[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]
[Page 68357-68360]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-77]
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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:
jennings.susan@epa.gov.
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:oconnell.cathryn@epa.gov.
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 opp-docket@epa.gov,
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