A - 1

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 
A - 2

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.