[Federal Register Volume 67, Number 181 (Wednesday, September 18, 2002)]
[Notices]
[Pages 58795-58797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23593]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0180; FRL-7198-7]


Chlorpropham Tolerance Reassessment Decision; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice constitutes the Agency's report on the Food 
Quality Protection Act (FQPA) tolerance reassessment progress and risk 
management decision for chlorpropham, announces the Agency's decision, 
and releases the human health risk assessment and related documents 
supporting this decision to the public. This notice of tolerance 
reassessment for chlorpropham starts the 30-day public comment period 
during which the public is invited to submit comments on the Agency's 
``Report of the FQPA Tolerance Reassessment Progress and Risk 
Management Decision (TRED)'' for chlorpropham. If any comment causes 
the Agency to revise its decision on tolerance reassessment for 
chlorpropham, the Agency will publish a notice of its amendment in the 
Federal Register. The Agency's reassessment of dietary risk, including 
public exposure through food and drinking water as required by the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by FQPA, 
indicate that dietary risk from stored potatoes treated with 
chlorpropham per se, poses no risk concerns within the limits of the 
reassessed tolerances associated with chlorpropham use on potatoes.

DATES: Comments must be submitted on or before October 18, 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-2002-0180 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Gary Mullins, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8044; 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. This action may, 
however, be of interest to those persons who are or may be required to 
conduct testing of chemical substances under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) or the FFDCA. 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

[[Page 58796]]

the entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    To access TRED documents electronically, go directly to the TREDs 
table on the EPA Office of Pesticide Programs Home Page, at http://www.epa.gov/pesticides/reregistration/status.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0180. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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-2002-0180 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 Hwy., 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 protected], 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-2002-0180. 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 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.
    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 
notice.
    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?

    This notice constitutes and announces the availability of the 
chlorpropham TRED. 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.
    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 that aggregate risks are not of 
concern. A reregistration eligibility decision (RED) was completed for 
chlorpropham in April 1995, prior to FQPA enactment, and therefore 
needed an updated assessment to consider the provisions of the Act.
    The FQPA requires that the Agency consider ``available 
information'' concerning the cumulative effects of a particular 
pesticide's residues and ``other substances that have a common 
mechanism of toxicity.'' The reason for consideration of other 
substances is due to the possibility that low-level exposures to 
multiple chemical substances that cause a common toxic effect by a 
common mechanism could lead to the same adverse health effect as would 
a higher level of exposure to any of the other substances individually. 
EPA did not perform a cumulative risk assessment as part of this 
reregistration review of chlorpropham, because the Agency has not 
determined if there are any other chemical substances that have a 
mechanism of toxicity common with that of chlorpropham. If EPA 
identifies other substances that share a common mechanism of toxicity 
with chlorpropham, then a cumulative risk assessment will be conducted 
that includes chlorpropham. Further, EPA is in the process of 
developing criteria for characterizing and testing endocrine disrupting 
chemicals and plans to implement an Endocrine Disruptor

[[Page 58797]]

Screening Program. Chlorpropham will be reevaluated at that time and 
additional studies may be required.
    Additionally, the Agency has evaluated the dietary risk associated 
with chlorpropham and has determined that provided the Special Local 
Need (SLN) registration for Easter lily bulb use is amended to reduce 
the maximum rate of application from 3.99 pounds active ingredient/acre 
to 2.0 pounds active ingredient/acre, as agreed upon by stakeholders, 
there is a reasonable certainty that no harm to any population subgroup 
will result from aggregate exposure to chlorpropham when considering 
dietary exposure and all other non-occupational sources of pesticide 
exposure for which there is reliable information. Therefore, with this 
mitigation measure in place, 15 tolerances are now considered 
reassessed and 9 new tolerances will be established for residues of 
chlorpropham in/on raw agricultural commodities under section 408(q) of 
the FFDCA.
    All registrants of pesticide products containing the active 
ingredient listed in this document have been sent the appropriate TRED 
document, and must respond to labeling requirements within 8 months of 
receipt. In addition, the Agency requests a response to the generic 
Data Call-In (DCI) letter 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. All 
comments received within 30 days of publication of this Federal 
Register notice will be considered by the Agency. If any comment 
significantly impacts this TRED, the Agency will amend its decision by 
publishing a Federal Register notice.

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

    The legal authority for this TRED 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 
ingredient are eligible for reregistration,'' and either reregistering 
products or taking ``other appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides, Tolerances.

    Dated: September 10, 2002.
 Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 02-23593 Filed 9-17-02; 8:45 am]
BILLING CODE 6560-50-S