NRDC Consent Decree - 3rd Annual Report
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
September 24, 2004: EPA Actions Implementing Regulatory Determinations Required under Certain Provisions of the NRDC Consent Decree
In September 2001, the Federal Court for the Northern District of California entered a Consent Decree to conclude litigation in the case, Natural Resources Defense Council v. Whitman. Under the Consent Decree, among other things, EPA is required to issue an annual report providing information on the steps that the Agency has taken to implement certain regulatory determinations that it is required to make by the Consent Decree. Specifically, the Consent Decree directs EPA, beginning one year after the entry of the Consent Decree and annually for several years thereafter, to issue a report addressing the risks identified in certain previously issued Reregistration Eligibility Decisions (REDs) and Interim Reregistration Eligibility Decisions (IREDs). With respect to each covered RED and IRED, EPA is to identify any risks from pesticide use and/or any pesticide tolerances that the Agency has determined do not meet applicable statutory standards and to describe its plans for addressing the risk or tolerance. For REDs and IREDs discussed in the first two annual reports, EPA must describe its steps toward completing its plan to address identified risks or tolerances.
In addition, with respect to certain groups of pesticides which EPA has determined share a common mechanism of toxicity, the Consent Decree required the first annual report on the group to contain a schedule for issuing a preliminary cumulative risk assessment and a revised cumulative risk assessment for the group. The second and subsequent annual reports for the group must describe EPA's steps toward completion of its schedules for completing these preliminary and revised cumulative risk assessments. The Consent Decree also requires EPA to post each annual report on its website.
Under the terms of the Consent Decree, the annual report must describe risks or tolerances of concern and EPA's plan for addressing those risks or tolerances for any REDs or IREDs issued at least three months prior to the annual reporting date of September 26. EPA therefore is providing this information on carbaryl, for which the Agency issued an IRED on June 30, 2003. The third annual report also must describe EPA's steps toward completing its plan, discussed in the first two annual reports, for addressing unreasonable risks associated with:
Finally, the third annual report must provide updates on EPA's steps toward meeting its schedules for completing preliminary and revised cumulative risk assessments for the triazines and the thiocarbamate and dithiocarbamate pesticides, common mechanism groups discussed in the first and second annual reports.
Implementing REDs and IREDs
A number of steps must take place in order to translate risk mitigation determinations contained in RED or IRED documents into label language on pesticide products in the marketplace. Typically, EPA signs a RED or IRED document and then sends it, along with its attachments and appendices, to affected registrants for follow-up actions. Unless all products containing the pesticide active ingredient are being voluntarily canceled, a product-specific Data Call-In (DCI) is sent to the affected end-use product registrants along with the RED or IRED so that EPA can obtain product chemistry, acute toxicity, and other data that are required for product reregistration. If the RED or IRED includes additional confirmatory data requirements, EPA also issues a generic DCI to the affected technical or manufacturing use product registrants. Typically, EPA transmits the DCI to registrants of the pesticide along with the RED or IRED. The RED or IRED contains instructions to the registrants about when and how to submit applications for amended registration reflecting the risk mitigation measures contained in the RED or IRED. Following receipt of the applications, EPA reviews and, if appropriate, approves the amendments by sending a stamped copy of the new labeling to the registrant. Either the approval of the amendment or the RED or IRED will establish a time frame for the registrant to implement the new labeling.
Because of its concerns about the pesticides discussed below, EPA has expedited the process of implementing the risk mitigation measures for several of them. Using Memoranda of Agreement, shorter deadlines for submission of applications, and other changes to our typical procedures, EPA is achieving implementation of the risk mitigation measures for these pesticides more quickly than usual.
REDs and IREDs as well as many supporting documents for the pesticides discussed in this third annual report are available from the pesticide reregistration status Web page . Many related support documents also are available from Regulations.gov.
I. REDs and IREDs
A. IRED Covered for the First Time
- The insecticide carbaryl, also known by the trade name Sevin, is registered for use on over 400 sites in agriculture, professional turf management and ornamental production, and residential settings. Carbaryl also is registered for use as a mosquito adulticide. Washington State has a Special Local Needs registration to control burrowing shimp in oyster beds.
- Carbaryl is used on many agricultural sites including fruit and nut tree, fruit and vegetable, and grain crops. More than 140 tolerances are established for carbaryl. Crops with the greatest amount (most pounds) of annual carbaryl use include apples, pecans, grapes, alfalfa, oranges, and corn. Crops with the highest percent of acres treated include avocados, asparagus, okra, cranberries, apples, blueberries, sweet cherries, pumpkins, and strawberries.
- Carbaryl is used by homeowners in residential settings for lawn care, gardening (vegetables and ornamentals), and pet care (pet collars, powders, and dips, in kennels, and on pet sleeping quarters).
- Carbaryl also is used in nursery, landscape, and golf course industries on annuals, perennials, and shrubs.
- A total of approximately 3.9 million pounds of carbaryl active ingredient are sold annually in the U.S.; about half is used in agriculture and half in non-agricultural settings (per 1998 data). The amount of carbaryl usage in agriculture declined from an average of 1.9 million pounds of active ingredient per year during 1992 through 2001, to 1 to 1.5 million pounds of active ingredient in 2001.
- Dietary Risks - Both acute and chronic (non-cancer and cancer) risks from food are below EPA's level of concern. Screening-level modeling estimates indicate that acute dietary risks from carbaryl residues in surface water sources of drinking water are above the Agency's level of concern for children and the general population. Due to uncertainties and limitations of model predictions, and based on results of monitoring data, however, actual concentrations of carbaryl in drinking water derived from surface water are likely to be much lower than estimated. Further, EPA expects conventional drinking water treatment to significantly reduce concentrations of carbaryl in drinking water. Chronic (non-cancer and cancer) dietary risks from surface water sources, based on screening-level modeling estimates, are below the Agency's level of concern. Estimated concentrations of carbaryl in ground water sources of drinking water also are below the Agency's level of concern for acute and chronic (non-cancer and cancer) exposure.
- Residential Risks - EPA is concerned about exposures to homeowners using carbaryl lawn, garden, ornamental plant, and pet flea control products, as well as adults doing yard work and toddlers playing on treated lawns. To address the greatest residential handler risk concerns, the carbaryl registrant is voluntarily canceling all pet uses except flea collars. The registrant also has agreed to measures that will effectively mitigate other residential handler risks, such as changes in the amount of active ingredient, packaging, and size of residential use products. Residential post-application risks of concern also will be mitigated by canceling liquid and dust use on pets (allowing flea collars only). With these mitigation measures, residential risks will no longer be of concern to the Agency. The IRED also identified post-application risks of concern to toddlers from broadcast use of carbaryl liquids on residential lawns. As a result of that finding, the registrants agreed not to produce new technical product labeled for that use until EPA considered data being developed to refine the Agency's risk assessment. See "Current Status of Implementing Risk Mitigation Measures".
- Aggregate Risks - EPA assessed the aggregate risks of exposures to carbaryl through food, drinking water, and residential uses, excluding uses that are being canceled to mitigate risks. The Agency made an interim determination that the human health risks from these combined exposures are within acceptable limits. Although combined exposures appear to "fill" the aggregate risk cup, the drinking water exposure estimate is based on screening-level modeling; actual drinking water exposures are believed to be lower than estimated. Confirmatory data are required to verify the Agency's conclusion that carbaryl does "fit" within the aggregate risk cup.
- Occupational Risks - Carbaryl poses risks of concern to occupational handlers who mix, load, and apply the pesticide in agricultural sites, and to workers who are exposed upon re-entering treated agricultural areas. EPA evaluated 28 major occupational exposure scenarios which resulted in about 140 crop/rate/acreage risk calculations to assess dermal and inhalation exposures to carbaryl handlers. Although several scenarios exceeded the Agency's level of concern, these handler risk concerns can be mitigated by implementing various levels of personal protective equipment and engineering controls, in most cases.
- Ecological Risks - Carbaryl is very highly toxic on an acute exposure basis to honey bees, estuarine/marine invertebrates, and other aquatic animals, including Atlantic salmon; thus, use of carbaryl can result in adverse effects to terrestrial and aquatic organisms. Based on a screening-level assessment, some ecological risks of carbaryl are low and some are of concern. Mitigation measures will help address these risk concerns. In addition, oyster growers in Washington State who use carbaryl to control burrowing shrimp on oyster beds in tidal mudflats have agreed to phase out this use, based on an agreement developed locally between the growers and environmental groups.
- Endangered Species - The ecological risk assessment in the Carbaryl IRED indicates that levels of concern are exceeded for several endangered species. These findings for carbaryl are based solely on EPA's screening-level assessment and do not constitute "may affect" findings under the Endangered Species Act (ESA). EPA currently is consulting with the National Marine Fisheries Service (NMFS) concerning carbaryl effects on endangered salmonids. Additional future consultations with both NMFS and the US Fish and Wildlife Service (FWS) would be initiated as necessary to cover other terrestrial and aquatic species.
- Carbaryl controls a wide spectrum of insect pests across a wide range of use sites, both agricultural and non-agricultural. EPA reviewed carbaryl's use patterns on many sites, and utilized that information in forming a regulatory position and determining the mitigation measures necessary to address risks of concern. In particular, the Agency considered the benefits associated with the use of carbaryl on citrus, especially in Florida and California, and grapes to evaluate occupational and ecological risks.
- The carbaryl technical registrants agreed not to produce new technical ingredient labeled for residential lawn broadcast application of carbaryl liquid formulations until EPA could consider data being submitted to refine the Agency's risk assessment for post-application exposures to toddlers.
- Home garden/ornamental dust products must be packaged in ready-to-use shaker can containers, with no more than 0.05 lbs. active ingredient per container.
- Certain uses and application methods will be canceled:
- Certain uses and application methods will be canceled:
- Maximum application rates are reduced for mosquito control, citrus, and asparagus.
- Aerial applications are prohibited for:
- Additional personal protective equipment (PPE) and engineering controls are specified for aerial/chemigation and ground airblast applications, and for use of granular and bait, liquid, and wettable powder formulations.
- Current 12-hour restricted entry intervals (REIs) for carbaryl are being extended for most crop uses;
- Maximum application rates are reduced for citrus (including California citrus and Florida 24(c) registration) and asparagus (including both pre-harvest and post-harvest applications);
- For brassica crops, leafy vegetables, and table beets and turnips when harvested for greens, carbaryl can only be applied within 30 days of crop emergence/ transplanting.
- To address toxicity concerns for honey bees, a bee precaution statement must be added to the Environmental Hazards section of carbaryl product labels, as follows:
- Several mitigation measures needed to address residential and occupational risks, described above, will also address risks to terrestrial and aquatic organisms, including:
- Oyster growers in Washington State who use carbaryl to control burrowing shrimp on oyster beds in tidal mudflats are phasing out this use in response to local agreements.
- The Carbaryl IRED was signed June 30, 2003, and EPA intends to issue the IRED with informational appendices for 60 days of public comment in October 2004. EPA will consider public comments and, if appropriate, amend the Carbaryl IRED. All public comments will be included in a docket established by the Federal Register notice that announces the formal public comment period for the Carbaryl IRED.
- On June 27, 2003, the carbaryl technical registrants agreed not to produce new technical ingredient labeled for residential lawn broadcast application of carbaryl liquid formulations until EPA could consider data being submitted to refine the Agency's risk assessment for post-application exposures to toddlers. BayerCrop Science has since submitted to the Agency new pharmacokinetic data, and a method for using the data in a deterministic calculation to refine risk estimates. EPA is planning to seek independent scientific review of the information through an SAP meeting in December 2004. EPA also plans to publish for comment in October 2004 a Federal Register notice announcing the availability of the Carbaryl IRED, with errata changes and other minor amendments, including documents relevant to the Agency's current conclusions regarding the residential turf use.
- EPA has prepared the Generic and Product Specific Data Call-Ins (DCIs) for carbaryl and plans to issue them in October 2004. Label changes will be due to the Agency eight months after the registrants' receipt of the DCI.
EPA has assessed the risks of carbaryl and, on June 30, 2003, reached an Interim Reregistration Eligibility Decision (IRED) for this n-methyl carbamate pesticide. Although some uses may pose unreasonable risks to human health and the environment, these effects can be mitigated by the measures identified in the Carbaryl IRED. Provided that these risk mitigation measures are adopted, aggregate risks for carbaryl alone will be within acceptable levels and the pesticide may be eligible for reregistration once EPA considers the cumulative risks of the n-methyl carbamate pesticides.
Carbaryl is one of the most widely used broad-spectrum insecticides in agriculture, professional turf management and ornamental production, and residential pet, lawn, and garden markets. Although dietary (food and drinking water) exposures are not of concern, carbaryl does pose risks of concern from uses in and around the home. With mitigation measures discussed in the IRED document, carbaryl will fit into its own "risk cup" and will not pose significant aggregate risk concerns. Carbaryl also poses risks of concern to occupational handlers who mix, load, and apply the pesticide in agricultural sites, and to workers who may be exposed upon re-entering treated agricultural areas. Carbaryl poses ecological risks, particularly to honey bees and aquatic invertebrates. With mitigation measures, these occupational and ecological risks also will not be of concern for reregistration.
The decisions outlined in the Carbaryl IRED do not include the final tolerance reassessment decision for carbaryl. Revocations, lowering tolerances, changing definitions, and other actions will occur after the IRED is finalized. Raising or establishing new tolerances will be deferred until cumulative risks have been considered. Nine (9) tolerances will be proposed for revocation, 31 tolerances will be lowered, and 21 tolerances will be increased based on residue data submitted to the Agency. Forty-nine (49) tolerances will be reassigned to conform with changes in commodity definitions, concomitant with establishing new tolerances. The Carbaryl IRED also provides that eight (8) tolerances must be established, for wet apple pomace, aspirated grain fractions, sugar beet roots, citrus oil, raisins, proso millet hay, rice hulls, and sorgum grain stover.
EPA must consider the cumulative effects of the n-methyl carbamate pesticides, which share a common mechanism of toxicity. When the Agency completes its cumulative assessment of these pesticides, final tolerance reassessment decisions for carbaryl and other n-methyl carbamates will be issued. At that time, EPA may need to pursue further risk mitigation for carbaryl to address any risks identified in the cumulative assessment.
The carbaryl decision was made through EPA's public participation process, which increases transparency and maximizes stakeholder involvement in the Agency's development of risk assessments and risk management decisions. EPA worked extensively with numerous affected parties to reach the decisions presented in the Carbaryl IRED document.
The Carbaryl IRED and related documents are available from the pesticide reregistration status.
Description of Unreasonable Adverse Effect Upon the Environment or Reason Tolerance Does Not Meet Section 408 Safety Standard.
A member of the n-methylcarbamate class of pesticides, carbaryl can cause cholinesterase inhibition in humans; that is, it can overstimulate the nervous system causing nausea, dizziness, confusion, and at high exposures, respiratory paralysis, and death. Carbaryl is a reversible inhibitor of acetylcholinesterase. Carbaryl is classified as a likely human carcinogen based on vascular tumors in mice. However, non-cancer risk is the primary risk driver for carbaryl because the cholinesterase inhibition seen for this chemical is a more sensitive health effect (endpoint) than cancer risk. Cancer risks estimated for all carbaryl exposure scenarios were found to be of no concern to the Agency.
EPA also evaluated post-application (reentry) risks to workers who enter areas previously treated with carbaryl. For workers involved in post-application activities, the Agency assessed risks at various time intervals after application, and then set restricted entry intervals (REIs) to ensure that workers wearing baseline protective clothing could safely reenter treated areas. Because reentry risks are of concern for many crops and scenarios at the currently labeled REI of 12 hours, the REI is being lengthened for many crops.
EPA's Plan for Addressing Risks
All pet uses (dusts and liquids) except collars;
Aerosol products for various uses;
Belly grinder applications of granular and bait products for lawn care spot treatments;
Hand applications of granular and bait products for ornamentals and gardens.
To addresshandler risk concerns:
Pet uses (except pet collars);
Applications by hand, spoon, and bellygrinder.
Wettable powder formulations and dusts;
Granular and bait formulations applied to corn (field, pop, and sweet), grain sorghum, alfalfa, rice, and sunflowers.
To addresspost-application worker risk concerns:
"This product is highly toxic to bees exposed to direct treatment or residues on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area."
Reducing maximum application rates for mosquito control, citrus, and asparagus;
Canceling use on wheat;
Prohibiting certain aerial applications.
Current Status of Implementation of Risk Mitigation Measures
B. Updates on REDs and IREDs Covered in the First and Second Annual Reports
- A report from the National Cancer Institute (NCI) on non-Hodgkin's lymphoma and a nested, case-control study conducted for Syngenta of workers at an atrazine manufacturing plant in St. Gabriel, Louisiana have been received and are in review.
- EPA expects to receive additional epidemiological studies and analyses concerning atrazine and cancer from NCI's Agricultural Health Study in 2005 and 2006.
- EPA issued generic and product-specific DCIs for the January 2003 Atrazine IRED in March 2004. In response to the DCIs, EPA is now receiving and reviewing amended atrazine product labels. We expect to complete the review of these amended labels by the end of November 2004. The amended labels will appear on atrazine products in the marketplace in 2005.
- All the atrazine technical registrants signed an Atrazine MOA in the Spring of 2004. The MOA puts the atrazine technical registrants on a fast track to implement label changes, so that all atrazine products will be relabeled by the 2005 growing season.
- EPA plans to issue generic and product-specific DCIs for the October 2003 Revised Atrazine IRED in Fall 2004.
- Both the drinking water monitoring program and the ecological monitoring of flowing water bodies associated with corn and sorghum are being implemented and monitoring is underway. For the ecological monitoring program, the data will be reviewed after the monitoring is completed in 2006. However, additional monitoring may be required depending on the results of this monitoring. For the current Community Water Systems in the drinking water monitoring program, monitoring will be conducted for at least five years. However, monitoring could last longer if new Community Water Systems are added to the monitoring program as a result of Safe Drinking Water Act monitoring.
- EPA is developing a protocol and choosing sites for atrazine monitoring in the Florida and Louisiana sugarcane growing regions. Sites will be chosen based on areas that have the highest sugarcane acreage and where waterbodies are determined to be most vulnerable to atrazine contamination. This protocol for monitoring should be completed by December 2004 and monitoring should begin in Spring 2005.
- After additional data are received and reviewed, EPA plans to explore further with the SAP the issue of atrazine and its possible association with carcinogenic effects.
- The SAP concluded in 2003 that additional amphibian studies should be conducted and that the Agency's proposed conceptual model for future studies was appropriate. Since the August 2003 SAP report, the atrazine registrant has developed protocols for Tier I studies to address the uncertainties regarding the potential for atrazine to affect gonadal development. The Tier I studies have been initiated and are scheduled to be completed in Spring 2006.
- EPA approved label language in August 2003 that began appearing on azinphos-methyl products in the marketplace during the 2004 use season. The new labeling implements all of the significant worker and ecological risk reduction measures outlined in the May 2002 MOA.
- EPA worked with USDA and stakeholders to develop clear, enforceable labeling to inform users and address potential risks associated with pesticide spray drifting from target application sites. The approved labels include spray drift language that differs from the language in the IRED and that was developed to address azinphos-methyl-specific risk concerns. The language used for azinphos-methyl is not intended to serve as a model for mitigating spray drift risks of other pesticides. The label language retains the existing generic statement and also requires management practices to mitigate risks from drift associated with azinphos-methyl use that were outlined in the IRED.
- EPA published a FIFRA section 6(f) notice in the Federal Register on September 30, 2002, announcing the Agency's receipt of requests for amendments to delete 22 uses from products containing azinphos-methyl. These uses have been removed from currently approved labeling. A follow-up cancellation order will be issued by the end of 2004.
- Data on worker exposure, biomonitoring, ground water monitoring, and eco toxicity have been submitted in compliance with the April 23, 2002, DCI and are currently in review.
- All indoor residential use product registrations were canceled and retail sale of these products ended as of December 31, 2002.
- All outdoor residential use product registrations are being canceled in 2004 and retail sale must end by December 31, 2004. After that time, a buy-back program will help remove remaining outdoor diazinon residential use products from the market and prevent further sale.
- EPA is preparing to issue a notice to hardware and home and garden retailers, reminding them of the approaching December 31, 2004, stop sale date for all outdoor diazinon home, lawn and garden products, and explaining the buy-back program. By anticipating the deadline, selling current inventories of diazinon home lawn and garden products this Fall, and understanding product recovery and disposal options for any products not sold after the deadline, retailers can play an important part in responsible stewardship for diazinon.
- The Diazinon IRED was issued with a 60-day public comment period through a Federal Register notice published on September 25, 2002. An addendum to the Diazinon IRED addressed minor mitigation changes based on public comments received. This addendum and a Response to Comments Memorandum are available in Docket #2002-0251.
- EPA issued the generic and product-specific DCIs for diazinon in June 2004. Within 8 months of that date (in early 2005), the Agency expects to receive and begin reviewing amended product labels reflecting the agricultural/worker and ecological risk mitigation measures recommended in the Diazinon IRED.
- In April 2004, EPA satisfied the requirement in paragraph 9(c) of the Consent Decree to address "those worker risks determined to be an unreasonable adverse effect on the environment as identified in the IRED." Through a letter to NRDC issued on April 19, 2004, posted on EPA's website, the Agency explained that it had satisfied this obligation through amendments to the terms and conditions of all affected diazinon registrations. Once these terms and conditions are implemented, EPA does not expect any of the unacceptable worker risks that were determined to be an unreasonable adverse effect on the environment in the IRED to remain.
- EPA published a Federal Register notice on November 6, 2002, announcing the availability of the Endosulfan RED and opening a 60-day public comment period that closed on January 6, 2003.
- EPA is requiring numerous additional generic studies for endosulfan, listed in the RED, to confirm its regulatory assessments and conclusions. The generic and product-specific DCIs for endosulfan were approved by OMB and the Agency issued those DCIs in 2004.
- Within 8 months of the mail-out of the August 2004 Endosulfan RED and DCI (by mid-2005), the Agency expects to receive and begin reviewing amended endosulfan product labels reflecting the risk mitigation measures recommended in the RED.
- Use on the 5 deleted crops (succulent beans, succulent peas, spinach, grapes, and pecans) will be eliminated over the next several years, consistent with EPA's existing stocks provisions.
- EPA's Office of Pesticide Programs (OPP) will work with the Endosulfan Task Force, interested federal and state agencies, and other stakeholders to finalize and implement a targeted monitoring protocol to resolve the uncertainty related to endosulfan use near vulnerable aquatic areas that may pose a risk to non-target aquatic animals. EPA is planning site visits in the Fall of 2004 to better assess these vulnerable areas.
- EPA requested public comments on the Lindane RED during a 60-day public comment period, as announced in a Federal Register notice published September 25, 2002. At the appropriate time, the Agency will prepare a response to comments document that addresses comments received during the comment period for the RED.
- The generic and product-specific DCIs for lindane were issued in February 2004. In response, EPA received requests for voluntary cancellation of 17 of the 29 currently registered products. An additional DCI for lindane is in preparation and will be issued in Fall 2004.
- EPA intends to expedite the review of revised lindane end-use product labels that are being submitted by end-use product registrants to implement the mitigation specified in the Lindane RED, and has initiated efforts to obtain revised labels.
- Through a previously issued DCI, EPA required a treated seed/grain crop metabolism study that could enable the Agency to establish new lindane tolerances. The registrant began the study in October 2003 and anticipates sending EPA the study report by the end of 2004.
- EPA intends to consider establishing tolerances for the seed treatment uses of lindane.
- EPA intends to revoke current tolerances for lindane, as proposed in the Lindane RED document. The Agency will be initiating this process shortly.
- EPA and FDA are participating with Mexico and Canada in the development of a North American Regional Action Plan (NARAP) for lindane. The goal of the NARAP is to eliminate unnecessary uses of lindane, reassess risk, and encourage the use of safer substitutes.
- The 60-day comment period for the Phosmet IRED closed on January 28, 2002. Approximately 70 comments were received, resulting in changes to the following crops: sweet potatoes; low bush blueberries; highbush blueberries; grapes; and citrus. EPA allowed these changes because either they did not increase risk or data is required to confirm that there is no increase in risk.
- The Agency agreed to allow the option of full PPE in place of closed cabs. This option will be phased out by the end of 2005.
- EPA agreed to allow a FIFRA section 24(c) special local needs registration for apple maggot control in Washington state. This use allows PCOs to apply phosmet to residential trees, provided that written warning is given to residents to prevent them from entering treated home orchards. These applications are occasionally needed to control a potentially serious threat to commercial apple production in Washington.
- Based on comments received, EPA is requiring a 14-day REI for harvesting crops at pick-your-own establishments.
- A revised IRED and response to comments document will be issued by the end of 2004 that will include these revisions.
- The generic and product-specific DCIs were issued on April 9, 2003.
- The generic DCI required the registrant to submit data on biomonitoring of workers, glove feasibility, and use and usage, among other things. EPA has reviewed the response to the DCI and is working with the company to develop a protocol for the biomonitoring study.
- Federal Register Notices were published on October 16, 2002, March 19, 2003, and June 19, 2003, announcing EPA's receipt of the requests for voluntary cancellation of various phosmet home and garden and veterinary products.
- The Agency received the revised labels for review on July 3, 2002. Resolution of issues about label language for spray drift delayed final approval of the labels; however, the Agency has reinitiated the label review and plans to complete it by the end of 2004.
- EPA issued the DCI and PDCI for propargite on January 6, 2003, and the registrants responded on April 8, 2003. The studies submitted are in review and some protocols are being developed.
- EPA issued a Federal Register notice on August 4, 2004, proposing all the tolerance actions recommended in the Propargite RED, including revoking, raising, lowering, revising, and creating new propargite tolerances. The public comment period closes October 4, 2004. EPA anticipates that the proposed changes in propargite tolerances will be effective by Spring 2005.
- EPA expects to rule on the registrant's requests for REI exceptions and runoff/spray drift revisions this fall, and subsequently will finalize the propargite reregistration resulting in revised labeling on propargite products.
As described in the second NRDC Annual Report, the January 31, 2003 Atrazine IRED and Memorandum of Agreement (MOA) with the principal registrant initiated an innovative and effective program to protect community drinking water systems from contamination by this widely used triazine herbicide. The Revised Atrazine IRED, completed October 31, 2003, initiated an ecological monitoring program to protect potentially vulnerable watersheds and aquatic ecosystems. Estimated to be the most heavily used herbicide in the U.S., atrazine is applied in agriculture, primarily to corn, sorghum, and sugarcane crops; on golf course turf; and on residential lawns. Because of its volume of use and tendency to persist and move with water, atrazine is also the most commonly detected pesticide in surface water. Atrazine has been associated with sub-lethal effects in aquatic organisms and amphibians in research presented in open, peer-reviewed literature. These include potential effects on endocrine-mediated processes in frogs and in largemouth bass, as well as olfactory effects in salmon. EPA has found that atrazine is not likely to be carcinogenic to humans, but will revisit this issue further with the FIFRA Scientific Advisory Panel (SAP) in the future, when additional data are received and reviewed. Although atrazine does not pose risks through food, the Agency's drinking water, residential, occupational, and ecological risk assessments for atrazine indicate risks of concern.
To mitigate the identified risks, additional monitoring for atrazine levels and certain changes in atrazine use are necessary, as described fully in the Atrazine IRED. These changes are being implemented through atrazine product label amendments. To further address atrazine areas of concern, EPA and the technical registrants of atrazine developed a Memorandum of Agreement that sets forth additional requirements designed to reduce the most significant atrazine exposures. Among other requirements, the atrazine MOA includes a performance standard for community water systems, targeted monitoring of raw water entering certain community water systems in areas of atrazine use, and if atrazine is detected in water at levels above Agency safety standards, prohibition of use in that watershed area.
Revised Atrazine IRED
The Revised Atrazine IRED, issued on October 31, 2003, addressed the potential association between atrazine exposure and the incidence of prostate cancer and other cancers in humans; potential effects of atrazine on amphibian endocrinology and development; and ecological monitoring and mitigation of atrazine in watersheds.
EPA's January 2003 Atrazine IRED did not include a quantitative risk assessment for cancer due to a determination by the Agency, consistent with June 2000 conclusions by the SAP, that it is unlikely that atrazine's cancer mode of action in the rat is operative in humans. Considering the animal data and human epidemiological data, EPA concluded that atrazine is "not likely to be carcinogenic to humans." Results of recent epidemiological studies regarding atrazine's potential link to cancer taken to the SAP in July 2003 did not alter that conclusion. Accordingly, the Agency concluded in the Revised IRED that atrazine is not likely to be a human carcinogen. More recently, EPA provided information on its position regarding atrazine carcinogenicity to the National Toxicology Program (NTP).
EPA has received and is reviewing two relevant studies, and expects to receive additional studies during the next one to two years.
After all this information has been submitted and reviewed, EPA plans to convene another SAP meeting concerning atrazine and its possible association with carcinogenic effects.
At the time of the January 2003 IRED, EPA did not have reliable evidence to state that atrazine caused endocrine effects in the environment. The IRED stated that based on the existing uncertainties in the database, atrazine should be subject to more definitive testing once the appropriate testing protocols have been established. The Agency was aware that several pertinent studies were being performed by researchers that may reduce some of the uncertainties in understanding potential atrazine effects on amphibian endocrinology and reproductive and developmental responses.
Following the Atrazine IRED, EPA conducted a comprehensive evaluation of the available data regarding the potential effects of atrazine on amphibian gonadal development, developed a white paper, and presented its assessment for external peer review to the SAP in June 2003. Based on its assessment, the Agency concluded and the SAP agreed that there is sufficient evidence to formulate a hypothesis that atrazine may impact gonadal development in amphibians, but currently there are insufficient data to confirm or refute the hypothesis.
The ecological risk assessment in the Atrazine IRED indicates that levels of concern are exceeded for several endangered species. These findings for atrazine are based solely on EPA's screening-level assessment and do not constitute "may affect" findings under the Endangered Species Act (ESA).
Ecological Watershed Monitoring Program
Ecological monitoring of watersheds was recommended in the January 2003 Atrazine IRED due to the potential for community-level and population-level risk to ecosystems from atrazine use. To mitigate these ecological risks to aquatic ecosystems, EPA recommended that atrazine registrants, in consultation with the Agency, develop a program under which the registrants monitor for atrazine concentrations and mitigate environmental exposures if EPA determines that mitigation is necessary. The program is to focus on watershed impacts of atrazine use. The October 2003 Revised Atrazine IRED described the specifics of the ecological monitoring and mitigation program. EPA's Office of Pesticide Programs, Office of Research and Devlopment, and Office of Water collaborated to develop the specifics of this program.
The monitoring protocol is initially focused on flowing water bodies (i.e., streams) associated with corn and sorghum production. The purpose of the monitoring program in flowing waters is to estimate the magnitude and extent to which water bodies with the greatest potential vulnerability to atrazine exposure (primarily based on atrazine use and runoff potential) are exceeding the level of concern set forth in the atrazine ecological risk assessment.
During 2004 through 2006, atrazine registrants will monitor 40 indicator watersheds, each for a period of two years, to determine whether atrazine levels of concern are exceeded. Watersheds exceeding this level will be subject to watershed management program remedies consistent with EPA's Total Maximum Daily Load (TMDL) program requirements. The 40 watersheds, located in 10 states, are representative of the 1,172 watersheds defined as most vulnerable to atrazine surface water loading from use on corn and sorghum. Results from monitoring the 40 watersheds will be used to determine if further monitoring or remedial efforts are needed. A list of the 40 watersheds included in the ecological monitoring program is available from the atrazine Web page.
EPA also must consider the cumulative effects of the triazine pesticides atrazine, simazine, and propazine, and their common chlorinated degradates, which share a common mechanism of toxicity. The Agency expects to complete a cumulative assessment of the triazines in 2006. Final tolerance reassessment decisions for atrazine and the other triazines will be issued at that time, and the Agency may need to pursue further risk mitigation for atrazine to address any risks identified in the triazine cumulative assessment.
EPA's risk mitigation plan, set forth in the Azinphos-methyl IRED and May 2002 Memorandum of Agreement (MOA), includes measures to delete, phase out, or continue under time-limited registrations the crop uses of this organophosphate insecticide, to improve worker safety and lessen ecological risk. During the phase-out and time-limited registration periods, a variety of new, more stringent use restrictions are included to protect agricultural workers, including longer REIs and PHIs, reductions in the amount of pesticide applied and number of applications, and prohibitions on most aerial applications. The registrants also must conduct studies and provide data on the effectiveness and feasibility of certain PPE, and must conduct ground water monitoring and worker biomonitoring studies. In addition to the measures to improve worker safety, other mitigation measures to reduce ecological risks include adding buffer zones to protect surface water, improved directions to reduce off-site exposure from airblast applications, and enforceable label language to address risks from spray drift.
EPA has completed its reregistration eligibility decision for the fungicide benomyl. Although benomyl was scheduled for a RED in 2002, the registrants requested voluntary cancellation in 2001 and 2002. After considering public comment, EPA granted the voluntary cancellation requests.
At present, all benomyl product registrations are canceled and all tolerances are revoked, with expiration dates ranging from January 1, 2006, to January 1, 2009. The sale and distribution of benomyl products ended on December 31, 2002. Any treated fresh commodity or processed food should have ample time during the next several years to clear trade channels.
EPA's plan to reduce worker and ecological risks, as set forth in the Chlorpyrifos IRED, included additional PPE and engineering controls, reductions in application rates, increasing retreatment intervals, reducing seasonal maximum amounts applied, and no-spray setback zones around water bodies. In June 2000, EPA entered into a Memorandum of Agreement (MOA) with the technical registrants of chlorpyrifos to eliminate virtually all homeowner uses, except ant and roach baits in child resistant packaging. All post-construction termite use was canceled as of December 31, 2002, and pre-construction termiticide use was permitted to continue at a reduced rate only until 2005, unless exposure data submitted in December 2003 show that residential risks from this use are not of concern.
As a result of implementation of the MOA and the issuance of the IRED, the number of products containing chlorpyrifos has dramatically decreased, from approximately 850 products before the June 2000 MOA to a current total of approximately 300 products. The chlorpyrifos IRED transmittal letter advised registrants that if they failed to implement any of the risk mitigation measures in the IRED document, EPA would continue to have concerns about the risks posed by chlorpyrifos and would initiate regulatory actions to address its concerns. To date, chlorpyrifos registrants have complied fully with the MOA requirements and IRED conclusions.
EPA currently is evaluating the pre-construction termiticide use of chlorpyrifos. Exposure data submitted in December 2003 consist of a Cumulative and Aggregate Risk Evaluation System (CARES) model assessment. CARES is a probabilistic model designed to simulate dietary and residential exposure for representative individuals within the US population based on characteristics of each individual. Results from a chlorpyrifos residential indoor air monitoring study and an estimate of 6% of U.S. homes treated are also included in the model. This assessment is currently under review. As required by the MOA, EPA will decide by December 31, 2004, whether or not chlorpyrifos can continue to be sold and used for pre-construction termite applications.
Labeling reflecting the mitigation measures set forth in the June 2000 MOA, specifically directed at reducing exposure to children, has been submitted, reviewed, approved, and is currently reflected on the approximately 300 chlorpyrifos products remaining in the marketplace. The MOA canceled and phased out nearly all indoor and outdoor residential uses, thus reducing exposure to children. This reduction represented approximately 50% of the use of chlorpyrifos or about 10 million pounds a year. All home lawn, indoor crack and crevice treatments, and whole house post construction termiticide treatments were canceled. Also, indoor and outdoor areas where children could be exposed (such as schools and parks) were canceled. Due to low exposure, the ant and roach bait in child resistant packaging is the only chlorpyrifos residential use remaining.
Registrants have already amended labels to reflect additional PPE and protective measures for some uses. The Chlorpyrifos IRED, which included generic and product-specific Data Call-In (DCI) notices, was issued to all registrants of products containing chlorpyrifos in March 2003. Full implementation of the additional risk mitigation measures specified in the IRED was accomplished by a second round of label amendments as current registrants submitted their responses to the IRED. EPA first focused on the approximately three dozen agricultural use products for which additional measures to mitigate worker risk were recommended. The Agency completed its review of the agricultural use product labels early in 2004 and approved new labels incorporating worker risk mitigation. A re-review of non-agricultural use product labels submitted in response to the IRED and the PDCI started in 2004.
In April 2004, EPA satisfied the requirement in paragraph 9(c) of the Consent Decree to address "those worker risks determined to be an unreasonable adverse effect on the environment as identified in the IRED." Through a letter to NRDC issued on April 26, 2004, posted on EPA's website, the Agency explained that it had satisfied this obligation through amendments to the terms and conditions of all affected registrations and through label changes for chlorpyrifos. Once these terms and conditions are implemented, EPA does not expect any of the unacceptable worker risks identified in the IRED to remain.
EPA completed the Diazinon IRED on July 31, 2002. Without mitigation, diazinon poses unreasonable risks to agricultural workers and to birds and other wildlife species. To increase protection for workers, birds, and the environment, the Agency's decision includes provisions to phase out and cancel certain agricultural crop uses, the granular formulation, and aerial applications; reduce the amount and frequency of use; and employ engineering controls and other protective measures. Even with the recommended mitigation measures in the IRED, diazinon's worker and ecological risks continue to be above levels of concern, but these risks are offset by strong benefits of diazinon use in fruit and vegetable production. These changes in diazinon use were developed through discussions with the technical registrants and were based on extensive stakeholder input.
An organophosphate, diazinon has been one of the most widely used insecticides in the U.S. for household as well as agricultural pest control. Under a December 2000 Memorandum of Agreement (MOA) with the technical registrants, all indoor and outdoor residential uses of diazinon are being canceled over a period of several years in order to reduce risks to children and others. Prior to residential mitigation, diazinon was used outdoors on household lawns and gardens to control insects, grubs, and nematodes in turf; indoors for fly control through crack and crevice treatments; and for veterinary use to control fleas and ticks through pet collars. Diazinon remains registered for use in agriculture to control foliage and soil insects and pests of many fruit, nut, and vegetable crops, and is used in cattle eartags.
Residential Risk Mitigation
To reduce risks to children and others, the December 2000 MOA is phasing out and canceling all residential uses of diazinon.
Agricultural and Ecological Risk Mitigation
To mitigate risks to agricultural workers as well as to birds and other wildlife, a number of mitigation measures are recommended by the Diazinon IRED, including cancellation of certain crop uses, cancellation of most uses of the granular formulation, deletion of aerial application, deletion of foliar applications on most vegetable crops, use rate reductions, cancellation of seed treatment uses, adoption of engineering controls including water soluble bags and closed cabs, reducing the number of applications per growing season, and other measures.
On July 31, 2002, EPA completed a RED for endosulfan, a chlorinated cyclodiene insecticide and acaricide registered for use on a wide variety of vegetables, fruits, cereal grains, and cotton, as well as on ornamental shrubs, trees, vines, and ornamental herbaceous plants in commercial agricultural settings. In the Endosulfan RED, EPA concluded that endosulfan exceeds its own "risk cup," and poses occupational and ecological risks that constitute unreasonable adverse effects on human health and the environment. However, if certain food uses are deleted and mitigation measures to prevent contamination of surface waters are implemented, the Agency believes that endosulfan will "fit" within its risk cup. EPA found that the 80 endosulfan tolerances meet FQPA safety standards, provided the risk mitigation measures outlined in the RED are fully implemented. EPA also believes that endosulfan's occupational and ecological risks can likely be acceptably mitigated through changes to pesticide labeling and formulations. Accordingly, the Agency determined that endosulfan is eligible for reregistration provided that: (1) additional required data will confirm this decision for occupational exposures associated with the application of dip treatment to roots or whole plants and ecological risks; and (2) the risk mitigation measures outlined in the RED are adopted, and label amendments are made to reflect these measures. If vulnerable areas in specific geographic areas are identified as a result of a stakeholder process explained in the RED, additional ecological risk mitigation measures may be necessary.
To mitigate dietary, worker, and ecological risks of concern for endosulfan, mitigation measures set forth in the RED included deleting use on several crops including succulent beans, succulent peas, spinach, grapes, and pecans; reducing maximum seasonal application rates for many crops; spray buffer and vegetative buffer strip requirements to protect bodies of water; Restricted Use Pesticide classification; engineering controls such as use of water soluble bags, closed mixing/loading systems, and closed cabs; cancellation of wettable powders on many crops; cancellation of aerial applications using wettable powders on many crops; and increased REIs for many crops.
Given the toxicity and persistence of endosulfan and potential risks to aquatic organisms, EPA developed a number of mitigation measures to reduce the risks to aquatic organisms, outlined in the RED. The Agency believes that these measures will reduce the potential for exposures to aquatic organisms and reduce the overall environmental loading of endosulfan. However, in specific geographic areas where conditions exist that make aquatic organisms especially vulnerable (e.g., shallow, leaky aquifers, highly erodible lands, the presence of especially sensitive organisms, and high use of endosulfan), additional measures may be identified. In order to more fully evaluate the risks in these vulnerable areas; the risk management strategies that may be in place or could potentially be implemented in such areas to reduce exposure; and the benefits of the use of endosulfan in those areas, the Agency plans to work with stakeholders to accomplish this objective. Additional mitigation measures may be needed following the completion of this process.
On July 31, 2002, EPA completed a Reregistration Eligibility Decision (RED) for the organochlorine lindane and identified risk mitigation measures necessary to address the human health and environmental risks associated with its use. The lindane food/feed uses supported for reregistration are pre-plant seed treatment on barley, corn, oats, rye, sorghum, and wheat; a new use on canola seed also has been proposed. EPA determined that currently registered lindane seed treatment products could be eligible for reregistration if the registrants make the changes to the registration terms and conditions specified in the RED document and provide the required data, and if EPA is able to establish all required tolerances for residues of lindane in food.
EPA determined that all existing tolerances for lindane should be revoked. These tolerances are no longer necessary because all lindane products for which the tolerances were originally established have been canceled. The Agency identified additional data needed to characterize lindane metabolites in order to complete its assessment of potential dietary risks. Finally, EPA has determined that the use of lindane for seed treatment is likely to result in residues in raw agricultural commodities derived from plants grown from seeds treated with lindane. Therefore, new tolerances are required before the currently registered lindane products may be reregistered. EPA also determined that a number of changes to the terms and conditions of registration of the seed treatment products are necessary to prevent unreasonable adverse effects on the environment.
EPA is considering whether the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Agency to include in its aggregate exposure and safety assessment those exposures resulting from use of lindane in pharmaceutical products. Lindane is approved by the Food and Drug Administration (FDA) for use in pharmaceutical products to control head lice and scabies. Although information for assessing exposure and risks is limited, EPA's assessment indicated that while use of lindane as a shampoo for head lice control does not pose risks of concern, use as a lotion for treatment of scabies may cause some adverse effects in some portion of the patient population. EPA solicited additional information and views that may help it determine how best to approach the public policy and statutory interpretation issues associated with the pharmaceutical uses of lindane.
EPA's Agricultural Pesticide Product Risk Mitigation
To mitigate human health and ecological risks of concern associated with lindane's registered pesticide uses, EPA required that revised labels be submitted to implement mitigation measures including prohibiting on-farm treatment of wheat, barley, oats, and rye seeds with the lindane dust formulation; reducing the maximum application rate for corn; requiring workers to wear double layer clothing, chemical-resistant gloves, and a dust/mist respirator for on-farm treatment of corn and sorghum seeds only with the dust formulation; a 24-hour REI for all seed treatment uses; and end-use product labels must specify a 30-day plantback interval for leafy vegetables and a 12-month plantback interval for all other unregistered crops. The registrant may conduct a confined accumulation of rotational crops study to show that these plantback intervals can be reduced.
FDA's Pharmaceutical Product Risk Mitigation
To reduce over-use and increase the safe use of lindane pharmaceutical (i.e., head lice and scabies control) products, FDA is implementing several measures, discussed on its lindane Web page.
Phosmet IRED indicated that risk mitigation measures were necessary to eliminate phosmet exposure in residential settings, improve worker safety, and lessen ecological risks. An OP insecticide, phosmet is widely used in agriculture and provides important pest control benefits, but also poses worker and ecological risks. To address phosmet's risks, 3 uses were to be canceled (use on domestic pets, household ornamentals, and household fruit trees); 9 crop uses would be eligible for time-limited registrations for 5 years if registrations were amended to require additional risk reduction measures and monitoring data; and 33 uses would continue with additional mitigation. To protect agricultural workers during the time-limited registration period, new precautions were needed including increased REIs and PHIs, closed transfer systems, and enclosed cabs or maximum PPE for applicators. To reduce ecological risks, recommendations included label language regarding spray drift, inward spraying of outside rows of orchards, limiting application amounts, and prohibiting application during bloom period. Additional generic data have been required including worker biomonitoring and other studies.
Changes to the IRED
The Propargite RED recommended mitigation measures to address worker and ecological risks. To reduce risks to agricultural workers, the recommended mitigation measures included closed mixing/loading systems for corn and cotton applications, enclosed cockpits for all aerial applications, water soluble packaging for all wettable powder formulations, enclosed cabs for all airblast spray applications, PPE, longer REIs for most crops, and Restricted Use Pesticide classification. To reduce ecological risks, mitigation measures included decreasing seasonal maximum application rates for several crops, adding spray intervals of 21 days for most food crops (28 days for citrus), decreasing the number of cotton applications annually from 3 to 2, adding no-treatment buffer zones around aquatic areas, adding label language to minimize spray drift, and requiring testing to better characterize risks to birds. Other generic studies were required. EPA was to propose several tolerance revocations.
The discussion below provides EPA's current thinking and plans for addressing the cumulative risks of certain groups of chemicals identified pursuant to the NRDC Consent Decree.
Update on Pesticide Groups Addressed in Earlier Reports
The cascade of biological events triggered by atrazine exposure leading to mammary gland tumors in female SD rats is not expected to occur in humans given the species difference in reproductive aging. However, the potential for disruption of the hypothalamic pituitary axis and consequent attenuation of the LH surge leading to other health consequencesnot associated with reproductive aging (e.g., delay in pubertal development) can not be dismissed. Thus, EPA has determined that the triazine pesticides (with a common mechanism group of atrazine, propazine, simazine, and their chlorometabolites) have a common mechanism of suppression of LH surge and consequent reproductive and developmental effects. It is expected that EPA will complete a preliminary cumulative risk assessment in early 2006; this is contingent on completion of the IREDs for the individual chemicals. The revised Atrazine IRED was completed on October 31, 2003, while the IRED for simazine is slated for completion in 2006. EPA expects to complete the revised cumulative risk assessment for the triazines in Summer 2006.
The thiocarbamate pesticides (EPTC, molinate, pebulate, and cycloate) were determined not to share a common mechanism of toxicity. See "Thiocarbamates: A Determination of the Existence of a Common Mechanism of Toxicity and A Screening Level Cumulative Food Risk Assessment," December 19, 2001 (51 pp, 480k, About PDF).
A subset of the dithiocarbamate pesticides (ziram and metam sodium) was determined not to share a common mechanism based on neuropathy. See "The Determination of Whether Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity," December 19, 2001 (46 pp, 348k, About PDF).
Another subset of the dithiocarbamate pesticides (mancozeb, maneb, and metiram) was determined to share a common mechanism based on thyroid effects. After the individual risk assessments are conducted (IREDs are scheduled to be completed in 2005), EPA will reassess all information to determine whether a screening level or a highly refined cumulative risk assessment is needed. If a highly refined assessment is needed, EPA projects that it would issue its preliminary cumulative risk assessment in fiscal year 2005 and the revised cumulative risk assessment in fiscal year 2006.