[Federal Register: June 21, 2010 (Volume 75, Number 118)]
[Notices]
[Page 35044-35045]
[DOCID:fr21jn10-95]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0002]

Notice of Approval of a Supplemental New Animal Drug Application;
Penicillin G Procaine Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice
that it has approved a supplemental new animal drug application (NADA)
filed by Norbrook Laboratories, Ltd. The supplemental NADA provides for
a revised formulation of penicillin G procaine injectable suspension
that includes lecithin as a surfactant.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed a supplement to NADA 065-010
for use of NOROCILLIN (penicillin G procaine) Injectable Suspension by
intramuscular injection in cattle, sheep, swine, and horses. The
supplement provides for a revised formulation that includes lecithin as
a surfactant. In accordance with section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(i)) and part 514 (21
CFR 514), in Sec. Sec.  514.105(a) and 514.106(a), the Center for
Veterinary Medicine is providing notice that this supplemental NADA is
approved as of April 23, 2010.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the act (21 U.S.C.
360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years
of marketing exclusivity beginning on the date of approval.
    FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.

    Dated: June 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-14865 Filed 6-18-10; 8:45 am]
BILLING CODE 4160-01-S


MEMORANDUM
To: 		Docket EPA-HQ-OAR-2023-0072
From: 		U.S. EPA
--------------------------------------------------------------------------------
Subject: 	Statutory Background and Regulatory History for CAA Section 111 References
--------------------------------------------------------------------------------

THE FOLLOWING ARE references the U.S. Environmental Protection Agency (EPA) cited in section V (Statutory Background and Regulatory History for CAA Section 111) of the preamble of the proposed New Source Performance Standards for Greenhouse Gas Emissions from New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions from Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule.


[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29949]
[DOCID:fr24my06-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application To Amend Article 405 of the License and
Soliciting Comments, Motions To Intervene, and Protests

May 18, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Request to amend Article 405 of the
license.
    b. Project No.: P-2496-137.
    c. Date Filed: March 17, 2006.
    d. Applicant: Eugene Electric and Water Board.
    e. Name of Project: Leaburg-Walterville Project.
    f. Location: The project is located on the McKenzie River in Lane
County, Oregon.
    g. Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Ms. Suzanne Pierce, Compliance Manager,
Eugene Water and Electric Board, 500 East 4th Avenue, P.O. Box 10148,
Eugene, OR 97440; Tel:<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Mr. Vedula Sarma at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: June 19, 2006.
    k. Description of Request: Article 405 of the license for the
Leaburg-Walterville Project requires the licensee to file final design
plan for raising the water level of Leaburg Lake by 1.5 feet to provide
additional hydraulic head needed to divert licensee's water right of
2,500 cubic feet per second. Because of local community opposition to
the lake raise, the licensee proposes to raise the Leaburg Lake by a
maximum of 6 inches rather than 1.5 feet.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to

be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. All documents (original and eight copies)
should be filed with: Magalie R. Salas, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. A
copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7961 Filed 5-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 22, 2008 (Volume 73, Number 205)]
[Rules and Regulations]
[Page 62902-62906]
[DOCID:fr22oc08-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-HQ-OAR-2008-0452; FRL-8728-3]

Completeness Findings for Section 110(a) State Implementation
Plans Pertaining to the Fine Particulate Matter (PM2.5)
NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is making a finding concerning whether or not each
state has submitted a complete State Implementation Plan (SIP) that
provides the basic program elements specified in section 110(a)(2) of
the Clean Air Act (CAA or Act) necessary to implement the 1997 Fine
Particulate Matter (PM2.5) National Ambient Air Quality
Standards (NAAQS). By this action, EPA is identifying those states
that: Have failed to make a complete submission for all requirements;
have failed to make a complete submission for specific requirements; or
have made a complete submission. The findings of failure to submit or
determinations of incompleteness for all or a portion of a state's SIP
establish a 24-month deadline for EPA to promulgate a Federal
Implementation Plan (FIP) to address the outstanding SIP elements
unless, prior to that time, the affected states submit, and EPA
approves, the required SIPs. The findings that all, or portions of a
state's SIP submission, are complete establish a 12-month deadline for
EPA to take action upon the complete SIP elements in accordance with
the CAA.

DATES: The effective date of this rule is November 21, 2008.

FOR FURTHER INFORMATION CONTACT: David Sanders, Office of Air Quality
Planning and Standards, Air Quality Policy Division, Mail Code C539-01,
Research Triangle Park, NC 27709; telephone<PHONE_NUMBER>; fax number
(919) 541-0824; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 553 of the Administrative Procedures
Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause
finds that notice and public procedure are impracticable, unnecessary
or contrary to the public interest, the agency may issue a rule without
providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making this action final
without prior proposal and opportunity for comment because no
significant EPA judgment is involved in making a finding of failure to
submit SIPs, or elements of SIPs, required by the CAA, where states
have made no submissions, or incomplete submissions, to meet the
requirement by the statutory date. Thus, notice and public procedure
are unnecessary. EPA finds that this constitutes good cause under 5
U.S.C. 553(b)(B).
    For questions related to a specific state please contact the
appropriate regional office below.

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            Regional offices                          States
------------------------------------------------------------------------
Region I--Dave Conroy, Acting Branch     Connecticut, Maine,
 Chief, Air Programs Branch, EPA New      Massachusetts, New Hampshire,
 England, I Congress Street, Suite        Rhode Island, and Vermont.
 1100, Boston, MA 02203-2211.
Region II--Raymond Werner, Chief, Air    New Jersey, New York, Puerto
 Programs Branch, EPA Region II, 290      Rico, and Virgin Islands.
 Broadway, 21st Floor, New York, NY
 10007-1866.
Region III--Cristina Fernandez, Branch   Delaware, District of Columbia,
 Chief, Air Quality Planning Branch,      Maryland, Pennsylvania,
 EPA Region III, 1650 Arch Street,        Virginia, and West Virginia.
 Philadelphia, PA 19103-2187.
Region IV--Richard A. Schutt, Chief,     Alabama, Florida, Georgia,
 Regulatory Development Section, EPA      Kentucky, Mississippi, North
 Region IV, Sam Nun Atlanta Federal       Carolina, South Carolina, and
 Center, 61 Forsyth Street, SW, 12th      Tennessee.
 Floor, Atlanta, GA 30303.
Region V--Jay Bortzer, Chief, Air        Illinois, Indiana, Michigan,
 Programs Branch, EPA Region V, 77 West   Minnesota, Ohio, and
 Jackson Street, Chicago, IL 60604.       Wisconsin.
Region VI--Thomas Diggs, Associate       Arkansas, Louisiana, New
 Director Air Programs, EPA Region VI,    Mexico, Oklahoma, and Texas.
 1445 Ross Avenue, Dallas, TX 75202-
 2733.
Region VII--Joshua A. Tapp, Chief, Air   Iowa, Kansas, Missouri, and
 Programs Branch, EPA Region VII, 901     Nebraska.
 North 5th Street, Kansas City, Kansas
 66101-2907.
Region VIII--Cynthia Cody, Unit Leader,  Colorado, Montana, North
 Air Quality Planning Unit, EPA Region    Dakota, South Dakota, Utah,
 VIII Air Program, 1595 Wynkoop St. (8P-  and Wyoming
 AR), Denver, CO 80202-1129.
Region IX--Lisa Hanf, Air Planning       American Samoa, Arizona,
 Office, EPA Region IX, 75 Hawthorne      California, Commonwealth of
 Street, San Francisco, CA 94105.         Northern Mariana Islands,
                                          Guam, Hawaii, and Nevada.

Region X--Mahbubul Islam, Manager,       Alaska, Idaho, Oregon, and
 State and Tribal Air Programs, EPA       Washington.
 Region X, Office of Air , Waste, and
 Toxics, Mail Code OAQ-107, 1200 Sixth
 Avenue, Seattle, WA 98101.
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Table of Contents

I. Background
II. This Action
    A. Finding of Failure To Submit for States That Failed To Make a
Submittal
    B. Finding of Failure To Submit Specific Elements of Section
110(a)(2)
    C. List of States That Submitted Complete Submissions To Satisfy
the Section 110(a)(2) Requirements
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act of 1995
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    J. National Technology Transfer Advancement Act
    K. Congressional Review Act
    L. Judicial Review

I. Background

    On July 18, 1997, EPA promulgated a revised NAAQS for
PM2.5. In that action, the annual PM2.5 standard
was set at 15 [mu]g/m3, based on the 3-year average of
annual arithmetic mean PM2.5 concentrations from single or
multiple community-oriented monitors. The 24-hour PM2.5
standard was set at 65 [mu]g/m3, based on the 3-year average
of the 98th percentile of 24-hour PM2.5 concentrations at
each population-oriented monitor within an area (see 62 FR 38652).
    CAA section 110(a) requires states to submit SIPs that provide for
the implementation, maintenance, and enforcement of a new or revised
NAAQS within 3 years following the promulgation of such NAAQS, or
within such shorter period as EPA may prescribe. Section 110(a) imposes
the obligation upon states to make a SIP submission to EPA for a new or
revised NAAQS, but the contents of that submission may vary depending
upon the facts and circumstances. In particular, the data and
analytical tools available at the time the state develops and submits
the SIP for a new or revised NAAQS necessarily affects the content of
the submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains.
    As of 2004, states had not submitted complete SIPs to satisfy all
of the section 110(a)(2) requirements for the 1997 PM2.5
NAAQS (as well as for the 8-hour ozone NAAQS). On March 4, 2004, Earth
Justice submitted a notice of intent to sue related to EPA's failure to
issue findings of failure to submit related to these requirements.
Subsequently, EPA entered into a Consent Decree with Earth Justice
which required EPA, among other things, to sign a notice for
publication in the Federal Register no later than October 5, 2008,
announcing EPA's determinations pursuant to section 110(k)(1)(B) as to
whether each state has made complete submissions to meet the
requirements of section 110(a)(2) for the 1997 PM2.5 NAAQS.
    Section 110(a)(2) lists specific elements that states must meet in
the general infrastructure SIP submissions. The requirements include
SIP infrastructure elements such as modeling, monitoring, and emissions
inventories that are designed to assure attainment and maintenance of
the NAAQS. In an October 2, 2007 memorandum entitled, ``Guidance on SIP
Elements Required Under Section 110(a)(1) and (2) for the 1997 8-hour
Ozone and PM2.5 National Ambient Air Quality Standards,''
EPA identified the specific requirements that are the subject of this
action and provided additional guidance on meeting the requirements.
    Of special interest is section 110(a)(2)(G) of the CAA which
requires SIPs to provide authority for emergency episode plans
comparable to that in section 303, as well as provide adequate
contingency plans to implement such authority. On that authority, EPA
previously established Significant Harm Levels (SHL) for five criteria
pollutants--sulfur dioxide, inhalable particulate matter
(PM10), nitrogen dioxide, carbon monoxide, and ozone. The
SHL represents ambient concentrations of said pollutant that EPA
determined, based on health effects data at that time, present an
imminent and substantial endangerment to public health or welfare, or
to the environment.\1\ Since EPA has yet to develop a SHL for
PM2.5, states have been placed at a disadvantage in meeting
this requirement under the CAA. Although EPA's delay in developing a
SHL for PM2.5 may have made it more difficult for states to
meet the section 110(a)(2)(G) obligation, nonetheless, states are still
required by statute to satisfy the obligation to have adequate
authority to protect the public in the event of a dangerous
PM2.5 air pollution episode and adequate contingency plans
to implement that authority. In this notice, we make findings that some
states have failed to make a submission addressing either statutory
authority for emergency powers or adequate contingency plans, or both.
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    \1\ The SHLs and associated requirements for developing
Emergency Episode Plans are codified at 40 CFR Part 51 Subpart H.
Appendix L of Part 51, provides an example regulation intended as a
guide for states that must develop emergency episode plans (51 FR
40668, November 7, 1986). Subpart H requires states to develop
emergency episode plans (where appropriate) that, at a minimum,
provide a set of actions that are necessary to prevent ambient
pollutant concentrations from reaching levels that could cause
significant harm and endangerment to the health of persons in the
affected areas.
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    Two elements identified in section 110(a)(2) are not governed by
the 3-year submission deadline of section 110(a)(1) because SIPs
incorporating necessary local nonattainment area controls are not due
within 3 years after promulgation of a new or revised NAAQS, but rather
are due at the time the nonattainment area plan requirements are due
pursuant to section 172. These requirements are: (i) Submissions
required by section 110(a)(2)(C) to the extent that subsection refers
to a permit program as required in part D Title I of the CAA, and (ii)
submissions required by section 110(a)(2)(I) which pertain to the
nonattainment planning requirements of part D, Title I of the CAA.
Therefore, this action does not cover these specific SIP elements. This
action also does not pertain to the requirements in section
110(a)(2)(D)(i), because EPA has previously addressed that
requirement.\2\
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    \2\ EPA published a finding that all states had failed to submit
SIPs addressing interstate transport for the 8-hour ozone and
PM2.5 NAAQS, as required by section 110(a)(2)(D)(i). See
70 FR 21,147 (April 25, 2005).

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II. This Action

    This notice reflects EPA's determinations with respect to the
section 110(a)(2) requirements for the 1997 PM2.5 NAAQS
only, based upon the submissions made by the states to fulfill the
requirements, or certifying that they have already met the
requirements, or both. For those states that have not yet made a
submittal, EPA is making a finding of failure to submit, and for those
states that made a submittal that was not complete with respect to each
element of section 110(a)(2), EPA is making an incompleteness finding.
    For those states that did not make any submittal, EPA is making a
finding of failure to submit with respect to all of the section
110(a)(2) SIP elements. For those states that did not make a submittal
that addressed all of the section 110(a)(2) elements, EPA is making
these findings only with respect to those specific section 110(a)(2)
SIP elements which a state has not certified that it has met, or not
made a SIP submission to meet, as of the signature date of this notice.
These findings establish a 24-month deadline for the promulgation by
EPA of a FIP, in accordance with section 110(c)(1). These findings of
failure to submit do not impose sanctions, or set deadlines for
imposing sanctions as described in section 179 of the CAA, because
these findings do not pertain to the elements of a Title I part D plan
for nonattainment areas as required under section 110(a)(2)(I), and
because this action is not a SIP call pursuant to section 110(k)(5).
    For states receiving an incompleteness finding for certain elements
in section 110(a)(2), EPA is also finding that the remaining elements
of section 110(a)(2) are complete. For states which EPA has not made
any findings of failure to submit for the section 110(a)(2) SIP
elements, EPA is by this action making a finding of completeness for
all elements. These full and partial completeness findings establish a
12-month deadline for EPA to take action upon such SIPs in accordance
with section 110(k).\3\
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    \3\ For those submissions that were made more than 6 months ago,
EPA's deadline to take action to approve those submissions is 18
months from the date of submittal.
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    This action will be effective on November 21, 2008.

A. Finding of Failure To Submit for States or Territories That Failed
To Make a Submittal

    The following states or territories failed to make a submittal to
satisfy the requirements of section 110(a)(2) as of the date of
signature of this notice. The effective date of this action starts a
24-month FIP clock for EPA to approve a SIP for the affected states or
territories that addresses section 110(a)(2) requirements, or for EPA
to finalize a FIP. The states and territories that are affected by this
finding of failure to submit are the following:

Region I: Vermont
Region VI: Oklahoma
Region VIII: North Dakota
Region IX: Hawaii, Guam, American Samoa, Commonwealth of the Northern
Mariana Islands
Region X: Alaska, Washington

B. Finding of Failure To Submit Specific Elements of Section 110(a)(2)

    The following states made submissions that address some, but not
all, of the section 110(a)(2) requirements as of the signature date of
this notice. EPA is by this action identifying the specific elements
for which states have not made a complete submission. The effective
date of this action starts a 24-month FIP clock for EPA to approve a
SIP for the affected states or territories that addresses these
specific section 110(a)(2) elements, or for EPA to finalize a FIP that
does so:
Region I
    Massachusetts: The State of Massachusetts has failed to submit a
SIP addressing section 110(a)(2)(C) and (J) pertaining to the Part C
PSD permit program. However, this requirement has already been
addressed by a FIP that remains in place, and therefore, this action
will not trigger any additional FIP obligations.
Region II
    New Jersey: The State of New Jersey has submitted a certification
letter which fails to address the contingency plans portion of the
section 110(a)(2)(G) element concerning emergency powers and adequate
contingency plans. Also, the State of New Jersey has failed to submit a
SIP addressing section 110(a)(2)(C) and (J) pertaining to the Part C
PSD permit program. However, this requirement has already been
addressed by a FIP that remains in place, and therefore, this action
will not trigger any additional FIP obligations.
    New York: The State of New York has submitted a certification
letter which fails to address the contingency plans portion of the
section 110(a)(2)(G) element concerning emergency powers and adequate
contingency plans. Also, the State of New York has failed to submit a
SIP addressing section 110(a)(2)(C) and (J) pertaining to the Part C
PSD permit program. However, this requirement has already been
addressed by a FIP that remains in place, and therefore, this action
will not trigger any additional FIP obligations.
    Puerto Rico: The Territory of Puerto Rico has submitted a
certification letter which fails to address the contingency plans
portion of the section 110(a)(2)(G) element concerning emergency powers
and adequate contingency plans. Also, the Territory of Puerto Rico has
failed to submit a SIP addressing section 110(a)(2)(C) and (J)
pertaining to the Part C PSD permit program. However, this requirement
has already been addressed by a FIP that remains in place, and
therefore, this action will not trigger any additional FIP obligations.
    Virgin Islands: The Territory of the Virgin Islands has submitted a
certification letter which fails to address the contingency plans
portion of the section 110(a)(2)(G) element concerning emergency powers
and adequate contingency plans. Also, the Territory of the Virgin
Islands has failed to submit a SIP addressing section 110(a)(2)(C) and
(J) pertaining to the Part C PSD permit program. However, this
requirement has already been addressed by a FIP that remains in place,
and therefore, this action will not trigger any additional FIP
obligations.
Region III
    Washington, DC: The District of Columbia has failed to submit a SIP
addressing section 110(a)(2)(C) and (J) pertaining to the Part C PSD
permit program. However, this requirement has already been addressed by
a FIP that remains in place, and therefore, this action will not
trigger any additional FIP obligations.
Region V
    Illinois: The State of Illinois has failed to submit a SIP
addressing section 110(a)(2)(C) and (J) pertaining to the Part C PSD
permit program. However, this requirement has already been addressed by
a FIP that remains in place, and therefore, this action will not
trigger any additional FIP obligations.
    Michigan: The State of Michigan has submitted a certification
letter which fails to address the contingency plans portion of the
section 110(a)(2)(G) element concerning emergency powers and adequate
contingency plans.
    Minnesota: The State of Minnesota has submitted a certification
letter which fails to address the contingency plans portion of the
section 110(a)(2)(G) element concerning emergency powers and adequate
contingency plans. Also, the State of Minnesota has failed to submit a
SIP addressing section

110(a)(2)(C) and (J) pertaining to the Part C PSD permit program.
However, this requirement has already been addressed by a FIP that
remains in place, and therefore, this action will not trigger any
additional FIP obligations.
    Wisconsin: The State of Wisconsin has submitted a certification
letter which fails to address the contingency plans portion of the
section 110(a)(2)(G) element concerning emergency powers and adequate
contingency plans.
Region IX
    Arizona: The State of Arizona has failed to submit a SIP addressing
section 110(a)(2)(C) and (J) pertaining to the Part C PSD permit
program. However, this requirement has already been addressed by a FIP
that remains in place, and therefore, this action will not trigger any
additional FIP obligations. Also, the State of Arizona has submitted a
certification letter which fails to address the section 110(a)(2)(E)(i)
and section 110(a)(2)(E)(ii) concerning the necessary assurances of
adequate resources and authority under state law and state compliance
with requirements respecting state boards. The State of Arizona has
submitted a certification letter which fails to address the section
110(a)(2)(G) element concerning emergency powers and adequate
contingency plans.
    California: The State of California has submitted a certification
letter which fails to address the section 110(a)(2)(G) element
concerning emergency powers and adequate contingency plans. The State
of California has failed to submit a SIP addressing section
110(a)(2)(C) and (J) pertaining to the Part C PSD permit program that
applies to some Air Districts within the State. However, this
requirement has already been addressed by a FIP that remains in place,
and therefore, this action will not trigger any additional FIP
obligations. All other areas of the state, exclusive of these Air
Districts have an approved PSD program in place.

C. States That Submitted Complete Submissions To Satisfy the Section
110(a)(2) Requirements

    The following states have been determined by EPA to have made
complete SIP submissions that address all of the section 110(a)(2)
requirements as of the signature date of this notice:

Region I: Connecticut, Maine, New Hampshire, Rhode Island
Region III: Delaware, Maryland, Pennsylvania, Virginia, West Virginia
Region IV: Alabama, Florida, Georgia, Kentucky, Mississippi, North
Carolina, South Carolina, Tennessee
Region V: Indiana, Ohio
Region VI: Arkansas, Louisiana, New Mexico, Texas
Region VII: Iowa, Kansas, Missouri, Nebraska
Region VIII: Colorado, Montana, South Dakota, Utah, Wyoming
Region IX: Nevada
Region X: Idaho, Oregon

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1230.3(b). This rule relates to the
requirement in the CAA for states to submit SIPs under section 110(a)
to satisfy certain infrastructure and general authority-related
elements required under section 110(a)(2) of the CAA for the 1997
PM2.5 NAAQS. Section 110(a)(1) of the CAA requires that
states submit SIPs that implement, maintain, and enforce a new or
revised NAAQS which satisfies the requirements of section 110(a)(2)
within 3 years of promulgation of such standard, or shorter period as
EPA may provide. The present action does not establish any new
information collection requirement apart from that already required by
law.

C. Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any action subject to
notice and comment rulemaking requirements under the Administrative
Procedures Act or any other statute unless the agency certifies that
the action will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For the purpose of assessing the impacts of this final action on
small entities, small entity is defined as: (1) A small business that
is a small industry entity as defined in the U.S. Small Business
Administration size standards (See 13 CFR 121); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which independently owned and operated is not dominate in
its field.
    After considering the economic impacts of this final action on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
action will not impose any requirements on small entities. This action
relates to the requirement in the CAA for states to submit SIPs under
section 110(a) to satisfy certain infrastructure and general authority-
related elements required under section 110(a)(2) of the CAA for the
1997 PM2.5 NAAQS. Section 110(a)(1) of the CAA requires that
states submit SIPs that implement, maintain, and enforce a new or
revised NAAQS which satisfies the requirements of section 110(a)(2)
within 3 years of promulgation of such standard, or shorter period as
EPA may provide.

D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action contains no Federal mandate under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-
1538 for state, local, and tribal governments and the private sector.
The action imposes no enforceable duty on any state, local or tribal
governments or the private sector. Therefore, this action is not
subject to the requirements of section 202 and 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This action relates
to the requirement in the CAA for states to submit SIPs under section
110(a) to satisfy certain infrastructure and general authority-related
elements required under section 110(a)(2) of the CAA for the 1997
PM2.5 NAAQS. Section 110(a)(1) of the CAA requires that
states submit SIPs that implement, maintain, and enforce a new or
revised NAAQS which satisfies the requirements of section 110(a)(2)
within 3 years of promulgation of such standard, or shorter period as
EPA may provide.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in

the Executive Order to include regulations that have ``substantial
direct effects on the states, or the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government.''
    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. The CAA establishes the scheme
whereby states take the lead in developing plans to meet the NAAQS.
This action will not modify the relationship of the states and EPA for
purposes of developing programs to implement the NAAQS. Thus, Executive
Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It does not have
a substantial direct effect on one or more Indian Tribes, because no
Tribe has implemented an air quality management program related to the
1997 PM2.5 NAAQS. Furthermore, this action does not affect
the relationship or distribution of power and responsibilities between
the Federal government and Indian Tribes. The CAA and the Tribal Air
Rule establish the relationship of the Federal government and Tribes in
developing plans to attain the NAAQS, and this rule does nothing to
modify that relationship. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it is making
findings concerning whether or not each state has submitted a complete
SIP that provides the basic program elements specified in CAA section
110(a)(2) necessary to implement the 1997 PM2.5 NAAQS. The
findings of failure to submit for all or a portion of a state's SIP
establish a 24-month deadline for EPA to promulgate FIPs to address the
outstanding SIP elements unless, prior to that time, the affected
states submit, and EPA approves, the required SIPs.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act
of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impracticable. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by VCS bodies. The
NTTAA directs EPA to provide Congress, through OMB, explanations when
the Agency decides not to use available and applicable VCS.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final action will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This notice is making a finding concerning whether each
state has submitted or failed to submit a complete SIP that provides
the basic program elements of section 110(a)(2) necessary to implement
the 1997 PM2.5 NAAQS.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the action in the Federal Register. A Major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This action will be effective November 21, 2008.

L. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the District of Columbia Circuit Court within 60 days from the days
from the date final action is published in the Federal Register. Filing
a petition for review by the Administrator of this final action does
not affect the finality of this action for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review must be final, and shall not postpone the effectiveness of such
action.
    Thus, any petitions for review of this action related to findings
of failure to submit related to the requirements of section 110(a) to
satisfy certain elements required under section 110(a)(2) of the CAA
for the 1997 PM2.5 NAAQS must be filed in the Court of
Appeals for the District of Columbia Circuit within 60 days from the
date final action is published in the Federal Register.

List of Subjects in 40 CFR Part 52

    Approval and promulgation of implementation plans, Environmental
protection, Administrative practice and procedures, Air pollution
control, Incorporation by reference, Intergovernmental relations, and
Reporting and recordkeeping requirements.

    Dated: October 3, 2008.
Robert J. Meyers,
Principal Deputy Assistant Administrator.
 [FR Doc. E8-25020 Filed 10-21-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Notices]
[Pages 38434-38436]
[FR Doc No: 2011-16397]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 3464743; File No. SR-ISE-2011-35]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Extend a Fee Discount Pilot Program for Large-Sized Foreign
Currency Options

 June 24, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 21, 2011, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change, as described in
Items I and II below, which items have been prepared by the self-
regulatory organization. The

Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to extend for an additional year the fee
discount for large-sized foreign currency (``FX'') option orders. The
text of the proposed rule change is available on the Exchange's Web
site (http://www.ise.com), at the principal office of the Exchange, and
at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to extend for an
additional year the fee discount for large-sized FX option orders. The
Exchange initially adopted the fee discount for large-sized FX option
orders in 2008.\3\ The fee discount pilot program was subsequently
extended \4\ and is now set to expire on June 30, 2011.\5\ The fee
discount applies to orders of 250 contracts or more and waives fees on
incremental volume above 250 contracts. Contracts at or under the
threshold are charged the constituent's prescribed execution fee. The
fee discount applies to all Customer \6\ orders, Firm Proprietary
orders, Market Maker orders and Non-ISE Market Maker orders in FX
options traded on the Exchange. ISE adopted this fee discount to
encourage members to execute large-sized FX option orders on the
Exchange in a manner that is cost effective. The Exchange now proposes
to extend this fee discount through June 30, 2012 in a continuing
effort to attract more activity in large-sized FX options.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 58139 (July 10,
2008), 73 FR 41142 (July 17, 2008) (SR-ISE-2008-54).
    \4\ See Securities Exchange Act Release No. 60192 (June 30,
2009), 74 FR 32211 (July 7, 2009) (SR-ISE-2009-42).
    \5\ See Securities Exchange Act Release No. 62506 (July 15,
2010), 75 FR 42801 (July 22, 2010) (SR-ISE-2010-67).
    \6\ The fee discount applies to both Professional and Priority
Customer orders. A Priority Customer is defined in ISE Rule
100(a)(37A) as a person or entity that is not a broker/dealer in
securities, and does not place more than 390 orders in listed
options per day on average during a calendar month for its own
beneficial account(s). A Professional Customer is a person who is
not a broker/dealer and is not a Priority Customer.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\7\ in general, and
furthers the objectives of Section 6(b)(4),\8\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. The Exchange believes the proposed rule change is
reasonable and equitable as it would extend a current fee discount,
thus effectively maintaining low fees for all market participants that
trade in large-sized FX options on the Exchange.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\ At any time within 60 days of the filing
of such proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal is
consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-ISE-2011-35 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-ISE-2011-35. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISE-2011-35 and should be
submitted on or before July 21, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-16397 Filed 6-29-11; 8:45 am]
BILLING CODE 8011-01-P


1975
                                     1980
                                     1985
                                     1990
                                     1994
                                     1998
                                     2002
                                     2006
                           5-Year Relative Survival
                                     81.8%
                                     83.9%
                                     86.1%
                                     89.2%
                                     88.8%
                                     90.9%
                                     92.9%
                                     92.8%
SEER 9 Incidence 1975-2011 & U.S. Mortality 1975-2010, All Races, Both Sexes. Rates are Age-Adjusted.

Béatrice Lauby-Secretan , Dana Loomis , Yann Grosse , Fatiha El Ghissassi , Véronique Bouvard , Lamia Benbrahim-Tallaa , Neela Guha , Robert Baan , Heidi Mattock , Kurt Straif , on behalf of the International Agency for Research on Cancer Monograph Working Group IARC, Lyon, France
In February 2013, 26 experts from 12 countries met at the International Agency for Research on Cancer (IARC), Lyon, France, to reassess the carcinogenicity of polychlorinated biphenyls (PCBs) and polybrominated biphenyls (PBBs). These assessments will be published as volume 107 of the IARC Monographs.1
PCBs are a class of aromatic compounds comprising 209 congeners, each containing one to ten chlorine atoms attached to a biphenyl nucleus. Technical PCB products, which were manufactured to obtain a specific level of chlorination, are mixtures of many PCB congeners. These products were widely used as dielectric fluid in capacitors and transformers, and to a lesser extent in building materials (eg, caulking, paints, and lighting ballasts). PCB production and new use were banned in most countries by the 1980s, but production has been reported recently in North Korea.
Earlier, occupational exposure was highest during manufacture of PCBs, transformers, and capacitors; today, exposure can come from demolition, dysfunction, or uncontrolled recycling of PCB-contaminated structures and equipment. PCBs are persistent and bioaccumulate; they have become ubiquitous environmental pollutants, including in polar regions and the deep ocean. Because of weathering and biotransformation, the PCB profiles noted in the environment or during biomonitoring differ from those of the commercial products. The general population is exposed mainly via food, mostly from contaminated animal fats; two major episodes of food poisoning took place in Japan and Taiwan, China, where cooking oil was accidentally contaminated with PCBs. Indoor air can also contribute to human exposure. Worldwide monitoring programmes have shown that PCBs are present in most samples of human milk.
PCB congeners can be categorised by their degree of chlorination, substitution pattern, and binding affinity to receptors. 12 congeners with a strong affinity for the aryl hydrocarbon receptor (AhR) are referred to as dioxin-like PCBs. PCBs are readily absorbed and distributed in the body, and accumulate in adipose tissue. Biotransformation of all PCB congeners starts with cytochrome P450-dependent mono-oxygenation. Low-chlorinated PCBs are readily metabolised into highly reactive electrophilic species (ie, arene oxides, quinones) which, in addition to producing DNA adducts and reactive oxygen species, are directly genotoxic and mutagenic.2 By contrast, highly chlorinated PCBs are poorly metabolised but, through induction of xenobiotic-metabolising enzymes, can also generate reactive oxygen species, lipid peroxidation, oxidative and alkylating DNA adducts, and can eventually cause genotoxic effects.
Individual PCBs activate numerous receptors, including AhR and the constitutive androstane and pregnane xenobiotic receptors (CAR/PXR). AhR activation is one of the key events linked to carcinogenesis mediated by dioxin-like PCBs. Sustained activation leads to deregulation of cell-cycle control and cell proliferation, inhibition of apoptosis, suppression of cell-to-cell communication and adhesion, and increased cell plasticity and invasiveness. Non-dioxin-like PCBs induce many of these effects via several AhR-independent mechanisms, including activation of the constitutive androstane and pregnane xenobiotic receptors, and perturbations in cell-to-cell communication and cell adhesion.
PCBs can compromise the immune surveillance mechanism. Highly chlorinated PCBs with a strong affinity for the AhR are potent immunotoxicants; less-chlorinated PCBs, which are less immunotoxic, act via AhR-independent mechanisms, including metabolic activation. Both low-chlorinated and high-chlorinated PCBs are associated with chronic inflammatory responses. Non-dioxin-like PCBs can stimulate the production of inflammatory mediators, whereas dioxin-like PCBs can inhibit such reaction. By contrast, some dioxin-like PCBs, but not non-dioxin-like PCBs, can compromise the normal function of the vascular endothelium.
PCBs target the endocrine system. Several models have shown direct modulation of nuclear steroid hormone-dependent gene expression by PCBs. Furthermore, depending on their structure, monohydroxylated PCB metabolites can act as oestrogen agonists or antagonists. These disruptions might have reproductive, toxic, and carcinogenic consequences.
The Working Group considered more than 70 independent epidemiological studies with informative data for carcinogenicity of PCBs in human beings. Excess risks for melanoma were reported in several studies, mainly cohort studies of workers in the manufacture of capacitors and transformers, and in electric power and equipment maintenance. A significant linear exposure -- response trend was noted in the largest study.3 In a population-based case-control study that assessed exposure with PCB serum levels, the association persisted after control for sun sensitivity and exposure.4 The association of melanoma and PCBs was noted consistently in occupational studies in different industries in North America and Europe, in studies of the general population, and with cohort and case-control designs. Thus, the Working Group concluded that there is sufficient evidence in humans for the carcinogenicity of PCBs. Notably, AhR can modulate melanogenesis,5 which lends mechanistic plausibility to this association. Increased risks for non-Hodgkin lymphoma and breast cancer were also reported, both of which are biologically plausible. However, the associations were not consistent and were considered as providing limited evidence. Data for cancers at other sites were too sparse to draw any conclusions.
The carcinogenicity of PCBs in animals has been assessed for individual congeners; binary mixtures of congeners; technical mixtures containing various congeners; and simulated environmental mixtures, with 2 year bioassays; studies with perinatal and postnatal exposure; and studies that examined the initiating and promoting activities of PCBs. Individual congeners (PCB118, PCB126) and several commercial products with a high chlorine content induced benign and malignant tumours of the liver, lung, and oral mucosa in rats; these studies provided sufficient evidence of carcinogenicity in experimental animals.6, 7 These congeners and mixtures include AhR agonists that exhibit dioxin-like activities, and CAR agonists.8 Other PCB congeners (PCB153) and low-chlorinated commercial products, which were less well studied than highly chlorinated products, showed limited evidence of carcinogenicity in experimental animals.9 The relative contributions of different PCB congeners to the carcinogenicity of the commercial mixtures are not known.
Overall, all PCBs can induce formation of reactive oxygen species, genotoxic effects, immune suppression, an inflammatory response, and endocrine effects to various extents and through different pathways. The dioxin-like PCBs exert their effects mainly through AhR activation and the downstream cascade of related events; less-chlorinated PCBs act more readily through metabolic activation and the downstream effects of these metabolites. Thus, mixtures might have more than additive effects.
On the basis of sufficient evidence of carcinogenicity in humans and experimental animals, the Working Group classified PCBs as carcinogenic to humans (Group 1). Additionally, dioxin-like PCBs were also classified in Group 1 on the basis of extensive evidence of an AhR-mediated mechanism of carcinogenesis that is identical to that of 2,3,7,8-tetrachlorodibenzo-para-dioxin, and sufficient evidence of carcinogenicity in experimental animals. However, the carcinogenicity of PCBs cannot be solely attributed to the carcinogenicity of the dioxin-like PCBs.
PBBs resemble PCBs, with bromine rather than chlorine atoms. PBBs were used mainly as flame retardants in the 1970s, but production has been discontinued in most countries for many years. One release of PBBs took place in Michigan, USA, where they were inadvertently distributed as cattle-feed supplement, contaminating many agricultural products. Similar to PCBs, PBBs are highly lipophilic, bioconcentrate and bioaccumulate, and are environmental contaminants worldwide. FireMaster FF-1, the most widely used commercial PBB product, consistently induced benign and malignant hepatocellular tumours in rats and mice, and cholangiocarcinomas in rats.10 PBBs, like their chlorinated analogues, are ligands to several cellular and nuclear receptors, including AhR. They are efficacious inducers of hepatic drug metabolism, accelerating the biotransformation of both endogenous and exogenous compounds. PBBs have various adverse effects including suppression of the immune system and disruption of normal hormone function. They are efficient promoters in two-stage rodent hepatocarcinogenesis bioassays. Although PBBs have received less attention and study, the available data indicate that PBB congeners exhibit their toxic effects and carcinogenic potential via many of the same pathways as their chlorinated counterparts. On the basis of these similarities with PCBs, and together with inadequate evidence for carcinogenicity in humans and sufficient evidence in experimental animals, PBBs were upgraded to Group 2A, probably carcinogenic to humans
References
1 IARC. IARC monographs on the evaluation of carcinogenic risks to humans, volume 107. Polychlorinated and polybrominated biphenyls. Lyon: International Agency for Research on Cancer (in press).
2 Ludewig G, Robertson LW. Polychlorinated biphenyls (PCBs) as initiating agents in hepatocellular carcinoma. Cancer Lett<PHONE_NUMBER>/j.canlet.2012.11.041. published online Dec 2. PubMed
3 Loomis D, Browning SR, Schenck AP, et al. Cancer mortality among electric utility workers exposed to polychlorinated biphenyls. Occup Environ Med 1997; 54: 720-728. PubMed
4 Gallagher RP, Macarthur AC, Lee TK, et al. Plasma levels of polychlorinated biphenyls and risk of cutaneous malignant melanoma: a preliminary study. Int J Cancer 2011; 128: 1872-1880. PubMed
5 Luecke S, Backlund M, Jux B, et al. The aryl hydrocarbon receptor (AHR), a novel regulator of human melanogenesis. Pigment Cell Melanoma Res 2010; 23: 828-833. PubMed
6 National Toxicology Program. NTP toxicology and carcinogenesis studies of 3,3′,4,4′,5-pentachlorobiphenyl (PCB 126) (CAS No. 57465-28-8) in female Harlan Sprague-Dawley rats (Gavage Studies). Natl Toxicol Program Tech Rep Ser 2006; 520: 4-246. PubMed
7 National Toxicology Program. NTP toxicology and carcinogenesis studies of 2,3′,4,4′,5-pentachlorobiphenyl (PCB 118) (CAS No. 31508-00-6) in female Harlan Sprague-Dawley rats (Gavage studies). Natl Toxicol Program Tech Rep Ser 2010; 559: 1-174. PubMed
8 Silberhorn EM, Glauert HP, Robertson LW. Carcinogenicity of polyhalogenated biphenyls: PCBs and PBBs. Crit Rev Toxicol 1990; 20: 440-496. PubMed
9 National Toxicology Program. NTP technical report on the toxicology and carcinogenesis studies of 2,2′,4,4′,5,5′-hexachlorobiphenyl (PCB 153) (CAS No. 35065-27-1) in female Harlan Sprague-Dawley rats (Gavage studies). Natl Toxicol Program Tech Rep Ser 2006; 529: 4-168. PubMed
10 National Toxicology Program. NTP toxicology and carcinogenesis studies of polybrominated biphenyls (CAS No. 67774-32-7) (Firemaster FF-1(R)) in F344/N Rats and B6C3F1 mice (Feed Studies). Natl Toxicol Program Tech Rep Ser 1993; 398: 1-235. PubMed


1 Screening Level Exposure Assessment for Residential Uses for ethylenediaminetetraacetic acid ( EDTA) ( CAS Reg. No. 60 00 4) and ethylenediaminetetraacetic acid, tetrasodium salt ( CAS Reg. No. 64 02 8)

EDTA and the tetrasodium salt both can be used in pesticide products although the tolerance exemptions specify use limitations.

EDTA and the tetrasodium salt can also be used in food contact surface sanitizing solutions.

EDTA has historically been used medically for the treatment of heavy metal poisoning. EDTA is also used as a chelating agent in boiler and cooling water, in nickel plating, and in wood pulping processes. EDTA is also in detergents for household and textile use, industrial germicides, metal cutting fluids, pharmaceuticals, cosmetics, and is used as a bleaching agent in color film processing, etching agent in metal finishing and semiconductor production, activator in butadiene styrene co polymerization, in gas scrubbing, and as a component of blood anticoagulants.

CEM Scenarios: Laundry detergent, General purpose cleaner, Cosmetics Other Scenarios: Food contact surface sanitizing solutions Weight fractions 50th percentile: 0.05 90th percentile: 0.05 EDTA Tetrasodium Salt CAS Number: 60 00 4 64 02 8 Molecular Weight: 292.245 380.17248 In CEM, a vapor pressure is needed to estimate inhalation exposure. The vapor pressures could not be located for either of these chemicals. However, the following was located:

° The vapor pressure of EDTA at 20 /

C was reported as negligible from one source ( Journal of Chemical Education; Vol. 79 No. 4 April 2002; JChemEd. chem. wisc. edu). ° An MSDS for " Formula 40" produced by Riverdale listed the vapor pressure of that product as less than 1 x 10 7 mm Hg @ 20 oC ( non volatile). Formula 40 contains 40 percent EDTA. ° No sources of vapor pressure information were located for the tetrasodium salt.

Based on this information, the value of 1 x 10 7 mm Hg was used as an approximate value for the vapor pressure for EDTA. Alternatively, the inhalation exposure could be removed from the EDTA report. Inhalation exposures were not evaluated for the tetrasodium salt. 2 Summary of Scenarios Used for EDTA Risk Assessments Use Scenario Summary of methodology/ sources General purpose cleaner Used CEM generic scenario with default parameters.

Laundry detergent Used CEM generic scenario with default parameters.

Cosmetics Used CEM user defined scenario with the following parameters: Amount retained on skin  1.9e 06 g/ cm2 event ( bar soap value from CEM) Years of Use  Used 50, based on scientific judgement Frequency of Use  365 days/ year ( upper 90th percentile frequency of use for foundations  EFH, 1999) Surface Area to Body Weight Ratio  calculated from values in EFH, 1999  half of mean adult female head surface area divided by mean adult female body weight.

Food contact surface sanitizing solutions Inhalation and dermal exposure estimates are the same as those for general purpose cleaners. Ingestion exposure calculated based on the assumption that food contact surface sanitizing solutions can include products such as dish washing detergents. See page 11 for details.

Summary of Scenarios Used for EDTA ( Tetrasodium Salt) Risk Assessments Use Scenario Summary of methodology/ sources General purpose cleaner Used CEM generic scenario with default parameters. Removed inhalation exposure scenario because no vapor pressure information was available. Product assumed to not be volatile.

Laundry detergent Used CEM generic scenario with default parameters. Removed inhalation exposure scenario because no vapor pressure information was available. Product assumed to not be volatile.

Cosmetics Followed same procedure as described above for EDTA.

Food contact surface sanitizing solutions Followed same procedure as described above for EDTA.

Reference:

U. S. EPA, 1999. Exposure Factors Handbook ( EFH). Office of Research and Development, Washington, D. C. EPA/ 600/ C 99/ 001. 3 Ethylenediaminetetraacetic Acid ( EDTA) ( CAS Reg. No. 60 00 4)

Use Scenario: General Purpose Cleaner CEM Inputs ID Number: EDTA, 1 Product: EDTA Chemical Name: None Scenario: General Purpose Cleaner Population: Adult Molecular Weight ( g/ mole): 292.2 Vapor Pressure ( torr): 1e 07 Weight Fraction  Median ( unitless): 0.05 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs Frequency of Use ( events/ yr): 300 Years of Use: 57 Mass of Product Used per Event  Median ( g): 61.5 Mass of Product Used per Event  90% ( g): 123 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.667 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 1.42 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111221542467422744411 Start Time: 7 Non User: Room of Use: 2. Kitchen Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 300 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 3.6e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADRpot, Cppot ( days) : 1.00e+ 00 4 CEM Inhalation Exposure Estimates ID Number: EDTA, 1 Scenario: General Purpose Cleaner Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 8.90e 05 2.74e+ 04 LADCpot ( mg/ m3) 4.84e 04 2.74e+ 04 Acute ADRpot ( mg/ kg day) 6.31e 06 1.00e+ 00 Cppot ( mg/ m3) 7.30e 05 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 5 CEM Dermal Exposure Estimates ID Number: EDTA, 1 Scenario: General Purpose Cleaner Population: Adult Years of Use ( years): 57 SA/ BW Body ( cm2/ kg): 15.6 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.75e 02 2.74e+ 04 Acute ADRpot ( mg/ kg day) 2.81e 02 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADR  Acute Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 6 Ethylenediaminetetraacetic Acid ( EDTA) ( CAS Reg. No. 60 00 4)

Use Scenario: Laundry Detergent CEM Inputs ID Number: EDTA, 2 Product: EDTA Chemical Name: None Scenario: Laundry Detergent Population: Adult Molecular Weight ( g/ mole): 292.2 Vapor Pressure ( torr): 1e 07 Weight Fraction  Median ( unitless): 0.05 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs Frequency of Use ( events/ yr): 312 Years of Use: 57 Mass of Product Used per Event  Median ( g): 200 Mass of Product Used per Event  90% ( g): 400 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.333 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 0.667 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111235542467422744411 Start Time: 9 Non User: Room of Use: 5. Utility Room Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 52 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 1.13e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADRpot, Cppot ( days) : 1.00e+ 00 7 CEM Inhalation Exposure Estimates ID Number: EDTA, 2 Scenario: Laundry Detergent ( Machine Washing) Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 312 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 8.23e 08 2.74e+ 04 LADCpot ( mg/ m3) 4.47e 07 2.74e+ 04 Acute ADRpot ( mg/ kg day) 5.13e 07 1.00e+ 00 Cppot ( mg/ m3) 7.16e 05 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 8 CEM Dermal Exposure Estimates ID Number: EDTA, 2 Scenario: Laundry Detergent ( Hand Washing) Population: Adult Years of Use ( years): 57 SA/ BW Body ( cm2/ kg): 15.6 Frequency of Use ( events/ year): 52 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 9.54e 04 2.74e+ 04 Acute ADRpot ( mg/ kg day) 8.81e 03 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADR  Acute Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 9 Ethylenediaminetetraacetic Acid ( EDTA) ( CAS Reg. No. 60 00 4)

Use Scenario: Cosmetics CEM Inputs ID Number: EDTA, C, 1 Product: Cosmetics Chemical Name: Cosmetic Scenario: User Defined Population: Adult Molecular Weight ( g/ mole): 0 Weight Fraction  Median ( unitless): 0.05 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs There are no Inhalation inputs for this scenario.

Activity Patterns There are no Activity Patterns for this scenario.

Dermal Inputs Frequency of Use  Body ( events/ yr): 365 SA/ BW  Body ( cm2/ kg): 8.41 Amount Retained/ Absorbed to Skin ( g/ cm2 event): 1.9e 06 Avg. Time, LADD ( days): 2.74e+ 04 Avg. Time, ADR ( days): 1.00e+ 00 10 CEM Dermal Exposure Estimates ID Number: EDTA, C, 1 Scenario: User Defined Population: Adult Years of Use ( years): 50 SA/ BW Body ( cm2/ kg): 8.41 Frequency of Use ( events/ year): 365 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 5.33e 04 2.74e+ 04 Acute ADRpot ( mg/ kg day) 7.99e 04 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADR  Acute Potential Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 11 Ethylenediaminetetraacetic Acid ( EDTA) ( CAS Reg. No. 60 00 4)

Use Scenario: Food contact surface sanitizing solutions The inhalation and dermal exposure estimates for food contact surface sanitizing solutions would be the same as those for general purpose cleaners. However, food contact surface sanitizing solutions also have the potential exposure pathway of ingestion. Based on the assumption that food contact surface sanitizing solutions can include products such as dish washing detergents, the following method was used to estimate exposure:

Potential Dose Rate ( PDR) = DD * SA * WF * TF, where:

DD = Deposition of product on Dishes = 0.0018 mg/ cm2 ( MRI, 1979) SA = Surface Area of all silverware, china, and glass used by a consumer for 3 meals = 4000 cm2 ( FDA, 2003) WF = Weight Fraction of EDTA in product = 0.05 TF = Transfer Factor = assumed to be 100% ( worst case)

Based on these inputs, the PDR is 0.36 mg/ day.

Normalized PDR ( PDR norm ) = PDR / BW, where:

BW = Body Weight = 71.8 kg ( EFH, 1999)

Based on this body weight, the PDR norm is 0.005 mg/ kg/ day.

Lifetime Average Daily Dose ( LADD) = PDR norm * ED * EF / ( AT * 365 days/ yr), where:

ED = Exposure Duration = 52 years ( EFH, 1999) EF = Exposure Frequency = 365 events/ year ( Versar, 1986) AT = Averaging Time = 70 years ( EFH, 1999)

Based on these inputs, the LADD is 3.7x10 3 mg/ kg/ day.

References:

April, 2003. http:// www. cfsan. fda. gov/~ dms/ opa cg3a. html. Last accessed June 9, 2003.

MRI, 1979. Chemical technology and economics in environmental perspective. Task IV Potential worker and consumer exposure to nitrilotriacetic acid ( NTA) in detergents. Midwest Research Institute. Washington, D. C.: Environmental Protection Agency. PB 297 753.

Versar, 1986. Standard Scenarios for Estimating Exposure to Chemical Substances During Use of Consumer Products. Volume 1. Washington, D. C.: Office of Pesticides and Toxic Substances, U. S. Environmental Protection Agency. EPA 68 02 3968. 12 13 Ethylenediaminetetraacetic Acid, Tetrasodium Salt ( CAS Reg. No. 64 02 8)

Use Scenario: General Purpose Cleaner CEM Inputs ID Number: EDTA Salt Product: Cleaner Chemical Name: EDTA, Tetrasodium Salt Scenario: General Purpose Cleaner Population: Adult Molecular Weight ( g/ mole): 380.2 Vapor Pressure ( torr): Not available Weight Fraction  Median ( unitless): 0.05 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs Frequency of Use ( events/ yr): 300 Years of Use: 57 Mass of Product Used per Event  Median ( g): 61.5 Mass of Product Used per Event  90% ( g): 123 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.667 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 1.42 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111221542467422744411 Start Time: 7 Non User: Room of Use: 2. Kitchen Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 300 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 3.6e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADRpot, Cppot ( days) : 1.00e+ 00 14 CEM Dermal Exposure Estimates ID Number: EDTA Salt Scenario: General Purpose Cleaner Population: Adult Years of Use ( years): 57 SA/ BW Body ( cm2/ kg): 15.6 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.75e 02 2.74e+ 04 Acute ADRpot ( mg/ kg day) 2.81e 02 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADR  Acute Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 15 Ethylenediaminetetraacetic Acid, Tetrasodium Salt ( CAS Reg. No. 64 02 8)

Use Scenario: Laundry Detergent CEM Inputs ID Number: EDTA Salt Product: Detergent Chemical Name: EDTA, Tetrasodium Salt Scenario: Laundry Detergent Population: Adult Molecular Weight ( g/ mole): 380.2 Vapor Pressure ( torr): 1e 07 Weight Fraction  Median ( unitless): 0.05 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs Frequency of Use ( events/ yr): 312 Years of Use: 57 Mass of Product Used per Event  Median ( g): 200 Mass of Product Used per Event  90% ( g): 400 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.333 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 0.667 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111235542467422744411 Start Time: 9 Non User: Room of Use: 5. Utility Room Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 52 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 1.13e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADRpot, Cppot ( days) : 1.00e+ 00 16 CEM Dermal Exposure Estimates ID Number: EDTA Salt Scenario: Laundry Detergent ( Hand Washing) Population: Adult Years of Use ( years): 57 SA/ BW Body ( cm2/ kg): 15.6 Frequency of Use ( events/ year): 52 Exposure Units Result AT ( days)

Chronic Cancer LADD pot ( mg/ kg day) 9.54e 04 2.74e+ 04 Acute ADRpot ( mg/ kg day) 8.81e 03 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADR  Acute Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 17 Ethylenediaminetetraacetic Acid ( EDTA) ( CAS Reg. No. 60 00 4)

Use Scenario: Cosmetics CEM Inputs ID Number: EDTA, C, 1 Salt Product: Cosmetics Chemical Name: Cosmetic Scenario: User Defined Population: Adult Molecular Weight ( g/ mole): 0 Weight Fraction  Median ( unitless): 0.05 Weight Fraction  90% ( unitless): 0.05 Inhalation Inputs There are no Inhalation inputs for this scenario.

Activity Patterns There are no Activity Patterns for this scenario.

Dermal Inputs Frequency of Use  Body ( events/ yr): 365 SA/ BW  Body ( cm2/ kg): 8.41 Amount Retained/ Absorbed to Skin ( g/ cm2 event): 1.9e 06 Avg. Time, LADD ( days): 2.74e+ 04 Avg. Time, ADR ( days): 1.00e+ 00 18 CEM Dermal Exposure Estimates ID Number: EDTA, C, 1 Salt Scenario: User Defined Population: Adult Years of Use ( years): 50 SA/ BW Body ( cm2/ kg): 8.41 Frequency of Use ( events/ year): 365 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 5.33e 04 2.74e+ 04 Acute ADRpot ( mg/ kg day) 7.99e 04 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADR  Acute Potential Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 19 Ethylenediaminetetraacetic Acid, Tetrasodium Salt ( CAS Reg. No. 64 02 8)

Use Scenario: Food contact surface sanitizing solutions The inhalation and dermal exposure estimates for food contact surface sanitizing solutions would be the same as those for general purpose cleaners. However, food contact surface sanitizing solutions also have the potential exposure pathway of ingestion. Based on the assumption that food contact surface sanitizing solutions can include products such as dish washing detergents, the same method used for EDTA ( shown on page 11 of this report) would be used to estimate exposure to the tetrasodium salt. All of the inputs are the same, therefore, the results remain the same. See page 11 for calculations.

Potential Dose Rate ( PDR) = 0.36 mg/ day.

Normalized PDR ( PDR norm ) = 0.005 mg/ kg/ day.

Lifetime Average Daily Dose ( LADD) = 3.7x10 3 mg/ kg/ day.


[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Rules and Regulations]
[Pages 48650-48651]
[FR Doc No: 2020-15826]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2018-F-3347]

Food Additives Permitted in Feed and Drinking Water of Animals;
Chromium Propionate

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of chromium
propionate.

DATES: This rule is effective August 12, 2020.

FOR FURTHER INFORMATION CONTACT: Chelsea Cerrito, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224),
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the regulations for food
additives permitted in feed and drinking water of animals at 21 CFR
573.304 Chromium Propionate to more accurately reflect the approved
conditions for the safe use of chromium propionate in horses.
    Publication of this document constitutes final action under the
Administrative Procedure Act (5 U.S.C. 704). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes to correct an inaccurate
statement and is nonsubstantive.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
Public Health Service Act, and under the authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 573 is amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
1. The authority citation for part 573 continues to read as follows:

    Authority:  21 U.S.C. 321, 342, 348.

Sec.  573.304  [Amended]

0
2. In Sec.  573.304, in paragraphs (d)(1) and (e)(1), remove the word
``complete''.

    Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15826 Filed 8-11-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 9, 2010 (Volume 75, Number 26)]
[Notices]
[Page 6433]
[DOCID:fr09fe10-116]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of a Draft Environmental Assessment and
Public Information Workshop for the Proposed ORD Airport
Surveillance Radar, Model 9, West Chicago, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Availability of a Draft Environmental Assessment and
Public Information Workshop for the Proposed ORD Airport Surveillance
Radar, Model 9, West Chicago, Illinois.

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

SUMMARY: The Federal Aviation Administration (FAA) proposes to fund,
construct, and operate an Airport Surveillance Radar, Model 9 (ASR-9)
to serve the western airspace of O'Hare International Airport (ORD),
Chicago, IL. The FAA's preferred alternative is to install the ASR-9 at
a site near the corner of Kress and Western Roads on the southeast side
of DuPage Airport, in western DuPage County. The purpose and need of
the ASR-9 is to enhance air traffic management for ORD to achieve the
benefits of providing expanded radar coverage that would allow terminal
air traffic control for additional new approach routes, as evaluated
and approved in the O'Hare Modernization Environmental Impact
Statement/Record of Decision.
    The FAA has prepared a Draft Environmental Assessment (EA) document
in conformance with requirements of the National Environmental Policy
Act (NEPA) and FAA Order 1050.1E, Environmental Impacts: Policies and
Procedures. The Draft EA analyzes the potential environmental effects
that may result from the construction and operation of the ASR-9. The
impacts of the radar are evaluated at the proposed Kress and Western
site and alternative sites, including the no action alternative (i.e.,
not installing the ASR-9). A copy of the Draft EA is available for
public review at the following locations:

West Chicago Public Library, 118 West Washington St., West Chicago, IL;
St. Charles Public Library, 1 South Sixth Ave., St. Charles, IL;
Geneva Public Library, 127 James St., Geneva, IL;
DuPage Airport, 2700 International Drive, West Chicago, IL.

The FAA will host a Public Information Meeting on Thursday, March 11,
2010 from 4 p.m. to 8 p.m. at: Hilton Garden Inn St. Charles, 4070 East
Main Street, Saint Charles, IL. The public is invited to attend the
meeting.

ADDRESSES: The FAA will accept written comments on the Draft EA until
close of business on March 26, 2010. Comments on the Draft EA will be
accepted at the meeting or may be sent to: Ms. Virginia Marcks, FAA,
AJW-C14D, 2300 East Devon Ave., Des Plaines, IL 60018, fax 847-294-
7698, e-mail<EMAIL_ADDRESS>Copies of the Draft EA may be
obtained by contacting Ms. Virginia Marcks. Comments received on the
Draft EA during the public comment period will be addressed in a Final
EA.

FOR FURTHER INFORMATION CONTACT: Ms. Virginia Marcks, Manager,
Infrastructure Engineering Center, Federal Aviation Administration,
2300 East Devon Avenue, Des Plaines, Illinois 60018. Telephone number:
847-294-7494. E-mail<EMAIL_ADDRESS>
    Issued in Des Plaines, Illinois February 1, 2010.
Virginia Marcks,
Manager, Infrastructure Engineering Center, Chicago, AJW-C14D, Central
Service Area.
[FR Doc. 2010-2710 Filed 2-8-10; 8:45 am]
BILLING CODE 4910-13-P