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## Attachment A

TITLE 21 > 

### CHAPTER 9 > 

### SUBCHAPTER IV > § 346a http://www4.law.cornell.edu/uscode/h tml/uscode21/usc_sec_21_00000346---a000-.html



### § 346a. Tolerances and exemptions for pesticide chemical residues

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(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 Heal th and Human Services develop a screening program, using appropriate validated test systems and other scien tifically relevant
information, to determine whethe r 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 Administ rator may designate.

(2) Implementation. Not later than 3 years after Au gust 3, 1996, after obtaining public comment and review of the screening program described in paragraph (1) by the scientific advisory panel esta blished 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 progra m 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 substa nce or other substance if the

Administrator determines that the substance is anticipated not to produce any effect in

humans similar to an effe ct 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 und er 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 reason able 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 fo r the same endocrine effect, develop, as appropriate, procedures for fair and equitabl e 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 su bstance referred to in paragraph (3)(A) fails to comply with an order under su bparagraph (A) of this paragraph, theA - 2 Administrator shall issue a notice of inte nt 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 noti ce of intent to suspend, unless during that period a person adve rsely affected by the noti ce requests a hearing or

the Administrator determines that the re gistrant has complied fully with this paragraph. (ii) Hearing If a person requests a hearin g under clause (i), the hearing shall

be conducted in accordance with sect ion 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 regi strant 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 subpa ragraph (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 a ssessed 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 othe r 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 Admini strator resulting from the screening program described in paragraph (1); (B) recommendations for further testing need ed 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 de termines are appropriate based on the findings.