[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Notices]
[Pages 68357-68360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26083]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0296; FRL-7685-3]


Captan; Cancer Reclassification; Amendment of 
ReregistrationEligibility Decision; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's modification of certain provisions 
of the 1999 Reregistration Eligibility Decision (RED) for the pesticide 
captan, and opens a public comment period on these changes. EPA is 
amending the captan RED in response to public comments received. EPA 
has made certain modifications to the captan RED which are discussed in 
the ``Amendment to the 1999 Captan RED'' document, which is available 
in the captan docket and e-docket. This notice also opens the public 
comment period announcing the results of the Agency's reevaluation of 
captan's cancer classification. The Captan Task Force voluntarily 
pursued a process to reclassify captan's initial cancer classification, 
as a probable human carcinogen, by supporting a third-party review of 
data to support a mode of action determination for captan. Based on the 
third-party review and subsequent Agency review, EPA has determined 
that captan acts through a non-genotoxic threshold mode of action. 
Although the Agency is issuing a single FR to announce both the 
amendment to the RED and the reevaluation of the cancer classification, 
the change in cancer classification does not change the risk management 
conclusions nor amend the 1999 Captan RED, and is not considered a 
reregistration action.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0296, must be received on or before January 24, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For questions regarding the cancer 
reclassification: Susan Jennings, Special Review and Reregistration 
Division (7508C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (706) 355-8574; e-mail address: 
[email protected].
    For questions regarding the ``Amendment to the 1999 Captan RED'' 
document: Cathryn O'Connell, Special Review and Reregistration Division 
(7508C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0136; 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0296. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket,

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will not be available for public viewing in EPA's electronic public 
docket. EPA's policy is that copyrighted material will not be placed in 
EPA's electronic public docket but will be available only in printed, 
paper form in the official public docket. To the extent feasible, 
publicly available docket materials will be made available in EPA's 
electronic public docket. When a document is selected from the index 
list in EPA Dockets, the system will identify whether the document is 
available for viewing in EPA's electronic public docket. Although not 
all docket materials may be available electronically, you may still 
access any of the publicly available docket materials through the 
docket facility identified in Unit I.B.1. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0296. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0296. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0296.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0296. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

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

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.

[[Page 68359]]

    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What Action is the Agency Taking?

    The Agency is issuing an ``Amendment to the 1999 Captan RED'' 
document for public comment. In addition, this notice announces the 
results of the Agency's reevaluation of captan's cancer classification. 
This reevaluation does not change the conclusions of the RED and does 
not amend the Captan RED.
    i. Amendment to the 1999 Captan RED. In 1999, EPA issued a RED for 
captan under section 4(g)(2)(A) of FIFRA. EPA has modified certain 
captan label requirements including: Double notification for all 
agricultural uses of captan; verbal notification of eye concerns 
associated with captan for 7 days following application; wettable 
powders applied aerially to be formulated in water soluble packages; 
reductions in the dichondra ornamental grass use rate; establishing a 
Re-Entry Interval for ornamentals, blackberries, blueberries, 
dewberries, raspberries, and grapes of 48 hours; removing the dust/mist 
respirator requirement for handling bags of treated seed.
    ii. Cancer reclassification. When the RED was issued, captan 
retained its previous classification as a B2 chemical carcinogen 
(probable human carcinogen). Cancer risk from captan was quantified 
using the Agency's default approach described in the Agency's 1986 
Cancer Risk Assessment Guidelines. When much uncertainty exists 
regarding the mode of carcinogenic action, EPA assumes the tumor dose 
response from a cancer study is linear. In the absence of adequate 
information to the contrary, the linearized multistage procedure is 
applied to the tumor response data to calculate the cancer unit risk 
(Q1*), which is the upper confidence limit (95th percentile) of the 
dose response curve. This linear low dose approach used to estimate 
cancer risk is believed to be conservative.
    Although the Captan Task Force (CTF) had submitted several 
mechanism studies for captan, the Agency determined that they did not 
contribute sufficient additional information to the mode of action nor 
have a significant bearing on the cancer risk assessment. In the RED, 
the Agency reaffirmed its decision that the linear low dose 
extrapolation model should continue to be used for risk assessment and 
determined that a reconsideration for captan according to the 1996 
Draft Cancer Risk Assessment guidelines was not required.
    In February of 2000, the CTF petitioned the Agency to reevaluate 
the cancer risk assessment for captan using a threshold approach rather 
than the traditional linear low dose (Q1*) approach. They submitted 
additional data, including data on thiophosgene, and stated that they 
strongly believed that captan should be regulated as a threshold 
carcinogen. Their comments were bolstered by portions of the RED, which 
stated that ``the carcinogenic process is thought to be triggered by 
the highly reactive but short-lived metabolite thiophosgene.''
    When the Agency reviewed this petition and additional data, it 
concluded that the information might be sufficient to warrant a cancer 
reclassification. However, the Agency also concluded that the resources 
required to conduct a thorough reclassification effort would not be 
available in the short-term. Since the reclassification would not 
change the conclusions of the RED, namely that the risk of cancer from 
exposure to captan was below the Agency's level of concern, the Agency 
determined that reevaluating captan's cancer classification was not a 
priority action at that time and was not necessary to reregister end-
use products containing captan.
    In 2001, based on a request from the CTF, EPA agreed to consider a 
re-evaluation of captan's cancer classification by a third party. It 
was envisioned that an organization, separate from the CTF, would 
manage an expert scientific peer review of the cancer information, and 
generate the supporting documentation and proposed conclusion from the 
third party. The Agency would then review the work of the third party 
and make its own decision regarding captan's cancer reclassification. 
The Agency was available for consultation, but did not manage or 
approve any portion of these proceedings. Records of interactions 
between the Agency and the CTF regarding this process are available in 
the public docket.
    The CTF chose Toxicology Excellence for Risk Assessment (TERA) to 
recruit and manage the process of reviewing the captan cancer mode of 
action data. On September 3 and 4, 2003, a third party of outside 
experts in various fields and affiliations reviewed the captan cancer 
mode of action data. This Peer Review Panel concluded that captan acted 
through a non-genotoxic threshold mode of action.
    In 2004, the CTF submitted the results of the Peer Review Panel 
meeting to the EPA for review. EPA reviewed this information and 
determined that the weight of evidence indicates that captan's 
carcinogenicity is limited to a single tumor type (adenomas and 
adenocarcinomas in the small intestine, primarily the proximal portion 
of the duodenum) in both sexes of a single species (mouse). EPA agreed 
that the results of the rat bioassays provide no evidence that captan 
is associated with kidney tumors in male rats or uterine tumors in 
female rats, and, therefore, these tumors do not add to the weight-of-
evidence considerations for the carcinogenicity of captan.
    The Agency accepts the proposed mode of action as set forth by the 
CTF that suggests that ``captan induces adenomas and adenocarcinomas in 
the duodenum of the mouse by a non-genotoxic mode of action involving 
cytotoxicity and regenerative cell hyperplasia that exhibits a clear 
dose threshold. These responses are reversible following cessation of 
captan exposure. There is a strong causal association (dose-response, 
temporality) indicating that tumor formation is secondary to 
cytotoxicity and hyperplasia and that the latter is a key event in the 
sequential cascade of events leading to cancer.''
    In September 2004, the Agency, in accordance with the EPA 1999 
Proposed Guidelines for Carcinogen Risk Assessment, classified captan 
as ``not likely to be a human carcinogen at dose levels that do not 
cause cytotoxicity and regenerative cell hyperplasia'' and ``likely to 
be carcinogenic to humans following prolonged, high-level exposures 
causing cytotoxicity and regenerative cell hyperplasia.''
    The new cancer classification considers captan to be a potential 
carcinogen at prolonged high doses that cause cytotoxicity and 
regenerative cell hyperplasia. These high doses of captan are many 
orders of magnitude above those likely to be consumed in the diet, or 
encountered by individuals in occupational or residential settings.

[[Page 68360]]

 Therefore, captan is not likely to be a human carcinogen nor pose 
cancer risks of concern when used in accordance with approved product 
labels.
    For further information and discussion about the cancer 
reclassification see the September 22, 2004 report, ``CAPTAN: Fourth 
Report of the Cancer Assessment Review Committee.'' In addition, the 
``Reader's Guide to the Captan E-Docket'' provides an organized list to 
help readers navigate the documents in the docket, including scientific 
supporting documents and registrant and third-party submissions.
    All comments should be submitted using the methods in Unit I. of 
the SUPPLEMENTARY INFORMATION, and must be received by EPA on or before 
the closing date. Comments and proposals will become part of the Agency 
Docket for captan. Comments received after the close of the comment 
period will be marked ``late.'' EPA is not required to consider these 
late comments. EPA will carefully consider all comments received by the 
closing date and will provide a Response to Comments Memorandum in the 
Docket and electronic EDOCKET. If any comment significantly affects the 
document, EPA also will publish an amendment to the RED in the Federal 
Register. In the absence of substantive comments requiring changes, the 
captan RED will be implemented as it is now presented.

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

    Section 4(g)(2) of FIFRA, as amended, directs that, after 
submission of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in product 
specific data on individual end-use products and either reregistering 
products or taking other ``appropriate regulatory action.''
    Section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for 
pesticide residues in effect as of August 2, 1996, to determine whether 
the tolerance or exemption meets the requirements of section 408(b)(2) 
or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: November 12, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 04-26083 Filed 11-24-04; 8:45 am]
BILLING CODE 6560-50-S