[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]


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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.

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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 ``[email protected],'' 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