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

submitted 38 years ago by Pub. L. 100-418 to r/title-21-FOOD-AND-DRUGS · 732 words · no verdicts yet

in plain englishAI-generated · not legal advice

This section requires the Secretary of Health and Human Services and the Food and Drug Administration to create and use computerized systems for pesticide-residue monitoring. It specifies the information to summarize, including food products analyzed for compliance with the Federal Food, Drug, and Cosmetic Act regarding pesticide residues, the volume data to collect, the annual reporting deadline, and who must receive the compilations.

(a) Data management systems.

(1) Within 480 days after August 23, 1988, the Secretary of Health and Human Services must put computerized data-management systems in place for the Food and Drug Administration. The systems must let the Administration: (A) record, summarize, and evaluate its food pesticide-residue monitoring results; (B) find gaps in monitoring pesticides, food products, and food from particular countries and domestic sources; (C) detect trends in residues and identify emerging public-health problems; (D) direct testing resources toward residues that threaten public health; (E) prepare the summaries described in subsection (b); and (F) provide information to help the Environmental Protection Agency perform its duties under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act.

(2) As soon as practicable, the Secretary must develop a way for the systems to produce the summary described in subsection (c).

(3)(A) Paragraph (1) does not limit the FDA’s authority to use these systems or create additional systems to help regulate any substance or product covered by the Federal Food, Drug, and Cosmetic Act. (B) In putting the systems in place and carrying out paragraph (2), the Secretary must follow applicable rules for computer-system design and procurement.

(b) Information. The FDA must use the systems to summarize: (1) information about the types of imported and domestically produced food products analyzed for compliance with the requirements of the Federal Food, Drug, and Cosmetic Act regarding the presence of pesticide residues; the number of samples of each kind by country of origin; residues detectable by the testing methods; residues found and their levels; each sample’s compliance status and the violation rate for each country-and-product combination; and the action and final disposition for each violating sample; and (2) the country of origin and United States entry district for each imported food product covered by paragraph (1)(A).

(c) Volume data. The FDA must use the systems to summarize, by country of origin and entry district, the volume of each kind of covered food imported into the United States when its entry value exceeds an amount set by the Secretary. When feasible, the FDA must obtain the volume information from other Federal agencies’ databases.

(d) Compilation. No later than 90 days after one year has passed since the systems were put in place, and every year after that, the Secretary must compile a summary of the subsection (b) information for the previous year. Once the FDA can make subsection (c) summaries, the Secretary must include that information too. These compilations must be available to Federal and State agencies and other interested people.

the actual law source: uscode.house.gov ↗public domain
(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 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 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 systems placed in effect under paragraph (1), or

(ii)

develop additional data management systems,

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 governing computer system design and procurement.

(b) Information

The Food and Drug Administration shall use the computerized data management systems placed into effect under subsection (a)(1) to prepare a summary of—

(1)

information on—

(A)

the types of imported and domestically produced food products analyzed for compliance 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 detected using the testing methods employed,

(D)

the pesticide residues in such food detected 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 disposition, 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 summarize 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 annually thereafter, the Secretary of Health and Human Services shall compile a summary of the information described in subsection (b) with respect 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 subsection shall be made available to Federal and State agencies and other interested persons.

Source credit: (Pub. L. 100–418, title IV, § 4702, Aug. 23, 1988, 102 Stat. 1412.)

history & why it existsrecord from the source credit
  • 1988Enacted · Pub. L. 100-418 · 102 Stat. 1412

A history note hasn’t been published yet. The record shows enactment by Pub. L. 100-418 on 1988-08-23.

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