pronamide (Kerb) Tolerance Reassessment Decisions 8/02
ENVIRONMENTAL PROTECTION AGENCY
Pronamide Tolerance Reassessment Decisions; Notice of
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice of a tolerance reassessment for pronamide starts a
30-day public comment period during which the public is encouraged to
submit comments on the Agency's ``Report of the Food Quality Protection
Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision
(TRED) for pronamide.'' The Agency is providing an opportunity, through
this notice, for interested parties to comment in accordance with
procedures described in Unit I of this document. All comments will be
carefully considered by the Agency. If any comment causes the Agency to
revise its decision on reassessment of these tolerances, EPA will
publish notice of its amendment in the Federal Register.
DATES: Comments, identified by docket control number OPP-2002-0159 must
be received on or before September 20, 2002.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket ID number
OPP-2002-0159 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Cecelia Watson, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-4329; e-mail address:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) or the Federal Food, Drug, and
Cosmetic Act (FFDCA); environmental, human health, and agricultural
advocates; pesticides users; and members of the public interested in
the use of pesticides. Since other entities may also 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 Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
To access TRED documents electronically, go directly to the TREDs
table on the EPA Office of Pesticide Programs Home Page, at http://
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0159. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number OPP-2002-0159 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2.In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: email@example.com, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0/9.0 or ASCII file format. All comments in electronic form must be
identified by docket ID number OPP-2002-0159. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
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 version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the appropriate person listed under FOR FURTHER
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
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
7. Make sure to submit your comments by the deadline in this
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
A. What Action is the Agency Taking?
This notice constitutes and announces the availability of the TRED
for pronamide. This decision has been developed as part of the public
participation process that EPA and the U.S. Department of Agriculture
(USDA) are using to involve the public in the reassessment of pesticide
tolerances under FFDCA. EPA must review tolerances and tolerance
exemptions that were in effect when FQPA was enacted in August 1996, to
ensure that these existing pesticide residue limits for food and feed
commodities meet the safety standard of the new law.
FFDCA requires EPA to review all the tolerances for registered
chemicals in effect on or before the date of the enactment. In
reviewing these tolerances, the Agency must consider, among other
things, aggregate risks from non-occupational sources of pesticide
exposure, whether there is increased susceptibility to infants and
children, and the cumulative effects of pesticides with a common
mechanism of toxicity. The tolerances are considered reassessed once
the safety finding has been made or a revocation occurs. A
reregistration eligibility decision (RED) was completed for pronamide
in April 1994, prior to FQPA enactment, and therefore needed an updated
assessment to consider the provisions of the Act.
FFDCA requires that the Agency, when considering whether to
establish, modify, or revoke a tolerance, consider ``available
information'' concerning the cumulative effects of a particular
pesticide's residue and ``other substances that have a common mechanism
As indicated above, the Agency will also evaluate the cumulative
risk, if necessary, posed by the entire group of chemicals with which a
common mechanism of toxicity is shared, and issue a final tolerance
reassessment decision once the cumulative
assessment for that group is completed. At this time, pronamide has not
been identified as sharing a common method of toxicity and is not
scheduled for a cumulative risk assessment.
All registrants of pesticide products containing one or more of the
active ingredients listed in this document are being sent the TRED, and
must respond to labeling requirements within 8 months of receipt.
Furthermore, the Agency requests a response to all generic confirmatory
data from technical registrants within 90 days of receipt.
The reregistration program is being conducted under
congressionally-mandated time frames, and EPA recognizes both the need
to make timely reregistration decisions and to involve the public.
Therefore, EPA is issuing this TRED as a final document with a 30-day
comment period. All comments will be carefully considered by the
Agency. If any comment significantly affects the TRED, EPA will amend
the TRED by publishing the amendment in the Federal Register.
B. What is the Agency's Authority for Taking this Action?
The legal authority for these TREDs falls under FIFRA, as amended
in 1988 and 1996. Section 4(g)(2)(A) of FIFRA directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredients are eligible for reregistration,'' and either reregistering
products or taking ``other appropriate regulatory action.''
List of Subjects
Environmental protection, Chemicals, Pesticides and pests,
Dated: August 2, 2002.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
[FR Doc. 02-21295 Filed 8-20-02; 8:45 am]