[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]
[Page 49354-49358]
[DOCID:fr23au06-15]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0461; FRL-8078-1]

Triflumizole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for
combined residues of triflumizole in or on turnip, greens.
Additionally, this regulation increases the tolerance levels and
extends time-limited tolerances for Chinese Napa cabbage, collards,
coriander leaves (cilantro), kale, kohlrabi, mustard greens and
parsley. Further, this regulation extends time-limited tolerances for
broccoli, dandelion and Swiss chard. This action is in response to
EPA's granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on parsley, dandelion, Swiss chard, collards, kale,
kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander
leaves (cilantro), and turnip greens. This regulation establishes,
revises, and/or extends a maximum permissible level for residues of
triflumizole in these food commodities. These tolerances expire and are
revoked on December 31, 2009.

DATES: This regulation is effective August 23, 2006. Objections and
requests for hearings must be received on or before October 23, 2006,
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-2006-0461. All documents in the
docket are listed on the regulations.gov website. 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, 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:
     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 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 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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0461 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 on or
before October 23, 2006.
    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 your copies, identified by docket ID
number EPA-HQ-OPP-2006-0461, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for combined residues of the
fungicide triflumizole,1-(1-((4-chloro-2-trifluoromethyl)phenyl)imino)-
2-propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent
compound, in or on turnip, greens at 20 parts per million (ppm) and
increasing the tolerance levels in or on cabbage, Chinese, Napa at 20
ppm; collards at 20 ppm; coriander, leaves at 20 ppm; kale at 20 ppm;
kohlrabi at 20 ppm; mustard, greens at 20 ppm; and parsley, leaves at
20 ppm. Further, this regulation extends time-limited tolerances for
broccoli at 1.0 ppm; dandelion, leaves at 7.0 ppm and Swiss chard at
7.0 ppm. These tolerances expire and are revoked on December 31, 2009.
EPA will publish a document in the Federal Register to remove the
revoked tolerances from the Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . .
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Triflumizole on Parsley, Dandelion, Swiss
Chard, Collards, Kale, Kohlrabi, Mustard Greens, Chinese Napa Cabbage,
Broccoli, Coriander Leaves (Cilantro), and Turnip Greens and FFDCA
Tolerances

    Texas has declared a crisis exemption under FIFRA section 18 for
the use of triflumizole on parsley, dandelion, Swiss chard, collards,
kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli,
coriander leaves (cilantro), and turnip greens for control of powdery
mildew. Texas states that the effective control of powdery mildew over
the 70-90 day growing season requires two additional applications of a
systemic pesticide beyond those permitted on the currently registered
alternative labels. After having reviewed the submission,

EPA concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of triflumizole in or on
parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard
greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro),
and turnip greens. In doing so, EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerances under section 408(l)(6) of the FFDCA would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemptions in order to address
urgent non-routine situations and to ensure that the resulting foods
are safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although these tolerances expire and are revoked on June 30,
2009, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerances remaining in
or on parsley, dandelion, Swiss chard, collards, kale, kohlrabi,
mustard greens, Chinese Napa cabbage, broccoli, coriander leaves
(cilantro), and turnip greens after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these tolerances at the time of that application. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether triflumizole
meets EPA's registration requirements for use on parsley, dandelion,
Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa
cabbage, broccoli, coriander leaves (cilantro), and turnip greens or
whether permanent tolerances for these uses would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of triflumizole by a State for special
local needs under FIFRA section 24(c). Nor do these tolerances serve as
the basis for any State other than Texas to use this pesticide on these
crops under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemptions
for triflumizole, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the FFDCA , 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 triflumizole and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for time-
limited tolerances for combined residues of triflumizole in or on
parsley, leaves at 20 ppm; dandelion, leaves at 7.0 ppm; Swiss chard at
7.0 ppm; collards at 20 ppm; kale at 20 ppm; kohlrabi at 20 ppm;
mustard, greens at 20 ppm; Cabbage, Chinese, Napa at 20 ppm; broccoli
at 1.0 ppm; coriander, leaves at 20 ppm; and turnip, greens at 20 ppm.
The most recent estimated aggregate risks resulting from the use of
triflumizole are discussed in the Federal Register for April 8, 2005
(70 FR 17908) (FRL-7701-6). This final rule established time-limited
tolerances for residues of triflumizole in or on parsley, leaves;
dandelion, leaves; Swiss chard; collards; kale; kohlrabi; mustard
greens; cabbage, Chinese, Napa; broccoli; and coriander, leaves
(cilantro) in connection with a crisis exemption declared by the state
of Texas, December 21, 2004.
     A new risk assessment was conducted for the current action to
include the proposed use on turnip greens and due to the submission of
new residue chemistry data and subsequent necessary revision to the
time-limited tolerances on the aforementioned crops. Refer to the April
8, 2005 Federal Register document for a detailed discussion of the
aggregate risk assessments and determination of safety. Below is a
brief summary of the aspects of the risk assessment which are affected
by the change of tolerances.
    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. A summary of the toxicological dose and endpoints for
triflumizole for use in human risk assessment is discussed in Unit
IV.A. of the Federal Register of April 8, 2005 (70 FR 17908).
     EPA assessed risk scenarios for triflumizole under acute and
chronic aggregate exposure (food + drinking water). Short-,
intermediate-, and long-term aggregate risk assessments were not
performed because there are no registered or proposed residential uses
for triflumizole. A cancer aggregate risk assessment was not performed
because triflumizole is not carcinogenic.
    The Dietary Exposure Evaluation Model - Food Commodity Intake
Database (DEEM- FCID\TM\) analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996, 1998
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity.
    Acute dietary exposure assessments were conducted for the general
U.S. population (including infants and children) and females 13-49
years old using tolerance level residues and 100% crop treated (CT)
information for all registered and proposed uses). Drinking water was
incorporated directly in the dietary assessment using the acute (peak)
concentration for surface water generated by the FIRST model.
     Using these exposure assessments, the EPA concluded that
triflumizole exposure from food and water consumption will utilize 9.3
% of the aPAD for U.S. Population, 21% of the a PAD for all infants
less than 1 year old, 25% of the aPAD for children 1-2 years old, the
subpopulation at greatest exposure and 17% of the aPAD for females 13-
49 years old. Therefore, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD.
    A refined, chronic dietary exposure assessment was performed for
the general U.S. population and various population subgroups using
anticipated residues (ARs) from average field trial residues for apple,
grape, pear, cherry, cucurbit, strawberry, and milk commodities;
registered and proposed tolerance for all other commodities; % CT
information for apples, grapes and pear commodities; and 100% CT
information for all other uses. Drinking water was incorporated
directly into the dietary assessment using the chronic (annual average)
concentration for surface water generated by the FIRST model.
    Using these exposure assumptions, the EPA concluded that exposure
to

triflumizole from food and water will utilize 17% of the cPAD for the
general U.S. population, 24% of the cPAD for all infants less that 1
year old and 31% of the cPAD for children 1-2 years old, the
subpopulation at greatest exposure. Therefore, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography(GC)/nitrogen-
phosphorus detector (NPD) method) has been deemed acceptable as a
tolerance enforcement method. 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 Codex, Canadian or Mexican maximum residue limits
established for triflumizole residues in/on crop commodities.
Therefore, no compatibility issues exist with regard to the proposed
U.S. tolerances discussed in this risk assessment.

VI. Conclusion

    Therefore, tolerances are established/revised for combined residues
of triflumizole, 1- (1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-
propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent
compound, in or on parsley, leaves at 20 ppm; dandelion, leaves at 7.0
ppm; Swiss chard at 7.0 ppm; collards at 20 ppm; kale at 20 ppm;
kohlrabi at 20 ppm; mustard, greens at 20 ppm; cabbage, Chinese, Napa
at 20 ppm; broccoli at 1.0 ppm; coriander, leaves at 20 ppm; and
turnip, greens at 20 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes/revises time-limited tolerances under
section 408 of the FFDCA. 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 due to its lack of significance, 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). 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., or 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). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
[tolerance/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. [If this rule is adopting a
proposed rule add the following sentence: The Agency hereby certifies
that this rule will not have significant negative economic impact on a
substantial number of small entities.] In addition, the Agency has
determined that this action will not have a substantial direct effect
on 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,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, 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 in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this 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: August 11, 2006.
Daniel J. Rosenblatt,
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 180.476 is amended, in paragraph (b), by revising the table
to read as follows:

Sec.  180.476  Triflumizole; tolerances for residues.

* * * * *
    (b) * * *

----------------------------------------------------------------------------------------------------------------
                Commodity                    Parts per million               Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Broccoli................................                      1.0                                       12/31/09
Cabbage, chinese, napa..................                       20                                       12/31/09
Collards................................                       20                                       12/31/09
Coriander, leaves.......................                       20                                       12/31/09
Dandelion, leaves.......................                      7.0                                       12/31/09
Kale....................................                       20                                       12/31/09
Kohlrabi................................                       20                                       12/31/09
Mustard, greens.........................                       20                                       12/31/09
Parsley, leaves.........................                       20                                       12/31/09
Swiss chard.............................                      7.0                                       12/31/09
Turnip, greens..........................                       20                                       12/31/09
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. E6-13659 Filed 8-22-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81933-81934]
[FR Doc No: 2020-27778]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease

product application. The Federal Food, Drug, and Cosmetic Act (FD&C
Act) authorizes FDA to award priority review vouchers to sponsors of
approved rare pediatric disease product applications that meet certain
criteria. FDA is required to publish notice of the award of the
priority review voucher. FDA has determined that ZOKINVY (lonafarnib),
manufactured by Eiger BioPharmaceuticals, Inc., meets the criteria for
a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-
796-9856, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that ZOKINVY (lonafarnib), manufactured by Eiger
BioPharmaceuticals, Inc., meets the criteria for a priority review
voucher.
    ZOKINVY (lonafarnib) is indicated in patients 12 months of age and
older with a body surface area of 0.39 m\2\ and above:

 To reduce the risk of mortality in Hutchinson-Gilford progeria
syndrome
 For the treatment of processing-deficient progeroid
laminopathies with either:
    [cir] Heterozygous LMNA mutation with progerin-like protein
accumulation or
    [cir] Homozygous or compound heterozygous ZMPSTE24 mutations

    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about ZOKINVY (lonafarnib), go to the ``[email protected]'' website
at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27778 Filed 12-16-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Rules and Regulations]
[Pages 78977-78978]
[FR Doc No: 2015-31878]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1902, 1903, 1904, 1952, 1953, 1954, 1955, and 1956

[Docket No. OSHA-2014-0009]
RIN 1218-AC76

Streamlining of Provisions on State Plans for Occupational Safety
and Health

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

ACTION: Final rule; confirmation of effective date; approval of
collections of information under the Paperwork Reduction Act of 1995.

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

SUMMARY: On August 18, 2015 OSHA published in the Federal Register a
direct final rule that streamlined provisions on State Plans. OSHA
stated in that document that it would withdraw the companion proposed
rule and confirm the effective date of the final rule if the Agency
received no significant adverse comments on the direct final rule or
the proposal. Since OSHA received no comments on the direct final rule
or the proposal, the Agency now confirms that the direct final rule
became effective as a final rule on October 19, 2015. The proposed rule
and the direct final rule also requested comments on the collections of
information contained in State Plan regulations under the Paperwork
Reduction Act of 1995. The Office of Management and Budget (OMB)
approved those collections of information.

DATES: The effective date for the direct final rule that published on
August 18, 2015 (80 FR49897) is confirmed as October 19, 2015.

ADDRESSES: Electronic copies of this Federal Register notice are
available at http://www.regulations.gov. This Federal Register notice,
as well as news releases and other relevant information, also are
available at OSHA's Web page at http://www.osha.gov.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Francis
Meilinger, Director, OSHA Office of Communications, Room N-3647, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For general and technical information: Douglas J. Kalinowski,
Director, OSHA Directorate of Cooperative and State Programs, Room N-
3700, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Confirmation of the effective date: On
August 18, 2015, OSHA published a direct final rule in the Federal
Register amending OSHA regulations to remove the detailed descriptions
of State Plan coverage, purely historical data, and other unnecessarily
codified information. In addition, this document moved most of the
general provisions of subpart A of part 1952 into part 1902, where the
general regulations on State Plan criteria are found. It also amended
several other OSHA regulations to delete references to part 1952, which
will no longer apply. A companion proposed rule was also published on
that date.
    In the direct final rule, OSHA stated that it would publish a
Federal Register document confirming the effective date of the direct
final rule and withdraw the proposed rule if it received no significant
adverse comments on the direct final rule or the proposal. OSHA
received no comments on the direct final rule or the proposed rule.
Accordingly, OSHA is confirming the effective date of the direct final
rule and the proposed rule is withdrawn.
    Approval of collections of information: The proposed rule and the
direct final rule also contained a request for comments on an
Information Collection Request under the Paperwork Reduction Act of
1995 (PRA), which covers all collections of information in OSHA State
Plan regulations. OMB received no comments. OMB has approved the
revised collections of information and is retaining OMB control number
1218-0247 for these requirements. The expiration date for the approval
is April 30, 2016.

List of Subjects in 29 CFR Parts 1902, 1903, 1904, 1952, 1953,
1954, 1955, and 1956

    Intergovernmental relations, Law enforcement, Occupational safety
and health.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210, authorized the
preparation of this final rule. OSHA is issuing this direct final rule
under the authority specified by Sections 8(c)(1), 8(c)(2), and 8(g)(2)
and 18 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 657
(c)(1), (c)(2), and (g)(2) and 667) and Secretary of Labor's Order No.
1-2012 (76 FR 3912).

    Signed at Washington, DC, on December 11, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2015-31878 Filed 12-17-15; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 133 (Tuesday, July 12, 2016)]
[Notices]
[Pages 45145-45147]
[FR Doc No: 2016-16397]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC16-12-000]

Commission Information Collection Activities (FERC-511, FERC-515,
and FERC-574); Consolidated Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collections and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
requirements and burden of the information collections described below.

DATES: Comments on the collections of information are due September 12,
2016.

ADDRESSES: You may submit comments (identified by Docket No. IC16-12-
000) by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Please reference the specific collection number and/or title in
your comments.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Type of Request: Three-year extension of the information collection
requirements for all collections described below with no changes to the
current reporting requirements. Please note that each collection is
distinct from the next.
    Comments: Comments are invited on: (1) Whether the collections of
information are 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 estimates of the
burden and cost \1\ of the collections of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility and clarity of the information collections; and
(4) ways to minimize the burden of the collections of information on
those who are to respond, including the use of automated collection
techniques or other forms of information technology.
---------------------------------------------------------------------------

    \1\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, refer to 5 Code of Federal
Regulations 1320.3.
    For the FERC-511, FERC-515, and FERC-574, the Commission staff
believes that industry is similarly situated to FERC in terms of
average wages and benefits. For the hourly burden cost, we are using
the FERC 2016 average cost (wages plus benefits) of $74.50/hour.
---------------------------------------------------------------------------

FERC-511, Transfer of Electric License

    OMB Control No.: 1902-0069.
    Type of Request: Three-year extension of the FERC-511 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the information collected under the
requirements of FERC-511 to implement the statutory provisions of
Sections 4(e) and 8 of the Federal Power Act (FPA).\2\ Section 4(e)
authorizes the Commission to issue licenses for the construction,
operation and maintenance of reservoirs, powerhouses, and transmission
lines or other facilities necessary for the development and improvement
of navigation and for the development, transmission, and utilization of
power.\3\ Section 8 of the FPA provides that the voluntary transfer of
any license is made only with the written approval of the Commission.
Any successor to the licensee may assign the rights of the original
licensee but is subject to all of the conditions of the license. The
information filed with the Commission is a mandatory requirement
contained in the format of a written application for transfer of
license, executed jointly by the parties of the proposed transfer. The
sale or merger of a licensed hydroelectric project may occasion the
transfer of a license. The Commission's staff uses the information
collection to determine the qualifications of the proposed transferee
to hold the license and to prepare the transfer of the license order.
Approval by the Commission of transfer of a license is contingent upon
the transfer of title to the properties under license, delivery of all
license instruments, and evidence that such transfer is in the public
interest. The Commission implements these filing requirements in the
Code of Federal Regulations (CFR) under 18 CFR part 9.
---------------------------------------------------------------------------

    \2\ 16 U.S.C. 797(e) and 801.
    \3\ Refers to facilities across, along, from, or in any of the
streams or other bodies of water over which Congress has
jurisdiction under its authority to regulate commerce with foreign
nations and among the several States, or upon any part of public
lands and reservations of the United States, or for the purpose of
utilizing the surplus water or water power from any Government dam.
---------------------------------------------------------------------------

    Type of Respondents: Hydropower Project Licensees.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden for the information collection as:

                                                         FERC-511--Transfer of Electric License
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                       Number of      Annual number   Total number of   Average burden   burden hours &      Cost per
                                                      respondents      of responses      responses       hours & cost     total annual      respondent
                                                                      per respondent                    per  response         cost
                                                               (1)              (2)      (1)*(2)=(3)              (4)      (3)*(4)=(5)          (5)/(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydropower Project Licensees......................              46                1               46         40 hrs.;      1,840 hrs.;           $2,980
                                                                                $2,980         $137,080
--------------------------------------------------------------------------------------------------------------------------------------------------------

FERC-515, Rules of Practice and Procedure: Declaration of Intention

    OMB Control No.: 1902-0079.
    Type of Request: Three-year extension of the FERC-515 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the information collected under the
requirements of FERC-515 to implement the statutory provisions of
section 23(b) of the Federal Power Act (FPA).\4\ Section 23(b)
authorizes the Commission to make a determination as to whether it has
jurisdiction over a proposed water project \5\ not affecting navigable
waters \6\ but across, along, over, or in waters over which Congress
has jurisdiction under its authority to regulate commerce with foreign
nations and among the several States. Section

23(b) requires that any person intending to construct project works on
such waters must file a declaration of their intention with the
Commission. If the Commission finds the proposed project will have an
impact on interstate or foreign commerce, then the entity intending to
construct the project must obtain a Commission license or exemption
before starting construction.\7\ The information is collected in the
form of a written application, containing sufficient details to allow
the Commission staff to research the jurisdictional aspects of the
project. This research includes examining maps and land ownership
records to establish whether or not there is Federal jurisdiction over
the lands and waters affected by the project. A finding of non-
jurisdictional by the Commission eliminates a substantial paperwork
burden for the applicant who might otherwise have to file for a license
or exemption application. The Commission implements these filing
requirements under 18 CFR part 24.
---------------------------------------------------------------------------

    \4\ 16 U.S.C. 817.
    \5\ Dams or other project works. (See 16 U.S.C. 817.)
    \6\ See 16 U.S.C. 796(8) for the definition of ``Navigable
Waters.''
    \7\ Upon a finding of non-jurisdictional by the Commission, and
if the project does not utilize surplus water or waterpower from a
government dam and no public lands or reservations are affected,
permission is granted upon compliance with State laws.
---------------------------------------------------------------------------

    Type of Respondents: Persons intending to construct project works
on certain waters described above.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden for the information collection as:

                       FERC-515--Rules of Practice and Procedure: Declaration of Intention
----------------------------------------------------------------------------------------------------------------
                    Annual number of                       Average burden      Total annual
    Number of        responses per     Total number of   hours  & cost per    burden hours &        Cost per
   respondents         respondent         responses           response      total annual cost   respondent  ($)
(1)                            (2)        (1)*(2)=(3)                (4)        (3)*(4)=(5)            (5)/(1)
----------------------------------------------------------------------------------------------------------------
              6                  1                  6           80 hrs.;          480 hrs.;             $5,960
                                                                  $5,960            $35,760
----------------------------------------------------------------------------------------------------------------

FERC-574, Gas Pipeline Certificates: Hinshaw Exemption

    OMB Control No.: 1902-0116.
    Type of Request: Three-year extension of the FERC-574 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the information collected under the
requirements of FERC-574 to implement the statutory provisions of
sections 1(c), 4 and 7 of the Natural Gas Act (NGA).\8\ Natural gas
pipeline companies file applications with the Commission furnishing
information in order to facilitate a determination of an applicant's
qualification for an exemption under the provisions of the section
1(c). If the Commission grants exemption, the natural gas pipeline
company is not required to file certificate applications, rate
schedules, or any other applications or forms prescribed by the
Commission.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 717-717w.
---------------------------------------------------------------------------

    The exemption applies to companies engaged in the transportation,
sale, or resale of natural gas in interstate commerce if: (a) They
receive gas at or within the boundaries of the state from another
person at or within the boundaries of that state; (b) such gas is
ultimately consumed in such state; (c) the rates, service and
facilities of such company are subject to regulation by a State
Commission; and (d) that such State Commission is exercising that
jurisdiction. 18 CFR part 152 specifies the data required to be filed
by pipeline companies for an exemption.
    Type of Respondents: Pipeline companies.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden for the information collection as:

                                                 FERC-574--Gas Pipeline Certificates: Hinshaw Exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                       Number of      Annual  number  Total number of  Average  burden   burden hours &      Cost per
                                                      respondents      of responses      responses       & cost  per      total annual   respondent  ($)
                                                                      per respondent                       response           cost
                                                               (1)              (2)      (1)*(2)=(3)              (4)      (3)*(4)=(5)          (5)/(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pipeline Companies................................               1                1                1         60 hrs.;         60 hrs.;           $4,470
                                                                                $4,470           $4,470
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: July 5, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-16397 Filed 7-11-16; 8:45 am]
 BILLING CODE 6717-01-P


MEMORANDUM

DATE:		November 21, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Region 7, EPA

SUBJECT:	June 18, 2014, Conference Call Regarding Proposed Carbon Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      A conference call was held between EPA and the attendees listed below on June 18, 2014 to discuss the proposed Carbon Power Plan for Existing Power Plants. The majority of the discussion centered on how goals were established for the states in Region 7: Iowa, Kansas, Missouri, and Nebraska. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES

EPA Region 7: Rebecca Weber Josh Tapp Mark A. Smith Ward Burns

Iowa Department of Natural Resources Catharine Fitzsimmons

Kansas Department of Health and Environment Rick Brunetti Tom Gross

Missouri Department of Natural Resources  Kyra Moore

Nebraska Department of Environmental Quality Shelly Schneider


[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Pages 16410-16413]
[FR Doc No: 2011-6550]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0284; FRL-8868-1]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: There will be a 3-day consultation meeting of the Federal
Insecticide, Fungicide, and Rodenticide Act, Scientific Advisory Panel
(FIFRA SAP) to consider and review a set of scientific issues related
to Integrated Approaches to Testing and Assessment strategies (IATA):
Use of new computational and molecular tools.

DATES: The meeting will be held on May 24-26, 2011, from approximately
8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted
by May 10, 2011 and requests for oral comments be submitted by May 17,
2011. However, written comments and requests to make oral comments may
be submitted until the date of the meeting, but anyone submitting
written comments after May 10, 2011 should contact the Designated
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
For additional instructions, see Unit I.C. of the SUPPLEMENTARY
INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before April 6,
2011.
    Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, http://www.epa.gov/scipoly/SAP for information on how
to access the webcast. Please note that the webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0284, 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 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>.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2011-0284. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instructions before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. 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. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: 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., 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 either 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 hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Fred Jenkins, Jr., PhD, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

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

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2011-0284 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than May 10,
2011, to provide FIFRA SAP the time necessary to consider and review
the written comments. Written comments are accepted until the date of
the meeting, but anyone submitting written comments after May 17, 2011
should contact the DFO listed under FOR FURTHER INFORMATION CONTACT.
Anyone submitting written comments at the meeting should bring 30
copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than May 17, 2011, in order to be included on the meeting agenda.
Requests to present oral comments will be accepted until the date of
the meeting and, to the extent that time permits, the Chair of FIFRA
SAP may permit the presentation of oral comments at the meeting by
interested persons who have not previously requested time. The request
should identify the name of the individual making the presentation, the
organization (if any) the individual will represent, and any
requirements for audiovisual equipment (e.g., overhead projector, 35 mm
projector, chalkboard). Oral comments before FIFRA SAP are

limited to approximately 5 minutes unless prior arrangements have been
made. In addition, each speaker should bring 30 copies of his or her
comments and presentation slides for distribution to the FIFRA SAP at
the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP
for this meeting. As part of a broader process for developing a pool of
candidates for each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals nominated
for this meeting should have expertise in one or more of the following
areas: toxicity testing in the 21st century risk assessment
applications (including mode of action framework, adverse Outcome
Pathway Concepts, threshold of toxicological concern, QSAR, in vitro
testing) biomonitoring, thyroid biology (endocrinology), genomics, and
risk assessment. The focus will be on both human health and ecological
applications so both types of experts are needed (though not
necessarily in each area of expertise).
    Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the scientific issues for this meeting.
Nominees should be identified by name, occupation, position, address,
and telephone number. Nominations should be provided to the DFO listed
under FOR FURTHER INFORMATION CONTACT on or before April 6, 2011. The
Agency will consider all nominations of prospective candidates for this
meeting that are received on or before this date. However, final
selection of ad hoc members for this meeting is a discretionary
function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the
function of the panel and the expertise needed to address the Agency's
charge to the panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a Federal department or agency or their employment by a Federal
department or agency except the EPA. Other factors considered during
the selection process include availability of the potential panel
member to fully participate in the panel's reviews, absence of any
conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of lack
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on FIFRA SAP. Numerous qualified
candidates are identified for each panel. Therefore, selection
decisions involve carefully weighing a number of factors, including the
candidates' areas of expertise and professional qualifications and
achieving an overall balance of different scientific perspectives on
the panel. In order to have the collective breadth of experience needed
to address the Agency's charge for this meeting, the Agency anticipates
selecting approximately 12 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by the EPA in 5
CFR part 6401. In anticipation of this requirement, prospective
candidates for service on the FIFRA SAP will be asked to submit
confidential financial information which shall fully disclose, among
other financial interests, the candidate's employment, stocks and
bonds, and where applicable, sources of research support. The EPA will
evaluate the candidates financial disclosure form to assess whether
there are financial conflicts of interest, appearance of a lack of
impartiality or any prior involvement with the development of the
documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on FIFRA
SAP. Those who are selected from the pool of prospective candidates
will be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP Web site at http://epa.gov/scipoly/sap
or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is
structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. FIFRA SAP is composed of a permanent
panel consisting of seven members who are appointed by the EPA
Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.

B. Public Meeting

    EPA's Office of Pesticide Programs (OPP) is committed to improving
and transforming its approaches to pesticide risk assessment and
management via enhanced Integrated Approaches to Testing and Assessment
(IATA). OPP views this as a critical time to prepare the program to
take advantage of rapidly advancing science and emerging technologies.
The goal is to improve OPP's ability to assess hazard and exposure and
ensure that pesticides are safe and effective when used according to
the label.
    The purpose of this SAP Review is to seek SAP guidance about OPP's
vision, initial efforts, and plans to adopt IATA. OPP is requesting the
SAP's input on plans to maximize use of existing data from similar
compounds, including information from new toxicity hazard computational
and in vitro predictive models, and exposure modeling to target in vivo
toxicity testing that is necessary to assess and manage chemical risks
appropriately. OPP plans to build on an established foundation of using
a variety of tools in a tiered testing and assessment framework by
systematically adding new tools, methodologies, and an advancing
understanding of key events in toxicity pathways. Two case studies
illustrate the use of these approaches.
    The first case study illustrates the use of genomic information to
assess risk using the fungicide propiconazole as an example. The second
case study

illustrates the use of adverse outcome pathway information to assess
risk using the antimicrobial triclosan as an example. The purpose of
both case studies is to demonstrate the approaches used to develop a
mechanistic basis to support efficient and defensible risk assessment.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc
members for this meeting), and the meeting agenda will be available by
mid-April. In addition, the Agency may provide additional background
documents as the materials become available. You may obtain electronic
copies of these documents, and certain other related documents that
might be available electronically, at http://www.regulations.gov and
the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.
    FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP Web site or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 15, 2011.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-6550 Filed 3-22-11; 8:45 am]
BILLING CODE 6560-50-P


MEMORANDUM

TO:		Amy Hambrick, EPA/OAQPS/SPPD/FIG

FROM:	Bradley Nelson, EC/R, Inc.

DATE:	April 22, 2016

SUBJECT:	Summary of the February 8, 2016, Meeting with the American Petroleum Institute and the U.S. Environmental Protection Agency
--------------------------------------------------------------------------------

I.	INTRODUCTION

This purpose of this meeting was to discuss the comments submitted by the American Petroleum Institute (API) related to the fugitive emission requirements in the September 18, 2015 proposed Oil and Natural Gas Sector NSPS (80 FR 56593) and draft CTG (80 FR 56577).

II.	ATTENDEES

The following is a list of participants in the meeting.

U.S. Environmental Protection Agency
Bruce Moore
Amy Hambrick
Jodi Howard
Ravi Srivastava
Jason Dewees
Jameel Alsalam
Marcia Mia
Charlene Spells

API and Member Organizations
Mike Ford, Hess
Tom Monahan, XTO
Phil Norwood, ERM
Brad Morello, Shell
Dana Wood, BP
Grover Campbell, Devon
Greg Johnston, Chesapeake
Mike O'Connor, XTO
Matt Todd, API
Dennis Newman, Oxy
Shankar Ananthakrishna, Chevron
Vanessa Ryan, Chevron
John Wagner, API
Andrew Baker, Encana
Jeff Adams, BP
Laura Perry, ConocoPhillips
Andy Woerner, ERM

EC/R Incorporated
Bradley Nelson

III.	SUMMARY OF DISCUSSION

Bruce Moore opened the meeting and explained to the attendees that since the EPA is in the post-proposal phase of the NSPS and CTG, EPA personnel would listen to their comments but cannot respond to any of the issues raised. However, the EPA welcomed the comments. The attendees offered the following comments.

NSPS Proposal
 Fugitive Emissions Monitoring Program
 Believes fugitive requirements include unintended sources such as covers, closed vent systems, atmospheric tanks and pneumatics.
 Suggested regulation changes that clarify that these items are not included in fugitive emission monitoring.

 Fugitive Emissions Components Definition
 Stated that the definition of "Fugitive Emission Components" in the proposed rule includes emissions from components that are intended to vent. These components include compressor rod packing and thief hatches.
 Suggested that components from a closed vent system may also be included in the definition.

 State LDAR Programs
 The API believes that the proposed rule fugitive emissions requirements should not be imposed on sites in states that already have an LDAR program.
 Commented on overlap of EPA and state rules and general permits. For example, Texas has two minor source and general states have annual reporting of fugitive emissions. Must send monitoring plan and annual report.
 Submit state records to EPA? Not different from Tanks. Tanks is applicability. Need enforcement.
 60.5365(e) not an affected facility under state program.
 Difficulty determining what is equivalent.
 Includes frequency, repair, and reporting.
 Indicated that there was no data available that shows the lack of leak detection technology or leak detection contractors.
 Believes that the incentive for less frequent monitoring for sites with less than 1% leaking components does not reduce fugitive emissions. Concerned that the 1% of leaking components may be high emitters.
 Provided data that shows that there are a disproportionate number of low throughput wells that are high methane emitters.
 Recommended having a tiered approach for fugitive monitoring based on production or revenue. Provided an analysis of monitoring cost analyses for natural and oil well sites (See attached presentation).
 Recommended basing incentives on innovation rather than the percentage of leaking components.

 Low Volume Production Wells
 The 15 BOE/day exemption will not be useful for new sites because this level is consistent with stripper wells and small businesses.
 If LDAR is required at these low producing wells, they may close down. The same exemption from the REC requirements based on a GOR of 300 should be used to exempt well sites from leak detection because LDAR would not be cost effective at that level.
 Stated the less than 4 tpy storage vessel emission exemption is based on cost effectiveness and LDAR would not be cost effective for low volume wells.
 A well site less than 15 BOE/day for 12 consecutive months after startup should not be an affected facility.

 Definition of Well Site
 Concerned that the definition of well site modification expands the affected source to include control battery tanks but should only include pads.
 Claimed hydraulically fracturing an existing well does not increase the probability of a leak (same equipment and components), thus the potential emissions rate is unchanged. Pressure/throughput do not change, equipment is not operated at capacity and operating pressure remains below design limits.
 Believed that addition of a new compressor at an existing compressor station does not automatically increase the compressor station's emission rate, thus meeting the definition of a "modification." Installation of a new compressor to replace one or more existing compressors may reduce emissions.
 Stated that increased compressor capacity does not necessarily increase throughput and fugitive emission rate, as it may be added for redundancy and increased reliability. Increased throughput can also occur without increasing the number of compressors if increases remain below currently installed compressor capacity.
 Concluded that EPA's definition of "modification" is overly inclusive. Recommended that the definition be based on the addition of certain large equipment such as a separator, heater or dehydrator, as used for the model plant count basis, to be consistent with the basis of the cost analysis and other fugitive rules. Replacement of existing equipment should not be considered a modification because it does not increase the component count.

 Survey Costs
 Additional costs beyond cost of actual survey were not considered and should be included including program design/setup, training, monitoring device calibration, data management and transportation.
 Costs based on survey for corporate plan includes purchase of equipment, which would be the same for small business.
 API added or updated EPA's survey costs based on company information received and claim key differences showing EPA underestimated or did not consider such costs as data collection, OGI equipment purchase and travel.
 EPA's resurvey cost reflects M21 use of soap bubble method for offline component repair, whereas API resurvey cost assumes 2 hours travel to/from site.
 API included the table: Comparison of Monitoring Costs  -  One Time Company Level Costs.

 Monitoring Plans
 Costs for developing and maintaining a corporate- and site-specific plan for every well subject to the rule have not been considered. Factors to consider include use of contract services in some areas and internal staff in others. Additionally, different production areas may dictate different monitoring approaches.
 Believe companies should be allowed to create area monitoring plans in place of site-specific monitoring plans or as an option for corporate-wide plans.
 Requiring a walking path for each site is unnecessary and onerous. Many production areas do not have developed site maps. Concern that plot plans would need to be created in order to then create walking paths.

 Recurring LDAR has Diminishing Returns
 Expressed confusion between EPA rule and Colorado Air Quality Control Commission on origin of 640/60/80 percent emission reduction assumptions.
 Colorado assumptions based on chemical manufacturing industry do not fit with LDAR data observed for upstream ONG industry.
 Number of leaks decrease over time because first survey identifies and correct most of the leaks, with significantly fewer leaks identified in subsequent surveys; however, cost of survey remains the same.
 Recommends annual surveying with no performance based adjustment to the survey frequency.

 Gross Emitters
 Insufficient data to define gross emitters.
 Compressors may be gross emitters due to vibration.
 Believe fugitive emission program should be targeted on identifying and correcting high emitting sources; resulting in great cost-efficiency and quicker emission reductions.
 Annual LDAR is sufficient for identifying and correcting the relatively few fugitive sources with very high emission rates.

 Comments on the CTG
 Noted that many of the comments and recommendations on the NSPS are also appropriate for the CTG.