[Federal Register Volume 67, Number 114 (Thursday, June 13, 2002)]
[Notices]
[Pages 40732-40734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14996]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0069; FRL-7177-9]


Methodology for Lower Toxicity Pesticide Chemicals; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is soliciting comments on a document entitled 
``Methodology for Determining the Data Needed and the Types of 
Assessments Necessary to Make FFDCA Section 408 Safety Determinations 
for Lower Toxicity Pesticide Chemicals.'' Interested parties may 
request a copy of the Agency's proposed guidance document as set forth 
in Unit IB of this Notice.

DATES: Comments, identified by docket ID number OPP-2002-0069, must be 
received on or before September 11, 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-2002-0069 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200

[[Page 40733]]

Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-
305-6304; fax number: 703-305-0599; 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 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/.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0069. 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 control number OPP-2002-0069 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: 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: 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 in this unit. 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 ID number OPP-2002-0069. 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.

 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. What Action is the Agency Taking?

    The Agency is announcing the availability of a methodology for 
assessing the hazards and risks of lower toxicity pesticide chemicals 
for public comment and review. This paper describes how lower toxicity 
pesticide chemicals, including inert ingredients, would be evaluated 
for use in pesticide products. The OPP is the Office within the 
Environmental Protection Agency (EPA or the Agency) that evaluates 
pesticide products. OPP's responsibilities (all of which could be 
affected by the use of this new methodology) include: registration of 
new active ingredients, reregistration of older active ingredients, 
reassessment of both tolerances and tolerances exemptions, approval of 
new inert ingredients, and list reclassification of inert ingredients.
    Development of this methodology began as a result of OPP's need to 
(1) develop a new methodology for assessing inert ingredients to comply 
with the requirements of the Food Quality Protection Act (FQPA) of 1996 
which amended both the FFDCA and the FIFRA, and (2) to improve the 
efficiency and effectiveness of the inert review process. In many 
instances, a chemical can be used as an inert ingredient in some 
pesticide products and as an active ingredient in other

[[Page 40734]]

pesticide products. Since FFDCA section 408 makes no distinction 
between active and inert ingredients of a pesticide product, EPA may 
use this tiered data screening methodology when evaluating any 
pesticide chemical of apparent low or low/moderate toxicity, regardless 
of whether it might be characterized as an active or inert ingredient.
    At this time, EPA has completed review of two tolerance exemption 
petitions and over 200 tolerance reassessments for low or low/moderate 
toxicity chemicals using essentially the process described in this 
paper. More reviews are underway. Based on these experiences, OPP 
intends to continue its chemical-by-chemical reviews of pesticide 
chemicals according to the process described herein for the foreseeable 
future. However, EPA remains interested in further improvements in the 
efficiency and reliability of its process, and therefore welcomes 
comments from interested persons.
    After evaluating several alternatives, OPP believes that a 
screening methodology is the most appropriate way to handle the variety 
of hazard and exposure issues posed by inert ingredients. This 
screening methodology will allow OPP to make decisions in a streamlined 
manner for low or low/moderate toxicity chemical substances. By being 
able to quickly review and approve the use of these chemical 
substances, more low or low/moderate toxicity chemical substances will 
be available for use in pesticide products. OPP will also be able to 
focus its resources on those chemical substances of potentially higher 
toxicity requiring in-depth evaluation.
    OPP has incorporated elements of a tiered data approach into this 
methodology. For these lower toxicity chemicals, OPP would use existing 
information on the hazard potential (both human health and ecological) 
of a chemical substance as the basis for deciding if additional data 
are needed to support the use of the chemical. The hazard potential - 
the toxicity - is the driving force in determining tier placement. 
Chemical substances that are of low or low/moderate toxicity may be 
appropriately placed in a lower tier, with fewer data needed to make 
the safety finding. Chemicals of higher toxicity that can not be 
appropriately addressed in the lower tiers would be evaluated in a 
manner substantially similar to that of an active ingredient.
    The process described in this paper has three tiers, with the first 
tier being subdivided into Tiers 1a and 1b. The process begins with a 
preliminary Tier determination that is based on widely available 
information on chemical families and categories which includes the 
hazards associated with these chemicals. Later as the Agency begins to 
review chemical-specific or surrogate information in the open 
literature, the preliminary Tier determination may be revised.
    The methodology is intended to provide guidance to EPA personnel 
and decision-makers, and to pesticide registrants. The policies and 
process described in this methodology are not binding on either EPA or 
pesticide registrants, and EPA may modify or disregard the process 
described herein where circumstances warrant and without prior notice. 
Likewise, pesticide registrants may assert that this process is not 
appropriate generally or not applicable to a specific pesticide 
chemical or situation.

III. Questions/Issues for Public Comment

     A significant challenge faced in developing a methodology 
for a comprehensive assessment program for chemicals of low or low/
moderate toxicity is determining the most appropriate procedure for 
evaluating such a diverse group of substances, with a very wide range 
of physical/chemical characteristics. Does the screening approach as 
described in the methodology paper reflect a workable, logical 
approach?
     It is likely that a large percentage of inert ingredients 
are not likely to be of significant toxicological concern. The Agency's 
expectation is that on the order of 50% of inert ingredients would be 
of low or low/moderate risk. At the same time, EPA must be able to 
identify problematic inert ingredients and then have the resources to 
take appropriate action to analyze and reduce these risks. Would this 
methodology give the Agency the necessary flexibility while allowing 
for an effficient and productive process?
     Several sources for credible, scientifically valid 
chemical information are given in the policy paper. What other possible 
sources of readily available credible, scientifically valid chemical 
information are available?
     The Agency has described, as best possible at this 
beginning stage, the process that would be used to evaluate inert 
ingredients as well as the role played by a petitioner for a tolerance 
or tolerance exemption or those seeking to support a chemical during 
tolerance reassessment. What additional information would be helpful to 
the regulated community?

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

    Dated: June 7, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 02-14996 Filed 6-12-02; 8:45 am]
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