01-1201. PR Notice on Worker Risk Mitigation for Organophosphate Pesticides; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of a Pesticide Registration (PR) Notice describing EPA's approach for managing risk to workers who may be exposed to organophosphate (OP) pesticide products by mixing, loading, applying, flagging, or otherwise handling OP pesticides, or are exposed to residues of these pesticides while performing tasks in recently treated areas. This approach generally provides for basic protective measures such as closed mixing and loading systems, enclosed cab equipment, or personal protective equipment, as well as increased restricted-entry intervals for occupational situations where revised risk assessments indicate that they are necessary and where these measures are feasible. Further, this PR Notice outlines the steps that EPA intends to take to address situations where baseline mitigation measures are not feasible, or situations where maximum feasible mitigation is still inadequate to protect workers.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Gwaltney, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax 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 environmental, human health, agricultural, and agricultural worker advocates; pesticide users; and persons who are or may be required to conduct testing of chemical substances under Federal Food, Drug and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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/​.

The OP worker risk mitigation PR notice is available on the Home Page for the Office of Pesticide Programs at http://www.epa.gov/​PR_​Notices/​pr2000-9.pdf. EPA's response to public comments received on the August 6, 1999, draft PR notice is available at http://www.epa.gov/​PR_​Notices/​draftprworker-response.htm . You may access information about the organophosphate pesticides at http://www.epa.gov/​pesticides/​op.

2. In person. The Agency has established an official record for this action under docket control number OPP-34191A. EPA previously established an official record under docket control number OPP-34191 when the Agency published an FR notice on August 6, 1999 (64 FR 41934) (FRL-6093-8), announcing the availability of the draft OP worker risk mitigation PR notice for public comment. 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].

II. What Action is the Agency Taking?

This notice announces the availability of Pesticide Registration (PR) Notice 2000-9, which presents EPA's approach for managing risks from organophosphate (OP) pesticides to occupational users. The approach described in this PR Notice applies to workers who may be exposed to OP pesticide products by mixing, loading, applying, flagging, or otherwise handling them, or by performing tasks in recently treated areas. The PR Notice outlines the six steps that EPA will follow in assessing and managing the human health risks of an OP pesticide, to evaluate risks to workers and mitigate risks of concern. It explains the protective measures that the Agency is recommending to reduce OP worker risk including use of personal protective equipment; use of engineering controls such as closed mixing and loading systems and enclosed cabs and cockpits; application modifications such as reducing the rate or frequency of pesticide applications; mechanical harvesting; and longer Restricted Entry Intervals. The PR Notice also addresses situations where the maximum feasible mitigation still is inadequate to protect workers, or where the baseline risk mitigation measures are not feasible.

The guidance set forth in this PR Notice is intended to inform manufacturers, formulators, and users of the type of risk management decisions EPA is likely to develop for the OP pesticides. These chemicals are being reviewed by the Agency as part of the larger process of implementing the Food Quality Protection Act of 1996 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Implementation of the FQPA amendments has been the subject of a joint effort by EPA, USDA, and interested stakeholders known as the Tolerance Reassessment Advisory Committee (TRAC), recently replaced by the Committee to Advise on Reassessment and Transition (CARAT). Among other initiatives, TRAC established a process for public participation in the review and refinement of risk assessments for the OP pesticides and for developing risk management options. USDA, stakeholders, and the public have the opportunity to participate by submitting comments on EPA's preliminary and revised risk assessments and by providing risk management proposals. During the final phase of this process, EPA prepares an Interim Reregistration Eligibility Decision (IRED) or a Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision (TRED) document for each OP pesticide, to implement interim risk management measures. Worker risk mitigation is but one aspect of the comprehensive mitigation strategy that is developed in concluding each individual OP assessment.

In a number of cases, the OP risk assessments show that, even with maximum feasible personal protective equipment and engineering controls, including all provisions required by the Worker Protection Standard (WPS), risks to workers still exceed EPA's levels of concern. Although each OP risk management decision and any associated mitigation measures will be implemented on a case-by-case basis, the Agency is outlining its decision process in the PR Notice because early notification to registrants will help to ensure that occupational risk management decisions for the OPs will be approached consistently and implemented quickly and equitably. EPA encourages registrants to demonstrate stewardship of their OP pesticides by adopting the protective measures described in this PR Notice prior to the Agency's completion of IRED and TRED documents for the OP chemicals, and to develop new packaging and application technologies that reduce worker exposure to pesticides. Further mitigation may be needed when the Agency issues its final, cumulative decision on the OP class of chemicals.

The PR Notice does not impose binding obligations on registrants or the Agency. The measures described will be implemented as appropriate based on chemical-specific reviews, including risk/benefit balancing where necessary, through pesticide reregistration and other decision-making processes. EPA is proposing specific worker risk mitigation measures for individual OP pesticides in completing interim risk management decisions for these chemicals, and will implement these measures shortly thereafter. The Agency envisions managing risks to workers exposed to other classes of pesticides posing similar risks, such as the carbamates, in a similar manner.

List of Subjects

• Environmental protection
• Chemicals
• Pesticides and pests

Dated: January 8, 2001.

Lois Rossi,

Director, Special Review and Reregistration Division.