21 U.S.C. § 350g — Hazard analysis and risk-based preven-

Page 141 TITLE 21—FOOD AND DRUGS § 350g AMENDMENTS 2011—Subsecs. (f) to (n). Pub. L. 111–353 added subsecs. (f) to (h) and redesignated former subsecs. (f) to (k) as (i) to (n), respectively. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 110–85, title X, § 1005(e), Sept. 27, 2007, 121 Stat. 969, provided that: ‘‘The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)], as added by subsection (a) [probably should be (b)], shall become effective 1 year after the date of the enactment of this Act [Sept. 27, 2007].’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under cer- tain other Acts, or in a manner inconsistent with inter- national agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. FINDINGS Pub. L. 110–85, title X, § 1005(a), Sept. 27, 2007, 121 Stat. 964, provided that: ‘‘Congress makes the following findings: ‘‘(1) In 1994, Congress passed the Dietary Supple- ment Health and Education Act of 1994 (Public Law 103–417) [see Short Title of 1994 Amendments note set out under section 301 of this title] to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary supplements are safe and properly labeled foods. ‘‘(2) In 2006, Congress passed the Dietary Supple- ment and Nonprescription Drug Consumer Protection Act (Public Law 109–462) [see Short Title of 2006 Amendment note set out under section 301 of this title] to establish a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States. ‘‘(3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act is intended to serve as an early warning system for potential public health issues associated with the use of these products. ‘‘(4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to target limited in- spection resources to protect the public health.’’ GUIDANCE Pub. L. 110–85, title X, § 1005(f), Sept. 27, 2007, 121 Stat. 969, provided that: ‘‘Not later than 9 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary [of Health and Human Services] shall issue a guidance to industry about submitting reports to the electronic portal established under section 417 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f] (as added by this section) and providing notifications to other persons in the supply chain of an article of food under such section 417.’’ § 350g. Hazard analysis and risk-based preven- tive controls (a) In general The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food man- ufactured, processed, packed, or held by such fa- cility, identify and implement preventive con- trols to significantly minimize or prevent the occurrence of such hazards and provide assur- ances that such food is not adulterated under section 342 of this title or misbranded under sec- tion 343(w) of this title, monitor the perform- ance 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 shall— (1) identify and evaluate known or reason- ably foreseeable hazards that may be associ- ated with the facility, including— (A) biological, chemical, physical, and ra- diological hazards, natural toxins, pes- ticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; 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 shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that— (1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be sig- nificantly minimized or prevented; (2) any hazards identified in the hazard anal- ysis conducted under subsection (b)(2) will be significantly minimized or prevented and ad- dressed, consistent with section 350i of this title, as applicable; and (3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 342 of this title or misbranded under section 343(w) of this title. (d) Monitoring of effectiveness The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under sub- section (c) to provide assurances that the out- comes described in subsection (c) shall be achieved. (e) Corrective actions The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly imple- mented or are found to be ineffective— (1) appropriate action is taken to reduce the likelihood of recurrence of the implementa- tion failure; (2) all affected food is evaluated for safety; and (3) all affected food is prevented from enter- ing into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title. (f) Verification The owner, operator, or agent in charge of a facility shall verify that— (1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b); Page 142 TITLE 21—FOOD AND DRUGS § 350g 1 So in original. Probably should be ‘‘title’’. (2) the owner, operator, or agent is con- ducting monitoring in accordance with sub- section (d); (3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e); (4) the preventive controls implemented under subsection (c) are effectively and sig- nificantly minimizing or preventing the occur- rence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and (5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats. (g) Recordkeeping The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the pre- ventive controls implemented under subsection (c), instances of nonconformance material to food safety, the results of testing and other ap- propriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive con- trols and corrective actions. (h) Written plan and documentation The owner, operator, or agent in charge of a facility shall prepare a written plan that docu- ments and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Such written plan, together with the documentation described in subsection (g), shall be made promptly available to a duly au- thorized representative of the Secretary upon oral or written request. (i) Requirement to reanalyze The owner, operator, or agent in charge of a facility shall conduct a reanalysis under sub- section (b) whenever a significant change is made in the activities conducted at a facility 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 re- analysis shall be completed and additional pre- ventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is opera- tive. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards and develop- ments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radio- logical, 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 if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility: (A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration. (B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration. (C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Con- tainers standards of the Food and Drug Ad- ministration (or any successor standards). (2) Applicability The exemption under paragraph (1)(C) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods 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 that are subject to section 350h of this title. (l) Modified requirements for qualified facilities (1) Qualified facilities (A) In general A facility is a qualified facility for pur- poses of this subsection if the facility meets the conditions under subparagraph (B) or (C). (B) Very small business A facility is a qualified facility under this subparagraph— (i) if the facility, including any sub- sidiary or affiliate of the facility, is, col- lectively, a very small business (as defined in the regulations promulgated under sub- section (n)); and (ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined). (C) Limited annual monetary value of sales (i) In general A facility is a qualified facility under this subparagraph if clause (ii) applies— (I) to the facility, including any sub- sidiary or affiliate of the facility, collec- tively; and (II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate. (ii) Average annual monetary value This clause applies if— (I) during the 3-year period preceding the applicable calendar year, the average Page 143 TITLE 21—FOOD AND DRUGS § 350g annual monetary value of the food man- ufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, proc- essed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such fa- cility (or collectively by any such sub- sidiary or affiliate) to all other pur- chasers during such period; and (II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation. (2) Exemption A qualified facility— (A) shall not be subject to the require- ments under subsections (a) through (i) and subsection (n) in an applicable calendar year; and (B) shall submit to the Secretary— (i)(I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified poten- tial hazards associated with the food being produced, is implementing preventive con- trols to address the hazards, and is moni- toring the preventive controls 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 de- partment of agriculture), or other evidence of oversight), as specified by the Sec- retary, that the facility is in compliance with State, local, county, or other applica- ble non-Federal food safety law; and (ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after January 4, 2011, that the facility is a qualified facility under paragraph (1)(B) or (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 facility subject to an exemption under this subsection, or if the Secretary 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 facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Sec- retary may withdraw the exemption pro- vided to such facility under this subsection. (B) Rule of construction Nothing in this subsection shall be con- strued to expand or limit the inspection au- thority of the Secretary. (4) Definitions In this subsection: (A) Affiliate The term ‘‘affiliate’’ means any facility that controls, is controlled by, or is under common control with another facility. (B) Qualified end-user The term ‘‘qualified end-user’’, with re- spect to a food, means— (i) the consumer of the food; or (ii) a restaurant or retail food establish- ment (as those terms are defined by the Secretary for purposes of section 350d of this title) that— (I) is located— (aa) in the same State as the quali- fied facility that sold the food to such restaurant or establishment; or (bb) not more than 275 miles from such facility; and (II) is purchasing the food for sale di- rectly to consumers at such restaurant or retail food establishment. (C) Consumer For purposes of subparagraph (B), the term ‘‘consumer’’ does not include a business. (D) Subsidiary The term ‘‘subsidiary’’ means any com- pany which is owned or controlled directly or indirectly by another company. (5) Study (A) In general The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine— (i) the distribution of food production by type and size of operation, including mone- tary value of food sold; (ii) the proportion of food produced by each type and size of operation; (iii) the number and types of food facili- ties 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 op- eration and the type of food facilities for which no reported or known hazard exists; and (v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw ag- ricultural commodities, including dif- ferences in risk based on the scale and du- ration of such activities. (B) Size The results of the study conducted under subparagraph (A) shall include the informa- tion necessary to enable the Secretary to de- fine the terms ‘‘small business’’ and ‘‘very small business’’, for purposes of promul- gating the regulation under subsection (n). In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested. Page 144 TITLE 21—FOOD AND DRUGS § 350g (C) Submission of report Not later than 18 months after January 4, 2011, the Secretary shall submit to Congress a report that describes the results of the study conducted under subparagraph (A). (6) No preemption Nothing in this subsection preempts State, local, county, or other non-Federal law re- garding the safe production of food. Compli- ance with this subsection shall not relieve any person from liability at common law or under State statutory law. (7) Notification to consumers (A) In general A qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall— (i) with respect to a food for which a food packaging label is required by the Sec- retary under any other provision of this chapter, include prominently and con- spicuously on such label the name and business address of the facility where the food was manufactured or processed; or (ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provisions of this chapter, prominently and conspicu- ously display, at the point of purchase, the name and business address of the facility where the food was manufactured or proc- essed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of busi- ness, or, in the case of Internet sales, in an electronic notice. (B) No additional label Subparagraph (A) does not provide author- ity to the Secretary to require a label that is in addition to any label required under any other provision of this chapter. (m) Authority with respect to certain facilities The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for ani- mals other than man, the storage of raw agricul- tural commodities (other than fruits and vegeta- bles) intended for further distribution or proc- essing, or the storage of packaged foods that are not exposed to the environment. (n) Regulations (1) In general Not later than 18 months after January 4, 2011, the Secretary shall promulgate regula- tions— (A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preven- tive controls, and documenting the imple- mentation of the preventive controls under this section; and (B) to define, for purposes of this section, the terms ‘‘small business’’ and ‘‘very small business’’, taking into consideration the study described in subsection (l)(5). (2) Coordination In promulgating the regulations under para- graph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate. (3) Content The regulations promulgated under para- graph (1)(A) shall— (A) provide sufficient flexibility to be practicable for all sizes and types of facili- ties, including small businesses such as a small food processing facility co-located on a farm; (B) comply with chapter 35 of title 44 (com- monly 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, 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 sep- arate standards that apply to separate foods; and (D) not require a facility to hire a consult- ant or other third party to identify, imple- ment, certify, or audit preventative con- trols, except in the case of negotiated en- forcement resolutions that may require such a consultant or third party. (4) Rule of construction Nothing in this subsection shall be con- strued to provide the Secretary with the au- thority to prescribe specific technologies, practices, or critical controls for an individual facility. (5) Review In promulgating the regulations under para- graph (1)(A), the Secretary shall review regu- latory hazard analysis and preventive control programs in existence on January 4, 2011, in- cluding the Grade ‘‘A’’ Pasteurized Milk Ordi- nance to ensure that such regulations are con- sistent, to the extent practicable, with appli- cable 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 process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. (2) Facility The term ‘‘facility’’ means a domestic facil- ity or a foreign facility that is required to reg- ister under section 350d of this title. (3) Preventive controls The term ‘‘preventive controls’’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowl- edgeable about the safe manufacturing, proc- essing, packing, or holding of food would em- Page 145 TITLE 21—FOOD AND DRUGS § 350h ploy to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific under- standing of safe food manufacturing, proc- essing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following: (A) Sanitation procedures for food contact surfaces and utensils and food-contact sur- faces of equipment. (B) Supervisor, manager, and employee hy- giene training. (C) An environmental monitoring program to verify the effectiveness of pathogen con- trols in processes where a food is exposed to a potential contaminant in the environment. (D) A food allergen control program. (E) A recall plan. (F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regu- lations). (G) Supplier verification activities that re- late to the safety of food. (June 25, 1938, ch. 675, § 418, as added Pub. L. 111–353, title I, § 103(a), Jan. 4, 2011, 124 Stat. 3889.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 111–353, title I, § 103(i), Jan. 4, 2011, 124 Stat. 3898, provided that: ‘‘(1) 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]. ‘‘(2) FLEXIBILITY FOR SMALL BUSINESSES.—Notwith- standing paragraph (1)— ‘‘(A) the amendments made by this section shall apply to a small business (as defined in the regula- tions 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 ‘‘(B) the amendments made by this section shall apply to a very small business (as defined in such reg- ulations) 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 agree- ments to which the United States is a party, see sec- tions 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 guid- ance 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 pre- ventive 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 sub- section (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 compli- ance policy guide setting forth in plain language the requirements of such section 418 and this section [en- acting this section, amending section 331 of this title, and enacting provisions set out as notes under this sec- tion 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 Sec- retary 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 Her- metically 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).’’ § 350h. Standards for produce safety (a) Proposed rulemaking (1) In general (A) Rulemaking Not later than 1 year after January 4, 2011, the Secretary, in coordination with the Sec- retary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Produc- tion Act of 1990 [7 U.S.C. 6501 et seq.]), and in consultation with the Secretary of Home- land Security, shall publish a notice of pro- posed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or cat- egories of fruits and vegetables, that are raw agricultural commodities for which the Sec- retary has determined that such standards minimize the risk of serious adverse health consequences or death. (B) Determination by Secretary With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under sub- paragraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Sec- retary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the appli- cable requirements of regulations promul- gated pursuant to this section. (2) Public input During the comment period on the notice of proposed rulemaking under paragraph (1), the