[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Rules and Regulations]
[Pages 56114-56115]
[FR Doc No: 2011-23134]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0733; FRL-9462-1]

Interim Final Determination to Stay and Defer Sanctions, San
Joaquin Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

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SUMMARY: EPA is making an interim final determination to stay the
imposition of offset sanctions and to defer the imposition of highway
sanctions based on a proposed approval of revisions to the San Joaquin
Valley Unified Air Pollution Control District (SJVUAPCD) portion of the
California State Implementation Plan (SIP) published elsewhere in this
Federal Register. The revisions concern SJVUAPCD Rule 4684, Polyester
Resin Operations.

DATES: This interim final determination is effective on September 12,
2011. However, comments will be accepted until October 12, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0733, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment.
    Docket: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: David Grounds, EPA Region IX, (415)
972-3019<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

I. Background

    On January 26, 2010 (75 FR 3996), we published a limited approval
and limited disapproval of SJVUAPCD Rule 4684, as adopted locally on
September 20, 2007 and submitted by the State on March 7, 2008. We
based our limited disapproval action on certain deficiencies in the
submittal. This disapproval action started a sanctions clock for
imposition of sanctions pursuant to section 179 of the Clean Air Act
(CAA) and our regulations at 40 CFR 52.31. Under 40 CFR 52.31(d)(1),
offset sanctions apply eighteen months after the effective date of a
disapproval and highway sanctions apply six months after the offset
sanctions, unless we determine that the deficiencies forming the basis
of the disapproval have been corrected.
    On August 18, 2011, SJVUAPCD adopted revisions to Rule 4684 that
were intended to correct the deficiencies identified in our limited
disapproval action. On July 22, 2011, the State submitted a proposed
rule with request for parallel processing to EPA. In the Proposed Rules
section of today's Federal Register, we have proposed full approval of
the rule once we receive the final adopted version as a revision to the
California SIP because we believe it corrects the deficiencies for
SJVUAPCD Rule 4684 identified in our January 26, 2010 disapproval
action. Based on today's proposed approval, we are taking this final
rulemaking action, effective on publication, to stay the imposition of
the offset sanctions and to defer the imposition of the highway
sanctions triggered by our January 26, 2010 limited disapproval. This
action only addresses SJVUAPCD Rule 4684.

SJVUAPCD Rules 4401 and 4605, Steam-Enhanced Crude Oil Production Wells
and Aerospace Assembly and Component Coating Operations, which were
also determined to be deficient in our January 26, 2010 limited
disapproval action, and the associated sanctions clocks, are being
addressed in a separate action.
    EPA is providing the public with an opportunity to comment on this
stay/deferral of sanctions. If comments are submitted that change our
assessment described in this final determination and the proposed full
approval of revised SJVUAPCD Rules 4684, we intend to take subsequent
final action to reimpose sanctions pursuant to 40 CFR 51.31(d). If no
comments are submitted that change our assessment, then all sanctions
and sanction clocks will be permanently terminated on the effective
date of a final rule approval.

II. EPA Action

    We are making an interim final determination to stay the imposition
of the offset sanctions and to defer the imposition of the highway
sanctions associated with SJVUAPCD Rule 4684 based on our concurrent
proposal to approve the State's SIP revision as correcting deficiencies
that initiated sanctions.
    Because EPA has preliminarily determined that the State has
corrected the deficiencies identified in EPA's limited disapproval
action, relief from sanctions should be provided as quickly as
possible. Therefore, EPA is invoking the good cause exception under the
Administrative Procedure Act (APA) in not providing an opportunity for
comment before this action takes effect (5 U.S.C. 553(b)(3)). However,
by this action EPA is providing the public with a chance to comment on
EPA's determination after the effective date, and EPA will consider any
comments received in determining whether to reverse such action.
    EPA believes that notice-and-comment rulemaking before the
effective date of this action is impracticable and contrary to the
public interest. EPA has reviewed the State's submittal and, through
its proposed action, is indicating that it is more likely than not that
the State has corrected the deficiencies that started the sanctions
clocks. Therefore, it is not in the public interest to initially impose
sanctions or to keep applied sanctions in place when the State has most
likely done all it can to correct the deficiencies that triggered the
sanctions clocks. Moreover, it would be impracticable to go through
notice-and-comment rulemaking on a finding that the State has corrected
the deficiencies prior to the rulemaking approving the State's
submittal. Therefore, EPA believes that it is necessary to use the
interim final rulemaking process to stay and defer sanctions while EPA
completes its rulemaking process on the approvability of the State's
submittal. Moreover, with respect to the effective date of this action,
EPA is invoking the good cause exception to the 30-day notice
requirement of the APA because the purpose of this notice is to relieve
a restriction (5 U.S.C. 553(d)(1)).

III. Statutory and Executive Order Reviews

    This action stays and defers Federal sanctions and imposes no
additional requirements.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget.
    This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action.
    The administrator certifies that this action will not have
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
    This rule does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule does not have tribal implications because it will not
have a substantial direct effect on one or more Indian tribes, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
    This action does not have Federalism implications because it does
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 (64 FR 43255, August 10, 1999).
    This rule is not subject to Executive Order 13045, ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. Sec.  272) do not apply
to this rule because it imposes no standards.
    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
    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 to Congress and the Comptroller
General. However, section 808 provides that any rule for which the
issuing agency for good cause finds that notice and public procedure
thereon are impracticable, unnecessary, or contrary to the public
interest, shall take effect at such time as the agency promulgating the
rule determines. 5 U.S.C. 808(2). EPA has made such a good cause
finding, including the reasons therefor, and established an effective
date of September 12, 2011. EPA will submit a report containing this
rule 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 rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    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 appropriate circuit by November 14, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purpose of judicial review nor does
it extend the time within which petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental regulations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: August 31, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-23134 Filed 9-9-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6889-6894]
[DOCID:fr11fe09-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0030]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements under which the
clinical investigation of the safety and effectiveness of unapproved
new drugs and biological products can be conducted.

DATES: Submit written or electronic comments on the collection of
information by April 13, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Investigational New Drug Regulations--21 CFR Part 312 (OMB Control
Number 0910 0014)--Extension

    FDA is requesting OMB approval for the reporting and recordkeeping
requirements contained in FDA's regulations ``Investigational New Drug
Application'' in part 312 (21 CFR part 312). Part 312 implements
provisions of section 505(i) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355(i)) to issue regulations under which the
clinical investigation of the safety and effectiveness of unapproved
new drugs and biological products can be conducted.
    FDA is charged with implementing statutory requirements that drug
products marketed in the United States be shown to be safe and
effective, properly manufactured, and properly labeled for their
intended uses. Section 505(a) of the act provides that a new drug may
not be introduced or delivered for introduction into interstate
commerce in the United States unless FDA has previously approved a new
drug application (NDA). FDA approves an NDA only if the sponsor of the
application first demonstrates that the drug is safe and effective for
the conditions prescribed, recommended, or suggested in the product's
labeling. Proof must consist, in part, of adequate and well-controlled
studies, including studies in humans, that are conducted by qualified
experts. The Investigational New Drug (IND) regulations establish
reporting requirements that include an initial application as well as
amendments to that application, reports on significant revisions of
clinical investigation plans, and information on a drug's safety or
effectiveness. In addition, the sponsor is required to give FDA an
annual summary of the previous year's clinical experience. Submissions
are reviewed by medical officers and other agency scientific reviewers
assigned responsibility for overseeing the specific study. The IND
regulations also contain recordkeeping requirements that pertain to the
responsibilities of sponsors and investigators. The detail and
complexity of these requirements are dictated by the scientific
procedures and human subject safeguards that must be followed in the
clinical tests of investigational new drugs.
    The IND information collection requirements provide the means by
which FDA can do the following: (1) Monitor the safety of ongoing
clinical investigations; (2) determine whether the clinical testing of
a drug should be authorized; (3) ensure production of reliable data on
the metabolism and pharmacological action of the drug in humans; (4)
obtain timely information on adverse reactions to the drug; (5) obtain
information on side effects associated with increasing doses; (6)
obtain information on the drug's effectiveness; (7) ensure the design
of well-controlled, scientifically valid studies; and (8) obtain other
information pertinent to determining whether clinical testing should be
continued and information related to the protection of human subjects.
Without the information provided by industry in response to the IND
regulations, FDA cannot authorize or monitor the clinical
investigations which must be conducted prior to authorizing the sale
and general use of new drugs. These reports enable FDA to monitor a
study's progress, assure subject safety, assure that a study will be
conducted ethically, and increase the likelihood that the sponsor will
conduct studies that will be useful in determining whether the drug
should be marketed and available for use in medical practice.
    There are two forms that are required under part 312:
    The first form is Form FDA-1571--``Investigational New Drug
Application.'' A person who intends to conduct a clinical investigation
submits this form to FDA. It includes the following information: (1) A
cover sheet containing background information on the sponsor and
investigator; (2) a table of contents; (3) an introductory

statement and general investigational plan; (4) an investigator's
brochure describing the drug substance; (5) a protocol for each planned
study; (6) chemistry, manufacturing, and control information for each
investigation; (7) pharmacology and toxicology information for each
investigation; and (8) previous human experience with the
investigational drug.
    The second form is Form FDA-1572--``Investigator Statement.''
Before permitting an investigator to begin participation in an
investigation, the sponsor must obtain and record this form. It
includes background information on the investigator and the
investigation, and a general outline of the planned investigation and
the study protocol.
    FDA is requesting OMB approval for the following reporting and
recordkeeping requirements in part 312:

  Table 1--Reporting and Recordkeeping Requirements in 21 CFR Part 312
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                         REPORTING REQUIREMENTS
-------------------------------------------------------------------------
          21 CFR Section                        Requirements
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312.7(d)..........................  Applications for permission to sell
                                     an investigational new drug

312.80............................  Charging for investigational drugs
                                     under an IND

312.10............................  Applications for waiver of
                                     requirements under part 312; as
                                     indicated in Sec.   312.10(a),
                                     estimates for this requirement are
                                     included under Sec.  Sec.   312.23
                                     and 312.31. In addition, separate
                                     requests under Sec.   312.10 are
                                     estimated in table 2 of this
                                     document.

312.20(c).........................  Applications for investigations
                                     involving an exception from
                                     informed consent under Sec.   50.24
                                     (21 CFR 50.24); estimates for this
                                     requirement are included under Sec.
                                       312.23.

312.23............................  INDs (content and format)
  (a)(1)..........................    Cover sheet FDA-1571
  (a)(2)..........................    Table of contents
  (a)(3)..........................    Investigational plan for each
                                    planned study
  (a)(5)..........................    Investigator's brochure
  (a)(6)..........................    Protocols--Phases 1, 2, and 3
  (a)(7)..........................    Chemistry, manufacturing, and
                                    control information
  (a)(7)(iv)(a), (b), and (c).....    A description of the drug
                                    substance, a list of all components,
                                    and any placebo used
  (a)(7)(iv)(d)...................    Labeling: Copies of labels and
                                    labeling to be provided each
                                    investigator
  (a)(7)(iv)(e)...................    Environmental impact analysis
                                    regarding drug manufacturing and use
  (a)(8)..........................    Pharmacological and toxicology
                                    information
  (a)(9)..........................    Previous human experience with the
                                    investigational drug
  (a)(10).........................    Additional information
  (a)(11).........................    Relevant information
  (f).............................    Identification of exception from
                                    informed consent

312.30............................  Protocol amendments
  (a).............................    New protocol
  (b).............................    Change in protocol
  (c).............................    New investigator
  (d).............................    Content and format
  (e).............................    Frequency

312.31............................  Information amendments
  (b).............................    Content and format
                                    Chemistry, toxicology, or technical
                                     information

312.32............................  Safety reports
  (c)(1)..........................    Written reports to FDA and to
                                    investigators
  (c)(2)..........................    Telephone reports to FDA for fatal
                                    or life-threatening experience
  (c)(3)..........................    Format or frequency
  (d).............................    Followup submissions

312.33............................  Annual reports
  (a).............................    Individual study information
  (b).............................    Summary information
  (b)(1)..........................    Adverse experiences
  (b)(2)..........................    Safety report summary
  (b)(3)..........................    List of fatalities and causes of
                                    death
  (b)(4)..........................    List of discontinuing subjects
  (b)(5)..........................    Drug action
  (b)(6)..........................    Preclinical studies and findings
  (b)(7)..........................    Significant changes
  (c).............................    Next year general investigational
                                    plan
  (d).............................    Brochure revision
  (e).............................    Phase I protocol modifications
  (f).............................    Foreign marketing developments

312.35............................  Treatment use of investigational new
                                     drugs
  (a).............................    Treatment protocol submitted by
                                    IND sponsor
  (b).............................    Treatment IND submitted by
                                    licensed practitioner

312.36............................  Requests for emergency use of an
                                     investigational new drug

312.38(b) and (c).................  Notification of withdrawal of an IND

312.42(e).........................  Sponsor requests that a clinical
                                     hold be removed and submits a
                                     complete response to the issues
                                     identified in the clinical hold
                                     order

312.44(c) and (d).................  Opportunity for sponsor response to
                                     FDA when IND is terminated

312.45(a) and (b).................  Sponsor request for, or response to,
                                     inactive status determination of an
                                     IND

312.47(b).........................  ``End-of-Phase 2'' meetings and
                                     ``Pre-NDA'' meetings

312.53(c).........................  Investigator information;
                                     investigator report (Form FDA-1572)
                                     and narrative; investigator's
                                     background information; Phase 1
                                     outline of planned investigation;
                                     and Phase 2 outline of study
                                     protocol

312.54(a) and (b).................  Sponsor submissions concerning
                                     investigations involving an
                                     exception from informed consent
                                     under Sec.   50.24

312.55(b).........................  Sponsor reports to investigators on
                                     new observations, especially
                                     adverse reactions and safe use;
                                     only ``new observations'' are
                                     estimated under this section;
                                     investigator brochures are included
                                     under Sec.   312.23

312.56(b), (c), and (d)...........  Sponsor monitoring of all clinical
                                     investigations, investigators, and
                                     drug safety; notification to FDA

312.58(a).........................  Sponsor's submission of records to
                                     FDA on request

312.64............................  Investigator reports to the sponsor
  (a).............................    Progress reports
  (b).............................    Safety reports
  (c).............................    Final reports

312.66............................  Investigator reports to
                                     Institutional Review Board;
                                     estimates for this requirement are
                                     included under Sec.   312.53

312.70(a).........................  Investigator disqualification;
                                     opportunity to respond to FDA

312.83............................  Sponsor submission of treatment
                                     protocol; estimates for this
                                     requirement are included under Sec.
                                      Sec.   312.34 and 312.35

312.85............................  Sponsors conducting Phase 4 studies;
                                     estimates for this requirement are
                                     included under Sec.   312.23 in
                                     0910-0014, and Sec.  Sec.   314.50,
                                     314.70, and 314.81 in 0910-0001

312.110(b)........................  Request to export an investigational
                                     drug

312.120...........................  Submissions related to foreign
                                     clinical studies not conducted
                                     under an IND

312.130(d)........................  Request for disclosable information
                                     for investigations involving an
                                     exception from informed consent
                                     under Sec.   50.24
------------------------------------------------------------------------

------------------------------------------------------------------------
                       RECORDKEEPING REQUIREMENTS
-------------------------------------------------------------------------
          21 CFR Section                        Requirements
------------------------------------------------------------------------
312.52(a).........................  Transfer of obligations to a
                                     contract research organization

312.57............................  Sponsor recordkeeping

312.59............................  Sponsor recordkeeping of disposition
                                     of unused supply of drugs;
                                     estimates for this requirement are
                                     included under Sec.   312.57

312.62(a).........................  Investigator recordkeeping of
                                     disposition of drugs

312.62(b).........................  Investigator recordkeeping of case
                                     histories of individuals

312.120(d)........................  Recordkeeping requirements for
                                     submissions related to foreign
                                     clinical studies not conducted
                                     under an IND; estimates for this
                                     requirement are included under Sec.
                                       312.57

312.160(a)(3).....................  Records maintenance: shipment of
                                     drugs for investigational use in
                                     laboratory research animals or in
                                     vitro tests

312.160(c)........................  Shipper records of alternative
                                     disposition of unused drugs
------------------------------------------------------------------------

    In tables 2 and 3 of this document, the estimates for ``No. of
Respondents,'' ``No. of Responses per Respondent,'' and ``Total Annual
Responses'' were obtained from the Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER) reports and data management systems for submissions received in
2007 and from other sources familiar with the number of submissions
received under part 312. The estimates for ``hours per response'' were
made by CDER and CBER individuals familiar with the burden associated
with these reports and from estimates received from the pharmaceutical
industry.
    FDA estimates the burden of this collection of information as
follows:

               Table 2--Estimated Annual Reporting Burden for Human Drugs and Biologics (CDER)\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        No. of Responses     Total Annual        Hours per
  21 CFR Section      Respondents       per Respondent       Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
312.7(d)                          28               1.58                 44                 24              1,056
----------------------------------------------------------------------------------------------------------------
312.10                             4                  1                  4                 10                 40
----------------------------------------------------------------------------------------------------------------
312.23(a) through              2,496               1.26              3,156              1,600          5,049,600
 (f)
----------------------------------------------------------------------------------------------------------------
312.30(a) through              2,030               8.91             18,079                284          5,134,436
 (e)
----------------------------------------------------------------------------------------------------------------
312.31(b)                        153               2.97                454                100             45,400
----------------------------------------------------------------------------------------------------------------
312.32(c) and (d)                985              23.06             22,713                 32            726,816
----------------------------------------------------------------------------------------------------------------
312.33(a) through              2,564               2.34              5,994                360          2,157,840
 (f)
----------------------------------------------------------------------------------------------------------------
312.35(a) and (b)                  9               1.11                 10                300              3,000
----------------------------------------------------------------------------------------------------------------
312.36                           525               1.23                645                 16             10,320
----------------------------------------------------------------------------------------------------------------
312.38(b) and (c)                654               1.34                874                 28             24,472
----------------------------------------------------------------------------------------------------------------
312.42(e)                        149               1.10                164                284             46,576
----------------------------------------------------------------------------------------------------------------
312.44(c) and (d)                159               1.13                179                 16              2,864
----------------------------------------------------------------------------------------------------------------
312.45(a) and (b)                254               1.43                362                 12              4,344
----------------------------------------------------------------------------------------------------------------
312.47(b)                        281                1.8                529                160             84,640
----------------------------------------------------------------------------------------------------------------
312.53(c)                        900              26.51             23,855                 80          1,908,400
----------------------------------------------------------------------------------------------------------------
312.54(a) and (b)                  1                  1                  1                 48                 48
----------------------------------------------------------------------------------------------------------------
312.55(b)                        985              2,306          2,271,300                 48        109,022,400
----------------------------------------------------------------------------------------------------------------
312.56(b), (c),                   18                  1                 18                 80              1,440
 and (d)
----------------------------------------------------------------------------------------------------------------
312.58(a)                         91               4.10                373                  8              2,984
----------------------------------------------------------------------------------------------------------------
312.64                       141,393                  1            141,393                 24          3,393,432
----------------------------------------------------------------------------------------------------------------
312.70(a)                          4                1.5                  6                 40                240
----------------------------------------------------------------------------------------------------------------
312.110(b)                        23              18.26                420                 75             31,500
----------------------------------------------------------------------------------------------------------------
312.120\2\                       115                  5                575                 32             18,400
----------------------------------------------------------------------------------------------------------------
312.130(d)                         3                  1                  3                  8                 24
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
  collection of information requirements.
\2\ Section 312.120 includes the burden estimate for both CDER and CBER.

             Table 3--Estimated Annual Recordkeeping Burden for Human Drugs and Biologics (CDER)\1\
----------------------------------------------------------------------------------------------------------------
                           No. of         No. of Records      Total Annual       Hours per
   21 CFR Section      Recordkeepers     per Recordkeeper       Records            Record         Total Hours
----------------------------------------------------------------------------------------------------------------
312.52(a)                          683                  1                683                2              1,366
----------------------------------------------------------------------------------------------------------------
312.57                              75             485.28             36,396              100          3,639,600
----------------------------------------------------------------------------------------------------------------
312.62(a)                       14,732                  1             14,732               40            589,280
----------------------------------------------------------------------------------------------------------------
312.62(b)                      147,320                  1            147,320               40          5,892,800
----------------------------------------------------------------------------------------------------------------

312.160(a)(3)                      547                1.4                782               .5                391
----------------------------------------------------------------------------------------------------------------
312.160(c)                         547                1.4                782               .5                391
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
  collection of information requirements.

                       Table 4--Estimated Annual Reporting Burden for Biologics (CBER)\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        No. of Responses     Total Annual        Hours per
  21 CFR Section      Respondents       per Respondent       Responses          Responses         Total Hours
----------------------------------------------------------------------------------------------------------------
312.7(d)                          12                1.1                 13                 24                312
----------------------------------------------------------------------------------------------------------------
312.23(a) through                168                1.5                256              1,600            409,600
 (f)\2\
----------------------------------------------------------------------------------------------------------------
312.30(a) through                372                6.4              2,369                284            672,796
 (e)
----------------------------------------------------------------------------------------------------------------
312.31(b)\2\                     703                7.7              5,417                100            541,700
----------------------------------------------------------------------------------------------------------------
312.32(c) and (d)                175               14.6              2,563                 32             82,016
----------------------------------------------------------------------------------------------------------------
312.33(a) through                512                2.3              1,168                360            420,480
 (f)
----------------------------------------------------------------------------------------------------------------
312.35(a) and (b)                  1                  1                  1                300                300
----------------------------------------------------------------------------------------------------------------
312.36                            10                  4                 40                 16                640
----------------------------------------------------------------------------------------------------------------
312.38(b) and (c)                 81                1.5                120                 28              3,360
----------------------------------------------------------------------------------------------------------------
312.42(e)                         74                1.5                108                284             30,672
----------------------------------------------------------------------------------------------------------------
312.44(c) and (d)                 34                1.1                 39                 16                624
----------------------------------------------------------------------------------------------------------------
312.45(a) and (b)                 41                1.4                 59                 12                708
----------------------------------------------------------------------------------------------------------------
312.47(b)                         31                1.2                 37                160              5,920
----------------------------------------------------------------------------------------------------------------
312.53(c)                        243               4.95              1,203                 80             96,240
----------------------------------------------------------------------------------------------------------------
312.54(a) and (b)                  1                  1                  1                 48                 48
----------------------------------------------------------------------------------------------------------------
312.55(b)                         42                  1                 43                 48              2,064
----------------------------------------------------------------------------------------------------------------
312.56(b), (c),                   10                1.6                 16                 80              1,280
 and (d)
----------------------------------------------------------------------------------------------------------------
312.58(a)                          7                  1                  7                  8                 56
----------------------------------------------------------------------------------------------------------------
312.64                         2,728               3.82             10,411                 24            249,864
----------------------------------------------------------------------------------------------------------------
312.70(a)                          5                  1                  5                 40                200
----------------------------------------------------------------------------------------------------------------
312.110(b)                        18                  1                 18                 75              1,350
----------------------------------------------------------------------------------------------------------------
312.130(d)                         1                  1                  1                  8                  8
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
  collection of information requirements.
\2\ The reporting requirement for Sec.   312.10 is included in the estimates for Sec.  Sec.   312.23 and 312.31.

                     Table 5--Estimated Annual Recordkeeping Burden for Biologics (CBER)\1\
----------------------------------------------------------------------------------------------------------------
                          No. of         Annual Frequency       Total Annual       Hours per
  21 CFR Section      Recordkeepers      per Recordkeeping        Records            Record        Total Hours
----------------------------------------------------------------------------------------------------------------
312.52(a)                          52                   1.4                 73                2              146
----------------------------------------------------------------------------------------------------------------
312.57                            168                  3.05                512              100           51,200
----------------------------------------------------------------------------------------------------------------
312.62(a)                       2,560                     1              2,560               40          102,400
----------------------------------------------------------------------------------------------------------------
312.62(b)                       2,560                    10             25,600               40        1,024,000
----------------------------------------------------------------------------------------------------------------
312.160(a)(3)                      55                   1.4                 77              0.5             38.5
----------------------------------------------------------------------------------------------------------------

312.160(c)                         55                   1.4                 77              0.5             38.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital and startup, or operation, maintenance, and purchase costs associated with the
  collection of information requirements.

Table 6--Totals for Estimated Annual Reporting and Recordkeeping Burdens
                            for CDER and CBER
Reporting Burden                     130,190,510
------------------------------------------------------------------------
Recordkeeping                        11,301,652
------------------------------------------------------------------------
Total                                141,492,162
------------------------------------------------------------------------

    Dated: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2846 Filed 2-10-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36277-36278]
[FR Doc No: 2021-14625]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-493-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Availability of
the Draft Environmental Impact Statement for the Proposed East 300
Upgrade Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft environmental impact statement (EIS)
for the East 300 Upgrade Project, proposed by Tennessee Gas Pipeline
Company, L.L.C. (Tennessee) in the above-referenced docket. Tennessee
requests authorization to modify two existing compressor stations and
construct one new compressor station in Pennsylvania and New Jersey to
create 115 million cubic feet per day of firm transportation capacity
on Tennessee's existing 300 Line for Consolidated Edison Company of New
York, Inc.
    The draft EIS responds to comments that were received on the
Commission's February 19, 2021 environmental assessment (EA) \1\ and
discloses downstream greenhouse gas emissions for the project. With the
exception of climate change impacts, the FERC staff concludes that
approval of the proposed

project, with the mitigation measures recommended in this EIS, would
not result in significant environmental impacts. FERC staff continues
to be unable to determine significance with regards to climate change
impacts.
---------------------------------------------------------------------------

    \1\ The project's EA is available on eLibrary under accession
no. 20210219-3034.
---------------------------------------------------------------------------

    The draft EIS incorporates the above-referenced EA, which addressed
the potential environmental effects of the construction and operation
of the following project facilities:
     Modifications at existing Compressor Station 321 in
Susquehanna County, Pennsylvania, including the installation of one
Solar Taurus 70 turbine with an International Organization for
Standardization (ISO) rating of 11,107 horsepower and auxiliary
facilities;
     modifications at existing Compressor Station 325 in Sussex
County, New Jersey, including installation of one Solar Titan 130
turbine with an ISO rating of 20,500 horsepower and auxiliary
facilities; and
     construction of the new Compressor Station 327 equipped
with a single 19,000-horsepower electric-driven compressor unit and
associated auxiliary facilities in Passaic County, New Jersey.
    The Commission mailed a copy of the Notice of Availability of the
Draft Environmental Impact Statement for the Proposed East 300 Upgrade
Project to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American tribes; potentially affected landowners and other
interested individuals and groups; and newspapers and libraries in the
project area. The draft EIS is only available in electronic format. It
may be viewed and downloaded from the FERC's website (www.ferc.gov), on
the natural gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In
addition, the draft EIS may be accessed by using the eLibrary link on
the FERC's website. Click on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search), select ``General Search,'' and
enter the docket number in the ``Docket Number'' field (i.e., CP20-
493). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    The draft EIS is not a decision document. It presents Commission
staff's independent analysis of the environmental issues for the
Commission to consider when addressing the merits of all issues in this
proceeding. Any person wishing to comment on the draft EIS may do so.
Your comments should focus on the draft EIS's disclosure and discussion
of potential environmental effects, including climate impacts due to
downstream greenhouse gas emissions, and measures to avoid or lessen
environmental impacts. To ensure consideration of your comments on the
proposal in the final EIS, it is important that the Commission receive
your comments on or before 5:00 p.m. Eastern Time on August 23, 2021.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. With eFiling, you can provide comments in a variety of
formats by attaching them as a file with your submission. New eFiling
users must first create an account by clicking on ``eRegister.'' If you
are filing a comment on a particular project, please select ``Comment
on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP20-
493-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, MD 20852.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR part 385.214). Motions to intervene are
more fully described at https://www.ferc.gov/ferc-online/ferc-online/how-guides. Only intervenors have the right to seek rehearing or
judicial review of the Commission's decision. The Commission grants
affected landowners and others with environmental concerns intervenor
status upon showing good cause by stating that they have a clear and
direct interest in this proceeding which no other party can adequately
represent. Simply filing environmental comments will not give you
intervenor status, but you do not need intervenor status to have your
comments considered.

Questions?

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings. In addition, the
Commission offers a free service called eSubscription that allows you
to keep track of all formal issuances and submittals in specific
dockets. This can reduce the amount of time you spend researching
proceedings by automatically providing you with notification of these
filings, document summaries, and direct links to the documents. Go to
https://www.ferc.gov/ferc-online/overview to register for
eSubscription.

    Dated: July 2, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-14625 Filed 7-8-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Rules and Regulations]
[Pages 48618-48621]
[FR Doc No: 2013-19025]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0901; FRL-9394-5]

Propylene Glycol; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of propylene glycol (CAS Reg. No. 57-55-6)
when used as an inert ingredient in antimicrobial formulations applied
to food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils under our
regulations. Exponent on behalf of Ecolab, Inc. submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of propylene glycol.

DATES: This regulation is effective August 9, 2013. Objections and
requests for hearings must be received on or before October 8, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2012-0901. 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, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; 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 are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0901 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 8, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2012-0901, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Exemption

    In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP IN-10525) by
Exponent[supreg], 1150 Connecticut Ave. NW., Suite 1100, Washington, DC
20036 on behalf of Ecolab, Inc., 370 N. Wabasha Street, St. Paul, MN
55102. The petition requested that 40 CFR 180.940(a) be amended by
establishing an exemption from the requirement of a tolerance for
residues of propylene glycol (CAS Reg. No. 57-55-6) when used as an
inert ingredient in antimicrobial formulations applied to food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. That notice referenced a summary of
the petition prepared by Ecolab, the petitioner, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined

in 40 CFR 153.125 and include, but are not limited to, the following
types of ingredients (except when they have a pesticidal efficacy of
their own): Solvents such as alcohols and hydrocarbons; surfactants
such as polyoxyethylene polymers and fatty acids; carriers such as clay
and diatomaceous earth; thickeners such as carrageenan and modified
cellulose; wetting, spreading, and dispersing agents; propellants in
aerosol dispensers; microencapsulating agents; and emulsifiers. The
term ``inert'' is not intended to imply nontoxicity; the ingredient may
or may not be chemically active. Generally, EPA has exempted inert
ingredients from the requirement of a tolerance based on the low
toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for propylene glycol including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with propylene glycol
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by propylene glycol as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    The acute oral toxicity of propylene glycol is low propylene glycol
did not cause dermal or eye irritation in rabbits. It was not a dermal
sensitizer.
    Propylene glycol administered via the oral route did not cause
systemic toxicity in rats or dogs in studies conducted for up to 2
years at doses as high as 2,500 mg/kg/day. Neither maternal,
developmental, offspring nor reproduction toxicity was observed at
doses up to approximately 10,000 mg/kg/day in a teratology screening
and a continuous breeding study in mice.
    Also, dermal exposure to propylene glycol did not cause systemic
toxicity nor increased skin tumor incidence at concentrations up to
100% (~100,000 mg/kg/day) propylene glycol in mice.
    Propylene glycol was not mutagenic or genotoxic on the basis of a
battery of studies that included the bacterial gene mutation assay
using Salmonella typhimurium (AMES) in vitro assay, in vitro Chinese
hamster ovary (CHO) mutation assay, Chinese hamster ovary (CHO)
chromosomal aberration assays, and an in vitro sister chromatid
exchange assay. In addition, EPA concluded that propylene glycol was
negative for carcinogenicity in studies conducted up to the testing
limit doses established by the Agency.
    Although no neurotoxicity or immunotoxicity studies on propylene
glycol are available, there is no evidence of neurotoxicity or
immunotoxicity in the available studies.
    Propylene glycol should be readily metabolized to lactic acid at
the typical low-level exposures. At higher concentrations (absorbed
doses), propylene glycol is primarily excreted unchanged in the urine.

B. Toxicological Points of Departure/Levels of Concern

    EPA has concluded that there are no toxicity endpoints of concern
for oral, dermal, or inhalation exposure to propylene glycol. This
conclusion is based on the results of toxicity testing of propylene
glycol at dose levels near or above testing limits (as established in
the OPPTS 870 series harmonized test guidelines). Since signs of
toxicity were not observed, a toxicological endpoint of concern for use
in risk assessment was not identified. Therefore, EPA has determined
that a quantitative risk assessment, which would use safety factors
applied to a point of departure that is protective of an identified
hazard endpoint, for propylene glycol is not appropriate.

C. Exposure Assessment

    1. Dietary exposure from food, feed, drinking water and non-dietary
exposures. In evaluating dietary exposure to propylene glycol, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance. For purposes of this action, EPA qualitatively assessed
dietary and non-dietary exposures from propylene glycol as follows:
    Dietary exposure (food and drinking water) could potentially occur
from the use of propylene glycol as a food additive, from food
packaging, from its use as an inert ingredient in pesticide
formulations. In addition, dietary exposure to propylene glycol could
occur as a result of contact with treated surfaces or food- or dairy-
processing equipment or food utensils. Residential exposure could also
potentially occur as a result of the use of propylene glycol in and
around the home as a sanitizer, disinfectant, and pet treatment. Since
an endpoint for risk assessment was not identified, a quantitative
dietary exposure assessment for propylene glycol was not conducted.
    2. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether

to establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found propylene glycol to share a common mechanism of
toxicity with any other substances, and propylene glycol does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
propylene glycol does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    As part of its qualitative assessment, the Agency did not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children. The toxicity
database for propylene glycol contains several acute, subchronic, and
chronic, developmental, and reproductive toxicity studies, as well as
carcinogenicity, mutagenicity, metabolism/pharmacokinetics, and dermal
toxicity studies. No hazard was identified based on those studies.
Although the toxicity database does not contain any neurotoxicity or
immunotoxicity studies, no evidence of neurotoxicity or immunotoxicity
effects was present in any of the available studies. Thus, there is no
residual uncertainty regarding prenatal and/or postnatal toxicity of
propylene glycol.
    Based on this information, there is no concern at this time for
increased sensitivity to infants and children to propylene glycol when
used as an inert ingredient in pesticide formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment,
and food-processing equipment and utensils.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on propylene
glycol, EPA concludes that there are no dietary or aggregate dietary/
non-dietary risks of concern as a result of exposure to propylene
glycol in food and water or from residential exposure. As discussed in
this unit, EPA expects aggregate exposure to propylene glycol to pose
no appreciable dietary risk given that the data show a lack of systemic
toxicity at doses < 2500 mg/kg/day and a lack of any increased
susceptibility of infants and children. Taking into consideration of
all available information on propylene glycol, EPA concludes that there
is a reasonable certainty that no harm will result to the general
population or to infants and children from aggregate exposure to
propylene glycol residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for propylene glycol.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for propylene glycol (CAS Reg. No.
57-55-6) when used as an inert ingredient in antimicrobial pesticide
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule exempts certain pesticide residues from the
requirement of a tolerance under FFDCA section 408(d) in response to a
petition submitted to the Agency. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology

Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113,
section 12(d) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 29, 2013.
Lois Rossi,
Director, Registration Division/Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.940, the table in paragraph (a) is amended by adding,
alphabetically, the following inert ingredient to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food contact surface sanitizing
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                          CAS Reg.
           Pesticide chemical               No.            Limits
------------------------------------------------------------------------

                                * * * * *
Propylene glycol.......................    57-55-6  None.

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-19025 Filed 8-8-13; 8:45 am]
BILLING CODE 6560-50-P