E7-18861. Dichlorvos (DDVP); Proposed Determination to Terminate Special Review

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice sets forth EPA's Proposed Determination to Terminate Special Review for the pesticide Dichlorvos (DDVP). On February 24, 1988, the Agency published a Notice of Special Review (PD 1) of pesticide products containing DDVP based on concerns for cancer, cholinesterase inhibition, and liver effects. (53 FR 5542). On September 28, 1995, the Agency published a Notice of Preliminary Determination to Cancel Certain Registrations and a Draft Notice of Intent to Cancel (PD 2/3). (60 FR 50337). In the 1995 PD 2/3, the Agency determined that exposure to dichlorvos from the registered uses posed carcinogenic risks of concern as well as risks of concern for cholinesterase inhibition. However, with respect to liver effects, the Agency determined that this endpoint was no longer of regulatory concern. Since the initiation of Special Review and publication of the PD 2/3, additional data have become available. Based in part on these data, the Agency has changed its assessment of some of the risks associated with DDVP, and modified the terms and conditions of DDVP registrations, accordingly. Moreover, during the recently-concluded reregistration process for DDVP, EPA conducted an intensive and public review of whether DDVP registrations meet the FIFRA standard for registration, culminating in the Agency's 2006 Interim Reregistration Eligibility Decision (IRED) for DDVP. Through the reregistration processes the Agency resolved remaining concerns regarding cancer and cholinesterase effects. Accordingly, EPA has revised its assessment of DDVP since the time when the PD 1 and the PD 2/3 were published. Based on the IRED, requested label amendments, and the voluntary cancellation of uses by the registrant pursuant to section 6(f) of FIFRA, EPA has determined that the risks that were the basis of the Special Review are no longer of concern and, therefore, the Agency is proposing to terminate the Special Review of DDVP. To the extent that the Agency further revises its assessment of DDVP, it will do so outside of the Special Review context.

DATES:

Comments must be received on or before October 26, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0396, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2006-0396. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Susan Bartow, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

DDVP is an organophosphate insecticide and fumigant registered for use in controlling flies, mosquitos, gnats, cockroaches, fleas, and other insect pests. Formulations of DDVP include pressurized liquids, emulsifiable concentrates, and impregnated materials. DDVP is applied with aerosols and fogging equipment, with spray equipment, and through slow release from impregnated materials, such as resin strips.

DDVP is registered to control insect pests on agricultural sites; commercial, institutional and industrial sites; and for domestic use in and around homes (i.e., resin strips). DDVP is used preplant in mushroom houses, and postharvest in storage areas for bulk, packaged and bagged raw and processed agricultural commodities, food manufacturing/processing plants, animal premises, and non-food areas of food-handling establishments. It is also registered for direct dermal treatment of cattle and poultry, and swine, sheep, and goats.

The mechanism of pesticidal action of DDVP is inhibition of cholinesterase. Although when the DDVP Special Review was first initiated, EPA identified concerns for cancer and liver effects as well as cholinesterase inhibition, the Agency has since determined that the adverse effects caused by DDVP that are of primary concern to human health are neurological effects related to inhibition of cholinesterase activity and the previously-identified cancer and liver effects do not present risks of concern.

A. What Action is the Agency Taking?

On February 24, 1988, the Agency published a Notice of Special Review (PD 1) of pesticide products containing DDVP based on concerns for cancer, cholinesterase inhibition, and liver effects (53 FR 5542). On September 28, 1995, the Agency published a Notice of Preliminary Determination to Cancel Certain Registrations and a Draft Notice of Intent to Cancel (PD 2/3) (60 FR 50337)(FRL-4954-7). For the reasons discussed below, EPA is now issuing this proposal to terminate the DDVP Special Review without taking any further action against the DDVP registrations. EPA is taking this action based upon the requested label amendments, the voluntary cancellation of uses by the registrant pursuant to section 6(f) of FIFRA, and the IRED, in which EPA determined that the risks that were the basis of the Special Review are no longer of concern. The Agency notes that it has received and is in the process of responding to a petition to cancel all DDVP registrations and revoke all DDVP tolerances. The breadth and scope of the petition is far greater than the discrete issues that were the triggers initiating the DDVP Special Review. The Agency is proposing to terminate the Special Review, and to assess the merits of the petition separately. Notwithstanding anything in this proposal or in the reregistration decision for DDVP, if EPA determines that some or all of the petition should be granted, the Agency will pursue appropriate changes to the terms and conditions of DDVP registrations.

B. What is the Agency's Authority for Taking this Action?

In order to obtain a registration for a pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq., as amended by the Food Quality Protection Act of 1996, Public Law 104-170), an applicant must demonstrate that the pesticide will not cause unreasonable adverse affects on the environment when used according to label directions. (FIFRA section 3(c)(5)). The term unreasonable adverse effects on the environment means: 1. Any unreasonable risk to humans or the environment, taking into account the economic, social and environmental costs and benefits of the use of any pesticide, or 2. A human dietary risk from residues that results from use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug and Cosmetic Act. (FIFRA section 2(bb)).

Tolerances, or the establishment of maximum permissible levels of pesticides in foods, are required when a pesticide or its identifiable degradates or metabolites are expected to be present in food. Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., as amended by the Food Quality Protection Act (FQPA) of 1996, (Public Law 104-170), authorizes EPA to establish a tolerance if the Agency determines the tolerance is safe. Without such a tolerance or an exemption from a tolerance, a food containing a pesticide residue is adulterated under section 402 of the FFDCA and may not be legally moved in interstate commerce.

In determining a pesticide's safety for establishing a tolerance or an exemption from the requirement of a tolerance, section 408 of the FFDCA requires, inter alia, that EPA examine aggregate exposures from all sources of pesticide residues, whether infants and children have heightened susceptibility to pesticide residues, and whether there are cumulative effects of pesticides and other compounds with a common mechanism of toxicity. Because it is not relevant to the outcome of this Special Review, we will not discuss in detail the differences between the current standard in section 408 and the standard that was in effect when the Special Review for DDVP was initiated. In proposing to terminate this Special Review, EPA is applying the more stringent standard currently found in section 408.

The Special Review process, which was previously called the Rebuttable Presumption Against Registration (RPAR), is described in 40 CFR part 154, published in the Federal Register of November 25, 1985 (50 FR 49015). EPA can initiate a Special Review if it determines that a pesticide may pose a serious risk to human health or the environment (40 CFR 154.7). The purpose of the Special Review process is then to determine whether the risk is in fact a serious one, and if so, whether some or all of the registrations of an affected pesticide meet the FIFRA standard for registration, or whether amendment of the terms and conditions of registration or cancellation of portions or all of the registrations is appropriate.

Prior to formal initiation of a Special Review, a preliminary notification is sent to registrants and applicants for registration pursuant to 40 CFR 154.21 announcing that the Agency is considering commencing a Special Review. Registrants and applicants for registration are allowed 30 days from receipt of the notification to comment on the Agency's proposal to commence a Special Review.

If the Agency determines, after issuance of a notification pursuant to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR 154.23(c) requires the Administrator to publish a Notice of Special Review in the Federal Register. To conclude the Special Review after a Special Review has been initiated, 40 CFR 154.31 requires the Administrator to first publish a Notice of Preliminary Determination in the Federal Register. This Notice is a Preliminary Determination as called for in 40 CFR 154.31.

A Special Review can be concluded in a number of ways. As noted earlier, the purpose of a Special Review is to determine whether a potentially serious risk (or risks) warrants changes to the terms and conditions of pesticide registrations. If the Agency determines that the scientific bases for the Special Review were erroneous; that the risks are not meaningful in light of the current terms and conditions of affected registrations; or that risk mitigation is not feasible and the risks are justified by the benefits associated with the use of the pesticide, a Special Review could be terminated without any changes to existing registrations. On the other hand, if the Agency determines that certain changes to the terms and conditions of registration are necessary in order for a pesticide to meet the FIFRA standard for registration, or that no changes could enable the pesticide to meet the FIFRA standard, the Agency could propose to initiate regulatory action under section 3(d) or 6 of FIFRA (and/or section 408 of the FFDCA) to assure that the affected pesticide registrations are either cancelled or appropriate changes to the registrations are made. Any final decision on a pesticide's registration through the Special Review process is set forth in a Notice of Final Determination issued in accordance with 40 CFR 154.33.

Reregistration is another process under which EPA examines whether an existing pesticide meets the FIFRA standard of registration. When Congress substantially amended FIFRA in 1972, it directed EPA to examine all existing pesticides to determine whether they met the new standards for registration Congress was promulgating. This directive to make reregistration decisions for existing registrations was formally added to FIFRA as a new section 4 in 1988. That section now requires EPA to make reregistration eligibility decisions by August 3, 2006 for all food-use chemicals that were first contained in a registered pesticide product before November 1, 1984, and by October 3, 2008 for all other chemicals subject to reregistration. (FIFRA section 4(g)(2)(A)).

The reregistration program EPA developed to comply with this Congressional directive and the similar directive adopted in the FQPA to reassess all existing tolorances against the new safety standard placed into section 408 of the FFDCA in 1996, was a major focus of EPA's pesticide program for a number of years. Under that program, EPA examined hundreds of pesticide active ingredients, including DDVP, to determine whether pesticide products containing DDVP could meet the FIFRA standard for registration. As part of the reregistration process, EPA called in large numbers of studies from pesticide registrants, and conducted detailed risk assessments of many of the affected pesticides. EPA also issued reregistration eligibility decisions, called REDs or IREDs, in which the Agency discussed the risks posed by particular pesticides, whether those risks could and should be mitigated, and whether registrations of the particular pesticide as modified as set forth in the RED or IRED met the FIFRA standard of not causing unreasonable adverse effects on the environment. The concerns that gave rise to the DDVP Special Review were addressed as part of the reregistration assessment of DDVP, and for that reason EPA now proposes to terminate the Special Review. EPA intends to continue its assessment of DDVP in light of the petition to cancel all DDVP registrations and revoke all DDVP tolerances. Notwithstanding anything in this proposal or in the reregistration decision for DDVP, if EPA determines that some or all of the petition should be granted, the Agency will pursue appropriate changes to the terms and conditions of DDVP registrations.

C. Why is the Agency Taking this Action?

On February 24, 1988, the Agency initiated a Special Review for pesticide products containing DDVP.(53 FR 5542). At that time, the Agency was concerned that exposure to DDVP from registered uses might pose a carcinogenic risk of concern and that there were inadequate margins of exposure for cholinesterase inhibition and liver effects to exposed individuals. In 1995, the Agency concluded upon further analysis that although liver toxicity was no longer a risk of concern, DDVP did pose carcinogenic risks of concern to the general population from dietary exposure. The Agency also concluded in 1995 that DDVP posed risks of concern for cholinesterase inhibition to residents in homes and to individuals mixing, loading, and applying this pesticide, as well as to those reentering treated areas. Subsequently, the Agency issued a Preliminary Determination to Cancel Certain Registrations (PD 2/3) and a Draft Notice of Intent to Cancel the DDVP uses which posed the greatest risks. (60 FR 50338, September 28, 1995). In its 1995 PD 2/3, the Agency concluded that the risks outweighed the benefits for most uses of DDVP under the conditions of registration at that time and, therefore, recommended a variety of measures to reduce those risks. The Agency proposed cancellation of certain uses of DDVP and cancellation of other uses unless certain labeling modifications were made to reduce risk.

Since 1995, additional data became available and, as part of the reregistration effort, the Agency conducted a thorough assessment of all the risks associated with DDVP (including, but not limited to, those risks that gave rise to the Special Review). This assessment is described in more detail in the Reregistration Eligibility Decision for DDVP and in the associated 2006 Human Health Assessment. In addition, as part of the reregistration process, EPA conducted an intensive and public review of whether or not DDVP registrations met the FIFRA standard for reregistration. As noted above, this determination of whether a pesticide causes unreasonable adverse effects is the ultimate focus of both reregistration and Special Review.

On June 30, 2006, the Agency issued an Interim Reregistration Eligibility Determination (IRED) for DDVP. Subsequently, EPA completed the organophosphate cumulative assessment (in which it concluded that, among other things, the tolerances for DDVP meet the safety standard of section 408 of the FFDCA), and on July 31, 2006, EPA issued a determination that each of the organophosphate pesticides for which an IRED had been issued was eligible for reregistration, including DDVP. See Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides, dated July 31, 2007 (attached to the DDVP IRED at http://www.epa.gov/​pesticides/​reregistration/​REDs/​ddvp_​ired.pdf).

The IRED was based in part on an irrevocable request from Amvac Chemical Corporation (Amvac), the sole technical product registrant, to cancel certain uses and include additional pest strip label restrictions on the DDVP technical product labels. Pursuant to section 6(f) of FIFRA, 7 U.S.C. 136d(f)(1), on June 30, 2006, the Agency published a notice in the Federal Register that it had received the request and sought comment on EPA's intention to grant the request and cancel the specified uses. (71 FR 37570)(FRL-8075-2). On October 20, 2006, EPA issued the final cancellation order granting Amvac's request. (71 FR 61968)(FRL-8075-8).

Specifically on May 9, 2006, Amvac submitted to EPA a request for cancellation of several existing DDVP products, uses and application methods, including the 100 gram pest strip, the total release fogger, use on lawn, turf and ornamentals, residential crack and crevice use, and hand held fogger applications in mushroom houses, greenhouses, and warehouses. Amvac also requested several label amendments further restricting residential use of pest strips and adding personal protective equipment requirements and more protective re-entry intervals for mushroom and greenhouse uses. The added restrictions on the use of the pest strip products provided, among other things, that large pest strips could no longer be used in homes except for garages, attics, crawl spaces, and sheds that are occupied for less than 4 hours per day. For a full description of the registrant's request, see the May 9, 2006 letter from AMVAC to EPA in the DDVP Special Review docket (EPA-HQ-OPP-2006-0396).

Subsequently, in early March, 2007, Amvac also requested the voluntary cancellation of all its pet collar and bait registrations and deletion of those uses from its technical label. Pursuant to section 6(f) of FIFRA, Amvac's requests to cancel the pet collar and bait registrations as well as deleting such uses from the technical label were published in the Federal Register on March 23, 2007. (72 FR 13786)(FRL-8120-7). On June 27, 2007, EPA granted Amvac's request and issued a final cancellation order for the pet collar and bait registrations. (72 FR 35235)(FRL-8127-5).

This proposal to conclude Special Review is based upon the label amendments requested by Amvac (as set forth in the May 9, 2006 letter) and EPA's determination that DDVP is eligible for reregistration as set forth in the June 30, 2006 IRED as well as the section 6(f) cancellations discussed above.

In sum, the Agency has determined that potential liver and cancer effects are no longer risks of concern, and based on the IRED and subsequent label changes that the cholinesterase inhibition issues have been adequately addressed through cancellations and other mitigation actions which limit exposure to DDVP. This Notice therefore proposes to terminate the DDVP Special Review based on the Agency's determination that all risks of concern identified in the PD 1 and earlier PD 2/3 have been satisfactorily addressed. Again, termination of this Special Review does not prejudice the Agency's review of the petition to cancel DDVP registrations and revoke DDVP tolerances, which will proceed separately and, if the Agency were to agree with the petition in whole or in part, could result in changes to the terms and conditions of DDVP registrations. For a complete description of the toxicity endpoints and risk assessment, see the DDVP Revised Human Health Risk Assessment, dated June 22, 2006, available in the DDVP reregistration docket (EPA-HQ-OPP-2002-0302) at http://www.regulations.gov.

III. Evaluation of Comments to PD 1

See section III.G of the September 1995 PD 2/3 for the evaluation of public comments received on the PD 1. This document is available in the DDVP Special Review docket (EPA-HQ-OPP-2006-0396) at the OPP Regulatory Public Docket (7508P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg), 2777 S. Crystal Dr., Arlington, VA.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: September 19, 2007.

Peter Caulkins,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.