Pesticide Briefs
August 15, 2006
THE NATIONAL SCENE
PRODUCT CANCELLATIONS
PESTICIDE TOLERANCE ACTIONS, REGISTRATION APPLICATIONS, REGISTRATION APPROVALS
After a tolerance has been established, the registrant decides if the commodity/site will be put on the label. Having a tolerance does not automatically mean you can use the chemical. Even when a pesticide has been registered by EPA, you can not use the product until the commodity/site is on the label in your hand. Always read the pesticide label before applying!
RISK ASSESSMENTS
It is important for you to know that EPA is conducting a risk assessment on a particular pesticide, because this means that there may be label restrictions in the future for this product. During the risk assessment period, you may make comments to EPA if you think label restrictions will impose a hardship on production of a commodity.
REREGISTRATION ELIGIBILITY DECISIONS
It is important for you to know that EPA is conducting a Reregistration study on a particular pesticide, because this means that there may be label restrictions in the future for this product. During the Reregistration period, you may make comments to EPA if you think label restrictions will impose a hardship on production of a commodity.
OTHER REGULATORY ACTIONS
NEWS BRIEFS
REPORTS/ WEB SITES/ PUBS:
****************************************************************************
U.S. PESTICIDE SAFETY HIGHEST IN THE WORLD -NEWS BRIEF
(Washington, D.C. - Aug. 1, 2006) Americans today can be confident that pesticides used in the United States meet the highest health and safety standards in the world, according to the Environmental Protection Agency. On Aug. 3, 2006, EPA is expected to complete a 10-year review of 231 food use pesticides that resulted in changes to how these chemicals are regulated in this country.
"EPA's groundbreaking effort is being welcomed at dinner tables across the nation. The Bush Administration is ensuring pesticides used to grow the fruits, vegetables and other foods families are serving meet the highest protective standards in the world," said EPA Administrator Stephen L. Johnson. "This 10-year review enables farmers to grow a bountiful, healthy food supply for generations of American families."
By strengthening standards for pesticides used in the United States, those who apply pesticides will be better protected. In addition, by ensuring that instructions for pesticide use are followed wildlife and water resources will be better preserved. Changes in pesticide uses include outright elimination of unsafe uses, stricter labeling provisions and safer food tolerances.
Under the Food Quality Protection Act, the EPA review will cover 1,100 of 1,105 pesticides used in the United States.
An example of an accomplishment is highlighted in the proposed cancellation of the six remaining seed treatment uses of the pesticide lindane. Because EPA made the determination that the remaining uses of lindane are not eligible for re-registration, the manufacturers responsibly chose to seek voluntary cancellation.
The chemical aldicarb remains to be completed this fall. When aldicarb is complete, EPA will be able to conclude the cumulative assessments for carbamates (aldicarb, formetanate, carbofuran, oxamyl and carbaryl) and complete the reassessment of the remaining tolerances.
To ensure that pesticides are continuously reviewed against the latest health and safety standards, EPA's final rule will include a registration review program for reviewing pesticides on a continuous 15-year cycle. This program will ensure that all pesticide registrations are systematically reviewed every 15 years.
More information on these accomplishments: http://www.epa.gov/pesticides/regulating/laws/fqpa/fqpa_accomplishments.htm
More information on pesticides: http://www.epa.gov/pesticides
ORGANOPHOSPHATE CUMULATIVE RISK ASSESSMENT COMPLETED; RISKS WITHIN FQPA BOUNDARIES
Fulfilling a major commitment to effect new human health and safety standards, especially to protect infants and children, EPA has completed its cumulative risk assessment for the organophosphate (OP) class of pesticides. With mitigation measures for over 40 individual OP pesticides from risk management decisions completed during the past several years - in particular, cancellations of several of the OP uses that contributed most significantly to dietary and residential risk - the cumulative risks associated with the OPs do not exceed Food Quality Protection Act of 1996 (FQPA) regulatory levels of concern. The Agency's review of the OPs over the past 10 years has resulted in the reassessment of nearly 1,700 OP tolerances (residue limits in food and feed), including the revocation of more than 700 OP tolerances and the lowering of more than 150 OP tolerance levels. The Agency's work has also resulted in the cancellation or phaseout of more than 50 OP uses on foods that make up a large part of children's diets.
Through this highly refined and complex cumulative risk assessment, the Agency has finalized Interim Reregistration Eligibility Decisions (IREDs) that were completed between 2000 and August 2006 for 22 OP pesticides. The OP class of pesticides now comprises 32 chemicals used primarily as insecticides on a wide variety of food and feed crops and for non-agricultural, residential, and other uses. Products containing certain OP pesticides still must complete product reregistration, through which product labeling changes and associated risk mitigation measures are being implemented.
The OPs are a group of closely related pesticides that share a common mechanism of toxicity, cholinesterase inhibition in humans. As part of the tolerance reassessment process under FQPA, EPA must consider available information concerning the cumulative effects on human health resulting from dietary, residential, and other non-occupational exposure to multiple chemicals that, like the OPs, share common mechanisms of toxicity. EPA began developing new tools and methods for conducting pesticide cumulative risk assessments shortly after FQPA was enacted, obtaining considerable input from the FIFRA Scientific Advisory Panel (SAP), advisory groups including TRAC and CARAT, interested stakeholders, and the public. The Agency issued the OP Pesticides: Preliminary Cumulative Risk Assessment in December 2001. The current OP cumulative assessment, an update to EPA's OP Pesticides: Revised Cumulative Risk Assessment issued in June 2002, incorporates risk mitigation measures taken by the Agency that affect food, drinking water, and/or residential risk estimates.
Through a Federal Register notice published on August 2, 2006, EPA opened a public comment period on the OP cumulative risk assessment and related documents that will close on October 2, 2006. For additional information, see the Agency's Assessing Pesticide Cumulative Risk web page, http://www.epa.gov/pesticides/cumulative/ , or docket number EPA-HQ-OPP-2006-0618 at http://www.regulations.gov . The Federal Register notice is available at http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12343.htm
REGISTRANTS REQUEST CANCELLATION OF ALL REMAINING LINDANE USES AND REGISTRATIONS.
The remaining uses of lindane will soon be canceled in the United States, as a result of voluntary requests by the registrants Chemtura USA Corporation, followed by AGSCO Inc, Drexel Chemical Co., and JLM Industries, Inc., to cancel all remaining pesticide registrations of this organochlorine pesticide. EPA also has made a determination that the remaining uses of lindane are not eligible for reregistration. The Agency plans to accept the producers' voluntary cancellation requests after announcing these requests in the Federal Register. The costs of continued lindane registration outweigh the benefits of the remaining seed treatment uses for barley, corn, oats, rye, sorghum, and wheat, according to EPA analysis. Cancellation of these uses is expected to result in no significant loss to U.S. agriculture due to the successful development and registration in recent years of safer alternative pesticides. Once the cancellation process is complete, EPA will propose to revoke the existing tolerances or limits for residues of lindane in animal fat.
The six seed treatment use cancellations are the last of many lindane voluntary cancellations that have taken place since the Food Quality Protection Act of 1996 was enacted. Since 1998, the registrants have voluntarily canceled many lindane uses, including direct treatment of livestock, pet products, ornamentals, home lawns, fallow areas, commercial food processing facilities and storage areas, wood treatment, military use on human skin and clothing, foliar treatment to many fruits and vegetables, pecans, and tobacco, and seed treatment of many additional field crops such as alfalfa, brassica and cole crops, cotton, soybeans, and sunflowers.
Lindane is recognized internationally as a toxic, persistent, and bio-accumulative pesticide. The seed treatment use has been a source of human exposure, contributing to the reservoir of lindane already present in the environment. Due to its persistence, residues of lindane may remain in the environment for some time. In addition, lindane is widely distributed in the environment due to its potential for long-range transport via air, water, and sediment. Ongoing exposure may be of particular concern due to lindane's tendency to bio-concentrate and bio-accumulate.
EPA's July 2006 Addendum to the July 2002 Lindane Reregistration Eligibility Decision (RED) reflects EPA's conclusions on the lindane seed treatment use in light of information gathered since the 2002 RED. This document is available at http://www.regulations.gov in docket number EPA-HQ-OPP-2002-0202, and on the lindane web page, http://www.epa.gov/oppsrrd1/reregistration/lindane/ . The Agency's August 2, 2006, Federal Register notice announcing the Addendum is available at http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12463.htm .
RESMETHRIN: RISK MANAGEMENT AND TOLERANCE REASSESSMENT DECISIONS ANNOUNCED
EPA has determined that resmethrin-containing insecticide products are eligible for reregistration, provided that the risk mitigation measures identified in the reregistration eligibility decision (RED) document are adopted and labels are amended accordingly. Resmethrin tolerances - residue limits in food and feed - have been reassessed and found to meet safety standards established by the Food Quality Protection Act. After considering the potential risks identified in the revised risk assessments, public comments, and risk mitigation suggestions from interested parties, the Agency developed its risk management decision for uses of resmethrin that pose risks of concern.
Preliminary risk assessments of resmethrin indicated potential residential, occupational, and ecological risks of concern. The preliminary risk estimates were revised based on refinements to the assessments, and in some cases, mitigation measures. Residential risks have been mitigated by improved warning labels and mandatory conveyance of proper use information. Occupational handler risks have been mitigated through personal protective equipment and a Restricted Entry Interval. Ecological risks have been addressed through maximum application rates, adding product stewardship statements to the labels, and amending use patterns. The Federal Register Notice announcing the risk management decision and tolerance reassessment is available on EPA's Web site at http://www.epa.gov/fedrgstr/EPA-PEST/2006/July/Day-26/p11821.htm.
Resmethrin is a member of the pyrethroid class of pesticides and was first registered in 1967. It is a broad spectrum, non-systemic, synthetic pyrethroid insecticide. Besides resmethrin, the pyrethroids include permethrin, allethrin, alphametrin, cypermethrin, deltamethrin, dimethrin, and others. Resmethrin is registered for use as a wide area mosquito abatement insecticide, for use on livestock and in livestock housing, in food item transportation vehicles, structures, buildings (including food handling establishments), and for residential use to control flying and crawling insects. EPA is not currently following a cumulative risk approach for the pyrethroids. EPA and pyrethroid registrants are undertaking research to evaluate the biochemical and physiological actions of pyrethroids. When the research is completed, the Agency will consider it in determining whether a common mechanism will be a basis for assessing cumulative risk for pyrethroids.
EPA DENIES STATES' PETITION TO REVOKE PESTICIDE TOLERANCES
EPA has denied, in part, a petition from four states requesting that the Agency modify or revoke all tolerances or legal limits for residues of the pesticides alachlor, chlorothalonil, methomyl, metribuzin, and thiodicarb in food. The petition was filed in December 2004 by the States of New York, California, and Connecticut, and the Commonwealth of Massachusetts. EPA has denied the petition with regard to alachlor, chlorothalonil, and metribuzin, and has not yet made a decision on the petition as to methomyl and thiodicarb.
Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act of 1996 (FQPA) requires EPA to apply an additional tenfold (10X) safety factor to protect infants and children in establishing tolerances. The Agency, however, may remove or reduce this factor if it has reliable data showing that a different factor is safe for children. The states contend that EPA must assess the risks posed by alachlor, chlorothalonil, methomyl, metribuzin, and thiodicarb tolerances using the additional 10X safety factor. Once this additional factor is included, the states claim, the challenged tolerances no longer meet the FFDCA safety standard and must be modified or revoked. EPA is denying the petition to modify or revoke tolerances for alachlor and metribuzin because the tolerances for these pesticides would continue to meet the safety standard even if the additional 10X safety factor sought by the States were added. For chlorothalonil, EPA has determined that there are reliable data showing that the additional 10X safety factor is not needed to protect the safety of infants and children. EPA has postponed ruling on the methomyl and thiodicarb tolerances because the Agency is currently reassessing the risks of these tolerances as part of the N-methyl carbamate cumulative risk assessment. Once that cumulative assessment is complete, EPA will rule on the petition with respect to methomyl and thiodicarb.
EPA's order denying, in part, the states' petition was effective upon publication in the Federal Register on August 2, 2006. This Federal Register document is available at http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p6605.htm. Objections and requests for hearings must be received by the Agency on or before October 2, 2006, and must be filed in accordance with instructions provided in 40 CFR Part 178. The States' petition, EPA's August 2, 2006 order, and related documents are available in docket number EPA-HQ-OPP-2005-0050 at http://www.regulations.gov/.
MANY USES OF ORGANOCHLORINE FUNGICIDE PCNB WILL NO LONGER BE ALLOWED, RISK MITIGATION PROPOSED FOR OTHER USES
EPA has completed its review of the organochlorine fungicide, pentachloronitrobenzene, or PCNB, and has determined that most uses are not eligible for reregistration. The eligible uses are: cole crops (for treatment of clubroot only), ornamental bulbs in commercial production, and seed treatments. This decision is based on ecological risks of concern and the impact of PCNB's ability to persist in the environment. Dietary risks are not of concern for the general population or for children. The Agency has identified a number of measures that it believes are necessary to reduce risks associated with the remaining uses of PCNB.
PCNB is used to control diseases on vegetables (predominantly green beans and cole crops), field crops (cotton, potatoes, and peanuts), turf, ornamentals, and seeds (seed treatments of barley, beans, corn, cotton, oats, peas, peanut, potato, rice, safflower, sorghum, soybean, sugar beet, and wheat). The Agency has reassessed the 14 tolerances (maximum allowable residue levels) established for PCNB.
The Agency has published in the Federal Register [http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12485.htm] a Notice of Availability for its decisions for the uses of PCNB for a 60-day public comment period, closing October 2, 2006. EPA is also soliciting comments on benefits for some of the minor uses that the Agency has determined to be ineligible in order to confirm an accurate assessment of the risks and benefits of PCNB for those uses. Electronic copies of the RED and all supporting documents also are available at http://www.regulations.gov/ in Docket Number EPA-HQ-OPP-2004-0202.
MALATHION: RISK MANAGEMENT AND TOLERANCE REASSESSMENT DECISIONS ANNOUNCED
EPA has determined that pesticide products containing malathion are eligible for reregistration, provided that risk mitigation measures identified in the Reregistration Eligibility Decision (RED) document are adopted and product labels are amended accordingly. Malathion tolerances - residue limits in food and feed - have been reassessed. With mitigation measures described in the RED document, malathion tolerances meet safety standards established by the Food Quality Protection Act (FQPA).
Malathion is a broad-spectrum organophosphate (OP) insecticide first registered in 1956. It is used widely in agriculture on over 100 food and feed crops, for homeowner outdoor uses, ornamental nursery stock, building perimeters, pastures and rangeland, and regional pest eradication programs including USDA's Boll Weevil Eradication Program, USDA’s Medfly Eradication Program, and regional public health mosquito control programs. Previous risk assessments indicated some drinking water, residential bystander, occupational handler and post-application, and ecological risks of concern.
Drinking water and residential bystander risk estimates have been revised, and are no longer of concern, based on refinements to the risk assessments and/or risk mitigation measures:
- 4 crop uses require reduced maximum application rates only.
- 69 crop uses require reduced maximum allowed number of applications per year only.
- 29 crop uses require both reduced maximum application rates and maximum number of applications allowed per year.
Occupational risks have been mitigated through personal protective equipment (PPE) or engineering control requirements on the labels and extending restricted-entry intervals (REIs) for some sites:
- PPE is specified for flaggers and applicators using motorized ground equipment, for mixers and loaders, for handlers of dust formulations, dip applications, airblast applications, and others.
- Closed mixing systems are required for all ultra low volume (ULV) applications.
- All wettable powder formulations must be packaged in water soluble packaging.
- Enclosed cockpits are required for all aerial applications.
- REIs are extended for 46 agricultural crops. Most are 12-24 hours, though some crops require 2-day (48-hour) or 3-day (72-hour) REIs.
Ecological risks have been addressed by adding buffer zone and spray drift requirements to the labels, and amending use patterns for many uses:
- Buffer zones of 25 feet are required along all water bodies for all aerial non-ULV agricultural applications.
- Buffer zones of 50 feet are required along all water bodies for all aerial ULV agricultural applications.
- Spray drift management language is to be added specific to Boll Weevil Eradication Program (BWEP) and non-BWEP product labels.
- Lower maximum application rates and/or reduced maximum numbers of applications per year for many agricultural applications as described above will help reduce ecological risks.
Some uses sites and product formulations of malathion are not being supported by the technical registrant and, therefore, were not included in the final assessment. The unsupported use and product formulations that are not being supported are ineligible for reregistration and are being deleted from product labels.
Malathion is a member of the OP class of pesticides, which share a common mechanism of toxicity by affecting the nervous system via cholinesterase inhibition. A cumulative risk assessment, which evaluates exposures based on a common mechanism of toxicity, was conducted to evaluate the risk from food, drinking water, residential, and other non-occupational exposures resulting from registered uses of OP pesticides, including malathion. With mitigation measures for over 40 individual OP pesticides from risk management decisions completed during the past several years - in particular, cancellations of several of the OP uses that contributed most significantly to dietary and residential risk - the cumulative risks associated with the OPs do not exceed Food Quality Protection Act of 1996 (FQPA) regulatory levels of concern. For additional information, see the OP Cumulative Assessment (2006 Update) in docket number EPA-HQ-OPP-2006-0618 and on the Agency's Web site at http://www.epa.gov/pesticides/cumulative/
The Malathion RED is available in docket number EPA-HQ-OPP-2004-0348 at http://www.regulations.gov, and on the Agency?s malathion reregistration Web page at http://www.epa.gov/oppsrrd1/op/malathion.htm. EPA will soon publish a Federal Register notice announcing the availability of the Malathion RED document.
CARBOFURAN CANCELLATION: (NEWS BRIEF)
(Washington, D.C. - Aug. 3, 2006) EPA is proposing to cancel all uses of the pesticide carbofuran and to revoke the associated tolerances (legal residue limits on food). The agency announced today its conclusion that there are considerable risks associated with carbofuran in food and drinking water, risks to pesticide applicators and risks to birds that are exposed in treated fields.
"Whether planting crops, de-bugging a home, working in the garden, or just sitting down at the dinner table, Americans everywhere can now be assured the pesticides used in the U.S. meet the highest health standards in the world," said EPA Administrator Stephen L. Johnson. "By maintaining the highest ethical and scientific standards in its pesticide review, EPA and the Bush Administration have planted the seeds to yield healthier lives for generations of American families."
"EPA is committed to moving America away from high-risk pesticides to newer, safer alternatives that deliver results, while ensuring the public, pesticide applicators, and the environment are protected," said Jim Gulliford, assistant administrator for the Office of Prevention, Pesticides and Toxic Substances at EPA.
EPA is proposing to immediately cancel the majority of carbofuran uses. A four-year phase-out is being proposed for six, minor agricultural uses, which will provide time to find effective alternatives.
The decisions on carbofuran and lindane are the latest accomplishments achieved under the Food Quality Protection Act. Over the last decade, EPA significantly restricted uses of formerly widely used pesticides such as: Chlorpyrifos (Dursban), CCA (Copper Chromated Arsenate), DDVP, Diazinon, Methyl Parathion and others.
Americans today can be confident that pesticides used in this country continue to meet the highest health and safety standards in the world.
More information on carbofuran: http://www.epa.gov/oppsrrd1/reregistration/carbofuran/
More information on pesticides: http://epa.gov/pesticides
10th ANNIVERSARY OF FQPA – MESSAGE FROM EPA
Dear colleague:
August 3, 2006, marked the tenth anniversary of the enactment of the Food Quality Protection Act (FQPA). When it passed Congress, House Commerce Committee Chairman Thomas Bliley characterized its importance as a 'landmark bipartisan agreement that will bring Federal regulation of the Nation's food producers into the 21st century.' Through this historic action, Congress presented the national pesticide program with the immense challenge of implementing the most comprehensive overhaul of the Nation's pesticide and food safety laws in decades. While this was a formidable task, it has inspired a complete transformation in national pesticide safety standards and regulation. On the tenth anniversary of FQPA adoption, we should all take pride in the advances in public health and environmental protection that our hard work and collaborative approach has achieved.
The centerpiece of Congress' challenge was the requirement to review and reassess the tolerances (maximum permitted residues) for all food-use pesticides within a decade. We are proud to report that we have completed reassessments for more than 99 percent of the 9,721 subject tolerances. As you know, this complex scientific effort required the detailed review of tens of thousands of studies and test results on toxicity, chemistry, and environmental data. Notably, this work resulted in the revocation or modification of nearly 4,000 food tolerances.
The United States now sets the bar for pesticide safety. EPA's pesticide standards significantly advance food safety, public health, and environmental protection. This 10-year effort, based on sound science and broad public participation, has resulted in the most protective measures for all Americans, especially infants and children. We now routinely consider the special susceptibility of infants and children to pesticide residues. Other new protective measures require us to conduct residential, drinking water, and other non-occupational exposure assessments. These were carried out simultaneously and in concert with the large effort to make determinations on the reregistration of existing pesticides. That program resulted in the cancellation of nearly 4,400 individual pesticide end-use product registrations while still ensuring safe pesticides are available to protect Americans, their homes, and their food supply.
The Agency has taken thousands of individual protective actions, resulting in enormous public health progress. For instance, the cumulative assessment of organophosphates has resulted in numerous real world benefits. Nearly 1,700 organophosphate tolerances have been reassessed to meet the safety standards established by FQPA. Of the 49 organophosphate pesticides (OP) that were registered at the beginning of the registration process, 17 have been voluntarily cancelled or are being phased out. Virtually all residential uses of the remaining 32 OP's have been eliminated. In addition to restricting organophosphate pesticide usage, the amount of these pesticides used on kids' foods from 1994 to 2004 has decreased from approximately 28 million pounds of active ingredient to approximately 12 million pounds - a 57 percent reduction. During this same period, the number of unintentional OP poisonings was reduced by 70 percent.
Equally important in achieving FQPA goals are the many new products and uses that we have registered. Over the past 10 years, we have registered 248 active ingredients and over 1,600 new uses of existing pesticides. Not only did all of these decisions meet the strict safety standards of FQPA, but these new products also provided critical alternatives to many of the uses we restricted or eliminated as part of the tolerance reassessment and reregistration program. Without these lower-risk alternatives, America's shift to safer pesticides would not have been possible.
FQPA created a number of other requirements. The enclosed matrix identifies some of the main provisions in the law and describes how the Agency carried them out. Just as important as the new requirements was the new approach reflected in our implementation of the law. Critical strategic principles of FQPA are ensuring that decisions are sound and science based, that government activities are open and transparent, that actions are timely, and that public policies are sensible. Our work to upgrade the national pesticide program has been guided by these principles, and they are embodied in our everyday work.
Successful FQPA implementation would not have been possible without the commitment and partnership of all members of the national pesticide community. As a consortium of Federal agencies, international organizations, states, tribes, environmental/public interest groups, registrants, users, researchers, and other stakeholders, we have all worked closely to implement the law and achieve its protections. Our collaborative work has proven that we do not have to choose between a safe and clean environment and a vigorous economy. Together, we have ensured that safe and effective pest management tools are always available to support production of an abundant, affordable, and healthy food supply. I believe you will agree that this degree of success for such an ambitious, controversial, and complex undertaking is unprecedented.
I thank you for your role in helping to ensure that the American people continue to enjoy one of the most plentiful, wholesome, and reliable food supplies in the world. Please join us in recognizing and celebrating the exceptional work that has been done to safeguard our Nation's health and prosperity.
Sincerely,
James J. Jones, Director
EPA Office of Pesticide Programs
August 4, 2006
Enclosure (click link below)
http://www.epa.gov/pesticides/regulating/laws/fqpa/fqpa_implementation.htm
PEST CONTROL DEVICE INFORMATION NOW AVAILABLE ON EPA WEB SITE
EPA has published information on its Web site to help manufacturers better understand the difference between a pest control device and a pesticide product. Previously, only a brief definition of pest control devices could be found on the Agency's Web site. The new page better elaborates on the distinctions between the two types of products to aid manufacturers in determining whether or not a certain product requires EPA registration. Please note that this page provides only general clarification. Manufacturers or applicants still need to consult EPA for a determination regarding the regulatory requirements for any product. The new page can be found at: http://www.epa.gov/pesticides/about/devices.htm.
METHYL BROMIDE RISK MITIGATION MEASURES
EPA has completed its review of the commodity uses of the fumigant methyl bromide. To reduce potential risks of concern to workers and bystanders from acute inhalation exposure, the Agency is requiring a number of mitigation measures, including site-specific fumigant management plans, respiratory protection, buffer zones, posting, and notification. Combined with the methyl bromide phase-out mandated by the Montreal Protocol, many of these measures will further reduce potential health risks from ozone depletion, such as skin cancer. EPA has determined that methyl bromide's commodity uses are eligible for reregistration and its tolerances meet FQPA safety standards, provided that risk mitigation measures identified in the methyl bromide decision document are adopted and product labels are amended accordingly.
Methyl bromide is a broad-spectrum fumigant with a variety of pest control uses. Its use is being phased out under the Montreal Protocol; however, critical use exemptions will still be available under special circumstances. While most often used as a soil fumigant, methyl bromide also is used as a structural fumigant and for post-harvest treatment of commodities. The current decision document covers methyl bromide uses that have accompanying food residue tolerances for post-harvest fumigation of food commodities in chambers at ports, or specialized structural fumigations at food processing facilities. Although some methyl bromide uses such as fumigation of timber, wood products, and industrial equipment do not require a food residue tolerance, the Agency has included them in the current decision since they are performed in similar facilities and were assessed using a similar risk assessment methodology.
EPA is currently assessing risks and will be developing risk management decisions for five soil fumigant pesticides: chloropicrin, dazomet, metam sodium, methyl bromide, and a new active ingredient, iodomethane. Risks of a sixth soil fumigant, 1,3-D (Telone), will be discussed for comparative purposes; the Telone risk management decision was completed in 1998. The Agency is evaluating these soil fumigants concurrently to ensure that human health risk assessment approaches are consistent, and that risk tradeoffs and economic outcomes can be considered appropriately in reaching risk management decisions. A decision on the reregistration of methyl bromide's pre-plant soil fumigation uses is scheduled to be completed in 2007 with the other soil fumigants.
EPA's Report on FQPA Tolerance Reassessment and Risk Management Decision (TRED) and Reregistration Eligibility Decision (RED) for Methyl Bromide’s Commodity Uses is available in docket number EPA-HQ-OPP-2005-0123 at http://www.regulations.gov , and on the Agency's methyl bromide reregistration web page at http://www.epa.gov/oppsrrd1/reregistration/methyl_bromide/ . The Agency’s August 9, 2006, Federal Register notice (http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-09/p12898.htm) announcing the availability of this decision document opened a public comment period that will close on October 10, 2006. Information on EPA’s Soil Fumigant Assessments is available at http://www.epa.gov/oppsrrd1/reregistration/soil_fumigants/ .
METALDEHYDE RISK MITIGATION MEASURES
EPA has completed its review of the supported uses of metaldehyde, a molluscicide used to control snails and slugs on a wide variety of sites including turf, ornamentals, berries, citrus, and vegetables. The Agency has determined that all of metaldehyde's supported uses, except turf and dichondra lawns, are eligible for reregistration; and, its sole tolerance meets the FQPA safety standard, provided that risk mitigation measures identified in the Metaldehyde Reregistration Eligibility Decision (RED) are adopted and product labels are amended accordingly. Registrants also must submit confirmatory data and domestic animal incident monitoring results to help the Agency determine whether the risk mitigation adequately reduces pesticide poisonings among domestic animals.
Metaldehyde poses no dietary, residential, or worker human health risks of concern. To further deter children and toddlers from accidental ingestion, a bittering agent currently in some products will be included in all residential use products. However, incident information suggests that many domestic animals, mainly dogs, are poisoned after ingesting metaldehyde pellets applied to home lawns and gardens as snail and slug baits. Birds and animals are also assumed to be at risk. To reduce risks to dogs, other domestic animals, and wildlife, the Agency is requiring a number of mitigation measures for residential use products, including:
* reduce numbers of applications and application rates
* add minimum retreatment intervals
* prohibit broadcast and foliar applications
* update product warnings and use directions
* provide information on cultural practices to reduce damage from snails and slugs
* always include bittering agents
* to discourage animals from mistaking metaldehyde pellets for food, formulate granular
products at a rate of fewer than 35 pellets per gram
* submit data on the efficacy of metaldehyde products formulated with non-food-based
inerts and bulking agents
EPA also is requesting input on several specific use-related issues during the public comment period for this risk management decision. These questions are listed in the Federal Register notice.
The Metaldehyde RED is available in docket number EPA-HQ-OPP-2005-0231 at http://www.regulations.gov , and on the Agency's reregistration status web page at http://www.epa.gov/pesticides/reregistration/status.htm . The Agency's August 9, 2006, Federal Register notice (see http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-09/p12896.htm) announcing the availability of this RED document opened a public comment period that will close on October 10, 2006.
EPA FINDS ORGANIC ARSENICAL HERBICIDES INELIGIBLE FOR REREGISTRATION
EPA has announced its decision that all uses of the organic arsenic herbicides -- MSMA, DSMA, CAMA, and cacodylic acid -- are not eligible for reregistration. The Agency's primary concern is the potential for applied organic arsenical products to transform to a more toxic inorganic form of arsenic in soil and subsequently be transported to drinking water.
The Agency's risk assessment, supported by field monitoring data in both surface and ground water, estimates levels of inorganic arsenic in drinking water from the pesticide use that raise a concern for cancer risk. Given this risk, EPA has determined that the tolerances for the organic arsenic herbicides do not meet the safety standard of the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, because there are readily available alternatives, EPA believes continued registration of the organic arsenic herbicides will pose an unreasonable risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The element arsenic is found naturally in the environment. Through erosion and industrial activities, arsenic is transported into water, air, food, and soil. As a result, people are exposed to small amounts of arsenic every day. EPA and other federal and state agencies have regulations in place that aim to reduce or limit arsenic exposure to individuals. In light of these facts, and given that alternative herbicides are readily available, EPA believes additional exposure to arsenic from the organic arsenic herbicides is unnecessary.
The organic arsenic herbicides are used primarily on cotton and turf, including golf courses, home lawns, recreational areas such as school yards and athletic fields, and rights-of-way. Overall, use in the U.S. appears to be declining, and alternative weed controls are available for each of these uses.
EPA's reregistration eligibility decision, revised risk assessments, and related documents are available in the organic arsenical herbicides docket #EPA-HQ-OPP-2006-0201 at http://www.regulations.gov. The Agency's August 2006 Federal Register notice announcing the availability of the decision document and the start of a 60-day public comment period is available at http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-09/p12905.htm. For additional information, see the Agency's cacodylic acid and MSMA, DSMA and CAMA reregistration Web pages at http://www.epa.gov/pesticides/reregistration/status.htm.
TITLE: ALACHLOR, CHLOROTHALONIL, METHOMYL, METRIBUZIN, THIODICARB; ORDER DENYING PETITION TO REVOKE TOLERANCES.
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43905-43924
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p6605.htm
Purpose: EPA denies, in part, a petition requesting the modification or revocation of the pesticide tolerances for alachlor, chlorothalonil, methomyl, metribuzin, and thiodicarb established under FFDCA. The petition was filed on December 17, 2004, by the States of New York, California, and Connecticut, and the Commonwealth of Massachusetts (``the States''). In their petition, the States contend that the risks posed by these pesticide tolerances must be assessed utilizing the additional tenfold (10X) safety factor for the protection of infants and children and that once this additional factor is included the challenged tolerances no longer meet the safety standard under FFDCA section 408. EPA is deferring action on the petition as regards the tolerances for methomyl and thiodicarb given the ongoing Agency proceedings to address the safety of these pesticides.
Chemical(s): Alachlor, Chlorothalonil, Methomyl, Metribuzin, Thiodicarb
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0050.
Contact: Terria Northern, Special Review and Reregistration Division, (7508P), telephone number: 703-305-7093; fax number: 703-308-7070; e-mail address: northern.terria@epa.gov.
TITLE: FENHEXAMID; PESTICIDE TOLERANCE.
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43660-43664
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12348.htm
Purpose: This regulation establishes tolerances for residues of fenhexamid in or on non-bell pepper, pomegranate, and cilantro leaves. Interregional Research Project No.4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
Chemical(s): Fenhexamid
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0245. This regulation is effective August 2, 2006. Objections and requests for hearings must be received on or before October 2, 2006.
Contact: Barbara Madden, Registration Division (7505P), telephone number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.
TITLE: IPRODIONE – NOTICE OF FILING OF PESTICIDE PETITIONS FOR ESTABLISHMENT AND AMENDMENT TO REGULATIONS FOR RESIDUES IN OR ON VARIOUS COMMODITIES.
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43760-43762
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12328.htm
Purpose: This notice announces the initial filing of pesticide petitions proposing the establishment and amendment of regulations for residues of iprodione in or on various commodities.
Chemical(s): Iprodione
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0637. Comments must be received on or before September 1, 2006.
Contact: Barbara Madden, Registration Division (7505C), telephone number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.
TITLE: QUIZALOFOP-P-ETHYL - NOTICE OF FILING OF A PESTICIDE PETITION FOR ESTABLISHMENT OF REGULATIONS FOR RESIDUES IN OR ON VARIOUS FOOD COMMODITIES.
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43762-43763
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12469.htm
Purpose: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of Quizalofop-P-Ethyl in or on barley, flax and sunflower seed, and wheat commodities.
Chemical(s): Quizalofop-P-Ethyl
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0204. Comments must be received on or before September 1, 2006.
Contact: Vickie Walters, Registration Division (7505P), telephone number: (703) 305-5704; e-mail address: walters.vickie@epa.gov.
TITLE: ORGANOPHOSPHATE CUMULATIVE RISK ASSESSMENT
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43740-43742
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12343.htm
Purpose: This notice announces the availability of EPA's cumulative risk assessment for the organophosphate group of pesticides and opens a public comment period on this document and other support documents. As required by the Food Quality Protection Act (FQPA), a cumulative risk assessment, which evaluates exposures based on a common mechanism of toxicity, was conducted to evaluate the risk from food, drinking water, residential, and other non-occupational exposures resulting from registered uses of organophosphate pesticides.
Chemical(s): Organophosphate
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0618. Comments must be received on or before October 2, 2006.
Contact: Kelly Sherman, Special Review and Reregistration Division (7508P), telephone number: (703) 305-8401; fax number: (703) 308-8005; e-mail address: sherman.kelly@epa.gov; or Kendra Tyler, Special Review and Reregistration Division (7508P); telephone number: (703) 308-0125; e-mail address: tyler.kendra@epa.gov.
TITLE: BORIC ACID/SODIUM BORATE SALTS – TOLERANCE REASSESSMENT Date of publication: August 2, 2006e Citation: Volume 71, Number 148, Page 43744-43745
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12347.htm
Purpose: This notice announces the availability of EPA's Tolerance Reassessment Decision (TRED) for the boric acid/sodium borate salts pesticides. Through the tolerance reassessment program, EPA is ensuring that all pesticides meet current health and food safety standards.
Chemical(s): boric acid/ sodium borate salts
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0062. Comments must be received on or before October 2, 2006.
Contact: Nathan Mottl, Special Review and Reregistration Division (7508P), telephone number: (703) 305-0208; fax number: (703) 308-7070; e-mail address: mottl.nathan@epa.gov.
TITLE: SODIUM CYANIDE – TOLERANCE REASSESSMENT DECISION FOR LOW RISK PESTICIDE
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43742-43744
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12346.htm
Purpose: This notice announces the availability of EPA's Tolerance Reassessment Decision (TRED) for the pesticide sodium cyanide. EPA has reviewed this pesticide sodium cyanide through a modified, streamlined version of the public participation process that the Agency uses to involve the public in developing pesticide tolerance reassessment and reregistration decisions.
Chemical(s): sodium cyanide
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0352. Comments must be received on or before October 2, 2006.
Contact: Wilhelmena Livingston, Special Review and Reregistration Division (7508P), telephone number: (703) 308-8025; fax number: (703) 308-8005; e-mail address: livingston.wilhelmena@epa.gov.
TITLE: LINDANE ADDENDUM TO REREGISTRATION ELIGIBILITY DECISION
Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43745-43746
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12463.htm
Purpose: This notice announces the availability of an addendum to EPA's Reregistration Eligibility Decision (RED) for the pesticide lindane. Lindane is a broad spectrum insecticide used as a pre-plant seed treatment on six crops. EPA has reviewed lindane through the public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions.
Chemical(s): Lindane
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2002-0202.
Contact: Kimberly Nesci, Special Review and Reregistration Division (7508P), telephone number: (703) 308-8059; fax number: (703) 308-8005; e-mail address: nesci.kimberly@epa.gov.
TITLE: PENTACHLORONITROBENZENE (PCNB) REREGISTRATION ELIGIBILITY. Date of publication: August 2, 2006
Citation: Volume 71, Number 148, Page 43746-43748
http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-02/p12485.htm
Purpose: This notice announces the availability of EPA's Reregistration Eligibility Decision (RED) for the pesticide PCNB. PCNB is an organochlorine fungicide used to control plant diseases on vegetables (predominantly green beans and cole crops), field crops (cotton, potatoes, and peanuts), and seeds. EPA has reviewed PCNB through the public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions.
Chemical(s): Pentachloronitrobenzene (PCNB)
Comments: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2004-0202. Comments must be received on or before October 2, 2006.
Contact: Jill Bloom, Special Review and Reregistration Division (7508P), telephone number: (703) 308-8019; fax number: (703) 308-7070; e-mail address: bloom.jill@epa.gov.
|
