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21 USC CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS 01/06/03

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TITLE 21 - FOOD AND DRUGS

CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

.

-HEAD-

CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-MISC1-

Sec.

1401. Pesticide monitoring and enforcement information.

(a) Data management systems.

(b) Information.

(c) Volume data.

(d) Compilation.

1402. Foreign pesticide information.

(a) Cooperative agreements.

(b) Information activities.

(c) Coordination with other agencies.

(d) Report.

1403. Pesticide analytical methods.

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21 USC Sec. 1401 01/06/03

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TITLE 21 - FOOD AND DRUGS

CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-

Sec. 1401. Pesticide monitoring and enforcement information

-STATUTE-

(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) of this section, 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) of this section.

(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) of

this section 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) of

this section 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)

of this section and annually thereafter, the Secretary of Health

and Human Services shall compile a summary of the information

described in subsection (b) of this section with respect to the

previous year. When the Food and Drug Administration is able to

make summaries under subsection (c) of this section, the Secretary

shall include in the compilation under the preceding sentence a

compilation of the information described in subsection (c) of this

section. Compilations under this subsection shall be made

available to Federal and State agencies and other interested

persons.

-SOURCE-

(Pub. L. 100-418, title IV, Sec. 4702, Aug. 23, 1988, 102 Stat.

1412.)

-REFTEXT-

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 subchapter II (Sec. 136 et seq.) of chapter

6 of Title 7, Agriculture. 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, as

amended, which is classified generally to chapter 9 (Sec. 301 et

seq.) of this title. For complete classification of this Act to

the Code, see section 301 of this title and Tables.

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SHORT TITLE

Section 4701 of Pub. L. 100-418 provided that: ''This subtitle

(subtitle G (Sec. 4701-4704) of title IV of Pub. L. 100-418,

enacting this chapter) may be cited as the 'Pesticide Monitoring

Improvements Act of 1988'.''

IMPORTED MEAT, POULTRY PRODUCTS, EGGS, AND EGG PRODUCTS

Section 4506 of Pub. L. 100-418 provided that:

''(a) Report. - Not later than 90 days after the date of the

enactment of this Act (Aug. 23, 1988), the Secretary of Agriculture

shall submit a report to Congress -

''(1) specifying 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

pesticides, drugs, and other products permitted in or on such

products;

''(2) describing current methods used by the Secretary to

enforce the requirements of such Acts with respect to the level

of residues of pesticides, drugs, and other products permitted in

or on such products;

''(3) responding to the audit report of the Inspector General

of the Department of Agriculture, Number 38002 - 2 - hy, dated

January 14, 1987;

''(4) providing a summary with respect to the importation of

covered products during fiscal years 1987 and 1988 that specifies

-

''(A) the number of samples of each such product taken during

each such fiscal year in carrying out the requirements

described in paragraph (1); and

''(B) for each violation of such requirements during each

such fiscal year -

''(i) the covered products with respect to which such

violation occurred;

''(ii) the residue in or on such product in violation of

such requirements;

''(iii) the country exporting such product;

''(iv) the actions taken in response to such violation and

the reasons for such actions; and

''(v) the level of testing conducted by the countries

exporting such products;

''(5) describing any research conducted by the Secretary to

develop improved methods to detect residues subject to such

requirements in or on covered products; and

''(6) providing any recommendations the Secretary considers

appropriate for legislation to add or modify penalties for

violations of laws, regulations, and other enforcement

requirements governing the level of residues that are permitted

in or on imported covered products.

''(b) Revision. - Not later than November 15, 1989, the Secretary

of Agriculture shall revise, as necessary, the report prepared

under subsection (a) and submit the revision to Congress.

''(c) Definition. - As used in this section, the term 'covered

products' means meat, poultry products, eggs, and egg products.''

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21 USC Sec. 1402 01/06/03

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TITLE 21 - FOOD AND DRUGS

CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-

Sec. 1402. Foreign pesticide information

-STATUTE-

(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 Federal 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)

of this section with governments of foreign countries shall specify

the action to be taken by the parties to the agreements to

accomplish the purpose described in subsection (a) of this section,

including the means by which the governments of the foreign

countries will provide to the Secretary of Health and Human

Services current information 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 agreement under subsection (a) of this

section or for which the information provided under paragraph (1)

is insufficient 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 private sources.

(3) The Secretary of Health and Human Services shall assure that

appropriate offices of the Food and Drug Administration which are

engaged in the monitoring of imported food for pesticide residues

receive the information obtained under paragraph (1) or (2).

(4) The Secretary of Health and Human Services shall make

available any information obtained under paragraph (1) or (2) to

State agencies engaged in the monitoring of imported food for

pesticide residues other than information obtained 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 Agriculture, the

Environmental Protection Agency, and the Department of State at

the initiation of negotiations with a foreign country to develop

a cooperative agreement under subsection (a) of this section; and

(2) coordinate the activities of the Department of Health and

Human Services with the activities of those departments and

agencies, as appropriate, during the course of such negotiations.

(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.

-SOURCE-

(Pub. L. 100-418, title IV, Sec. 4703, Aug. 23, 1988, 102 Stat.

1413.)

-REFTEXT-

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, as amended,

which is classified generally to chapter 9 (Sec. 301 et seq.) of

this title. For complete classification of this Act to the Code,

see section 301 of this title and Tables.

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21 USC Sec. 1403 01/06/03

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TITLE 21 - FOOD AND DRUGS

CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS

-HEAD-

Sec. 1403. Pesticide analytical methods

-STATUTE-

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 -

(A) new and improved analytical methods capable of detecting

at one time the presence of multiple pesticide residues in

food, and

(B) rapid pesticide analytical methods, and

(2) conduct a review to determine whether the use of rapid

pesticide analytical methods by the Secretary would enable the

Secretary to improve the cost-effectiveness of monitoring and

enforcement activities under the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 301 et seq.), including increasing the number of

pesticide residues which can be detected and the number of tests

for pesticide residues which can be conducted in a cost-effective

manner.

The Secretary shall report the plan developed under paragraph (1),

the resources necessary to carry out the research described in such

paragraph, recommendations for the implementation of such research,

and the result of the review conducted under paragraph (2) not

later than the expiration of 240 days after August 23, 1988, to the

Committee on Agriculture, Nutrition, and Forestry and the Committee

on Labor and Human Resources of the Senate and the House of

Representatives.

-SOURCE-

(Pub. L. 100-418, title IV, Sec. 4704, Aug. 23, 1988, 102 Stat.

1414.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in text, is

act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is

classified generally to chapter 9 (Sec. 301 et seq.) of this

title. For complete classification of this Act to the Code, see

section 301 of this title and Tables.

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