[Federal Register: January 29, 2009 (Volume 74, Number 18)]
[Notices]
[Page 5150-5151]
[DOCID:fr29ja09-30]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC09-585-000]

Commission Information Collection Activities (FERC-585); Comment
Request; Extension

January 23, 2009.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of proposed information collection and request for
comments.

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SUMMARY: In compliance with the requirements of section 3506(c)(2)(a)
of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Federal
Energy Regulatory Commission (Commission) is soliciting public comment
on the specific aspects of the information collection described below.

DATES: Comments in consideration of the collection of information are
due March 24, 2009.

ADDRESSES: An example of the FERC-585 contingency plan may be obtained
from the Commission's Web site (at http://www.ferc.gov/docs-filing/
elibrary.asp). Comments may be filed either electronically or in paper
format, and should refer to Docket No. IC09-585-000. Documents must be
prepared in an acceptable filing format and in compliance with the
Federal Energy Regulatory Commission submission guidelines at http://
www.ferc.gov/help/submission-guide.asp.
    Comments may be filed electronically via the eFiling link on the
Commission's Web site at http://www.ferc.gov. First time users will
have to establish a user name and password (http://www.ferc.gov/docs-
filing/eregistration.asp) before eFiling. The Commission will send an
automatic acknowledgement to the sender's e-mail address upon receipt
of comments through eFiling.
    Commenters filing electronically should not make a paper filing.
Commenters that are not able to file electronically must send an
original and 14 copies of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street, NE.,
Washington, DC 20426.
    Users interested in receiving automatic notification of activity in
this docket may do so through eSubscription (at http://www.ferc.gov/
docs-filing/esubscription.asp). In addition, all comments and FERC
issuances may be viewed, printed or downloaded remotely through FERC's
Web site using the ``eLibrary'' link and searching on Docket Number
IC09-585. For user assistance, contact FERC Online Support (e-mail at
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC-585 ``Reporting of Electric Energy Shortages and
Contingency Plans under PURPA'' (OMB No. 1902-0138) is used by the
Commission to implement the statutory provisions of section 206 of the
Public Utility Regulatory Policies Act of 1979 (PURPA) Public Law 95-
617, 92 Stat. 3117. Section 206 of PURPA amended the Federal Power Act
(FPA) by adding a new subsection (g) to section 202, under which the
Commission by rule, was to require each public utility to (1) report to
the Commission and appropriate state regulatory authorities of any
anticipated shortages of electric energy or capacity which would affect
the utility's capability to serve its wholesale customers; and (2)
report to the Commission and any appropriate state regulatory authority
contingency plan that would outline what circumstances might give rise
to such occurrences.

    In Order No. 575, the Commission modified the reporting
requirements in 18 CFR 294.101(b) to provide that, if a public utility
includes in its rates schedule, provisions that: (a) During electric
energy and capacity shortages it will treat firm power wholesale
customers without undue discrimination or preference; and (b) it will
report any modifications to its contingency plan for accommodating
shortages within 15 days to the appropriate state regulatory agency and
to the affected wholesale customers, then the utility need not file
with the Commission an additional statement of contingency plan for
accommodating such shortages. This revision merely changed the
reporting mechanism; the public utility's contingency plan would be
located in its filed rate rather than in a separate document.
    In Order No. 659, the Commission modified the reporting
requirements in 18 CFR 294.101(e) to provide that the means by which
public utilities must comply with the requirements to report shortages
and anticipated shortages is to submit this information electronically
using the Office of Electric Reliability's pager system at
<EMAIL_ADDRESS>in lieu of submitting an original and two copies
with the Secretary of the Commission.
    The Commission uses the information to evaluate and formulate an
appropriate option for action in the event an unanticipated shortage is
reported and/or materializes. Without this information, the Commission
and State agencies would be unable to: (1) Examine and approve or
modify utility actions, (2) prepare a response to anticipated
disruptions in electric energy, and (3) ensure equitable treatment of
all public utility customers under the shortage situations. The
Commission implements these filing requirements in the Code of Federal
Regulations (CFR) under 18 CFR Part 294.
    Action: The Commission is requesting a three-year extension of the
current expiration date, with no changes to the existing collection of
data.
    Burden Statement: Public reporting burden for this collection is
estimated at:

----------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                     Number of       Number of    Average burden   burden hours
         FERC data collection (FERC-585)            respondents    responses per     hours per      (1) x (2) x
                                                   annually (1)   respondent (2)   response (3)         (3)
----------------------------------------------------------------------------------------------------------------
Contingency Plan................................               1               1           73              73
                                                 ---------------------------------------------------------------
Capacity Shortage...............................               1               1            0.25            0.25
----------------------------------------------------------------------------------------------------------------

    Estimated annual cost to respondents is $4,450.78 (73.25 hours/
2,080 hours per year times $126,384 per year average per employee =
$4,450.78).
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting, or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (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 those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission of
responses.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-1889 Filed 1-28-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78111-78112]
[FR Doc No: 2022-27647]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-0614]

Determination That ZYBAN (Bupropion Hydrochloride) Tablets,
Extended Release, 150 Milligrams, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ZYBAN (Bupropion Hydrochloride) Tablets, Extended
Release, 150 Milligrams, was not withdrawn from sale for reasons of
safety or effectiveness. This

determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Michelle Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-
402-0374, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but it must be made prior to FDA's approval of an ANDA that refers to
the listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve
an ANDA that does not refer to a listed drug.
    ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150
Milligrams, is the subject of NDA 020711, held by GlaxoSmithKline LLC,
and initially approved on May 14, 1997. ZYBAN is indicated as an aid to
smoking cessation treatment.
    ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150
Milligrams, is currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
    Yichang Humanwell Pharmaceutical Co., Ltd. submitted a citizen
petition dated April 18, 2022 (Docket No. FDA-2022-P-0614), under 21
CFR 10.30, requesting that the Agency determine whether ZYBAN
(Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams,
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ZYBAN (Bupropion Hydrochloride) Tablets,
Extended Release, 150 Milligrams, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ZYBAN (Bupropion Hydrochloride)
Tablets, Extended Release, 150 Milligrams, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list ZYBAN (Bupropion
Hydrochloride) Tablets, Extended Release, 150 Milligrams, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to this drug product. Additional
ANDAs for this drug product may also be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27647 Filed 12-20-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77474-77475]
[FR Doc No: 2014-30051]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-634-000]

Cottonwood Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Cottonwood Solar, LLC's application for market-based rate authority,
with an accompanying rate schedule, noting that such application
includes a request for blanket authorization, under 18 CFR part 34, of
future issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal

Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a
motion to intervene or protest must serve a copy of that document on
the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is January 6, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 17, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-30051 Filed 12-23-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Rules and Regulations]
[Page 19150-19154]
[DOCID:fr09ap08-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0303; FRL-8357-2]

Fenhexamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
fenhexamid in or on asparagus. Interregional Research Project Number 4
(IR-4) requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 9, 2008. Objections and
requests for hearings must be received on or before June 9, 2008, 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-2007-0303. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail 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 those engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0303 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before June 9, 2008.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0303, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line 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'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 Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7187) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.553 be amended by
establishing a tolerance for residues of the fungicide, fenhexamid, (N-
2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in or
on asparagus at 0.02 parts per million (ppm). This notice referenced a
summary of the petition prepared by Arysta LifeScience, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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.''
These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 the petitioned-for tolerance
for residues of fenhexamid on asparagus at 0.02 ppm. EPA's assessment
of exposures and risks associated with establishing the tolerance
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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. In general, the toxicology studies conducted on fenhexamid
demonstrated that it has few or no biologically significant toxic
effects at relatively low dose levels in many animal studies and only
mild or no toxic effects at high dose levels which often approach or
exceed the limit dose. In subchronic and chronic oral studies, the most
toxicologically significant effects were anemia in dogs, and decreased
body weights, increased food consumption and mild liver and/or kidney
effects in rats and mice. Fenhexamid is not acutely toxic, neurotoxic,
carcinogenic, or mutagenic and is not a developmental or reproductive
toxicant. Although no increased susceptibility of fetuses was
demonstrated in developmental toxicity studies in rats and rabbits,
equivocal results, with respect to evaluating potentially increased
sensitivity of pups, were observed in the reproduction study in rats.
Specific information on the studies received and the nature of

the adverse effects caused by fenhexamid 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 the final rule
published in the Federal Register of April 13, 2000 (65 FR 19842) (FRL-
6553-7)http://www.epa.gov/fedrgstr/EPA-PEST/2000/April/Day-13/
p9144.htm.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short, intermediate, and long-term risks are evaluated
by comparing aggregate exposure to the LOC to ensure that the margin of
exposure (MOE) called for by the product of all applicable UFs is not
exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for fenhexamid used for
human risk assessment can be found at http://www.regulations.gov in
document Fenhexamid Human Health Risk Assessment for a Proposed Section
3 Registration for Use on Asparagus on pages 25-26 in docket ID number
EPA-HQ-OPP-2007-0303.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenhexamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenhexamid tolerances in (40 CFR
180.553). EPA assessed dietary exposures from fenhexamid in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
fenhexamid; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996,
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level residues for all commodities with existing and proposed
tolerances, DEEM default processing factors, and assumed 100% crop
treated.
    iii. Cancer. Based on the studies of carcinogenicity studies in
rats and mice, EPA has concluded that fenhexamid is ``not likely to be
carcinogenic to humans.'' Consequently, a quantitative cancer exposure
and risk assessment is not appropriate for fenhexamid.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for fenhexamid in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
fenhexamid. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://
www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of fenhexamid for surface
water are estimated to be 29 parts per billion (ppb) for acute and 1.1
ppb for chronic exposure. The EECs for groundwater are estimated to be
0.0007 ppb for acute and chronic exposure.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 1.1 ppb was used to access
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Fenhexamid is not registered for use on any sites that would result
in residential exposure.
    4. 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fenhexamid and any other
substances and fenhexamid does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that fenhexamid has 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1.  In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold (``10X'') margin of safety for infants and
children in the case of threshold effects to account for pre-natal and
post-natal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional FQPA safety factor value based on the use of
traditional UFs and/or special FQPA safety factors, as appropriate.

    2. Pre-natal and post-natal sensitivity. In the rat and the rabbit
developmental toxicity studies, neither quantitative nor qualitative
evidence of increased susceptibility of fetuses to in utero exposure to
fenhexamid was observed. In the rat reproduction study, qualitative
susceptibility was evidenced as significantly decreased pup body
weights in both generations during the lactation period (on lactation
days 7, 14, and 21 in the F2 generation and lactation days 14 and 21 in
the F1 generation offspring) in the presence of lesser maternal
toxicity (alterations in clinical chemistry parameters and decreased
organ weights without collaborative histopathology). Considering the
overall toxicity profile and the doses and endpoints selected for risk
assessment for fenhexamid, the degree of concern for the effects
observed in this study was characterized as low, noting that there is a
clear NOAEL and well-characterized dose response for the offspring
effects observed and that these effects occurred in the presence of
parental toxicity. No residual uncertainties were identified. The NOAEL
of 17 milligrams/kilograms day (mg/kg/day) from the chronic dog study
used to establish the chronic Reference Dose (cRfD) for the General
Population is lower than the NOAEL of 38.2 mg/kg/day in the
reproduction study in which the offspring effects of concern were
observed (LOAEL = 406 mg/kg/day), and is therefore protective of any
potential offspring effects.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicology data base is complete; there are no residual
uncertainties in the expose database.
    ii. Developmental neurotoxicity studies are not required for
fenhexamid, and no additional uncertainty factors are needed based on
the following weight-of-the-evidence considerations:
    The lack of evidence of abnormalities in the development of the
fetal nervous system in the pre/post natal studies; and
    Neither brain weight nor histopathological examination of the
nervous system was affected in the subchronic and chronic studies.
Decreased body temperatures observed in male rats in the acute
neurotoxicity study were also not considered to be toxicologically
significant.
    iii. As discussed above in Unit III D., there are no residual
uncertainties for pre and/or post natal sensitivity.
    iv. The dietary (food) exposure assessment utilizes existing and
proposed tolerance level residues and assumes 100% of crops treated
with fenhexamid. The assessment is based on reliable data and is not
expected to underestimate exposure/risk. Fenhexamid is not registered
for use sites that would result in residential exposure. Conservative
assumptions are used in the drinking water models. The drinking water
exposure assessment is not expected to underestimate exposure/risk.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. No toxicological endpoint attributable to a single
(acute) dietary exposure was identified. Therefore, acute risk from
exposure to fenhexamid is not expected.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fenhexamid from food and water will utilize 27% of the cPAD for
children 1-2 years old, the subpopulation at the greatest exposure.
There are no residential uses for fenhexamid that result in chronic
residential exposure to fenhexamid.
    3. Aggregate cancer risk for U.S. population. The Agency has
classified fenhexamid as a ``not likely'' human carcinogen based on
lack of evidence of carcinogenicity in male and female rats as well as
in male and female mice, and on the lack of genotoxicity in an
acceptable battery of mutagenicity studies. Therefore, fenhexamid is
not expected to pose a cancer risk.
    4. Determination of safety. Based on these risk assessments, 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 fenhexamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography (HPLC) method using electrochemical detection (ECD)) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Canadian, Mexican or Codex
MRLs for fenhexamid on asparagus, therefore there are no issues for
international harmonization for this current petition.

V. Conclusion

    Therefore, the tolerance is established for residues of fenhexamid,
(N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in
or on asparagus at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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 section 408(d) of FFDCA, such as the tolerance 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This
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) (Public Law 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).

VII. 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: March 26, 2008.
Daniel C. Kenny,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.553 is amended by alphabetically adding the following
commodities to/in the table in paragraph (a) to read as follows:

Sec. 180.553  Fenhexamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Asparagus............................................               0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-7038 Filed 4-8-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37274-37276]
[FR Doc No: 2019-16315]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0750; FRL-9997-17]

Registration Review Proposed Interim Decisions for Several
Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's proposed
interim registration review decisions and opens a 60-day public comment
period on the proposed interim decisions for the following pesticides:
2,4-DB, 3-Methyl-2-cyclohexen-1-one, alkyl imidazolines, bromoxynil,
dikegulac sodium, fluthiacet-methyl, imazalil, inorganic polysulfides
(also known as lime sulfur), IR3535, linuron, octenol, o-benzyl-p-
chlorophenol, p-Menthane-3,8-diol (PMD), pyridaben, starlicide,
uniconazole-P, tri-n butyl tetradecyl phosphonium chloride, zinc and
zinc salts, and zoxamide. This notice also announces the availability
of EPA's human health and ecological risk assessments for the
pesticides alkyl imidazolines, uniconazole-P, dikegulac sodium
(ecological risk assessment only), and zoxamide, and opens a 60-day
public comment period on the risk assessments.

DATES: Comments must be received on or before September 30, 2019.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the Table in Unit IV., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.

Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information, contact: The Chemical Review
Manager for the pesticide of interest identified in the Table in Unit
IV.
    For general questions on the registration review program, contact:
Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), 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?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager for the pesticide of interest
identified in the Table in Unit IV.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information on a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed proposed interim decisions for all pesticides
listed in the Table in Unit IV. Through this program, EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed interim registration review decisions for the
pesticides shown in the following table, and opens a 60-day public
comment period on the proposed interim decisions. This notice also
announces the availability of EPA's human health and ecological risk
assessments for the pesticides alkyl imidazolines, uniconazole-P,
dikegulac sodium (ecological risk assessment only), and zoxamide, and
opens a 60-day public comment period on the risk assessments.

----------------------------------------------------------------------------------------------------------------
 Registration review case name and                                                   Chemical review manager and
                No.                                   Docket ID No.                      contact information
----------------------------------------------------------------------------------------------------------------
2,4-DB. Case 0196..................  EPA-HQ-OPP-2013-0661                            Samantha Thomas,
<EMAIL_ADDRESS><PHONE_NUMBER>.
3-Methyl-2-cyclohexen-1-one. Case    EPA-HQ-OPP-2014-0671                            Joseph Mabon,
 Number 6074.                                                                         mabon.joseph@epa.gov,(703)
                                                                                347-0177.
Alkyl Imidazolines. Case 3010......  EPA-HQ-OPP-2011-0620                            Kim Wilson,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Bromoxynil and Bromoxynil Esters.    EPA-HQ-OPP-2012-0896                            Tiffany Green,
 Case 2070<EMAIL_ADDRESS><PHONE_NUMBER>.
Dikegulac Sodium. Case 3061........  EPA-HQ-OPP-2014-0771                            Jonathan Williams,
<EMAIL_ADDRESS>                                                                                ,<PHONE_NUMBER>.
Fluthiacet-methyl. Case Number 7280  EPA-HQ-OPP-2013-0285                            Eric Fox<EMAIL_ADDRESS><PHONE_NUMBER>.
Imazalil and Imazalil Sulfate. Case  EPA-HQ-OPP-2013-0305                            Michelle Nolan,
 Number 2325<EMAIL_ADDRESS><PHONE_NUMBER>.
Inorganic Polysulfides. (also known  EPA-HQ-OPP-2016-0102                            Katherine St. Clair,
 as Lime Sulfur). Case Number 4054<EMAIL_ADDRESS><PHONE_NUMBER>.
IR3535. Case Number 6046...........  EPA-HQ-OPP-2014-0106                            Alexandra Boukedes,
<EMAIL_ADDRESS>                                                                                ,<PHONE_NUMBER>.
Linuron. Case Number 0047..........  EPA-HQ-OPP-2010-0228                            Katherine St. Clair,
<EMAIL_ADDRESS><PHONE_NUMBER>.

o-benzyl-p-chlorophenol. Case        EPA-HQ-OPP-2011-0423                            Erin Dandridge,
 Number 2045<EMAIL_ADDRESS><PHONE_NUMBER>.
Octenol.Case Number 6033...........  EPA-HQ-OPP-2012-0940                            Joseph Mabon,
                                                                                mabon.joseph@epa.gov,(703)
                                                                                347-0177.
p-Menthane-3,8-diol (PMD). Case      EPA-HQ-OPP-2015-0693                            Susanne Cerrelli,
 Number 6017<EMAIL_ADDRESS><PHONE_NUMBER>.
Pyridaben. Case Number 7417........  EPA-HQ-OPP-2010-0214                            Steven R. Peterson,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Starlicide. Case Number 2610.......  EPA-HQ-OPP-2011-0696                            Nathan Sell,
<EMAIL_ADDRESS>(703)
                                                                                347-8020.
Tri-N Butyl Tetradecyl Phosphonium   EPA-HQ-OPP-2011-0952                            Daniel Halpert,
 Chloride (TTPC). Case Number 5111.                                                   halpert.daniel@epa.gov,(70
                                                                                3) 347-0133.
Uniconazole-P. Case 7007...........  EPA-HQ-OPP-2015-0729                            Susan Bartow,
                                                                                bartow.susan@epa.gov,(703)
                                                                                603-0065.
Zinc and Zinc Salts. Case Number     EPA-HQ-OPP-2009-0011                            Michael McCarroll,
 4099<EMAIL_ADDRESS><PHONE_NUMBER>.
Zoxamide. Case Number 7032.........  EPA-HQ-OPP-2014-0391                            Jocelyn Hospital,
<EMAIL_ADDRESS><PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review case. For example, the
review opened with a Preliminary Work Plan, for public comment. A Final
Work Plan was placed in the docket following public comment on the
Preliminary Work Plan.
    The documents in the dockets describe EPA's rationales for
conducting additional risk assessments for the registration review of
the pesticides included in the table in Unit IV, as well as the
Agency's subsequent risk findings and consideration of possible risk
mitigation measures. These proposed interim registration review
decisions are supported by the rationales included in those documents.
Following public comment, the Agency will issue interim or final
registration review decisions for the pesticides listed in the table in
Unit IV.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed interim
registration review decisions. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the proposed interim decision. All comments
should be submitted using the methods in ADDRESSES and must be received
by EPA on or before the closing date. These comments will become part
of the docket for the pesticides included in the Table in Unit IV.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and may provide a ``Response to Comments Memorandum'' in
the docket. The interim registration review decision will explain the
effect that any comments had on the interim decision and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
http://www.epa.gov/pesticide-reevaluation.

    Authority:  7 U.S.C. 136 et seq.

    Dated: July 24, 2019.
Mary Reaves,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2019-16315 Filed 7-30-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: January 19, 2006 (Volume 71, Number 12)]
[Notices]
[Page 3068]
[DOCID:fr19ja06-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP04-38-002]

Cheniere Sabine Pass Pipeline Company; Notice of Compliance
Filing

January 11, 2006.
    Take notice that on February 22, 2005, Cheniere Sabine Pass
Pipeline Company (Sabine Pipeline), tendered for filing First Revised
Pro Forma Tariff Sheet Nos. 1 through 512, in compliance with the
Commission's December 21, 2004 Order in Docket Nos. CP04-47-000 and
CP04-38-000, et al. (109 FERC ] 61,324).
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 1, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-557 Filed 1-18-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Proposed Rules]
[Pages 22156-22158]
[FR Doc No: 2022-07857]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0457; Project Identifier MCAI-2022-00263-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus SAS Model A318 series airplanes, Model A319-111, -
112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211,
-212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -
112, -131, -211, -212, -213, -231, and -232 airplanes. This proposed AD
was prompted by a report that cracks were found on the web horizontal
flange and inner cap on frame (FR) 68, left-hand (LH) and right-hand
(RH) side, at stringer (STGR) 22. This proposed AD would require
repetitive high frequency eddy current (HFEC) inspections for cracks on
the web horizontal flange and inner cap on FR 68, LH and RH side at
STGR 22, and applicable corrective actions, as specified in a European
Union Aviation Safety Agency (EASA) AD, which is proposed for
incorporation by reference. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 31,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2022-0457.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0457; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th Street, Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0457; Project Identifier
MCAI-2022-00263-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
should be sent to Dan Rodina, Aerospace Engineer, Large Aircraft
Section, International Validation Branch, FAA, 2200 South 216th Street,
Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected]. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0030, dated February 25, 2022
(EASA AD 2022-0030) (also referred to as the MCAI), to correct an
unsafe condition for certain Airbus SAS Model A318-111, A318-112, A318-
121, A318-122, A319-111, A319-112, A319-113, A319-114, A319-115, A319-
131, A319-132, A319-133, A320-211, A320-212, A320-214, A320-215, A320-
216, A320-231, A320-232, A320-233, A321-111, A321-112, A321-131, A321-
211, A321-212, A321-213, A321-231 and A321-232 airplanes.
    Model A320-215 airplanes are not certificated by the FAA and are
not included on the U.S. type certificate data sheet; this proposed AD
therefore does not include those airplanes in the applicability.
    This proposed AD was prompted by a report that during the
inspection for the door stop fitting holes at FR 66 and FR 68 required
by EASA AD 2016-0238, dated December 2, 2016; corrected January 4, 2017
(which corresponds to FAA AD 2018-03-12, Amendment 39-19185 (83 FR
5906, February 12, 2018), cracks were found on web horizontal flange
and inner cap on FR 68, LH and

RH sides, at STGR 22. The FAA is proposing this AD to address the
cracks on web horizontal flange and inner cap on FR 68, LH and RH
sides, at STGR 22, which could result in reduced structural integrity
of the fuselage. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0030 specifies procedures for repetitive HFEC
inspections for cracks at the web horizontal flange and inner cap on FR
68, LH and RH sides, at STGR 22, and applicable corrective actions
(e.g., repairs). This material is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2022-0030 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0030 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0030 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2022-0030 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2022-
0030. Service information required by EASA AD 2022-0030 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0457 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 1,585
airplanes of U.S. registry. The FAA estimates the following costs to
comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
28 work-hours x $85 per hour = $2,380........................              $0           $2,380       $3,772,300
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition actions specified in this proposed AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus SAS: Docket No. FAA-2022-0457; Project Identifier MCAI-2022-
00263-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 31, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS airplanes specified in paragraphs
(c)(1) through (4) of

this AD, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) AD 2022-0030, dated February 25,
2022 (EASA AD 2022-0030).
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, fuselage.

(e) Unsafe Condition

    This AD was prompted by a report that cracks were found on web
horizontal flange and inner cap on frame (FR) 68, left-hand (LH) and
right-hand (RH) sides, at stringer (STGR) 22. The FAA is issuing
this AD to address the cracks on web horizontal flange and inner cap
on FR 68, LH and RH sides, at STGR 22, which could result in reduced
structural integrity of the fuselage.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2022-0030.

(h) Exceptions to EASA AD 2022-0030

    (1) Where EASA AD 2022-0030 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2022-0030 does not apply
to this AD.
    (3) Where paragraph (2) of EASA AD 2022-0030 specifies
``Accomplishment on an aeroplane of (repetitive) maintenance
instructions, issued and approved by Airbus,'' for this AD, those
instructions must have been approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (4) Where paragraph (3) of EASA AD 2022-0030 specifies if
``discrepancies and/or cracks are detected, before next flight,
contact Airbus for approved corrective action(s) instructions and,
within the compliance time specified therein, accomplish those
instructions accordingly,'' for this AD, if cracks are detected, the
cracks must be repaired before further flight using a method
approved by the Manager, Large Aircraft Section, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA DOA. If
approved by the DOA, the approval must include the DOA-authorized
signature.
    (5) Where paragraph (4) of EASA AD 2022-0030 specifies ``the
instructions provided by Airbus,'' for this AD, those instructions
must be approved by the Manager, Large Aircraft Section,
International Validation Branch, FAA; or EASA; Airbus SAS's EASA
DOA. If approved by the DOA, the approval must include the DOA-
authorized signature.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch of the
certification office, send it to the attention of the person
identified in paragraph (j)(2) of this AD. Information may be
emailed to: [email protected]. Before using any approved
AMOC, notify your appropriate principal inspector, or lacking a
principal inspector, the manager of the responsible Flight Standards
Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Related Information

    (1) For EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this EASA AD on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0457.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

    Issued on April 7, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-07857 Filed 4-13-22; 8:45 am]
BILLING CODE 4910-13-P