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21 U.S.C. § 1401 — Pesticide monitoring and enforcement in-

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21 U.S.C. § 1401 — Pesticide monitoring and enforcement in-

Page 935 TITLE 21—FOOD AND DRUGS § 1401 the Commission were first appointed unless the Presi- dent extended the authority of the Commission by Ex- ecutive order. Statutory Notes and Related Subsidiaries SHORT TITLE Pub. L. 99–570, title VIII, § 8001, Oct. 27, 1986, 100 Stat. 3207–161, provided that title VIII of Pub. L. 99–570, which enacted this chapter, was to be cited as the ‘‘President’s Media Commission on Alcohol and Drug Abuse Prevention Act’’. CHAPTER 19—PESTICIDE MONITORING IMPROVEMENTS Sec. 1401. Pesticide monitoring and enforcement infor- mation. 1402. Foreign pesticide information. 1403. Pesticide analytical methods. § 1401. Pesticide monitoring and enforcement in- formation (a) Data management systems (1) Not later than 480 days after August 23, 1988, the Secretary of Health and Human Serv- ices shall place in effect computerized data man- agement systems for the Food and Drug Admin- istration under which the Administration will— (A) record, summarize, and evaluate the re- sults of its program for monitoring food prod- ucts for pesticide residues, (B) identify gaps in its pesticide monitoring program in the monitoring of (i) pesticides, (ii) food products, and (iii) food from specific countries and from domestic sources, (C) detect trends in the presence of pesticide residues in food products and identify public health problems emerging from the occurrence of pesticide residues in food products, (D) focus its testing resources for moni- toring pesticide residues in food on detecting those residues which pose a public health con- cern, (E) prepare summaries of the information listed in subsection (b), and (F) provide information to assist the Envi- ronmental Protection Agency in carrying out its responsibilities under the Fede

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Page 935 TITLE 21—FOOD AND DRUGS § 1401 the Commission were first appointed unless the Presi- dent extended the authority of the Commission by Ex- ecutive order. Statutory Notes and Related Subsidiaries SHORT TITLE Pub. L. 99–570, title VIII, § 8001, Oct. 27, 1986, 100 Stat. 3207–161, provided that title VIII of Pub. L. 99–570, which enacted this chapter, was to be cited as the ‘‘President’s Media Commission on Alcohol and Drug Abuse Prevention Act’’. CHAPTER 19—PESTICIDE MONITORING IMPROVEMENTS Sec. 1401. Pesticide monitoring and enforcement infor- mation. 1402. Foreign pesticide information. 1403. Pesticide analytical methods. § 1401. Pesticide monitoring and enforcement in- formation (a) Data management systems (1) Not later than 480 days after August 23, 1988, the Secretary of Health and Human Serv- ices shall place in effect computerized data man- agement systems for the Food and Drug Admin- istration under which the Administration will— (A) record, summarize, and evaluate the re- sults of its program for monitoring food prod- ucts for pesticide residues, (B) identify gaps in its pesticide monitoring program in the monitoring of (i) pesticides, (ii) food products, and (iii) food from specific countries and from domestic sources, (C) detect trends in the presence of pesticide residues in food products and identify public health problems emerging from the occurrence of pesticide residues in food products, (D) focus its testing resources for moni- toring pesticide residues in food on detecting those residues which pose a public health con- cern, (E) prepare summaries of the information listed in subsection (b), and (F) provide information to assist the Envi- ronmental Protection Agency in carrying out its responsibilities under the Federal Insecti- cide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. (2) As soon as practicable, the Secretary of Health and Human Services shall develop a means to enable the computerized data manage- ment systems placed into effect under paragraph (1) to make the summary described in sub- section (c). (3)(A) Paragraph (1) does not limit the author- ity of the Food and Drug Administration to— (i) use the computerized data management systems placed in effect under paragraph (1), or (ii) develop additional data management sys- tems, to facilitate the regulation of any substance or product covered under the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. (B) In placing into effect the computerized data management systems under paragraph (1) and in carrying out paragraph (2), the Secretary shall comply with applicable regulations gov- erning computer system design and procure- ment. (b) Information The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to pre- pare a summary of— (1) information on— (A) the types of imported and domestically produced food products analyzed for compli- ance with the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] regarding the presence of pesticide residues, (B) the number of samples of each such food product analyzed for such compliance by country of origin, (C) the pesticide residues which may be de- tected using the testing methods employed, (D) the pesticide residues in such food de- tected and the levels detected, (E) the compliance status of each sample of such food tested and the violation rate for each country-product combination, and (F) the action taken with respect to each sample of such food found to be in violation of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and its ultimate dis- position, and (2) information on— (A) the country of origin of each imported food product referred to in paragraph (1)(A), and (B) the United States district of entry for each such imported food product. (c) Volume data The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to sum- marize the volume of each type of food product subject to the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] which is imported into the United States and which has an entry value which exceeds an amount established by the Secretary of Health and Human Services. The summary shall be made by country of origin and district of entry. Information with respect to volumes of food products to be included in the summary shall, to the extent feasible, be obtained from data bases of other Federal agencies. (d) Compilation Not later than 90 days after the expiration of 1 year after the data management systems are placed into effect under subsection (a) and annu- ally thereafter, the Secretary of Health and Human Services shall compile a summary of the information described in subsection (b) with re- spect to the previous year. When the Food and Drug Administration is able to make summaries under subsection (c), the Secretary shall include in the compilation under the preceding sentence a compilation of the information described in subsection (c). Compilations under this sub- section shall be made available to Federal and State agencies and other interested persons. (Pub. L. 100–418, title IV, § 4702, Aug. 23, 1988, 102 Stat. 1412.) Page 936 TITLE 21—FOOD AND DRUGS § 1402 Editorial Notes REFERENCES IN TEXT The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsec. (a)(1)(F), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to sub- chapter II (§ 136 et seq.) of chapter 6 of Title 7, Agri- culture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables. The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a) to (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables. Statutory Notes and Related Subsidiaries SHORT TITLE Pub. L. 100–418, title IV, § 4701, Aug. 23, 1988, 102 Stat. 1411, provided that: ‘‘This subtitle [subtitle G (§§ 4701–4704) of title IV of Pub. L. 100–418, enacting this chapter] may be cited as the ‘Pesticide Monitoring Im- provements Act of 1988’.’’ IMPORTED MEAT, POULTRY PRODUCTS, EGGS, AND EGG PRODUCTS Pub. L. 100–418, title IV, § 4506, Aug. 23, 1988, 102 Stat. 1404, required the Secretary of Agriculture, not later than 90 days after Aug. 23, 1988, to submit a report to Congress concerning the planned distribution, in fiscal years 1988 and 1989, of the resources of the Department of Agriculture available for sampling imported covered products to ensure compliance with the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) that govern the level of residues of pes- ticides, drugs, and other products permitted in or on such products. § 1402. Foreign pesticide information (a) Cooperative agreements The Secretary of Health and Human Services shall enter into cooperative agreements with the governments of the countries which are the major sources of food imports into the United States subject to pesticide residue monitoring by the Food and Drug Administration for the purpose of improving the ability of the Food and Drug Administration to assure compliance with the pesticide tolerance requirements of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with regard to imported food. (b) Information activities (1) The cooperative agreements entered into under subsection (a) with governments of for- eign countries shall specify the action to be taken by the parties to the agreements to ac- complish the purpose described in subsection (a), including the means by which the governments of the foreign countries will provide to the Sec- retary of Health and Human Services current in- formation identifying each of the pesticides used in the production, transportation, and storage of food products imported from production regions of such countries into the United States. (2) In the case of a foreign country with which the Secretary is unable to enter into an agree- ment under subsection (a) or for which the infor- mation provided under paragraph (1) is insuffi- cient to assure an effective pesticide monitoring program, the Secretary shall, to the extent practicable, obtain the information described in paragraph (1) with respect to such country from other Federal or international agencies or pri- vate sources. (3) The Secretary of Health and Human Serv- ices shall assure that appropriate offices of the Food and Drug Administration which are en- gaged in the monitoring of imported food for pesticide residues receive the information ob- tained under paragraph (1) or (2). (4) The Secretary of Health and Human Serv- ices shall make available any information ob- tained under paragraph (1) or (2) to State agen- cies engaged in the monitoring of imported food for pesticide residues other than information ob- tained from private sources the disclosure of which to such agencies is restricted. (c) Coordination with other agencies The Secretary of Health and Human Services shall— (1) notify in writing the Department of Agri- culture, the Environmental Protection Agen- cy, and the Department of State at the initi- ation of negotiations with a foreign country to develop a cooperative agreement under sub- section (a); and (2) coordinate the activities of the Depart- ment of Health and Human Services with the activities of those departments and agencies, as appropriate, during the course of such nego- tiations. (d) Report Not later than one year after August 23, 1988, the Secretary of Health and Human Services shall report to the Committee on Agriculture, Nutrition, and Forestry and the Committee on Labor and Human Resources of the Senate and the House of Representatives on the activities undertaken by the Secretary to implement this section. The report shall be made available to appropriate Federal and State agencies and to interested persons. (Pub. L. 100–418, title IV, § 4703, Aug. 23, 1988, 102 Stat. 1413.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables. Statutory Notes and Related Subsidiaries CHANGE OF NAME Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999. § 1403. Pesticide analytical methods The Secretary of Health and Human Services shall, in consultation with the Administrator of the Environmental Protection Agency— (1) develop a detailed long-range plan and timetable for research that is necessary for the development of and validation of—

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 1401 — Pesticide monitoring and enforcement information

**(a) Data management systems** (1) Not later than 480 days after August 23, 1988, the Secretary of Health and Human Services shall place in effect computerized data management systems for the Food and Drug Administration under which the Administration will— (A) record, summarize, and evaluate the results of its program for monitoring food products for pesticide residues, (B) identify gaps in its pesticide monitoring program in the monitoring of (i) pesticides, (ii) food products, and (iii) food from specific countries and from domestic sources, (C) detect trends in the presence of pesticide residues in food products and identify public health problems emerging from the occurrence of pesticide residues in food products, (D) focus its testing resources for monitoring pesticide residues in food on detecting those residues which pose a public health concern, (E) prepare summaries of the information listed in subsection (b), and (F) provide information to assist the Environmental Protection Agency in carrying out its responsibilities under the Federal Insecticide, Fungicide, and Rodenticide Act [[7 U.S.C. 136](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section136&num=0&edition=prelim) et seq.] and the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.]. (2) As soon as practicable, the Secretary of Health and Human Services shall develop a means to enable the computerized data management systems placed into effect under paragraph (1) to make the summary described in subsection (c). (3) (A) Paragraph (1) does not limit the authority of the Food and Drug Administration to— (i) use the computerized data management

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21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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21 U.S.C. § 301 — Short title

Page 30 TITLE 21—FOOD AND DRUGS § 301 Sec. 398. Notices to States regarding imported food. 399. Grants to enhance food safety. 399a. Office of the Chief Scientist. 399b. Office of Women’s Health. 399c. Improving the training of State, local, terri- torial, and tribal food safety officials. 399d. Employee protections. 399e. Nanotechnology. 399f. Ensuring adequate information regarding pharmaceuticals for all populations, par- ticularly underrepresented subpopulations, including racial subgroups. 399g. Food and Drug Administration Intercenter Institutes. 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufac- turing. 399i. Food and Drug Administration Working Cap- ital Fund. SUBCHAPTER I—SHORT TITLE § 301. Short title This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. (June 25, 1938, ch. 675, § 1, 52 Stat. 1040.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro- vided that: ‘‘[SEC. 1] (a) The effective date of the following provi- sions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title]. ‘‘(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the ef- fective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (

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21 U.S.C. § 451 — Congressional statement of findings

Poultry and poultry products are an important source of the Nation’s total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded poultry products impair the effective regulation of poultry products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to consumers. It is hereby found that all articles and poultry which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary of Agriculture and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

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21 U.S.C. § 451 — Congressional statement of findings

Page 718 TITLE 21—FOOD AND DRUGS § 451 or actual charges for personal services, mate- rials, equipment, information technology, and other expenses. Charges for equipment and in- formation technology shall include costs associ- ated with maintenance, repair, and depreciation (including improvement and replacement). (b) Appropriations Of any discretionary resources appropriated in this Act for fiscal year 2018 for ‘‘Department of Health and Human Services, Food and Drug Ad- ministration, Salaries and Expenses’’, not to ex- ceed $5,000,000 of amounts available as of Sep- tember 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable pur- pose limitations. (c) Emergency funds excluded No amounts may be transferred pursuant to this section that are designated by the Congress as an emergency requirement pursuant to a con- current resolution on the budget or the Bal- anced Budget and Emergency Deficit Control Act of 1985. (Pub. L. 115–141, div. A, title VII, § 722, Mar. 23, 2018, 132 Stat. 387.) Editorial Notes REFERENCES IN TEXT This Act, referred to in subsec. (b), is div. A of Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 351, known as the Ag- riculture, Rural Development, Food and Drug Adminis- tration, and Related Agencies Appropriations Act, 2018. For complete classification of this Act to the Code, see Tables. The Balanced Budget and Emergency Deficit Control Act of 1985, referred to in subsec. (c), is title II of Pub. L. 99–177, Dec. 12, 1985, 99 Stat. 1038, which enacted chapter 20 (§ 900 et seq.) and sections 654 to 656 of Title 2, The Congress, amended sections 602, 622, 631 to 642, and 651 to 653 of Title 2, sections 1104 to 1106, and 1109 of Title 31, Money and Finance, and

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21 U.S.C. § 601 — Definitions

As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below: **(a)** The term “Secretary” means the Secretary of Agriculture of the United States or his delegate. **(b)** The term “firm” means any partnership, association, or other unincorporated business organization. **(c)** The term “meat broker” means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation. **(d)** The term “renderer” means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter. **(e)** The term “animal food manufacturer” means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines. **(f)** The term “State” means any State of the United States and the Commonwealth of Puerto Rico. **(g)** The term “Territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. **(h)** The term “commerce” means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legisl

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21 U.S.C. § 601 — Definitions

Page 741 TITLE 21—FOOD AND DRUGS § 601 Sec. SUBCHAPTER II—MEAT PROCESSORS AND RELATED INDUSTRIES 641. Prohibition of subchapter I inspection of arti- cles not intended for use as human food; de- naturation or other identification prior to distribution in commerce; inedible articles. 642. Recordkeeping requirements. 643. Registration of business, name of person, and trade names. 644. Regulation of transactions, transportation, or importation of 4–D animals to prevent use as human food. 645. Federal provisions applicable to State or Ter- ritorial business transactions of a local na- ture and not subject to local authority. SUBCHAPTER III—FEDERAL AND STATE COOPERATION 661. Federal and State cooperation. SUBCHAPTER IV—AUXILIARY PROVISIONS 671. Inspection services; refusal or withdrawal; hearing; business unfitness based upon cer- tain convictions; other provisions for with- drawal of services unaffected; responsible connection with business; finality of Sec- retary’s actions; judicial review; record. 672. Administrative detention; duration; pending judicial proceedings; notification of govern- mental authorities; release. 673. Seizure and condemnation. 674. Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations of section 607(e) of this title. 675. Assaulting, resisting, or impeding certain persons; murder; protection of such persons. 676. Violations. 677. Other Federal laws applicable for administra- tion and enforcement of chapter; location of inquiries; jurisdiction of Federal courts. 678. Non-Federal jurisdiction of federally regu- lated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, pa

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7 U.S.C. § 136 — Definitions

For purposes of this subchapter— **(a) Active ingredient** The term “active ingredient” means— (1) in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which will prevent, destroy, repel, or mitigate any pest; (2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof; (3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant; (4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue; and (5) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria. **(b) Administrator** The term “Administrator” means the Administrator of the Environmental Protection Agency. **(c) Adulterated** The term “adulterated” applies to any pesticide if— (1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold; (2) any substance has been substituted wholly or in part for the pesticide; or (3) any valuable constituent of the pesticide has been wholly or in part abstracted. **(d) Animal** The term “animal” means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds, fish, and shellfish. **(e) Certified applicator, etc.** (1) **Certified applicator** — The term “certified applicator” means any individual who is certified under [section 136i of this title](https://uscode.house.gov/view.

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7 U.S.C. § 136 — Definitions

Page 202 TITLE 7—AGRICULTURE §§ 135 to 135k with respect to any violations, liabilities incurred, or appeals taken prior to such date of repeal or to sales, shipments, or deliveries of insecticides and fungicides exempted by the Secretary. SUBCHAPTER II—ENVIRONMENTAL PESTICIDE CONTROL §§ 135 to 135k. Omitted Editorial Notes CODIFICATION Sections 135 to 135k, acts June 25, 1947, ch. 125, §§ 2–13, 61 Stat. 163–172; Aug. 7, 1959, Pub. L. 86–139, § 2, 73 Stat. 286; May 12, 1964, Pub. L. 88–305, §§ 1–6, 78 Stat. 190–193; Oct. 15, 1970, Pub. L. 91–452, title II, § 204, 84 Stat. 928; Dec. 30, 1970, Pub. L. 91–601, § 6(b), formerly § 7(b), 84 Stat. 1673, renumbered, Aug. 13, 1981, Pub. L. 97–35, title XII, § 1205(c), 95 Stat. 716, which related to economic poison control, were superseded by the amendments made to act June 25, 1947, by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 975. See section 4 of Pub. L. 92–516, set out as a note under section 136 of this title. The provisions of act June 25, 1947, as amended by Pub. L. 92–516, are set out in section 136 et seq. of this title. Section 135 provided definitions for the purposes of this subchapter. Section 135a related to prohibited acts. Section 135b related to registration of economic poi- sons. Section 135c related to access, inspection, and use in criminal prosecutions of books and records. Section 135d related to rules and regulations, exam- ination of economic poisons or devices, notification to violators, certification to United States attorney, duty of attorney, and publication of judgments. Section 135e related to exemptions from penalties. Section 135f provided for penalties. Section 135g related to seizure, disposal, and award of costs against claimant. Section 135h related to refusal of

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