21 U.S.C. § 1401 : US Code - Section 1401: Pesticide monitoring and enforcement information

Search 21 U.S.C. § 1401 : US Code - Section 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) 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.