[Federal Register Volume 72, Number 186 (Wednesday, September 26, 2007)]
[Notices]
[Pages 54658-54662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18861]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0396; FRL-8148-9]


Dichlorvos (DDVP); Proposed Determination to Terminate Special 
Review

AGENCY: Environmental Protection Agency (EPA).

[[Page 54659]]


ACTION: Notice.

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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 (703) 305-5805.
    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 (703) 
305-5805.

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: (703) 603-0065; fax 
number: (703) 308-8005; e-mail address: [email protected].

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

[[Page 54660]]

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

[[Page 54661]]

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

[[Page 54662]]

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.
[FR Doc. E7-18861 Filed 9-25-07; 8:45 am]
BILLING CODE 6560-50-S