DuPont Chemical Solutions Enterprise

Chambers Works

Deepwater, NJ  08023

July 23, 2009

Document Control Office

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 6428

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Re: 	EPA – HQ – OPPT – 2003 - 0012

	DuPont Chambers Works NJPDES Permit No. NJ0005100

	PFOA Data Submittal – Outfall DSN662 Weekly Grab Samples

	March 2009 Sample Data

Dear Document Control Office:

As per Part IV, Section G.5.a of the NJPDES permit, we are submitting a summary of PFOA analytical results for the weekly grab samples taken at internal outfall DSN662A to NJDEP on a monthly basis. Per your request, we are sending you a paper and electronic copy of the report for samples taken during March 2009. We will continue to send you the reports each month.

If you have any questions, please do not hesitate to call me at (856) 540-3015.

Sincerely,

Karen L. Pinder

SHE Consultant – Environmental

DuPont Chambers Works

Enclosures

Copies to:

Director, Chemical Control Division

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 4146

1201 Constitution Avenue, NW

Washington, DC 20004

Ms. Susan Rosenwinkel (cover letter only)

Principal Environmental Engineer

NJDEP Division of Water Quality

Bureau of Point Source Permitting – Region 2

401 E. State Street

P.O. Box 029

Trenton, NJ 08625-0029


[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36194-36195]
[DOCID:fr22jy09-60]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0039; FRL-8933-7]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Reporting and Recordkeeping
Requirements of the HCFC Allowance System (Renewal); EPA ICR No.
2014.04, OMB Control No. 2060-0498

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before August 21,
2009.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2003-0039, to (1) EPA online using http://www.regulations.gov (our
preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Air and Radiation
Docket and Information Center, Mail Code 28221T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Robert Burchard, Office of Atmospheric
Programs, Office of Air and Radiation, Mail Code 6205J, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On February 24, 2009 (74 FR 8252), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2003-0039, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air and
Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Reporting and Recordkeeping Requirements of the HCFC
Allowance System (Renewal).
    ICR numbers: EPA ICR No. 2014.04, OMB Control No. 2060-0498.
    ICR status: This ICR is scheduled to expire on July 31, 2009. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. An
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
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The international treaty The Montreal Protocol on
Substances That Deplete the Ozone Layer (Protocol) and Title VI of the
Clean Air Act Amendments (CAAA) established limits on total U.S.
production, import, and export of class I and class II controlled ozone
depleting substances (commonly referred to as ``controlled
substances'').
    Under its Protocol commitments, the United States was obligated to
cease production and import of class I controlled substances (e.g.,
chlorofluorocarbons or CFCs) with exemptions for essential uses,
critical uses, previously used material, and material that is
transformed, destroyed, or exported to developing countries. The
Protocol also establishes limits and reduction schedules leading to the
eventual phaseout of class II controlled substances (i.e.,
hydrochlorofluorocarbons or HCFCs).
    The U.S. is obligated to limit HCFC consumption (defined by the
Protocol as production plus imports, minus exports). The schedule
called for a 35 percent reduction on January 1, 2004, followed by a 75
percent reduction on January 1, 2010, a 90 percent reduction on January
1, 2015, a 99.5 percent reduction on January 1, 2020, and a total
phaseout on January 1, 2030. The U.S. Environmental Protection Agency
(EPA) is responsible for administering the phaseout. The U.S.
comfortably met the 35% reduction of the cap, and is on schedule to
meet the 75% reduction for January 1, 2010.
    To ensure the U.S. compliance with these limits and restrictions,
EPA established an allowance system to control U.S. production and
import of HCFCs by granting control measures referred to as baseline
allowances. Baseline allowances are based on the historical activity of
individual companies. There are two types of allowances: consumption
and production allowances. Since each allowance is equal to 1 kilogram
of HCFC, EPA is able to monitor the quantity of HCFCs being produced,
imported and exported. Transfers of production and consumption
allowances among producers and importers are allowed and are tracked by
EPA.
    The limits and restrictions for individual U.S. companies are
monitored by EPA through the recordkeeping and reporting requirements
established in the regulations in 40 CFR part 82, subpart A. To submit
required information, regulated entities can download reporting forms
from EPA's Web site (http://www.epa.gov/ozone/record.index.html),
complete them, and send them to EPA electronically, via mail, courier,
or fax. Almost all of the large regulated companies use the EPA
reporting forms.

    Upon receipt of the reports, the data is entered into the ODS
Tracking System. The ODS Tracking System is a secure database that
maintains the data submitted to EPA and helps the Agency: (1) Maintain
oversight over total production and consumption of controlled
substances; (2) monitor compliance with limits and restrictions on
production, imports, and trades and specific exemptions from the
phaseout for individual U.S. companies; (3) enforce against illegal
imports; and (4) assess, and report on, compliance with the U.S.
phasedown caps established under the Montreal Protocol.
    EPA has implemented an electronic reporting system through the
Agency's Central Data Exchange (CDX) that allows regulated entities to
prepare and submit data electronically. Coupled with the widespread use
of the standardized forms, electronic reporting has improved data
quality and made the reporting process efficient for both reporting
companies and EPA. Most reports that are submitted to the Agency with
the largest amount of data are submitted electronically.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 5
hours per response. 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. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Companies that produce, import, and
export class II controlled ozone depleting substances
    Estimated Number of Respondents: 53
    Frequency of Response: Occasionally
    Estimated Total Annual Hour Burden: 1,860 hours
    Estimated Total Annual Cost: $181,532, which includes $1,140
annualized capital or O&M costs.
    Changes in the Estimates: There is an increase of 228 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This change can be attributed to two major
changes: (1) An increase in the number of responses for the Request for
Additional Allowance Report and Domestic Transfer of Allowances/Inter-
pollutant Transfer Report and (2) an increase in the number of
activities per year for the Petition to Import Used Substances.

    Dated: July 16, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-17399 Filed 7-21-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24735-24736]
[FR Doc No: 2014-09910]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0682; FDA-2011-E-0683]

Determination of Regulatory Review Period for Purposes of Patent
Extension; YERVOY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for YERVOY and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product YERVOY
(ipilimumab). YERVOY is indicated for the treatment of unresectable or
metastatic melanoma. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
YERVOY (U.S. Patent Nos. 6,984,720 and 7,605,238) from Medarex, Inc.,
and the Patent and Trademark Office requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated July 2, 2012, FDA advised the Patent and Trademark Office
that this human biological product had undergone a regulatory review
period and that the approval of YERVOY represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
YERVOY is 3,879 days. Of this time, 3,605 days occurred during the
testing phase of the regulatory review period, while 274 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 12,
2000. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on August 12,
2000.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): June 25, 2010. FDA has verified the
applicant's claim that the biologics license application (BLA) for
YERVOY (BLA 125377/0) was initially submitted on June 25, 2010.

    3. The date the application was approved: March 25, 2011. FDA has
verified the applicant's claim that BLA 125377/0 was approved on March
25, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 966 or 398 days
of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 30, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by October 28, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09910 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Proposed Rules]
[Pages 21065-21066]
[FR Doc No: 2012-8473]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 799

[EPA-HQ-OPPT-2010-0520; FRL-9343-9]
RIN 2070-AJ66

Certain High Production Volume Chemicals; Test Rule and
Significant New Use Rule; Fourth Group of Chemicals; Notice of Public
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; public meeting.

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SUMMARY: EPA will hold a public meeting on May 16, 2012, to give the
public an opportunity to comment on a proposed test rule for 23 high
production volume (HPV) chemical substances and a significant new use
rule (SNUR) for another 22 HPV chemical substances under the Toxic
Substances Control Act (TSCA). The test rule would require
manufacturers and processors to develop screening-level health,
environmental, and fate data based on the potential for substantial
exposures of workers and consumers to the 23 HPV chemical substances,
and the SNUR would require persons to file a significant new use notice
(SNUN) with EPA prior to manufacturing, importing, or processing any of
the 22 HPV chemical substances for use in a consumer product or for any
use, or combination of uses, that would be reasonably likely to expose
1,000 or more workers at a single-corporate entity to the chemical
substances. The required notification would provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs. The opportunity to present
oral comment was offered in the proposed rule and, in response to that
offer, a request to present oral comments was received.

DATES: The meeting will be held on Wednesday, May 16, 2012, from 1:30
p.m. to 5 p.m. Requests to participate in the meeting must be received
on or before May 15, 2012.
    To request accommodation of a disability, please contact either
technical person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, EPA East Rm. 1153, 1201 Constitution Ave. NW., Washington DC
20460-0001.
    Requests to participate in the meeting, identified by docket
identification (ID) number EPA-HQ-OPPT-2010-0520, may be submitted to
either technical person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Robert Jones or Paul Campanella, Chemical Control Division (7405M),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone numbers:<PHONE_NUMBER> and<PHONE_NUMBER>; email addresses:
<EMAIL_ADDRESS>and<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process any of the chemical
substances that are listed in 40 CFR 799.5090(j) or 40 CFR 721.10228(a)
of the proposed rule's regulatory text published in the Federal
Register issue of October 21, 2011 (76 FR 65580) (FRL-8876-6).
Potentially affected entities may include, but are not limited to:
     Manufacturers (defined by statute to include importers) of
one or more of the subject chemical substances (NAICS codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
     Processors of one or more of the subject chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult either technical person listed under FOR FURTHER
INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. See Unit
VI. of the October 21, 2011 proposed rule for export notification
requirements.

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

    EPA has established a docket for this action under docket ID number
EPA-HQ-OPPT-2010-0520. All documents in the docket are listed in the
docket index available at http://www.regulations.gov. Although listed
in the index, some information is not publicly available, e.g.,
Confidential Business Information (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 electronically at
http://www.regulations.gov, or, if only available in hard copy, at the
OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW.,
Washington, DC. The EPA/DC Public Reading Room hours of operation are
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification,

pass through a metal detector, and sign the EPA visitor log. All
visitor bags are processed through an X-ray machine and subject to
search. Visitors will be provided an EPA/DC badge that must be visible
at all times in the building and returned upon departure.

II. Background

    In the Federal Register issue of October 21, 2011, EPA published a
proposed test rule and SNUR to regulate 45 HPV chemical substances. EPA
is proposing a test rule under TSCA section 4(a)(1)(B) for 23 of these
45 HPV chemical substances to require manufacturers, importers, and
processors to conduct testing to obtain screening level data for health
and environmental effects and chemical fate. EPA has preliminarily
determined that: Each of the 23 HPV chemical substances included in
that proposed rule is produced in substantial quantities and that there
is or may be substantial human exposure to each of them; there are
insufficient data to reasonably determine or predict the effects on
health or the environment of the manufacture, distribution in commerce,
processing, use, or disposal of the chemical substances or of any
combination of these activities; and the testing program proposed is
necessary to develop such data. Data developed under the proposed rule,
when finalized, will provide critical information about the
environmental fate and potential hazards associated with the subject
chemical substances. When combined with information about exposure and
uses, these data will allow the Agency and others to evaluate potential
health and environmental risks and to take appropriate follow-up
actions.
    EPA is also proposing to establish significant new use reporting
and recordkeeping under TSCA section 5(a)(2) for the other 22 HPV
chemical substances that would require EPA notification prior to worker
or consumer exposures rising to substantial levels. The SNUN allows EPA
to evaluate the use according to the specific parameters and
circumstances for that intended use and, if warranted, be able to
regulate prospective manufacturers or processors of the chemical
substance before the designated significant new uses of the chemical
substance occur.
    In response to the proposed rule, EPA received a request to present
oral comment from the People for the Ethical Treatment of Animals
(PETA). Written comments provided during the comment period for the
proposed rule, including those requesting an opportunity for oral
comment, are available and can be reviewed in the docket under docket
ID number EPA-HQ-OPPT-2010-0520.

III. How can I request to participate in this meeting?

    You may submit a request to participate in this meeting to either
technical person listed under FOR FURTHER INFORMATION CONTACT. Do not
submit any information in your request that is considered CBI.
    Requests to participate in the meeting, identified by docket ID
number EPA-HQ-OPPT-2010-0520, must be received on or before May 15,
2012.

List of Subjects

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements.

    Dated: April 3, 2012.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2012-8473 Filed 4-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63174-63175]
[FR Doc No: 2014-25142]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Executive Order 13650 Improving Chemical Facility Safety and
Security Webinar: Implementation Updates

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

ACTION: Notice of Listening Session Webinar.

-----------------------------------------------------------------------

SUMMARY: The Department of Labor (DOL), in coordination with the
Department of Homeland Security (DHS) and the Environmental Protection
Agency (EPA), is announcing a webinar to update stakeholders on issues
pertaining to implementation of Executive Order [E.O.] 13650: Improving
Chemical Facility Safety and Security.

DATES: The Webinar will take place on November 10th, from 4:00 p.m. EST
to 5:30 p.m. EST.
    Registration to Participate: Please click www.cvent.com/d/n4qt96/4w
to register. Each participant will be provided with webinar connection
instructions by email once their registration has been completed. There
is no fee to register.

FOR FURTHER INFORMATION CONTACT: For further information please email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On August 1, 2013, President Obama issued E.O. 13650 to improve
chemical facility safety and security. The Working Group charged with
implementing the E.O. is co-chaired by DHS, DOL, and EPA, and includes
participation from the Departments of Justice, Agriculture, and
Transportation, all of whom play a role in Chemical Facility safety and
security. During the initial months from the issuance of the E.O., the
Working Group met the deliverables outlined in the E.O. as well as
conducted a number of in-person listening sessions and webinars to
gather input from stakeholders. This work is reflected in a report to
the President released June 6,

2014, Executive Order 13650: Actions To Improve Chemical Safety and
Security--A Shared Commitment. The report was a milestone, not an end
point, and includes a Federal Action Plan for the path forward.
    The Working Group has made significant progress on the
implementation front of the Federal Action Plan since the release of
the report by initiating community planning preparedness measures,
increasing Federal coordination, improving data management techniques
and technology, revising regulations, issuing guidance and advisory
documents, and creating a best practices repository, among other
initiatives.

II. Scope of Webinar

    The purpose of this webinar is to update stakeholders and the
public on progress made on issues related to E.O. 13650 and
implementation of items from the Federal Action Plan contained in the
report to the President, and to raise awareness of the E.O. 13650
Working Group Web site, located at www.osha.gov/chemicalexecutive
order.

III. Public Participation

    This webinar will accommodate over 250 participants. As time
permits, participants will be able to ask questions on a first come,
first serve basis. We will do our best to accommodate all persons who
wish to ask questions during the session. We request that participants
refrain from making statements, and use this time to ask questions.
Should time run out, participants may submit questions, or those
wishing to submit statements, may do so via<EMAIL_ADDRESS>For
general inquiries regarding the E.O., please contact the Working Group
at<EMAIL_ADDRESS>
Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice.

    Signed at Washington, DC, on October 17, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-25142 Filed 10-21-14; 8:45 am]
BILLING CODE 4510-26-P


1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STANDARDS OF PERFORMANCE MACT Subpart II National Emission Standards For Shipbuilding and Ship Repair ( Surface Coating)

1. Identification of the Information Collection 1( a) Title of the Information Collection ICR for MACT Subpart II  National Emission Standards For Shipbuilding and Ship Repair ( Surface Coating)

1( b) Short Characterization/ Abstract The Maximum Achievable Control Technology ( MACT) for the National Emission Standards For Shipbuilding and Ship Repair ( Surface Coating) were proposed on December 6,

1994 and promulgated on December 15, 1995. These standards apply to all new and existing shipbuilding and repair facilities that are major sources of hazardous air pollutants ( HAP). The Clean Air Act ( CAA) defines major source as a source, or group of sources located within a contiguous area and under common control that emits or has the potential to emit, considering controls, 10 tons per year or more of any individual HAP, or 25 tons per year or more of any combination of HAP. This information is being collected to assure compliance with 40 CFR Part 63 Subpart II.

Owners or operators of shipbuilding and ship repair facilities to which this regulation is applicable must choose one of the four compliance options described in the final rule or install and monitor a specific control system to control coating emissions and reduce HAP emissions to the compliance level. The respondents would be subject to sections of subpart A relating to national 2 emission standards for hazardous air pollutants. These requirements include those associated with the initial notification and the notification of compliance status for the first six months, and every six months thereafter. In addition, respondents would be required to submit with the initial notification an implementation plan that describes the coating compliance procedures; record keeping procedures; and transfer, handling, and storage procedures that the source intends to use.

Respondents choosing any of the four compliance options described in the final rule must record the following: the total volume of coating applied at the source to ships; the volume of each low usage exempt coating applied; the identities of the coatings used, their appropriate coating categories, and applicable volatile organic hazardous air pollutants ( VOHAP) limits;

certifications of the as supplied volatile organic compounds ( VOC) content of each batch of coating; a determination of whether containers meet the standards; and the results of any Method 24 or approved VOHAP measurement test conducted on individual containers of coating, as applied. These notifications, reports, and records are essential in determining compliance; and are required, in general, of all sources subject to MACT surface coating rules. Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least 5 years following the date of such measurements.

Respondents are owners and operators of new and existing shipbuilding and ship repair facilities that emit hazardous air pollutants. Of the 598 facilities that comprise the source category, 45 facilities are expected to meet the applicability criteria defined in the final rule. No new facilities are expected to be constructed in the next three years. The cost of this ICR will be $ 1,195,603. All reports are sent to the delegated State or Local authority. In the event that there 3 is no such delegated authority, the reports are sent directly to the EPA Regional Office.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction. In addition, Section 114( a) States that:

. . . the Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C)

install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) sample such emissions, ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F) submit compliance certifications, and ( G)

provide such other information as he may reasonably require.

In the Administrator's judgment, HAP emissions from surface coating at shipbuilding and repair facilities cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, MACT standards were promulgated for this source category at 40 CFR Part 63 SUBPART II. 4 2( b) Practical Utility/ Users of the Data These standards rely on the reduction of HAP emissions by using coatings which comply with the volatile organic compound ( VOC) limits set forth in this MACT standard. In some cases, the control of emissions of HAP from surface coating at shipbuilding and repair facilities also requires the installation of properly designed equipment, and the operation and maintenance of that equipment. The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to check if the standard is being met. The implementation plans from facilities are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved. In addition, the semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, record keeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the MACT achieve continuous compliance with the regulation. Adequate monitoring, record keeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act. The information collected from record keeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria 3( a) Nonduplication The record keeping and reporting requested is required under 40 CFR Part 63 Subpart II.

If the standard has not been delegated the information is sent to the appropriate EPA Regional 5 Office. Otherwise, the information is sent directly to the delegated State or Local Agency. If a State or Local Agency has adopted their own similar regulation to implement the Federal Regulation, a copy of the report submitted to the State or Local agency can be sent to the Administrator in lieu of the report required by the Federal Standard. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on May 27, 1999.

3( c) Consultations No comments were received on the burden published in the Federal Register. EPA solicits comments to:

( i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

( ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

( iii) enhance the quality, utility, and clarity of the information to be collected; and ( iv) minimize the burden of the collection of information on those who are to respond,

including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g.,

permitting electronic submission of responses.

3( d) Effects of Less Frequent Collection 6 Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and record keeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of the reporting or record keeping requirements contained in ( 40 CFR Part 63 Subpart II, or otherwise pertinent to this request violate any of the regulations established by OMB in 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251,

September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or record keeping requirements contained in 40 CFR Part 63 Subpart II or otherwise pertinent to this request contain sensitive questions.

4. The Respondents and the Information Requested 7 4( a) Respondents/ SIC Codes The respondents of the record keeping and reporting requirements are owners and operators of new and existing shipbuilding and ship repair facilities that are classified as major sources ( of HAP) under Section 112 of the CAA. The primary SIC code for the respondents affected by the rule is 3731 ( Shipbuilding and Repairing). The regulation applies only to shipbuilding and ship repair operations affecting commercial and military vessels; it does not apply to boat yards that only build or repair pleasure crafts, which the final rule defines as any marine or fresh water vessel that is used by individuals for non commercial, non military, and recreational purposes and which is less than 20 meters in length.

4( b) Information Requested All data in this ICR that is recorded and/ or reported is required by 40 CFR Part 63 Subpart II. The two tables further on in this document specify the reporting and record keeping requirements of affected sources. Records are required to be retained for 5 Years. The first 2 years of records must be kept onsite.

The respondents will have to undertake the following activities:

 Read instructions( 63.10( b)( 1));

 Install, calibrate, maintain, and operate control devices ( if control device approved and used)( 63.10 ( c) and ( e));

 perform initial performance test ( if control device approved used) ( 63.10 ( c) and ( e));

 write the notifications and reports listed above ( 63.10 ( c) and ( e)) and ( 63.9 ( a) ( d));  enter information required to be recorded above ( 63.10 ( c) and ( e)); 8  submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information ( 63.6( e));

 develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information;

 develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information;

 adjust the existing ways to comply with any previously applicable instructions and requirements;

 train personnel to be able to respond to a collection of information;

 transmit, or otherwise disclose the information.

 volume of coating applied/ supplied coating ( 63.788 ( b)( 2));

 certification of applied/ supplied coating ( 63.788 ( b)( 2));

 calculate maximum allowable thinning ratios ( 63.788 ( b)( 3));

 calculate allowable and used volume of thinner ( 63.788 ( b)( 3)).

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage,

and distribution of the information required under 40 CFR Subpart II:

 Observes initial performance tests and repeat performance tests if necessary;

 Reviews notifications and reports, including performance test reports, and 9 excess emissions reports, required to be submitted by industry;

 Audits facility records;

 Inputs, analyze, and maintains data in the Aerometric Information Retrieval System ( AIRS) database.

5( b) Collection Methodology and Management Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The implementation plan, and semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into AIRS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AIRS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AIRS for tracking air pollution compliance and enforcement by Local and State regulatory agencies, and EPA Regional Offices and Headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data. The records required by this regulation must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility The record keeping and reporting requirements were selected within the context of this specific subpart and the specific process equipment and pollutant( s). The requirements reflect the burden on small businesses. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced. Although the record keeping and 10 reporting requirements are the same for small and larger businesses, the Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses. However, there is a " low usage" exemption, which may reduce the record keeping and reporting burden for some small businesses. This " low usage" exemption stipulates that the provisions of the regulation do not apply to coatings used in volumes of less than 200 liters per year.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown on Table 1 below.

6. Estimating the Burden and Cost of the Collection Table 1 documents the computation of individual burdens for each of the record keeping and reporting requirements applicable to the industry. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified.

Responses to this information collection are mandatory. 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.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these record keeping and reporting requirements is estimated at 22,149 ( total from industry table) person hours.

These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the MACT program, the 11 previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates from the United States Department of Commerce Bureau of Labor Statistics, March 1999, Table 10: Employment Costs for Private Industry. The wage rates have been loaded by adding 110% overhead.

Executive, Administrative, and Managerial $ 73.90 Technical $ 54.94 Clerical $ 34.42 ( ii) Estimating Capital and Operations and Maintenance Costs The only type of industry costs associated with the information collection activity in the standards are labor costs. There are no capital or operations and maintenance costs, unless a new source gains the approval of the Administrator and uses an alternative compliance option which includes the use of a control device for coatings operations. This is not anticipated in the next 3 years.

( iii) Capital/ Start up vs. Operating and Maintenance ( O& M) Costs This is not applicable since there is no continuous monitoring required.

6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information.

Publication and distribution of the information are part of the AIRS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program. 12 The average annual Federal Government cost during the 3 years of the ICR is estimated to be $ 6,711. This cost is based on an average wage of a GS10 step 1 employee rate. Details upon which this estimate is based appear in Table 2: Agency Burden ( table 2).

6( d) Estimating the Respondent Universe and Total Burden and Costs The number of existing sources subject to 40 CFR 63 Subpart II is 45, and these sources are expected to meet the record keeping and reporting criteria. The total annual labor costs are $ 1,195,603. Details upon which this estimate is based appear in Table 1: Industry Burden.

6( e) Bottom Line Burden Hours And Cost Tables Table 1. Estimated Annual Burden and Total Capital and Start Up Cost to Industry to Implement Reporting and Record keeping Requirements B Over the Next Three Years.

Table 2. Estimate of Annual Burden and Cost To The Federal Government to Reporting and Record keeping Requirements B Over the Next Three Years.

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to an adjustment.

This burden a more accurate estimate of existing sources, and the number of person hours required to respond to the ICR. In addition, cost burden increase is mostly due to more accurate ( higher) labor rate estimates. The compliance date for this regulation was over two years ago,

and therefore most facilities in this industry have completed the initial implementation work required for this ICR. This reduces the number of person hours, industry wide, required to fulfill regulatory requirements associated with this regulation.

6( g) Burden Statement 13 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An 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 are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW,

Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1712.03, and OMB control number 2060 0330 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

JANUARY 9 - 12, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket No.: EPA-HQ-OPP-2006-0856

TUESDAY, JANUARY 9, 2007

U.S. Environmental Protection Agency, One Potomac Yard, South Building

Conference Center, Lobby Level

2777 S. Crystal Drive, Arlington, Virginia 22202

REVIEW OF WORKER EXPOSURE ASSESSMENT METHODS

8:30 a.m.	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., FIFRA SAP Chair

8:40 a.m.	Administrative Procedures by Designated Federal Official –
Myrta R. Christian

8:45 a.m.	Opening Remarks – Tina Levine, Ph.D., Director, Health
Effects Division, Office of Pesticide Programs, EPA

8:55 a.m.	Introduction and Overview – Jeff Evans, Health Effects
Division, Office of Pesticide Programs, EPA

9:20 a.m.	Historical Perspective – John Worgan, Health Canada, Pest
Management Regulatory Agency

10:00 a.m.	BREAK

10:15 a.m.	Case Study – Jeff Dawson, Health Effects Division, Office
of Pesticide Programs, EPA

11:45 a.m.	Issues Related to Antimicrobial Pesticides – Cassi Walls,
Ph.D., Antimicrobial Division, Office of Pesticide Programs, EPA

12:00 noon	LUNCH

1:00 p.m.	AHETF Overview and Approach – AHETF Representatives Richard
H. Collier, Ph.D., Victor Canez, Ph.D., and Curt Lunchick

2:40 p.m.	AEATF Overview and Approach – AEATF Representative Ryan
Williams, Ph.D.

3:00 p.m.	BREAK

3:15 p.m.	Public comments

5:00 p.m.	ADJOURNMENT

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

 OPEN MEETING

JANUARY 9 - 12, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket No.: EPA-HQ-OPP-2006-0856

WEDNESDAY, JANUARY 10, 2007

U.S. Environmental Protection Agency, One Potomac Yard, South Building

Conference Center, Lobby Level

2777 S. Crystal Drive, Arlington, Virginia 22202

REVIEW OF WORKER EXPOSURE ASSESSMENT METHODS

8:30 a.m.	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., FIFRA SAP Chair

8:35 a.m.	Administrative Procedures by Designated Federal Official –
Myrta R. Christian

8:40 a.m.	Follow-up from Previous Day’s Discussion – Jeff Dawson,
Jeff Evans, Health Effects Division, Office of Pesticide Programs, EPA

9:00 a.m.	Agency – Biological Monitoring/Passive Dosimetry Comparison
– Sheryl Beauvais Ph.D., California EPA, Department of Pesticide
Regulation

9:45 a.m. 	Agency Methods for Measuring Hand Exposure – Jeff Dawson,
Jeff Evans, Health Effects Division, Office of Pesticide Programs, EPA

10:15 a.m.	BREAK

10:30 a.m.	AHETF Comparison of Passive Dosimetry and Biological
Monitoring – AHETF Representatives John Ross, Ph.D. Graham Chester,
Doug Baugher, Ph.D., Bruce Houtman and Curt Lunchick

12:00 noon	LUNCH

1:00 p.m.	Questions to the Panel

1) Data Needs

EPA believes that many studies within our current database have
limitations.  In some

cases, the Agency is lacking data to address modern pesticide
application equipment and techniques.  EPA believes that additional data
could significantly improve our ability to estimate and better
characterize the range of worker exposure with greater certainty.

Please comment on these limitations and EPA’s conclusion that
additional data could improve significantly the Agency’s ability to
assess worker exposure.  Also, please comment on the selection criteria
proposed by the AHETF and AEATF in their respective submissions for
evaluating the extent to which existing data would meet EPA’s exposure
assessment needs.

2:30 p.m.	BREAK

2:45 p.m.	Panel Discussion (continued)

2) Passive Dosimetry Performance

The common approach for conducting dermal exposure monitoring studies
relies on the use of whole-body dosimetry, handwashing, and facial/neck
wipes.  In some cases, biological monitoring is also used as an
alternative method.  Exposure estimates in Agency risk assessments,
however, typically rely on “to the skin” measurements (i.e.,
potential dose) coupled with dermal absorption data or dermal toxicity
studies in order to calculate risks.  The Agency believes that these
methods are complementary and that they can provide appropriate
estimates for exposure assessment but that the results directly relate
to the reliability of the inputs used.  Please comment on the Agency’s
conclusion regarding passive dosimetry and biological monitoring,
including whether a systematic bias exists in either approach.

Based on the information presented, the Agency has particular concerns
over three specific aspects of how these studies are conducted including
(1) the possible need to correct for the efficiency of the handwashing
technique; (2) compensating for absorption of residues through the skin
during sample collection periods; and (3) the breakthrough of residues
under whole-body dosimeter garments. Please comment on the need to
systematically account for residue losses due to these potential method
biases.  If there is a need, please describe how these corrections
should be accomplished in a way that could reduce uncertainties in the
resulting exposure estimates.

4:15 p.m.	Panel Discussion (continued)

3) Passive Dosimetry vs. Biomonitoring

EPA believes that a comparison of exposure estimates derived from data
collected through biomonitoring with data collected through passive
dosimetry is the most appropriate way to assess the predictive nature of
a passive dosimetry-based approach for estimating worker exposure.
Please comment on the strengths and limitations of this kind of
comparison for judging the potential utility of passive dosimetry data
in conducting exposure assessments.

EPA has conducted such a comparison using available data and believes
that the

comparison shows sufficient concordance of estimates based on
biomonitoring data and passive dosimetry data to support the conclusion
that a passive dosimetry-based approach can generate data that can be
used to develop relatively predictive estimates of worker exposure for a
wide variety of scenarios and activities.  Please comment on the
adequacy of the analysis to support EPA’s conclusion.

5:30 p.m.	ADJOURNMENT

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

 OPEN MEETING

JANUARY 9 - 12, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket No.: EPA-HQ-OPP-2006-0856

THURSDAY, JANUARY 11, 2007

U.S. Environmental Protection Agency, One Potomac Yard, South Building

Conference Center, Lobby Level

2777 S. Crystal Drive, Arlington, Virginia 22202

REVIEW OF WORKER EXPOSURE ASSESSMENT METHODS

8:30 a.m.	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., FIFRA SAP Chair

8:35 a.m.	Follow-up from Previous Day’s Discussion – Jeff Dawson,
Jeff Evans, Health Effects Division, Office of Pesticide Programs, EPA

8:50 a.m.	Proportionality Between Exposure and Amount of Active
Ingredient Handled – Matthew Crowley, David J. Miller, Health Effects
Division, Office of Pesticide Programs, EPA

10:00 a.m.	BREAK

10:15 a.m.	Statistical Basis for AHETF Data Development Program –
AHETF representatives Bryce Landenberger, Curt Lunchick and Larry
Holden, Ph.D.

12:00 noon	LUNCH

1:00 p.m.	Questions to the Panel

4) Normalization of Exposure by Amount of Active Ingredient Handled
(AaiH)

The normalization of exposure by AaiH – the unit exposure – has,
since the mid-1980s, been the principle relationship underlying the use
of exposure data in the Agency's pesticide handler exposure assessments.
 It is based on the assumption that the two variables are proportional.
That is, if one doubles the amount of pesticide they handled or applied,
the resultant exposure will be doubled as well.

The Agency is unsure whether the results of our exploratory work showing
that proportionality between exposure and AaiH is reasonable in some but
not all cases, is a function of limitations of the data within PHED or
whether this relationship is in fact not a reasonable assumption for all
scenarios.  It may be the case that an additional ancillary variable
(e.g., boom length, # of tank mixes, or # de-couplings in a closed
loading system), in addition to or in place of AaiH, may improve the
predictive capabilities of our exposure model.

Though it is recognized that neither the studies in our current database
nor the proposed studies by the AHETF were designed for the primary
purpose of examining proportionality between exposure and AaiH or to
determine the extent to which other parameters influence exposure,
compared with our current database, the Agency believes that the
proposed AHETF studies will generate data that will reinforce the
assumption of proportionality between exposure and AaiH or,
alternatively, inform the applicability of another variable as a more
appropriate predictor of exposure.

Based on the themes presented on this topic including its historical
precedent, its application in risk assessment and subsequent risk
management decisions, the Agency’s exploratory work using the six PHED
scenarios in the case study, and the study design and objectives of the
AHETF, please comment on the assumption of proportionality between
exposure and AaiH, as a default.   Also, please provide comments on
whether the proposed AHETF study design is adequate to evaluate
proportionality between exposure and AaiH?  What other parameters should
AHETF study designs measure in order to improve the prediction
capabilities of our exposure model?

2:30 p.m.	BREAK

2:45 p.m.	Panel Discussion (continued)

5) Within-worker and Between-worker Variability

The proposed AHETF study design does not include true worker replicates
and is not intended to examine the issue of variability within workers.
The AHETF notes that to appropriately investigate this issue would
require significantly more sampling and resources.  They propose,
however, that their single-day exposure distribution results can be used
to evaluate longer term multiple day exposures by placing reasonable
limits on expected intra-class correlation coefficients (ICC):  they
indicate that, from their own research and review of the literature, the
ICC is likely to be between 0.3 and 0.5 over relatively short periods of
time (e.g., seasonal), and likely to be even lower over longer periods
of time.

Please comment on the AHETF’s approach to estimating the number of
samples (MU) needed to determine within worker variability and their
conclusion on the importance of measuring such variability in their
proposed studies.

4:15 p.m.	Defining the Scope of a Research Plan Designed to Quantify
Occupational Handler Exposures – David J Miller, Jeff Evans, Health
Effects Division, Office of Pesticide Programs, EPA

5:30 p.m.	ADJOURNMENT

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

 OPEN MEETING

JANUARY 9 - 12, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket No.: EPA-HQ-OPP-2006-0856

FRIDAY, JANUARY 12, 2007

U.S. Environmental Protection Agency, One Potomac Yard, South Building

Conference Center, Lobby Level

2777 S. Crystal Drive, Arlington, Virginia 22202

REVIEW OF WORKER EXPOSURE ASSESSMENT METHODS

8:30 a.m.	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., FIFRA SAP Chair

8:35 a.m.	Follow-up from Previous Day’s Discussion – Matthew
Crowley, David J Miller, Health Effects Division, Office of Pesticide
Programs, EPA

8:50 a.m.	AHETF Research Plan Development and Considerations – AHETF
representatives Victor Canez, Ph.D., Richard Collier, Ph.D., Bruce
Houtman, Curt Lunchick and Larry Holden, Ph.D.

10:00 a.m.	BREAK

10:15 a.m.	Questions to the Panel

6) Sample Size: Number of Sites and Subjects per Scenario/Activity

The Agency’s goal is to ensure that monitoring studies rely on sample
sizes that adequately represent the range of exposure of people who
engage in a particular handler scenario and activity.  It is also
recognized that occupational monitoring studies are costly and have many
logistical obstacles.  The Agency is also concerned about limiting the
numbers of participants in these types of studies in accordance with the
ethical requirements described in Subpart K (40CFR26) and the recent
criteria outlined by the Agency’s Human Studies Review Board.  The
Agency’s current guidelines recommend 15 monitoring units for each
scenario.  In addition, the AHETF has provided a rationale for the
number of samples in their study design.

Please comment on the uncertainties associated with the Agency’s and
AHETF’s recommended number of monitoring units.  In your comments,
please include any recommendations you may have regarding specific
statistical analyses that may assist the Agency in developing better
understanding of these uncertainties and characterizing them in a
complete and transparent manner in Agency assessments based on these
data.

12:00 noon	ADJOURNMENT

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Ms. Myrta Christian, via telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>
  PAGE  6  of   NUMPAGES  6