[Federal Register Volume 63, Number 153 (Monday, August 10, 1998)]
[Notices]
[Pages 42627-42629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21356]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[FRL-6141-1]
Pesticides; Application for New or Amended Pesticide
Registration; Submission of EPA ICR No. 0277.11 to OMB for Review and
Approval; Agency Information Collection Activities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of submission to OMB.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that the Information Collection
Request
[[Page 42628]]
(ICR) entitled: Application For New or Amended Pesticide Registration,
[EPA ICR No. 0277.11, OMB No. 2070-0060] has been forwarded to the
Office of Management and Budget (OMB) for review and approval pursuant
to the OMB procedures in 5 CFR 1320.12. The ICR, which is abstracted
below, describes the nature of the information collection and its
estimated cost and burden. The Agency is requesting that OMB renew for
3 years the existing approval for this ICR, which is currently
scheduled to expire on September 30, 1998. A Federal Register document
announcing the Agency's intent to seek OMB approval for this ICR and a
60-day public comment opportunity, requesting comments on the request
and the contents of the ICR, was issued on April 17,1998 (63 FR 19250).
EPA did not receive any comments on this ICR during the comment period.
Additional comments may be submitted on or before [Insert date 30 days
after publication in the Federal Register].
FOR FURTHER INFORMATION CONTACT: Sandy Farmer by phone at 202-260-2740,
or via e-mail at farmer.sandy@epa.gov,'' or using the address
indicated below. Please refer to EPA ICR No. 0277.11 and OMB Control
No. 2070-0060.
ADDRESSES: Send comments, referencing EPA ICR No. 0277.11 and OMB
Control No. 2070-0060, to the following addresses:
Ms Sandy Farmer, U.S. Environmental Protection Agency, Regulatory
Information Division (Mail Code: 2137), 401 M Street, S.W., Washington,
DC 20460;
and to:
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W.,
Washington, DC 20503.
SUPPLEMENTARY INFORMATION:
Review Requested: This is a request to renew a currently approved
information collection pursuant to 5 CFR 1320.12.
ICR Numbers: EPA ICR No. 0277.11; OMB Control No. 2070-0060.
Current Expiration Date: Current OMB approval expires on September
30, 1998.
Title: Application For New or Amended Pesticide Registration.
Abstract: Under section 3 of the Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the Environmental Protection Agency (EPA, the
Agency) is responsible for registering pesticide products on the basis
of scientific data adequate to show that, when used according to label
directions, they will not pose unreasonable risk to human health, or
the environment, including endangered species. Regulations that govern
the implementation of this mandate are found in 40 Code of Federal
Regulations (CFR) parts 152 and 158.
An individual or entity wanting to obtain a registration for a
pesticide product must submit an application package consisting of
information relating to the identity and composition of the product,
and supporting data (or compensation for other's data) for the product
as outlined in 40 CFR part 158. The EPA bases registration decisions
for pesticides on its evaluation of a battery of test data provided
primarily by the applicants for registration. Required studies include
testing to show whether a pesticide has the potential to cause
unreasonable adverse human health or environmental effects. The Agency
currently collects data on physical chemistry, acute and chronic
toxicology, environmental fate, ecological effects, worker exposure,
residue chemistry, environmental chemistry, and product performance. If
the data show that the benefits of the pesticide product outweigh the
risks, then a registration is approved.
Burden Statement: The information covered by this request is
collected when an individual or entity applies for registration of a
pesticide product. The EPA makes small businesses aware of the
``Formulators's Exemption Statement'' (EPA Form 8570-27) that allows an
applicant to reduce their data submission burden when the pesticide
product is comprised of an EPA-registered pesticide product by
exempting the applicant from furnishing much of the data.
The annual registration applicant respondent burden for collection
of information associated with this activity is estimated to average in
a range from 8 hours to 188 hours per application depending upon the
type of application made. Estimates for the annual applicant respondent
burden for collection of information associated with the four
categories of pesticide product applicants average: 188 hours per
application for ``Type A'' antimicrobial products; 188 hours per
application for new active ingredient, biochemical, new food use and
new use products; eight hours per application for ``Type B''
antimicrobial products; and eight hours per application for amendments
and notifications, etc. This estimate includes the time reading the
regulations, planning the necessary data collection activities,
conducting tests, analyzing data, generating reports and completing
other required paperwork, and storing, filing, and maintaining the
data.
Respondents/Affected Entities: Pesticide registrants. SIC codes 286
(Industrial Organic Chemicals) and 287 (Agricultural Chemicals).
Estimated Number of Respondents: 2,100 pesticide registrants.
Frequency of Response: One time, on occasion.
Estimated Total Annual Burden: 187,640 hours.
Estimated Total Annualized Costs: $12 million.
Estimated Total Annual Capital Costs: There are no capital costs.
Changes in Burden Estimates: This information collection request
has changed since the last OMB approval. After extensive consultation
with stakeholders, the Office of Pesticide Programs has streamlined
several forms and created two new ones. The revised and new forms take
less time to complete and reduce the volume of paper pesticide
registrants send to the Agency. Burden time and cost will decrease for
the industry and the Agency. The first streamlining measure created two
forms from three existing ones. The revised data compensation form (EPA
Form 8570-34) replaced two older forms. This new form allows pesticide
registrants to indicate the data requirements they have completed and
to reference existing data produced by another company. The second
revised form, the data matrix (EPA Form 8570-35), replaced an older
form by clarifying the instructions and providing more protection for
data submitters. For consistency, both revised forms are used for
registration and reregistration.
In response to the President's Reinventing Government Initiative,
EPA developed through a public notice and comment process a self-
certification initiative. The outcome of this effort was the creation
of two new forms, (EPA Forms 8570-356 and 8570-37), for the voluntary
self-certification of product chemistry data for manufacturing-use and
end-use products. The forms reduce industry's paperwork burden,
expedite the review process and reduce the amount of time the Agency
needs to review the product chemistry for registration or
reregistration of these products.
Last year, EPA submitted an amendment to this ICR and obtained OMB
approval for these revised forms and adjusted the OMB approved burden
hours accordingly. These changes have now been fully integrated into
this ICR. Other changes in this ICR relate to the removal of certain
activities from coverage by this ICR. This ICR no longer includes
burden hour or cost estimates
[[Page 42629]]
for activities conducted for the EPA Training Verification Program or
the Pesticide Worker Protection Standards because these activities are
now covered under a separate ICR. In addition, information previously
collected as a one time information collection to support amended
labeling requirements for termiticide products, Pesticide Regulation
Notice 96-7, is complete and no longer estimated in this information
request.
In addition to the removal of these items, the Agency has also
added to its basic registration information collection. The additional
burden hours represent an estimated increase in the activities related
to the implementation of the 1996 amendments to FIFRA and include the
implementation of the Reduced-Risk Initiative (PR Notice 97-3,
attachment C).
These changes account for a total burden hour decrease from the
total burden of the last approved ICR, which was 218,938 hours, to
187,640 hours per year, for a total net reduction of 31,298 hours from
3 years ago. However, since EPA has already adjusted the total burden
hours in OMB's inventory to reflect the majority of the decreases, the
total burden hours in OMB's inventory, which is currently 190,505
hours, will decrease to 187,640, for a total net reduction of just
2,865 hours.
The total respondent costs have increased from approximately $6.0
million to $12 million per year, for a total net increase of $6
million. The reason for this increase in costs is due mainly to the
update in the loaded labor hourly rates used to calculate the costs.
According to the procedures prescribed in 5 CFR 1320.12, EPA has
submitted this ICR to OMB for review and approval. Any comments related
to the renewal of this ICR should be submitted within 30 days of this
document, as described above.
Dated: July 30, 1998.
Richard T. Westlund,
Acting Director, Regulatory Information Division.
[FR Doc. 98-21356 Filed 8-7-98; 8:45 am]
BILLING CODE 6560-50-P
