May 4, 2001
U.S. Environmental Protection Agency
Public Information and Records Integrity Branch (7502C)
Office of Pesticide Programs
1200 Pennsylvania Ave., NW
Washington, DC 20460
RE: Docket for Comments on Proposed Consent Decree and Settlement Agreement -- FQPA Implementation
To Whom It May Concern:
IWG Comments on the EPA/NRDC Consent Decree
The undersigned members of the Implementation Working Group (IWG) represent a coalition of farm, fiber, food, pest management, and manufacturing organizations that joined together in 1997 to address and respond to the requirements of the Food Quality Protection Act (FQPA) of 1996.
The IWG has established an ongoing record of proactive and constructive interactions with EPA, USDA, and Congress with respect to the implementation of the FQPA changes to the evaluation and regulation of the use of pesticides in the U.S., under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). IWG recognized that the passage of the FQPA was a watershed event for manufacturers and users of pesticide products and for people potentially exposed to pesticides. The law establishes a new standard for evaluation of food-use pesticides - “reasonable certainty of no harm” as compared with the prior zero tolerance standard. It requires the U.S. EPA to adopt new processes to assess risks associated with pesticide exposure. The law also stipulates an organized process of adopting the changes in regulation that FQPA created, namely:
§ to determine if additional data or information are reasonably required to support the continuation of a tolerance. (FFDCA sec. 408(f))
§ to define new data requirements to address such new science needs. (FIFRA sec. 3(C)(2)(A))
§ to prescribe protocols and timetables for developing and submitting new data. (FIFRA sec. 3(C)(2)(A))
§ to base regulatory decisions on reliable information, not default assumptions. (FFDCA sec (b)(2)(A)(ii) and FFDCA sec. 408(b)(2)(D)(i)) IWG’s participation in the FQPA implementation process has included, but is not limited to, the following:
§ June 1998: IWG submitted it’s Road Map Report: A Science-based, Workable Framework for Implementing the Food Quality Protection Act.
§ June 1998: IWG conducted EPA and USDA staff briefings and discussions of the IWG Road Map.
IWG submitted Scientific and Technical comments on all EPA draft policy and guidance documents examples of which include:
§ Guidance for identifying pesticide chemicals that have a common mechanism of toxicity, for use in assessing the cumulative toxic effects of chemicals.
§ January 19, 1999: Office of Pesticide Program’s (OPP’s) Science Policy on the Use of Cholinesterase inhibition for risk assessments of organophosphate and carbamate pesticides.
§ January 19, 1999: OPP’s Guidance for Submission of Probabilistic Exposure Assessments.
§ February 18, 1999: OPP’s Proposed threshold of Regulation Policy defining when a food use does not require a tolerance.
§ March 5, 1999: OPP’s “Estimating the Drinking Water Component of a Dietary Exposure Assessments.
§ March 5, 1999: OPP’s SOP for Residential Exposure Assessment and Framework for Assessing non-Occupation, Non-Dietary residential exposure to pesticides
§ June 7, 1999: OPP’s Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern.
EPA’s FQPA Implementation Process to Date
EPA’s early approach to implementing the admittedly complex changes in the regulatory process prescribed by FQPA were characterized by inconsistency, unannounced changes in established practices, lack of meaningful public review, and lack of transparency. A resulting directive from the Vice-President in 1998, brought some process improvements and the formation of a Tolerance Reassessment Advisory Committee (TRAC). In the year 2000, TRAC was succeeded by the Committee to Advise on Reassessment and Transition (CARAT). The advisory committees defined some of the new science policies created by FQPA and EPA then published at least 15 draft policy documents for comment. These were favorable initial steps toward defining a science-based regulatory process for addressing FQPA amendments.
Unfortunately, the draft science policies have not been established through rule making, data requirements addressing those policies have not been published, and product decisions continue to be based on constantly changing regulatory procedures that are neither predictable nor science-based. Even more disconcerting to IWG members is the lack of evidence to date that EPA intends to clearly define a science-based regulatory process reflecting the changes required by FQPA. Even as recent as March 20, 2001 in an EPA directive to the Acting Assistant Administrator for Office of Prevention, Pesticides and Toxic Substances (OPPTS), clarity of process is left unresolved. For example, this directive states that EPA will review and comment on any proposed protocol for conducting new toxicity studies. It even indicates the agency will set a date by which new toxicity studies must be submitted. The directive does not however indicate any intention by the agency to clearly define what new toxicity studies they will require to address the new science policies. Setting dates for completion of new toxicity studies is of little value if EPA has not identified what new studies are needed.
Later in that directive the Agency directs its staff to make available to the public the toxicity studies it already has and is relying on to conduct preliminary and revised cumulative risk assessments for organophosphate insecticides, clearly referring to existing data. Again, there is no commitment to inform registrants or the public what new toxicity data must be developed to address the new regulatory standard. EPA leaves the new requirements undefined, which in turn, leaves near and long-term regulatory decisions to the agency’s discretion and to arbitrary default assumptions where needed data are lacking. Data that could be available but has never been defined or requested.
The Agency has developed a draft policy dealing with the determination of when a group of similar pesticide chemicals share a common mechanism of toxicity. This draft policy is intended to guide the assessment of cumulative risk as required by FQPA. In negotiations with EPA regarding the provisions of the proposed consent decree that would require the Agency to make specific common mechanism determinations, the Agency refused to commit to follow its own established policy and process on common mechanism determinations. This particular process has been in place for more than 2 years. The Agency has had sufficient time to initiate and follow the outlined steps for these decisions. Yet, one final paragraph in the above mentioned Agency directive on implementation of FQPA obligations under the consent decree demonstrates the lack of intention with regard to predictability of implementation process that is of concern to IWG members. That paragraph states, “As now provided in the Consent Decree, when determining whether a class of pesticides share a common mechanism of toxicity, EPA will either follow written policies pertaining to common mechanism determinations that are current at the time of the particular determination, or EPA will include in writing in the determination a description of any deviations from current common mechanism policy and an explanation of why we believe such deviations are appropriate”. The implication is that once approved, the consent decree will tie the agency’s hands and force it to set aside its own implementation processes to meet consent decree mandated decision time tables.
The IWG must ask how stakeholders can reasonably prepare for a common mechanism of toxicity review process that won’t necessarily follow policies that exist in draft or final form at the time of a particular common mechanism determination, a number of which will be set in stone by an approved consent decree.
It was this ongoing lack of clarity and predictability in process that prompted IWG to promote legislative clarification for the evolving FQPA implementation process. The Regulatory Fairness and Openness Act of 1999 was introduced in the House and Senate in the 106th Congress and was supported by 277 members of congress. Clearly there is congressional interest in seeing that the process of adopting FQPA regulations is properly implemented for both near- and long-term stability and predictability.
Adverse Impact of the Consent Decree
The consent decree mandates a schedule of regulatory decisions on the organophosphate insecticide class of chemicals and on other chemicals that would only be appropriate if a clearly defined regulatory process reflecting FQPA provisions was in place. This process, which should be based on accepted regulatory protocol, is not in place. EPA has ignored Congressional intent to base regulatory process on formal rule-making with clear definition of common toxic end points, data requirements, and study protocols, the Agency is not prepared to make science-based assessments on single chemicals (aggregate risk) or multiple chemical groups (cumulative risk). It can only meet the consent decree deadlines by using undefined parameters and processes. Such a process will result in both short-term and long-term disruptions and disadvantages to U.S. growers and other product users.
Minor crops will be negatively impacted the most, because uses will be forced to be discontinued unnecessarily, where the science is incomplete. And the science will be incomplete because EPA has not defined the new science requirements and registrants are understandably and justifiably reluctant to guess what those requirements might be. If EPA misses the consent decree timetables, it is subject to resumption of litigation and follow-on lawsuits for missing court-approved dates.
The IWG strongly urges the U.S. District Court of the Northern District of California not to approve the January 19, 2001 consent decree as amended, which was negotiated between EPA and NRDC, only one of several parties to this litigation on the implementation of the FQPA. The consent decree seeks to impose a court-enforceable schedule for implementing only selected parts of the FQPA, including conducting cumulative risk assessments on groups of chemicals with similar modes of toxicity.
The deadlines in such a schedule are unreasonable as well as impractical because they do not allow time for EPA to receive or consider information critical to the assessments mandated by the consent decree. The deadlines ignore essential steps necessary to achieve the specified assessments and decisions, leaving the Agency free to cut corners, and take shortcuts at the expense of good science. Because EPA has not finalized a cumulative risk assessment methodology, nor clarified all necessary data requirements, the Agency is not prepared to make the decisions the consent decree dictates. If this decree is approved, EPA will proceed with a court approved process of pesticide evaluation, which will not be based on the best information or process, but which would make far reaching decisions on the continued availability of specific pesticide uses. Pesticide uses which are important tools in integrated pest management programs for specific crops will be jeopardized leaving growers with alternatives that may be less effective or more damaging to beneficial insects. Pesticide tools that are key to managing the development of chemical resistance in damaging pests will be threatened or lost. Pesticide tools that represent the only available product for certain pests on very minor crops will be lost. These negative outcomes have a high likelihood of occurring because an adequate process of evaluation is not in place and its development will be pre-empted by the consent decree deadlines.
It is IWG’s position that the consent decree’s preemptive deadlines for making FQPA decisions have the potential to create major disruptions to U.S. Agriculture and other industries that rely on pest management tools. Consent decree decision deadlines are not based on actual risks from current pesticide uses and should be deferred until EPA completes definition of an FQPA implementation process that is based on finalized and adapted science policies that fairly and uniformly address the subject changes in pesticide regulation