02-23593. Chlorpropham Tolerance Reassessment Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; e-mail address: [e-mail].

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 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 [phone].

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 [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], 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 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.