[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Notices]
[Pages 42362-42365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19593]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00608; FRL-6088-5]


Data Acquisition for Anticipated Residue and Percent of Crop 
Treated; Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this notice announces that EPA is seeking public 
comment on the following new Information Collection Request (ICR): 
``Data Acquistition for Anticipated Residue and Percent of Crop 
Treated.'' This ICR proposes a new collection activity that is not 
currently approved. The ICR describes the nature of the information 
collection activity and its expected burden and costs. Before 
submitting this ICR to the Office of Management and Budget (OMB) for 
review and approval under the PRA, EPA is soliciting comments on 
specific aspects of the collection.

DATES: Written comments, identified by the docket control number ``OPP-
00608,'' must be received on or before October 4, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section of 
this notice.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Office of Pesticide 
Programs, Mail Code 7506C, Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460, telephone: 703-305-5454, fax: 703-305-5884, 
e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does This Notice Apply to Me?

    You may be potentially affected by this notice if you are a 
pesticide registrant with a pesticide registration subject to a 
tolerance action that is 5 years old that relies on anticipated or 
actual residues level data. Sections 408(b)(2)(E)(i) and 408(b)(2)(F) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the EPA 
to use anticipated or actual residues (ARs) and the percent crop 
treated (PCT) to establish, modify, maintain, or revoke a tolerance for 
a pesticide residue. After using ARs or PCT, the Agency must verify 
that residues in or on food do not unacceptably exceed those relied on 
for

[[Page 42363]]

establishing the tolerances. Specifically, section 408(b)(2)(E)(ii) of 
FFDCA requires data to be called in within 5 years after each tolerance 
decision that relies on ARs; section 408(b)(2)(F)(iv) of FFDCA requires 
periodic reevaluation if PCT estimates are used.
    Potentially affected categories and entities may include, but are 
not limited to the following:


----------------------------------------------------------------------------------------------------------------
                                                                                       Examples of Potentially
              Category                     NAICS Code               SIC Codes             Affected Entities
----------------------------------------------------------------------------------------------------------------
Pesticide and other agricultural     325320                  286--Industrial         Pesticide registrants whose
 chemical manufacturing                                       organic chemicals       registration relies on a
                                                                                      tolerance action which is
                                                                                      based on ARs or PCT data
                                                             287--Agricultural
                                                              chemicals
----------------------------------------------------------------------------------------------------------------

    This table 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 in this table could also be 
affected. You or your business are affected by this action if you have 
a conditional pesticide registration with the Agency. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed in the ``FOR FURTHER 
INFORMATION CONTACT'' section.

II. How Can I Get Additional Information or Copies of This Document 
or Other Support Documents?

A. Electronic Availability

    Electronic copies of this document and the ICR are available from 
the EPA Home Page at the Federal Register - Environmental Documents 
entry for this document under ``Laws and Regulations'' (http://
www.epa.gov/fedrgstr/). You can easily follow the menu to find this 
Federal Register notice using the publication date or the Federal 
Register citation for this notice. Although a copy of the ICR is posted 
with the Federal Register notice, you can also access a copy of the ICR 
by going directly to http://www.epa.gov/icr/. You can then easily 
follow the menu to locate this ICR by the title of the ICR.

B. Fax-on-Demand

    Using a faxphone call 202-401-0527 and select item 6073 for a copy 
of the ICR.

C. In Person or By Phone

    If you have any questions or need additional information about this 
notice or the ICR referenced, please contact the person identified in 
the ``FOR FURTHER INFORMATION CONTACT'' section.
    In addition, the official record for this notice, including the 
public version, has been established under docket control number OPP-
00608, (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of any electronic comments, which does not include any 
information claimed as Confidential Business Information (CBI), is 
available for inspection in the Office of Pesticide Programs (OPP) 
Public Docket, Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, 
VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The OPP Public Docket telephone number is 703-305-5805.

III. How Can I Respond to This Notice?

A. How and to Whom Do I Submit the Comments?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number, OPP-00608, in your correspondence.
    1. By mail. Submit written comments to: OPP Public Docket, Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments to: OPP Public 
Docket, Public Information and Records Integrity Branch, Rm. 119, CM 
#2, 1921 Jefferson Davis Highway, Arlington, VA, Telephone: 703-305-
5805.
    3. Electronically. Submit your comments and/or data electronically 
by e-mail to: [email protected]. Please note that you should not 
submit any information electronically that you consider to be CBI. 
Electronic comments must be submitted as an ASCII file avoiding the use 
of special characters and any form of encryption. Comments and data 
will also be accepted on standard computer disks in WordPerfect 5.1/6.1 
or ASCII file format. All comments and data in electronic form must be 
identified by the docket control number OPP-00608. Electronic comments 
on this notice may also be filed online at many Federal Depository 
Libraries.

B. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    You may claim information that you submit in response to this 
notice 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. A copy of the comment that does 
not contain CBI must also be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. If you have any questions 
about CBI or the procedures for claiming CBI, please consult with the 
technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

C. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits 
comments and information to enable it to:
    1. Evaluate whether the proposed collections of information are 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burdens 
of the proposed collections of information.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collections of information on those 
who are to respond, including through the use of appropriate automated 
or electronic collection technologies or other forms of information 
technology, e.g., permitting electronic submission of responses.

D. What Should I Consider When I Prepare My Comments for EPA?

    We invite you to provide your views on the estimates provided, new 
approaches we haven't considered, the potential impacts of the various 
options (including possible unintended

[[Page 42364]]

consequences), and any data or information that you would like the 
Agency to consider during the development of the final action. You may 
find the following suggestions helpful for preparing your comments:
     Explain your views as clearly as possible.
     Describe any assumptions that you used.
     Provide solid technical information and/or data to support 
your views.
     If you estimate potential burden or costs, explain how you 
arrived at the estimate.
     Provide specific examples to illustrate your concerns.
     Offer alternative ways to improve the collection activity.
     Make sure to submit your comments by the deadline in this 
notice.
     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. You can do this by providing the docket control number 
assigned to the notice.

IV. What Information Collection Activity or ICR Does This Notice 
Apply to?

    EPA is seeking comments on the following ICR:
    Title: Data Acquisition for Anticipated Residue and Percent of Crop 
Treated.
    ICR status: This ICR is a new proposed information collection that 
has not been approved by OMB. An Agency may not conduct or sponsor, and 
a person is not required to respond to a collection of information that 
is subject to approval under the PRA, unless it displays a currently 
valid OMB control number. The OMB control numbers for EPA's information 
collections appear on the collection instruments or instructions, in 
the Federal Register notices for related rulemakings and ICR notices, 
and, if the collection is contained in a regulation, in a table of OMB 
approval numbers in 40 CFR part 9.
    Abstract: The Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA), as amended, requires EPA to register pesticides prior to 
distribution and sale within the United States. FIFRA also requires 
applicants for pesticide registration to provide EPA with the data 
needed to assess whether the registration of a pesticide would cause 
unreasonable adverse effects on human health or the environment, and 
grants EPA the authority to require registrants to provide additional 
data to maintain an existing registration.
    Sections 408(b)(2)(E)(i) and 408(b)(2)(F) of the FFDCA, as amended 
by the Food Quality Protection Act of 1996, authorizes the EPA to use 
ARs data and the PCT data to establish, modify, maintain, or revoke a 
tolerance for a pesticide residue. However, the new law also requires 
that tolerance decisions based on ARs or PCT data be verified to ensure 
that residues in or on food are not above the residue levels relied on 
for establishing the tolerance. Specifically, section 408(b)(2)(E)(ii) 
of FFDCA requires data to be called in within 5 years after each 
tolerance decision that relies on ARs; section 408(b)(2)(F)(iv) of 
FFDCA requires periodic reevaluation if PCT estimates are used. Section 
408(f) of FFDCA lists the methods which EPA may use to obtain the data, 
which include: Data Call-In notices (DCIs) or Federal Register notices 
to request data.
    Under this proposed ICR, EPA will issue a DCI to affected 
registrants under the authority of FIFRA section 3(c)(2)(B). Currently, 
there are two main categories of applications for registration: Those 
requiring submission of a full complement of supporting data (e.g., new 
chemicals and biorationals), and those requiring submission of little 
or no data (e.g., ``me-too'' products) for previously registered 
chemicals and use patterns. Applicants for a ``me-too'' product (e.g., 
a pesticide claimed to be substantially similar in composition and use 
to a product previously registered by the EPA) may be required only to 
use EPA Form 8570-34 (``Certification with Respect to Citation of 
Data'') and EPA Form 8570-35 (``Data Matrix'') to certify that the 
applicant intends to rely on data previously submitted to the EPA by 
another producer, the applicant has contacted the appropriate company 
(owning the data that the applicant is referencing), and the applicant 
has offered to pay reasonable compensation for the use of the data.
    The kinds of data that may be the subject of a DCI include, but are 
not limited to the requirments in 40 CFR part 158:
     Monitoring data (Pesticide Data Program (PDP), Food and 
Drug Administration (FDA), Food Safety Inspection Service (FSIS), 
States, special monitoring [market basket, single serving, etc.]).
     Field trials.
     Processing studies.
     Reduction in residue data (washing, peeling, cooking, 
etc.).
     Livestock feeding studies.
     Metabolism studies.
     PCT data.
    EPA has published guidelines for studies listed in 40 CFR part 158. 
Internal guidelines have also been established for monitoring studies 
which require a registrant to submit and obtain approval of protocol 
prior to initiating a study and specific requirements when ARs are 
used. The protocol must describe crops and pesticides to be covered by 
the study. After approval, the applicant must adhere to the protocol or 
seek approval for major deviations.
    If EPA relies on ARs data when establishing or reassessing a 
tolerance, it must issue a DCI, and if the EPA used the PCT data 
estimates for a tolerance action, it may issue a DCI. A DCI is a letter 
sent to the registrant explaining the data submission requirement, 
requests specific data, sets out a time frame for a response to EPA, 
and provides applicable forms and guidelines to assist the registrant 
with the completion of the DCI request. A registrant must respond 
within 90 days of receipt of the DCI. The response must describe plans 
to submit the required data in accordance with the time frame 
specified, and, if applicable, contain suggested protocols for 
monitoring studies. Failure to generate the requested data, or respond 
to the DCI in a timely manner could result in Agency action to modify 
or revoke the tolerance.

V. What are EPA's Burden and Cost Estimates for This ICR?

    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal Agency. For this 
collection it includes the time needed to review instructions; develop, 
acquire, install, and utilize technology and systems for the purposes 
of collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    The ICR provides a detailed explanation of this estimate, which is 
only briefly summarized in this notice. The annual public burden for 
the Data Acquisition for Anticipated Residue and Percent of Crop 
Treated information collection is estimated to average in a range from 
59 hours to 13,636 hours per DCI depending upon the type of response 
requested. The respondent burden for this collection contains four 
categories: (1) Anticipated residues requiring a base set of data; (2) 
anticipated residues requiring minimum data; (3) anticipated residues 
collected

[[Page 42365]]

from publically available sources; and (4) PCT using existing 
information. Burden estimates for each category include: (1) 13,636 
hours per DCI for anticipated residues requiring a base set of data; 
(2) 69 hour per DCI for anticipated residues requiring minimum data; 
(3) 137 hours per DCI for anticipated residues collected from 
publically available sources; and (4) 59 hours per DCI for PCT using 
existing information. The following is a summary of the estimates taken 
from the ICR:
    Respondents/affected entities: Pesticide registrants whose 
registration relies on a tolerance action which is based on ARs or PCT 
data.
    Estimated total number of potential respondents: 31.
    Frequency of response: Once. Five years after tolerance decision 
using ARs/PCT data.
    Estimated total/average number of responses for each respondent: 1.
    Estimated total annual burden hours: 29,807.
    Estimated total annual burden costs: $2,773,866.

VI. Are There Changes in the Estimates from the Last Approval?

    No. This is a new proposed ICR.

VII. What is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce 
the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the person listed in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

List of Subjects

    Environmental protection, Information collection requests.

    Dated: July 20, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-19593 Filed 8-3-99; 8:45 am]
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