[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77825-77827]
[FR Doc No: 2011-32060]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0953; FRL-9506-6]

Human Studies Review Board; Notification of a Public
Teleconference

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The EPA Office of the Science Advisor announces a public
teleconference of the HSRB to discuss its draft report from the October
19-20, 2011 HSRB meeting.

DATES: The teleconference will be held on Wednesday, January 11, 2012
from approximately 1 p.m. to approximately 4 p.m. Eastern Time.
Comments may be submitted on or before Wednesday, January 4, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0953, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the Web site
instructions for submitting comments.
    Email<EMAIL_ADDRESS>    Mail: Environmental Protection Agency, EPA Docket Center EPA/DC,
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW., Washington,
DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building,
located at 1301 Constitution Avenue NW., Washington, DC 20460. The
hours of operation are 8:30 a.m. to 4:30 p.m.

Eastern Time, Monday through Friday, excluding Federal holidays. Please
call<PHONE_NUMBER> or email the ORD Docket at<EMAIL_ADDRESS>for
instructions. Updates to Public Reading Room access are available
online at http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0953. The Agency's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comments includes information claimed
to be Confidential Business Information or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through http://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, the EPA recommends that you include
your name and other contact information in the body of your comments
and with any disk or CD-ROM you submit. If the EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any members of the public who wish to
receive further information should contact Jim Downing on telephone
number<PHONE_NUMBER>; fax<PHONE_NUMBER>; email address
<EMAIL_ADDRESS>or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
mailing address Environmental Protection Agency, Office of the Science
Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC
20460. General information concerning the EPA HSRB can be found on the
EPA Web site at http://www.epa.gov/osa/hsrb.

SUPPLEMENTARY INFORMATION: Location: The meeting will take place via
telephone only.
    Meeting access: For information on access or services for
individuals with disabilities, please contact Lu-Ann Kleibacker at
least ten business days prior to the meeting using the information
under FOR FURTHER INFORMATION CONTACT, so that appropriate arrangements
can be made.
    Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in section
I, ``Public Meeting,'' under subsection D, ``How May I Participate in
this Meeting?'' of this notice.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by the EPA,
or to persons who are, or may be required to conduct testing of
chemical substances under the Federal Food, Drug, and Cosmetic Act or
the Federal Insecticide, Fungicide, and Rodenticide Act. Since other
entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult Jim Downing or Lu-Ann Kleibacker listed
under FOR FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other
related information?

    You may use http://www.regulations.gov, or you may access this
Federal Register document via the EPA's Internet site under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC
Public Reading Room. The EPA/DC Public Reading Room is located in the
EPA Headquarters Library, Room Number 3334 in the EPA West Building,
located at 1301 Constitution Avenue NW., Washington, DC 20460; its
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday
through Friday, excluding Federal holidays. Please call<PHONE_NUMBER>,
or email the ORD Docket at<EMAIL_ADDRESS>for instructions. Updates
regarding the Public Reading Room access are available at http://www.epa.gov/epahome/dockets.htm.

C. What should I consider as 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 used
that support your views.
    4. Provide specific examples to illustrate your concerns and
suggest alternatives.
    5. To ensure proper receipt by the EPA, be sure to identify the
docket ID 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. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this section. To ensure proper receipt by the EPA, it is imperative
that you identify Docket ID No. EPA-HQ-ORD-2011-0953 in the subject
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be
accepted up to and including Wednesday, January 4, 2012. To the extent
that time permits, interested persons who have not pre-registered may
be permitted by the Chair of the HSRB to present oral comments during
the meeting. Each individual or group wishing to make brief oral
comments to the HSRB is strongly advised to submit their request
(preferably via email) to Jim Downing or Lu-Ann Kleibacker under FOR
FURTHER INFORMATION CONTACT no later than noon, Eastern Time,
Wednesday, January 4, 2012, in order to be included on the meeting
agenda and to provide sufficient time for the HSRB Chair and HSRB
Designated Federal Official to review the meeting agenda to provide an

appropriate public comment period. The request should identify the name
of the individual making the presentation and the organization (if any)
the individual will represent. Oral comments before the HSRB are
generally limited to five minutes per individual or organization.
Please note that this includes all individuals appearing either as part
of, or on behalf of, an organization. While it is our intent to hear a
full range of oral comments on the science and ethics issues under
discussion, it is not our intent to permit organizations to expand the
time limitations by having numerous individuals sign up separately to
speak on their behalf. If additional time is available, further public
comments may be possible.
    2. Written comments. Please submit written comments prior to the
meeting. For the HSRB to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least five business days prior to the beginning
of this teleconference. If you submit comments after this date, those
comments will be provided to the Board members, but you should
recognize that the Board members may not have adequate time to consider
those comments prior to making a decision. Thus, if you plan to submit
written comments, the Agency strongly encourages you to submit such
comments no later than noon, Eastern Time, Wednesday, January 4, 2012.
You should submit your comments using the instructions in section I,
under subsection C, ``What Should I Consider as I Prepare My Comments
for EPA?'' In addition, the Agency also requests that persons
submitting comments directly to the docket also provide a copy of their
comments to Jim Downing or Lu-Ann Kleibacker listed under FOR FURTHER
INFORMATION CONTACT. There is no limit on the length of written
comments for consideration by the HSRB.

E. Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 5 U.S.C. App.2 section 9. The
HSRB provides advice, information, and recommendations to EPA on issues
related to scientific and ethical aspects of human subjects research.
The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports
of completed research with human subjects; and (3) how to strengthen
EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through the EPA Science Advisor.
    1. Topics for Discussion. The HSRB will be reviewing its draft
report from the October 19-20, 2011, HSRB meeting. The Board may also
discuss planning for future HSRB meetings. Background on the October
19-20, 2011 HSRB meeting can be found at the HSRB Web site: http://www.epa.gov/osa/hsrb. The October 19-20, 2011 meeting draft report is
now available. You may obtain electronic copies of this document, and
certain other related documents that might be available electronically,
from regulations.gov Web site and the HSRB Web site at http://www.epa.gov/osa/hsrb. For questions on document availability or if you
do not have Internet access, consult the persons listed under FOR
FURTHER INFORMATION CONTACT.
    2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information regarding the Board's final meeting report will be found at
http://www.epa.gov/osa/hsrb or from the persons listed under FOR
FURTHER INFORMATION CONTACT.

    Dated: December 7, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-32060 Filed 12-13-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Notices]
[Pages 20850-20851]
[FR Doc No: 2012-8331]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0010]

1,2-Dibromo-3-Chloropropane (DBCP) Standard; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified by the 1,2-Dibromo-3-
Chloropropane (DBCP) Standard (29 CFR 1910.1044).

DATES: Comments must be submitted (postmarked, sent, or received) by
June 5, 2012.

ADDRESSES: Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
erulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2012-0010, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2012-
0010). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information
is in the desired format, reporting burden (time and costs) is minimal,
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain
such information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    The information collection requirements in the DBCP Standard
provide protection for workers from the adverse health effects
associated with exposure to DBCP. In this regard, the DBCP Standard
requires employers to: Monitor workers' exposure to DBCP; monitor
worker health, and provide workers with information about their
exposures and the health effects of exposure to DBCP.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    After extensive research, OSHA found no U.S. employer who currently
produce DBCP or DBCP-based end-use products, most likely because the
Environmental Protection Agency (EPA) registration suspension for this
substance remains in effect; therefore, no cost or time burdens accrue
to employers under the Standard. The Agency requests one hour for OMB
to approve the information collection provisions of the Standard so
that it can enforce the paperwork requirements of the Standard if EPA
lifts the suspension or technology develops new applications for DBCP.
    Type of Review: Extension of a currently approved collection.
    Title: 1, 2-Dibromo-3-Chloropropane (DBCP) Standard (29 CFR
1910.1044).
    OMB Control Number: 1218-0101.
    Affected Public: Business or other for-profits; Federal Government;
State, Local or Tribal Government.
    Frequency: On occasion.
    Average Time Per Response: 0.
    Estimated Total Burden Hours: 1.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
erulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2012-0010. You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
    Information on using the http://www.regulations.gov Web site to
submit comments and access the docket is available at the Web site's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available through the Web site, and for assistance
in using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on April 3, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-8331 Filed 4-5-12; 8:45 am]
BILLING CODE 4510-26-P


            Pesticide Reregistration Performance Measures and Goals;
                            Annual Progress Report;
                               Fiscal Year 2017
           Docket identification (ID) number:  EPA-HQ-OPP-2014-0125

I.  Introduction
      The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a et seq.) requires EPA to publish information about EPA's annual achievements in meeting its performance measures and goals for pesticide reregistration.  This report addresses EPA's achievements in this area during fiscal year 2017.  This report discusses the integration of tolerance reassessment with the reregistration process, and describes the status of various regulatory activities associated with reregistration and tolerance reassessment.  The report also presents total numbers of products reregistered and products registered under the "fast-track" provisions of FIFRA.
II.  Background
      EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, under section 4(l) of FIFRA, 7 U.S.C. 136a-1(l).  Specifically, such measures and goals are to include:
 The status of reregistration.
 The number of products reregistered, canceled, or amended.
 The number and type of data requests of Data Call-In (DCI) notices under FIFRA section 3(c)(2)(B) issued to support product reregistration by active ingredient.
 Progress in reducing the number of unreviewed, required reregistration studies.
 The aggregate status of tolerances reassessed.
 The number of applications for registration submitted under FIFRA section 4(k)(3) (which provides for expedited processing and review of certain applications) that were approved or disapproved.
 The future schedule for reregistrations in the current and succeeding fiscal year.
 The projected year of completion of the reregistrations under FIFRA section 4.
	FIFRA required EPA to conduct a comprehensive pesticide reregistration program -- a complete review of the human health and environmental effects of older pesticides originally registered before November 1, 1984.  Pesticides meeting today's scientific and regulatory standards could be declared "eligible" for reregistration.  To be eligible, an older pesticide must have a substantially complete data base, and must not cause unreasonable adverse effects to human health or the environment when used according to Agency approved label directions and precautions.
	In addition, all pesticides with food uses must meet the safety standard of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a.  Under FFDCA, EPA must make a determination that pesticide residues remaining in or on food are "safe;" that is, "that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue" from dietary and other sources.  In determining allowable levels of pesticide residues in food, EPA must, among other requirements, perform a comprehensive assessment of each pesticide's risks, considering:
 Aggregate exposure (from food, drinking water, and residential uses).
 Cumulative effects from all pesticides sharing a common mechanism of toxicity.
 Possible increased susceptibility of infants and children.
 Possible endocrine or estrogenic effects.
	The 1996 FFDCA amendments also required the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they met the safety standard of the law.  EPA was directed to give priority to the review of those pesticides that appeared to pose the greatest risk to public health.  The Agency completed the last of 9,721 required tolerance reassessment decisions in September 2007, ensuring that all pesticides used on food in the United States meet the law's safety standard.  EPA's approach to tolerance reassessment under FFDCA was described fully in the Agency's document, "Raw and Processed Food Schedule for Pesticide Tolerance Reassessment" (62 FR 42020, August 4, 1997) (FRL-5734-6).
	The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004 (Pub. Law 108-199, Div. G, Title V, Sec. 501, 118 Stat. 419).  Among other things, PRIA amended FIFRA section 4(g)(2) to require EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use REDs by October 3, 2008.  The Agency completed REDs for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadline.  REDs are available on the Agency's Pesticide Chemical Search web page at https://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.
III.  Program Accountability
	Through this summary of performance measures and goals for pesticide reregistration and expedited registration, EPA describes progress made during 2017 in each of the program areas specified in FIFRA section 4(l).
A.  Status of Reregistration
	The last reregistration eligibility decisions for 613 reregistration cases (representing pesticide active ingredients or groups of pesticide active ingredients) were completed in FY 2008.  Product reregistration was not complete in FY 2017; the Agency's progress towards completion is discussed in detail below.  During FY 2017, as in the intervening years, the Agency focused on implementing the REDs as applicable to individual pesticide products.
B.  Product Reregistration; Numbers of Products Reregistered, Canceled, and Amended
	At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered.  This concluding part of the reregistration process is called "product reregistration."
	In issuing a completed RED document, EPA sends registrants a DCI notice requesting any product-specific data and specific revised labeling needed to complete reregistration for each of the individual pesticide products covered by the RED.  Based on the results of EPA's review of these data and labeling, products found to meet FIFRA and FFDCA standards may be reregistered.
	A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process.  Ideally, in response to the DCI, the pesticide producer, or registrant, will submit the required product-specific data and revised labeling, which EPA will review and find acceptable.  At that point, the Agency may reregister the pesticide product.  However, some products contain multiple active ingredients and receive multiple DCIs issued at different times.  Products containing multiple active ingredients may require more than one round of label revisions depending on the timing of the REDs and DCIs.  A product with multiple active ingredients could not be fully reregistered until the last active ingredient in its formulation was determined to be eligible for reregistration and all requirements of the applicable REDs satisfied (e.g., label changes, data requirements).  In other situations, the Agency may temporarily suspend a product's registration if the registrant has not submitted required product-specific studies within the time frame specified.  The Agency may cancel a product's registration because the registrant did not pay the required registration maintenance fee.  Alternatively, the registrant may request a voluntary cancellation of their end-use product registration.
	1.  Product reregistration actions in FY 2017.  EPA counts each of the post-RED product outcomes described above as a product reregistration action.  A single pesticide product may be the subject of several product reregistration actions within the same year.  For example, a product's registration initially may be amended, then the product may be reregistered, or the product may first be suspended and later it may be voluntarily canceled.  During FY 2017, with a goal of 600 total product reregistration actions, the EPA completed the product reregistration actions detailed in Table 1.

        TABLE 1. -- PRODUCT REREGISTRATION ACTIONS COMPLETED IN FY 2017
                          (AS OF SEPTEMBER 30, 2017)

                                    Actions
                                                                        FY 2017
Product reregistration actions
                                                                             14
Product amendment actions
                                                                            113
Product cancellation actions
                                                                            128
Product suspension actions
                                                                              0
Total actions
                                                                            255

	2.  Status of the product reregistration universe for FY 2017.  EPA also keeps track of the status of the universe of products subject to reregistration, that is, the overall number of products reregistered, amended, canceled, and sent for suspension, as well as the number of products with actions pending, as of the end of the fiscal year.  This overall status information is not "cumulative" -- it is not derived from summing up a series of annual actions.  Adding annual actions would result in a larger overall number since each individual product is subject to multiple actions -- it can be amended, reregistered, and/or canceled, over time.  Instead, the "big picture" status information in Table 2 should be considered a snapshot in time.  As registrants and EPA make marketing and regulatory decisions in the future, the status of individual products may change, and numbers in this table are expected to fluctuate.
TABLE 2. -- STATUS OF THE UNIVERSE OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2017 (AS OF SEPTEMBER 30, 2017)

                                    Status
                                                                        FY 2017
Products reregistered
                                                                         5,135
Products amended
                                                                          3,604
Products canceled
                                                                         11,826
Products sent for suspension
                                                                             40
Total products with actions completed
                                                                         20,605
Products with actions pending
                                                                          4,370
Total products in product reregistration universe
                                                                         24,975

      At the end of FY 2017, 4,370 products had product reregistration decisions pending.  Some pending products awaited science reviews, label reviews, or reregistration decisions by EPA.
	The universe of products in product reregistration has increased in some years and decreased in other years.  Generally, an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).
	3.  Product reregistration goal in FY 2018.  EPA's goal for FY2018 was to complete 400 product reregistration actions.  Additional information is available on EPA's Reregistration and Other Review Programs Predating Pesticide Registration Review web page at https://www.epa.gov/pesticide-reevaluation/reregistration-and-other-review-programs-predating-pesticide-registration.
C.  Applications for Registration Requiring Expedited Processing; Numbers Approved and Disapproved

	By law, EPA must expedite its processing of certain types of applications for pesticide product registration, i.e., applications for end-use products that would be identical or substantially similar to a currently registered product (me-too products); amendments to current product registrations that do not require review of scientific data; and products for public health pesticide uses.  During FY 2017, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as "fast track" applications) shown in Table 3.
                       TABLE 3. -- FAST TRACK APPLICATIONS APPROVED IN FY 2017
                               Application Type
                                                                        FY 2017
Me-too product registrations/Fast track
                                                                            272
Amendments/Fast track
                                                                          2,302
Total applications processed by fast track means
                                                                          2,574

	For those applications not approved, the Agency generally notifies the registrant of any deficiencies in the application that need to be corrected or addressed before the application can be approved.  Applications may have been withdrawn after discussions with the Agency, and 4 (Antimicrobial=1, Biopesticide=3) were formally "denied" during FY 2017.
	On a financial accounting basis, EPA devoted 22.4 full-time equivalents (FTEs) in FY 2017 to reviewing and processing applications for fast track me-too product registrations and label amendments.  The Agency spent approximately $3.2 million in FY 2017 in direct costs (i.e., time on task, not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.
D.  Projected Year of Completion of Reregistrations
	EPA completed the last reregistration eligibility decisions in FY 2008.  The Agency plans to complete product reregistration for conventional pesticides in FY 2022 and antimicrobial pesticides in FY 2026.
IV. Can I Comment on this Report?
      EPA does not expect these reports to lead to any particular action and, therefore, is not seeking particular public comment.  However, EPA welcomes input from stakeholders and the general public.  Written comments, identified by the docket identification number EPA-HQ-OPP-2014-0125, and received by EPA on or before 60 days after date of publication in the Federal Register, will be taken into consideration in the event that EPA determines that further action in warranted.
      Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2014-0125, by one of the following methods:
      ::  Federal eRulemaking Portal:  http://www.regulations.gov.  Follow the on-line instructions for submitting comments.  Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
      ::  Mail:  Office of Pesticide Programs (OPP) Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
 	:: Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
      Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
V.  For Further Information Contact
      Ramé Cromwell, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>