SM: CRE Regulatory Action of the Week
Comments By The Center For Regulatory Effectiveness On EPA's Revised Preliminary Human Health Risk Assessment
The Center for Regulatory Effectiveness (CRE) appreciates the opportunity to comment on the Preliminary Human Health Risk Assessment (Preliminary Risk Assessment) for atrazine. As explained below, EPA should reconsider its Preliminary Risk Assessment for many reasons, including the following.
TO ASSESS AND REGULATE ATRAZINE
EPA's Preliminary Risk Assessment for atrazine is based on a Draft Risk Assessment that improperly relies heavily on "special studies" using tests that have not been validated through public notice and comment procedures. E.g., Preliminary Risk Assessment at 12. These ‘special studies" developmental effects tests are not included in EPA's currently effective Guidelines for Developmental Toxicity Risk Assessment.
EPA proposed its Developmental Toxicity Guidelines in the Federal Register for public comment in 1989. 54 Fed. Reg. 9386. EPA published final Developmental Toxicity 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 Toxicity 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.
EPA's Draft Risk Assessment for atrazine stated repeatedly that there is no basis for concluding that atrazine causes any significant adverse developmental under EPA's currently effective Developmental Toxicity Guidelines. For example, 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 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.
Because EPA could not show developmental effects under its currently effective guidelines, the Agency resorted to "special, " non-guideline studies: "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).
These "special studies" use tests that are not included among EPA's currently effective Developmental Toxicity Guidelines 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). This endocrine screening and testing program is part of a national rulemaking required by the FQPA. 21 U.S.C. § 346a(p). Final rulemaking action on these tests has not occurred.1
Thus, EPA is assessing atrazine's non-cancer risks, and will regulate based on that risk assessment, using:
The D.C. Circuit has already 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 current Developmental Toxicity 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.
The currently effective Developmental Toxicity Guidelines and test protocols do not include the proposed, unvalidated endocrine disruptor screening tests used in the atrazine "special studies." EPA obviously views the results of these tests as binding on the registrant, and they will have substantial weight in determining the registrant's rights and duties. Under similar circumstances, the courts have held EPA's use of EPA "guidance" improper under the APA because the "guidance" was in fact a rule subject to the APA's public notice and comment requirements. 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 itself requires EPA to develop rules establishing a national endocrine disruptor screening program, and validating the tests used for that program. 21 U.S.C. §346a(p). 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, as it has done with atrazine.
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. The proposed, unvalidated tests used in the atrazine "special studies" are part of EPA's proposed implementation of this national screening and testing program required by the FQPA. These tests are not final and have never been submitted to Congress and the Comptroller General. Consequently, they cannot be used in the atrazine review.
The APA, FQPA and CRA requirements are not limited to Developmental Toxicity Guidelines tests. For example, EPA proposed Reproductive Toxicity Guidelines for public comment in 1994. 59 Fed. Reg. 10385. EPA published final Reproductive Toxicity 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 Toxicity 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.
Therefore, if EPA is using reproductive effects tests that are not part of the Reproductive Toxicity Guidelines tests during the atrazine review, or elsewhere, then those tests are also improper for the reasons set forth above.
Section 12(d)(1) of the National Technology and Transfer and Advancement Act of 1995, Public law 104-113,15 U.S.C. § 272 note, as implemented by OMB Circular A-119, requires federal departments and agencies to "use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments." In complying with this statutory duty, Section 12(d)(2) of the Technology Transfer Act requires federal agencies and departments to "consult with voluntary, private sector, consensus standards bodies and...when such participation is in the public interest and is compatible with agency and departmental missions, authorities, priorities, and budget resources, participate with such bodies in the development of technical standards."
Under Section 12(d)(3) of the Technology Transfer Act:
"[i]f compliance with [the requirements identified above] is inconsistent with applicable law or otherwise impractical, a Federal agency or department may elect to use technical standards that are not developed or adopted by voluntary consensus standards bodies if the head of each such agency or department transmits to the Office of Management and Budget an explanation of the reasons for using such standards. Each year, beginning with fiscal year 1997, the Office of Management and Budget shall transmit to Congress and its committees a report summarizing all explanations received in the preceding year under this paragraph."
The American Society for Testing Methods and Materials of the American National Standards Institute has a "Test method E1483-92(1996) Standard Test Method for Assessing Developmental Toxicity in Rats and Rabbits." It "is designed to assess the potential of a pesticide or chemical to present a hazard to the unborn arising from exposure of the maternal animal during pregnancy."
This is not the "special study" rat test that EPA is using in the atrazine review to assess developmental toxicity. For the reasons explained above, EPA must use its currently effective Developmental Toxicity Guidelines tests until and unless it validates and promulgates final new tests in accordance with the APA, the FQPA, and the CRA. If EPA does decide to develop new tests in the statutorily required manner, then the Technology Transfer Act requires that EPA either adopt the ANSI/ASTM developmental effects tests or explain to OMB and Congress why use of this voluntary consensus standard would be inconsistent with applicable law or otherwise impractical.
1. The "UNPUBLISHED MANUSCRIPT" for the female rat study explains that this protocol "is currently undergoing testing to evaluate its reliability and reproducibility as such a screen" for "chemicals that alter male and female pubertal development and thyroid function through steroid-mediated mechanisms of action." Manuscript at 1.