Attachment A - FFDCA 408(p)

Attachment A
TITLE 21 > CHAPTER 9 > SUBCHAPTER IV > § 346a

http://www4.law.cornell.edu/uscode/html/uscode21/usc_sec_21_00000346---a000-.html

§ 346a. Tolerances and exemptions for pesticide chemical residues
[…]
(p) Estrogenic substances screening program.
(1) Development. Not later than 2 years after August 3, 1996, the Administrator shall
in consultation with the Secretary of Health and Human Services develop a screening
program, using appropriate validated test systems and other scientifically relevant
information, to determine whether certain substances may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or such other endocrine
effect as the Administrator may designate.
(2) Implementation. Not later than 3 years after August 3, 1996, after obtaining
public comment and review of the screening program described in paragraph (1) by the
scientific advisory panel established under section 25(d) of the Federal Insecticide,
Fungicide, and Rodenticide Act [7 U.S.C. 136w (d)] or the science advisory board
established by section 4365 of title 42, the Administrator shall implement the program.
(3) Substances. In carrying out the screening program described in paragraph (1),
the Administrator—
(A) shall provide for the testing of all pesticide chemicals; and
(B) may provide for the testing of any other substance that may have an effect that
is cumulative to an effect of a pesticide chemical if the Administrator determines that
a substantial population may be exposed to such substance.
(4) Exemption. Notwithstanding paragraph (3), the Administrator may, by order,
exempt from the requirements of this section a biologic substance or other substance if the
Administrator determines that the substance is anticipated not to produce any effect in
humans similar to an effect produced by a naturally occurring estrogen.
(5) Collection of information.
(A) In general. The Administrator shall issue an order to a registrant of a
substance for which testing is required under this subsection, or to a person who
manufactures or imports a substance for which testing is required under this
subsection, to conduct testing in accordance with the screening program described in
paragraph (1), and submit information obtained from the testing to the
Administrator, within a reasonable time period that the Administrator determines is
sufficient for the generation of the information.
(B) Procedures. To the extent practicable the Administrator shall minimize
duplicative testing of the same substance for the same endocrine effect, develop, as
appropriate, procedures for fair and equitable sharing of test costs, and develop, as
necessary, procedures for handling of confidential business information.
(C) Failure of registrants to submit information.
(i) Suspension If a registrant of a substance referred to in paragraph (3)(A)
fails to comply with an order under subparagraph (A) of this paragraph, the

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Administrator shall issue a notice of intent to suspend the sale or distribution
of the substance by the registrant. Any suspension proposed under this
paragraph shall become final at the end of the 30-day period beginning on the
date that the registrant receives the notice of intent to suspend, unless during
that period a person adversely affected by the notice requests a hearing or
the Administrator determines that the registrant has complied fully with this
paragraph.
(ii) Hearing If a person requests a hearing under clause (i), the hearing shall
be conducted in accordance with section 554 of title 5. The only matter for
resolution at the hearing shall be whether the registrant has failed to comply
with an order under subparagraph (A) of this paragraph. A decision by the
Administrator after completion of a hearing shall be considered to be a final
agency action.
(iii) Termination of suspensions The Administrator shall terminate a
suspension under this subparagraph issued with respect to a registrant if the
Administrator determines that the registrant has complied fully with this
paragraph.
(D) Noncompliance by other persons. Any person (other than a registrant) who
fails to comply with an order under subparagraph (A) shall be liable for the same
penalties and sanctions as are provided under section 16 of the Toxic Substances
Control Act [15 U.S.C. 2615] in the case of a violation referred to in that section.
Such penalties and sanctions shall be assessed and imposed in the same manner as
provided in such section 16.
(6) Agency action. In the case of any substance that is found, as a result of testing
and evaluation under this section, to have an endocrine effect on humans, the Administrator
shall, as appropriate, take action under such statutory authority as is available to the
Administrator, including consideration under other sections of this chapter, as is necessary
to ensure the protection of public health.
(7) Report to Congress. Not later than 4 years after August 3, 1996, the
Administrator shall prepare and submit to Congress a report containing—
(A) the findings of the Administrator resulting from the screening program described
in paragraph (1);
(B) recommendations for further testing needed to evaluate the impact on human
health of the substances tested under the screening program; and
(C) recommendations for any further actions (including any action described in
paragraph (6)) that the Administrator determines are appropriate based on the
findings.

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