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NRDC Consent Decree - 1st 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 Although the information provided here was accurate and current when first created, it is now outdated.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 2001: EPA Actions Implementing Regulatory Determinations Required under Certain Provisions of the NRDC Consent Decree
Resources
- Fourth Annual Report (9/26/2005)
- Third Annual Report (9/24/2004)
- Second Annual Report (9/26/2003)
- First Annual Report (9/2002)
- Consent Decree (Amended) (29 pp, 244k, About PDF)
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, 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 Determinations (REDs) and Interim Reregistration Eligibility Determinations (IREDs). With respect to each covered RED and IRED, EPA is to identify any risks from pesticide use and/or any pesticide tolerances that EPA has determined do not meet applicable statutory standards and to describe its plans for addressing the risk or tolerance. In addition, with respect to certain groups of pesticides which EPA has determined share a common mechanism of toxicity, the Consent Decree requires the first annual report on the group to contain a schedule for issuance of a preliminary cumulative risk assessment and a revised cumulative risk assessment for the group. The Consent Decree also requires EPA to post the annual report on its website. None of the schedules or plans contained in this or subsequent annual reports are judicially enforceable.
Under the terms of the Consent Decree, the first annual report must cover the following individual active ingredients for which EPA has issued a RED or IRED:
- azinphos-methyl,
- chlorpyrifos,
- phosmet, and
- propargite.
In addition, the annual report must cover the following groups for which EPA has made a determination that certain chemicals share a common mechanism of toxicity: certain thiocarbamates that inhibit cholinesterase, certain dithiocarbamates that produce the same thyroid effects, and certain dithiocarbamates that inhibit cholinesterase. The following sections provide the information specified in the Consent Decree.
A number of steps must take place in order to translate risk mitigation determinations contained in a RED or IRED into label language on pesticide products in the marketplace. Typically, EPA signs a RED or IRED and then sends it to affected registrants. If the reregistration eligibility determination documents identify additional data requirements, EPA must also issue a Data Call-In Notice (DCI) to the registrants. In some cases, EPA may need to obtain from OMB approval under the Paperwork Reduction Act to issue the DCI. Typically, EPA transmits the DCI and RED or IRED at the same time. 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 label 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.
Under FIFRA, Congress envisioned a process that could take up to 14 months for EPA to review applications to amend product labeling to implement the risk mitigation measures determined in a RED or IRED. Congress left EPA discretion about how quickly to require registrants to begin placing the new labeling on products entering the marketplace. EPA has often allowed companies more than a year to use up existing stocks of old product labels. Because of its concerns about the four pesticides discussed below, EPA has departed from its typical practice, in order to speed up the process of implementing the risk mitigation measures for azinphos-methyl, chlorpyrifos, phosmet, and propargite. Using Memoranda of Agreement, shorter deadlines for submission of applications, and other changes to our typical procedures, EPA believes that it will achieve implementation of the risk mitigation measures for these pesticides as soon as or sooner than the statute would otherwise envision.
Azinphos-methyl
1. Background.
In October, 2001, EPA released its IRED for azinphos-methyl, which includes a determination to cancel, phase out, or continue under time-limited registrations the crop uses of this pesticide. The Agency has determined that products containing azinphos-methyl are eligible for reregistration provided that: 1) the data needs are addressed, 2) the risk reduction measures outlined in the IRED (and summarized here) are adopted, and 3) the cumulative risk conclusions for the organophosphates support a final reregistration eligibility determination.
An organophosphate (OP) insecticide first registered in 1959, azinphos-methyl is widely used in agriculture and provides important pest control benefits to growers of orchard fruit, nut, and other crops. However, azinphos-methyl also poses a high degree of risk to agricultural workers, as well as significant acute and chronic ecological risks. The Agency's actions address both the high risks and benefits associated with current agricultural uses of azinphos-methyl.
The azinphos-methyl IRED concluded EPA's review of this individual pesticide through the OP pilot public participation process. Through this process, EPA exchanged information on azinphos-methyl's uses, risks, and benefits with stakeholders and the public, and obtained significant input from interested parties. This input helped the Agency determine whether azinphos-methyl was eligible for reregistration and met the safety standard set by the Food Quality Protection Act (FQPA) of 1996. On November 28, 2001, the Agency published in the Federal Register a Notice of Availability and opened a 60 day public comment period on the IRED (66 FR 59419). A final reregistration decision will be issued following completion of the cumulative risk assessment for the organophosphate pesticides.
EPA previously implemented and risk reduction measures for azinphos-methyl after agency risk assessments showed that the pesticide could not meet the safety standard set by the FQPA. Those earlier actions, initiated in August 1999, effectively reduced dietary risks to children and others, and began reducing worker and ecological risks.
2. Description of unacceptable risks.
In the IRED the Agency determined that "all uses of azinphos-methyl are ineligible for reregistration based on their currently approved labeling." In assessing azinphos-methyl, the Agency concluded that the current agricultural uses pose a high degree of risk to agricultural workers, as well as significant acute ecological risks. EPA has concluded that for dietary risk, considering all issues other than cumulative risk issues with other organophosphates, there is a reasonable certainty that the tolerances for azinphos-methyl will not result in harm and that the uses of azinphos-methyl will therefore not result in dietary risks in excess of the safety standard in section 408 of the FFDCA.
3. EPA's plan for addressing risk.
The Agency has determined to cancel, phase out, or continue under time-limited registrations the crop uses of this pesticide in order to improve worker safety and lessen ecological risk. Following issuance of the IRED and receipt of comments from the public, EPA and all of the registrants of products containing azinphos-methyl negotiated a Memorandum of Agreement (MOA) to implement the provisions of the IRED. The MOA was signed on May 23, 2002. A copy of the MOA was provided to NRDC on June 28, 2002 and was placed in the Public Docket. It will also be available on OPP's web site. Under the MOA, the actions to mitigate risk for azinphos-methyl include:
- 23 crop uses will be cancelled without phaseout because safer pest control alternatives are available. 7 crop uses will be phased out over 4 years, allowing time to shift to safer pest control alternatives.
- 10 crop uses will be issued time-limited registrations for 4 years, allowing time to develop safer pest control alternatives. Prior to the expiration of the 4-year period, EPA will conduct a comprehensive review of these 10 crop uses, based on the latest scientific information, to determine if they should continue.
To protect agricultural workers during the phase-out and time-limited registration periods, the IRED concluded that a variety of new and stringent precautions were needed. These include:
- longer intervals before workers may re-enter treated areas (i.e., the restricted entry interval [REI]),
- increase the time between application and harvest (i.e., pre-harvest interval [PHI]),
- reduce the amount of pesticide that may be applied,
- limit the number of applications, and
- prohibit most aerial applications.
In addition, the registrants must conduct studies and provide data comparing exposure to airblast applicators with enclosed cabs, chemical resistant suits, or other personal protective equipment [PPE]; monitoring cholinesterase levels of harvesters; and glove feasibility. These data were required by the DCI issued on April 23, 2002.
To reduce ecological risks, the IRED identified the need for the following mitigation measures:
- prohibit most aerial applications,
- adding enforceable label language to address risks from spray drift,
- establish the buffer zones for the protection of surface water,
- adding label language that would require inward spray for airblast applications to outer two rows of orchards,
- reduce the amount of pesticide that may be applied, and
- limit the number of applications.
In addition, the IRED identified risks to consumers patronizing "Pick Your Own" businesses. To reduce consumer risks, "Pick Your Own" operations may use azinphos-methyl only more than thirty days prior to harvest. In addition, use of azinphos-methyl in "Pick Your Own" operations is being phased out. In addition, sale of nursery stock to the public is prohibited sooner than 30 days after treatment of the stock with azinphos- methyl.
Label changes are currently in process to implement the risk mitigation measures pertaining to worker and ecological risk concerns called for in the IRED. These changes will occur prior to the 2003 use season. The MOA provided for submission of the first round of label amendments within 3 weeks of the signing of the MOA. Labels have been submitted and are currently undergoing final review. All products released for shipment 90 days after the registrant's receipt of stamped, approved labeling must bear the new labels.
The following tables identify the specific uses of azinphos-methyl that are subject to either cancellation, phase out, or a time-limited registration, and the implementation timeframes.
Provisions of the Azinphos-methyl IRED
| Action: Cancellation | Date: Under the MOA, registrants have submitted applications to amend their products' registration, and within 90 days after receiving EPA approval, they must remove these uses from the products' label |
|---|
| Crop: | Alfalfa Beans (succulent and snap) Birdsfoot trefoil Broccoli Cabbage (including Chinese) Cauliflower Citrus Celery Clover |
Cucumbers Eggplant Filberts Grapes Melons (honeydew melon muskmelon/canteloupe, watermelons, other melons) Onions, dry bulb |
Onions, green Pecans Peppers Plums/dried plums Quince Spinach Strawberries Tomatoes |
|---|
| Action: Phase out /cancellation | Date: Over a 4 year period |
|---|
| Crop: | Caneberries (blackberries, boysenberries, loganberries,
raspberries): applications to canes and soil
| Cotton Cranberries Nectarines Peaches |
Potatoes Southern pine seed orchards |
|---|
| Action: Time-limited Registration | Date: Period of 4 years |
|---|
| Crop: | Almonds Apples and crab apples Blueberries, lowbush and highbush Brussel sprouts: application to soil at transplant Cherries, sweet and tart |
Nursery stock, for control of black vine weevil
in association with meeting state nursery stock inspection and certification
requirements Parsley Pears Pistachios Walnuts |
|---|
Chlorpyrifos
1. Background.
EPA has assessed the risks of chlorpyrifos and released an IRED for this OP pesticide in September 2001. The Agency has determined that products containing chlorpyrifos are eligible for reregistration provided that: 1) the data needs are addressed, 2) the risk reduction measures outlined in the IRED (and summarized here) are adopted, and 3) the cumulative risk conclusions for the organophosphates support a final reregistration eligibility determination.
Used on a variety of food and feed crops, golf courses, as a non-structural wood treatment, and as an adult mosquitocide, chlorpyrifos residues in food and drinking water do not pose risk concerns. With mitigation eliminating virtually all homeowner uses, chlorpyrifos fits into its own "risk cup." With other mitigation measures, chlorpyrifos worker and ecological risks also will be within acceptable levels for reregistration.
The chlorpyrifos IRED was developed through the OP pilot public participation process, which increases transparency and maximizes stakeholder involvement in EPA's development of risk assessments and risk management decisions. EPA worked with affected parties to reach the decisions presented in this interim decision document, which concludes the OP pilot process for chlorpyrifos. On November 14, 2001, the Agency published in the Federal Register a Notice of Availability and opened a 60 day public comment period on the IRED (66 FR 57073).
As indicated above, in June, 2000, the Agency entered into an agreement with the technical registrants to eliminate virtually all homeowner uses, except ant and roach baits in child resistant packaging. Residential post-application exposures may occur after termiticide use in residential structures. To mitigate risks from this use, the technical registrants agreed in June 2000 to limit termiticide treatments to 0.5% solution, and to cancel all post-construction uses. Pre-construction use will remain only until 2005, unless acceptable exposure data are submitted in 2004 that show that residential risks from this use are not a concern.
2. Description of unacceptable risks.
In assessing chlorpyrifos, the Agency determined that dietary exposures from eating food crops treated with chlorpyrifos are below the level of concern for the entire U.S. population, including infants and children. Drinking water risk estimates based on screening models and monitoring data from both ground and surface water for acute and chronic exposures are generally not of concern. The Agency has determined that agricultural uses are of concern for agricultural workers and the environment.
Occupational exposure to chlorpyrifos is of concern to the Agency. Exposures of concern include mixing/loading liquids for aerial/chemigation and groundboom application, mixing wettable powder for groundboom application, aerial application, and application by backpack sprayer, high-pressure handwand, and hand-held sprayer or duster. Generally, these risks can be mitigated by a combination of additional personal protective equipment and engineering controls, and by reductions in application rates. Additionally, the Agricultural Handler Task Force and the U. S. Forest Service will be developing exposure data to better characterize the risk from certain uses (e.g., applying granulars by air).
Risk quotients indicate that a single application of chlorpyrifos poses risks to small mammals, birds, fish and aquatic invertebrate species for nearly all registered outdoor uses. Multiple applications increase the risks to wildlife and prolong exposures to toxic concentrations. To address these risks, a number of measures including reduced application rates, increased retreatment intervals, reduced seasonal maximum amounts applied per acre, and no-spray setback zones around water bodies will be needed.
3. EPA's plan for addressing risk.
In order to support a reregistration eligibility determination for chlorpyrifos, the IRED identified the following risk mitigation measures as necessary:
- To mitigate risks to agricultural workers, PPE consisting of double layers, chemical resistant gloves, chemical resistant shoes plus socks, chemical resistant headgear for overhead exposure, chemical resistant apron when cleaning and mixing or loading and a dust/mist respirator are required for the following scenarios: mixing/loading liquids for groundboom and airblast application, loading granular formulations for ground application, tractor drawn granular spreader, and low pressure handwand. Additionally, engineering controls are required for the following scenarios: mixing wettable powder for groundboom application (water soluble packaging), mixing wettable powder formulations for airblast application (water soluble packaging), and aerial application of sprays (enclosed cockpit).There are still some occupational risk scenarios that are still below the target MOE of 100, even with all feasible PPE or engineering controls. The risk assessments for these uses will be refined with additional data to be required under the DCI described in the IRED.
- To mitigate ecological risks, use restrictions are required which include the use of buffer zones to protect water quality, fish and wildlife, reductions in application rates, number of applications per season, seasonal maximum amounts applied, and increases in the minimum intervals for retreatment.
Labeling reflecting the mitigation measures set forth in the June, 2000 MOA, specifically directed at reducing exposure to children, has been submitted, reviewed and is currently reflected on the over 300 chlorpyrifos products remaining in the marketplace. In addition, registrants have already amended labels to reflect additional PPE and protective measures for some uses. Full implementation of the additional risk mitigation measures specified in the IRED will be accomplished by a second-round of label amendments that will occur once all public comments have been addressed and the generic and product-specific Data Call-In notices have been issued. EPA anticipates issuing the DCIs within the next 60 days. Although the initial chlorpyrifos IRED provided that registrants would be required to submit label amendments reflecting these restrictions within eight months after receiving Product-specific Data Call-In notices, EPA now will require submission of applications to amend the product labels within 60 days after receipt of the DCI. EPA expects to focus first on reviewing applications which affect those approximately three dozen agricultural use products for which additional measures to mitigate worker risk have been required in the IRED. EPA anticipates completing its review of these applications early in 2003, and the remaining applications later that year. The IRED transmittal letter advises registrants that, if the registrant failed to implement any of the risk mitigation measures, the Agency would continue to have concerns about the risks posed by chlorpyrifos and intends to initiate regulatory actions to address its concerns.
In addition, EPA intends to propose revocation of the tolerance for chlorpyrifos on tomatoes and to propose lowering the tolerances for chlorpyrifos on apples and grapes. The proposals will include guidance concerning the Food and Drug Administration's (FDA) enforcement of the "safe harbor" provisions in FFDCA section 408 that allow the sale and distribution of foods which may contain residues of chlopyrifos that are present as a result of lawful use of chlorpyrifos. EPA and FDA are working together to determine the approximate time it will take for legally treated commodities (including both raw and processed foods) to clear channels of distribution and sale. (Note: labels have already been amended to delete use on tomatoes and to restrict use on apples to trunk-directed applications.) As soon as the two agencies have collected sufficient information to provide a basis for a proposal, EPA intends to publish a Federal Register Notice seeking comment on the action.
The following tables provide the timetable for implementation of the risk mitigation measures, including the agreement with registrants concerning residential uses.
Provisions of the Agreement and Associated EPA Actions
Food
Uses |
||
|---|---|---|
| Apples | Production of chlorpyrifos products labeled for post-bloom application
is prohibited (only production for pre-bloom, dormant application
is allowed)
Post-bloom use is prohibited Tolerance will be lowered |
August - September 2000
|
| Tomatoes | Production of products for tomato use is prohibited Use will be canceled Tolerances will be revoked |
August - September 2000 Stop use as of 12-31-00 |
| Grapes | Tolerance will be lowered | |
| All Agricultural Uses | Classify new end-use products for restricted use or package in large
containers
New end-use products must bear revised Restricted Entry Intervals (REIs) |
As of 12-1-00
|
| Home Uses | ||
|---|---|---|
| Home lawn and most other outdoor uses | Classify new end-use products for restricted use
or package in large containers (except baits in child resistant packaging)
Use will be canceled |
As of 12-1-00
Stop formulation 12-1-00 |
| Crack and crevice and most other indoor uses | Classify new end-use products for restricted use
or package in large containers
Use will be canceled |
As of 12-1-00
Stop formulation 12-1-00 |
Termiticides
•Pre-construction use |
Classify new products for restricted use or package
in large containers
Limit use to 0.5% solution
|
As of 12-1-00
Stop formulation 12-1-00 unless label has stop use date of 12-31-02 Stop production 12-31-04 Stop use 12-31-05 |
Non-Residential
Uses |
||
|---|---|---|
| Indoor areas where children could be exposed (such as schools) | Uses will be canceled | Stop formulation 12-1-00
Formulators stop sale 2-1-01 Retailers stop sale 12-31-01 |
| Outdoor areas where children could be exposed (such as parks) | Uses will be canceled | Stop formulation 12-1-00
Formulators stop sale 2-1-01 Retailers stop sale 12-31-01 |
Non-Agricultural Uses that Will
Remain |
||
|---|---|---|
| Residential use of containerized baits | Already in child resistant packaging | Use allowed to continue |
| Indoor areas where children will not be exposed, including only ship holds, railroad boxcars, industrial plants, manufacturing plants, or food processing plants | New end-use product labels must reflect only these uses as of 12-1-00 | |
Outdoor areas where children will not be exposed, including only: •Golf courses
• Road medians
• Industrial plant sites
• Non-structural wood treatments including fenceposts, utility poles, railroad ties, landscape timbers, logs, pallets, wooden containers, poles, posts, and processed wood products Public health uses: •Fire ant mounds •Mosquito control |
Reduce application rate from 4 lbs/acre to 1 lb/acre
Reduce maximum application rate to 1 lb ai/acre (Continue at current rate) For professional use onlyFor professional use only For professional use only |
New end-use product labels must reflect only these uses as of 12-1-00 |
Phosmet
1. Background.
On October 30, 2001 EPA released its IRED for phosmet, which reflects registrants' decisions to voluntarily cancel certain uses and includes EPA's determination to allow continued registration of certain uses subject to additional risk reduction and to allow continuation of other uses under time-limited registrations with interim risk mitigation. The Agency has determined that products containing phosmet are eligible for reregistration provided that: 1) the data needs are addressed, 2) the risk reduction measures outlined in the IRED (and summarized here) are adopted, and 3) the cumulative risk conclusions for the organophosphates support a final reregistration eligibility decision.
An OP insecticide first registered in 1966, phosmet is widely used in agriculture and provides important pest control benefits to growers of orchard fruit, nut, and other crops. However, some uses of phosmet also pose risks to agricultural workers. The Agency's actions address both the risks and benefits associated with current agricultural uses of phosmet.
The phosmet IRED concludes EPA's review of this individual pesticide through the organophosphate pilot public participation process. Through this process, EPA exchanged information on phosmet's uses, risks, and benefits with stakeholders and the public, and obtained significant input from interested parties. This input helped the Agency determine whether phosmet is eligible for reregistration and meets the safety standard set by the Food Quality Protection Act (FQPA) of 1996. On November 28, 2001, the Agency published in the Federal Register a Notice of Availability and opened a 60 day public comment period on the IRED (66 FR 59419). A final reregistration decision will be issued following completion of the cumulative risk assessment for the organophosphate pesticides.
2. Description of unacceptable risks.
In assessing phosmet, the Agency determined that current uses pose risks of concern in residential settings, to occupational workers.
3. EPA's plan for addressing risk.
In order to support a reregistration eligibility determination for phosmet, the IRED identified the following risk mitigation measures as necessary:
To protect agricultural workers during the time-limited registration period, a variety of new and stringent precautions were needed. These include:
- increase REIs,
- increase PHIs where appropriate,
- require closed transfer systems, and
- require enclosed cabs or maximum PPE for applicators (Note: the PPE alternative will not be available after 2005).
To reduce ecological risks:
- add spray drift language to labels,
- adding label language that would require inward spraying of outside rows of orchards, and
- limit application amount,
- prohibit application during bloom period.
The Agency and phosmet registrants have agreed to cancel or continue under time-limited registrations the crop uses of phosmet in order to improve worker and consumer safety and lessen ecological risk. EPA's actions for phosmet include:
- 3 uses will be canceled since safer pest control alternatives are available - EPA plans to issue a Federal Register Notice in October 2002, announcing receipt of the requests for voluntary cancellation;
- 9 crop uses would be eligible for time-limited registrations for 5 years if the registrations are amended to require additional risk reduction measures;
- 33 uses would continue with additional risk mitigation measures.
Implementation of risk mitigation measures will be accomplished by label amendments that are currently under review by EPA. The Agency anticipates that the new labels will be on products shipped for the 2003 growing season. The IRED instructed registrants to submit labeling within 120 days of the date of the IRED, i.e., by March 1, 2002. However, resolution of issues about the IRED raised during the public comment period has delayed final approval of the labels. EPA expects to receive the applications for amended registration within the next 30 days and to complete its review of the applications in time for the new labeling to be implemented for the 2003 growing season. The IRED transmittal letter advised registrants that, if the registrant failed to implement any of the risk mitigation measures, the Agency would continue to have concerns about the risks posed by phosmet and intends to initiate regulatory actions to address any unresolved concerns.
EPA has also determined that additional data will be required including generic data relating to the following areas:
- environmental fate
- biomonitoring of workers
- glove feasibility
- benefits
EPA plans to issue Data Call-In notices for these generic data, as well as for product-specific data, in October 2002.
The following tables provide the uses of phosmet and their associated risk mitigation plans according to the current IRED.
Provisions of the Phosmet IRED
| Action: Voluntary Cancellation | Date: EPA plans to publish FIFRA sec. 6(f) notices in October 2002 and to complete the voluntarily cancellation process expeditiously thereafter |
| Use: | Domestic pets | Household ornamental | Household fruit trees |
| Action: Time-limited Registration | Date: Over a 5-year period |
| Crop: | Apples Apricots Blueberries, highbush | Crabapples Grapes Nectarines | Peaches Pears Plums/prunes |
|---|
| Action: Continued Registration with New Requirements |
| Crop: | Alfalfa Almonds Beech nut Brazil nut Blueberries, lowbush Butternut Cashews Cattle (except high-pressure hose application) Cherries, tart Cherries, sweet | Chestnut Chinquapin nuts Christmas trees Clover Cotton Cranberries Evergreen trees Filberts Fire ants Hickory nuts Kiwifruit | Macadamia nuts Ornamental nursery stock Peas, dry Peas, fresh Pecans Pine seed orchards Pine seedlings Pistachios Potatoes Sweet Potatoes Swine Walnuts |
|---|
Propargite
1. Background.
On September 28, 2001, EPA signed and released its RED for propargite, which
reflects the registrant's decision to voluntarily cancel certain uses, and EPA's determination to allow continued registration of certain uses subject to additional risk reduction. The Agency has determined that products containing propargite are eligible for reregistration provided that: 1) the data needs are addressed, and 2) the risk reduction measures outlined in the RED (and summarized here) are adopted. The Agency does not believe that propargite shares a common mechanism of toxicity with other chemicals. Therefore, propargite is not subject to any cumulative risk assessment as required by the FQPA. On April 18, 2002, the Agency published in the Federal Register a Notice of Availability and opened a 60 day public comment period on the RED (67 FR 19178).
Propargite was first registered as a pesticide in the U.S. in 1969. Propargite is an insecticide used to control mites on a variety of field, fruit, and vegetable crops, as well as ornamentals. Propargite is applied by aerial application, chemigation, airblast sprayer, and high pressure handwand, and is sold in both liquid and wettable powder formulations.
On April 5, 1996, the Agency and the registrant signed an agreement under which the registrant voluntarily canceled certain uses of the pesticide. The uses canceled under the agreement included those for apricots, apples, peaches, pears, plums, figs, cranberries, strawberries, green beans, and lima beans. Based on Agency analysis of submitted residue monitoring data, those uses were believed to pose an unacceptable carcinogenicity dietary risk. Tolerances for these 10 uses were subsequently revoked (64 FR 39068; July 21, 1999).
2. Description of unacceptable risks.
EPA has reassessed the remaining propargite tolerances and found that no changes are necessary due to risk concerns. Therefore these tolerances will remain in effect, except those for dried citrus pulp and poultry meat/meat by-products, which are no longer needed. The Agency will establish new tolerances for aspirated grain fractions, cotton gin by-products, and citrus oil.
Based on current use patterns, handlers (mixers, loaders, and applicators) may be exposed to propargite during and after application. Several exposure scenarios exceed the Agency's level of concern for short term health effects. Also, the cancer risk to certain pesticide mixers and loaders, when calculated without personal protective equipment or engineering controls, exceed the Agency's level of concern. Those exposures can be reduced to acceptable levels by the mitigation measures described below. To prevent unreasonable cancer risks to harvesters, weeders, scouts, and other post-application workers, all such workers will observe Restricted Entry Intervals ("REIs") of 1 to 36 days, depending on crop and activity. In most cases, these REIs are more stringent than that set by the Worker Protection Standard. Although drinking water risks were not deemed unacceptable, the Agency had some concerns about human exposures via surface water and is requiring confirmatory drinking water monitoring data to ensure adequate margins of exposure.
There are no propargite exposures via residential applications because no residential uses of propargite are approved.
Ecological risks are of concern to the Agency. Propargite poses a potential for adverse effects on reproduction in birds and mammals. Risk to aquatic organisms and plants is generally lower than the risk for birds and mammals; however, the chronic risk concern levels for freshwater invertebrates and freshwater fish are either approached or exceeded from multiple propargite applications. Propargite is also expected to be highly toxic to amphibians. To address these ecological risks, the registrant has agreed to the risk reduction measures described below.
3. EPA's plan for addressing risk.
To reduce risks to agricultural workers who may be exposed to propargite, the RED concluded that the following measures are necessary:
- 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;
- personal protective equipment (socks, shoes, long-sleeved shirts, long pants, and gloves) for all other applications;
- longer REIs for most crops after propargite application; and
- restriction of the product to use only by certified applicators and individuals under their direct supervision.
To reduce the risk to birds, mammals, and aquatic organisms, the RED concluded that the following measures are necessary:
- decreasing seasonal maximum rates for beans, citrus cotton, corn, jojoba, mint, oranges, grapefruit, lemons, potatoes, and walnuts;
- adding spray intervals of 21 days for most food crops (28 days for citrus);
- decreasing the number of annual applications for cotton from 3 to 2.
- prohibiting application of propargite by ground within 50 feet or by air within 75 feet of aquatic areas.
- adding label requirements to minimize spray drift exposures.
- conducting testing to better characterize exposure and risk to birds.
The IRED also determined that additional data will be required including generic data relating to the following areas:
- product chemistry
- residue chemistry
- spray drift
- ecological toxicity and exposure
- drinking water monitoring
All propargite end-use products must comply with the label changes described in the RED document for additional worker protection requirements, engineering controls, application intervals, spray buffers around surface waters, spray drift controls, and decreases in certain application rates. EPA expects to receive the applications for amended registration within the next 30 days and to complete its review of the applications by January 2003. All products formulated 90 days after the registrant's receipt of stamped, approved labeling must bear the new labels. The RED transmittal letter advises registrants that, if the registrant failed to implement any of the risk mitigation measures, the Agency would continue to have concerns about the risks posed by propargite and intends to initiate regulatory actions to address its concerns. Finally, EPA only recently received OMB approval to issue the DCIs and intends to issue them in October 2002.
EPA will propose to revoke the tolerances for propargite on dried citrus pulp and poultry meat/meat by-products by the end of 2002.
Common Mechanism Determinations
The discussion below provides EPA's current thinking and plans for addressing the cumulative risks of certain groups of chemicals identified as sharing a common mechanism of toxicity. EPA has not developed detailed schedules for the conduct of cumulative risk assessments for the common mechanism groups (CMGs) identified pursuant to the NRDC Consent Decree. The following plans, however, reflect the Agency overall approach. In particular, EPA generally does not intend to perform a cumulative risk assessment for a CMG until after each individual chemical in the CMG has a complete individual risk assessment, including an aggregate risk assessment. (Among other things, this sequence allows incorporation of risk mitigation measures on each individual chemical in the CMG to be reflected in the assumptions of the cumulative risk assessment.) Because one or more of the chemicals in each CMG listed below are not currently scheduled for an individual IRED in FY 2003, EPA currently projects that individual IREDs for all of the chemicals in each of these CMGs would not be finished any sooner than FY 2004, and expects that assessment of cumulative risks would start in the following fiscal year. In the event that the assessment of cumulative risks for any of these CMGs requires extensive resources, EPA anticipates that it could need two years to complete a revised cumulative risk assessment.
The Agency notes, however, that not all cumulative assessments need to be of the same depth and scope. Thus, early in the cumulative assessment process, it is important to determine the need for a comprehensive risk assessment. This is done by considering the number and types of possible exposure scenarios in conjunction with the associated residue values available. Initial toxicity and exposure information is collected. A screening-level assessment may be conducted that applies more conservative approaches than would a comprehensive and refined cumulative risk assessment. For example, margins of exposure may be based on no-observed adverse-effect-levels (NOAELs) for the common toxic effect rather than modeling dose-response curves of each chemical member to derive more refined relative potencies and points of departures. For exposure to food, treatment of 100% of crops and tolerance level residues may be assumed for each CMG chemical registered for use on a crop. If a screening-level analysis including such overestimates of exposure indicates that there is no risk concern, then no further detailed assessment may be necessary. But if this conservative approach indicates a potential for unacceptable risk, then a refined assessment should be conducted. This may engender the need for additional data.
In light of the above, EPA notes that the schedules for the CMGs listed below could change substantially.
Thiocarbamates
A subset of the thiocarbamates pesticides (EPTC, molinate, pebulate, and cycloate) was determined to share a common mechanism based on cholinesterase inhibition. EPA has conducted a screening level assessment of these and all other thiocarbamates, making assumptions that are likely to overstate potential exposure and risk significantly. 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). Based on this assessment, EPA does not believe a full cumulative risk assessment will be needed for the subgroup. Even with the very conservative assumptions, no risks of concern would be expected for the subgroup. After the individual risk assessments are conducted, EPA will reassess all information to determine if a more refined cumulative risk assessment is needed. If such an 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.
Dithiocarbamates
A subset of the dithiocarbamate pesticides (ziram and metam sodium) was determined to share a common mechanism based on cholinesterase inhibition. After the individual risk assessments are conducted, EPA will then 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.
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, EPA will then 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.