[Federal Register: August 25, 2008 (Volume 73, Number 165)]
[Notices]
[Page 50064-50065]
[DOCID:fr25au08-90]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice for Waiver of Aeronautical Land-Use Assurance;
Mansfield Lahm International Airport; Mansfield, OH

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of intent of waiver with respect to land.

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SUMMARY: The Federal Aviation Administration (FAA) is considering a
proposal to change a portion of the airport from aeronautical use to
non-aeronautical use and to authorize the sale of the airport property.
The proposal consists of the sale of vacant, much of which is farmed
and owned by the City of Mansfield. The Hummel Parcel 35A is
approximately 89.86 acres. There are no impacts to the airport by
allowing the airport to dispose of the property. The proposed land for
release is vacant, not required for future development, safety, or
compatible land use. The intended land use is infrastructure
development, including roads, utilities, and industrial development.
Approval does not constitute a commitment by the FAA to financially
assist in the disposal of the subject airport property nor a
determination of eligibility for grant-in-aid funding from the FAA. The
disposition of proceeds from the disposal of the airport property will
be in accordance with FAA's Policy and Procedures Concerning the Use of
Airport Revenue, published in the Federal Register on February 16,
1999.

    In accordance with section 47107(h) of title 49, United States
Code, this notice is required to be published in the Federal Register
30 days before modifying the land-use assurance that requires the
property to be used for an aeronautical purpose.

DATES: Comments must be received on or before September 24, 2008.

FOR FURTHER INFORMATION CONTACT: Stephanie Swann, Program Manager,
Detroit Airports District Office, 11677 South Wayne Road, Suite 107,
Romulus, Michigan 48174. Telephone Number:<PHONE_NUMBER>/FAX Number:
(734)-229-2950. Documents reflecting this FAA action may be reviewed at
this same location or at Mansfield Lahm International Airport,
Mansfield, Ohio.

SUPPLEMENTARY INFORMATION: Following is a legal description of the
property located in Madison Township, County of Richland, State of
Ohio, and described as follows: (Legal Description of Property).

    Being a part of the northeast Quarter of Section 5, Township 21,
Range 18 of Madison Township, and more fully described as follows:
    Beginning at the intersection of the east line of the Northeast
Quarter of Section 5 and the centerline of Nail Road (which is the
south line of the Northeast Quarter of Section 5); thence west along
and with the centerline of Nail Road a distance of 1724 ft. to a
point in the centerline of Bowman Street Road (CH 215); thence north
28 degrees 30 minutes west along and with the centerline of Bowman
Street Road a distance of 1254.5 ft.; thence south 80 degrees 00
minutes east a distance of 389 ft.; thence north 2 degrees 30
minutes east a distance of 1884 ft. to a point in the centerline of
Crall Road (CH237); thence south 89 degrees 48 minutes east along
and with the centerline of Crall Road a distance of 1854 ft.; thence
south 0 degrees 8 minutes east a distance of 2900 ft. to the place
of beginning and contains 129.80 acres more or less and subject to
all legal highways.
    Also the following described premises:
    Being a part of the northwest Quarter of Section 4, Township 21,
Range 18 of Madison Township, and more particularly described as
follows:
    Beginning at the intersection of the west line of the Northwest
Quarter of Section 4 and the centerline of Nail Road (which is the
south line of the northwest Quarter of Section 4); thence east along
and with the centerline of Nail Road a distance of 720 feet; thence
north 1 degree 16 minutes east a distance of 2344 feet; thence north
88 degrees 44 minutes west a distance of 391 feet; thence south 2
degrees 43 minutes west a distance of 383 feet; thence south 89
degrees 40 minutes west a distance of 372.7 feet; thence south 0
degrees 8 minutes east a distance of 1974 feet to the place of
beginning and contains 37.31 acres more or less and subject to all
legal highways. Now located in the City of Mansfield.

    Issued in Romulus, Michigan on July 28, 2008.
Matthew J. Thys,
Manager, Detroit Airports District Office, FAA, Great Lakes Region.
[FR Doc. E8-19565 Filed 8-22-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: June 2, 2006 (Volume 71, Number 106)]
[Notices]
[Page 32073-32075]
[DOCID:fr02jn06-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-115-000]

Texas Eastern Transmission, LP; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Texas Eastern Incremental
Market Expansion II Project and Request for Comments on Environmental
Issues

May 26, 2006.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Texas Eastern Incremental
Market Expansion (TIME) II Project involving construction, replacement,
and operation of facilities by Texas Eastern Transmission, LP (Texas
Eastern) in Pickaway and Monroe Counties, Ohio and Somerset, Bedford,
Franklin, Bucks, Fayette, and Adams Counties, Pennsylvania. The TIME II
Project would provide additional natural gas pipeline capacity to the
New Jersey market area, alleviating the constraints currently
experienced as a result of increasing market demand. The TIME II
Project would provide up to 150,000 dekatherms per day (dth/d) of
transportation capacity.
    This notice announces the opening of the scoping period that will
be used to gather environmental input from the public and interested
agencies on the project. Please note that the scoping period will close
on June 30, 2006.
    This notice is being sent to potentially affected landowners;
Federal, state, and local government agencies; elected officials;
environmental and public interest groups; Native American Tribes, other
interested parties; local libraries and newspapers. State and local
government representatives are asked to notify their constituents of
this planned project and encourage them to comment on their areas of
concern.
    If you are a landowner receiving this notice, you may be contacted
by a pipeline company representative about the acquisition of an
easement to construct, operate, and maintain the proposed facilities.
The pipeline company would seek to negotiate a mutually acceptable
agreement. However, if the project is approved by the Commission, that
approval conveys with it the right of eminent domain. Therefore, if
easement negotiations fail to produce an agreement, the pipeline
company could initiate condemnation proceedings in accordance with
state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Internet Web site (http://www.ferc.gov). This fact

sheet addresses a number of typically asked questions, including the
use of eminent domain and how to participate in the Commission's
proceedings.

Summary of the Proposed Project \1\

    In 2007, Texas Eastern proposes to:
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    \1\ Texas Eastern's application was filed with the Commission
under section 7 of the Natural Gas Act and part 157 of the
Commission's regulations.
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     Remove about 6.4 miles of its existing 24-inch-diameter
Line 1 pipeline and replace it, within the same trench, with a 36-inch-
diameter pipeline in Somerset and Bedford Counties, Pennsylvania
(Uniontown Discharge);
     Remove about 4.9 miles of its existing 24-inch-diameter
Line 1 pipeline and replace it, within the same trench, with a 36-inch-
diameter pipeline in Franklin County, Pennsylvania (Bedford Discharge);
     Remove about 10.3 miles of its existing 20-inch-diameter
Line 2 pipeline and replace it, within the same

trench, with a 36-inch-diameter pipeline in Bucks County, Pennsylvania
(Eagle Discharge);
     Construct the new Heidlersburg Compressor Station, which
would include a 16,000 horsepower (hp) electric motor/centrifugal
compressor and related facilities near Heidlersburg in Adams County,
Pennsylvania; and
     Remove, relocate, or install appurtenant facilities.
    In 2008, Texas Eastern proposes to:
     Remove about 6.3 miles of its existing 24-inch-diameter
Line 1 pipeline and replace it, within the same trench, with a 36-inch-
diameter pipeline in Pickaway County, Ohio (Five Points Discharge);
     Construct about 4.0 miles of 36-inch-diameter pipeline
loop \2\ in Monroe County, Ohio (Berne Discharge);
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    \2\ A loop is a segment of pipeline that is installed adjacent
to an existing pipeline and connected to it on both ends. The loop
allows more gas to be moved through the pipeline system.
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     Install a 16,000 hp electric motor/centrifugal compressor
unit at its existing Uniontown Compressor Station in Fayette County,
Pennsylvania; and
     Install appurtenant facilities.
    The general location of Texas Eastern's proposed facilities is
shown on the map attached as Appendix 1.\3\
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    \3\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of all appendices, other
than Appendix 1 (maps), are available on the Commission's Web site
at the ``eLibrary'' link or from the Commission's Public Reference
Room, 888 First Street, NE., Washington, DC 20426, or call (202)
502-8371. For instructions on connecting to eLibrary refer to the
last page of this notice. Copies of the appendices were sent to all
those receiving this notice in the mail.
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Land Requirements for Construction

    Construction of Texas Eastern's proposed pipeline facilities would
require about 571.6 acres of land, including construction rights-of-way
for the loop and replacements, additional temporary workspaces, access
roads, staging areas, and pipeyards/wareyards. Following construction,
about 319.9 acres would be maintained as permanent rights-of-way. The
remaining 251.7 acres would be restored and allowed to revert to its
former use.
    Construction at the existing Uniontown Compressor Station would
require disturbance of about 0.5 acre within the existing compressor
station site and would not require the clearing of additional land.
    Construction of the Heidlersburg Compressor Station would require
about 6.3 acres of land. Following construction, about 6.2 acres would
be maintained as a new aboveground facility site.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\4\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping''. The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this Notice of Intent, the Commission staff
requests public comments on the scope of the issues to address in the
EA. All comments received are considered during the preparation of the
EA. By this notice, we are also asking Federal, state, and local
agencies with jurisdiction and/or special expertise with respect to
environmental issues to formally cooperate with us in the preparation
of the EA. Agencies that would like to request cooperating status
should follow the instructions for filing comments below.
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    \4\ ''We'', ``us'', and ``our'', refer to the environmental
staff of the Office of Energy Projects (OEP).
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    Our independent analysis of the issues will be in the EA. Depending
on the comments received during the scoping process, the EA may be
published and mailed to Federal, state, and local agencies, public
interest groups, interested individuals, affected landowners,
newspapers, libraries, and the Commission's official service list for
this proceeding. A comment period will be allotted for review if the EA
is published. We will consider all comments on the EA before we make
our recommendations to the Commission.

Currently Identified Environmental Issues

    In the EA, we will discuss impacts that could occur as a result of
the construction and operation of the project. We will also evaluate
possible alternatives to the proposed project or portions of the
project.
    We have already identified several issues that we think deserve
attention based on a preliminary review of the proposed facilities,
environmental information provided by Texas Eastern, and comments
gathered from concerned citizens at Texas Eastern's open houses. This
preliminary list of issues may be changed based on your comments and
our analysis.
     Potential noise levels due to the operation of the
compressor stations;
     Safety concerns;
     Eight federally-listed threatened and endangered species
may potentially occur in the project areas;
     56 perennial waterbodies would be crossed; and
     About 6.2 acres of agricultural land would be converted to
industrial use for the Heidlersburg Compressor Station.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. By becoming a commentor, your
concerns will be addressed in the EA and considered by the Commission.
You should focus on the potential environmental effects of the
proposal, alternatives to the proposal (including alternative locations
and routes), and measures to avoid or lessen environmental impact. The
more specific your comments, the more useful they will be. Please
carefully follow these instructions to ensure that your comments are
received in time and properly recorded:
     Send an original and two copies of your letter to: Magalie
R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First
St., NE., Room 1A, Washington, DC 20426.
     Label one copy of the comments for the attention of Gas
Branch 1.
     Reference Docket No. CP06-115-000.
     Mail your comments so that they will be received in
Washington, DC on or before June 30, 2006.
    Please note that the Commission strongly encourages electronic
filing of any comments or interventions or protests to this proceeding.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site at http://www.ferc.gov under the ``e-Filing'' link and the

link to the User's Guide. Before you can file comments you will need to
create an account which can be created online.

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an official party to the proceeding, or ``intervenor''. To
become an intervenor you must file a motion to intervene according to
Rule 214 of the Commission's Rules of Practice and Procedure (18 CFR
385.214). Intervenors have the right to seek rehearing of the
Commission's decision. Motions to Intervene should be electronically
submitted using the Commission's eFiling system at http://www.ferc.gov.

Persons without Internet access should send an original and 14 copies
of their motion to the Secretary of the Commission at the address
indicated

previously. Persons filing Motions to Intervene on or before the
comment deadline indicated above must send a copy of the motion to the
Applicant. All filings, including late interventions, submitted after
the comment deadline must be served on the Applicant and all other
intervenors identified on the Commission's service list for this
proceeding. Persons on the service list with e-mail addresses may be
served electronically; others must be served a hard copy of the filing.
    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your environmental comments considered.

Environmental Mailing List

    An effort is being made to send this notice to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed project. This includes all landowners who are
potential right-of-way grantors, whose property may be used temporarily
for project purposes, or who own homes within distances defined in the
Commission's regulations of certain aboveground facilities.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.

Click on the eLibrary link, click on ``General Search'' and enter the
docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,

contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/ esubscribenow.htm.

    Finally, public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/

EventsList.aspx along with other related information.

Magalie R. Salas,
Secretary.
[FR Doc. E6-8595 Filed 6-1-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71704-71705]
[FR Doc No: 2021-27307]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0107]

Agency Information Collection Activities; Approval of a New
Information Collection Request; Waiver and Exemption Requirements

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
Federal Motor Carrier Safety Administration (FMCSA) announces its plan
to submit the Information Collection Request (ICR) described below to
the Office of Management and Budget (OMB) for its review and approval
and invites public comment. This notice invites comment on a new
information collection titled ``Waiver and Exemption Requirements.''
The ICR estimates the burden applicants incur to comply with the
reporting tasks required for requesting waivers and exemptions. FMCSA
has not previously accounted for these burdens.

DATES: Comments on this notice must be received on or before January
18, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Pearlie Robinson, Driver and Carrier
Operations Division, DOT, FMCSA, West Building 6th Floor, 1200 New
Jersey Avenue SE, Washington, DC 20590. Telephone:<PHONE_NUMBER>. Email:
[email protected].

SUPPLEMENTARY INFORMATION:
    Title: Waiver and Exemption Requirements.
    OMB Control No.: To be determined by OMB upon OMB approval of the
ICR.
    Type of Request: New information collection.
    Respondents: States, State Drivers Licensing Authorities,
individuals, and motor carriers.
    Estimated Number of Respondents: 131 per year.
    Estimated Time per Response: 2 minutes to 2 hours.
    Expiration Date: This is a new information collection request.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 97 burden hours.
    Background: In 1998, the Federal Highway Administration (FHWA), the
predecessor agency of FMCSA, adopted 49 CFR part 381 as an interim
final rule (IFR), establishing procedures for applying for waivers,
exemptions, and pilot programs (63 FR 67600, December 8, 1998). Section
4007 of the Transportation Equity Act for the 21st Century (TEA-21)
amended 49 U.S.C. 31315 and 31136(e) to provide authority to the
Secretary of Transportation to grant waivers and exemptions from motor
carrier safety regulations. Section 4007 of TEA-21 requires that the
terms and conditions for all waivers and exemptions likely achieve a
level of safety equivalent to or greater than what would be achieved by
complying with the safety regulations. In 2004, FMCSA adopted its IFR
as final at 49 CFR part 381, consistent with section 4007 of TEA-21 (69
FR 51589, August 20, 2004). The final rule also established procedures
that govern how FMCSA reviews, grants, or denies requests for waivers
and applications for exemptions. The final rule included requirements
for publishing notice of exemption applications in the Federal Register
to afford the public an opportunity for comment. There is no statutory
requirement to publish Federal Register notices concerning waiver
applications.
    When the waiver and exemption provisions were first adopted, FHWA
stated that it would ``consider the information collection requirements
for each waiver, exemption, and pilot program and, if necessary,
request approval from the Office of Management and Budget for any
special recordkeeping requirements associated with the waiver,
exemption, or pilot program.'' (63 FR 67608). FMCSA included a similar
statement when finalizing its IFR in 2004 (69 FR 51597). Recently,
FMCSA determined that it now receives a sufficient number of waiver and
exemption requests per year to require OMB approval.
    A 60-day notice for public comment was published on August 16, 2021
(86 FR 45803). The comment period for that notice closed on October 15,
2021. There were no comments submitted to the docket.
    Public Comments Invited: You are asked to comment on any aspect of
this

information collection, including: (1) Whether the proposed collection
is necessary for the performance of FMCSA's functions; (2) the accuracy
of the estimated burden; (3) ways for the FMCSA to enhance the quality,
usefulness, and clarity of the collected information; and (4) ways that
the burden could be minimized without reducing the quality of the
collected information.

    Issued under the authority of 9 CFR 1.87.
Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2021-27307 Filed 12-16-21; 8:45 am]
BILLING CODE 4910-EX-P


DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 1 of 17 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection: Submission of Unreasonable Adverse Effects Information under FIFRA Section 6( a)( 2)

ICR Nos.: OMB No. 2070 0039; EPA No. 1204.09 1( b) Short Characterization/ Abstract This Information Collection Request ( ICR) is a renewal of an existing ICR that is currently approved by OMB and is due to expire January 31, 2004. Section 6( a)( 2) of the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA) requires pesticide registrants to submit information to the Agency that they acquire which may be relevant to the balancing of the risks and benefits of a pesticide product ( see Attachment A). In CSMA and NACA v. EPA 484 F. Supp. 513 ( 1980), the U. S. District Court for 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.

The statute requires the registrant to submit any factual information that it acquires regarding adverse effects associated with its pesticidal products, and it is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect. 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 ( 62 FR 49370) that provided a detailed description of the reporting obligations of registrants under FIFRA section 6( a)( 2). The regulations became effective on August 17, 1998.

As expected, implementation of the final regulations initially resulted in an increase in the number of incident reports submitted annually. That was assumed to be the result of increased awareness and understanding on the part of pesticide registrants of their reporting responsibilities under FIFRA section 6( a)( 2). After the first year under the regulations, reporting leveled off and has remained generally consistent for both studies and incident reports. DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 2 of 17 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection This information collection stems from a non discretionary statutory requirement. Submission of information about unreasonable adverse effects is specifically required under section 6( a)( 2) of the Federal Insecticide Fungicide and Rodenticide Act ( FIFRA) ( 7 USC 136d( a)( 2)):

" If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator."

The Agency's FIFRA section 6( a)( 2) regulations are codified in the Code of Federal Regulations ( CFR) at 40 CFR part 159. ( Attachment B)

2( b) Practical Utility/ Users of the Data The Office of Pesticide Programs ( OPP) is the primary user of the information that registrants would submit to the Agency under FIFRA section 6( a)( 2). The information submitted is an essential component of the Agency's pesticide registration and reregistration programs because it requires the submission of important information regarding a pesticide's adverse effects  information which may not have been available at the time of the Agency's initial review of a registration application. Because this information has possible significant consequences for human health or the environment, had the information been available earlier, the Agency's determination with regard to the registration of the pesticide may well have been different. If warranted by the information provided, EPA may seek to amend the registration in order to address the concerns raised by the information.

In essence, this information provides an important means of focusing EPA attention on key problem areas regarding the use of the pesticide in question. The adverse effects information submitted under section 6( a)( 2) is considered by EPA in conjunction with other information to determine whether pesticides containing a specific active ingredient should be reregistered, or whether the terms and conditions of registration should be changed. This type of information may also be pertinent to granting emergency exemptions under section 18 of FIFRA.

Registrants perform studies voluntarily in support of registration applications or in response to data call ins issued by EPA. The authority to call in data is found in section 3( c)( 2)( B) of FIFRA, and are covered by other ICRs that are also approved by OMB. The outcome of those studies  whether they demonstrate known effects or new adverse effects  are carefully analyzed by registrants and presented to the Agency. This rule does not impose the DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 3 of 17 requirement to perform studies but merely to identify and promptly submit adverse effects information to the Agency. DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 4 of 17 Many registrants have indicated that adverse effects information is valuable to them as well. Registrants who actively seek 6( a)( 2) information justified their actions as part of product stewardship, customer relations, minimizing liability, and protecting or expanding market share. According to feedback that EPA has received, registrants acquire and use this information as a way of determining whether actual product use circumstances reveal new risk issues that did not emerge when the data were developed for the original registration application. These registrants believe that it is an integral part of their product stewardship program and that collecting, analyzing and reacting to adverse effects information is essential to the way in which they conduct business as a routine matter. For example, the web site for CropLife America, the trade association for registrants of agricultural pesticide products, describes its stewardship practices for crop protection and specialty pest management products. Among the practices for customer product stewardship is implementation of a system to obtain feedback of information related to product use, misuse, and adverse effects. The web site for Consumer Specialty Products Association, the trade association for registrants of antimicrobial pesticide products, describes its Product Care program. Among the principles of the voluntary program is In Market Support, Incident Evaluation and Follow Up.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non Duplication The information required to be submitted is generally available only from registrants who have opted to secure registration of their pesticide product( s). The only feasible means of collecting the required information is from pesticide registrants because it is either health and safety data generated, owned or used by the registrants, or is submitted to registrants by consumers and other interested parties. This information collection avoids duplication by limiting the submission requirements under FIFRA section 6( a)( 2) to information which has not been submitted to the OPP previously. Further, it exempts information submitted under section 8( e) of the Toxic Substances Control Act ( TSCA). Information in published articles is generally also exempt from submission.

3( b) Public Notice Required Prior to ICR submission to OMB Pursuant to 5 CFR 1320.8( d), EPA published a Federal Register notice on [ Insert date and cite of FRN] soliciting comments on this information collection activity and the Agency's intent to renew the OMB approval of this ICR. The Agency [ did/ did not] receive any comments on this ICR renewal. DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 5 of 17 3( c) Consultations [ Insert information about consultation with 5  9 registrants]

[ Insert response to comments received on either of the FRN's].

In addition to the activities discussed above, dialogue between industry and the Agency on adverse effects information reporting requirements, content, definitions, format, and timing is frequent and on going. In addition to phone conversations, e mails, and letters, Agency staff from time to time participate in meetings with individual registrants as well as gatherings of large groups of registrants. These communications permit an exchange of issues, problems, and solutions on many issues.

3( d) Effect of Less Frequent Collection Under FIFRA section 6( a)( 2) the information collection activity is a one time, nonrepetitive submission of information. As such, there is no set interval for multiple collections. The information is submitted one time, according to the timeframes described in the rule for various categories of information.

3( e) General Guidelines This information collection is well within the guidelines provided under the PRA and the implementing regulations issued by OMB. It should be noted, however, that even though the regulations do not prescribe specific recordkeeping requirements, the EPA requirements in 40 CFR Section 169.2( k) state that records containing research data relating to registered pesticides be retained as long as the registration is valid and the producer remains in business. Registrations are valid until they are either voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration. Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records not be required to be retained for more than three years will be exceeded for those studies which are required to support registration or reregistration under FIFRA section 3 or section 4, and which show adverse effects that make them reportable under section 6( a)( 2). The burdens associated with this recordkeeping requirement have already been approved by OMB under another ICR and are therefore excluded from this ICR.

3( f) Confidentiality Much of the information submitted pursuant to section 6( a)( 2) constitutes FIFRA section 10( d)( 1) safety and efficacy information. On September 28, 1999, the Agency issued a class determination that safety and efficacy information submitted under section 6( a)( 2) of FIFRA is DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 6 of 17 not entitled to confidential treatment. The determination enables the Agency to respond more quickly and efficiently to requests for information submitted under section 6( a)( 2).

Data submitted to the Agency are handled in accordance with the provisions of the FIFRA Confidential Business Information ( CBI) Security Manual which provides procedures for protecting information claimed as confidential in accordance with FIFRA section 10. If the information is not protected under FIFRA section 10, and it is not otherwise protected from release under the Freedom of Information Act ( FOIA), EPA is obligated to make it available to members of the public upon request under FOIA.

3( g) Sensitive Questions No questions of a sensitive or private nature are included in this information collection. If information of a sensitive nature is submitted, the Agency will protect it appropriately, as provided by the Privacy Act or other relevant statutes.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS Codes Potential respondents affected by the collection activities under this ICR include anyone who holds or ever held a registration for a pesticide product issued under FIFRA section 3 or 24( c). The North American Industrial Classification System ( NAICS) code is 325320 ( Pesticide and Other Agricultural Chemical Manufacturing).

4( b) Information Requested i) Data items, including record keeping requirements As further defined by the final rule implementing the FIFRA section 6( a)( 2) requirements, registrants are required to report on:

( 1) studies showing new or more severe toxicological responses than previously reported of any type in any strain of test organism; ( 2) epidemiological or exposure studies of human population groups indicating greater exposure than previously reported; ( 3) studies or incidents tending to show lack of efficacy of certain pesticide products with public health related uses; ( 4) incidents involving toxic or adverse effects to human or other non target organisms; ( 5) information on excess residues on food or feed, or residues in surface water, ground water or drinking water; DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 7 of 17 ( 6) information on metabolites, degradates, contaminants or impurities which may be of toxicological concern; ( 7) information showing that certain health related products fail to perform as claimed or that pests have developed resistance to a product; and ( 8) other information which may be relevant to risk/ benefit determinations of any type.

ii) Respondent Activities Respondents must:

( 1) read the final rule or instructions, ( 2) plan activities to ensure required information is identified and submitted, ( 3) process, compile and review information for accuracy and appropriateness, ( 4) complete written instruments to effectuate a submission, and ( 5) submit the information to EPA.

Under FIFRA section 6( a)( 2), as implemented by the final rule, pesticide registrants have no obligation to create or seek out adverse effects information. Such activities may be conducted by the registrant in support of pesticide registration under FIFRA section 3, or reregistration under section 4 ( which are approved by OMB under separate ICR approvals), or in the normal course of business, such as following up on consumer complaints to gather more information. Regardless of how the information comes into the possession of the registrant, once the registrant acquires information subject to submission under section 6( a)( 2) as defined by the final rule, the registrant must submit it to EPA.

5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities The Agency will continue the following current activities with regard to the FIFRA section 6( a)( 2) program: 1) answering questions and providing guidance to respondents; 2) receiving and recording data submissions; 3) analyzing claims of confidentiality and providing appropriate protection; 4) storing the data submitted; and 5) screening and analyzing the information for significance. DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 8 of 17 5( b) Collection Methodology and Management The final rule allows flexibility in the method or format for the required submission. In essence, the final rule specifies the types of data that should be reported to the extent the information is available and the reporting time frames. For incident information ( but not studies), these vary according to the significance of the information.

Scientific studies containing 6( a)( 2) information are assigned a Master Record Identifier Number as are all other pesticide studies. Adverse effects incident reports are entered into a computerized data base which can track incidents by chemical, submitter, type of incident, date of submission, and other parameters. All 6( a)( 2) submissions are screened by subject matter experts throughout the pesticide program. Data are forwarded to and reviewed by pesticide product managers and science reviewers for relevance to the regulatory status of the pesticide product( s) to which the submitted information pertains. The public may access the data by making a request under FOIA.

OPP has established standards for voluntary submission of study reports in electronic form ( Adobe PDF on CD ROM). A 6( a)( 2) study could be submitted electronically just as easily as a non 6( a)( 2) study. Regarding incidents, electronic submission is possible, but would require a number of activities to be completed as prerequisites. First, OPP would work with registrants to develop a standard form for submitting incident reports. The resulting form would have to be approved by OMB. This standard form would be an essential precursor to electronic submission of incident data. In addition, the Agency is developing technical specifications for its Central Data Exchange, the portal for submission of direct reports to EPA via a telecommunications network. Finally, OPP is working on conversion of all its existing databases to a single integrated system. The current incident data base is expected to become part of integrated system, but conversion has not yet been scheduled. This too would be an essential precursor to electronic submission of incident data.

It should be noted that at the time the final regulations went into effect and at the request of the regulated community, OPP staff worked with industry representatives and trade associations on voluntary forms for incident reporting. This was done by the trade associations as a service for their members. The agency accepts incident reports using the voluntary forms as well as incidents formatted in other ways. The voluntary forms may well serve as the foundation for standardized forms.

5( c) Small Entity Flexibility Regardless of the size of the registrant, the 6( a)( 2) regulations provide simplified reporting and extended reporting time frames for most incident reports. The Agency does not mandate a specific format for the required submission, but, as noted above, has worked with industry to DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 9 of 17 provide one to facilitate submissions. It is interesting to note that of the 1,877 registrants with active registrations, 849 hold only one product registration and 780 hold from two to ten registrations.

The requirements of FIFRA section 6( a)( 2) related to studies fall largely on basic producers, i. e., a producer who produces the active ingredient from raw materials, because they are the registrants most likely to generate and possess data subject to the information collection. Formulators ( companies that do not manufacture active ingredients) are exempt from generating most health effects data required to support registration except for product specific acute toxicity studies.

Both basic producers and formulators, however, may register and market end use products and receive incident reports from distributors and users of their products as well as other sources such as state regulatory agencies. The number of incident reports associated with a pesticide product depends on such variables as the volume of sales of that product, and whether it is sold to the general public or is restricted to experienced and trained applicators. Some registrants put toll free telephone numbers on their labels making it easy for consumers to contact them with incident reports. Other registrants, however, do not. Thus, it is difficult to generalize about the relative burden of incident reporting in terms of small versus large companies.

To further simplify compliance, EPA has issued detailed Guidance, see attachments D and E. The 6( a)( 2) regulations, however, provide the maximum possible flexibility to pesticide registrants, including small entities.

5( d) Collection Schedule The information required to be submitted under FIFRA section 6( a)( 2) is not based on any schedule because the information is non repetitive in nature. As such, the information required to be submitted by respondents is generally on an " as received basis". The regulations establish timeframes within which reportable information received by registrants must be submitted to EPA. The reporting time frames vary according to the organism exposed and the relative severity or rarity of the alleged effects. Allegations of human deaths must be reported individually by registrants within 15 days of acquiring the information. Other serious and rare incidents are reported individually. Generally, they may be accumulated for one month and submitted by the end of the month following the accumulation period. Minor or common incidents are reported as aggregate counts of incidents and effects for each product registration number or active ingredient. They may be accumulated for three months and submitted by the end of the second month following the accumulation period. DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 10 of 17 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden To estimate the respondent burden, the Agency used current statistics on the number of registrants of active products. For burden estimates related to study and incident data submissions, actual statistics for FY 2002 were used.

As of March 2003, for purposes of this analysis, the Agency assumes 1,877 registrants with active registrations. The number of registrations held by each registrant ranges from 1 to 697 and the median is two. For example, 856 registrants hold only one product registration and 1,629 hold ten or fewer registrations. Thirty one registrants hold 51  100 product registrations. Only 39 companies hold more than 100 registrations.

Former registrants have an obligation to report adverse effects information for one year after the cancellation or transfer of their product so long as the former registrant holds no active registrations. Since stocks of the formerly registered products diminish, it is unlikely these former registrants would acquire or submit much adverse effects information to the Agency. Former registrants, therefore, are not included in the estimated 1,877 registrants assumed for this analysis.

The Agency received 312 study related submissions in FY 2002. For purposes of this analysis, the Agency assumes 325 study related submissions will be received each year. This gives some margin for studies showing adverse effects submitted in support of Food Quality Protection Act registration reviews and tolerance reassessments over the life of the ICR.

During FY 2002, the Agency received 914 submissions from registrants containing reports of nearly 46,000 incidents. Of these, approximately 5,100 were individually reported and 40,600 were reported as aggregate statistics. A small number of incidents  approximately 700  were reported by parties other than registrants. These include states, EPA regional offices, and private groups and individuals. These parties are not required to report adverse effects information to the Agency, but their reports are received and processed in the same way as registrant submitted information.

The level of registrant reporting could have been substantially higher had it not been for action taken by the Agency to eliminate certain types of incident reports. The final regulations included the following as a condition for reporting incidents:

40 CFR 159.184( a)( 2)  The registrant is aware or has been informed that the person or non target organism suffered a toxic or adverse effect or may suffer a delayed or chronic adverse effect in the future. ( Emphasis added) DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 11 of 17 A literal interpretation of the italicized language above could have resulted in registrants reporting all asymptomatic exposures. Those are cases in which someone alleges exposure to a pesticide, but is experiencing no symptoms. Or someone may call a registrant to ask if they may get sick after an exposure or to express concern that they may get sick in the future as a result of an exposure. ( These were referred to as ` may suffer' incidents.) OPP consulted with a major poison control center to determine the volume of asymptomatic exposure calls they receive. According to the poison control center's statistics for a major pesticide company, nearly half the calls they handled were asymptomatic exposures. In order to focus resources  both the Agency's and registrants'  on a manageable volume of useful incident reports, the Agency eliminated the requirement to report ` may suffer' incidents. This was accomplished in PR Notice 98 4 ( Attachment E), which referenced the Agency's authority under Part 159.155 of the FIFRA 6( a)( 2) regulations to eliminate specified requirements by written notice to registrants. Elimination of the requirement is still in effect.

The number of registrants represented by the incident report submissions is 150. Registrants may report for themselves alone or they may report for themselves and related entities such as their divisions or subsidiaries. Registrant task forces such as the Acetochlor Registration Partnership may report for their member registrants for specific types of incidents.

For purposes of this ICR, the Agency estimates that it will continue to receive 46,000 incident reports from the regulated community each year. It is the estimated number of incidents  not the total number of registrants or number of registrants represented by current incident reporting  that drives the burden estimates in this analysis.

Another aspect of the respondents' burden is ongoing employee training on compliance with 6( a)( 2) reporting requirements. New employees would require training and experienced employees are likely to receive refresher training. Each company would plan training and track the status of training efforts. For purposes of determining the number of employees that need to be trained on adverse effects information reporting, EPA assumed an average of 10 [ need to consult on this] employees per registrant or 18,770 individuals requiring training each year. Please note that this estimate is strictly an average. The actual number would range from one person in a small company to several dozen in a large company. The Agency does not believe that a high proportion of people in any company need detailed training in 6( a)( 2) requirements. Most employees who are likely to receive information concerning the effects of pesticide products are simply made aware of the need to pass information along to an appropriate individual or unit within the company that evaluates reports and prepares submissions to the Agency.

The ICR that accompanied the final regulations estimated substantial burden associated with the first year of implementation of the regulatory program. Since the one time effort to learn about the regulations and establish or modify internal processes and systems has been accomplished, this ICR estimates burden hours and costs associated with a mature, on going DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 12 of 17 6( a)( 2) program.

6( b) Estimating Respondent Costs i) Estimating Labor Costs The following tables illustrate the estimated respondent burden and costs. While the spreadsheets that underlie the tables calculated in dollars and cents, the results are rounded to the nearest dollar. Please note that the burden/ costs are calculated differently for 6( a)( 2) studies and incidents and for training as an additional activity. Respondent costs are based on managerial, technical and clerical burden hours estimated at $ 130, $ 88, and $ 40 per hour, respectively. EPA has increased its estimated labor rates for respondents factoring in an inflation cost index of 1.056 based on the Gross Domestic Product. These labor rates are fully loaded and include benefits and overhead costs. Respondent labor rates in the existing ICR are $ 123, $ 83, and $ 38 per hour.

Table 1: Annual Respondent Burden/ Cost Estimates per Submission  STUDIES BURDEN HOURS ( PER YEAR) TOTAL COLLECTION ACTIVITIES Mgmt $ 130/ hr Tech $ 88/ hr Cler $ 40/ hr Hours Costs ($)

Read Instructions 0.10 0.20 0.00 0.30 31.00 Create Information 0.00 1.00 0.00 1.00 88.00 Compile and Review 0.10 0.50 0.00 0.60 57.00 Complete Paperwork 0.00 0.10 0.50 0.60 29.00 Store and Maintain Data 0.00 0.20 0.50 0.70 38.00 TOTAL 0.20 2.00 1.00 3.20 242.00 ANNUAL BURDEN: 3.2 Total Hours x 325 Studies = 1,040 Hours ANNUAL COSTS: ( a) Management: 0.20 hours x $ 130 x 325 Studies = $ 8,450 ( b) Technical: 2.00 hours x $ 88 x 325 Studies = $ 57,200 ( c) Clerical: 1.00 hours x $ 40 x 325 Studies = $ 13,000 TOTAL = $ 78,650 DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 13 of 17 Table 2: Annual Respondent Burden/ Cost Estimates per Submission  INCIDENTS BURDEN HOURS ( PER YEAR) TOTAL COLLECTION ACTIVITIES Mgmt $ 130/ hr Tech $ 88/ hr Cler $ 40/ hr Hours Costs ($)

Read Instructions 0.00 0.10 0.00 0.10 9.00 Create Information 0.00 0.50 0.00 0.50 44.00 Compile and Review 0.20 0.50 0.00 0.70 70.00 Complete Paperwork 0.00 0.00 0.50 0.50 20.00 Store and Maintain Data 0.00 0.10 0.20 0.30 17.00 TOTAL 0.20 1.20 0.70 2.10 160.00 ANNUAL BURDEN: 2.10 Total Hours x 46,000 Incidents = 96,600 Hours ANNUAL COSTS: ( a) Management: 0.20 hours x $ 130 x 46,000 Incidents = $ 1,196,000 ( b) Technical: 1.20 hours x $ 88 x 46,000 Incidents = $ 4,857,600 ( c) Clerical: 0.70 hours x $ 40 x 46,000 Incidents = $ 1,288,000 TOTAL = $ 7,341,600 Table 3: Total Annual Respondent Burden/ Cost for Required Submissions Per Submission Estimates Total Submissions Expected each Year Totals Burden Hours Costs ($) Burden Hours Costs ($)

Studies 3.2 242.00 325 1,040 78,650 Incident 2.1 160.00 46,000 96,600 7,360,000 TOTAL 5.3 402.00 46,325 97,640 7,438,650 Table 4: Registrant Burden/ Cost Estimates for Additional Activities  TRAINING Activities/ registrants Burden Hour per Respondent Totals Mgmt $ 130/ hr Tech $ 88/ hr Cler $ 40/ hr Hours Costs ($)

Plan training 0.50 0.10 0.00 0.60 74.00 Conduct employee training 0.50 1.50 1.00 3.00 237.00 Follow up, tracking 0.00 0.10 0.20 0.30 17.00 Total 1.00 1.70 1.20 3.90 328.00 DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 14 of 17 Table 5: Total Registrant Burden/ Cost Estimates for Additional Activities  TRAINING Activity Per Registrant  Total # Expected Totals Hours Costs ($) Hours Costs ($)

Plan training 0.6 74.00 1,877 1,126 138,898 Conduct employee training 3.0 237.00 18,770 56,310 4,448,490 Follow up, tracking 0.3 17.00 1,877 563 31,909 Total 3.9 328.00 22,524 57,999 4,619,297 Table 6: Total Annual Burden/ Cost for Registrants Per Activity Total Estimates Total Activities Totals Burden Hours Costs ($) Burden Hours Costs ($)

Studies 3.2 242.00 325 1,040 78,650 Incidents 2.1 160.00 46,000 96,600 7,360,000 Training 3.9 328.00 22,524 57,999 4,619,297 TOTAL 155,639 12,057,947 ii) Estimating Capital and Operations and Maintenance Costs There are no capital expenditures associated with this information collection activity.

6( c) Estimating Agency Burden and Cost Agency activities include: screening 6( a)( 2) submissions by subject matter experts to determine the significance of the information; information management activities to record, file, and track the submissions; communicating with registrants, providing guidance on the requirements; and management and oversight of the process.

Screening and managing submitted information involves fairly high level of management/ technical personnel due to the complex and variable nature of submitted material. For purposes of this estimate we have used an average grade of GS 14, Step 5 with an hourly rate of $ 78. Some tasks can be performed by clerical workers with an average grade of GS 7, Step 5 with an hourly rate of $ 29. The Agency contracts out much of the incident data and document management activities. ( This is reflected in Table 8 below.) This practice will continue over the DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 15 of 17 life of the ICR.

The Agency burden estimate does not include the effort to fully review a 6( a)( 2) study or to prepare the resulting documents. Nor does the burden estimate include the effort to take regulatory action that may result from 6( a)( 2) adverse effects information. The burden associated with those activities is covered under other ICR's.

The following tables illustrate the estimated Agency burden and costs:

Table 7: Annual Agency Burden/ Cost Estimates per Submission  STUDIES BURDEN HOURS ( per year) TOTAL COLLECTION ACTIVITIES Mgmt/ Tech $ 83/ hr ( GS 14, Step 5) Cler $ 33/ hr ( GS 7, Step 5) Hours Costs ($)

Screen submitted information 2.00 0.00 2.00 166.50 Record, file and track submissions 3.60 0.90 4.50 329.76 TOTAL 5.60 0.90 6.50 496.26 ANNUAL BURDEN: 6.5 Total Hours x 325 studies = 2,112 Hours ANNUAL COSTS: ( a) Mgmt/ Tech: 5.6 hours x $ 83 x 325 studies = $ 151,060 ( b) Clerical: 0.9 hours x $ 33 x 325 studies = $ 9,652 TOTAL = $ 160,712 Table 8: Annual Agency Burden/ Cost Estimates per Submission  INCIDENTS BURDEN HOURS ( per year) TOTAL COLLECTION ACTIVITIES Mgmt/ Tech $ 83/ hr ( GS 14, Step 5) Cler $ 33/ hr ( GS 7, Step 5) Hours Costs ($)

Screen submitted information 0.052 0.00 0.052 4.33 Record, file and track submissions 0.020 0.006 0.026 1.87 Communications, Guidance 0.017 0.00 0.017 1.41 TOTAL 0.089 0.006 0.095 7.61 ANNUAL BURDEN: 0.095 Total Hours x 46,000 submissions = 4,370 Hours ANNUAL COSTS: ( a) Mgmt/ Tech: 0.089 hours x $ 83 x 46,000 submissions = $ 339,802 ( b) Clerical: 0.006 hours x $ 33 x 46,000 submissions = $ 9,108 ( c) Contractor Costs = $ 80,000 TOTAL = $ 428,910 DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 16 of 17 Table 9: Total Annual Burden/ Cost for Agency Per Submission Estimates Total Submissions Expected each Year Totals Burden Hours Costs ($) Burden Hours Costs ($)

Studies 6.50 496.26 325 2,112 160,712 Incidents 0.095 7.61 46,000 4,370 428,910*

TOTAL 6,482 589,622 * Includes $ 80,000 contractor costs 6( d) Bottom Line Hours and Cost Tables The total burden hours and costs for respondents and the Agency have been calculated and are presented in Table 10:

Table 10: MASTER TABLE TOTAL Hours Cost Annual Respondent Burden/ Cost Estimates 155,639 $ 12,057,947 Annual Agency Burden/ Cost Estimates 6,483 $ 589,622 TOTAL 162,122 $ 12,647,569 The average per respondent burden is 83 hours( 155,639 total hours ÷ 1,877 total potential respondents), and the average cost is $ 6,424 per respondent ($ 12,057,947 total cost ÷ 1,877 total potential respondents). Not all of the potential respondents are likely to submit information each year. This calculation is a simple average of the burden and does not reflect a the more likely potential respondent burden which is characterized by the type of submission, the number registrations held, and the number of incidents that need to be reported.

6( e) Reasons for Change in Burden In the previous ICR, OMB approved 166,266 burden hours for submission of information from pesticide registrants under FIFRA 6( a)( 2) with a cost of $ 12,414,068. This ICR renewal request reflects a decrease of approximately 10,600 burden hours to an annual respondent burden of 155,640 hours at cost of $ 12,057,947. The change in burden reflects a number of adjustments. First, for the renewal ICR, there are slightly fewer registrants of active products ( 1,877 versus 1,890) and fewer employees to be trained ( 18,770 versus 18,900) than reflected in the prior ICR. Burden estimates associated with the number of studies the respondents might submit on an annual basis have been reduced because the estimated number of study submissions is reduced DRAFT FOR PUBLIC COMMENT April 3, 2003 Page 17 of 17 from 350 studies to 325. Based on four years experience with the 6( a)( 2) regulations, the burden hour estimate for study and incident report submissions are reduced by nine per cent. For studies, the burden hours are reduced from 5.9 to 3.2 hours per study. For incident reports, the burden hours are reduced from 2.3 to 2.1 hours. These reductions reflect a mature program and the familiarity with the regulations that comes with experience. Burden costs, however, are not comparably reduced because of the higher labor rates.

6( f) Burden Statement The total annual " respondent" ( applicant) burden for ICR entitled Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6( a)( 2), which is approved by OMB under OMB Control No. 2070 0039, is estimated to be 155,640 hours, with an average potential per respondent burden of 83 hours. According to 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 is 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. The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9, and appear on the information collection instrument as applicable, i. e., form or instructions.

Send comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460. Include the OMB control number in any correspondence but do not submit the requested information to this address. The requested information should be submitted in accordance with the instructions accompanying the form, or as specified in the corresponding regulation.