02-4794. Pesticides; Consideration of the FQPA and Other Safety Factors in Cumulative Risk Assessment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

To assure that EPA's policies related to implementing the Food Quality Protection Act of 1996 (FQPA) are transparent and open to public participation, EPA is soliciting comments on the pesticide draft science policy document titled, “Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity.” This notice is one in a series concerning science policy documents related to the implementation of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by FQPA.

DATES:

Comments for the draft science policy document, identified by docket control number OPP-00759, must be received on or before April 29, 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 control number OPP-00759 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Randy Perfetti, Health Effects Division (7509C), 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?

You may be potentially affected by this action if you manufacture or formulate pesticides. Potentially affected categories and entities may include, but are not limited to:

Categories	NAICS codes	Examples of potentially affected entities
Pesticide producers	32532	Pesticide manufacturers
		Pesticide formulators

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action affects certain entities. 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 or Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, the draft science policy document, and certain other related documents that might be available from the Office of Pesticide Programs' Home Page at http://www.epa.gov/​pesticides/​. On the Office of Pesticide Programs' Home Page select “FQPA” and then look up the entry for this document under “Science Policies.” You can also go directly to the listings at the EPA Home Page at http://www.epa.gov/​. On the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under “Federal Register—Environmental Documents.” You can go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. Fax-on-demand. You may request a faxed copy of the draft science policy document, as well as supporting information, by using a faxphone to call [phone]. Select item 6050 for the document titled “Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity.” You may also follow the automated menu.

3. In person. The Agency has established an official record for this action under docket control number OPP-00759. In addition, the documents referenced in the framework notice, which published in the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5), under docket control number OPP-00557, are considered as part of the official record for this action under docket control number OPP-00759 even though not placed in the official record. The official record consists of the documents specifically referenced in this action, and 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 control number OPP-00759 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 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 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00759. 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?

EPA invites you to provide your views on the various draft science policy documents, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider. 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 solid technical information and/or data to support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate.

5. Indicate what you support, as well as what you disagree with.

6. Provide specific examples to illustrate your concerns.

7. Make sure to submit your comments by the deadline in this notice.

8. At the beginning of your comments (e.g., as part of the “subject” heading), be sure to properly identify the document you are commenting on. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00759 in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background Information

On August 3, 1996, FQPA was signed into law. The FQPA significantly amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the FFDCA. Among other changes, FQPA established a stringent health-based standard (“a reasonable certainty of no harm”) for pesticide residues in foods to assure protection from unacceptable pesticide exposure and strengthened health protections for infants and children from pesticide risks.

Thereafter, the Agency established the Food Safety Advisory Committee (FSAC) as a subcommittee of the National Advisory Council for Environmental Policy and Technology (NACEPT) to assist in soliciting input from stakeholders and to provide input to EPA on the broad policy choices facing the Agency and on strategic direction for the Office of Pesticide Programs (OPP). The Agency has used the interim approaches developed through discussions with FSAC to make regulatory decisions that meet the new FFDCA standard, but that could be revisited if additional information became available or as the science evolved. In addition, the Agency seeks independent review and public participation, generally through presentation of the science policy issues to the FIFRA Scientific Advisory Panel, a group of independent, outside experts who provide peer review and scientific advice to OPP.

During 1998 and 1999, EPA and the U.S. Department of Agriculture (USDA) established a second subcommittee of NACEPT, the Tolerance Reassessment Advisory Committee (TRAC) to address FFDCA issues and implementation. TRAC comprised more than 50 representatives of affected user, producer, consumer, public health, environmental, States, and other interested groups. The TRAC met from May 27, 1998, through April 29, 1999.

In order to continue the constructive discussions about FFDCA, EPA and USDA have established, under the auspices of NACEPT, the committee to advise on reassessment and transition (CARAT). The CARAT provides a forum for a broad spectrum of stakeholders to consult with and advise the Agency and the Secretary of Agriculture on pest and pesticide management transition issues related to the tolerance reassessment process. The CARAT is intended to further the valuable work initiated by the FSAC and TRAC toward the use of sound science and greater transparency in regulatory decision-making, increased stakeholder participation, and reasonable transition strategies that reduce risks without jeopardizing American agriculture and farm communities.

As a result of the 1998 and 1999 TRAC process, EPA decided that the implementation process and related policies would benefit from providing notice and comment on major science policy issues. The TRAC identified nine science policy areas it believed were key to implementation of tolerance reassessment. EPA agreed to provide one or more documents for comment on each of the nine issues by announcing their availability in the Federal Register. In a notice published in the Federal Register of October 29, 1998 (63 FR 58038), EPA described its intended approach. Since then, EPA has been issuing a series of draft documents concerning the nine science policy issues. This notice announces the availability of a pesticide draft science policy document concerning the Agency's use of the FQPA safety factor in cumulative risk assessments.

III. Summary of Draft Document

The guidance document provides the current thinking of OPP on application of the provision in FFDCA section 408(b)(2)(C), regarding an additional safety factor for the protection of infants and children in the context of cumulative risk assessments. OPP, in an earlier science policy paper for individual chemicals, addressed how its risk assessments will consider the FQPA safety factor provision for individual chemicals (EPA, 1999, and EPA, 2002a). Additionally, OPP has prepared guidance on how to conduct a cumulative risk assessment for two or more pesticides sharing a common mechanism of toxicity (EPA, 2002b). Each of these papers provided some general information and guidance on the FQPA safety factor, but did not address in detail the application of the FQPA safety factor provision on cumulative risk assessment.

OPP has developed the current document to provide a more expansive discussion of the use of uncertainty and safety factors in the context of cumulative risk assessment and to restructure its presentation to follow more closely the framework and terminology presented in the FQPA safety factor guidance for individual chemicals (EPA, 2002a). This document also draws on definitions contained in the revised cumulative risk assessment guidance, which has been revised and issued (EPA, 2002b).

OPP believes that it is critical to the protection of infants and children that it not rely on and not apply a default value or presumption in making decisions under section 408 where reliable data are available that support use of a different safety factor in the assessment of risk. Use of the default value may result in an under-or over-statement of risk. OPP's reasoning applies with even more force in the context of cumulative risk assessments due to the additional complexities involved. Accordingly, for cumulative risk assessments, OPP also intends to make specific case-by-case determinations as to the size of the additional FQPA safety factor rather than rely on the 10X default value if reliable data permit. Further, this individualized determination may involve application of FQPA safety factors to both the individual chemical members as well as to the entire cumulative assessment group (referred to as the “CAG”) of common mechanism chemicals. This guidance document focuses primarily on the considerations relevant to determining a safety factor “different” than the default 10X that protects the safety of infants and children.

V. Policies Not Rules

The draft science policy document discussed in this notice is intended to provide guidance to EPA personnel and decision-makers, and to the public. As a guidance document and not a rule, the policy in this guidance is not binding on either EPA or any outside parties. Although this guidance provides a starting point for EPA risk assessments, EPA will depart from its policy where the facts or circumstances warrant. In such cases, EPA will explain why a different course was taken. Similarly, outside parties remain free to assert that a policy is not appropriate for a specific pesticide or that the circumstances surrounding a specific risk assessment demonstrate that a policy should be abandoned.

EPA has stated in this notice that it will make available revised guidance after consideration of public comment. Public comment is not being solicited for the purpose of converting any policy document into a binding rule. EPA will not be codifying this policy in the Code of Federal Regulations. EPA is soliciting public comment so that it can make fully informed decisions regarding the content of each guidance document.

The “revised” guidance will not be unalterable. Once a “revised” guidance document is issued, EPA will continue to treat it as guidance, not a rule. Accordingly, on a case-by-case basis EPA will decide whether it is appropriate to depart from the guidance or to modify the overall approach in the guidance. In the course of inviting comment on each guidance document, EPA would welcome comments that specifically address how a guidance document can be structured so that it provides meaningful guidance without imposing binding requirements.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests

Dated: February 20, 2002.

 Stephen L. Johnson,

Assistant Administrator for Prevention, Pesticides and Toxic Substances.