FIFRA: What s New, What s Hot

Transcription

1 FIFRA: What s New, What s Hot by Lynn L. Bergeson, Lisa M. Campbell, & Eileen Salathé Gernhard* For Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) practitioners, the current state of play at the United States Environmental Protection Agency (EPA), the change in Senate leadership, and the dynamics in the agricultural and antimicrobial chemicals market place, make work anything but dull. This article identifies key FIFRA issues, largely brought about by EPA s continuing efforts to implement the 1996 amendments to FIFRA the Food Quality Protection Act (FQPA). The ultimate resolution of these issues will influence greatly the registration and reregistration of agricultural and antimicrobial chemical products for years to come. Political Landscape Before proceeding, we summarize briefly the current political landscape. The pace of the Bush Administration s selection of second and third level government appointees has been the slowest on record. This pace has left a decided leadership vacuum at the EPA senior management level. The defection of Senator Jeffords will delay the confirmation process even more. While the absence of permanent leadership at EPA has added an element of uncertainty to the political and policy agenda the new Administration may pursue, the confirmation of career EPA staffer Stephen 623 Johnson as Assistant Administrator for Toxics has inspired both comfort and concern among toxics practitioners. On the one hand, Johnson is a known element, well-liked and respected in pesticide and related chemical product circles. On the other hand, because he is a career EPA staffer, some wonder whether he will be as receptive to the political agenda of the new Administration, particularly since Johnson s fingerprints touch some of the sources of considerable concern with EPA s implementation of FQPA under the former Administration. Linda Fisher s Senate confirmation eliminates the uncertainty regarding the direction of EPA s day-to-day management. Fisher served for ten years in various capacities at EPA during the Reagan and Bush Administrations. As former Vice President of Government Affairs for Monsanto Company, one of the world s largest agricultural chemical companies, Fisher is no newcomer to the vexing legal, policy, and public health issues confronting the new Administration in the area of agricultural chemicals and genetically modified organisms. Fisher s savvy, experience, and legal expertise will serve her well. Little is known about the preferences and predelictions of General Counsel designate Robert Fabricant. Fabricant served as Chief Counsel to * Lynn L. Bergeson and Lisa M. Campbell are founding EPA Administrator Whitman when she was the shareholders of Bergeson & Campbell, P.C., a Washington, D.C. law firm concentrating on chemical, medical device, Governor of New Jersey. Previously, Fabricant and diagnostic product approval and regulation, and was the Deputy Attorney General in the associated business issues. Eileen Salathé Gernhard is Of Environmental Protection Section of the New Counsel with Bergeson & Campbell, P.C. and concentrates Jersey Division of Law. Fabricant is likely a on chemical product regulation, including antimicrobial and relative newcomer to the toxics area, but will learn pesticide product regulation. quickly by necessity.

2 Administrator Whitman s announcement of the creation of a position of Counselor to the Administrator on Agriculture Policy, and her selection of Jean-Mari Peltier to fill the post, are encouraging developments. Peltier will also serve as the primary contact for EPA cooperation and coordination with the United States Department of Agriculture (USDA). This will include working on joint policies, cooperative efforts between agency staff, and other interagency issues. The last time an official position at the EPA was geared towards advising the Administrator on agriculture issues was under the previous Bush Administration. Peltier most recently represented the California Citrus Quality Council, serving as its President since May of Prior to joining the California Citrus Quality Council, Peltier was Chief Deputy Director in the Department of Pesticide Regulation for the California Environmental Protection Agency. In addition, Peltier represented California on the implementation of FQPA through the Tolerance Reassessment Advisory Committee and represented the state at the pesticide harmonization negotiations under the North America Free Trade Agreement. Peltier s experience also includes time as the Executive Director of the California Pear Advisory Board and the President of the California Pear Growers. Peltier was a Senior Policy Analyst in the Office of Governor George Deukmejian for the California State World Trade Commission and was a Legislative Assistant for Congressman Tony Coelho, where she worked on agriculture and interior issues. Prior to joining the Congressman s staff, Peltier was the Director of Public and Government Relations for the California Grape and Tree Fruit League. Summarized below, in no particular order, are key FIFRA/FQPA issues, with a brief description of the business and legal implications of these issues. These issues include the status of multiple litigations challenging EPA s implementation of FQPA, EPA s interpretation of cumulative risk, changes in the reregistration of pesticides, and developments pertinent to antimicrobials. FQPA Litigation EPA s implementation of the FQPA has been hotly contested in multiple federal courts for over two years. Presently, three lawsuits are pending, one in the Ninth Circuit, 1 another in the U.S. District Court for the District of Columbia, 2 and a third in the Northern District of California. 3 The lawsuit commanding the most attention is the suit in the Northern District of California, which raises many substantive and procedural issues, several of which are described below. Congress enacted FQPA in While at first industry practitioners rejoiced over the demise of the much maligned Delaney Clause, that momentary jubilation was quickly replaced with a closer look at the statute and the realization that all was not well. Compounding the concern arising from the substantive changes in FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA) brought about by FQPA, was EPA s much changed administrative process by which pesticide registrations are granted, reregistrations are conducted, and risk assessments are undertaken. In particular, EPA decided to forego the more customary notice and comment Administrative Procedure Act (APA) rulemaking process for implementing FQPA, instead choosing to engage in lengthy discussions with various stakeholders and to issue science policy and guidance documents rather than rules. Under FQPA, EPA is required for the first time to make specific determinations regarding the safety of pesticide chemical residues for infants and children. Under the statute, EPA must evaluate available information in several areas. Specifically, EPA is required to look at the aggregate exposure of a pesticide. This is defined as dietary exposure, as well as exposure to the pesticide from nonoccupational sources, such as residential, home use, and animal health care products. Additionally, EPA is directed to evaluate the cumulative effects of exposure to pesticide residues and other substances that are determined by EPA to have a common mechanism of action. How EPA determines that pesticide residues and other substances share a common mechanism of toxicity and how EPA determines what a cumulative effect of exposure to 624

3 a pesticide residue is are challenging concepts that require out of the box thinking. The process that EPA has chosen to craft new science policies to accommodate these new principles is the source of considerable concern and litigation. Here is a brief rundown of the litigations that are in play now. dismiss all claims except for the Section 18 cause of action. The motion to dismiss alleges that ACPA s claims are not ripe, and that no final agency action or harm has yet occurred. 2nd Case Northern District of California 1st Case U.S. District Court for the District of Columbia The American Crop Protection Association (ACPA) and others filed suit in the U.S. District Court for the District of Columbia on June 2, The suit requests the court to: (1) update its regulations specifying the information EPA needs with respect to FQPA; (2) utilize actual data, rather than rely on defaults, theoretical models, and assumptions; (3) publish a revised schedule for tolerance reassessments; (4) issue regulations governing the issuance of FIFRA Section 18 exemptions (authorizing EPA to exempt state governments or other federal agencies from FIFRA requirements, as necessary, to control pests, protect crop loss under certain circumstances, or control the spread of disease); and (5) implement notice and comment procedures rather than informal policies in choosing a percentile of acute dietary exposure and in determining an appropriate FQPA safety factor. 4 ACPA amended its lawsuit on August 19, 1999, requesting the court to require that EPA s tolerance reassessment schedule take into consideration all of EPA s responsibilities under FFDCA pertaining to tolerance reassessment. ACPA asserted that final EPA action assessing tolerances must also comply with EPA s duty to consider the cumulative effects of exposure to compounds with a common mechanism of toxicity under FFDCA Section 408(b)(2)(D), and EPA s duty to obtain additional data that are required to support the continuation of tolerances under FFDCA Section 408(f)(1). ACPA also amended its complaint to request that when EPA implements its endocrine screening program, another statutory requirement under FQPA, it must take into account appropriate validation test systems and other scientifically relevant information. 625 The Natural Resources Defense Council, Inc. (NRDC) and six environmental organizations coplaintiffs filed suit in the Northern District of California on August 3, Plaintiffs alleged that EPA failed to reassess, as mandated by FQPA, the riskiest one-third tolerances and failed to implement an endocrine screening program by the specified statutory date. NRDC seeks an injunction ordering EPA to assess the riskiest pesticides, including all organophosphates (OPs), as quickly as possible. Environmental plaintiffs additionally seek an injunction ordering EPA expeditiously to implement the endocrine screening program proposed by EPA in the August 1998 Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) Final Report. 5 Eight days before the Clinton Administration left office, EPA advised intervenors in the action (American Farm Bureau Federation (AFBF), ACPA, and the People for the Ethical Treatment of Animal (PETA)), that it had reached an agreement with NRDC. EPA shared a copy of the agreement with intervenors, and requested comment on the lengthy document by January 17, Despite an AFBF/ACPA request for more time to comment, the court signed the Consent Decree on January 19, Importantly, the Consent Decree in many respects is as controversial and legally questionable as the issues its entry is intended to resolve. Industry intervenors, with considerable merit, assert that the Consent Decree imposes new and burdensome requirements pertinent to the reregistration of pesticides not now required under FIFRA. Other provisions appear to be inconsistent with FQPA. Comments submitted by ACPA and others address several core issues. First, the Consent Decree sets interim and final deadlines for EPA responded to ACPA s amended complaint completing the cumulative risk assessment for OPs. on September 8, EPA filed a motion to ACPA identifies in its comments 18 specific steps

4 that must be undertaken for each compound prior to conducting a cumulative risk assessment. ACPA comments express the view that these steps simply cannot be undertaken within the timeframe specified under the Consent Decree. Other comments express concern with the fact that EPA science policies have not been established through rulemaking and, as a consequence, the process and substance of EPA s science reviews are uncertain, unpredictable, and unscientifically indefensible. On February 16, 2001, industry interests filed a motion to compel publication of the proposed Consent Decree for public comment. In short, intervenors argued that they were improperly excluded from the settlement negotiations. The Consent Decree imposes new legal obligations meriting notice and comment under the APA. Moreover, intervenors asserting EPA s commitment to openness and transparency and public participation demand that public comment be allowed, and that the new Administration needs an opportunity to review the agreement. The Court granted the motion in April and allowed 60 days for public comment. While falling short of deciding that the Consent Decree imposed new regulations on registrants, the Court concurred with industry intervenor concerns that the requirements were significant and that additional public comment was needed. In response to apparent concerns that EPA believes that only the Court should consider the public comments filed on the Consent Decree, ACPA filed a legal memorandum June 1 with EPA demonstrating that EPA has the authority to withdraw from the proposed Consent Decree if comments submitted during the comment period present information showing that the public interest would not be served by entry of the Consent Decree. On June 14, the Court convened a hearing to discuss the Consent Decree and comments received on it. Briefs on the lawsuit were due on June 26, NRDC has requested an extension to submit a brief. The disposition of that motion is not known as of this writing. Because the judge hearing the case is retiring on June 30, however, it is likely that delay will occur regardless of the disposition of the matter, since a new judge must be appointed and then be brought up to speed in the case. 3rd Case U.S. Court of Appeals for the Ninth Circuit ACPA petitioned the United States Court of Appeals for the Ninth Circuit. ACPA s petition seeks relief from EPA s failure to assess one-third of all tolerances and to implement an endocrine screening program by August This case is not now active. The parties are awaiting direction from the Northern District of California before proceeding. Cumulative Risk FQPA established a stringent safety standard for pesticide residues in food (tolerances), namely that there must be a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. 6 EPA is required, when determining whether a tolerance of a pesticide chemical residue is safe, to factor into the risk assessment the cumulative effects of the pesticide residues and other substances that have a common mechanism of toxicity. 7 EPA has defined a cumulative risk assessment as the process of combining exposure (the amount of a pesticide to which an individual is exposed) and hazard (the health effects a pesticide could cause) from all substances that share a common mechanism of toxicity. 8 Issues of significant concern to industry are how cumulative assessments are to be performed, and equally importantly, the timeline for completing them, particularly whether a cumulative assessment must be completed before a tolerance is counted as reassessed under the FQPA schedule for tolerance reassessment. With regard to the OP pesticides, for example, EPA has stated that it will not count the individual OP decisions as completed REDs [Reregistration Eligibility Decisions] or tolerance reassessments until the Agency reaches a cumulative risk management decision for all the OP pesticides, as required by FQPA

5 In early 1999, EPA issued a guidance document describing its approach for identifying pesticides and other substances that cause common toxic effects by common mechanisms of action. 10 In this document, EPA defined the term common mechanism of toxicity to mean that two or more pesticide chemicals or other substances that cause a common toxic effect to human health by the same, or essentially the same, sequence of major biochemical events. 11 A common toxic effect is the same toxic effect in or at the same organ or tissue. 12 EPA stated in its guidance document that substances would not be found to have a common mechanism of toxicity unless both the target organ or tissue in the body and the mechanism of action are the same. EPA s first step in the process of identifying pesticides with a common mechanism of toxicity is the creation of a preliminary group of chemicals based upon either structural similarity, mechanism of pesticidal action, general mechanism of mammalian toxicity, or a particular toxic effect. Second, EPA states that it will conduct an in-depth review of toxicity and mechanistic data to definitively identify those substances that act by a common toxic effect. In the third step, EPA states that it will refine the group by identifying the major biochemical pathways responsible for causing the common toxic effect. Next, EPA plans to compare the identified mechanisms of toxicity for the substances in the group. Finally, EPA intends to eliminate from the group any substances that cause a common toxic effect by a different mechanism. The end result of this process is a list of candidate chemicals, called the Common Mechanism Group (CMG), for which scientifically reliable data demonstrate a common toxic effect by a common mechanism of action. 13 For each member of the CMG, EPA will perform an aggregate risk assessment an assessment of all uses of a particular pesticide before conducting the cumulative risk assessment. 14 In mid-2000, EPA issued a guidance document describing the process that is being developed for performing cumulative risk assessments. 15 EPA characterized its current process as a first generation approach that will evolve with experience and improved databases In late 2000, EPA issued a cumulative risk assessment pilot case study for 24 OP pesticides. 17 The assessment was based on the Relative Potency Factor (RPF) approach, using both the 10% effective dose (ED 10 ) and the no observed adverse effect level (NOAEL), based on plasma cholinesterase inhibition in male rats by the oral route. EPA included in the risk assessment only those foods (or reasonable surrogates) monitored by the United States Department of Agriculture s (USDA s) Pesticide Data Program (PDP) over the years Only data from composite samples were used, and the assumption was made that pesticides with no entries in the PDP database had zero residues. The geographic area was limited to the Piedmont area of Virginia, North Carolina, and South Carolina. The assessment considered two exposure groups children 1-3, and adults 18 and older. EPA displayed the results of the analysis as margins of exposure (MOEs) for the various pathways, routes, and total exposures over the course of a year. An important conclusion reached by the analysis is that the selection of an appropriate point of departure is critical. In particular, with the OPs, the use of the oral NOAEL, compared to the ED 10, significantly changed the relative risk contribution of oral exposure by dietary and non-dietary sources. The pesticide industry provided extensive comments to EPA pointing out many significant problems with EPA s cumulative risk assessment approach, and its OPs case study. Specifically, ACPA; the FQPA Implementation Working Group (IWG), a coalition of farm, food, pest management, manufacturing, and consumer protection and health benefit industry organizations; and the American Chemistry Council, among others, all submitted extensive comments on EPA s Cumulative Risk Assessment Guidance, and ACPA and IWG submitted comments on the OP pilot case study. As discussed above, the tolerance reassessment process is subject to much litigation, including the two suits against EPA. In the first, Natural Resources Defense Council v. Whitman, filed in the U.S. Court of Appeals for the Ninth Circuit, plaintiffs challenged EPA s progress in meeting pesticide reregistration responsibilities. 18 In the

6 second, filed in the U.S. District Court for the Northern District of California, plaintiffs challenged EPA s compliance with deadlines for tolerance reassessment and establishing an endocrine disruptor screening and testing program. 19 ACPA and the Farm Bureau intervened in both cases. 20 The draft Consent Decree resolving the issues in the California District Court case, Natural Resources Defense Council v. Whitman discussed above would require EPA to determine by specified dates whether pesticides in certain listed groups share a common mechanism of toxicity. The listed groups, and decision dates, are methyl carbamates (June 30, 2001); thiocarbamates and dithiocarbamates (December 31, 2001); chloroacetanilides (June 30, 2001); and triazines (March 31, 2002). 21 EPA also would be required to conduct and solicit public comment on a preliminary cumulative risk assessment for the OP pesticides by December 1, 2001, and conduct a revised cumulative risk assessment for the OP pesticides within 240 days of the preliminary risk assessment. 22 deadlines for reassessment that EPA staff now are working hard to meet industry fears may be realized. This will be particularly true if EPA continues to take the position under this Administration, as it did under the past Administration, that a tolerance does not count as being reassessed for purposes of the FQPA deadlines unless it has been the subject of a cumulative risk assessment. Many in industry believe that EPA should abandon this position for what they believe is a more reasonable interpretation of the statute that would count an assessment as complete when the individual aggregate assessment is complete The stance of the new Administration on this issue is unclear. Administrator Whitman made a very public expression of support for the NRDC Consent Decree and its deadlines in the 100 Days Accomplishment Report published on EPA s website. 23 Whether with the delay in the suit now being experienced there is opportunity for industry to persuade the Whitman Administration of what they believe is a more reasonable pathway forward remains to be seen. Although many within industry and EPA believe that the first actual cumulative risk assessment conducted that for the OPs may not result in an additional loss of significant uses, there is considerable concern in industry that this will not be the case for subsequent groups of pesticides that undergo the process. They believe that the timeframes for completing the assessments are too tight to allow EPA to develop and implement scientifically sound and defensible procedures and assumptions for an adequate cumulative risk assessment. Even assuming that the use of overly conservative assumptions and default values, and an inadequately developed assessment process would not affect the OPs to any significant degree a far from certain assumption itself the fear is that the use of these flawed assumptions, values, and processes will have dramatic adverse effects on subsequent groups undergoing a cumulative assessment. The outcome of the proposed Consent Decree will affect the pathway forward on cumulative assessments. If EPA is bound to the deadlines in the Consent Decree which are tied to the statutory environmental effects; and to determine whether the 628 Reregistration of Pesticides FQPA amended the process established by the 1988 FIFRA amendments for reviewing pesticides containing active ingredients (AIs) that were initially registered before November 1, 1984, to determine if the pesticides should continue to be registered in light of current data and safety standards. 24 This process, called reregistration, considers the human health and ecological effects of pesticides and results in actions to reduce risks that are of concern. 25 EPA is currently in the last phase of the reregistration process established by the 1988 FIFRA amendments, and is reviewing studies submitted by registrants to decide whether to reregister products containing the AIs reviewed. EPA publishes its decision to reregister a pesticide in a RED, and announces the availability of the RED in the Federal Register. 26 The purpose of the review that results in the RED is to reassess the potential hazards arising from currently registered uses of the pesticide; to determine the need for additional data on health and

7 pesticide meets the no unreasonable adverse effects criterion of FIFRA. REDs must be based on a thorough examination of all data submitted on the pesticides at issue and the review must be conducted within one year after the submission of all applicable data. 27 REDs also must adequately assess the elements of the new safety standard established by FQPA. REDs state whether, and under what conditions, the pesticides discussed in the RED may be reregistered, and may include statements that registrants of those pesticides are required to include on the pesticide label. The RED includes requirements for product-specific data and/or generic data on the AI, if necessary, before a product can be eligible for reregistration. EPA has issued REDs covering over 200 AIs. Copies of REDs are available from the National Technical Information Service or on the Internet. 28 EPA has integrated its reregistration process with tolerance reassessments under the new FQPA standards. 29 FQPA requires EPA to review by 2006 the safety of all existing tolerances and exemptions established prior to FQPA s enactment in mid-1996, concentrating on the tolerances or exemptions that appear to pose the greatest risk to public health first. 30 In its review of these tolerances and exemptions, EPA is required to review 33 percent of applicable tolerances by August 1999, 66 percent by August 2002, and 100 percent by August FQPA also required EPA to publish a schedule of its reassessments. 32 EPA satisfied this latter requirement by publishing on August 4, 1997, a Federal Register notice placing all pesticides into one of three priority groups. 33 EPA has made OPs its first priority group of pesticides for review, and stated that it hoped to complete the tolerance reassessment for OPs in the first three years, a goal it did not meet. 34 By uniting the two processes tolerance reassessment and reregistration EPA has broadened significantly the opportunity for public comment, and, many in industry believe, the opportunities for the public release of flawed draft EPA documents. Moreover, because pesticides with a common mechanism of toxicity are considered during a cumulative risk assessment, a RED that, on its face, may not impose significant and/or FQPA tolerance reassessment decisions on 629 changes, may nevertheless have adverse implications for the products it addresses in a future cumulative risk assessment. It is thus essential to monitor closely all REDs that are issued; even if they do not themselves reach adverse decisions about a pesticide, any flawed assumptions, models, or data could carry over to a cumulative risk assessment, with potentially disastrous consequences. With the FQPA amendments, EPA developed two new types of REDs interim REDs (IREDs) and tolerance reassessment eligibility decisions (TREDs) that pose the same issues as REDs with respect to early public availability and, many in industry believe, potential for damage in a cumulative risk assessment. EPA issues IREDs for pesticides undergoing reregistration that require a cumulative risk assessment under FQPA essentially an assessment of the combined risks of all pesticides in a group designated by EPA as having a common mechanism of toxicity. The IRED is issued after completion of the aggregate risk assessment essentially an assessment of all uses of a particular pesticide. The IRED may include taking risk reduction measures, for example, reducing risks to workers or eliminating uses that the registrant no longer wishes to maintain, to gain the benefits of those changes before the final RED can be issued after the cumulative assessment. 35 EPA prepares a TRED for a pesticide that requires a tolerance reassessment decision, but is not subject to reregistration at present because: (1) it was registered after November 1, 1984 (the date that triggers the reregistration requirement); (2) EPA completed a RED before FQPA was enacted; or (3) it is not registered for use in the U.S. but import tolerances have been established. A TRED is a report on FQPA tolerance reassessment progress and Interim Risk Management Decisions. Like IREDs, TREDs become final after EPA completes its cumulative assessment for all relevant pesticides to that assessment. 36 Both IREDs and TREDs, and the process used to develop them, have been the subject of a pilot program intended to facilitate greater public involvement and participation in the reregistration

8 pesticides. EPA is now beginning to apply this process to REDs generally. This process is not set forth in a rule and is subject to much discretion by EPA. EPA has applied the process more formally to OPs undergoing preliminary risk assessments. EPA has attempted in a number of recent RED proceedings to apply the OP process to REDs, with the result of making public much earlier in the process than previously EPA s draft risk assessment conclusions. Because registrants often have grave concerns with the results of EPA reviews that have not undergone registrant review and comment, the publication of the EPA results can have grave consequences for products. Currently, eight pesticides are candidates for FY2001 REDs, 19 pesticides are candidates for IREDs, and eleven pesticides (including four OPs) are candidates for TREDs. 37 Many of those candidates are listed in the schedule in the proposed Consent Decree in California District Court, which would require EPA to issue IREDs or final REDs for specific pesticides by dates ranging from August 31, 2001, to June 30, 2003, and a revised risk assessment for one chemical by August 31, Antimicrobials in making non-pesticidal label changes, accelerate the registration and amendment of antimicrobials, and coordinate federal and state data requirements. FQPA also requires EPA to establish by rule procedures for the registration of certain antimicrobial pesticide products. On September 17, 1999, EPA proposed its registration requirements for antimicrobial pesticide products that will be codified in a separate subpart to 40 C.F.R. Part 152 devoted to antimicrobial registration procedures new Subpart W, entitled Registration of Antimicrobial Products. 42 EPA s proposed registration requirements for antimicrobial pesticides differ in some respects from registration requirements of other pesticides. These differences occur in part because the pests are themselves invisible disease-causing microbes, rather than insects or rodents that may be harboring disease organisms. 43 Further, evaluating human and ecological risks from exposure to antimicrobial pesticides requires a different approach than the approach needed for pesticides largely applied to crops and other plants. 44 According to the regulatory agenda, the new subpart is scheduled to be issued in final September Treated Articles Data Issues FIFRA, as amended by FQPA, defines antimicrobial as a pesticide that is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime. 39 Antimicrobial pesticides also must in the intended use, be exempt from, or otherwise not subject to, a tolerance under FFDCA Section 408 or a food additive regulation under FFDCA Section Certain pesticide wood preservatives or antifouling paint products, agricultural fungicide products, and aquatic herbicide products also are excluded from In early 2000, EPA issued guidance with respect the definition of antimicrobial pesticide. 41 to the scope of the treated article exemption. 47 In the guidance, EPA provides examples of claims and FQPA requires EPA to reform the antimicrobial terms that are consistent with the treated article pesticide registration process to permit greater ease exemption. 48 An article or substance not meeting 630 FIFRA regulations state that certain articles or substances treated with, or containing, a pesticide to protect the integrity of the article or substance itself are exempt from FIFRA and need not be registered as pesticides, where threshold criteria are met. First, the pesticide used to treat the article must be registered for that use, and second, the claims must be limited to the protection of the article itself. 46 Paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation may be considered treated articles. In contrast, paint treated with a pesticide to protect the surface that is being painted is not a treated article, because the article itself the paint is not what is intended to be protected.

9 the conditions of the exemption must be registered as a pesticide product and meet all registration requirements. Since the issuance of the guidance, there has been concern that treated article intermediate products" may not be considered by EPA to be exempt from registration. Treated article intermediate products are materials treated with a pesticide registered for such use that are further made into other treated article intermediate products or into treated article end-use products. EPA stated in an April 12, 2001, letter that, assuming such products meet the regulatory criteria, they are not subject to registration requirements. 49 Pentachlorophenol (PCP) The Toxicological Review of PCP, a preliminary document in support of information on the Integrated Risk Information System, was recently issued. 50 Comments will be considered if received by EPA by June 30, PCP and two other major wood preservatives, creosote and inorganic arsenicals (CCA-treated wood), have been subject to a great deal of attention lately, due to publicity regarding EPA s concerns about adequate availability of consumer information sheets on the safe use and handling of CCA-treated wood to consumers purchasing CCA-treated wood products. 52 Notes 1 United Farm Workers v. Browner, No (9th Cir.) 2 American Farm Bureau v. EPA, 121 F.Supp.2d 84 (D.D.C. 2000). 3 National Resources Defense Council v. Whitman, No. C (N.D. Cal.). 4 On July 29, 1999, the industry lawsuit was amended to add the names of seven additional coplaintiffs. Co-plaintiffs include ACPA, the American Farm Bureau Federation, Agricultural Retailers Association, American Agri-Women, California Citrus Mutual, Chemical Producers and Distributors Association, Georgia Peanut Producers Association, International Sanitary Supply Association, Kansas Fertilizer and Chemical Association, Michigan Agri-Business Association, Mid-America Crop Protection Association, National Association of Wheat Growers, National Grain Sorghum Producers, Southern Crop Protection Association, United Fresh Fruit and Vegetable Association, Western Crop Protection Association, Western Grower s Association, Chemical Manufacturers Association, (now American Chemistry Council), Michigan Bean Commission, National Agricultural Aviation Association, National Pest Control Association, Oregon for Food and Shelter, Women Involved in Farm Economics, and Wyoming Ag Business Association. 5 On August 11, 1998, EPA published a Federal Register notice announcing the development of an Endocrine Disruptor Screening Program (Screening Program). 63 Fed. Reg The Screening Program, required by the FQPA and the Safe Drinking Water Act Amendments of 1996 (SDWA), is intended to determine which pesticide chemicals and other substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. EPA plans to publish another Federal Register notice regarding the operational and implementation details of the Screening Program, and will provide an opportunity for public comment at that time. The Screening Program is an ambitious and potentially costly program which may trigger testing requirements for a large number of chemicals. The structure of the Screening Program is derived, in large part, from the recommendations of EDSTAC, which EPA created to assist it in developing a Screening Program. In the final draft report EDSTAC submitted to EPA, EDSTAC 631

10 estimated that 86,000 chemicals could be subject to the Screening Program. EDSTAC also estimated that the costs of the testing assays could range from $400,000 - $700,000 for the first phase of testing, to $1-2 million for the second phase of testing. 6 FFDCA 408(b)(2)(A), 21 U.S.C.A. 346a(b)(2)(A). 7 FFDCA 408(b)(2)(C)(i)(III) and (b)(2)(d)(v), 21 U.S.C.A. 346a(b)(2)(C)(i)(III) and (b)(2)(d)(v). 16 at EPA OPP, Cumulative Risk: A Case Study of the Estimation of Risk from 24 Organophosphate Pesticides (Nov. 9, 2000), at scipoly/sap/2000/december/sap_casestudy2.pdf. 18 EPA OPP, EPA Agrees to Settle Lawsuits on Implementing Certain Provisions of the Food Quality Protection Act, at 1 (last updated May 15, 2001), at /nrdcfacts.htm (EPA Agrees to Settle). 8 EPA OPP, Questions and Answers, Proposed Guidance on Cumulative Risk Assessment of Pesticide Chemicals that Have a Common Mechanism of Toxicity, at 1 (July 2000), at on at 2. 9 EPA OPP, Reregistration Eligibility Decisions Projected for FY 2000 FY 2001 (June 2000), at mingreds.htm. 10 EPA OPP, Guidance for Identifying Pesticide Chemicals That Have a Common Mechanism of Toxicity, for Use in Assessing the Cumulative Toxic Effects of Pesticides (Jan. 29, 1999), at on. 11 at EPA, The First 100 Days: January 20 to April 30, 2001 (Apr. 27, 2001) (EPA Headquarters Press Release). 24 Those pesticides for which EPA previously determined that there were no outstanding data requirements and that the registration requirements had been met need not be reregistered. FIFRA 4(a), 7 U.S.C. 136a-1(a). 25 EPA OPP, Pesticides Tolerance Reassessment and Reregistration (last updated March 16, 2001), at (Pesticide Tolerance Reassessment). 12 at See id. 13 EPA OPP, Proposed Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity, at 3 (June 22, 2000), at on (Proposed Cumulative Risk Guidance) See id. generally. 27 FIFRA 4(g)(1), 7 U.S.C.A. 136a-1(g)(1). 28 EPA OPP, Candidates for Reregistration Decisions in FY2001, at ates.htm (Candidates for Reregistration Decisions). 29 See Pesticide Tolerance Reassessment. 632

11 30 FFDCA 408(q), 21 U.S.C.A. 346a(q); 62 Fed. Reg , (Aug. 4, 1997); Tolerance Reassessment, EPA OPP (last updated March 22, 2001), at (Tolerance Reassessment) FFDCA 408(q), 21 U.S.C.A. 346a(q). 33 See 62 Fed. Reg. at 42019; Tolerance Reassessment. 34 See 62 Fed. Reg. at ( EPA has placed into Group 1 those tolerances and exemptions associated with the following types of pesticides, which based on the best available information to date appear to pose the greatest risk to the public health: (1) Pesticides of the organophosphate, carbamate, and organochlorine classes (it is EPA s intent to conduct tolerance reassessments for organophosphate pesticides in the first three years of the schedule). (2) Pesticides that EPA has classified as probable human (groups B1 and B2) carcinogens, and possible human (group C) carcinogens for which EPA has quantified a cancer potency See Candidates for Reregistration Decisions in FY EPA OPP, Antimicrobial Pesticides (July 7, 2000), (Antimicrobial Pesticides). 44 at 1. Indeed, EPA recently made available Standard Operating Procedures (SOPs) for antimicrobial testing methods. See, e.g., Microbiology Laboratory Antimicrobial Testing Methods & Procedures, EPA OPP (last updated May 18, 2001), at m Fed. Reg (May 14, 2001). A pesticide registration kit containing links to important documents for registering a pesticide but not reflecting the draft rules specific to antimicrobials is available on EPA s website. See 46 See 40 C.F.R U.S. EPA, Applicability of the Treated Articles Exemption to Antimicrobial Pesticides (PR Notice ) (Mar. 6, 2000); see also Questions & Answers: Applicability of the Treated Articles Exemption to Antimicrobial Pesticides (Feb. 2000), available at m See PR Notice See EPA Agrees to Settle. 39 FIFRA 2(mm); EPA OPP, What Are Antimicrobial Pesticides? (July 3, 2000), at (What Are Antimicrobials) FIFRA 2(mm) Fed. Reg (Sept. 17, 1999) (proposed antimicrobial registration requirements). 49 Letter from Frank Sanders, EPA Antimicrobials Division, to Mr. James P. Palmquist, Chairman, Antimicrobial Treated Article Coalition (Apr. 12, 2001). 50 EPA OPP, US EPA Toxicological Review of Pentachlorophenol (Oct. 16, 2000), at pdf. 51 at i. 52 EPA OPP, Chromated Copper Arsenicals (CCA) and Its Use as a Wood Preservative (last updated May 24, 2001), at 633