[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Notices]
[Pages 12227-12229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5392]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00643; FRL-6493-9]


Submission of Unreasonable Adverse Effects Information Under 
FIFRA Section 6(a)(2); 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 the EPA is seeking 
public comment on the following Information Collection Request (ICR): 
``Submission of Unreasonable Adverse Effects Information Under FIFRA 
Section 6(a)(2)'' (EPA ICR No. 1204.08, OMB No. 2070-0039). This ICR 
involves a collection activity that is currently approved and due to 
expire on September 30, 2000. 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-
00643, must be received on or before May 8, 2000.

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.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00643 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Cameo Smoot, Field and 
External Affairs Division, (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 305-5454; fax 
number: (703) 305-5884; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a 
pesticide registrant. Under section 6(a)(2) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) pesticide registrants are 
required to submit any factual information regarding adverse effects 
associated with their pesticidal products, and it is up to the Agency 
to determine whether or not that factual information constitutes an 
unreasonable adverse effect. Potentially affected categories and 
entities may include, but are not limited to:

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                                                                                       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. The North American Industrial Classification System (NAICS) 
codes and the Standard Industrial Classification (SIC) codes are 
provided to assist you and others in determining whether or not this 
action might apply to certain entities. If you have questions regarding 
the applicability of this action to a particular entity, consult the 
person listed under ``FOR FURTHER INFORMATION CONTACT.''

II. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

A. 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/. On the Home Page 
select ``Laws and Regulations'' 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/.

B. Fax-on-Demand

    Using a faxphone call (202) 401-0527 and select item 6080 for a 
copy of the ICR.

C. In Person

    The Agency has established an official record for this action under 
docket control number OPP-00643. The official record consists of the 
documents specifically referenced in this action,

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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.

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit the 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-00643 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, Ariel Rios Bldg., 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 8:30 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 and/or data 
electronically by e-mail to: ``[email protected],'' or you can submit 
a computer disk as described in Units III.A.1. and 2. 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-00643. Electronic comments may also be filed online 
at many Federal Depository Libraries.

B. 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.''

C. What Should I Consider when 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 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 
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.

D. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act 
(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.

IV. What Information Collection Activity or ICR Does this Action 
Apply to?

    EPA is seeking comments on the following ICR:
    Title: Submission of Unreasonable Adverse Effects Information Under 
FIFRA Section 6(a)(2).
    ICR numbers: EPA ICR No. 1204.08, OMB No. 2070-0039.
    ICR status: Currently approved and due to expire on September 30, 
2000.
    Abstract: This information collection renewal proposal covers the 
burden estimates related to section 6(a)(2) of FIFRA requirements for 
pesticide registrants to submit information to the Agency which may be 
relevant to the balancing of the risks and benefits of a pesticide 
product. In CSMA and NACA v. EPA 484 F. Supp. 513 (1980), the District 
Court of the District of Columbia agreed with EPA that FIFRA section 
6(a)(2) covers all information relevant to EPA's determination of 
whether a pesticide may cause unreasonable adverse effects. The Court 
agreed that submissible information includes the same type of 
information as that provided by a registrant as part of an application 
for registration. The Court specifically rejected the argument that the 
responsibility for determining what constitutes an unreasonable adverse 
effect shifts to industry once EPA has granted a registration. In order 
to limit the amount of less meaningful information that might be 
submitted to the Agency, the EPA has limited the scope of factual 
information that the registrant must submit. On September 19, 1997 the 
Agency published final regulations in the Federal Register (62 FR 
49370) (FRL-5739-1) that provided a detailed description of the 
reporting obligations of registrants under FIFRA section 6(a)(2). The 
regulations became effective on the deferred date of August

[[Page 12229]]

17, 1998 (63 FR 41192) (FRL-6016-2). There are no forms associated with 
this collection.

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 is 
estimated at 166,266 burden hours. The following is a summary of the 
estimates taken from the ICR:
    Respondents/affected entities: 1,890.
    Estimated total number of potential respondents: 260.
    Frequency of response: As necessary, when applicable information is 
available to respondent.
    Estimated total annual burden hours: 166,266.
    Estimated total annual burden costs: $13,870,860.

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

    In the previous ICR, OMB approved 120,762 burden hours for 
submission of information from pesticide registrants under FIFRA 
section 6(a)(2) with an estimated cost of $11 million. This ICR renewal 
request reflects an increase of approximately 45,000 burden hours to an 
annual respondent burden of 166,266 hours at a cost of nearly $14 
million. The change in burden reflects a number of adjustments over the 
prior ICR. First, for the renewal ICR, there are fewer registrants of 
active products (1,890 versus 2,100) and fewer employees to be trained 
(18,900 versus 21,000) than reflected in the prior ICR. In addition, 
the prior ICR's efforts associated with learning the new regulatory 
program, establishing processes and systems to implement the new 
program, and training all employees on the new requirements are 
eliminated in the renewal. Burden estimates related to the amount of 
studies the respondents might submit on an annual bases have been 
reduced from the previous projection of 600 studies to 350 studies. The 
ICR renewal request anticipates submission of many more incident 
reports than estimated in the prior ICR (46,000 versus 15,540). EPA 
proposes to seek approval for 166,266 annual burden hours for this 
renewal 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 under ``FOR 
FURTHER INFORMATION CONTACT.''

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: February 25, 2000.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 00-5392 Filed 3-7-00; 8:45 am]
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