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IS EPA SETTING THE STAGE FOR ANOTHER LOSS IN COURT?

CRE's Letter to EPA

June 15, 2000

Dear Mr. Hardy:

We are writing to express concerns that a portion of an upcoming FIFRA Science Advisory Panel/Science Review Board proceeding will not be conducted in accordance with the SAP's FACA charter. It is our understanding that it is the responsibility of your office to ensure that EPA advisory committees comply with their FACA charters.

The SAP/SRB have been asked to review, at a June 27-29 meeting, a proposal by the Office of Pesticide Programs to upgrade the cancer hazard classification of atrazine from "possible" to "likely". There are two related legal problems with the charge and the background materials on which the charge is based: (1) The proposed upgrade of the cancer classification from "possible" to "likely" which the SAP is being asked to review is clearly based on policy rather than science, and therefore is outside the scope of the SAP's advisory authority; (2) the "policy" on which the proposed upgrade is based is contained in a July 1999 draft of the cancer risk assessment guidelines which states explicitly that it does not represent agency policy, and the draft guidelines are draft "rules" under the APA and cannot have any legal effect under the terms of the Congressional Review Act until finalized and submitted to Congress and the Comptroller General for review. (5 U.S.C. §§ 801, 804.) In addition, the preliminary OPP hazard assessment document appears to dismiss without adequate basis the very recent, and contrary, findings on the same issue by IARC.

The SAP FACA Charter

The Federal Advisory Committee Act ("FACA") states that an advisory committee such as the SAP/SRB can "meet or take any action" only if such meeting or action is within "the committee's objectives and the scope of its activity" as set out in its properly filed FACA charter. (FACA § 9(c), 5 U.S.C. Appendix.)

The SAP's FACA charter provides only for review of scientific issues; there is no authority to review agency proposals based on policy rather than science. The SAP charter provides, insofar as relevant here, that the committee's objectives and scope of activities include only authority to --

"b. Review EPA analyses and reports and provide operating guidelines to improve the effectiveness and quality of scientific analyses;

. . .

d. Provide peer review of major scientific studies and issues."

(Charter ID #119, Jan. 28, 1999, emphasis added.) There is nothing in the SAP charter allowing it to give advice or views on EPA policy positions, and as a scientific body it is not qualified to do so.

The Charge to the Committee and Supporting Draft Hazard Characterization Document

The portion of the charge to the SAP/SRB for the June 27-29 meeting relating to "Issue 4:Human Relevance", and Question 4.4 requesting comment on the proposal to upgrade the cancer hazard classification to "likely", are based on agency policy views and on draft cancer risk assessment guidelines.

The agency's preliminary draft hazard characterization document which supports the charge to the SAP makes it very clear that the upgrade to "likely" would be based primarily on agency policy rather than science. While this position is conveyed via a multitude of statements throughout the draft hazard document, particularly in Chapter 3, starting with the explicit reference to policy in the Chapter title, the following statements, considered together, illustrate the agency's proposed position:

• "Therefore, if atrazine affected the hypothalmic GnRH in humans like in the rat, it is plausible to assume that this neuroendocrine mode of action would apply to humans." (At 55, emphasis added.)



• "Therefore, if atrazine affected hypothalamic GnRH as in the rat, this opens the possibility that an endocrine imbalance may result which could lead to several different health consequences including cancer at hormone responsive tissues." (At 65, emphasis added.)



• "This [potential] neuroendocrine mechanism also raises concern for potential cancer risk in humans." (At 69, emphasis added.)



• "The [pesticide program Cancer Assessment Review] Committee agreed that . . . the neuroendocrine mode of action for the mammary and pituitary tumors (in some rats) is 'biologically plausible' and is supported overall by the weight of the evidence." (At 77, emphasis added.)



• "It is EPA science policy that animal tumor responses are presumed to be indicative of human cancer potential unless there is substantive information to the contrary. This default is intended to be public health protective and departure from this default must have a strong accompanying scientific basis. OPP views the differences between reproductive aging in humans and rats as an insufficient scientific basis to depart from the default. Therefore, if atrazine were to act on the hypothalamus of humans as in the rat and caused CNS alterations which influence endocrine function on physiological processes including ovarian cycling, there is the potential for various adverse health outcomes, including cancer [and therefore atrazine should be classified as a "likely human carcinogen"]." (At 78, emphasis added.)

In other words, if there is any potential for human cancer, it is agency policy that the substance will be classified as "likely" to cause cancer, and this policy position can be overcome only with compelling scientific data showing that such a potential does not exist. Not only is this clearly a policy position which the SAP is being asked to endorse, but it obviously distorts plain English. "Likely" is a synonym for "probable", not for "possible".⁽²⁾ On the other hand, upgrading a major pesticide such as atrazine to a characterization of "likely human carcinogen" is "likely" to have major practical impacts in the agricultural sector.

Reliance in the Charge on Preliminary Draft Revisions to the EPA Hazard Classification System

The EPA 1986 cancer risk assessment guidelines are final rules that have not been rescinded and therefore are still legally in effect, unlike the July 1999 draft. Those 1986 guidelines set out a cancer hazard classification scheme which is very different from the one relied on by OPP for its proposal to upgrade atrazine to a "likely" human arcinogen. The 1986 guidelines do not contain a "likely" category, and previously the agency and the SAP have concurred in classifying atrazine as a "possible" human carcinogen under the 1986 guidelines.

Under the APA amendments commonly referred to as the Congressional Review Act ("CRA"), 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 cancer risk assessment guidelines meet the definition of a "rule" under the CRA. Obviously they are not final and have not been submitted under the CRA. Thus, they cannot form the basis for an SAP review which is required as part of a FIFRA proceeding.

Apart from the legal aberrations discussed above, it is surprising that the charge relies to any extent on the July 1999 draft revisions to the guidelines for its policy position, since the draft guideline revisions state prominently on their cover that they "should not . . . be construed to represent Agency policy."

Downplaying of the Very Recent IARC Conclusions in the Draft Hazard Characterization

Although EPA and other federal agencies frequently rely on IARC findings, in the present instance the hazard document seems to go to some lengths to downplay the 1999 IARC Monograph findings on atrazine by a 22-member working group.⁽³⁾ The draft EPA hazard characterization document mentions in only the briefest way the IARC review, and indicates that the IARC findings support the EPA mode of action analysis. (At 81, 82.)

The IARC working group, which included three scientists from U.S. federal agencies -- two from EPA and one from NCI⁽⁴⁾ -- reached conclusions very opposed to the proposed EPA hazard characterization. IARC focused on the same mode of action as EPA does in its draft hazard classification; but it found that there were "critical interspecies differences in the hormonal changes associated with reproductive senescence", and therefore concluded that "there is strong evidence that the mechanism by which atrazine increases the incidence of mammary gland tumors in Sprague-Dawley rates is not relevant to humans."⁽⁵⁾ Consequently, IARC found that atrazine "is not classifiable as to its carcinogenicity to humans (Group 3). (At 97-99, italics as in original, indicating defined terms; underlining added.)

It is important to understand the significance of the ultimate IARC hazard classification. Under IARC's classification scheme, the category of "not classifiable" given to atrazine is lower than its category of "possibly carcinogenic". (Monograph p. 27.) After a 1990 review, IARC had classified atrazine as "possibly carcinogenic". (Monograph Vol. 54, 1991.) In its 1998 review, IARC examined studies on atrazine's mode of action that had been published since the 1990 review, and concluded that the classification should be downgraded from "possibly" to "not classifiable". In other words, within approximately 18 months of IARC determining, with participation by U.S. agency scientists, that atrazine is not even "possibly carcinogenic", EPA has asked the SAP to endorse an upgrade from "possible" to "likely", based primarily on policy considerations (which are not even finalized) rather than scientific evidence.

Conclusions and Recommendations

As currently drawn, the charge addressing cancer hazard classification asks for SAP views on policy; and the SAP is not authorized, under either FIFRA or its FACA charter, to provide such views. The charge and draft hazard characterization are also based on agency guidance which cannot be given any effect, and do not utilize the 1986 final guidance that is still in effect. Unless the charge is redrawn to ask for SAP views based on science and current final guidance, any SAP action on the proposed classification of "likely" will be outside its authority and will taint any subsequent related FIFRA regulatory proceedings.

We recommend that the charter for the SAP/SAB review be redrawn. OCEM should consult with the SAP Designated Federal Official, the Office of Pesticide Programs, and the Office of Science Coordination and Policy on how to redraw the charge so that any SAP/SRB views are based on scientific evaluation without policy intrusion, and are based on final cancer risk assessment guidance rather than draft guidance.

Sincerely,


Jim J. Tozzi
Member, CRE Advisory Board

1. We note also that the only SAP projects and issues shown in OCEM's "FACA Strategic Agenda for 2000" (Nov. 1999) concern "scientific review" or review of "scientific issues". (return to text)

2. It is also disturbing that the draft hazard characterization document does not discuss, or even mention, that there are two hazard categories below "likely" in the July 1999 draft guidelines that appear more fitting: "Suggestive Evidence of Carcinogenicity" and "Not Likely To Be Carcinogenic To Humans" (At 2-45 to 46.) The SAP should consider whether one of these categories is more fitting than "likely". (return to text)

3. IARC Monograph Vol. 73, Some Chemicals That Cause Tumours Of The Kidney Or Urinary Bladder In Rodents And Some Other Substances, 59-113 (1999). (return to text)

4. Oddly, another member of the IARC working group, Charles Capen of Ohio State University, who is also a Member of the SAP, will apparently not be participating in the SAP review. This raises the issue of why only two out of the current six SAP members (a full complement is seven) are listed as reviewers, and whether it is legal for the SAP to conduct a review in which the full membership does not participate. (return to text)

5. The draft EPA hazard document indicates that IARC made a finding of "not relevant", but it omits stating that it found that the scientific evidence for lack of human relevance was "strong". All of the six reviews listed by EPA are at odds with its proposed classification as a "likely" human carcinogen. (return to text)

June 22, 2000

Jim J. Tozzi
Center for Regulatory Effectiveness
11 Dupont Circle, N.W., Suite 700
Washington, DC 20036

Dear Mr. Tozzi:

Thank you for your letter of June 15 to W. Clarence Hardy concerning the June 27-29 meeting of the Agency's Scientific Advisory Panel (SAP), established under the Federal Insecticide, Fungicide and Rodenticide Act and chartered in compliance with the Federal Advisory Committee Act (FACA). In my capacity as the Designated Federal Officer for the SAP, I have conferred with the Office of Cooperative Environmental Management and am responding on behalf of the Agency. Your letter outlines your concern that some of the questions that the Environmental Protection Agency (EPA) has asked SAP to address regarding the cancer classification of atrazine purportedly go beyond the charter SAP and do not conform to the requirements of FACA.

You object to EPA's asking the SAP to advise the Agency about the proposed cancer designation for atrazine because framework the Agency used for assessing the evidence relating to the carcinogenic potential of atrazine is in draft cancer assessment guidelines rather than final cancer assessment guidelines. You assert that EPA's 1986 cancer assessment guidelines are "final rules" and are still legally in effect. You maintain that the draft cancer assessment guidelines are "draft rules" under the Administrative Procedure Act (APA) and cannot have any legal effect until the terms of the Congressional Review Act (CRA) have been met.

EPA has always been very clear that its cancer assessment guidelines, as well as other science policy guidelines, are intended to provide guidance to EPA personnel and decisionmakers and to the public. The document constitutes guidance which is not binding on either EPA or any outside parties, and is therefore not a rule. Accordingly, it is not subject to the notice and comment rulemaking requirements of the APA or to the CRA. Moreover, since enactment of the CRA, EPA consistently has interpreted this statute as only applying to documents with legally binding requirements. Since the 1999 draft guidelines are not legally binding, they are not subject to the CRA. If EPA had promulgated a rule in 1998 rather than issuing guidelines, the rule would nonetheless not pertain to EPA's presenting to the SAP science issues based on the new draft guidelines.

You also assert that the proposed change of the cancer classification of atrazine is clearlybased on "policy" rather than "science" and therefore evaluation of this proposed change is outside of the scope of the SAP's advisory authority. The Agency's proposal is soundly grounded on a scientific evaluation of the extensive data documenting the potential hazards of atrazine. Although our use of these data is informed by policy positions that have been evolving since the Agency issued its cancer assessment guidelines in 1986, whether we have appropriately assessed the data (the question presented to the SAP) is a science issue and not merely a policy issue. Furthermore because the SAP's charter states, "The Panel shall also provide independent scientific advice concerning other issues of relevance to the Office of Prevention, Pesticides, and Toxic Substances (OPPTS), "the Agency may rely upon the SAP to provide independent scientific judgment concerning both science and policy issues facing OPPTS. Therefore, even if the proposed change were mere policy, the charge to the SAP would be within the panel's charter.

You also disagree with the Agency's tentative conclusions about the carcinogenicpotential of atrazine that EPA presented in its draft hazard characterization document. You cite five statements to support your contention that the carcinogenic potential of atrazine should be described by a term other than likely. The SAP and the Agency will carefully evaluate this comment on the draft hazard characterization document. You additionally assert that EPA's draft hazard characterization document misrepresented the findings of the International Agency for Research On Cancer (IARC) in its 1999 evaluation of the carcinogenic potential of atrazine. EPA provided the IARC monograph to the SAP as background for its consideration. Although not explicitly included in the Agency's charge to the SAP, the difference between EPA's draft hazard characterization document and the 1999 IARC monograph is clearly identified in EPA's draft hazard characterization on document and is an appropriate topic for discussion by the SAP.

Finally, you note that Charles Capen, a member of the IARC working group thatproduced the 1999 monograph on atrazine and a member of the SAP is not participating in the SAP review of atrazine. You also question whether it is legal for the SAP to conduct a review in which only two of six current members participate. Dr. Capen was invited to this session but was unable to attend. It is not accurate to assert that only two of the members of the SAP are participating in the review. FIFRA provides for the formation of subpanels which are composed of permanent members of the panel and other scientists. As required by Section 11 of the SAP Charter, the subpanels do not work independently of the chartered panel. Each session of the SAP is chaired by a member of the chartered panel (permanent panel member). All reports from the panel and subpanels are reviewed and approved by the chartered panel and approved by the SAP Chair before the report is transmitted to the Agency. The SAP will follow this procedure for the atrazine review as well.

Sincerely,

Larry C. Dorsey
Executive Secretary
FIFRA Scientific Advisory Panel