (a)(1)](#a-1) shall describe methods that seek to ensure that resources available to the Secretary for [food](/usc/21/346a.md?p=a-1) safety-related activities are directed at those actions most likely to reduce risks from [food](/usc/21/346a.md?p=a-1), including the use of preventive [strategies](/usc/21/1701.md?p=12) and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the [food](/usc/21/346a.md?p=a-1) supply.
- (c) **Capability for laboratory analyses; research—** The report developed under [subsection (a)(1)](#a-1) shall provide a description of methods to increase capacity to undertake analyses of [food](/usc/21/346a.md?p=a-1) samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by [Food](/usc/21/346a.md?p=a-1) Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory [facilities](/usc/21/350g.md?p=o-2) and progress toward laboratory accreditation under [section 350k of this title](/usc/21/350k.md) (as added by [section 202](/usc/21/202.md)).[^2]
- (d) **Information technology—** The report developed under [subsection (a)(1)](#a-1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, [State](/usc/21/321.md?p=a-1), local, and tribal governments, other Federal agencies, the [food](/usc/21/346a.md?p=a-1) industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the [facility](/usc/21/350g.md?p=o-2) registration system under [section 350d of this title](/usc/21/350d.md), and the prior notice system under [section 381(m) of this title](/usc/21/381.md?p=m) with other information technology systems that are used by the Federal Government for the processing of [food](/usc/21/346a.md?p=a-1) offered for import into the United States.
- (e) **Automated risk assessment—** The report developed under [subsection (a)(1)](#a-1) shall include a description of progress toward developing and improving an automated risk assessment system for [food](/usc/21/346a.md?p=a-1) safety surveillance and allocation of resources.
- (f) **Traceback and surveillance report—** The Secretary shall include in the report developed under [subsection (a)(1)](#a-1) an analysis of the [Food](/usc/21/346a.md?p=a-1) and [Drug](/usc/21/321.md?p=g-1) Administration’s performance in foodborne illness outbreaks during the 5-year period preceding January 4, 2011, involving fruits and vegetables that are raw agricultural commodities (as defined in [section 321(r) of this title](/usc/21/321.md?p=r)) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and [State](/usc/21/321.md?p=a-1) and local governments, as such communication and coordination relates to outbreak identification and traceback.
- (g) **Biennial food safety and food defense research plan—** The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint [food](/usc/21/346a.md?p=a-1) safety and [food](/usc/21/346a.md?p=a-1) defense research plan which may include studying the long-term health effects of foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.
- (h) **Effectiveness of programs administered by the Department of Health and Human Services—**
  - (1) **In general—** To determine whether existing Federal [programs](/usc/21/1523.md?p=8) administered by the Department of Health and Human Services are effective in achieving the stated goals of such [programs](/usc/21/1523.md?p=8), the Secretary shall, beginning not later than 1 year after January 4, 2011—
    - (A) conduct an annual evaluation of each [program](/usc/21/1523.md?p=8) of such Department to determine the effectiveness of each such [program](/usc/21/1523.md?p=8) in achieving legislated intent, purposes, and objectives; and
    - (B) submit to Congress a report concerning such evaluation.
  - (2) **Content—** The report described under [paragraph (1)(B)](#h-1-B) shall—
    - (A) include conclusions concerning the reasons that such existing [programs](/usc/21/1523.md?p=8) have proven successful or not successful and what factors contributed to such conclusions;
    - (B) include recommendations for consolidation and elimination to reduce duplication and inefficiencies in such [programs](/usc/21/1523.md?p=8) at such Department as identified during the evaluation conduct[^3] under this subsection; and
    - (C) be made publicly available in a publication entitled “Guide to the U.S. Department of Health and Human Services [Programs](/usc/21/1523.md?p=8)”.
- (i) **Unique identification numbers—**
  - (1) **In general—** Not later than 1 year after January 4, 2011, the Secretary, acting through the Commissioner of [Food](/usc/21/346a.md?p=a-1) and [Drugs](/usc/21/321.md?p=g-1), shall conduct a study regarding the need for, and challenges associated with, development and implementation of a [program](/usc/21/1523.md?p=8) that requires a unique identification number for each [food](/usc/21/346a.md?p=a-1) [facility](/usc/21/350g.md?p=o-2) registered with the Secretary and, as appropriate, each broker that imports [food](/usc/21/346a.md?p=a-1) into the United States. Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system.
  - (2) **Report—** Not later than 15 months after January 4, 2011, the Secretary shall submit to Congress a report that describes the findings of the study conducted under [paragraph (1)](#i-1) and that includes any recommendations determined appropriate by the Secretary.

## Footnotes

[^1]: So in original. Probably should be “title).”
[^2]: See References in Text note below.
[^3]: So in original. Probably should be “conducted”.

## Source credit

(Pub. L. 111–353, title I, § 110, Jan. 4, 2011, 124 Stat. 3913.)

## Notes

### Editorial Notes

### References in Text

The Secretary, referred to in subsecs. (a), (b), (d), (f), (g), (h)(1), and (i), probably means the Secretary of Health and Human Services.

This Act, referred to in subsec. (a)(1)(H), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Section 350d of this title, referred to in subsec. (a)(1)(H), and section 321(r) of this title, referred to in subsec. (f), were in the original “section 415 (21 U.S.C. 350d)” and “section 201(r) (21 U.S.C. 321(r))”, respectively, and were translated as meaning sections 415 and 201(r) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, to reflect the probable intent of Congress.

Section 201, referred to in subsec. (a)(1)(I), and section 202, referred to in subsec. (c), mean sections 201 and 202, respectively, of Pub. L. 111–353.