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®: CRE Regulatory Action of the Week

EPA Is Improperly Using Proposed, Unvalidated Tests To Assess And Regulate Herbicides And Other Substances

CRE previously pointed out that EPA cannot not legally use draft, proposed Cancer Guidelines to regulate pesticides or other substances. Instead, EPA is bound by its currently operative 1986 Cancer Guidelines until EPA promulgates final new Cancer Guidelines in accordance with the Administrative Procedure Act ("APA") and the Congressional Review Act ("CRA"). Similarly, EPA cannot use proposed endocrine disruptor tests to regulate any product until and unless they have been validated, standardized, and promulgated as final rules.

EPA Must Use Its Currently Operative Non-Cancer Guidelines And Test Protocols Until And Unless EPA Promulgates Final, New Rules Changing Them In Accordance With The APA, FQPA, And CRA

EPA has promulgated several currently operative non-cancer effects guidelines and tests: e.g., EPA's Guidelines for Reproductive Toxicity Risk Assessment; and EPA's Guidelines for Developmental Toxicity Risk Assessment.

EPA proposed its Reproductive Guidelines for public comment in 1994. 59 Fed. Reg. 10385. EPA published final Guidelines, along with a response to comments, on October 31, 1996. 61 Fed. Reg. 56274. EPA's Federal Register notice for the final Guidelines stated, "These Guidelines will be effective October 31, 1996." Id. EPA's Federal Register notice explained, "These Guidelines describe the procedures that the EPA follows in using existing data to evaluate the potential toxicity of environmental agents to the human male and female reproductive systems and to developing offspring." 61 Fed. Reg. 56277. EPA's Reproductive Guidelines incorporate "testing guidelines (U.S. EPA, 1982, 1985b, 1996a) that provide protocols designed to determine the potential of a test substance to produce reproductive (including developmental) toxicity in laboratory animals." 61 Fed. Reg. 56274-75.

EPA proposed the Developmental Guidelines in the Federal Register for public comment in 1989. 54 Fed. Reg. 9386. EPA published final Developmental Guidelines, along with a response to comments, on December 5, 1991. 56 Fed. Reg. 63798. The Agency's Federal Register notice for the final Guidelines stated, "The Guidelines will be effective December 5, 1991." Id. EPA's Federal Register notice explained, "These Guidelines describe the procedures that the EPA follows in evaluating potential developmental toxicity associated with human exposure to environmental agents." 56 Fed. Reg. 63800-01. EPA's final Developmental Guidelines incorporate "testing guidelines (U.S. EPA, 1982b, 1985a, 1989a, 1991a) that provide protocols designed to determine the potential of a test substance to induce structural and/or other adverse effects during development." 56 Fed. Reg. 63800-01.

The D.C. Circuit explained that EPA's 1986 Cancer Guidelines are final rules promulgated after a public notice and comment rulemaking. International Fabricare Institute v. EPA, 972 F. 2d 384, 397 (D.C. Cir. 1992). EPA's currently operative Non-cancer Guidelines, and their incorporated test protocols, were developed and promulgated in the same manner and serve the same uses. They too are rules. See id. EPA has to comply with its own rules. See Pfizer, Inc. v. Heckler, 735 F.2d 1502, 1507 (D.C. Cir. 1984) ("It is axiomatic that an administrative agency is bound by its own regulations"). Consequently, EPA has to apply the currently effective Guidelines and test protocols until and unless EPA changes them in a rulemaking complying with the APA. See Appalachian Power Co. v. EPA, 208 F. 3d 1015 (D.C. Cir. 2000) (EPA cannot use "guidance" that has never gone through APA notice and comment rulemaking process to determine permit applications under the Clean Air Act).

The FQPA requires EPA to develop rules, after public notice and comment, establishing a national endocrine disruptor screening program, and validating the tests used for that program. 21 U.S.C. 346a(p). According to EPA, final rulemaking action on these tests is not expected until sometime in 2001. 63 Fed. Reg.71561 (Dec. 28, 1998). EPA cannot circumvent this national rulemaking requirement by using proposed, unvalidated endocrine disruptor tests to assess and regulate individual products on a case-by-case basis.

Under the APA amendments commonly referred to as the Congressional Review Act, 5 U.S.C. 801-808, "[b]efore a rule can take effect" the agency must submit the final rule to Congress and the Comptroller General along with a report for their review and possible action. The endocrine disruptor screening program and tests required by the FQPA constitute a rule under the CRA. This program and these tests are not final and have never been submitted to Congress and the Comptroller General. Consequently, endocrine disruptor tests under development by EPA cannot be used to regulate until they have been properly validated, standardized, and finally promulgated in accordance with the FQPA, APA, and CRA.

There are very good reasons for these procedural requirements. A scientific review panel was convened October 10-12, 2000 in Research Triangle Park by the National Toxicology Program at EPA's request. The panel was charged with determining whether there is sufficient evidence to determine whether endocrine effects are occurring at low doses and, if so, to evaluate the standard dose-setting approach's utility in detecting such effects. Scientists at this meeting pointed out that there is wide variation and uncertainty among many of the new, unvalidated tests being used to determine endocrine effects. For some substances, one test showed endocrine effects, while other tests did not. At this time no one knows which test results are correct. "Summary Points from Endocrine Disruptors Low-Dose Peer Review-October 10-12, 2000"(available at under "What's New").EPA cannot use new tests and protocols to regulate on the basis of endocrine effects until these problems are solved and they are properly validated and standardized.

EPA has in the past agreed that pesticides, herbicides and other substances could not be screened for endocrine effects under new guidelines and tests until the new guidelines and tests had been properly validated and standardized.

For example, EPA stated with regard to flufenacet,

EPA is currently developing an [sic] screening, testing program and a priority setting scheme for endocrine disruptors. Based on the toxicity findings, flufenacet should be considered as a candidate for evaluation as an endocrine disruptor when the criteria are established.

Pesticide Fact Sheet, Flufenacet, p.4, EPA OPP (April 1998) (emphasis added).

As another example, EPA stated with regard to Fenthion,

EPA is required to develop a screening program to determine whether certain substances (including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect..." The Agency is currently working with interested stakeholders, including other government agencies, public interest groups, industry and research scientists in developing a screening and testing program and a priority setting scheme to implement this program. Congress has allowed 3 years from the passage of FQPA (August 3, 1999) to implement this program. At that time, EPA may require further testing of this active ingredient and end-use products for endocrine disruptor effects.

HED Chapter of the Registration Eligibility Decision Document, Fenthion, at p. 98, EPA OPP , 4/16/98 Draft (emphasis added).

Based on recent proceedings, however, EPA is no longer willing to wait until it promulgates final rules implementing the national endocrine disrupter screening and testing program required by the FQPA, by sound science, and by basic principles of good government.

EPA Has Recently Ignored Its Currently Operative Guidelines and Tests, And Instead Used Proposed, unvalidated Endocrine Screening Tests

In some recent regulatory proceedings, EPA has ignored its currently effective non-cancer effects guidelines, and instead used new tests and protocols that have never been properly validated and promulgated.

For example, EPA's draft carcinogenicity hazard assessment and characterization for the herbicide atrazine states repeatedly that there is no basis for concluding that atrazine causes any significant adverse developmental or reproductive effects under EPA's currently effective non-cancer effects guidelines. EPA admitted that

results of developmental or reproductive toxicity guideline studies with atrazine do not show that the dam or her offspring express effects of atrazine treatment that can be associated with disruption of the hypothalamic-pituitary-ovarian axis.

Draft Atrazine Risk Assessment ("R.A."), Part A, p.15.

EPA further admitted, "The multi-generation [guideline rat] study results provided no evidence of reproductive or developmental toxicity." Draft Atrazine R.A., Part A, p. 21.

EPA determined that atrazine did not cause developmental or reproductive effects under its currently operative guidelines. "Special, " non-guideline studies were conducted by EPA: "Special studies have been conducted that show that atrazine has reproductive and developmental effects that can be attributed to alterations in endocrine function." Draft Atrazine R.A., Part A, p.19 (emphasis added). EPA further explained,

Adverse reproductive or developmental consequences have been identified following treatment of different strains of pregnant rats or neonates with atrazine or its metabolites. [T]his evidence does not come from results of EPA guideline studies but from results of special studies conducted with atrazine or its metabolites.

Draft Atrazine R.A., Part A, p. 49 (emphasis added).

Two of these "special studies" use protocols that are not included among EPA's currently operative guideline tests: i.e., "'Research Protocol for Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats (U.S. EPA, 1998b...."; and "'Research Protocol for the Assessment of Pubertal Development and Thyroid function in Juvenile Male Rats (U.S. EPA, 1998b)." Draft Atrazine R.A., Part C, pp. 9-10. Both these test protocols are proposed as part of EPA's Tier I screening tests for endocrine effects in the Agency's Endocrine Disruptor Screening Program ("EDSP"). 63 FR 71542, 71551-52 (Dec. 28, 1998). As explained above, this endocrine screening and testing program is part of the national rulemaking required by the FQPA. 21 U.S.C. 346a(p).

Thus, EPA is assessing atrazine's non-cancer risks using:

  • Tests that are not part of EPA's currently effective non-cancer guidelines and incorporated test protocols;
  • Tests that have never been validated; and
  • Tests that are part of proposed EDSP rules that have not yet been promulgated in final form.

EPA is bound by its current operative non-cancer guidelines until EPA promulgates new validated and standardized non-cancer effects guidelines and tests in accordance with the APA, FQPA, and CRA. Neither atrazine nor any other substance can be regulated on the basis of tests for which "reliability and reproducibility" are still being evaluated.

Conclusions and Recommendations

EPA must use its currently operative non-cancer effects guidelines and test protocols to assess and regulate chemicals and other substances until EPA promulgates new validated and standardized guidelines and tests in accordance with the APA, FQPA, and CRA.

CRE invites all interested parties to submit comments on these issues to CRE's Interactive Public Docket.

Please click below to submit comments regarding EPA's Use of Proposed Unvalidated Tests.

EPA's Use of Proposed Unvalidated Tests: Interactive Public Docket

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