Office of Pesticide Programs Biennial Report for FY 1998 and 1999

United States Prevention, Pesticides, EPA 735-R-99-002 Environmental Protection And Toxic Substances December 1999 Agency (7506C) Office of Pesticide Programs Biennial Report for FY 1998 and 1999

Printed on Recycled Paper Office of Pesticide Programs Biennial Report

Fiscal year 1 998 and 1 999

United States Environmental Protection Agency Office of Pesticide Programs (7506C)

Foreword by MARCIA E. MULKEY, Director Office of Pesticide Programs

The Office of Pesticide Programs (OPP) is pleased to provide you with a summary report regarding many of the important activities carried out by the Program during 1998 and 1999. Clearly, the Food Quality Protection Act (FQPA) of 1996 has resulted in fundamental changes to the way pesticides are regulated in our country–providing the Agency with new tools and standards for assessing and reducing potential risks from pesticides, especially to children. This has been a

▼ remarkable period of time in OPP’s history and one in which we've made tremendous progress not only in implementing FQPA but also in carrying out our many other important regulatory ...the Food Quality responsibilities. Protection Act of Throughout the past two years, the program has made great strides in increasing transparency 1996 has resulted in and stakeholder consultation in all of its activities, including, for example, developing and fundamental changes revamping many key science policies and working with the Tolerance Reassessment Advisory to the way pesticides Committee (TRAC) to develop and implement the pilot process for public involvement in assess- are regulated in our ing and managing risk from organophosphates. Significantly, the program met the first tolerance country... reassessment deadline in FQPA by completing over 33% by August 3, 1999, with 3,430 tolerances reassessed. Progress is not always about achieving higher numbers. While over the last two years, we exceeded our historic performance by registering 53 new active ingredients, it is important to note that we are continuing to bring to market higher numbers of “safer” or “reduced risk” conventional products. These products will continue to replace older, more toxic chemicals and thus help reduce potential risks from pesticides. Incorporating FQPA’s new safety standard, we also completed 1,046 emergency exemption decisions and achieved significant risk reductions through the completion of 27 Reregistration Eligibility Decisions in 1998 and 1999. In virtually all areas involving routine registration actions, we substantially reduced or eliminated backlogs. Working with our regional, state and tribal partners, OPP made progress in implementing worker protection programs, reassessing the applicator certification and training programs, and advancing many other field programs–all described more fully in this report. We also remain strongly committed to expanding the public’s right to know through website development, communication activities and stakeholder involvement. I hope you will take a few moments to review our Biennial Report for 1998 and 1999. Let’s also look ahead with a commitment to make even more progress together in safeguarding public health and the environment from pesticide risks. PAGE Contents

OPP BIENNIAL REPORT FY 1998 AND 1999

7 OPP At A Glance ▼ The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) The Federal Food, Drug, and Cosmetic Act (FFDCA) Pesticide Time Line OPP’s Structure How to Reach the Office of Pesticide Programs on the Internet Registration

▼ 11 Registering New Active Ingredients in Pesticide Products Approving “Other Ingredients” in Pesticide Products Registering Antimicrobial Pesticide Products Focusing on Public Health Pesticides Supporting Minor Crops and Public Health Pesticides

15 Reregistration

▼ Achieving Risk Reduction through Reregistration Establishing Stakeholder Process During Pesticide Reregistration Reviews

17 Tolerance Reassessment

▼ Reassessing Tolerances Establishing the Tolerance Reassessment Advisory Committee (TRAC) Publishing Tolerance Processing Fees Rule Proposed 20 Sound Science ▼ Developing New Science Policies Improving Our Protection for Infants and Children Expanding Our Understanding of Endocrine Disruptors Protecting Human Test Subjects Understanding and Predicting Spray Drift Identifying and Developing Ecological Risk Assessment Methods Improving Drinking Water Exposure Assessments Developing an Aggregate Exposure and Risk Assessment Tool: Hampshire Research Institute’s (HRI) Lifeline Software Model Collecting Pesticide Use Information

24 Partnerships ▼ Providing Support for Regional Initiatives Developing Stakeholder Partnerships Partnering with States and Other Agencies Coordinating International Activities

29 Field Programs ▼ Focusing on the Endangered Species Protection Program Developing the Ground Water Pesticide Management Plan Program Preventing Pesticides in the Environment through Container and Containment Standards and Support of Collection Programs Developing Tribal Initiatives and Programs Supporting Agricultural Workers Developing an Interagency Initiative: Pesticides and the National Strategies for Health Care Providers

33 Right to Know ▼ Expanding Pesticide Education and Outreach Materials to the Public Providing Toll-Free Access to Pesticides Information

36 Appendices ▼ ▼ The mission of the Office of Pesticide Programs (OPP) is to protect human health and the environment from unreasonable adverse effects resulting from the use of pesticides and to assure that there is a reasonable certainty of no harm from pesticides in the diet of all Americans, especially children. OPP at a Glance ▼ Our regulatory decisions affect HE MISSION OF THE OFFICE OF PESTICIDE PROGRAMS (OPP) IS TO PROTECT approximately: human health and the environment from unreasonable adverse effects resulting from the ▼ T use of pesticides and to assure that there is a reasonable certainty of no harm from pesticides in the diet of all Americans, especially children. OPP regulates pesticides under two major 30 major pesticide federal statutes: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal producers plus Food, Drug, and Cosmetic Act (FFDCA), both significantly amended by the Food Quality Protection Act of 1996 (FQPA). another 100 small The Federal Insecticide, Fungicide, • Restrictions – certain high risk pesticides are producers and Rodenticide Act (FIFRA) restricted for use only by trained and state-certified ▼ applicators. FIFRA is a product licensing statute. Many provi- • Enforcement – FIFRA contains enforceable provi- 2,500 pesticide sions of FIFRA provide regulatory tools for OPP to use sions on the manufacture, sale, distribution, and to fulfill the intent of the law: use of pesticides (Section 18’s). formulators • Registration – pesticide products for use in the U.S. • Emergency exemption authority – in certain emer- ▼ generally must be registered or licensed by EPA gency cases, FIFRA permits approval of unregis- based on a scientific evaluation prior to manufac- tered uses of registered products on a time-and 29,000 ture, transport, and sale. geographically-limited basis. • Labeling – all pesticide products must have a label • Reregistration – all pesticides registered before distributors that describes, among other things, the content, November 1, 1984, must be reevaluated to ensure ▼ directions for use, safety precautions, and disposal that they meet today’s more stringent safety requirements. standards. 40,000 • Data-Call-In – since 1978, FIFRA has provided • Registration review – after EPA completes the strong authority to require data (results from pesti- reregistration process, FIFRA requires the Agency commercial pest cide testing) enabling OPP to evaluate the safety of to establish a registration review program through control firms pesticide products. which all pesticide registrations will be reviewed periodically in light of new standards and ▼ information. • Suspension or cancellation – through the appeals 1 million farms and adjudicatory processes, some or all of a pesti- ▼ cide product’s uses can be suspended or canceled to prevent unreasonable adverse effects. 3.5 million • Antimicrobials program – FIFRA requires OPP to review antimicrobial actions within prescribed farm users time-frames. Antimicrobial products are used to ▼ control germs such as bacteria and fungi (molds and mildews) that can cause infections, food several million spoilage and odors. • Minor use program – FIFRA requires EPA to estab- industry and lish a program that gives special consideration and government users support to minor uses of pesticides, which may be of low value to pesticide producers but high value ▼ to farmers. Most fruits and vegetables are grown with “minor use” pesticides. 90 million households OPP AT A GLANCE OPP AT

FY 98-99 OPP BIENNIAL REPORT 7 ▼ The Federal Food, Drug, and • Cumulative risk and common mechanisms of toxic- Cosmetic Act (FFDCA) ity- EPA must consider the cumulative effects of ▼ related pesticides that share common mechanisms FFDCA provides the Office of Pesticide Programs of toxicity. 1906 with the authority to set tolerances (maximum allow- • Benefit-based tolerances – under very limited con- the Pure Food Law able residue levels) for pesticides in or on foods and ditions, EPA may retain a tolerance for a pesticide (FFDCA) set labeling animal feed. Key elements of FFDCA include: that does not meet the new safety standard if it is deemed to be in the public interest. standards for • Tolerance reassessment – all tolerances that were in place as of August 1996 must be reassessed – 33% • Right To Know – the Agency must develop infor- truthful labeling by August 1999; 66% are due by August 2002; and mation to educate the public about the risks and ▼ all must be completed by August 2006. benefits inherent in using pesticides on foods. EPA 1910 • Reasonable certainty of no harm safety standard – must also list any tolerances that are set based on FFDCA now includes a health-based safety standard benefits considerations, and explain ways con- the Insecticide Act for pesticide residues in both raw and processed sumers may reduce their exposure to pesticides in (early FIFRA) was a foods. “Reasonable certainty of no harm” is now or on food. consumer protection the general safety standard, both for tolerances • Endocrine disruptors – because of concern from human exposure to chemicals that may disrupt the law intended to under FFDCA and registration of pesticides with food uses under FIFRA. endocrine hormone system, EPA must develop an prevent the • Special protection of children – EPA must make an endocrine disruptor screening and testing program manufacture, sale, explicit determination that tolerances are safe for to evaluate potential adverse effects. or transportation children. EPA must apply an additional ten-fold safety factor, unless there is sufficient reliable infor- of products that do mation to support application of a different safety not work factor. ▼ • Aggregate risk – pesticide risk assessments must 1947 consider all sources of non-occupational exposures (i.e., dietary, drinking water, and residential expo- FIFRA enacted sures). ▼ 1954 FDA gained the authority to establish pesticide tolerances ▼ 1958 Delaney clause added to FFDCA ▼ 1964 FIFRA amended to give USDA authority to refuse registration for unsafe as well as ineffective pesticides OPP AT A GLANCE OPP AT ▼ 8 FY 98-99 OPP BIENNIAL REPORT OPP’s Structure ▼ The Office of Pesticide Programs (OPP) is divided into nine divisions and a resource manage- 1970 ment staff, employing nearly 900 scientists, administrative and regulatory personnel. For more pesticide regulation information on OPP’s structure, please refer to List 4 in the Appendix and visit our website at http://www.epa.gov/pesticides. transferred from USDA to the newly Office of the Resource Director (OD) Management established EPA Staff (RMS) ▼ 1972 Senior Science Advisor Budget and Minor Use Officer Personnel FIFRA amended to Deputy Director for consider risks and Pesticide Programs benefits of pesticides Deputy Director for Pesticide rather than efficacy Program Management ▼ 1974 EPA sets the first Antimicrobial Special Review Registration Biopesticides standard for worker Division (AD) and Division (RD) and Pollution reentry into treated Reregistration Prevention fields Risk Assessment Division (SRRD) Risk Management Division (BPPD) and Management ▼ Risk Management Risk Assessment 1978 and Management FIFRA amended; allowed for conditional registration; gave manufacturers Health Effects Environmental ten year rights Division (HED) Fate and Effects Division (EFED) to data ▼ Risk Assessment Risk Assessment 1984 EPA publishes extensive data testing requirements in 40 CFR Part 158–pesticide companies now Biological and Field and Information have to perform Economic External Affairs Resources and numerous hazard Analysis Division (FEAD) Services and exposure testing Division (BEAD) Division (IRSD) Field Programs studies prior to Usage Data Policy and Information applying for a Benefits Analysis Regulation Support Management and registration Chemistry Labs Communications Systems Support OPP AT A GLANCE OPP AT

FY 98-99 OPP BIENNIAL REPORT 9 ▼ How to Reach the Office of Pesticide Programs on the Internet http://www.epa.gov/pesticides ▼ Office of Pesticide Programs new Websites developed in 1998 and 1999: 1988 Sign up for Electronic Updates from the Office of Pesticide Programs at: FIFRA amended http://www.epa.gov/oppfead1/cb/csb_page/form/form.html and required Learn about OPP’s fiscal year 1999 (FY99) work plan registering re-registration new conventional pesticides in the registration pipeline at: program be http://www.epa.gov/opprd001/workplan/ established to Explore conventional chemical specific fact sheets at: review chemicals http://www.epa.gov/opprd1/factsheets/ registered prior Explore OPP’s Ecological Risk Assessment Page at: to 11/84 http://www.epa.gov/oppefed1/ecorisk/ ▼ Check on the status of FQPA Science Policy Issues 1996 & Guidance Documents at: FQPA established a http://www.epa.gov/oppfead1/trac/science/ single, health-based Review EPA’s data (crop by crop) organophosphate use standard for being used in assessments at: pesticides used on http://www.epa.gov/oppbead1/matrices/ food crops; added Learn how health care providers can become more aware protection for and of pesticide health issues at: infants and children http://www.epa.gov/pesticides/safety/healthcare/healthcare.htm ▼ Visit our Pesticide Program Dialogue Committee (PPDC) website at: 1998 http://www.epa.gov/pesticides/ppdc Pilot process for Visit our Tolerance Reassessment Advisory Committee (TRAC) website at: organophosphate http://www.epa.gov/oppfead1/trac/ risk assessments Learn more about EPA’s program to register biopesticides at: initiated http://www.epa.gov/pesticides/biopesticides/ ▼ Review OPP’s 3-year Progress Report on FQPA implementation at: 1999 http://www.epa.gov/oppfead1/fqpa/fqpareport.pdf Met first tolerance Examine the official docket for chemicals under reassessment review in the organophosphate tolerance reassessment process at: deadline and http://www.epa.gov/pesticides/op/ canceled significant Exercise your right to know about food uses of two pesticides and your food at: organophosphate http://www.epa.gov/pesticides/food/ pesticides The Office of Pesticide Programs may also be reached by writing to: 401 M St., S.W. Mailcode 7506c Washington, D.C. 20460 Or you can visit our offices at: 1921 Jefferson Davis Hwy., CM#2 Arlington, VA (703) 305-5017 OPP AT A GLANCE OPP AT ▼ 10 FY 98-99 OPP BIENNIAL REPORT Registration ▼ To move less risky pesticides into the PPROXIMATELY 20,000 PESTICIDE PRODUCTS ARE CURRENTLY REGISTERED marketplace quickly, or licensed for use in the U.S. Pesticide products are used in or on food, around homes, A businesses, schools, hospitals, and in parks. Before EPA will register a pesticide prod- we placed high uct for sale and use, we evaluate test data on all of its ingredients. The test data, which include priority on reviewing studies on the effects the product will have on humans, wildlife, fish, and plants (including endangered species), are provided by the registration applicant (known as the registrant). these applications. Depending on the type of pesticide, a registrant may be required to generate data from as many as 100 different tests in order for us to determine the product’s safety. Pesticides which are cru- cial to public health, such as hospital disinfectants and tuberculocides, are tested in EPA’s Office of Pesticide Program’s Microbiology Laboratory to ensure that they work as claimed. Registering New Active for “reduced-risk” status if they have at PROPORTION OF NEW Ingredients in Pesticide Products least one or more of the following charac- ACTIVE INGREDIENTS teristics: CONSIDERED SAFER During the last two years, OPP made significant progress in • low risk to human health; IN FY 1998-1999 registering new pesticides. In 1998, the Agency registered 27 • low toxicity to non-target organisms; new pesticide active ingredients and in 1999, we registered 26 • low ground water contamination new pesticide active ingredients. More than half of these new potential to contaminate ground water, pesticide registrations were for biopesticides and “reduced surface water, or other valued environ- OTHER risk” conventional pesticides which pose less risk than the mental resources; PESTICIDES– more toxic conventional pesticides registered years ago. • broaden the adoption and effectiveness SAFER 20 Biopesticides include “microbial pesticides” (bacte- of integrated pest management PESTICIDES– 33 ria, viruses, or other microorganisms used to control strategies. pests); “biochemical pesticides,” such as pheromones To move these less risky pesticides into (compounds that disrupt the mating behavior of the market-place more quickly, we placed insects); and plant pesticides, substances that plants high priority on reviewing these applica- produce from genetic material that has been added to tions. Registration decisions for conven- the plant. New conventional pesticides are considered tional “reduced risk” pesticides and

EPA Sought Public on our risk and bene- effects. Chlorfenapyr birds. For these rea- sion-making. The and Scientific fits assessments prior is the first pyrrole sub- sons–and our limited Agency also consulted Comments on New to making any regula- mitted for U.S. regis- experience with with the U.S. Fish and Pesticide– tory decision through tration. Chlorfenapyr pyrroles–we believe Wildlife Service, Chlorfenapyr a Federal Register has clear economic this chemical presents solicited external (Pirate) Notice and the benefits to the cotton special issues for pes- scientific peer review Internet. Chlorfenapyr industry because it ticide regulation. on our ecological risk PP took ground- is a member of a new can play an important Accordingly, in 1999 assessment, and will Obreaking steps in class of chemical role in controlling sev- we took this extra consider the alterna- 1999 in order to compounds known as eral important cotton step of seeking public tives and their effec- inform OPP’s registra- ‘pyrroles’–a class pests. However, comment, of a specif- tiveness as part of the tion decision-making which has a unique chlorfenapyr appears ic nature, on this decision-making process for the new mode of action, clear to be persistent in the chemical’s human process. chemical compound, economic benefits to environment, and health and ecological chlorfenapyr. The the cotton industry, studies show a poten- risk and benefit Agency sought public and data indicating tial adverse impact to assessments before comment and input avian reproductive wildlife, particularly any regulatory deci- REGISTRATION

FY 98-99 OPP BIENNIAL REPORT 11 ▼ biopesticides were generally made in half the time that were no longer in use from the list of “other ingredi- it takes for other conventional pesticides. We also ents” permitted for use in pesticide products which expedited the introduction of organophosphate alter- were no longer in use. In June 1999, EPA removed 12 natives into the marketplace. additional chemicals, all considered toxic and listed on the OPPT Toxics Release Inventory. As a result, regis- Approving “Other Ingredients” in trants wishing to include these chemicals as “other Pesticide Products ingredients” in pesticide formulations need to satisfy the data requirements for new other ingredients, as if Pesticide products contain “active” ingredients to the chemicals had never been used before. prevent, destroy, repel or mitigate a pest. By law, the EPA also took action to remove formaldehyde as an active ingredient must be identified by name on the approved “other ingredient” in pesticide products. In label together with its percentage by weight. “Other response to this initiative, manufacturers of pesticide ingredients” in pesticide products are not intended to products that contained formaldehyde as an “other affect a target pest, but are used to help, among other ingredient” agreed to cancel or reformulate their prod- things, formulate, stabilize, or disperse the product. ucts, thereby eliminating this chemical as an “other Before 1997, these other ingredients were known as ingredient.” “inert ingredients.” The law does not require other ingredients in pesticides to be identified by name and Registering Antimicrobial Pesticide percentage on the label unless they are of toxicological Products concern. Over the past two years, OPP approved 210 of these In 1998 and 1999, we continued to improve our kinds of “other ingredients” in pesticide products. Antimicrobials Program. Antimicrobial pesticides are These ingredients are safer than many of the older used to control harmful microorganisms including ingredients of this type. At the same time, the Agency bacteria, viruses, or fungi in or on inanimate objects continues to review existing “other ingredients.” In the and hard surfaces. Antimicrobial products include summer of 1998, EPA removed 249 chemicals which sterilants, disinfectants, and sanitizers, as well as swimming pool chemicals, wood preservatives, and antifoulant paints. Approximately 1,000 antimicrobial EPA’s Review of “other ingredients” icological concern. pesticide products are registered for use on food and “Other Ingredients” available and requires List 2: Potentially food contact surfaces as disinfectants, sanitizers, and in Pesticide the development of toxic “other ingre- preservatives. Products data necessary to dients,” with high The Agency has made substantial progress in fulfill- determine the condi- priority for testing. ing the antimicrobial provisions of FQPA. A backlog of tions of safe use of List 3: “Other pending actions has been reduced from a high of 388 PA announced its products that contain ingredients” of in December 1996, to only 24 outstanding actions as of policy on toxic E other ingredients unknown toxicity. September 1999. “other ingredients” which are toxic. In List 4: “Other In September 1999, as required by FQPA, we pub- in pesticide products developing this policy ingredients” of lished in the Federal Register a proposed rule detailing in the Federal Register EPA placed “other minimal concern. procedures and policies for reviewing antimicrobial of April 22, 1987 (52 ingredients” in the The list of other applications for registration, including review time FR 13305). Through following four lists pesticide product frames, a sunset provision for continued efficacy of this policy, EPA according to toxicity: ingredients is revised public health products, and labeling standards for pub- encourages the use List 1: “Other as new data become lic health products, along with assorted definitions and of the least toxic ingredients” of tox- available. exemptions. A number of other provisions were also proposed, including: a policy on nitrogen stabilizers;

FY 1999 tration process, OPP Agency committed to ly published registra- ue to provide this Registration Work published its fiscal make decisions on tion work plan type of information Plan Made Public year 1999 registration new active ingredi- updates via the to the public. The work plan in the ents, new uses of Internet, including Agency is making Federal Register and previously-registered dates when decisions annual registration n keeping with the posted it on the active ingredients, had been made. work plans a routine Agency’s efforts to I Internet. This work and food use “other Many external cus- part of its operations. improve transparency plan announced the ingredients.” During tomers encouraged in the pesticide regis- quarter by which the 1999, OPP periodical- the Agency to contin- REGISTRATION ▼ 12 FY 98-99 OPP BIENNIAL REPORT EPA Registers used on marine ves- the company provides antifoulants contain- is 2006. EPA is work- Alternative to sels and structures to additional ecological ing tributyltin (TBT) ing with international Tributylin (TBT) inhibit growth of effects data. EPA on non-aluminum- organizations to Antifouling Paints fouling organisms, issued the time-limit- hulled vessels shorter address issues associ- e.g., barnacles and ed registration than 25 meters. ated with the algae. The new because the benefits Despite noticeable planned phase-out of n March 20, antifouling products of introducing Irgarol improvement, ten TBT antifoulants and 1998, OPP regis- O are approved for ves- products quickly were years after this and is reviewing data on tered five new sels of any size, and deemed to outweigh related restrictions additional new antifouling paint appear to present any potential ecologi- took effect, TBT is still antifouling active products containing minimal risks to the cal risks. present in the aquatic ingredients and prod- the new active ingre- environment. After Since 1988, the environment at levels ucts. Having alterna- dient Irgarol, in com- two years, the condi- United States and that harm organisms tives available is criti- bination with copper, tional registration of other industrialized such as snails and cal to meeting the to enhance efficacy. Irgarol and its prod- countries have pro- oysters. The TBT phase-out date. Antifoulant paints are ucts will expire unless hibited the use of phase-out target year permission for single applications for identical non- public health protection uses. Public health pesticides “Minor Uses” are data labeling changes affecting multiple products; and are afforded the same considerations as other minor pesticide uses for labeling revisions affecting the signal word, the “Keep use pesticides, such as priority review and the waiving which the total Out of the Reach of Children” statement, use dilution of some of the fees associated with registration. As United States treat- and first aid statements. EPA expects to publish a final with pesticide registrations in general, EPA is seeking ed acreage is less rule in 2000. low risk alternatives to traditional public health pesti- than 300,000 acres cides. (minor crops) or Focusing on Public Health uses for which the Pesticides Supporting Minor Crops and Public market does not Health Pesticides provide sufficient During 1998 and 1999, EPA continued its efforts to economic incentive coordinate with USDA and the Department of Health The Food Quality Protection Act (FQPA) called for to support the initial and Human Services (HHS) regarding the regulation of EPA to develop a new approach to managing minor or continuing regis- pesticides with public health uses, such as mosquito crop and public health pesticides. In response, during tration. Minor uses and cockroach control. For pesticides which have both 1998 OPP appointed a full-time Minor Use Crop of pesticides are food and public health uses, FQPA requires that the Coordinator and an OPP Public Health coordinator, often critical Agency consider exposure from the public health use supported by a Minor Use Team and a Public Health because they sup- when conducting an aggregate exposure assessment. Steering Committee. The teams share common mem- port many fruit and FQPA defines public health pesticides as any minor bers and coordinate activities with USDA and the vegetable crops and use pesticide product used predominantly in public Department of Health and Human Services (HHS). public health pesti- health programs for vector control or other recognized The primary goals of the Minor Use Team and Public cides.

Proposed Rule lishing tolerances time-limited toler- channels of trade of Agriculture and the Published Outlining under the emergency ances will cover both after the tolerance Association of Procedures for exemption require- domestic commodi- expires, provided the American Pesticide Establishing ments of FIFRA ties and those import- levels are within Control Officials. EPA Tolerances for Section 18. The pro- ed into the U.S. dur- acceptable limits. will evaluate the com- Emergency posed regulation dis- ing the duration of In addition to EPA’s ments on these rec- Exemption cusses the Agency’s the emergency proposed process, the ommendations sepa- Requests plan to use available exemption. The pro- proposal lists recom- rately from the com- data to determine the posed rule also details mendations for ments on the rule. Agency’s ability to provisions which changes to the We expect to publish n June 3, 1999, establish time-limited ensure that food Section 18 process a final rule in 2000. EPA published a O tolerances for Section legally treated under developed by the proposed regulation 18 uses on a case-by- the Section 18 may National Association outlining the suggest- case basis. These continue through the of State Departments ed criteria for estab- REGISTRATION

FY 98-99 OPP BIENNIAL REPORT 13 ▼ EPA Takes Action these products have ing often contains and are not registered taken against non- Against Illegally claimed to protect words and phrases with EPA. complying companies Pesticide-Treated consumers against such as “antibacteri- EPA has taken as of September 30, Articles diseases caused by al,” “germ-free,” or major steps to 1999, and more than bacteria, fungi, and “kills harmful E.coli.” address the prolifera- $1,000,000 in fines other microorgan- Any pesticidal prod- tion of unregistered were collected to fur- n recent years, the isms. Types of pesti- uct making public “treated articles,” ther assure compli- marketplace has I cide-impregnated health claims must such as cutting ance with the law. seen a proliferation of products include food work as claimed and boards and kitchen- EPA expects to issue new types of unregis- cutting boards, toys, be registered with ware, that make guidance in 2000 tered consumer prod- kitchen sponges, cat EPA as a pesticide. unlawful pesticidal that will clarify ucts that are treated litter, articles of cloth- These products are health claims. Over acceptable claims. with pesticides. ing, and even writing unlawful if they make 20 enforcement Among other things, pens. Their packag- public health claims actions had been

Health Steering Committee are to: mates and B2 carcinogens, with special emphasis on • provide growers and public health program admin- reduced-risk products. Beginning three years ago, IR-4 istrators an opportunity to discuss their needs and has focused heavily on reduced-risk products. Over concerns with the Agency before the Agency final- 60% of their fiscal year 1999 projects are for reduced- izes regulatory actions; risk products, and current projections are that this fig- • work with USDA, industry, growers, public health ure will exceed 70% for fiscal year 2000. Several current agencies and other stakeholders to promote registra- EPA/IR-4 partnership projects are worthy of note: tion and use of reduced-risk pesticides for minor uses; • developing blanket tolerances for selected reduced- • encourage development and submission of “real risk chemicals, reducing review time potentially by world” pesticide use, usage and residue data by years; growers, public health agencies, USDA and other • improving the tolerance petition format and creat- stakeholders for use in refined risk assessments. ing new crop groupings; This increased focus has strengthened EPA’s com- • streamlining the reduced risk justification format munication with the minor use community and has for minor uses; helped bring registrants and minor use stakeholders • harmonizing registration data development with together early in the regulatory process. other countries. Cooperative Efforts with USDA's IR-4 These efforts are already providing benefits. Whereas the Agency established only one IR-4 spon- EPA’s Office of Pesticide Programs and USDA’s sored tolerance in 1997, in 1999 the Agency established Interregional Research Project 4 (IR-4) have a long his- 32 tolerances for minor crops or minor crop groupings. tory of working together to register pesticides for Based on its review of the IR-4 work plan, EPA plans to minor crops. With input from affected grower groups, review over 100 petitions on 40 active ingredients in FY IR-4 and EPA are working together to accelerate regis- 2000, which could result in 300 new registrations for tration of alternatives to organophosphates, carba- minor crops.

Biopesticide Profile: These bacteria are has been added to and filter flies are non-target organisms. Bacillus thuringiensis toxic to certain the plant. Once controlled that can An effective, low-risk, subspecies species of insects and ingested by insects, transmit diseases such low-toxicity pesticide, israelensisi (Bti) can be used as insec- Bti bacteria release a as malaria, dengue Bti can be used ticides. Called a toxic protein into the fever and encephali- instead of conven- microbial pesticide, digestive system, tis. Bti is a natural tional public health n October 1998, the Bti contains a bacteri- which results in bacteria that kills pesticides, many of Agency registered I um as its active ingre- death. Primarily used insects by releasing which are Bacillus thuringiensis dient. Bti differs from to control mosquito toxins which bind to organophosphates subspecies israelen- plant-pesticides which larvae in aquatic habi- specific receptors in which are toxic to sisi, part of a large are pesticides that tats, other public their digestive sys- humans and other group of bacteria that plants produce from health pests includ- tems. It poses no risk non-target species. occur naturally in soil. genetic material that ing, black flies, gnats, to humans or other REGISTRATION ▼ 14 FY 98-99 OPP BIENNIAL REPORT Reregistration

HE OBJECTIVE OF EPA’S REREGISTRATION PROGRAM IS TO ENSURE THAT OLDER pesticides meet contemporary standards of health, safety and product labeling and that T their risks are adequately mitigated. As directed by amendments to FIFRA in 1988, EPA ▼ has been conducting a comprehensive review of pesticides initially registered before November Through the 1, 1984. In 1996, FQPA added new dimensions to the pesticide reregistration program. It set a new, stricter safety standard for pesticide residues in or on food, and requires EPA to reassess all reregistration existing tolerances within 10 years to ensure that they meet the new standard. FQPA’s require- program, significant ments – to consider the special sensitivities of infants and children, aggregate exposure and improvements in cumulative effects of pesticides with a common mechanism of toxicity, and their possible endocrine disruptor effects – apply to reregistration decisions for all food use pesticides. pesticide safety and Achieving Risk Reduction through tection of users, the general public, and the environ- use are being made. Reregistration ment. Some examples of risk reduction measures include: Through the reregistration program, significant • limits on amount, frequency or timing of applica- improvements in pesticide safety and use are being tions; made. EPA reviews and reregisters products, reassess- • improved use directions and precautions; es their tolerances and requires labeling changes to • ground water and surface water safeguards; achieve risk reduction. These reassessed products can • requirements for personal protective equipment to then be used more safely in the future, enhancing pro- be worn when applying the pesticide;

Profile of uses eliminates residen- fied captan as a B2 of both captan and enhanced PPE required Reregistration tial exposure. Worker (probable human) car- folpet, and concluded includes eye protection Eligibility Decision risk is acceptable for cinogen; however, all that thiophosgene as well as chemical- (RED): Captan most occupational sce- dietary risk estimates does not pose risks of resistant gloves, narios. New require- are below 1 X 10–6, concern. Because of aprons/coveralls, and ments for water solu- and worker risks are toddlers’ exposure to dust/mist respirators in n 1999, EPA complet- ble bags, reductions in below the level of con- treated lawns, the various scenarios. Eye ed a Reregistration I application rates, use cern. There is no evi- technical registrants wash stations are Eligibility Decision of personal protective dence of special sensi- have agreed to volun- required for occupa- (RED) for captan. equipment (PPE), and tivity to infants and tarily cancel captan’s tional field workers Because this fungicide revised reentry intervals children so the safety residential lawn uses entering treated fields has a wide array of will mitigate remaining factor was removed. and all other turf uses as is repeated notifica- agricultural and non- occupational concerns. A potential common except sod farms and tion for workers enter- agricultural uses, our Revised labeling will mechanism of toxicity golf courses. Risks to ing treated fields. reevaluation included reduce risks to non-tar- exists for captan and mixers and loaders of Updated reentry inter- all of the major new get aquatic concerns. another fungicide, wettable powder for- vals, ranging from 12 FQPA factors and occu- Captan is used to folpet, because they mulations for aerial hours for seed treat- pational and ecological control diseases in have a common applications will be ments to 4 days for risk assessments as orchard crops, berries, metabolite, thiophos- mitigated by requiring ornamentals, also are well. We found it does seeds, turf, and orna- gene. EPA conducted the use of water solu- required to protect not pose acute, chronic mentals, and is also a conservative aggre- ble bags or a suitable reentry workers. or cancer risks of con- incorporated into gate assessment for reduction in application cern through food or paints and adhesives as thiophosgene, assum- rate. Captan is also drinking water. an in-can preservative. ing people may be severely irritating to the Cancellation of lawn The Agency has classi- exposed through use eyes. Thus, the REREGISTRATION

FY 98-99 OPP BIENNIAL REPORT 15 ▼ • special programs to enhance protection of young of the alternative ways to reduce risks. The Agency children; and plans to issue a revised set of proposed risk mitigation • cancelling pesticide uses. measures in late 1999 and final risk mitigation measures in 2000. Establishing Stakeholder Process To identify feasible risk mitigation measures before During Pesticide Reregistration releasing a new proposal, we have been working with Reviews the National Institute of Occupational Safety and Health, the Occupational Safety and Health Aluminum and Magnesium Phosphide Administration, and a coalition of industry groups and Stakeholder Process user organizations. In addition, we are consulting with In December 1998, EPA initiated an extensive public the Phosphine Task Force, a group of experts from and stakeholder process to obtain input and ideas Land Grant Universities and USDA Agricultural about ways to reduce the risks associated with alu- Research Service scientists with expertise in commodi- minum and magnesium phosphide, two fumigants ty storage pest management systems who are investi- used to control insects and rodents where agricultural gating possible alternative risk mitigation measures. commodities are stored. Our reevaluation had identi- EPA recognizes the importance of phosphine to agri- fied risks to bystanders and pesticide applicators from culture, the lack of viable alternatives, and the poten- exposure to phosphine, a highly toxic gas created when tial impacts from the initial set of risk mitigation mea- these fumigants are used. sures. Final decisions will be based on sound science The Agency originally proposed 15 risk reduction and a full understanding of agricultural needs. With measures to increase the level of protection to full participation from stakeholders, EPA will be able to bystanders and pesticide applicators from exposure to develop improved risk mitigation measures that are phosphine. The Agency received extensive comments both protective and practical. on the risk reduction measures and decided to extend Rodenticide Cluster Stakeholder Process the schedule to allow more time for stakeholder In March 1998, EPA assembled a stakeholder work involvement, public input and complete consideration group to explore and recommend ways to reduce the risk of exposure to rodent control products, especially Insect Repellent health risks when In partnership with accidental exposures experienced by young children. DEET: they are used correct- the American The Rodenticide Stakeholder Workgroup was estab- Reregistration ly, but it is important Mosquito Control lished under OPP’s advisory committee, the Pesticide Review and for consumers to fol- Association, OPP Program Dialogue Committee. Members of the work Outreach Materials low label directions developed two fact group represent public health and environmental orga- and take proper pre- sheets for consumers: nizations, industry groups, government agencies, and cautions. OPP How to Use Insect the general public. Through an ongoing series of pub- n 1998, OPP com- required several Repellents Safely , lic meetings in the spring and summer of 1999, the pleted its review of I changes to current and Mosquitoes: work group has developed an initial recommendation DEET, a common product labels to How to Control for improved product labeling. EPA will use all the insect repellent and ensure that DEET is Them. This consumer workgroup’s recommendations in developing a strate- an important public applied safely, partic- information was gy to reduce the risks of exposure to rodenticides while health pesticide. ularly on children. available for the sum- preserving their public health benefits. Meanwhile, DEET repels biting DEET products can no mer use season in EPA is requiring rodenticide registrants to incorporate pests such as mosqui- longer claim that 1998 and 1999. an indicator dye and a bittering agent into their prod- toes and ticks, includ- their products are During the late sum- uct formulations. ing ticks that may “child safe,” and new mer and fall of 1999, carry Lyme disease. labels will instruct the fact sheet Every year, approxi- parents not to allow Mosquitoes: How to mately one-third of children to handle Control Them was in the U.S.population is these products. high demand on the expected to use DEET. Labeling for insect East Coast due to In a 1998 reevalua- repellency must be mosquito-borne ill- tion, OPP concluded displayed prominently nesses in the New insect repellents con- on any DEET products York City metropoli- taining DEET do not that also have cos- tan area. present significant metic uses. REREGISTRATION ▼ 16 FY 98-99 OPP BIENNIAL REPORT Tolerance Priority Groups for Tolerance Reassessment Reassessment • EPA placed all pesticides with PA SETS TOLERANCES (MAXIMUM RESIDUE LEVELS) FOR PESTICIDES USED TO tolerances that must be reassessed into three priority grow food. By 2006, EPA must review the safety of all tolerances that were in effect when groups. FQPA requires EPA E FQPA was passed in 1996. Each of these reassessments must ensure that the resulting to give highest priority to tolerance level is safe for all consumers, particularly infants and children, and represents an affir- pesticides that appear to mation of public health protection and the safety of the U.S. food supply. The law requires EPA pose the greatest risk. to place the highest priority for tolerance reassessment on pesticides that appear to pose the Group 1 (228 pesticides/ greatest risk. 5546 tolerances) includes: • Reassessing Tolerances • 9,721 tolerances were in effect when Organophosphates FQPA was passed; • Tolerance reassessment is being • EPA met (and surpassed) the first Carbamates accomplished through the pesticide FQPA goal as we completed the • reregistration program. Through the reassessment of over 33% of all Organochlorines tolerance reassessment process, we can tolerances subject to reassessment by • make decisions to raise, lower, or main- August 3, 1999. Probable carcinogens tain existing tolerance levels, or to By the end of 1999, EPA reassessed • revoke existing tolerances entirely to 3430 tolerances. Each of these toler- Reference dose exceeders* protect consumers from unsafe pesticides residues in ances are in conformity with the stringent new safety • or on food. standard of FQPA and are based on the latest sound High-hazard Tolerance reassessment is a large task: scientific methods, data, and policies. EPA placed all “other ingredients” pesticides with tolerances that must be reassessed into • more than 450 pesticides and other ingredients Group 2 (93 pesti- one of three priority groups. Most (two-thirds) of the have tolerances or exemptions from the require- cides/1928 tolerances) ment for a tolerance; tolerances reassessed are for pesticides in our highest priority group–those that appear to pose the greatest • • there can be many tolerances associated with a Possible carcinogens given chemical, which contributes to the complexi- risk to public health, including the organophosphates, carbamates, organochlorines, and carcinogens. • ty of the review; All remaining reregistration Many of these tolerances were for pesticides used chemicals (those that were on the top 20 raw agricultural commodities frequent- first registered before 1984) ly eaten by kids. Almost 40% of “kids’” food toler- Group 3 (148 pesticides/ ances have been reassessed. Many decisions were also 2247 tolerances) for ‘minor’ uses, or pesticide uses on crops with less • Remaining pre-FQPA EPA Reduces from risks posed by rots, certain peas, peaches. By the end pesticides with reregistration Pesticides Risks to two of the oldest, certain beans, and of next year, EPA is eligibility decisions Children most widely used tomatoes, among scheduled to com- • chemical compounds other fruits and veg- plete its reassessment Remaining post-1984 in use as pesticides etables. For azinphos of the organophos- pesticides The U.S. Environ- today. Based on its methyl, also consid- phates and several • mental Protection concerns, EPA is elim- ered to be a pesticide other older, more Biological pesticides Agency announced inating the use of of concern, the commonly used pes- • on August 2, 1999, methyl parathion– Agency is reducing ticides, and to meet Remaining cancellation agree- one of the more application rates and the Food Quality “other ingredients” ments and risk reduc- potent organophos- requiring practices Protection Act’s food tion strategies to *Dietary exposure at levels phates–on apples, that will result in sig- safety goals. increase protections above the amount that is peaches, pears, nificant reductions in for American families believed to be safe for life-long, grapes, nectarines, allowable residues on daily consumption and their children cherries, plums, car- apples, pears and TOLERANCE REASSESSMENT

FY 98-99 OPP BIENNIAL REPORT 17 ▼ than 300,000 acres of total U.S. production, which • identified key science policy issues related to toler- include many fruits and vegetables. (See Appendix, ance reassessment and defined an approach to ▼ Figure 2) refining these policies that includes substantial public and expert input; The law requires Establishing the Tolerance • initiated a pilot approach for obtaining public com- Reassessment Advisory Committee ment on preliminary risk assessments for the EPA to place the (TRAC) organophosphate class of pesticides as part of highest priority OPP’s effort to improve transparency of decision On April 30, 1998, in a response to a request from making; for tolerance Vice President Gore to enhance stakeholder input on • increased focus on transition issues to prepare grow- FQPA implementation, EPA and USDA established the ers for possible changes in pesticide use patterns. reassessment on Tolerance Reassessment Advisory Committee (TRAC) In July 1998, in consultation with TRAC, EPA and pesticides that as a subcommittee under the auspices of EPA’s USDA implemented a process that allows all stake- National Advisory Council for Environmental Policy holders to review preliminary risk assessments and appear to pose the and Technology. TRAC was established to consult contribute to their improvement, as well as to provide with, and make recommendations to, the risk management ideas later in the process. This pilot greatest risk. Administrator of EPA and the Secretary of Agriculture process was designed to increase transparency and on how best to reassess tolerances, including those for improve opportunities for stakeholder involvement. It organophosphate pesticides, as required by FQPA. helps ensure that risk assessments are based on the TRAC Accomplishments best available and most realistic data. By October 1, 1999, EPA had released 31 preliminary risk assess- TRAC has met seven times and followed the four ments and 15 revised risk assessments through the implementation principles outlined by the Vice pilot process. President: use of sound science in decision-making, establishing a transparent regulatory process, ensuring a reasonable transition for agriculture to new methods and alternatives, and fostering the involvement of stakeholders. The group helped the EPA and USDA make significant progress in several areas critical to the successful implementation of FQPA. For example, TRAC: • fostered a broader understanding of the complexity of pesticide regulation, the special considerations that each sector brings to the table, and the ratio- nale that EPA uses in making decisions;

TRAC Profile of Agriculture. environmental and tribal, state, and local Members were public interest governments; acade- selected based on groups; pesticide mia; and consumer RAC was com- their relevant experi- industry and trade groups. The Deputy posed of approxi- T ence and diversity of associations; user, Administrator of EPA mately 50 members perspectives on grower and com- and the Deputy approved by the organophosphate modity organizations; Secretary of Deputy Administrator pesticide/food safety pediatric and public Agriculture served as of EPA and the issues from the health organizations; Co-Chairs of TRAC. Deputy Secretary of following sectors: federal agencies, the U.S. Department TOLERANCE REASSESSMENT ▼ 18 FY 98-99 OPP BIENNIAL REPORT Visits to the field help OPP officials identify the components of an effective federal program.

The final meeting of TRAC was held October 20 and Publishing Tolerance Processing 21, 1999. At the meeting, the Committee reviewed Fees Rule Proposed lessons learned from the pilot process. EPA and USDA received valuable feedback on how the process could be FQPA requires industry to cover the costs of setting modified for reassessment of other chemicals in the tolerances for pesticide residues on food. EPA is revis- future. This discussion included the role and involve- ing the current fee structure to bring it in line with the ment of growers and other pesticide users. The input new responsibilities mandated by FQPA, the increased from TRAC and other informal sources will be used to complexities of science reviews, and more sophisticat- develop a proposed new process, which will be pub- ed data management systems. Estimates show that, to lished for public comment by the end of 1999. This sufficiently recover costs, tolerance fees need to proposed process would be used for all pesticides sub- increase. ject to reregistration or tolerance reassessment. The Agency’s proposed rule on Pesticide Tolerance Processing Fees was published in the Federal Register on June 9, 1999 for comment. We will be assessing these comments and working with our various stakeholders during 2000 to refine our approach. TOLERANCE REASSESSMENT

FY 98-99 OPP BIENNIAL REPORT 19 ▼ Sound Science WHAT ARE THE NINE SCIENCE POLICIES? ▼ OUND SCIENCE IS A NECESSARY FOUNDATION FOR THE TOUGH DECISIONS OPP Applying the FQPA must make every day. Whether establishing new science policies to support FQPA imple- 10-Fold Factor mentation or improving our understanding of how pesticides interact with humans and ▼ S the environment, OPP tackled a number of important issues in 1998 and 1999. Dietary Exposure Developing New Science Policies during FY 2000. The documents are posted on the Assessment–Whether Internet when they are completed. and How to Use Shortly after passage of FQPA, EPA began using a set (http://www.epa.gov/pesticides/trac/science/) ‘Monte Carlo’ Analysis of guidance (developed with input from the Food ▼ Safety Advisory Committee) in making various pesti- Improving Our Protection for cide-related decisions. In response to subsequent Infants and Children Exposure Assessment advice from the Tolerance Reassessment Advisory –Interpreting Committee (TRAC), EPA identified nine science policy In 1998, we published updated testing guidelines for ‘No Residues Detected’ issue areas important to the implementation of FQPA. use by registrants in conducting studies to evaluate the prenatal, developmental and reproductive effects pesti- Findings On October 29, 1998, EPA published a framework to ▼ describe these issues and a preliminary schedule for cides may have on infants and children. New guide- the release of the policy and guidance documents asso- lines on conducting studies to evaluate the effects of Dietary (Food) ciated with each issue. By the end of fiscal year 1999, pesticides to their immune system were also published. Exposure Estimates EPA had released for comment 14 of the original 19 In May 1999, we submitted to the FIFRA Scientific ▼ planned science policy papers and issued one science Advisory Panel (SAP) for review our draft policy and policy paper that had been revised in light of public operational practices for making decisions on the 10- Drinking Water Exposures comments. In addition to the nine policy areas initial- fold safety factor required by FQPA to protect infants ▼ ly identified, EPA issued four additional draft papers and children. The policy was released in July 1999 for Assessing Residential on related science issues for public comment. In late public review and comment based on the process established in conjunction with the TRAC. FQPA Exposure fall 1999, EPA released two additional draft science pol- ▼ icy papers and two revised papers. The remaining sci- requires that each pesticide tolerance be protective of ence policy papers are scheduled for final publication infants and children, and that we use an appropriate Aggregating safety factor during risk assessment to account for Exposures from All Non- their special sensitivities. Occupational Sources ▼ How to Conduct a New Partnerships pose of the new office is Advisory Panel and OSCP coordinates OPPTS Cumulative Risk with the Office of to coordinate the devel- Science Review Board, activities related to the Science opment and implementa- OSCP gives OPP access updating and harmoniza- Assessment for Coordination and tion of cross-cutting sci- to top scientific and tion of national and Organophosphate Policy ence policies and pro- technical experts and international testing Insecticides or Other grams that underpin peer reviewers. OSCP is guidelines, standard sci- EPA's toxic chemical and coordinating the devel- entific operating proce- Pesticides with a Common uring 1999, OPP pesticide programs. opment of EPA's dures, and Agency collaborated with the Mechanism of Toxicity D OSCP is helping OPP to Endocrine Disruptor research objectives. Office of Science ▼ identify and incorporate Screening Program, a Most importantly, OSCP Coordination and Policy the latest scientific and program that will have will work to ensure that Use of Data on (OSCP), a new organiza- technological information an important impact on OPPTS's science-based Cholinesterase Inhibition tion within the Office of into its risk assessment OPP-regulated chemicals. methods and policies set Prevention, Pesticides, for Risk Assessments of and regulatory decisions. Working with the nation- the standard by which and Toxic Substances Organophosphates and Through its management al and international sound science is judged. (OPPTS). Established in of the FIFRA Scientific scientific communities, Carbamates January 1999, the pur- SOUND SCIENCE ▼ 20 FY 98-99 OPP BIENNIAL REPORT program has the following characteristics: • a two-tiered screening program for chemicals, pesticides, and environmental contaminants to detect FIFRA Scientific effects on the estrogen, androgen, and thyroid hor- Advisory Panel (SAP) mone systems; • inclusion of evaluation of potential for effects on o help make decisions human health and wildlife; Tand policies based on • potential use of high-volume, automated technolo- sound scientific principles, gy to screen large numbers of chemicals to help set OPP frequently consulted priorities (under research and development); with the FIFRA Scientific • development of a relational database to help set Advisory Panel (SAP) on priorities and track data; and key issues. Managed by EPA’s Office of Science • standardization and validation of all assays before Coordination and Policy regulatory use. (OSCP), the FIFRA EPA is beginning to implement the Endocrine Scientific Advisory Panel Disruptor Screening Program using a tiered approach. consists of independent The tiered approach uses a priority setting process outside scientific experts for selecting the initial chemicals for the screening pro- who provide scientific gram, developing methods for endocrine disruptor advice on health and envi- screening and testing, and standardizing and validat- ronmental impacts of pes- Specifically, EPA is required to apply an additional ticides and pesticide relat- safety factor of 10 during its risk assessments to ing the screening and testing methods for regulatory programs. ed issues. The panel was account for the potential pre-and post-natal toxicity, as created in 1975 through well as for the completeness of the toxicology and Protecting Human Test Subjects amendments to the exposure database, unless the Agency determines that Federal Insecticide, another factor is adequately protective. Many of Fungicide, and Rodenticide FQPA’s provisions to protect children are based on rec- EPA is concerned about the welfare of people who Act, and modified by ommendations in the 1993 National Academy of participate as test subjects in scientific research on FQPA. Sciences (NAS) report, Pesticides in the Diets of human health or the environment, regardless of who The SAP’s role extends Infants and Children. In keeping with FQPA, each conducts the research or how it comes to the Agency’s to peer-reviewing current scientific issues which may tolerance decision issued in 1998 and 1999 contained a attention. influence the direction of specific finding that the tolerance levels are appropri- EPA neither requires nor encourages human toxicity testing with pesticides, and will not rely on these data OPP's regulatory decisions. ately protective of children. EPA used available, reli- During 12 scheduled able data when considering the need to retain or to make final decisions under FQPA until a policy is in place which can ensure that any such testing meets the meetings in FY1998 and replace the 10-fold additional safety factor. 1999, OPP consulted with highest ethical and scientific standards. the SAP on over 20 issues, Expanding Our Understanding of In December 1998, EPA convened a special joint sub- including: Endocrine Disruptors committee of its Science Advisory Board and the • human testing ethics, FIFRA Scientific Advisory Panel to discuss ethical and • determination of the In recent years, evidence has arisen to suggest that scientific issues surrounding human testing. The sub- appropriate risk assess- chemicals may disrupt the hormone (endocrine) sys- committee met again in November 1999. EPA will ment safety factor for children, tem of humans and wildlife and cause reproductive develop its policy after the subcommittee submits their recommendations. • methods to estimate disorders, birth defects, immune dysfunction and basin-scale pesticide other harmful effects. Because of the potential concern Understanding and Predicting concentrations in drink- from human exposure to endocrine-disrupting chemi- Pesticide Spray Drift ing reservoirs, cals, Congress included a mandate to EPA in the FQPA • residential exposure and the 1996 amendments to the Safe Drinking Water assessment procedures, Act (SDWA) to develop an endocrine disruptor screen- OPP made significant progress during the last two • assessment of risk from ing program. years towards gaining a more comprehensive under- opportunistic human Since receiving the statutory authority, EPA has standing of the science of pesticide spray drift and pathogens, moved quickly to set up a screening program that can improving our ability to predict spray drift and the • assessment of cumula- be used to gather data on the endocrine-disrupting associated potential risks under a wide array of agri- tive risk from pesticides with a common mecha- potential of pesticides and other chemicals. On cultural applications and weather conditions. We com- nism of toxicity, December 28, 1998, we published in the Federal pleted our assessment of the results of spray drift studies submitted by the registrants’ Spray Drift Task Force • the Endocrine Disruptor Register a proposal for an Endocrine Disruptor Screening Program. Screening Program (EDSP). EPA’s proposed screening and cooperated with EPA’s Office of Research and SOUND SCIENCE

FY 98-99 OPP BIENNIAL REPORT 21 ▼ Development and the Task Force to develop predictive tation team was organized in August. The team’s goal modeling for our risk assessment and management is to prioritize the recommendations made by the com- Acute Dietary Risk responsibilities for pesticides. mittee, to set short term, intermediate and long term Assessments OPP sought outside expert opinions of these studies goals for the program, and to identify data and Using Monitoring and the modeling by consulting with the SAP and research needs that will provide the Agency with the Data: other independent experts. Overall, these experts sup- ability to perform refined probabilistic risk assess- ported our conclusions of the studies and utility of the ments on those pesticides which most adversely affect spray drift model. Data from these studies are superi- ecosystems and the environment. n 1999, the Office of or to using the standard assumptions OPP previously The program is enthusiastically moving forward and IPesticide Programs used to assess drift from aerial and ground applications working with other offices within EPA, including the (OPP) continued the of agricultural pesticide sprays. These new data will Office of Water and the Office of Research and process of developing enable OPP to better understand the risks from spray Development, to develop new risk assessment tools, new and refined tools drift and will result in better informed decisions on exposure models and appropriate test guidelines need- for estimating acute how applicators can control spray drift. OPP plans to ed for probabilistic ecological risk assessment. By dietary exposure and begin using these conclusions and the predictive model improving methods and the ability to refine ecological risk to pesticides. for its risk assessments and, where necessary, risk risk assessments for those chemicals which have the Significant accomplish- reduction strategies for applications of agricultural greatest potential to adversely impact the environ- ments include: devel- pesticide sprays will be implemented. ment, the risk managers in OPP will possess the infor- opment of proposed mation required to make more informed regulatory guidelines for conduct- Identifying and Developing decisions that are based on sound, defensible science ing probabilistic, aggre- Ecological Risk Assessment and good public policy. gate and cumulative Methods risk assessments; devel- Improving Drinking Water opment of proposed In May 1996, the FIFRA Scientific Advisory Panel Exposure Assessments guidelines on regulating advised the Office of Pesticide Programs (OPP) to acute dietary risk at the improve the ecological risk assessment process by mov- FQPA mandates EPA to add the contribution of pes- 99.9th percentile of the ing from the currently used methods which are useful ticide residues in drinking water to the total dietary exposed population; for screening purposes to more sophisticated, scientifi- exposure to pesticide residues. In order to improve its and the development of cally rigorous methods which could better support reg- methods of estimating pesticide concentrations in statistical models to ulatory decisions. These new methods must be able to drinking water and to obtain actual occurrence data on expand the applicability predict the magnitude of the expected impact of pesti- these residues, OPP began working closely with the of monitoring data to cide use on non-target organisms as well as the uncer- Office of Water, the U.S. Geological Survey (USGS) and assess acute dietary tainty and variability involved in these estimates. In industry to obtain occurrence data of pesticides in sur- exposure and risk by response to this recommendation, OPP began a new face and ground waters which supply drinking water to “decompositing” initiative in 1997 to strengthen the core elements of the public. The ideal situation is to obtain monitoring composited pesticide the ecological assessment process by identifying, devel- data on finished water taken during high pesticide use residue samples to oping, and validating tools and methods to conduct seasons in agricultural areas throughout the United better reflect pesticide probabilistic assessments and to improve the charac- States, or to be able to reliably approximate concentra- residues on single- terization of the risk by describing all attendant uncer- tions using validated, predictive models. In addition: serving sized samples. tainties in the assessment. EPA formed the Ecological • USGS and OPP have launched a reservoir pilot pro- Committee on FIFRA Risk Assessment Methods gram which will monitor surface water and finished (ECOFRAM) to review current assessment methods water in 12 reservoirs throughout the United States; and to develop new tools and approaches for terrestri- • The Office of Water (OW) and OPP have set up a al and aquatic assessments. This committee was com- coordination workgroup for the purpose of sharing posed of scientific experts drawn from government data on occurrence of pesticides in drinking water agencies, academia, industry, environmental advocacy monitored under the requirements of the Safe groups and contract laboratories. Members represent- Drinking Water Act. OPP now has access to occur- ed the appropriate disciplines and represented a cross- rence levels of regulated pesticide contaminants, section of affiliations. pesticides considered as priorities for regulation In May 1999, the terrestrial and aquatic reports were and others that are unregulated but are being moni- issued. They contained detailed and thorough recom- tored due to production, release and physical prop- mendations on risk assessment methodologies and erties. In addition, OPP and OW are working data requirements needed to perform probabilistic risk together on cross-cutting science policy issues and assessments in these two areas. The reports received recommending research priorities to ORD for the peer review and comments in June and an implemen- development and validation of exposure models SOUND SCIENCE ▼ 22 FY 98-99 OPP BIENNIAL REPORT which can estimate pesticides in drinking water tool uses new approaches to risk assessment evaluating human health risk assessments and for use in prob- multiple exposures (aggregate) in a computer-based abilistic ecological risk assessments; platform that allows for input of currently available Opening of EPA’s • OPP has improved the screening level model by information (the U.S. Census) and user-specified infor- Environmental developing an index reservoir scenario to replace mation. Science Center the small pond model which also considers the per- An additional goal of the project is to facilitate the centage of the acreage treated with the pesticide (s); availability of the aggregate risk modeling tool to the n January 1999, labo- • OPP is working with the American Crop Protection public at a cost that is not prohibitive. OPP believes it Iratory staff from the Association (ACPA) to design a national survey is important to encourage the distribution of aggregate Office of Pesticide with emphasis on surface water sources for drink- risk assessment concepts and models to all interested Programs (OPP) and ing water; members of the general public in an understandable Region 3 moved into • OPP is also developing a predictive model for and is format and at a cost that is affordable. OPP believes their new laboratory at studying the effects of water treatment methods on that support of this software development, addressing Fort Meade, Maryland. pesticide concentrations in drinking water. both aggregate exposure and cumulative risk, will help The new lab replaces to make scientific advancements compatible with more outdated laboratory Developing an Aggregate effective public involvement in environmental deci- facilities with state-of- Exposure and Risk Assessment sion making. the-art technology and Tool: Hampshire Research consolidates six EPA Institute’s (HRI) Lifeline Software Collecting Pesticide Use facilities formerly located Model Information in Annapolis and Beltsville, Maryland; In June 1998, OPP entered into a co-operative agree- In 1998, EPA began collecting available information Cincinnati, Ohio; and ment with the Hampshire Research Institute (HRI) to about current pesticide use (starting with the Research Triangle Park, support the development of an aggregate and cumula- organophosphates) and organizing it into tables or North Carolina; and is tive risk modeling tool to be made available to the gen- crop matrices to improve accessibility and ease of use the first non-Department eral public. The computer-based modeling tool will by analysts, decision-makers, and stakeholders. Crop of Defense federal facili- allow professional and non-professional persons inter- matrices present, on a crop basis, the best available ty at Fort Meade. The ested in risk assessment to better engage in a discus- information on actual use of organophosphates. The new Environmental sion of exposure and risks from pesticides in the envi- information, largely quantitative, describes the percent Science Center supports ronment. This effort is geared toward more effective of each crop treated, average and maximum rates of enforcement & monitor- protection of public health and the environment pesticide use, and number of applications. They also ing for Region III and through fostering the dissemination of reliable infor- identify target pests, alternatives to the organophos- analytical chemistry and mation on risk, and by increasing the public’s ability phates (OPs), and their constraints. OPP uses data microbiology for the to analyze, understand and make decisions about envi- from the matrices to assess risks and to make decisions Office of Pesticide ronmental problems. about regulatory actions. Draft OP matrices for ten Programs. Its analytical There are three main goals to this software modeling crops are posted on the Internet at capabilities include project. The first is to stimulate investigation and dis- http://www.epa.gov/oppbead1/matrices. Matrices chemistry (organic, inor- semination of aggregate risk assessment concepts. The for other crops will be posted as they are completed. ganic, and metals) project will develop literature and tools to help the analysis, biology, micro- public understand the concept and role of risk assess- biology, and other scien- ment in environmental decision making to allow for tific activities that fur- greater public involvement. This is especially relevant ther the mission and in light the new requirements of FQPA to investigate goals of the Agency. aggregate exposure (exposure to a pesticide from multiple sources and by multiple routes) and, in the future, EPA Region III cumulative risk (risk associated with concurrent expo- Administrator, sure to multiple pesticides that act via a common Mike McCabe, mechanism of toxicity). The second goal is to support speaks during the dedication development of a flexible computer model which per- ceremony of the forms aggregate risk assessment by combining expo- new Environmental sures to chemicals used as pesticides from the dietary, Science Center in drinking water and residential routes of exposure Fort Meade, MD. through utilization of a flexible computer model. The SOUND SCIENCE

FY 98-99 OPP BIENNIAL REPORT 23 ▼ Partnerships

Y MAINTAINING STRONG COMMUNICATIONS WITH EPA REGIONS, OTHER government agencies, states, and tribes, OPP promotes the Agency’s mission of pro- ▼ B tecting public health and the environment from the risks pesticides may pose and pro- OPP works with moting safer means of pest control. OPP works with these partners, as well as the diverse stakeholder community, in developing and applying better, more consistent pesticide program poli- these partners, as cies and decisions. well as the diverse Providing Support for Regional training and compliance assistance to states in imple- stakeholder Initiatives menting this program, such as workshops with state agriculture departments and cooperative extension community, in Pesticide Urban Initiative services. EPA issued a public service announcement providing developing and Misuse of pesticides in residential settings has been a recurring problem for many years, with a series of information on how to hire an appropriate pest control applying better, highly dangerous incidents sharply increasing OPP’s service and about the dangers of pesticide misuse. level of concern. In several separate incidents a highly Articles describing the consequences of pesticide mis- more consistent toxic agricultural pesticide, methyl parathion, was ille- use and pest control methods were published in various medical and consumer publications. EPA regional pesticide program gally used indoors to control cockroaches. EPA took action on two fronts: our Superfund program led a offices have developed a wide variety of outreach mate- policies and lengthy and expensive cleanup efforts in private rials, often in cooperation with extension service and homes; enforcement actions focused on stopping this state agencies, and are actively conducting seminars decisions. extremely dangerous practice and developing ways to and training sessions for state and local health depart- prevent future misuse incidents. Our enforcement ment staff, homeowners and apartment residents. partnership included pesticide and enforcement programs–especially in our EPA regional offices and our Developing Stakeholder state lead agencies. Partnerships In response to our increased concern, EPA developed a strategy in 1999 called the Pesticide Urban Pesticide Environmental Stewardship Initiative, to help stop pesticide misuse. Key compo- Program nents of the strategy include increased regulatory and The Pesticide Environmental Stewardship Program enforcement presence in urban communities to detect (PESP) is a voluntary partnership between EPA and the diversion of agricultural pesticides to urban areas, and pesticide user community to reduce pesticide risk in enhanced outreach effort to educate the public on the agricultural and nonagricultural settings. Organi- dangers of misuse of pesticides. EPA is providing zations with a commitment to reducing pesticide risk

Regional Region 4 (Atlanta) Region 5 (Chicago) Region 9 (San Region 10 (Seattle) Agricultural enrollment of more than a pesticide residue study Francisco) a cooperative agree- Initiatives 163 thousand acres of conducted by Michigan a joint project between ment with Washington farmland in the Delta State University and the the California grape State University to study F.A.R.M. project Michigan Department of industry, the University biological controls, alter- o increase communi- (Mississippi), designed Agriculture, which will of California, USDA, and native crop systems, cations between EPA T to increase the accep- result in more accurate others to develop a precision pesticide and stakeholders on tance of best environ- risk assessments for comprehensive overview application, and other issues relating to FQPA, mental practices, and minor use crops. and analysis of the mechanical and cultural four pilot projects were development of crop problems faced by grape practices which might initiated. Highlights of profiles in Florida, which growers, current pesti- mitigate pesticide risk. the four pilots include: will provide better data cide use, and available on current pesticide use. alternatives. PARTNERSHIPS ▼ 24 FY 98-99 OPP BIENNIAL REPORT cialists, and Zeneca Ag Products, EPA issued an Experimental Use Permit (EUP) to test azoxystrobin, a “reduced risk” pesticide for use on potatoes in ▼ Wisconsin to control early and late blight. The Profile on Experimental Use Permit generated information that PESP was useful for the preparation of the risk assessment for the registration of the use on potatoes. The latest As funds allow, OPP health risk assessment including potatoes reinforced provides PESP with the benign nature of azoxystrobin, as determined dur- money to support pest ing previous registration activities on this chemical. management projects The tolerance on potatoes was established later in 1999. that reduce pesticide The Consumer Labeling Initiative risk. The Texas Association of The Consumer Labeling Initiative (CLI) is a volun- Nurserymen, with assis- tary, cooperative effort among OPP, the Office of OPP staff and pineapple farmers discuss tance from Texas A&M Pollution Prevention and Toxics (OPPT), other federal integrated pest management (IPM) strategies University and EPA, and state agencies, industry, and the public, to foster under the PESP program have succeeded in get- pollution prevention and to improve consumer under- ting IPM information standing of safe pesticide use and information on are eligible to join PESP either as Partners or about horticultural household consumer product labels. The CLI has been Supporters. Partners are organizations that either use crops into the hands of focusing on indoor insecticides, household hard sur- pesticides or represent pesticide users. Supporters are growers over the Inter- face cleaners, and outdoor pesticides. organizations that have an interest in pesticide issues. net. Their website at, In 1999, EPA approved most of the CLI Partner/Task PESP’s membership now includes over 100 Partners http://www.hortipm.tam Force recommendations, including label changes, and 25 Supporters who have agreed to develop and u.edu averages 1.5 mil- ingredient information, and disposal instructions. implement strategies to reduce pesticide risk and to lion hits per month, OPP will issue Pesticide Registration Notices and/or report regularly on their progress. OPP provides each 36% from growers, and Federal Register Notices, as appropriate, to implement Partner and Supporter with a liaison to help them 32% from extension the label changes. OPP continues to work with state obtain information not only about the partnership, but agents who advise and local and industry representatives to develop about other EPA programs, policies, and procedures. growers. The site pro- revised disposal label instructions; a draft proposal is PESP also works to reduce pesticide risk in non-agri- vides detailed informa- planned for late in 1999. Outreach efforts included cultural settings. A PESP Supporter, the Bay Area tion on, and pictures of presentations to EPA staff and other interested organi- Stormwater Management Agencies Association (BAS- pest identification, zations around the country, a CLI web site, and other MAA) reported that diazinon and chlorpyrifos, pesti- scouting methods, and program status updates. The CLI team, at manage- cides widely used in urban landscapes, were exceeding cultural, biological and ment’s direction, continued to develop educational acceptable levels in the surface water runoff in the San chemical pest control materials, a logo, and an implementation strategy for Francisco Bay area. In this urban area (population of methods. The site’s the consumer education campaign. All of the research 4.7 million), homeowner use was identified as a major users highly rate the and work done under Phase II was included in the CLI source of diazinon and chlopyrifos reaching the creeks. advice they get from Phase II Report. This report was peer reviewed and the Using funds from OPP and the State of California, the site: 47% of users CLI plans to publish the report in late 1999. BASMAA developed a program to educate sales per- think the pest solutions sons and the general public in pesticide retail outlets Coordination with Infection Control provided are good or (landscape nurseries, hardware stores) about the use of Specialists in Medical Facilities outstanding; and 100% less toxic pesticides and integrated pest management. One of OPP’s successful outreach activities involved say they will continue In one hardware store, diazinon sales decreased 20% the Association for Professionals in Infection Control using the site. Quick, while the sales of less toxic pesticides increased 20%. and Epidemiology (APIC). Members are infection con- reliable access to this The store personnel attributed these results to the edu- trol specialists who work primarily in health care set- information will allow cational program. BASMAA plans to expand this pro- tings. APIC has the formidable task of trying to reduce growers to make pest gram from four pilot stores to more than 100 in the Bay the number of hospital-acquired infections occurring control decisions using area. Detailed information on PESP, its members and in the United States, currently estimated at more than the latest reduced-risk their activities, and funded projects is available on the 2 million annually. Because approximately 1,000 out technologies. Internet at www.pesp.org. of 5,000 registered antimicrobials products are hospi- EPA Partnerships with Potato Grower tal disinfectants, OPP has opened a dialogue with APIC Stakeholders members to explore areas of mutual interest. APIC members indicated a need to know which In October 1998, in a cooperative effort with the agency to call with specific questions about infection

Wisconsin potato growers, University extension spe- PARTNERSHIPS

FY 98-99 OPP BIENNIAL REPORT 25 ▼ Working Closely develop critically sitive as the old meth- ment to improve the methods are suit- with State and needed methods for ods. Using those tuberculocidal test. able for enforce- Federal analyzing herbicides methods, FDA OPP laboratories ment monitoring; Laboratories which require newer through its existing include: and analytical and instru- network of field labo- • a microbiology lab, • an environmental mental technologies. ratories and compli- which conducts chemistry lab spe- PP operates three More and better ance monitoring pro- efficacy testing of cializing in evaluat- laboratories O residue monitoring gram, will analyze a antimicrobial pesti- ing test methods which work closely data for organophos- thousand imported cide products of for pesticides in soil with State FIFRA labo- phates (with emphasis and domestic food public health signif- and water to deter- ratories providing on children’s foods) samples in the com- icance, such as mine if they are technical support for will be the result of a ing year. hospital disinfec- suitable for gener- compliance monitor- new agreement OPP’s Microbiology tants; ating reliable data ing and enforcement between OPP and Laboratory has begun • an analytical chem- to support pesti- activities, as well as FDA. Our Analytical a collaborative istry lab, which cide registration assistance with quality Chemistry Laboratory research project with evaluates analytical and reregistration assurance and train- is working with FDA the FDA’s Engineering methods to detect decisions. ing. In 1998 and to develop multi- and Analytical Center pesticides in foods 1999, OPP and states residue methods at to evaluate new pro- and fibers to cooperated to help least ten times as sen- cedures and equip- ensure that the

control practices and products. OPP, with input from OPP and the Association of American other agencies, prepared a document to answer APIC s Pesticide Control Officials (AAPCO) most immediate questions. The document explains Celebrate 20 Years of Partnership that EPA generally is responsible for products that con- In an effort to fulfill the need for information trol germs on inanimate surfaces and objects; such as exchange between OPP and state regulatory officials walls and bedpans, and for some products that treat regarding the implementation of the amended Federal medical waste before disposal. (Liquid chemical steri- Insecticide, Fungicide and Rodenticide Act, a coopera- lant products used on critical and semi-critical medical tive agreement was entered into in 1978 by OPP and devices are FDA’s responsibility.) APIC and OPP have AAPCO. It created the State FIFRA Issues Research and exchanged drafts of various manuscripts to help Evaluation Group (SFIREG), which consists primarily of ensure their accuracy and usefulness. Future activities state pesticide regulatory officials. Reports that contain may include: arranging site visits between OPP staff valuable information and recommendations on matters and APIC members, making APIC training courses relating to pesticide registration, enforcement, training available to OPP staff, working together to make label- and certification, water quality, disposal, and other areas ing more user friendly; and discussing ways of treating of environment concern are received from co-sponsored medical waste before disposal. meetings with SFIREG. Both parties continue to work together to ensure the development, guidance and Partnering with States and Other approval of state pesticide programs and policies. Agencies Working with USDA to Bring Conventional Reduced Risk Pesticides EPA and Texas Aquatic Herbicide to the Marketplace Workgroup As a result of a January 1999 meeting between the OPP and our Region 6 office in Dallas, Texas estab- Environmental Protection Agency and the U.S. lished an Aquatic Herbicide Workgroup to work with Department of Agriculture, the Interregional Research the Texas Department of Agriculture to negotiate risk Project 4 (IR-4) has accelerated data development mitigation measures that would allow Texas to use efforts to support tolerances for the pesticide spinosad endothall and diquat dibromide. These efforts provid- for all crop groups. The expanded use of this pesticide ed the necessary tools to the state to control of aquatic is expected to provide alternatives to many weeds, while ensuring that the use of these pesticides organophosphates (OPs) used on a wide variety of would not cause unreasonable adverse effects to fruits and vegetables. The IR-4 expects to complete all humans and/or the environment. spinosad residue data requirements and submit tolerance petitions, covering major and minor crops, to the Agency early in the year 2000. PARTNERSHIPS ▼ 26 FY 98-99 OPP BIENNIAL REPORT In 1999, the Agency approved an emergency exemp- International Agreements tion (Section 18) for the use of spinosad for the 1999 Regional Treaty on Persistent Organic season’s Medfly program of the Florida Department of Pollutants–In June 1998, the U.S., Canada, and Agriculture. The Agency is hopeful that with its European countries (including the Russian Federation approval, spinosad will become the principal pesticide and Newly Independent States), signed a legally bind- used in Florida to address Medfly outbreaks. The avail- ing protocol on persistent organic pollutants. ability of this lower risk pesticide will allow Florida to Persistent organic pollutants are toxic chemicals that phase-down and/or phase-out the use of malathion in do not readily break down in the environment and that their Medfly programs. bioaccumulate through the food chain. Initially, the Joint EPA/USDA Seminars on chemicals covered by the agreement include aldrin, Pesticide Use chlordane, DDT, dieldrin, endrin, heptachlor, mirex, toxaphene, hexachlorobenzene, PCBs, dioxins and In a joint venture with USDA, OPP provides staff furans. Other chemicals may be added as scientific evi- with in-service education by hosting approximately 22 dence warrants. The protocol establishes obligations seminars a year. Speakers come from universities and aimed at restricting or eliminating persistent organic industries throughout the U.S. to discuss a variety of pollutants and will inform ongoing efforts to develop a subjects, ranging from minor crops to non-agricultural global persistent organic pollutant agreement. uses of pesticides. Topics cover field experience in pest management in a variety of crops, such as sweet pota- Prior Informed Consent–In September 1998, toes, apples, cotton, wheat, stored grains, corn and the United States signed the Convention on the Prior sorghum, canola, and wild rice, as well as regional Informed Consent Procedure for Certain Hazardous crops in the northeast, mid-Atlantic, southeast and Chemicals and Pesticides in International Trade. This New Mexico. Seminars in the past year outlined pro- agreement governs trade in pesticides and other haz- duction of California pistachios, northwest small ardous chemicals that have been banned or severely berries, California carrots, wine grapes, and processed restricted in the U.S. or other countries based on health tomatoes in California. Alternative pesticides were dis- or environmental risk concerns, or which pose special cussed in various seminars, most notably for atrazine risks in developing countries. Participating countries in corn and sorghum weed management and for syn- are obligated to provide information about regulatory thetic fungicides. Even pesticide tracking and report- actions and to prohibit the export of PIC chemicals ing systems were described in seminars on The when importing countries indicate that they do not California Pesticide Use Reporting System and An want to receive shipments. Overview of Non-agricultural Uses of Insecticides in Working with the Organization for the U.S. All seminars were well attended and provided Economic Cooperation and excellent opportunities for meaningful dialogue. Development Coordinating International Harmonization and Work Sharing–The Activities Organization for Economic Cooperation and Development’s (OECD) Pesticide Working Group provides a forum where governments can express their points The overall goals of OPP’s international efforts are of view, share their experiences, and search for common to promote improved health and environmental pro- answers on pesticide regulatory issues. One of the main tection world-wide, and to ensure that international objectives of the OECD Program is to make registration trade initiatives and other agreements are consistent and re-registration evaluations more efficient by harmo- with the high level of protection afforded by U.S. laws. nizing the structure and content of pesticide review With the expansion of international trade in agricul- reports and sharing the work of reviews. In 1998-1999, tural and chemical products, it is no longer possible to OECD Member countries reached agreement on harmo- separate domestic and international issues, and a glob- nized formats for dossiers (industry data submissions) al approach is often required. In 1998, we worked with and monographs (country review reports). Common for- a number of partners at the bilateral, regional, and mats are critical to sharing the work of pesticide registra- global levels. These cooperative activities will result in tion successfully. Guidance documents on dossier and reducing risks more quickly, promoting food safety, monograph formats were adopted in February 1998 and helping save resources by avoiding redundant efforts, made available on the Internet. An expanded version of and leading to better and more consistent program these documents will be published in 2000. decisions grounded in sound science. In 1998-1999, progress was made on harmonizing data requirements, including a workshop on common core data requirements for pheromones and an initial PARTNERSHIPS

FY 98-99 OPP BIENNIAL REPORT 27 ▼ proposal for common core requirements for microbial ments. In 1999, OPP worked with the Office of pesticides. The outcome of a series of workshops held Enforcement and Compliance Assurance to complete a in 1999 to develop a proposal for common data require- United States-Canada Memorandum of Understanding ments to establish Maximum Residue Limits (MRL) will (MOU) on Good Laboratory Practices, aimed at pro- be presented to the OECD Pesticide Working Group in moting reciprocal acceptance of high quality data to 2000. Agreement on data requirements for MRLs is support pesticide registrations in both countries. important not only to OECD Member countries, but Under NAFTA, a cooperative project between OPP also to the work of the Codex Alimentarius and its Canadian counterpart, the Pesticide Commission, which sets international MRLs. Management Regulatory Agency (PMRA) was initiated Classification, Labeling and Test to determine the distribution of landscapes in the northern tier states of the United States which are sim- Guidelines–The 1992 United Nations Conference ilar to the soil landscapes in the southern regions of on The Environment and Development endorsed the several Canadian provinces. development of a globally harmonized system of Assuming pesticide dissipation is comparable chemical hazard classification and labeling, with a goal among similar soil landscapes and climatic regions for completion by the end of the year 2000. Through with corresponding management practices and crop- OECD, international consensus was achieved in late ping patterns, the identified landscapes could be used September 1998 on classification criteria for eight for conducting terrestrial field dissipation studies in health and environmental endpoints: acute toxicity; support of pesticide registration in both countries. aquatic toxicity; carcinogenicity; eye and skin irrita- Field studies conducted in similar landscapes would tion/corrosivity; germ cell mutagenicity; reproductive reduce the costs associated with field dissipation stud- and developmental toxicity; and sensitization. Criteria ies and increase knowledge of pesticide dissipation for physical hazards, such as flammability and explo- under field conditions. Comparable soil landscapes sivity, are also substantially complete. Efforts are will be identified using a customized Geographic ongoing to harmonize hazard labeling and approaches Information System (GIS) application with crop distri- for dealing with chemical mixtures. butions, ecological regions of North America, rainfall EPA completed work on a number of test guidelines, distribution, soil temperature regimes, and various soil harmonizing EPA’s requirements internationally attributes in the Canadian Soil Landscapes System and through OECD. Among the guidelines published in the U.S. State Soil Geographic Database (STATSGO). 1998 were those governing testing for key reproductive OPP will further benefit from the project through and developmental endpoints. increased access to geo-spatial data (e.g., crop distribu- Codex tions, soils information) to refine risk characterizations OPP continued to support the Codex Alimentarius and improve guidance for evaluating terrestrial field Commission, a joint program of the United Nations dissipation studies. Food and Agriculture Organization (FAO) and World Cooperating with Developing Countries Health Organization (WHO) that sets international stan- To enhance environmental protection world-wide, dards for pesticide residues in foods. The United States is OPP and its Regional offices work with developing working to improve the scientific basis and timeliness of countries to improve pesticide regulation and promote Codex decisions, and to boost public participation. the sound management of chemical production, distri- North American Free Trade Agreement bution, use and disposal. Activities in 1998 included: (NAFTA) Activities • training and consulting with the Pesticide Cooperative work with Canada and Mexico under the Secretariat of the Indonesian Ministry of NAFTA Technical Working Group on Pesticides contin- Agriculture as part of a capacity-building project ued to grow in 1998 and 1999. The first joint review of funded by the World Bank; the conventional “reduced risk” pesticide was successful- • developing a Central American regional pesticide ly completed in 1998, with coordinated registrations laboratory training seminar, in collaboration with issued in Canada and the United States. In 1999, the international development agencies; United States and Canada completed the joint reviews of • working with the Choluteca community in two additional conventional “reduced risk” pesticides Honduras on a community-based pesticide risk and one pheromone. NAFTA countries developed a pro- reduction plan which could serve as a model for cedure and priority scheme for handling agricultural other Central American communities; and impediments to trade (e.g., different registrations or tol- • initiating new pest/pesticide management project erances) and are continuing to work with growers and with Ukraine, under the leadership of Region 5 and pesticide producers to resolve them, particularly with in cooperation with the Agency for International

PARTNERSHIPS respect to canola production and pesticide seed treat- Development and Virginia Tech. ▼ 28 FY 98-99 OPP BIENNIAL REPORT Field Programs

HE EPA’S OFFICE OF PESTICIDE PROGRAMS (OPP) RELIES HEAVILY ON cooperative relationships with EPA regional offices, state pesticide regulatory agencies, T and tribes, in addition to public and private organizations and other stakeholders to carry out its regulatory programs in the field. ▼ tations with the FWS to include specific pesticides and species. Finally, the Endangered Species Protection The removal of Program continues to work with the pesticide indus- these birds from try’s FIFRA Endangered Species Task Force, which was formed to address certain endangered species protec- the Endangered tion conditions on new registrations. Species list is the Highlighting a Success: The Peregrine Falcon and the American Bald Eagle culmination of the On August 20, 1999, the Department of the Interior announced final action removing the peregrine falcon good work of many from the Endangered Species List. A proposal to people and agencies remove the American bald eagle from the list was announced in July 1999. through the years. The removal of these birds from the Endangered The woodstork is protected by the Species list is the culmination of the good work of Endangered Species Protection Program many people and agencies through the years. It is a reminder that laws, such as FIFRA and the Endangered Focusing on the Endangered Species Act, in combination with the will and skill to Species Protection Program administer them, can make a profound difference in our environment. The Endangered Species Protection Program relies Recovery of these birds began with, and would not on cooperation between the U.S. Fish and Wildlife have been possible without, the cancellation of DDT in Service (FWS), EPA Regions, states, and pesticide users. the 1970’s. The decision to cancel DDT was difficult The goal of the Endangered Species Protection Program and controversial, but the results have paid off many- is to protect threatened and endangered species from fold for protecting human health and the environment. potentially harmful effects of pesticides, while mini- mizing the impact of the program on pesticide users. Developing the Ground Water In 1998 and 1999, the Endangered Species Pesticide Management Plan Protection Program focused on improving the avail- Program ability of public and technical information, and consultation with stakeholders. OPP upgraded its toll-free The ground water Pesticide Management Plan endangered species information line to include “fax- (PMP) program continued to move forward in 1998- back” capability for county bulletins, which contain 99. When final, the PMP program will provide states measures pesticide users can take to prevent harm to and tribes the opportunity to manage use of pesticides endangered species. OPP also upgraded the species- known to be found in ground water. The PMP pro- by-county database to include all species listed through gram employs management measures that can be tai- June 1999, and made the database Internet-accessible. lored by states or tribes to reflect their philosophy on With development of a new Geographic Information ground water protection, pesticide use in their area, System data for several states, OPP is overlaying crop, and the use, value, and vulnerability of ground water. rangeland and forestry information with species loca- The regulatory review team continued efforts to tions and pesticide use data for two pilot states in the address public comments on the proposed regulation western United States. Preliminary results indicate and to develop the final regulation, which is anticipat- that this will be a powerful tool in focusing our consul- ed to be promulgated in the Spring of 2000. FIELD PROGRAMS

FY 98-99 OPP BIENNIAL REPORT 29 ▼ The PMP program is unique in that it recognizes the these products from winding up in ditches, streams, local knowledge possessed by states and tribes regard- and ground water. ing the ground water resource; the regulatory review These efforts, referred to as Clean Sweep Programs, New Regional team is unique in that all 10 EPA Regional Offices, plus play an important role in pollution prevention and, as Approach to 10 states and three tribes, are represented. funding allows, are supported by EPA Regional Offices Pesticide Two innovative PMP outreach activities began in through grants and technical assistance. While some Education and 1998 and 1999. OPP designed a new approach to pro- programs are fully implemented and permanent oper- Enforcement viding information and technology transfer in Indian ations for regular collection and disposal of unwanted Country. More than 5% of the nation’s land base is products, many states face unpredictable funding and n 1998, EPA located on tribal lands and over sixty tribes have been operate their programs on an occasional or one-time IRegion 10 initiated identified as having significant agricultural operations basis when funds are available. a new “circuit rider” affected by the proposed PMP rule. The Agency’s tribal During 1999, OPP began tabulating data on Clean staff position to outreach efforts were designed to improve the knowl- Sweep Programs, and developing a clearinghouse for work with six tribes edge of tribal environmental agencies and staff about information on this topic. Information gathered by in the region. The developing PMPs using training which considers Native OPP shows these programs are increasing and are col- new staff person American land-use and cultural beliefs and practices. lecting greater volumes of unwanted pesticides. travels among the In 1998 and 1999, the regulatory review team con- Between 1989 and 1998, over 13 million pounds of six reservations and ducted 22 training sessions or workshops in Indian unwanted product were collected and disposed of enforces tribal and Country. These included outreach sessions, rule-edu- safely. federal pesticide cation workshops to guide participants through the OPP will compile the data and individual state infor- regulations, while essentials of OPP’s rulemaking and chemical-specific mation in a Clean Sweep Report during the year 2000. sharing information management programs, and workshops for training The report will publicize successes of Clean Sweep pro- with the tribes that interested tribes in developing a model or “shell” PMP. grams nationwide, and provide ideas and information use pesticides or During the first six months of the program, more than for program managers wishing to initiate or improve a are impacted by 250 tribal officials and environmental professionals program. The report will also support EPA’s integrated pesticides. were introduced to the PMP concept of adopting man- strategy on persistent and bioaccumulative toxic chem- agement measures based on local natural conditions icals (PBTs), which includes both national programs, and levels of pesticide use. such as the Great Lakes National Program Office, and Also in 1998, a team from EPA Headquarters and EPA international treaty negotiations, such as the Persistent Region 7, joined by state agencies from Missouri, Organic Pollutants (POPs) Protocol. Kansas, Iowa and Nebraska, and two grower organiza- In 1999, OPP issued a Call for Proposals to fund pro- tions, developed, planned and executed a process to bet- jects for states, tribes, or counties to monitor and ter inform growers of the provisions of the PMP rule. report the amount of specific pesticides collected dur- Approximately 100 people representing growers, ing Clean Sweep Programs and to estimate the cost of industry, natural resources protection agencies, public tracking this additional information. OPP is interested interest groups, universities, and federal agencies, in data on amounts of all pesticides, but is focusing on attended a workshop that allowed participants to devel- those which support EPA’s broad PBT Initiative and the op parts of a “mock” PMP and put it into practice based POPs treaty negotiations. on several different scenarios of pesticide use and ground water contamination detections. According to Developing Tribal Initiatives and evaluations from participants, the workshop was a suc- Programs cess and can be used as a model to engage the grower community on a variety of issues in the future. Like states, tribes have primary responsibility for enforcing pesticide regulations under FIFRA. A num- Preventing Pesticides in the ber of tribes provide this function under a grant agree- Environment Through Container ment with EPA Regions and are in the process of devel- And Containment Standards and oping programs for these areas as needed. OPP works Support of Collection Programs with tribes, EPA Regions, states, other EPA program offices (e.g., the American Indian Environmental OPP continued developing final regulations for pes- Office, Office of General Counsel) and other federal ticide container standards and containment areas. agencies coordinating efforts related to tribes and pes- While the regulations do not specifically address dis- ticides. It is OPP’s goal to help tribes resolve pesticide posal of unwanted pesticides, OPP continues to sup- issues regardless of their capacity or whether they have port state efforts. States have taken the initiative to col- an established pesticide program. lect and dispose of unwanted pesticides to prevent FIELD PROGRAMS ▼ 30 FY 98-99 OPP BIENNIAL REPORT Currently, OPP works with over 25 tribes that have Supporting Agricultural Workers pesticide programs, helping them develop ground water, certification and training, worker protection Special Protection for Agricultural ▼ and endangered species components of their pro- Workers Tribes and EPA lost a true grams. Other activities relating to Tribal Initiatives EPA places strong emphasis on assuring the health and Programs include: of workers whose jobs require mixing, loading, or environmental advocate applying pesticides, and is committed to strengthening National Tribal Pesticide Council–In with the October 1999 September 1999, EPA awarded a cooperative agree- national efforts to safeguard upwards of 3.5 million ment to Native Ecology Initiative (NEI) to organize a farm workers and their families. EPA’s Worker death of Conner Protection Standard, first implemented in 1992, has national group–the Tribal Pesticide Program Council Byestewa, Jr. of the (TPPC). Membership will initially include 30 tribes resulted in safety education and training efforts across that now have EPA pesticide programs and a number of the country. Colorado River Indian During 1998 and 1999, our Worker Protection tribes with pesticide interests. The TPPC will promote Tribes in Parker, Arizona. and enhance tribal pesticide program development, Program devoted significant resources to producing raise pesticide issues important to tribes and their peo- and distributing bilingual or multi-lingual educational He contributed signifi- materials. Communications include a new Pesticide ple, and deal with policy at the national level. TPPC cantly to the develop- issues will include pesticide registration, training, Workers Website, publication of over 1 million grower enforcement, certification, ground water, disposal and compliance manuals, over 2.7 million safety training ment of the Tribal manuals, over 680,000 safety posters, and more than spray drift. The national group give tribes a mecha- Pesticide Program nism for communication and organization similar to 11,000 safety training videos. that provided by the State FIFRA Issues Research and EPA began reviewing worker protection activities, Council. Conner was including risk assessment methods, to determine if Evaluation Group (SFIREG) for the States. well known for his ability workers are receiving adequate protection. Last year, Outreach to Tribes on Groundwater EPA initiated a national assessment of implementation to create change through Management–During 1998 and 1999, through a and enforcement of the worker protection regulation. personal involvement and grant with the Native Ecology Initiative, EPA provided We are establishing a worker protection assessment tribes across the country with information on EPA’s group comprised of EPA, USDA, the Department of positive relationships. We proposed Pesticide Management Plan rule, as well as Labor, the Department of Health and Human Services, appreciated his gentle technical and legal assistance for developing ground- state regulators, state extension service safety educa- water management plans. EPA also entered into an tors, farm worker advocacy groups, farm worker ser- way, his humor, and his Interagency Agreement (IAG) with the U.S. Geological vice/training associations, agricultural employer asso- presence. He will be Survey (USGS) to support tribes and states in the ciations, farm worker clinicians networks, and others. development of PMP’s. In this IAG, USGS assists The group’s goals are to: greatly missed. tribes and states as they collect, integrate and interpret • assess the current program’s status; existing technical information and apply it to their • generate stakeholder interest that can effect change lands of interest as they develop a PMP. in the programs; Tribal Pesticide Projects–In 1998, OPP solicited • foster the partnerships essential to make the Conner Byestewa, Jr., Colorado River Indian tribal pesticide project proposals through the Regions program work; and, most importantly, Tribes, shares news and awarded grants for the projects to tribes across the • provide a continuing forum to focus on, and hope- fully resolve, worker protection issues. from Indian country nation. The projects addressed various pesticide issues with OPP staff. on tribal land. Six out of ten project proposals were chosen. There was a significant increase in the submission of tribal project proposals in 1999. Eight out of 25 groundwater project proposals submitted were funded from Regions 6, 7, 8 and 9. Six out of 19 special pesticide project proposals submitted were funded from Regions 8, 9 and 10. The types of projects selected for funding ranged from the development of groundwater pesticide management plans to assessing the impact of pesticides on culturally significant plants and subsis- tence hunting and fishing. FIELD PROGRAMS

FY 98-99 OPP BIENNIAL REPORT 31 ▼ The worker protection assessment group will devel- Developing an Interagency op a strategic plan for the national worker protection Initiative: Pesticides and the FIFRA Section program and issue annual reports detailing accom- National Strategies for Health Care 6(a)(2) plishments and progress towards achieving its goals. Providers Submissions Applicator Certification and Training More than 1.2 million applicators are currently cer- In 1998, an EPA-led interagency initiative began with the support of the U.S. Department of Agriculture, the ection 6(a)(2) of tified nationwide, including over 800,000 private applicators and about 400,000 commercial applicators. U.S. Department of Health and Human Services, and SFIFRA requires pesti- the U.S. Department of Labor. The interagency group cide product registrants Over the past two years, approximately 160,000 private and 170,000 commercial applicators received initial sponsored a workshop to identify strategies to improve to submit adverse the ability of health care providers to recognize, diag- effects information certification and more than 400,000 private and 380,000 commercial applicators were recertified. nose, manage and prevent adverse health effects due to about their products to pesticide exposure. OPP. OPP reviews these EPA also conducted a national assessment of the applicator certification and training program. A certi- Based on the proceedings of the workshop, EPA submissions and studies Pesticides and National fication and training assessment group, consisting of published a report, to see if there are risks Strategies for Health Care Providers, which outlines a associated with the representatives from EPA, USDA, state pesticide agencies, tribes, and pesticide safety educators, was formed series of recommendations for improving the training product that were not that health care providers receive on health concerns anticipated at the time to draft proposals to guide the program’s future. The proposals for review by the nation’s program partners related to pesticide exposures. Among the recommen- of registration. In late dations are the need to: 1998, OPP's new are grouped under five program goals: • reduce risks to the public from exposure to pesti- • specify competencies that healthcare providers adverse effects report- should demonstrate upon completion of their edu- ing requirements took cides; • provide high quality pesticide use education and cation and other specialty training; effect. These regula- • develop educational tools and training materials tions clarified and in safety training programs; • maintain the consistency, integrity and validity of that will motivate students and health care many cases lowered the providers to acquire an understanding and knowl- threshold for adverse the certification and recertification programs and processes; edge of possible health effects resulting from pesti- incident reporting. As a cide exposure; result, 6(a)(2) submis- • ensure adequate and equitable funding for education and training programs; and, • raise awareness and make more information avail- sions increased consid- able to providers on health complaints and illnesses erably during FY99. For • improve the efficiency of program organization and operations. that may be related to pesticide exposure through additional information materials and resource development, professional on 6(a)(2), please refer Response from the program partners and the program stakeholders will help frame a national strategy meetings, marketing and outreach programs, and to the Appendix, other activities. Figure 3. for the future of the applicator certification and training program. To carry forward this initiative, and further develop • In FY 1998, OPP these broad strategies, workgroups were created in received approxi- Pesticide Worker Website three core areas: Formal Education of Health Care mately 1,800 sub- In 1999, EPA launched a new website Providers; Health Care Provider Practice; and missions containing (www.epa.gov/pesticides/safety) to inform farm work- Resources for Health Care Providers. reports of more than ers, certified applicators, and health care providers In May 1999, EPA and several other federal agencies 22,000 incidents. about the Agency’s pesticide safety programs. This convened the Education and Practice workgroups to • In FY 1999, OPP site, which provides easy access to information in both further develop components of an implementation received nearly English and Spanish, marks an important step in the plan for raising knowledge and awareness of pesticide 1,500 submissions Agency’s pesticide worker safety outreach efforts. It issues in the educational and practice settings of pri- containing reports of provides specific information on applicator certifica- mary care providers. Workgroup members came from more than 46,000 tion and training requirements and EPA’s Worker academic faculty, professional associations for physi- incidents. Protection Standard, including pesticide safety train- cians, nurses and physician assistants, farmworker and ing, notification of pesticide application, use of per- community interest groups, federal and state agencies, sonal protective equipment, and emergency medical and pesticide experts. A third workgroup on Resources assistance. Finally, the web site contains the 5th began its deliberations in August 1999. Edition of Recognition and Management of Pesticide Once the workgroups have developed proposals, a Poisonings, a manual that assists health care providers draft national implementation plan will be published in diagnosing and managing pesticide poisonings, which will serve as a working document for the next which was published in 1999. year of activity on this initiative, culminating in a national forum in 2000. FIELD PROGRAMS ▼ 32 FY 98-99 OPP BIENNIAL REPORT Right to Know

ROVIDING ALL AMERICANS WITH ACCESS TO INFORMATION ABOUT PESTICIDES and involving them in our work are essential parts of the Agency’s comprehensive P approach to protecting public health and the environment. This goal is premised on the concept that all U.S. citizens have a right to know about the pesticides in their environment, as well as those used to grow food they consume. Access to such information six million copies have been dis- enables Americans and the inter- tributed to 30,000 grocery stores, national community to make public health officials, libraries, ▼ informed decisions about their and the medical community and environment. In 1998 and 1999, it is also available on our website. This goal is the Office of Pesticide Programs Responding to Written premised on the expanded its pesticide education and Electronic Inquiries and outreach programs by dis- OPP places great importance concept that all U.S. seminating information about on listening and responding in a pesticides to the public through timely fashion to comments and citizens have a right fact sheets, brochures, other writ- inquiries from the general public ten correspondence and docu- to know about the on the various pesticide pro- ments, the Internet, mass media, grams. In 1998 and 1999, OPP pesticides in their public meetings, press announce- responded to over 2,700 inquiries ments, and other outreach tools. from the public and their repre- environment as well Highlights of some these docu- sentatives in Congress. These ments are provided below. as those used to inquiries came in the form of e- Expanding Pesticide mails, postcards, letters, and grow food they phone calls and ranged from citi- Education and consume. Outreach Materials zens seeking information on pes- to the Public ticide health issues to expressions of opinions regarding pesticide Disseminating Fact regulations. Sheets and Brochures Providing Pesticide Over the past two years, we Information on the developed over 30 fact sheets for Internet: the public on topics ranging from www.epa.gov/pesticides pesticides and mosquito control OPP’s use of the Internet con- to Integrated Pest Management and food production. tinued to grow during the past two years, offering With advice from the Pesticide Program Dialogue information for consumers, businesses, researchers, Committee and consumers, and in consultation with states, and international partners. The Website has USDA and FDA, EPA developed in English and become an important resource to OPP’s customers and Spanish, the brochure, “Pesticides and Food: What You is beginning to have a fundamental effect on the way and Your Family Need to Know.” The brochure OPP communicates. informs consumers about pesticide use on food, gov- The increase in Internet access has made it easier for ernment programs that protect them from pesticide the public and stakeholders to get the information they risks, and ways they can reduce their exposure to pesti- need and want, saving them time and natural cides. The brochure also explains how the Food Quality Protection Act (FQPA) increases protection of infants and children from exposure to pesticides. Over RIGHT TO KNOW

FY 98-99 OPP BIENNIAL REPORT 33 ▼ resources. Highlights of new items added to OPP’s • a FIFRA Section 18 database listing actions, by website over the past two years include: chemical name (FIFRA Section 18 allows states, • the activities of the Pesticide Program Dialogue under emergency conditions, to use a pesticide for Committee and Tolerance Reassessment Advisory an unregistered use for a limited time); Committee; • various forms and guidance information required • guidance for submitting pesticide registration docu- for pesticide registration; ments electronically known as “CADDY”; • a regional, state and tribal web page, which • EPA’s scientific reviews of the class of pesticides includes information on OPP’s field programs that called organophosphates. This is the first time risk help put pesticide laws and regulations into prac- assessments have been published on the website, tice; making them widely available for public comment. • extensive information about biopesticides; This effort to increase transparency has evolved • the “Pesticides and Food” website, which is refer- into a comprehensive organophosphate homepage, enced in the printed brochure, provides consumers providing updated schedules, risk assessments, and with more detailed information on pesticide regula- other information on the organophosphate pesti- tion (www.epa.gov/pesticides/food); cides as the information is placed in the Pesticides’ • “Sign up” through the Web site to a mailing list for Docket (an information collection and dissemina- electronic OPP Updates. tion service that provides public access to proposed Finally, OPP made significant changes to the web- rules and regulations relating to pesticides); site’s design, making it easier and quicker for people to • the Pesticide Management Resource Guide; find information. For example, at the home page, the • the Label Review Manual, developed as a training browsing public now has access to enhanced search and guidance tool for reviewing pesticide product tools, as well as a “site map” which presents major cat- labels; egories of information and related documents. Providing Toll-Free Access to Pesticide Information

Sometimes people want to pick up the telephone and communicate with a real person on a particular issue. To answer questions the public may have about pesticides, the Office of Pesticide Programs provided a grant to Oregon State University in Corvallis, Oregon, to operate two toll-free telephone services: the National Pesticide Telecommunications Network and the National Antimicrobial Information Network. National Pesticide Telecommunications Network (NPTN) NPTN provides objective, science-based information on a wide variety of pesticide-related subjects. The NPTN website is an increasingly popular source of information and can be accessed at http://ace.orst.edu/info/nptn. In 1998 and 1999, NPTN answered over 46,000 requests from the public, including over 36,800 calls received between March and October of both years. This coincides with the RIGHT TO KNOW ▼ 34 FY 98-99 OPP BIENNIAL REPORT time of year when most pest pressures are the highest. Over 20,000 calls were health-related inquiries. Approximately 10,000 calls were for information about pesticide usage, and nearly 5,000 calls were of a regulatory nature. National Antimicrobial Information Network (NAIN) Another toll-free service available to the public is the National Antimicrobial Information Network (NAIN), which provides a wide variety of information about antimicrobial pesticides. NAIN also has an Internet service. Organized as a cooperative effort between Oregon State University and EPA, NAIN maintains information on the toxicity, health effects, and safety of antimicrobial pesticides. It also maintains lists of antimicrobial products registered with EPA, including sterilants, disinfectants, tuberculocides, and products effective against HBV and HIV. NAIN also helps callers interpret product labels and EPA’s antimicrobial poli- plaints, including complaints about unregistered or Staff from NPTN cies and regulations. The website, which receives ineffective antimicrobial products. Common ques- answer an average of about 20,000 hits annually, contains regulatory and tions include: 2,000 inquiries per policy documents to help keep interested parties up-to- • can household bleach be used for cleaning blood month. date about antimicrobial activities. spills in medical settings? Within the last two years, NAIN has received an • is product X registered for use in nursing homes? average of 2,000 telephone calls. More than half of the • should my restaurant install “antimicrobial” callers are from the medical community, with manu- carpeting? facturers and the general public accounting for most of While continuing to respond to all inquiries, NAIN the remainder. Most callers request information about plans to maintain, expand, and publicize its antimicro- specific products or types of products; the next largest bial website, and develop documents and fact sheets set of calls covers regulation, registration, and com- that answer frequently asked questions and that provide information on common antimicrobial products. NAIN operates toll free at 1-800-447-6349, Monday through Friday 7:30 a.m. to 4:30 p.m. Pacific time. The fax number is 541-737-0761; e-mail: [email protected]; website: http://ace.orst.edu/info/nain/ RIGHT TO KNOW

FY 98-99 OPP BIENNIAL REPORT 35 ▼ Appendices

TABLES AND FIGURES OF OPP’S FISCAL YEAR 1998 AND 1999 ACCOMPLISHMENTS

PAGE

TABLE 1 Registration of Safer Chemicals 37

TABLES 2 & 3 Pesticide Active Ingredients Registered 38

TABLES 4 & 5 Registration Decisions versus Targets 40

TABLES 6 & 7 Risk Reduction Measures Achieved through REDs 42

FIGURE 1 Cumulative Status of Reregistration: 44 Reregistration Eligibility Decisions (REDs) FIGURE 2 Tolerance Reassessment Accomplishments 45

FIGURE 3 Outcome of 6(a)(2) Submissions 46

LIST 1 Pesticide Stewardship Program Partners and Supporters 47

LIST 2 OPP Divisions 49

LIST 3 Regional Pesticide Offices 50

LIST 4 Acronyms 51 APPENDICES ▼ 36 FY 98-99 OPP BIENNIAL REPORT TABLE 1 Registration of Safer Chemicals

The proportion of pesticide active ingredients that are considered to be safer (biological chemicals and reduced-risk conventional chemicals) than conventional chemical pesticides has steadily increased over the past several years, as the chart below indicates.

NUMBER OF PESTICIDE REGISTRATIONS BY CATEGORY

BIOLOGICALS REDUCED-RISK CONVENTIONAL CONVENTIONAL CHEMICALS CHEMICALS 40

15 REGISTRATION

1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 YEAR APPENDICES

FY 98-99 OPP BIENNIAL REPORT 37 ▼ TABLE 2 Pesticide Active Ingredients Registered in FY 1998

Of the 27 new active ingredients registered, 14 are safer pesticides. For the purpose of this chart, safer pesticides are those that have at least one or more of the following characteristics: they have low risk to human health; low toxicity to non-target organisms (birds, fish and plants); low ground water contamination potential; low use rates; low pest resistance potential; are compatible with integrated pest management (IPM); or are biopesticides. Non-reduced-risk pesticides do not pose unreasonable adverse affects, but may have the potential to cause greater harm than reduced risk pesticides if not properly used.

PESTICIDE TYPE CLASS USES SAFER Bt Isrealensis Strain insecticide microbial mosquito yes Canola oil insecticide biochemical range of fruit, vegetables, ornamentals yes Carfentrazone-ethyl herbicide conventional corn, soybeans, wheat yes Cloransulam-methyl herbicide conventional soybeans no Cry9C Protein insecticide plant-pesticide field corn yes Cuprous Chloride fungicide conventional non-food no 2-Cyclopenten-1-one, 2 hydroxy- insect attractant biochemical roach attractant-non food yes 3-methyl Maple lactone Cymoxanil fungicide conventional potatoes no Cyprodinil fungicide conventional stone fruit, pome fruit, grape, almond yes Dimethomorph fungicide conventional potatoes no Fish oil mammal repellent biochemical ornamentals yes (deer, rabbits) Flufenacet herbicide conventional corn, soybeans no Fluroxypyr herbicide conventional wheat, barley, oats no Gamma aminobutyric acid plant regulator biochemical field crops, vegetables, ornamentals yes Gliocladium catenulatum fungicide microbial range of fruit, vegetables, ornamentals yes strain J1446 Hypochlorous acid biocide antimicrobial indoor, non-food use no Imiprothrin insecticide conventional indoor, non-food use no Isoxaflutole herbicide conventional corn no Kaolin insecticide, fungicide biochemical all ag crops yes Kresoxim-methyl fungicide conventional non-food use no L-Glutamic acid plant regulator biochemical field crops, vegetables, ornamentals yes Mono and di potassium salts fungicide biochemical turf, ornamentals, bedding plants yes of phosphorous acid Monobasic potassium fungicide biochemical apples, grapes, cucurbits, stone yes phosphate fruits, peppers, tomatoes, roses Paccilomyces fumororoseus insecticide microbial greenhouses, interiorscapes yes Apopka Strain 97 Potassium hypochlorite disinfectant antimicrobial indoor, non-food use no Propazine herbicide conventional greenhouses no Pyrimethamil fungicide conventional imported wine grapes no APPENDICES ▼ 38 FY 98-99 OPP BIENNIAL REPORT TABLE 3 Pesticide Active Ingredients Registered in FY 1999

Of the 26 new active ingredients registered, 19 are safer pesticides. For the purpose of this chart, safer pesticides are those that have at least one or more of the following characteristics: they have low risk to human health; low toxicity to non-target organisms (birds, fish and plants); low ground water contamination potential; low use rates; low pest resistance potential; are compatible with integrated pest management (IPM); or are biopesticides. Non-reduced-risk pesticides do not pose unreasonable adverse affects, but may have the potential to cause greater harm than reduced risk pesticides if not properly used.

PESTICIDE TYPE CLASS USES SAFER Agrobacterium radiobacter fungicide biopesticide crown gall yes (strain K 1026) Anthraquinone repellent biopesticide geese yes Bifenazate insecticide conventional ornamentals yes reduced risk Diflufenzopyr herbicide conventional corn yes a-dod.... reduced risk (E)-90dodecenyl acetate insecticide/pheremone biopesticide shoot borers yes Emamectin Benzoate insecticide conventional brassica, lettuce, celery no Fenhexamid fungicide conventional grapes, strawberries yes reduced-risk Fluthiacct-metyl (Action) herbicide conventional soybean seed no Formic Acid insecticide biopesticide mites yes IR 3535 repellent biopesticide mosquitoes yes Lithium P. Sulfonate insecticide conventional wasp bait station no Methylcyclopropene plant growth regulator biopesticide cut flowers yes 3-methyl-2-cyclohex-1-one pheremone type biopesticide beetles (forestry) yes n-Methylneodecanamide insecticide conventional indoor use no Nonanoyloxybenzene Sulfonate antimicrobial conventional laundry sanitizer no Oxypurinol insecticide biopesticide cockroach yes Potato Leafroll Virus fungicide plant-pesticide potatoes yes Resistance Gene Pseudomonas aureofaciens strain fungicide biopesticide turf yes TX-1 Pymetrozine insecticide conventional tuberous and corn vegetables, yes reduced-risk tobacco, ornamentals s-Dimethenamid herbicide conventional dry beans, corn, popcorn, peanuts, yes reduced-risk soybean Sulfosulfuron herbicide conventional wheat no Tralkoxydim herbicide conventional wheat, barley no Trifloxystrobin fungicide conventional pome fruits, grapes, cucurbits, yes peanuts, bananas, turf Xanthine insecticide biopesticide cockroach yes Z,E-9, 12-Tetradecadien-1-yl insecticide biopesticide beet army worm yes acetate(4) Z-9-Tetradecen-1-ol(4) insecticide biopesticide beet army worm yes APPENDICES

FY 98-99 OPP BIENNIAL REPORT 39 ▼ TABLE 4 Registration Decisions Versus Targets in FY 1998

The following table summarizes, by action, the number of decisions that were made in the Office of Pesticide Programs versus the target, or goal, that the program anticipated could be made. The target numbers are determined by anticipating market influences and taking into account past trends.

REGISTRATION CATEGORY TARGETS DECISIONS

Old chemicals (fast track1) 364 478 Old chemicals (non-fast track2) 275 334 Amendments (fast track1) 1810 2946 Amendments (non-fast track2) 246 375

New uses 99 320 New active ingredients 29 27 Experimental use permits3 —8 Tolerances 91 236 Temporary tolerances — 18 Inerts (non-active ingredients) 41 110 Emergency exemption (Section 18) decisions 366 504 Emergency exemption (Section 18) tolerances — 95 Special local needs4 — 349 Biotech notification5 —3

1Fast Track An application for registration of a pesticide product that is substantially similar or identical in its uses and composition (both active and other ingredients) to a currently registered product. Typically, no significant data need to be reviewed before the Agency can issue a registration decision. 2Non-Fast Track An application for a registration of a pesticide product that is sufficiently different in composition and/or uses that additional product specific data must be reviewed prior to the issuance of a registration decision. Typically, these data include acute toxicology, product chemistry, and product-specific efficacy. 3Experimental Use Permits (EUP) EPA normally must first authorize field testing of unregistered pesticides through an experimental use permit (EUP). The EUP establishes limited conditions for the transportation, application and disposal of unregistered test products. The granting of an EUP limits the sale and distribution of the test product only between approved participants in the test program, and use of the test product only under conditions specified in the EUP. Registrants typically request EUPs to gather large-scale efficacy testing and/or crop-specific residue chemistry data. 4Special Local Needs Under Section 24(c) of FIFRA, states may register an additional use of a federally registered pesticide product, or a new end use product to meet special local needs. “Special local need” means an existing or imminent pest problem within a state for which the state lead agency, based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide product is not sufficiently available. EPA reviews these registrations, and may disapprove the state registration if, among other things, the use is not covered by necessary tolerances, or the use has been previously denied, disap- proved, suspended or canceled, or voluntarily canceled subsequent to a notice concerning health or environmental concerns. 5Biotech Notification A Biotech Notification is a submission of information to OPP prior to any small-scale testing of certain genet- ically modified and nonindigenous microbial pesticides. OPP has 90 days to solicit public comment, review the submission, and decide, among other options, whether to allow the release or not, or to require an EUP. APPENDICES ▼ 40 FY 98-99 OPP BIENNIAL REPORT TABLE 5 Registration Decisions Versus Targets in FY 1999

REGISTRATION CATEGORY TARGETS DECISIONS

Old chemicals (fast track1) 342 513 Old chemicals (non-fast track2) 258 509 Amendments (fast track1) 1760 3141 Amendments (non-fast track2) 240 445

New uses 90 681 New active ingredients 24 26 Experimental use permits3 —29 Tolerances 95 351 Temporary tolerances — 6 Inerts (non-active ingredients) 45 109 Emergency exemption (Section 18) decisions 370 542 Emergency exemption (Section 18) tolerances — 62 Special local needs4 — 596 Biotech notification5 —1

1Fast Track An application for registration of a pesticide product that is substantially similar or identical in its uses and composition (both active and inert (other) ingredients) to a currently registered product. Typically, no significant data need to be reviewed before the Agency can issue a registration decision. 2Non-Fast Track An application for a registration of a pesticide product that is sufficiently different in composition and/or uses that additional product specific data must be reviewed prior to the issuance of a registration decision. Typically, these data include acute toxicology, product chemistry, and product-specific efficacy. 3Experimental Use Permits (EUP) EPA normally must first authorize field testing of unregistered pesticides through an experimental use permit (EUP). The EUP establishes limited conditions for the transportation, application and disposal of unregistered test products. The granting of an EUP limits the sale and distribution of the test product only between approved participants in the test program, and use of the test product only under conditions specified in the EUP. Registrants typically request EUPs to gather large-scale efficacy testing and/or crop-specific residue chemistry data. 4Special Local Needs Under Section 24(c) of FIFRA, states may register an additional use of a federally registered pesticide product, or a new end use product to meet special local needs. “Special local need” means an existing or imminent pest problem within a state for which the state lead agency, based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide product is not sufficiently available. EPA reviews these registrations, and may disapprove the state registration if, among other things, the use is not covered by necessary tolerances, or the use has been previously denied, disap- proved, suspended or canceled, or voluntarily canceled subsequent to a notice concerning health or environmental concerns. 5Biotech Notification A Biotech Notification is a submission of information to OPP prior to any small-scale testing of certain genet- ically modified and nonindigenous microbial pesticides. OPP has 90 days to solicit public comment, review the submission, and decide, among other options, whether to allow the release or not, or to require an EUP. APPENDICES

FY 98-99 OPP BIENNIAL REPORT 41 ▼ TABLE 6 Risk Reduction Measures Achieved through FY 1998 REDs

RED

Some usesLimit canceled, amount,Residential/kids’ deleted, frequency,ApplicationRestricted not risks timing yetrestrictions addressedPPE/REIeligible ofuse use pesticideUser safetyEngineering requirements,Ground controls/specialSpray or surface recommendations driftOther labelingwater environmentalpackagingEcological safeguardsImprove safeguards safeguardsOther labeling, measuresTolerances use directions reassessed & precautions ✔ ✔✔✔✔✔✔✔✔ ✔ ✔ Alachlor ✔1 ✔✔✔ Aluminum phosphide Magnesium phosphide ✔1 ✔✔✔ Bromoxynil ✔✔ ✔✔ ✔✔ ✔ Chlorothalonil ✔ ✔✔✔✔✔✔✔✔✔✔ ✔2 ✔ DEET ✔3 ✔✔ ✔ ✔ 1,3-Dichloropropene ✔✔✔✔✔ ✔✔✔ ✔✔ ✔4 Dicofol ✔5 ✔✔✔ ✔✔✔ ✔✔✔ ✔ Hydramethylnon ✔✔ ✔✔ ✔ ✔ ✔ ✔✔✔ ✔✔✔✔✔✔✔ ✔ Iprodione ✔ ✔✔✔✔✔✔✔✔✔ ✔6 ✔ Methomyl ✔ ✔ ✔✔✔✔✔✔✔✔ ✔ Propachlor ✔ ✔✔✔✔✔✔✔✔✔ ✔6 ✔ Thiodicarb Total 7 7 7 11 7 10 11 8 8 9 8 6 5 4 11 ✔1 STAKEHOLDER PROCESS UNDERWAY WILL HELP DETERMINE ELIGIBILITY AND FINAL RISK MITIGATION MEASURES FOR AL AND MG PHOSPHIDE. ✔2 PRODUCTION CONTROLS–MUST REDUCE LEVEL OF HCB IMPURITY TO 40 PPM BY 1/1/03. ✔3 STAKEHOLDER PROCESS UNDERWAY WILL HELP DETERMINE ELIGIBILITY OF DEET-PLUS-SUNSCREEN PRODUCTS ✔4 TECHNOLOGICAL CONTROLS, IMPROVED PRODUCT STEWARDSHIP MATERIALS ARE REQUIRED FOR 1,3-D. ✔5 RESIDENTIAL USES OF DICOFOL VOLUNTARILY CANCELED; NEW STUDIES TO DETERMINE ELIGIBILITY OF REMAINING USES; VOLUNTARY CANCELLATION IF RISKS DO NOT DECLINE. ✔6 STATEMENT SUPPORTING USE OF AN IPM PLAN MUST BE ADDED TO METHOMYL AND THIODICARB LABELS. APPENDICES ▼ 42 FY 98-99 OPP BIENNIAL REPORT TABLE 7 Risk Reduction Measures Achieved through FY 1999 REDs

RED

VoluntarySome cancellation usesLimit canceled, amount,Residential/kids’ deleted, frequency,ApplicationRestricted not risks timing yetrestrictions addressedPPE/REIeligible ofuse use pesticideUser safetyEngineering requirements,Ground controls/specialSpray or surface recommendations driftEnvironmental labeling/advisorywater packagingImprove safeguards Otherhazards labeling, measuresTolerances statements use*This directions includesment reassessed decisions the &number precautionsmade and for typeeach of chemical tolerance listed. reassess- Bendiocarb ✔1 ✔✔1 2 R2

Captan ✔3 ✔✔✔ ✔✔✔ ✔✔✔ 60 ✔ EPTC ✔4 ✔✔✔ ✔✔✔ ✔✔✔ 20 ✔ Folpet ✔5 ✔✔✔✔✔✔ 10 ✔ Fonfos ✔ 35 R Isofenphos ✔✔6 24 R Niclosamide ✔7 ✔✔✔✔✔ ✔✔ N/A8 Oxythioquinox ✔ 22 R Pebulate ✔ ✔ ✔✔✔ ✔✔✔ 3 ✔ Ryanodine ✔ 1 R Sulfotepp ✔ ✔✔✔✔✔ ✔✔✔9 N/A TFM ✔✔✔✔✔ ✔✔ N/A TPTH ✔ ✔✔✔✔✔✔✔✔✔ 13 ✔ Vernolate ✔ 13 R Total 7 4 6 4 8 4 8 8 5 1 5 8 7 3 106 ✔ +97 R =203 Total ✔1 BENDIOCARB VOLUNTARY CANCELLATION INCLUDES PRODUCTION CAP AND PHASE OUT. R2 NUMBER OF TOLERANCE REVOCATIONS: AS A RESULT OF THE VOLUNTARY CANCELLATION, (2) TOLERANCES ARE BEING REVOKED. ✔3 CAPTAN RED INCLUDES VOLUNTARY CANCELLATION OF RESIDENTIAL TURF USES TO MITIGATE RISKS TO CHILDREN. ✔4 EPTC RED PROHIBITS RESIDENTIAL USE OF EMULSIFIABLE CONCENTRATE FORMULATIONS, AND PROHIBITS USE OF BELLY GRINDER FOR HOMEOWNER PRODUCTS. ✔5 FOLPET RED INCLUDES VOLUNTARY CANCELLATION OF MOST AGRICULTURAL, ORNAMENTAL, AND GREENHOUSE USES (IMPORT TOLERANCES REMAIN)– THE ONLY REMAINING ELIGIBLE USES INCLUDE USE ON FLORIDA AVOCADOS AND IN PAINTS, COATINGS, AND SEALANTS. ✔6 ISOFENPHOS VOLUNTARY CANCELLATION INCLUDES A SALES CAP FOR THE TECHNICAL PRODUCT. ✔7 MOLLUSCICIDE USES OF NICLOSAMIDE ARE BEING VOLUNTARILY CANCELED OR DECLARED INELIGIBLE. N/A8 NOT APPLICABLE (I.E., THE PESTICIDE HAS NO FOOD USES). ✔9 SULFOTEPP VOLUNTARY CANCELLATION INCLUDES A PRODUCTION CAP. APPENDICES

FY 98-99 OPP BIENNIAL REPORT 43 ▼ FIGURE 1 Cumulative Status of Reregistration: Registration Eligibility Decisions (REDs) Completed

OPP presents the results of its reregistration reviews in Reregistration Eligibility Decision (RED) documents. In FY1998, OPP completed 13 REDs, and in FY 1999, OPP completed 14 REDs. At present, the pesticide reregistration program has completed 70% of the number of reviews to be performed. OPP has issued 198 REDs, which represent 32% of the original 612 cases that were subject to reregistration when the program began in late 1988. (14 of the 198 are voluntary cancellations counted as REDs–OPP had made significant progress in developing RED documents for these pesticides when requests for their voluntary cancellation were received.) An additional 231 cases (38%) were voluntarily canceled earlier through the reregistration process. Therefore, 183 reregistration cases (30%) remain to be completed.

PROGRESS IN COMPLETING REDS

183 TO COMPLETE (30%)

198 COMPLETED (32%)

231 CANCELED (38%) APPENDICES ▼ 44 FY 98-99 OPP BIENNIAL REPORT FIGURE 2 Tolerance Reassessment Accomplishments

STATUS OF FY 1998 TOLERANCE REASSESSMENT REGISTRATION ACTIONS

TOTAL NUMBER OF 311 278 REREGISTRATION ACTIONS REASSESSMENT DECISIONS IN FY 1998=1398 FR REVOCATIONS

OTHER REGISTRATION ACTIONS–22.2% 809

FR REVOCATIONS–57.9% REREGISTRATION ACTIONS–19.9%

(OTHER IS 0 FOR FY 1998)

STATUS OF FY 1999 TOLERANCE REASSESSMENT

TOTAL NUMBER OF REASSESSMENT DECISIONS 340 359 REREGISTRATION ACTIONS–24.8% IN FY 1999=1445

OTHER–16.2% 233 REGISTRATION ACTIONS–23.5% 513

FR REVOCATIONS–35.5%

STATUS OF TOLERANCE REASSESSMENT CUMULATIVE SINCE AUG. 3, 1996

TOTAL NUMBER OF 872 999 REASSESSMENT DECISIONS REREGISTRATION ACTIONS–29.1% AS OF OCTOBER 1, 1999=3430 234 OTHER–6.8% 1325 REGISTRATION ACTIONS–25.4%

FR REVOCATIONS–38.6% APPENDICES

FY 98-99 OPP BIENNIAL REPORT 45 ▼ FIGURE 3 Outcome of 6(a)(2) Submissions

Section 6(a)(2) of FIFRA requires pesticide product registrants to submit adverse effects information about their products to OPP. OPP reviews these submissions and studies to determine if there are risks associated with the product that were not anticipated at the time of registration. In late 1998, OPP's new adverse effects reporting requirements took effect. These regulations clarified and in many cases lowered the threshold for adverse incident reporting. As a result, 6(a)(2) submissions increased considerably during FY99. Incidents: In FY 1998, OPP received approximately 1,800 submissions, containing reports of more than 22,000 incidents. Incidents: In FY 1999, OPP received nearly 1,500 submissions, containing reports of more than 46,000 incidents. Studies: In FY 1998, OPP screened 411 adverse effects submissions consisting of studies and preliminary reports of possible adverse effects. About 15 percent of these submissions warranted expedited review and are being further tracked. In FY 1999, OPP streamlined the 6(a)(2) study screening process by imaging key study information and routing it electronically to subject matter experts. This reduced the time necessary to complete the screening process. OPP screened 337 adverse effects submissions consisting of studies and preliminary reports of possible adverse effects. About 12 percent warranted expedited review and are being further tracked. Outcome of submissions warranting expedited review: Since 1992, over 700 6(a)(2) submissions were judged to warrant expedited review. The outcomes for these submissions are presented in the chart that follows.

LABEL CHANGE—17% REASSESSMENT—27% (THE RISK ISSUES PRESENTED BY THESE DATA ARE ADDRESSED BY PLANNED OR REVIEW INITIATED—11% COMPLETED REGISTRATION (THIS INCLUDES STUDY REVIEWS ELIGIBILITY DECISIONS, SPE- AS WELL AS RELATED PEER REVIEWS.) CIAL REVIEWS, FQPA TOLER- ANCE REASSESSMENTS, OR RISK MITIGATION NEGOTIATIONS.) MORE DATA NEEDED—8%

OTHER—4% (THIS INCLUDES AMENDED TOLERANCES [PRE-FQPA], VOLUNTARY CANCELLATIONS, AND CHANGES IN REGULATORY AUTHORITY FOR SOME PESTICIDES TO FDA.)

NO FURTHER ACTION—32% APPENDICES ▼ 46 FY 98-99 OPP BIENNIAL REPORT LIST 1 Pesticide Stewardship Program Partners and Supporters

New Partners during FY 1999 New Supporters during FY 1999 Kansas Grain Sorghum Producers Association National Council of Farmer Cooperatives Kansas Corn Growers Association Miami Tribe of Oklahoma Low Input Viticulture and Enology of Oregon New Supporters during FY 1998 Central Virginia Electric Cooperative Agricultural Conservation Innovation Center Sarasota County Government Public Works Bio-Integral Resource Center Massachusetts IPM Council Claymont Center for Continuous Education Ecolutions, Inc. Northeast Research & Extension Committee–IPM New Partners during FY 1998 Existing Partners (prior to FY 1998) All Service Pest Management, Inc. Almond Board of California American Peanut Council American Pest Management, Inc. Artichoke Research Association American Mosquito Control Association California Floral Council American Nursery and Landscape Association California Lettuce Research Board American Electric Power Service Corporation California Cling Peach Growers Advisory Board Arizona Public Service California Fresh Carrot Advisory Board California Tomato Commission City/County of San Francisco, CA Dept. of Agriculture California Pear Growers Creative Technology, Inc. California Pear Advisory Board Daystar Termite Control, Inc. California Citrus Research Board Enviroguard Pest Control California Pistachio Commission Florida Pest Control Association California Prune Board Georgia Peach Council Carolina Power & Light Hawaii Banana Industry Association Central Maine Power Company Massey Services, Inc. Chevy Chase Village, MD National Pest Control Association City of Davis, CA Nature's Safeway Pest Control Connectiv New York City Board of Education Cranberry Institute Northeast Utilities Delta Pest Control Pest Birds, Inc. Duke Power Company Roses, Inc. Eastern Utilities Sprague Pest Solutions Edison Electric Institute Steritech Group, Inc. Environ "Pest Elimination" Inc. Texas Association of Nurserymen, Inc. Fillmore Citrus Protective District U.S. Hop Industry Plant Protection Committee Florida Fruit & Vegetable Association U.S. Canola Association Global Integrated Pest Management Walnut Marketing Board Golf Course Superintendents Association of America Griggs County (ND) 319 Water Quality Project Hawaii Agriculture Research Center Hawaiian Electric Company Hood River Grower-Shipper Association Lodi-Woodbridge Wine Grape Commission Michigan Cherry Committee APPENDICES

FY 98-99 OPP BIENNIAL REPORT 47 ▼ (Continued) Existing Supporters (prior to FY 1998) Mint Industry Research Council Aqumix, Inc. Monroe County School Corporation Association of Applied Insect Ecologists National Potato Council Audubon Cooperative Sanctuary System New Orleans Mosquito Control Board Bay Area Stormwater Management Agencies Assoc. New England Vegetable & Berry Growers Association Campbell Soup Company New York State Gas & Electric Del Monte New York Berry Growers Association Farm A Syst/Home A Syst National Office Northern Indiana Public Service Company Gempler’s, Inc. Northwest Alfalfa Seed Grower Association General Mills, Inc. Owen Specialty Services, Inc. Gerber Products Company Pacific Coast Producers Glades Crop Care, Inc. Pear Pest Management Research Fund Institute for Agriculture and Trade Policy Pebble Beach Company Rainforest Alliance–ECO o.k. Program Pennsylvania Power & Light United States Golf Association Pennsylvania Electric Pennsylvania Rural Electric Association Pest Police Pest Control Pineapple Growers Association of Hawaii Planet Pest Products Corporation Processed Tomato Foundation Professional Lawn Care Association of America Redi National Pest Elimination Reliable Pest Control Sanitary Exterminating Company South Dakota Cattlemen’s Association South Texas Cotton and Grain Association, Inc. Sun-Maid Growers of California Sunkist Growers Tennessee Valley Authority Texas Pest Management Association U.S. Department of Defense U.S. Apple Association U.S. Public Health Service University of Georgia Utilicorp United VA, MD, & DE Association of Electric Cooperatives Vegetation Managers, Inc. West Virginia Power Winter Pear Control Committee Wisconsin Public Service Corporation Wisconsin Ginseng Growers Association APPENDICES ▼ 48 FY 98-99 OPP BIENNIAL REPORT LIST 2 OPP Divisions

Office of the Director 703-305-7090 Responsible for overall management of the Office of Pesticide Programs.

Antimicrobials Division Health Effects Division 703-308-6411 703-305-7351 Responsible for all regulatory activities Responsible for reviewing and validating data associated with antimicrobial pesticides, on properties and effects of pesticides, as well including product registrations, amendments, as characterizing and assessing exposure and and reregistrations. risks to humans and domestic animals.

Biological and Economic Analysis Information Resources and Services Division Division 703-308-8200 703-305-5440 Responsible for assessing pesticide use and Responsible for information support; Public benefits; and operating analytical chemistry Docket; records computer support; FIFRA and antimicrobial testing laboratories. section 6(a) (2) issues; pesticide incident monitoring; and National Pesticide Telecommunications Network. Biopesticides and Pollution Prevention Division 703-308-8712 Registration Division Responsible for risk/benefit assessment and 703-305-5447 risk management functions for microbial Responsible for product registrations, pesticides; tolerance reassessment for amendments, reregistrations, tolerances, biopesticides; biochemical pesticides; experimental use permits, and emergency plant-pesticides and Pesticide Environmental exemptions for all pesticides not assigned to Stewardship Program. BPPD or AD.

Environmental Fate and Effects Special Review and Reregistration Division Division 703-305-7695 703-308-8000 Responsible for evaluating and validating Responsible for Reregistration Eligibility environmental data submitted on pesticide Decisions (REDs), product reregistration, properties and effects. tolerance reassessment; and Special Reviews.

Field and External Affairs Division 703-305-7102 Responsible for program policies and regulations; legislation and Congressional interaction; regional, State, and tribal coordination and assistance; international and field programs; and communication and outreach activities. APPENDICES

FY 98-99 OPP BIENNIAL REPORT 49 ▼ LIST 3 Regional Pesticide Offices

Region 1 Region 7 617-918-1501 913-551-7307 John F. Kennedy Federal Building 901 North 5th Street One Congress Street Kansas City, KS 66101 Boston, MA 02203-0001 Region 8 Region 2 303-312-6390 212-637-4000 999 18th Street, Suite 500 290 Broadway Denver, CO 80202-2466 New York, NY 10007-1866 Region 9 Region 3 415-744-1585 215-814-3127 75 Hawthorne Street 1650 Arch Street San Francisco, CA 94105 Philadelphia, PA 19103 Region 10 Region 4 206-553-4181 404-562-9077 1200 Sixth Avenue 61 Forsyth Street Seattle, WA 98101 Atlanta, GA 30303

Region 5 312-886-7475 77 West Jackson Boulevard Chicago, IL 60604-3507

Region 6 214-665-7200 Fountain Place, 12th Floor Suite 1200 1445 Ross Avenue Dallas, TX 75202-2733 APPENDICES ▼ 50 FY 98-99 OPP BIENNIAL REPORT LIST 4 List of Acronyms

AD Antimicrobials Division APIC Association for Professionals in Infectious Control and Epidemiology ARS Agricultural Research Service BBPD Biopesticide and Pollution Prevention Division CADDY Computer Aided Dossier and Data Supply CDPR California Department of Pesticide Regulation CLI Consumer Labeling Initiative DDT Dichloro diphenyl trichloroethane (DDT) EIIS Ecological Incident Information System FAO Food and Agricultural Organization FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FEAD Field and External Affairs Division FFDCA Federal Food, Drug and Cosmetic Act FQPA Food Quality Protection Act GLP Good Laboratory Practices HHS Department of Health and Human Services IFCS Intergovernmental Forum on Chemical Safety IPM Integrated Pest Management IR-4 Interregional Research Project No. 4 LAN Local Area Network MOU Memorandum of Understanding MRL Maximum Residue Limits NAFTA North American Free Trade Agreement NTIS National Technical Information Service OECD Organization for Economic Cooperation and Development OP Organophosphates OPP Office of Pesticide Programs PDSL Pesticide Data Submitters List PESP Pesticide Environmental Stewardship Program PIC Prior Informed Consent PMRA Pesticide Management Regulatory Agency (Canada) POPs Persistent Organic Pollutants PPDC Pesticide Program Dialogue Committee RED Reregistration Eligibility Decision TRAC Tolerance Reassessment Advisory Committee USDA United States Department of Agriculture WHO World Health Organization WPS Worker Protection Standard APPENDICES

FY 98-99 OPP BIENNIAL REPORT 51 ▼ NOTES APPENDICES ▼ 52 FY 98-99 OPP BIENNIAL REPORT