[Federal Register Volume 64, Number 115 (Wednesday, June 16, 1999)]
[Notices]
[Pages 32225-32228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14863]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00602; FRL-6082-5]


Data Generation for Pesticide Reregistration; Renewal of 
Pesticide Information Collection Activities and 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 Information Collection Request (ICR): ``Data 
Generation for Pesticide Reregistration,'' [EPA ICR No.1504, OMB No. 
2070-0107]. This ICR involves a collection activity that is currently 
approved and scheduled to expire on July 31, 1999. 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-
00602, must be received on or before August 16, 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 and are required to submit data to support 
continued registration of your product. EPA must assess health and 
safety data for all pesticide active ingredients originally registered 
before November 1, 1984, to determine whether the pesticide use poses 
unreasonable risks to human health or the environment. Section 4 of the 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 
amended, also establishes a process and a schedule for the development 
of the information EPA needs before these pesticides can be 
reregistered. The EPA may require registrants to generate and submit 
data to the Agency when data is needed to determine whether the 
pesticide is eligible for reregistration (see section 3(c)(2) (B) of 
FIFRA).
    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
 chemical manufacturing                                       organic chemicals
                                                             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 
registered a pesticide with the Agency pursuant to the Federal 
Insecticide, Fungicide, and Rodenticide Act. 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 EPA ICR number, the OMB 
control number, or the title of the ICR.

[[Page 32226]]

B. Fax-on-Demand

    Using a faxphone call 202-401-0527 and select item 6072 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-
00602, (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-00602, 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-00602. 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 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, along with the EPA and OMB ICR numbers.

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

    EPA is seeking comments on the following ICR:
    Title: Data Generation for Pesticide Reregistration.
    ICR numbers: EPA ICR No. 1507.04, OMB No. 2070-0107.
    ICR status: This ICR is currently scheduled to expire on July 31, 
1999. 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 Paperwork Reduction Act, 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: Under the FIFRA section 4 reregistration program, EPA 
examines health and safety data for active ingredients in pesticides 
initially registered before November 1, 1984, and determines whether 
they are eligible for reregistration. To be eligible, a pesticide must 
have a substantially complete data base and the Agency must assess all 
the information/data necessary to determine whether use of a pesticide 
presents unreasonable risks to man or the environment when used in 
accordance with its approved label directions. Registrants may be 
required to generate additional information on human health and 
environmental effects beyond the information submitted to the Agency 
when a pesticide was first registered. Prior to 1984, only acute 
testing or short-term environmental testing was required for many 
pesticides before registration. However, by 1984, EPA had determined 
that data on chronic health

[[Page 32227]]

effects and long-term environmental effects (e.g., tests for 
carcinogenicity or mutagenicity, or life cycle tests of organisms 
exposed to a pesticide) are necessary in many cases and issued updated 
data requirements for registration.
    In addition, all pesticides must meet the safety standards of the 
Food Quality Protection Act of 1996 (FQPA). FQPA directs the Agency to 
consider aggregate exposures from dietary and other non-occupational 
sources when assessing the risks of a chemical. In addition to dietary 
exposure, such sources as drinking water and residential use need to be 
considered. EPA must make the statutory determination that the 
resulting pesticide residues in food or feed will result in a 
reasonable certainty of no harm to human health from aggregate exposure 
through dietary, non-occupational, and drinking water routes of 
exposure as part of the consideration for reregistration. FQPA also 
directs EPA to consider the cumulative effects of pesticides that share 
a ``common mechanism of toxicity,'' consider special sensitivities of 
infants and children, and consider possible endocrine disruptor 
effects. The Agency is to reassess all existing tolerances (maximum 
limits for pesticides residues in food or feed) by 2006. EPA is 
implementing these new FQPA provisions primarily through the 
reregistration program.
    When the need for additional information/data occurs in developing 
pesticide reregistration decisions, the Office of Pesticide Programs 
(OPP) will issue a data call-in (DCI) pursuant to FIFRA section 
3(c)(2)(B) to obtain data and when necessary, the registrant may be 
required to certify compliance with data compensation requirements 
under the authority of FIFRA section 3(c)(2)(D). Agency scientists and 
analysts integrate the new data received from registrants with the 
existing data in EPA's files. EPA reviews all relevant information to 
assess the potential risks associated with the use of the pesticide to 
make a determination whether the pesticide should be reregistered. If a 
determination is made that a pesticide is eligible to be reregistered, 
and the registrant submits acceptable product-specific data and revised 
labeling, products containing the pesticide shall be reregistered 
within a specified time period. However, if after a review of the data, 
it is determined that a pesticide should not be reregistered, the 
Agency will take appropriate regulatory action.
    A record of each study submitted is maintained in the Agency's 
Pesticide Document Management System (PDMS), and the public may access 
the PDMS bibliography through the National Pesticides Information 
Retrieval System (NPIRS). NPIRS supports searches of the PDMS database 
by chemical, subject, submission date, laboratory, guideline number, 
and document type. The public may request copies of studies that are 
non-confidential, through the mechanism of a Freedom of Information Act 
(FOIA) request.
    This information collection program is separate from the 
information collection program described in the ICR entitled ``Data 
Call in for Special Review Chemicals and Registration Review Program'' 
(OMB No. 2070-0057) implemented pursuant to section 3(g) of FIFRA. The 
Registration Review Program is a recent amendment to the OMB No. 2070-
0057 ICR authorized by the 1996 amendments to FIFRA and requires EPA to 
establish a procedure for periodic review of all pesticide 
registrations every 15 years. Similar to the FIFRA section 4 
reregistration program, the Registration Review Program directs EPA to 
use the authority in FIFRA section 3(c)(2)((B) to require pesticide 
registrants to generate and submit data to the Agency where such data 
is needed to assess whether registration of an existing pesticide poses 
unreasonable risk to man or the environment. By the time the 
reregistration program is completed, the new section 3(g) Registration 
Review Program should be fully implemented.

Process and Program Status

    Section 4 of FIFRA mandates reregistration of all pesticides 
registered before November 1, 1984, with the goal that these pesticides 
were to be reregistered by 1997. The reregistration process is divided 
into in five phases with mandated deadlines.
    Phase 1-List active ingredients: FIFRA directs EPA to create a list 
of the active ingredients used in pesticides registered before November 
1, 1984, and requested pesticide registrants to notify EPA of the 
intent to seek reregistration. EPA created a list that is divided into 
four categories, Lists A through D.
    Phase 2-Declare intent and identify studies: This phase requires 
pesticide registrants to notify EPA, whether or not they intended to 
reregister their products; to identify and commit to providing the 
necessary studies including either making a generic data exemption 
claim or commitment to generate or share data; and to pay the first 
installment of the reregistration fee. During this phase, EPA issued 
guidance for registrants to assist in Phase 2 and Phase 3 responses. 
Phase 2 was completed in 1990.
    Phase 3-Summarize studies: This phase required registrants to 
submit summaries and reformat acceptable studies, ``flag'' studies 
indicating adverse effects, re-commit to satisfying all applicable data 
requirements, and pay the final installment of the reregistration fee. 
Phase 3 was completed in October 1990.
    Phase 4-EPA review and data call-in: During Phase 4, EPA reviewed 
all data submitted in Phase 2 and Phase 3 and required registrants to 
meet any unsatisfactory data requirements within 4 years. This phase 
was completed in 1993.
    Phase 5-Reregistration decisions: Currently, EPA is implementing 
Phase 5. The Agency is actively reviewing the studies submitted on each 
active ingredient and determining whether or not the pesticide is 
eligible for reregistration.
    It was OPP's intent to complete all DCI's for necessary information 
under the ICR approved through June 30, 1999. However, this goal was 
not met because of workload demands. The chemicals on List A moved 
directly to Phase 5 because the Agency had substantially reviewed these 
under the Registration Standard program. Therefore, the data call-in 
for List A chemicals has been completed and no additional data call-ins 
are expected unless the submitted data are inadequate or tiered 
requirements need to be satisfied. For chemicals on lists B, C, and D, 
data call-ins will not be completed during the current ICR 
authorization. Once an eligibility decision is made, the Agency will 
issue a Reregistration Eligibility Document (RED) to the registrant who 
then must provide product-specific data to EPA within 8 months of 
receipt of the RED.
    Therefore, the Agency seeks a renewal of this ICR because there may 
be a need to request additional or supplemental data before final 
reregistration decisions can be made. This re-approval will also allow 
EPA to continue to use all forms associated with this ICR; e.g., EPA 
Data Call-In Response Form; EPA Requirements Status and Registrant's 
Response Form; Certification of Offer to Cost Share in the Development 
of Data Form (EPA No. 8570-32); and Certification with Respect to 
Citation of Data (EPA No. 8570-34).

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

[[Page 32228]]

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 Generation for Pesticide Reregistration information collection 
is estimated to average 359.5 hours per an average 111 respondents. The 
average burden estimates assume that that respondents recieving product 
specific DCIs have an average of 8.9 products. The following is a 
summary of the estimates taken from the ICR:
    Respondents/affected entities: Pesticide registrants.
    Estimated total number of potential respondents: 111.
    Frequency of response: As needed only when specific data is 
required.
    Estimated total/average number of responses for each respondent: 
8.9.
    Estimated total annual burden hours: 2,715 to 33,120.
    Estimated total annual burden costs: $183,870 to $2,701,872.

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

    Yes. Three factors distinguish this ICR from the previous one. Both 
the unit test costs and labor rates were updated to reflect more 
current values. The unit test costs for list ``C'' and ``D'' chemicals 
almost doubled from the prior ICR. Secondly, the data requirements for 
list ``B'', ``C'', and ``D'' chemicals were revised. Lastly, the 
anticipated number of cases per year, the number per chemical list and 
the respondents affected changed from the previous ICR. The previous 
ICR anticipated an average number of 668 respondents and this ICR 
estimated a total of 269 respondents over 3 years or 90 per year which 
is about 60 percent lower.

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: June 3, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-14863 Filed 6-15-99; 8:45 am]
BILLING CODE 6560-50-F