Pesticides; Expedited Review of Experimental Use Permits (EUPs) for Conventional Pesticides

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: December 19, 2001 (Volume 66, Number 244)]
[Notices]
[Page 65488-65490]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de01-38]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00755; FRL-6814-8]
 
Pesticides; Expedited Review of Experimental Use Permits (EUPs) 
for Conventional Pesticides

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.

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SUMMARY: The Agency seeks public comment on a draft Pesticide 
Registration (PR) Notice titled ``Guidelines for Expedited Review of 
Experimental Use Permits (EUPs) for Conventional Pesticides.'' This 
draft Notice provides criteria that, if met, can result in a greater 
number of food use EUPs being issued on an expedited basis for 
conventional pesticides. EUP applications submitted that meet all of 
the criteria identified in the Notice will be expedited through the 
Agency's review process and registrants will not need to utilize their 
priority slots. The Notice applies to all applicants for EUPs for non-
antimicrobial, conventional pesticides. The Notice does not apply to 
biological pesticides because these pesticides present different risk 
factors and because the Agency has not heard that the lack of 
biological pesticide EUPs is an issue.

DATES: Comments, identified by docket control number OPP-00755, must be 
received on or before February 19, 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.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00755 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Rachel Holloman, Registration Division 
(7505C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-7193; fax number: 
(703) 305-6920; e-mail address: holloman.rachel@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 65489]]

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may 
be of particular interest to those persons who apply for EUPs for 
conventional pesticides or are required to submit data to EPA to 
register pesticides or to establish tolerances for pesticides under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as well as to growers and 
grower groups. 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 
information in this Notice, 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 the PR Notice from the Office of Pesticide Programs' Home 
Page at http://www.epa.gov/pesticides/. You can also go directly to the 
listings 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. Fax-on-demand. You may request a faxed copy of the draft 
Pesticide Registration (PR) Notice titled ``Guidelines for Expedited 
Review of Experimental Use Permits (EUPs) for Conventional 
Pesticides,'' by using a faxphone to call (202) 401-0527 and selecting 
item [6119]. 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-00755. 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 Highway, 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-00755 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 Highway, 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: opp-docket@epa.gov, 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-00755. 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 identified 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.
    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 
control 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 Guidance Does This PR Notice Provide?

    The purpose of the proposed PR Notice is to provide criteria that, 
if met, can result in a greater number of food use EUPs being issued on 
an expedited basis for conventional pesticides.
    Before issuing a new EUP, the Agency must review a subset of the 
toxicity and exposure data that would otherwise be required for full 
registration under FIFRA and make several statutory findings. When food 
is to be treated and allowed to enter domestic commerce under the EUP, 
EPA must determine (under FFDCA) that ``there is a reasonable certainty 
of no harm'' from aggregate exposures to the pesticide, including 
exposures resulting from use under the EUP. Prior to the passage of

[[Page 65490]]

the Food Quality Protection Act (FQPA), EPA issued approximately 20 
EUPs and established corresponding tolerances each year. Since passage 
of FQPA, however, the Agency has issued only approximately three EUPs 
for food uses each year. Information gathered under EUPs can be 
extremely useful and allow growers and others to gain a better 
understanding of new and emerging pesticide technologies prior to full 
market introduction, providing opportunity to refine the product's use. 
The Agency gains valuable information as well on pesticide alternatives 
for higher-risk pesticides. This information can be used to support 
both registration and reregistration decisions EPA must make. In 
response to requests from interested parties, the Agency undertook an 
effort to ascertain what conditions and criteria could be developed 
that would allow for more EUPs, while maintaining EPA's ability to meet 
the applicable safety findings under FIFRA and FFDCA, resulting in the 
proposed PR Notice.

B. What Questions/Issues Should You Consider and Provide Specific 
Comments On and/or Data/Information to Explain Why the Agency Should 
Make Changes?

    1. The Agency is proposing certain acreage limitations based upon a 
determination that crops treated on these limited acreages would have a 
marginal impact on both acute and chronic dietary risk. The criteria 
have been developed in such a way that, if the criteria are satisfied, 
the Agency can easily determine, based upon existing Agency 
assessments, that the requisite FIFRA and FFDCA safety findings can be 
met. How might the Agency expand these limitations, while utilizing 
existing risk assessments, to ensure that the statutory findings are 
satisfied? Should the Agency consider a sliding scale of acres per 
total acres planted of a minor crop? If so, what should that scale be 
to cover all of the diverse micro-climates, soils, growing seasons and 
cropping practices for the various commodities across the United 
States?
    2. The Agency is proposing no more than 100 acres per watershed 
using the U.S. Geological Survey's (USGS) watershed definition as one 
of the ``risk criteria'' in this proposal. What might EPA consider as 
other options, to ensure that this criteria is not too confusing and/or 
too limiting for certain commodity grower industries and/or in certain 
states so as not to eliminate the possibility of conducting larger 
scale EUPs under this program?
    3. The Agency has proposed several active ingredient criteria for 
this program, choosing to initially limit the program to those active 
ingredients which need evaluation prior to registration to ensure 
growers that the products are effective alternatives to already 
registered products they know. Along with those criteria, the Agency 
has proposed other criteria for this program that, if met, could result 
in a greater number of food use EUPs being issued on an expedited 
basis. What other criteria might the Agency consider (i.e., ``minor 
crop priorities'' being added to the active ingredient criteria), and 
why?
    4. What else, if anything, might the Agency consider incorporating 
into the proposed program to ensure that the field efficacy and crop 
tolerance data for minor crops, needed by registrants to add minor crop 
uses to their labels after tolerances are granted, are provided?
    5. What other conventional chemicals might the Agency consider 
adding to the proposed ``eligible pesticides'' listing up front 
(besides those that will be considered, if submitted, on a case-by-case 
basis)?

C. PR Notices are Guidance Documents

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and decision-makers and to pesticide 
registrants. This notice is not binding on either EPA or pesticide 
registrants, and EPA may depart from the guidance where circumstances 
warrant and without prior notice. Likewise, pesticide registrants may 
assert that the guidance is not appropriate generally or not applicable 
to a specific pesticide or situation.

List of Subjects

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

    Dated: December 6, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 01-31250 Filed 12-18-01; 8:45 am]
BILLING CODE 6560-50-S
Pesticides; Expedited Review of Experimental Use Permits (EUPs) for Conventional Pesticides

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