Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2); Renewal of Pesticide Information Collection Activities and Request for Comments

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 8, 2000 (Volume 65, Number 46)]
[Notices]
[Page 12227-12229]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr00-54]

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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: smoot.cameo@epa.gov.

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,

[[Page 12228]]

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: ``opp-docket@epa.gov,'' 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]
BILLING CODE 6560-50-F

Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2); Renewal of Pesticide Information Collection Activities and Request for Comments

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