MEMORANDUM
To: 		Docket EPA-HQ-OAR-2023-0072
From: 		U.S. EPA
--------------------------------------------------------------------------------
Subject: 	Carbon Capture References
--------------------------------------------------------------------------------

THE FOLLOWING ARE carbon capture references the U.S. Environmental Protection Agency (EPA) cited in the preamble and technical support documents.


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Pages 43493-43494]
[FR Doc No: 2014-17590]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0019]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Customer/Partner
Service Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
25, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0360.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Customer/Partner Service Surveys--(OMB Control Number 0910-0360)--
Extension

    Under section 903 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 393), FDA is authorized to conduct research and public
information programs about regulated products and responsibilities of
the Agency. Executive Order 12862, entitled, ``Setting Customer Service
Standard,'' directs Federal Agencies that ``provide significant
services directly to the public'' to ``survey customers to determine
the kind and quality of services they want and their level of
satisfaction with existing services.'' FDA is seeking OMB clearance to
conduct a series of surveys to implement Executive Order 12862.
Participation in the surveys is voluntary. This request covers
customer/partner service surveys of regulated entities, such as food
processors; cosmetic, drug, biologic, and medical device manufacturers;
consumers; and health professionals. The request also covers
``partner'' (State and local governments) customer service surveys.
    FDA will use the information from these surveys to identify
strengths and weaknesses in service to customers/partners and to make
improvements. The surveys will measure timeliness, appropriateness, and
accuracy of information; courtesy; and problem resolution in the
context of individual programs.
    FDA estimates conducting 15 customer/partner service surveys per
year, each requiring an average of 15 minutes for review and
completion. We estimate respondents to these surveys to be between 100
and 20,000 customers. Some of these surveys will be repeats of earlier
surveys for purposes of monitoring customer/partner service and
developing long-term data.
    In the Federal Register of April 17, 2014 (79 FR 21765), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                    Annual
               Type of survey                    Number of      frequency per   Average  burden    Total hours
                                                respondents        response      per  response
----------------------------------------------------------------------------------------------------------------
Mail, telephone, Web-based..................          50,000                1         \2\ 0.25           12,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Fifteen (15) minutes.

    Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17590 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P


qualifying pesticide chemical residue that—

		(A) is issued under this section after August 3, 1996, and determined
by the Administrator to meet the standard under subsection (b)(2)(A) (in
the case of a tolerance) or (c)(2) (in the case of an exemption) of this
section; or

		(B)(i) pursuant to subsection (j) of this section is remaining in
effect or is deemed to have been issued under this section, or is
regarded under subsection (k) of this section as exempt from the
requirement for a tolerance; and

		(ii) is determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case
of an exemption) of this section.

	(3) LIMITATION.—The Administrator may make the determination
described in paragraph (2)(B)(ii) only by issuing a rule in accordance
with the procedure set forth in subsection (d) or (e) of this section
and only if the Administrator issues a proposed rule and allows a period
of not less than 30 days for comment on the proposed rule. Any such rule
shall be reviewable in accordance with subsections (g) and (h) of this
section.

	(4) STATE AUTHORITY.—Except as provided in paragraphs (5), (6), and
(8) no State or political subdivision may establish or enforce any
regulatory limit on a qualifying pesticide chemical residue in or on any
food if a qualifying Federal determination applies to the presence of
such pesticide chemical residue in or on such food, unless such State
regulatory limit is  identical to such qualifying Federal determination.
A State or political subdivision shall be deemed to establish or enforce
a regulatory limit on a pesticide chemical residue in or on a food if it
purports to prohibit or penalize the production, processing, shipping,
or other handling of a food because it contains a pesticide residue (in
excess of a prescribed limit).

		(5) PETITION PROCEDURE.—

		(A) IN GENERAL.—Any State may petition the Administrator for
authorization to establish in such State a regulatory limit on a  in or
on any food that is not identical to the qualifying Federal
determination applicable to such qualifying pesticide chemical residue.

				(B) PETITION REQUIREMENTS.—Any petition under subparagraph (A)

		shall—

						(i) satisfy any requirements prescribed, by rule, by the
Administrator; and

		(ii) be supported by scientific data about the pesticide chemical
residue that is the subject of the petition or about chemically related
pesticide chemical residues, data on the consumption within such State
of food bearing the pesticide chemical residue, and data on exposure of
humans within such State to the pesticide chemical residue.

		(C) AUTHORIZATION.—The Administrator may, by order, grant the
authorization described in subparagraph (A) if the Administrator
determines that the proposed State regulatory limit—

						(i) is justified by compelling local conditions; and

						(ii) would not cause any food to be a violation of Federal law.

		(D) TREATMENT.—In lieu of any action authorized under subparagraph
(C), the Administrator may treat a petition under this paragraph as a
petition under subsection (d) of this section to modify or revoke a
tolerance or an exemption. If the Administrator determines to treat a
petition under this paragraph as a petition under subsection (d) of this
section, the Administrator shall thereafter act on the petition pursuant
to subsection (d) of this section.

		(E) REVIEW.—Any order of the Administrator granting or denying the
authorization described in subparagraph (A) shall be subject to review
in the manner described in subsections (g) and (h) of this section.

	(6) URGENT PETITION PROCEDURE.—Any State petition to the
Administrator pursuant to paragraph (5) that demonstrates that
consumption of a food containing such pesticide residue level during the
period of the food's likely availability in the State will pose a
significant public health threat from acute exposure shall be considered
an urgent petition. If an order by the Administrator to grant or deny
the requested authorization in an urgent petition is not made within 30
days of receipt of the petition, the petitioning State may establish and
enforce a temporary regulatory limit on a  in or on the food. The
temporary regulatory limit shall be validated or terminated by the
Administrator's final order on the petition.

	(7) RESIDUES FROM LAWFUL APPLICATION.—No State or political
subdivision may enforce any regulatory limit on the level of a pesticide
chemical residue that may appear in or on any food if, at the time of
the application of the pesticide that resulted in such residue, the sale
of such food with such residue level was lawful under this section and
under the law of such State, unless the State demonstrates that
consumption of the food containing such pesticide residue level during
the period of the food's likely availability in the State will pose an
unreasonable dietary risk to the health of persons within such State.

	(8) SAVINGS.—Nothing in this chapter preempts the authority of any
State or political subdivision to require that a food containing a
pesticide chemical residue bear or be the subject of a warning or other
statement relating to the presence of the pesticide chemical residue in
or on such food.

	(o) CONSUMER RIGHT TO KNOW.—Not later than 2 years after August 3,
1996, and annually thereafter, the Administrator shall, in consultation
with the Secretary of Agriculture and the Secretary of Health and Human
Services, publish in a format understandable to a lay person, and
distribute to large retail grocers for public display (in a manner
determined by the grocer), the following information, at a minimum:

	(1) A discussion of the risks and benefits of pesticide chemical
residues in or on food purchased by consumers.

	(2) A listing of actions taken under subparagraph (B) of subsection
(b)(2) of this section that may result in pesticide chemical residues in
or on food that present a yearly or lifetime risk above the risk allowed
under subparagraph (A) of such subsection, and the food on which the
pesticide chemicals producing the residues are used.

	(3) Recommendations to consumers for reducing dietary exposure to
pesticide chemical residues in a manner consistent with maintaining a
healthy diet, including a list of food that may reasonably substitute
for food listed under paragraph (2).

Nothing in this subsection shall prevent retail grocers from providing
additional information.

	(p) ESTROGENIC SUBSTANCES SCREENING PROGRAM.—

	(1) DEVELOPMENT.—Not later than 2 years after August 3, 1996, the
Administrator shall in consultation with the Secretary of Health and
Human Services develop a screening program, using appropriate validated
test systems and other scientifically relevant information, to determine
whether certain substances may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen, or such other
endocrine effect as the Administrator may designate.

	(2) IMPLEMENTATION.—Not later than 3 years after August 3, 1996,
after obtaining public comment and review of the screening program
described in paragraph (1) by the scientific advisory panel established
under section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136w(d)) or the science advisory board
established by section 4365 of title 42, the Administrator shall
implement the program.

	(3) SUBSTANCES.—In carrying out the screening program described in
paragraph (1), the Administrator —

				(A) shall provide for the testing of all pesticide chemicals; and

		(B) may provide for the testing of any other substance that may have
an effect that is cumulative to an effect of a pesticide chemical if the
Administrator determines that a substantial population may be exposed to
such substance.

	(4) EXEMPTION.—Notwithstanding paragraph (3), the Administrator may,
by order, exempt from the requirements of this section a biologic
substance or other substance if the Administrator determines that the
substance is anticipated not to produce any effect in humans similar to
an effect produced by a naturally occurring estrogen.

		(5) COLLECTION OF INFORMATION.—

		(A) IN GENERAL.—The Administrator shall issue an order to a
registrant of a substance for which testing is required under this
subsection, or to a person who manufactures or imports a substance for
which testing is required under this subsection, to conduct testing in
accordance with the screening program described in paragraph (1), and
submit information obtained from the testing to the Administrator,
within a reasonable time period that the Administrator determines is
sufficient for the generation of the information.

		(B) PROCEDURES.—To the extent practicable the Administrator shall
minimize duplicative testing of the same substance for the same
endocrine effect, develop, as appropriate, procedures for fair and
equitable sharing of test costs, and develop, as necessary, procedures
for handling of confidential business information.

				(C) FAILURE OF REGISTRANTS TO SUBMIT INFORMATION.—

		(i) SUSPENSION.—If a registrant of a substance referred to in
paragraph (3)(A) fails to comply with an order under subparagraph (A) of
this paragraph, the Administrator shall issue a notice of intent to
suspend the sale or distribution of the substance by the registrant. Any
suspension proposed under this paragraph shall become final at the end
of the 30-day period beginning on the date that the registrant receives
the notice of intent to suspend, unless during that period a person
adversely affected by the notice requests a hearing or the Administrator
determines that the registrant has complied fully with this paragraph.

		(ii) HEARING.—If a person requests a hearing under clause (i), the
hearing shall be conducted in accordance with section 554 of title 5.
The only matter for resolution at the hearing shall be whether the
registrant has failed to comply with an order under subparagraph (A) of
this paragraph. A decision by the Administrator after completion of a
hearing shall be considered to be a final agency action.

		(iii) TERMINATION OF SUSPENSIONS.—The Administrator shall terminate
a suspension under this subparagraph issued with respect to a registrant
if the Administrator determines that the registrant has complied fully
with this paragraph.

		(D) NONCOMPLIANCE BY OTHER PERSONS.—Any person (other than a
registrant) who fails to comply with an order under subparagraph (A)
shall be liable for the same penalties and sanctions as are provided
under section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) in
the case of a violation referred to in that section. Such penalties and
sanctions shall be assessed and imposed in the same manner as provided
in such section 16.

	(6) AGENCY ACTION.—In the case of any substance that is found, as a
result of testing and evaluation under this section, to have an
endocrine effect on humans, the Administrator shall, as appropriate,
take action under such statutory authority as is available to the
Administrator, including consideration under other sections of this
chapter, as is necessary to ensure the protection of public health.

	(7) REPORT TO CONGRESS.—Not later than 4 years after August 3, 1996,
the Administrator shall prepare and submit to Congress a report
containing—

		(A) the findings of the Administrator resulting from the screening
program described in paragraph (1);

		(B) recommendations for further testing needed to evaluate the impact
on human health of the substances tested under the screening program;
and

		(C) recommendations for any further actions (including any action
described in paragraph (6)) that the Administrator determines are
appropriate based on the findings.

	(q) SCHEDULE FOR REVIEW.—

	(1) IN GENERAL.—The Administrator shall review tolerances and
exemptions for pesticide chemical residues in effect on the day before
August 3, 1996, as expeditiously as practicable, assuring that—

		(A) 33 percent of such tolerances and exemptions are reviewed within 3
years of August 3, 1996;

		(B) 66 percent of such tolerances and exemptions are reviewed within 6
years of August 3, 1996; and

		(C) 100 percent of such tolerances and exemptions are reviewed within
10 years of August 3, 1996.

In conducting a review of a tolerance or exemption, the Administrator
shall determine whether the tolerance or exemption meets the
requirements of subsections (b)(2) or (c)(2) of this section and shall,
by the deadline for the review of the tolerance or exemption, issue a
regulation under subsection (d)(4) or (e)(1) of this section to modify
or revoke the tolerance or exemption if the tolerance or exemption does
not meet such requirements.

	(2) PRIORITIES.—In determining priorities for reviewing tolerances
and exemptions under paragraph (1), the Administrator shall give
priority to the review of the tolerances or exemptions that appear to
pose the greatest risk to public health.

	(3) PUBLICATION OF SCHEDULE.—Not later than 12 months after August 3,
1996, the Administrator shall publish a schedule for review of
tolerances and exemptions established prior to August 3, 1996. The
determination of priorities for the review of tolerances and exemptions
pursuant to this subsection is not a rulemaking and shall not be subject
to judicial review, except that failure to take final action pursuant to
the schedule established by this paragraph shall be subject to judicial
review.

	(r) TEMPORARY TOLERANCE OR EXEMPTION.—The Administrator may, upon the
request of any person who has obtained an experimental permit for a
pesticide chemical under the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.) or upon the Administrator's own
initiative, establish a temporary tolerance or exemption for the
pesticide chemical residue for the uses covered by the permit.
Subsections (b)(2), (c)(2), (d), and (e) of this section shall apply to
actions taken under this subsection.

	(s) SAVINGS CLAUSE.—Nothing in this section shall be construed to
amend or modify the provisions of the Toxic Substances Control Act (15
U.S.C. 2601 et seq.) or the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.)

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment D

Final Rule; Time-Limited Tolerances for Pesticide Emergency Exemptions
(65 FR 65125)

ATTACHMENT D

[Federal Register: October 25, 2000 (Volume 65, Number 207)]

[Rules and Regulations]

[Page 64125-64132]

[DOCID:fr25oc00-23]

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

Part III

Environmental Protection Agency

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

40 CFR Part 176

Time-Limited Tolerances for Pesticide Emergency Exemptions; Final Rule

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 176

[OPP-181051A; FRL-6749-7]

RIN 2070-AD15

Time-Limited Tolerances for Pesticide Emergency Exemptions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This final rule governs the establishment of time-limited
tolerances and exemptions for residues of a pesticide chemical resulting
from its emergency use as authorized under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The

purpose of this rule is to set into place a process that will ensure
timely decisions on any tolerance related issue in response to a request
for an emergency use of a pesticide chemical to be used in or on food or
feed. Under this rule, EPA will implement the provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA) related to FIFRA section 18
time-limited tolerances by evaluating each petition on a case-by-case
basis to determine if adequate reliable data are available to make the
required safety finding mandated under FFDCA section 408. This rule
pertains only to regulatory changes resulting from the 1996 enactment of
the Food Quality Protection Act (FQPA) which amended FFDCA.

DATES:  This rule is effective November 24, 2000.

FOR FURTHER INFORMATION CONTACT:  For general information contact:
Joseph E. Hogue, Office of Pesticide Programs (7506C), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>For
applicability questions contact: Robert Forrest, Chief, Minor

Use, Inerts and Emergency Response Branch (7505C), Registration
Division, Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 308-9376; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this final rule if you are the
Federal government or a State or Territorial government agency charged
with pesticide authority. Regulated categories and entities may include,
but are not limited to:

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

Category	NAICS codes	Examples of

potentially affected

entities

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

Federal government	9241	Federal agencies that petition EPA for FIFRA
section 18 use authorization

State or Territorial governments

States or territories charged with pesticide authority that petition EPA
for FIFRA section 18 use authorization

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

     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 table could also be
affected. The North American Industrial Classification System (NAICS)
codes are provided to assist you and others in determining whether or
not this action might apply to certain entities. If you have questions
regarding the applicability of this action to a particular entity,

consult Sec. 176.1 or the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

     1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select “Laws and

Regulations,” “Regulations and Proposed Rules,” and then look up
the entry for this document under the “Federal Register--Environmental
Documents.” You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.

     2. In person. The Agency has established an official record for
this action under docket control number OPP-181051A. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed as
Confidential Business Information (CBI). This official record includes
the documents that are physically located in the docket, as well as the
documents that are referenced in those documents. The public version of
the official record does not include any information claimed as CBI. The
public version of the official record, which includes printed, paper
versions of any electronic comments submitted during an applicable
comment period, is available for inspection in the Public Information
and Records Integrity Branch (PIRIB), Room 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding Federal holidays. The PIRIB telephone number
is<PHONE_NUMBER>.

II. Background

A. What Action is the Agency Taking?

     The amendments to FFDCA, as prescribed by FQPA, went into effect
immediately upon enactment on August 3, 1996. Under these amendments,
EPA is required to conduct all pesticide tolerance-setting activities,
including those approved for section 18 emergency exemptions, under an
amended FFDCA section 408 with a new safety standard and new regulatory
procedures. In the Federal Register of June 3, 1999 (64 FR 29823) (FRL-
5750-1), EPA published, and opened for public comment, proposed
regulations for setting time-limited tolerances for section 18 emergency
exemptions. In its proposal, EPA described its current emergency
exemption program and the interim practices taken to evaluate requests
for section 18 tolerances or tolerance exemptions, and to establish
section 18 tolerances, prior to the issuance of this final rule.

     In the time period spanning from August 1996 to the present, EPA
has been evaluating section 18 exemption requests and issuing associated
tolerances or tolerance exemptions on a case-by-case basis. These
evaluations have been determined based on materials submitted by

Federal and State agencies in accordance with EPA guidance and interim
procedures sent to them in September 1996 and further elaborated in
Pesticide Registration Notice 97-1, dated January 1997, which

is available in the OPP Docket (see Unit I.B.2). This non-binding
interim approach to current section 18 tolerance decisions has remained
in place while the Agency has developed this FFDCA section 408(l)(6)
procedural regulation.

     The June 3, 1999 proposal was strictly a procedural scheme and did
not modify any regulatory policies associated with the approval of the
emergency exemption itself under FIFRA. EPA proposed to establish a new
part 176 in the CFR to house exclusively regulations governing the
setting of time-limited tolerances for emergency exemptions. In summary,
EPA proposed to:

     1. Review data for establishing a time-limited tolerance only after
a section 18 request has been submitted;

     2. Evaluate each submission individually on a case-by-case basis to
determine if adequate reliable information is available to make the
required safety finding;

     3. Not routinely require additional data to be generated and
instead rely on submitted data already reviewed and evaluated; and

     4. Strive to make a regulatory decision in a timely manner.

     If a tolerance could not be established then the emergency
exemption would not be granted. Time-limited tolerances would typically
be set for a period of 24 months to allow the treated crop from the
previous year’s emergency application to clear the channels of trade.

     In addition to the above proposed procedure, EPA solicited comments
on several other options for addressing time-limited tolerances. One
approach was to require a full data set to support section 18 tolerances
in the same manner as is required for the establishment of

permanent tolerances. EPA also considered requiring a minimum data set
in which the applicant would need to provide a specific subset of the
data normally required to establish a permanent tolerance. Under this
approach, the Agency would evaluate only those defined studies in making
its safety finding. EPA did not include either approach as its primary
option because they did not allow for timely decisions. Another approach
for setting time-limited tolerances was suggested by the National Food
Processors’ Association. If this approach were adopted, EPA would not
conduct a full-risk assessment for a section 18 tolerance, but would
instead assess the incremental risk of the proposed emergency pesticide
use, that is, the amount that the proposed

use would increase dietary risk above the risk from existing uses.

B. What is the Agency’s Authority for Taking this Action?

     Section 18 of 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.” Regulations regarding
EPA’s implementation of FIFRA section 18 are codified in 40 CFR part
166.

     FQPA amended the FFDCA by directing EPA to establish time-limited
tolerances or tolerance exemptions for pesticide use authorized by EPA
under section 18 of FIFRA that may result in residues in or on food or
feed. Specifically the FFDCA section 408(l)(6) requires EPA to establish
a tolerance or exemption from the requirement of a tolerance for
pesticide chemical residues in or on food that will result from the use
of a pesticide under an emergency exemption. Section 408(l)(6) also
requires EPA to promulgate regulations governing the establishment of

tolerances and tolerance exemptions for pesticide uses approved for
emergency situations under FIFRA section 18. Section 408(e)(1)
authorizes the Administrator to establish, modify, suspend, or revoke
any tolerance or exemption from the requirement of a tolerance on her
own initiative, and to establish general procedures and requirements to
implement section 408. This final rule is issued under the authority of
sections 408(e)(1)(c) and 408(l)(6) of FFDCA, as amended by FQPA.

III. Public Comment and EPA Response

     EPA received a total of 10 comments in response to its proposed
rule. Five States, two growers groups, two pesticide manufacturing
companies, and one public interest group submitted comments. In
addition, the National Food Processors’ Association attached its
previously submitted petition requesting that EPA use an incremented
risk approach to its comments. This petition, entitled “Petition To
Issue A Regulation Governing Establishment Of Section 18 Tolerances,”
was co-sponsored by 19 associated grower groups. Everyone expressed
support of EPA’s premise that timeliness and rapid review of section
18 requests is the essence of the program. In this regard, all parties
agreed that the Agency should only utilize “available data in its
section 18 tolerance reviews.”

     EPA, in addition to considering changes based on public comments,
also made minor changes to Sec. Sec. 176.5 and 176.11(a) in the final
rule to clarify the provisions and to conform to other regulations
(particularly 40 CFR part 166). EPA has also changed the text of Sec.
176.3 slightly by changing “a State, U.S. Territory, or Federal
agency” to “any entity, authorized under section 18 of FIFRA to
request an emergency exemption,” and by changing “declares”a
crisis exemption to “issues.” A similar change has been made to Sec.
176.15. These changes will eliminate any future need to amend these
rules in the event that EPA’s regulations or FIFRA are ever changed so
that an entity other than a State, U.S. Territory, or Federal agency
would be allowed to request an emergency exemption. Other changes to the
final rule were made as discussed in this unit. Following is a summary
of the significant comments received by EPA and its response to these

comments.

A. EPA Should Adopt an Incremental Risk Approach to Setting Tolerances
for Emergency Exemptions

     Eight submitters commented on the approach EPA should take to
establish time-limited tolerances for emergencies. Two commenters agreed
with EPA’s proposed scheme to set tolerances on a case-by-case basis
using available, reliable information to make the required safety
finding. Six commenters, while not critical of EPA’s proposed
approach, urged the Agency to instead implement an accelerated review
process based on the incremental risk of the emergency use. One
commenter thought that the minimum data set approach was
“intriguing” and could deserve further consideration. This approach,
it was stated, had the potential to lend clarity and objectivity to the
section 18 process and eliminate the need for the Agency to use “best
judgement.”

     The proponents of the incremental-risk approach argued that since
emergency exemptions are by their very nature extreme situations, the
process for addressing them should take this into account and they
should be given special treatment. Pesticide use in an emergency is for
a short term and generally is limited to a single-geographic area,
therefore there is less exposure to the pesticide and minimal associated
risk. One commenter noted that the Agency’s policy of

conducting a full-risk assessment for section 18 tolerances does not
consider the limited scope and duration of the use. The commenter stated
that performing full risk assessments each time a section 18 tolerance
is requested not only slows down the entire section 18 review process,
but also diverts Agency resources. According to the commenter

an incremental-risk approach would eliminate the time pressures and
would avoid the disruption to EPA’s base pesticide regulatory
programs.

     In spite of the thoughtful comments on the fourth option, EPA
believes that the case-by-case approach outlined in its proposal is the
most practical approach that does not significantly sacrifice timeliness
or efficiency and is in compliance with the law. It allows the Agency to
make appropriate decisions quickly while fully protecting human health,
especially infants and children, and safeguarding the environment.
Moreover, this approach, coupled with the Agency’s newly established
Threshold of Regulation Policy for pesticide tolerances (see Unit IV.)
may resolve many concerns expressed by those who favor the
incremental-risk approach.

     EPA is not prepared at this time to adopt the approach suggested by
the commenters. In addition to presenting difficult legal issues, the
incremental-risk approach may not be needed to address the commenters’
concerns regarding purported EPA denial of section 18 emergency

exemption petitions or a lack of timely review by the Agency of such
petitions. EPA’s initial implementation of the new tolerance
requirement necessitated adjusting Agency procedures and involved some
deviation from past EPA review times in handling section 18 emergency
exemption requests. Now that EPA has had 4 years experience in setting
section 18 emergency exemption tolerances, it believes that it has
adequately adapted the emergency exemption process to deal with the
longer lead-time inherent in the requirement for establishment of these
tolerances. Further, as noted in this unit, the Agency’s newly
established Threshold of Regulation Policy for pesticide tolerances (see
Unit IV.) may address many of the commenters’ concerns.

B. The Timely Establishment of a Tolerance After Granting an Emergency
Exemption is Crucial

     Several commenters said that EPA should establish a tolerance at
the time of the section 18 approval. The underlying concern was that the
Agency would not be able to establish a tolerance before the crop is
harvested or the commodity enters into interstate commerce. One person
remarked that in addition to the presence of an emergency condition,
growers are subject to increased uncertainty and anxiety the longer it
takes the Agency to establish a tolerance. The commenters were concerned
that crops treated in the course of an emergency would be considered
adulterated and seized for the lack of an established tolerance.

     As a general matter, the Agency agrees with the submitter. For new
pesticides, the Agency grants a registration and establishes the
required tolerances simultaneously. However, due to the urgent nature of
pest emergencies, growers need to be able to lawfully apply a pesticide
as soon as possible or face significant economic loss for that year. If
the Agency concludes that it is unable to establish a time-limited
tolerance for that use, it will notify the applicant immediately so that
some other method of control for the emergency pest situation can be
sought. EPA often has to balance its workload between establishing
tolerances and processing section 18 requests. During peak periods for
emergency exemption requests, resources used to set a tolerance could
result in the delay of another State’s section 18 application.
Nonetheless, EPA is committed to working toward the goal of being able
to set a tolerance at the same time as granting the

emergency exemption. For example, in Fiscal Year (FY) 1999, EPA’s
average time to establish a tolerance once the exemption was granted was
66 days. This is significantly faster than the average of 87 days it
took the Agency in FY 1998.

     FFDCA section 408(l)(5) explains the conditions upon which foods
and feeds may be subject to enforcement action due to pesticide
residues. Under this subsection, if a tolerance is no longer in effect,
i.e., it has been revoked or has expired, the crop may continue to be
marketed if:

     1. The crop was treated with an approved use of the pesticide at
the time of treatment, and

     2. The level of the residues do not exceed the tolerance in effect
at the time the pesticide was applied.

  In the second instance, it is important to note that the tolerance
must be in place at the time the pesticide is used. This is why many
States often submit section 18 emergency exemption requests several
months prior to the onset of the emergency in anticipation of the 2-3
month time between issuing the exemption and establishing the tolerance.
They acknowledge that for residues resulting from the use to be
considered lawful once the tolerance has expired, the tolerance must

be in place at the time of application, not the time of harvest.
Nonetheless, EPA’s policy of setting tolerances for longer duration
than the exemption ensures that crops treated during an emergency
situation should lawfully clear trade channels while the tolerance is
still in effect.

C. All Emergency Exemptions Issued Under Section 18 Should Be Covered
Under the “Pipeline” Provision

     Many of those who submitted comments thought that the
“pipeline” provision of 408(l)(5) should apply to exemptions
declared under crisis situations. The “pipeline” can be described as
those crops that have been treated legally with a pesticide that are
still in the channels of

trade when the tolerance is either revoked or, as in the case of an
emergency exemption, has expired. Those who commented on this felt that
although a tolerance is not in place at the time the unregistered
pesticide is used, since the pesticide use was legal under FIFRA section
18, any resulting pesticide residues should also be considered legal and
not subject to enforcement actions.

     Crisis exemptions are by definition unpredictable. In instances
where an emergency condition occurs suddenly and there is no time to
formally request a specific emergency exemption, a State or Federal
agency may issue a crisis exemption and permit the use of an
unregistered pesticide (40 CFR 166.40). Under a crisis exemption a
pesticide is almost always used in the field prior to the establishment
of a tolerance. However, this situation can occur for specific
exemptions as well. In many instances, a specific exemption request
(especially with first-time tolerance requests) is granted and the
pesticide may be used in the field prior to the establishment of the

time-limited tolerance, where appropriate. EPA later conducts a full
review and establishes the time-limited tolerance. If the time-limited
tolerance is not set at a length of time to allow for crops to clear
trade channels, or is not extended and therefore expires, commodities
treated under these circumstances could be adulterated and subject to
seizure.

     In both of these instances the “pipeline” provision does not
apply because a tolerance was not set at the time the pesticide is
applied. The statutory requirement of FFDCA section 408(l)(5)(B) is not
met. EPA cannot alter the requirements in the FFDCA through regulations.
Nonetheless, as noted in this unit, EPA’s policy of setting tolerances
for longer duration than the section 18 exemption generally ensures that
crops treated during an emergency situation should clear trade channels
while the tolerance is still in effect.

     Some commenters expressed concern that even though they legally
applied a pesticide under a crisis emergency exemption, if after EPA
review the

necessary tolerance level would exceed the safety standard and by law
could not be set, their entire crop could be subject to Federal
enforcement measures. To avoid this potentially dire situation, States
and Federal agencies are urged to consult with the Agency to determine
whether the pesticide in question has particular safety issues or
concerns before declaring a crisis.

D. Time-Limited Tolerances Should Be Set for Longer Than 24 Months

     A few commenters thought EPA should consider establishing
time-limited tolerances for longer than 2 years. One commenter remarked
that certain exemptions will likely be needed for 3 or more years
because issues such as new pest pressures or the development of
resistance are

not likely to go away once they have appeared. The commenter suggested
EPA set tolerances for 3 years upon initially granting the section 18
request based on circumstances which are likely to persist over several
years. The commenter added that an exemption such as one based on
unusual weather patterns probably will not reoccur in succeeding years
and a 2-year tolerance is adequate in this situation.

     Under EPA’s regulations, specific exemptions and public health
exemptions can be authorized for periods of up to 1 year (40 CFR
166.28(a)). Since actions taken under this section are intended to
address an emergency need for temporary pest relief, most section 18
exemptions are granted for one growing season. In the preamble to the
proposed rule, EPA stated that it will typically set a time-limited
tolerance for a 2-year period. This is expected to allow treated crops

from the previous year to clear the channels of trade. The Agency is
flexible on this point and may set time-limited tolerances for longer
time periods if warranted. In addition, EPA may modify or extend a
time-limited tolerance at any time on its own initiative or at the
applicant’s request. EPA has changed Sec. 176.13 in the final rule to
clarify that it may extend the duration of a tolerance for various
reasons. EPA strongly recommends that if an applicant believes that 24

months is insufficient for a time-limited tolerance, the applicant
should request a more appropriate length of time in the initial section
18 request. This will permit the Agency to judge whether a longer period
would be appropriate.

     One commenter noted that in the proposed regulatory text, the words
“unless extended” should be added to Sec. 176.11(b) to be consistent
with the language in Sec. 176.13. Section 176.11(b) states that “(b)
Tolerances will automatically expire and be revoked, without further

action by EPA, at the time set out in the Federal Register notice
establishing the tolerance.” EPA agrees with this suggestion and has
added the phrase to this section.

E. This Rulemaking Should Be Considered a “Significant Action” that
Requires OMB Review

     Two commenters disagreed with the determination that the proposed
rule was not a “significant regulatory action” as defined under
section 3(f) of Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), and stated it should have

therefore undergone review by the Office of Management and Budget (OMB),
and that the final rule should be reviewed by OMB. One commenter stated
that emergency exemptions are by definition “of economic
importance.” In addition, crop losses associated with emergency

exemptions are routinely multi-million dollar situations and that
individual States and individual growers are “significantly”
impacted by a cumbersome tolerance setting process. It was suggested
that OMB review the potential impacts associated with delays in
establishing tolerances.

     E.O. 12866 defines as “significant” a regulatory action that is
likely to:

     1. Have an annual effect on the economy of $100 million or more, or
adversely and materially affect a sector of the economy; productivity;
competition; jobs; the environment; public health or safety; or State,
local, or tribal governments or communities;

     2. Create serious inconsistency or otherwise interfere with an
action taken or planned by another agency;

     3. Materially alter the budgetary impacts of entitlements, grants,
user fees, or loan programs; or

     4. Raise novel legal or policy issues.

     The determination of whether or not a regulatory action should be
reviewed by OMB under E.O. 12866 is made in consultation with OMB. Since
this rule is a procedural rule that codifies the internal process by
which EPA will set emergency tolerances, OMB determined that it was

not a significant regulatory action that required OMB review under E.O.
12866. As stated in the proposal’s preamble, EPA estimates that the
direct cost of this rule will be minimal because only EPA and applicants
are directly affected, and this action does not require applicants to
submit new or additional information.

     The Agency determined that this rule, once promulgated, is not
expected to significantly change applicant activities, such that it
would increase the current burden to applicants and therefore is
unlikely to have a major economic impact on the States or Federal
agencies that apply for section 18 exemptions. In addition, EPA affirms
that promulgation of this rule will have no direct impact on any other
sector of the economy, or on any other government entities, programs, or
policies. A copy of the economic analysis is available in the public
version of the official record for this rule (see Unit I.B.2.).

IV. Is a Tolerance Needed?

     On October 27, 1999, EPA published in the Federal Register a notice
of availability of a policy entitled, “Threshold of Regulation
Policy--Deciding Whether a Pesticide With a Food Use Pattern Requires a
Tolerance” (64 FR 57881) (FRL-6388-2). This policy pertains to the use

of a pesticide (including an emergency use) on, in, or near food which
does not result in residues that are detectable in food. EPA is adopting
this policy which sets forth criteria to consider in

evaluating whether there is no “need” to establish a tolerance,
i.e., there is no reasonable expectation of finite residues of the
pesticide in the food. If the criteria are met, there is no requirement
for a tolerance or tolerance exemption. The Threshold of Regulation
policy

will be applicable for pesticide uses that result in no detected
residues in food and for which the degree of potential risk posed by any
theoretically possible residues is so minimal that tolerance

setting serves no purpose.

     The Threshold of Regulation Policy can apply to time-limited
tolerances for section 18 emergency exemptions. In these instances, the
Agency will consider surrogate data in the case of emergency exemption
requests where all the data needed on the performance of the analytical

method or the magnitude of the residue as determined by field trial
studies on the subject commodity are unavailable. Given the emergency
circumstances, EPA may consider accepting data from a different crop to
establish eligibility for the threshold of regulation. Persons wishing

a Threshold of Regulation policy decision should make the request in
writing and submit materials and information that are ordinarily
required to support time-limited tolerances or tolerance exemptions.

V. Regulatory Assessment Requirements

A. Executive Order 12866

     Pursuant to Executive Order 12866, entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993), it has been determined that this
action is not a “significant regulatory action” and is therefore not
subject to review by OMB. OMB has made this determination because this
final rule is a procedural rule that codifies the internal process by

which EPA will set emergency tolerances. Applicants for section 18
emergency exemptions (i.e., Federal and State agencies) are the only
parties, other than EPA, directly affected by this action. According to
the economic assessment conducted by the Agency, the applicants of
section 18 emergency exemptions are not expected to experience any
adverse impacts as a result of this rule because the rule does not
require any new or additional data from applicants.

     A copy of the economic assessment is available in the public
version of the official record for this rule (see Unit I.B.2.).

B. Regulatory Flexibility Act

     Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this regulatory
action does not have a significant economic impact on a substantial
number of small entities. Applicants for section 18 emergency exemptions
are U.S. States, territories, or Federal agencies which, by definition,
are not small entities under the RFA. Applicants for section 18
emergency exemptions are the only parties, other than EPA, directly
affected by this action.

     Information regarding this determination will be provided to the
Chief Counsel for Advocacy of the Small Business Administration (SBA)
upon request.

C. Paperwork Reduction Act

     Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not required
to respond to, an information collection request unless it displays a
currently valid OMB control number. The OMB control numbers for EPA’s
regulations, after appearing in the preamble of the final rule, are
listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the
related collection instrument. This regulatory action does not contain
any new information collection requirements that would require
additional OMB review and approval.

     The information collection activities related to the procedures for
emergency exemptions under section 18 of FIFRA, which are contained in
40 CFR part 166, are already approved by OMB under OMB control number
2070-0032 (EPA ICR No. 596), and the process and informational needs for
requesting that the Agency establish or provide an exemption from the
establishment of a tolerance or maximum-residue level for the use of a
pesticide on food or feed crops, which are contained in 40 CFR part 180,
are already approved by OMB under OMB control number 2070-0024 (EPA ICR
No.597). As described in the information collection instruments, the
annual respondent burden for the information collection activities in 40
CFR part 166 is estimated to average 103 hours per application,
including time for reading the regulations, processing, compiling and
reviewing the requested data, generating application correspondence or
summary reports, and storing, filing, and maintaining the data. The
annual respondent burden for the information collection activities in 40
CFR part 180 is estimated to average 1,726 hours per petition, including
time for reading the regulations, processing, compiling and reviewing
the requested data, generating the request, storing, filing, and
maintaining the data.

     As defined by the PRA and 5 CFR 1320.3(b), “burden” means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or for
a Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.

D. Environmental Justice Considerations

     This final rule does not involve special considerations of
environmental-justice issues pursuant to Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority Populations
and Low-Income Populations (59 FR 7629, February 16, 1994). The Agency
has determined that this final rule does not affect the environmental
and health conditions in low-income and minority communities because
this rule codifies the internal process by which EPA will set emergency
tolerances, and only applies to applicants for section 18 emergency
exemptions (i.e., Federal and State agencies). In general, low-income
and minority communities are more likely to benefit from the risk
assessment process needed for the establishment of tolerances for
section 18 actions that might impact their community.

E. Unfunded Mandates Reform Act

     Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not contain
a Federal mandate that may result in expenditures of $100 million or
more for State, local, and tribal governments, in the aggregate, or the
private sector in any 1 year. As applicants for section 18 emergency
exemptions, Federal and State agencies are the only parties, other than
EPA, directly affected by this action. The potential impact on State
agencies, however, is expected to be minimal because this action does
not require applicants to submit new or additional information. In
addition, EPA has determined that this rule does not significantly or
uniquely affect small governments. Accordingly, this action is not
subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

F. Federalism

     Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), requires EPA to develop an accountable process to ensure
“meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.”
“Policies that have federalism implications” is defined in the
Executive Order to include regulations that have “substantial direct
effects on the States, 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 will not have substantial direct effects on the States, on the

relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132. Since this rule
codifies an internal process for the Agency, and does not impose
requirements on others, the Agency determined that this rule will not
adversely impact the entities that apply for section 18 exemptions. The
process established by this final rule will more likely benefit
applicants and others by establishing an effective and efficient process
for the Agency to take the necessary tolerance actions in a timely
manner. Thus, the requirements of

section 6 of the Executive Order do not apply to this rule.
Nevertheless, the Agency provided an opportunity for Federal and State
agencies to review and provide comments on the proposed process. A
discussion of the comments EPA received, which includes comments from
several State and local officials, and how those comments are addressed
in the final rule, is provided in Unit III.

G. Consultation and Coordination with Indian Tribal Governments

     Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. This final
rule implements requirements specifically set forth by the Congress in

FFDCA section 408(l)(6) without the exercise of any discretion by EPA.
The final rule does not significantly or uniquely affect the communities
of Indian tribal governments. Accordingly, the requirements of section
3(b) of Executive Order 13084 do not apply to this final rule.

H. Children’s Health Protection

     This final rule is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866 (see
Unit V.A.). In addition, this final rule is procedural in nature and
does not involve decisions on environmental health or safety risks that
may disproportionately affect children.

I. National Technology Transfer and Advancement Act

     This regulatory 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). Section 12(d) directs EPA to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, business practices,
etc.) that are developed or adopted by voluntary consensus standards
bodies. The NTTAA requires EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and applicable
voluntary consensus standards.

J. Civil Justice Reform

     In issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR
4729, February 7, 1996).

K. Constitutionally Protected Property Rights

     EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property Rights
 (53 FR 8859, March 15, 1988), by examining the takings implications of
this rule in accordance with the ``Attorney General’s Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the Executive Order.

VI. Submission to Congress and the General Accounting Office

     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 the
rule in the Federal Register. This action is not a “major rule” as
defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 176

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

     Dated: October 16, 2000.

Carol M. Browner,

Administrator.

     Therefore, 40 CFR chapter I is amended by adding new part 176 to
read as follows:

PART 176--Time-Limited Tolerances for Emergency Exemptions

Sec.

176.1   Scope and applicability.

176.3   Definitions.

176.5   Establishment of a time-limited tolerance or exemption.

176.7   Information needed to establish a tolerance.

176.9   Publication of a tolerance.

176.11   Duration of a tolerance.

176.13   Modification of a time-limited tolerance.

176.15   Effect of a tolerance.

     Authority:  21 U.S.C. 346a and 371.

Sec. 176.1  Scope and applicability.

     This part describes the procedures and criteria under which EPA
will establish time-limited tolerances and exemptions from the
requirement of a tolerance for pesticide chemical residues associated
with use of pesticides under emergency or crisis exemptions under FIFRA

section 18. This part applies only to tolerances issued on the
initiative of EPA as the result of the issuance of an emergency
exemption or the declaration of a crisis exemption. This part does not

cover time-limited tolerances in any other circumstances.

Sec. 176.3  Definitions.

     The terms have the same meaning as in the Federal Insecticide,
Fungicide, and Rodenticide Act section 2, and in the Federal Food, Drug,
and Cosmetic Act section 201 and Sec. 166.3 of this chapter. In
addition, the following terms are defined for the purposes of this part.

     Agency means the U.S. Environmental Protection Agency.

     Applicant means any entity authorized under section 18 of FIFRA to
request an emergency exemption that requests such an exemption under
Sec. 166.20 of this chapter, or issues a crisis exemption under Sec.
166.40 of this chapter.

     Crisis exemption means an exemption authorized under FIFRA section
18, in accordance with Sec. Sec. 166.40 through 166.53 of this chapter.

     Emergency exemption means a specific, quarantine, or public health
exemption authorized under FIFRA section 18 and the regulations at Sec.
Sec. 166.20 through 166.35 of this chapter.

     EPA means the U.S. Environmental Protection Agency.

     FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
et seq.).

     FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C 136 et seq.).

     Tolerance means the maximum amount of a pesticide chemical residue
that may lawfully be present in or on a raw agricultural commodity, or
processed food, or animal feed, expressed as parts per million by weight
of the pesticide chemical residue in the food or feed.

     Tolerance exemption means a formal determination by the Agency
pursuant to FFDCA section 408(c), 21 U.S.C 346a(c), that no tolerance is
needed for a given pesticide chemical residue in or on a particular food
commodity. For purposes of this part, the term “tolerance” shall

include an exemption from the requirement of a tolerance.

Sec. 176.5   Establishment of a time-limited tolerance or exemption.

     EPA will establish a time-limited tolerance for pesticide chemical
residues in or on raw or processed food or feed resulting from the use
of a pesticide chemical, if EPA authorizes an emergency exemption or a
crisis exemption. EPA will consider establishing such a tolerance only

if an applicant acting under authority of FIFRA section 18 either has
requested an emergency exemption, has stated its intention to issue a
crisis exemption, or has issued a crisis exemption for a use that may
result, directly or indirectly, in pesticide chemical residues in food
or feed.

Sec. 176.7   Information needed to establish a tolerance.

     (a) EPA will establish a time-limited tolerance only if EPA can
determine that the tolerance is safe, that is, there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue. EPA will base its determination upon data
submitted by the applicant and other readily available data. If, taking
into account the limited duration and emergency nature of a section 18
application, and based on the available data the Agency cannot conclude
that there is a reasonable certainty that no harm will result from the
use proposed by the applicant or granted pursuant to a crisis exemption,
EPA will not establish a tolerance.

     (b) Data and other relevant information to support the
establishment of a time-limited tolerance may be submitted by the
applicant, or by any other person, in support of the time-limited
tolerance. The applicant may also cite relevant data previously
submitted to the Agency.

Sec. 176.9  Publication of a tolerance.

     (a) If EPA issues an emergency exemption or crisis exemption under
FIFRA section 18, and EPA concludes that the tolerance for residues
resulting from use of the pesticide under the exemption will be safe,
then EPA will establish the tolerance by publishing an amendment to 40

CFR part 180 in the Federal Register.

     (b) A tolerance under this part may be established without prior
publication of a proposed tolerance or comment period.

Sec. 176.11  Duration of a tolerance.

     (a) Tolerances issued under this part will become effective upon
publication in the Federal Register, unless otherwise specified by the
Administrator.

     (b) Unless extended, tolerances will automatically expire and be
revoked, without further action by EPA, at the time set out in the final
rule published in Federal Register.

     (c) The Administrator may revoke a tolerance at any time if the
Administrator determines that the tolerance is no longer safe.

Sec. 176.13  Modification of a time-limited tolerance.

     If additional emergency or crisis exemptions are authorized that
would extend use beyond the date originally authorized, or if EPA
determines that the duration of a time-limited tolerance is

insufficient to allow treated commodities to clear the channels of
trade, EPA may modify the time-limited tolerance by publication of a
final rule in the Federal Register. EPA will use the same criteria and
procedures for modification as for establishing tolerances under this
part.

Sec. 176.15  Effect of a tolerance.

     The establishment of a tolerance under this part does not alter the
requirement that any applicant comply with procedures established in
part 166 of this chapter for emergency exemptions of FIFRA.

[FR Doc. 00-27405 Filed 10-24-00; 8:45 am]

BILLING CODE 6560-50-S

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment E

Public Comment Received Regarding

the Proposed Renewal ICR and EPA Response to Comment

ATTACHMENT E – reserved for public comment – see docket entries, if
any, at EPA-HQ-OPP-2007-0320

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment F

Consultant Contacts and Comments Received in the Consultation Process

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment F

Consultant Contacts and Comments Received in the Consultation Process

ATTACHMENT F

Application and Summary Report for an Emergency Exemption for Pesticides

(OMB 2070-0032)

Consultant Contacts and Comments Received in the Consultation Process

Dr. Brian J. Hughes

Toxicologist/Pesticide Registration Manager

Pesticide and Plant Pest Management Division 5th Floor, Constitution
Hall North

Lansing, Michigan 48933

(517) 241-3267

Cynthia Crowley, Environmental Chemist l

New York State Department of Environmental Conservation

Bureau of Pesticides Management

Division of Solid & Hazardous Materials

625 Broadway

Albany, New York 12233

(518) 402-8768

Dr. Laura Quakenbush

Colorado Department of Agriculture

Division of Plant Industry

700 Kipling Street, Suite 4000

Lakewood, Colorado 80215

(303) 239-4147

EPA Questions asked in Consultation

(1)	Publicly Available Data

Is the data that the Agency seeks available from any public source, or
already collected by another office at EPA or by another agency?  The
states agreed that all of the necessary data the Agency seeks is not
available anywhere else and that each application is unique.  However,
parts of the section 18 package can be pulled from other sources, such
as reference to a previously submitted application from another state
for the same use pattern.

CO	No

MI	No.  The specifics of pest problems, range, and economic impacts vary
from state to state.  There are agencies that make parts of the
information public.  For example, the USDA Michigan Agricultural
Statistic Service has amounts of acreage for a particular commodity by
county, but the extent and magnitude of the economic impacts are
different.  Only partial data can be obtained through alternate
resources.  It is usually the technical expertise to evaluate the data
in the context of pest management that gives meaning to it.

NY	No. While other resources are available for parts of the submission
(Our state and national ag databases, extension agents), we still need
to collate the information into a single submission

If yes, where can you find the data?  (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are
available, but that they do not meet our data needs very well?)

NY	Crop statistics are available publicly from the New York State
Agriculture & Markets and the National Agriculture Statistical Service
websites; this would include acreage planted and harvested as well as
value of the crop.  These sites also give the historical information for
previous years.  Cornell also uses data that are not publicly available.
 Many times we have to rely on grower information relative to crop
inputs such as cost of materials, chemicals/fertilizers, harvesting, to
determine the cost of producing a commodity on a per acre basis.  Also,
grower spray records are collected to evaluate resistance and the number
of sprays being made

(2)	Frequency of Collection

Can the Agency collect the information less frequently and still produce
the same outcome?

CO	Not without a federal rule change.  Frequency is mandated by rule
(CFR).  We would support more regional and national submissions.  For
example, a national submission from USDA for soybean rust.

MI	Yes, particularly when the section 18s are repeated from year to
year.

NY	We are probably constrained by the CFR, but could specific exemptions
be for more than one use season?  The streamlined re-certification
process makes this less of an issue.  Can more regional or national
submissions be made?  The states would certainly support a national
submission (from USDA) for soybean rust quarantine exemptions

(3)	Clarity of Instructions

The ICR is intended to require that respondents provide certain data so
that the Agency can utilize them.

Based on the instructions (regulations, PR Notices, etc.), is it clear
what you are       required to do and how to submit such data? If not,
what suggestions do you have to clarify the instructions?

CO	Clarity of instructions is relatively good.  I have built my own
template for initial section 18 requests using the November 8, 2001
Instructions document from EPA.

MI	 The instructions are sufficient.

NY	Instructions are detailed and clear.  Cornell has an outline and
instructions on their PMEP website that provides	assistance to those
wanting to create an emergency exemption.

Do you understand that you are required to maintain records?

CO	Yes.

MI	Yes, we maintain the records for 3 years in our files.

NY	Yes

Considering that there is no required submission format, is it difficult
to submit information in ways that are clear, logical and easy to
complete?

CO	I understand what is required for submission, but the learning
process was not that easy.  Editing an example from another state or a
previous submission is easier than using the EPA guidance.  It would be
useful if the 2001 “Instructions” were updated to reflect the recent
changes.

MI	There is an outline in 40 CFR 166.20 that provides adequate guidance
on the information that must be in the section 18 applications.

NY	No

Are there forms associated with this process?  Do you use them?  Are
they clear, logical, and easy to complete?

CO	There are no EPA-provided forms associated with this process.

MI	There are no forms associated with this process from EPA.  AAPCO has
a created a format for the letters of recertification.  However, states
can choose to create their own format.  In this case, I prefer my own
submission format.

NY	No

(4)	Electronic Reporting and Record keeping

The Government Paperwork Elimination Act requires agencies make
available to the public electronic reporting alternatives to paper-based
submissions by 2003, unless there is a strong reason for not doing so.
One such reason is that, at the present time, the Agency is unable to
ensure the security of CBI that might be transmitted over the Internet.

What do you think about electronic alternatives to paper-based records
and data submissions?  Current electronic reporting alternatives include
the use of web forms/XML based submissions via the Agency’s Internet
site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc.
Would you be interested in pursuing electronic reporting?

CO	It would be useful to be able to submit initial requests, repeat
requests, and use reports electronically.  We would be interested in
submitting via email, but with any information that might be considered
CBI (under Colorado definitions) submitted has hardcopy and/or on CD.
We would be less interested using any web-based systems.

MI	The Michigan Department of Agriculture is in favor of electronic
submission and would like to explore this opportunity.  However, I think
there should be some security measure if submissions are sent over the
internet (encryption).

NY	The New York Department of Environmental Conservation submitted
re-certifications only electronically this year.  We are moving towards
having all of our information in electronic format and would support
electronic submissions (email, FTP, or through an Agency web site).

Are you keeping your records electronically?  If yes, in what format?

CO	The request is a word file (which we could easily submit as a .pdf
file if preferred).  However, some of the additional documents may not
be provide to us in electronic format.  We have increasingly been asking
for electronic versions of section 3 labels, section 18 use directions,
supporting efficacy data, residue study data, and other supporting
documents.

We currently keep as many of the documents as possible needed for or
related to a particular section 18 submission in electronic form.  Each
year has a folder with each candidate section 18 request having a
sub-folder on a network drive.  It is easier to find the documents on
the network drive than digging out the hard file.  Formats vary,
including .doc (word), .xls (excel), .pdf and an occasional PowerPoint
file of efficacy data.

Our section 18 responsibilities are considered a critical function under
our emergency planning, and much of our planning resolves around access
to information on the networked drives (not my hard files).  I need to
be able to continue on with section 18 activities within 12 hours of
losing access to our building.

MI	The submissions are kept on the Department of Agriculture’s server
on the hard drive.  The files are Word 2002 and in .pdf format. Yes, we
maintain the records for 3 years in our files.

NY	WordPerfect, Word, PDF, Excel.  Emergency exemptions are posted on
the Cornell website for the current and previous year(s).

Although the Agency does not offer an electronic reporting option
because of CBI-related security concerns at this time,

Would you be more inclined to submit CBI on diskette (CD or DVD) than on
paper?

CO	Most section 18 submissions do not involve submission of CBI.  In a
few rare cases, detailed economic data may be provided by a business.
This is kept as a separate attachment instead of including it as part of
the section 18 request document.  We would be more inclined to submit
CBI as a hard-copy than electronic.  Papers are shredded and it is less
clear how to destroy information on electronic media.  We currently send
back CD’s when submitted by our state pesticide registration
registrants for this reason (they may stick the CSF on a CD along with
labels and MSDS’s.)

MI	We would more than likely transmit CBI via CD.

NY 	New York State does not have any CBI concerns for Sec 18
submissions.

What benefits would electronic submission bring you in terms of burden
reduction or greater efficiency in compiling the information?

CO	The major benefit for an electronic submission to EPA would be the
assurance that the submission reached the correct person more quickly
and more dependably.  There would also be a cost savings.  We wouldn’t
need to pay for shipment via federal express, wouldn’t have
photocopying costs, and would require less staff time for copying and
mailing.  Electronic submissions would not provide a benefit in terms of
compiling the information.

MI	There is no overall burden reduction or efficiency in compiling the
data.

NY 	Reduction of duplication and shipping costs (both time and $).  Also
no postage is necessary as there is no “snail” mail along with easy
storage and access.  It is also easier to post to a website since there
is no need for xeroxing and duplicating.  Email has made the turnaround
time much quicker relative to getting information from the registrant.

(5)	Burden and Costs

Are the labor rates accurate?

CO	The labor rates for Mgmt. and Tech are reasonable, but the clerical
rate is high.     We would estimate only $24/hour for clerical, not $42.

MI	EPA labor rates may reflect national average.  However, costs to the
state in Michigan may be less.

NY	Yes

The Agency assumes there is no capital cost associated with this
activity.  Is that correct?

CO	Yes, there are no capital costs associated with this activity.

MI	Yes, there are no capital costs associated with this activity.

NY	Yes, there are no capital costs associated with this activity.

Bearing in mind that the burden and cost estimates include only burden
hours and costs associated with the paperwork involved with this ICR,
e.g., the ICR does not include estimated burden hours and costs for
conducting studies, are the estimated burden hours and labor rates
accurate? If you provide burden and cost estimates that are
substantially different from EPA’s, please provide an explanation of
how you arrived at your estimates.

CO	The burden hours for Clerical should be higher.

The amount of time required from clerical will depend on how many
applicators use the section 18 product.  For many of our section 18
requests, we require each applicator to be a licensed applicator, obtain
a special permit from us, and submit a final use report providing the
information we need to supply to EPA in our use report.  Clerical staff
talks to each applicator on the phone, issues a permit number, sends
them an application package, makes sure each permittee returns there
permit application and the final the use report, and compiles a summary
of the total amount and area of use.  This is the source of the
information we send to EPA in our final use report.

The burden hours for “technical” is too high, we estimate 40 hours
for CDA staff; not 93.  We also consult with University extension people
and also grower groups and industries that want a section 18.  If we
include their time as well (not including effort to conduct efficacy
studies or summarize studies that they would be doing regardless of use
in a section 18 request) it might add an additional 15 hours.  (= 55
hours total for technical).

How this was determined:  In a typical year, the pesticide registration
coordinator prepares about 10 section 18 requests.  During previous
years, this would occupy 50% of her time for one month and 25% for an
additional 2 months on section 18’s during the winter months.  That
works out to 40 hours.

MI	Cost burdens are not vastly different.

New York State Burden/Cost Estimates

COLLECTION ACTIVITY

Burden Hours

(per application)

Total

Mgmt.

$65/hr

Tech.

$54/hr

Cler.

$42/hr

Hours

Costs ($)

Read FIFRA and FQPA requirements and CFR regulations.

2

4

0

6

346

Process, compile, and review the requested data for accuracy and
appropriateness.

4

15.6

0

15.6

1,102

Generate application correspondence and follow-up summary report.

0

4

0

4

216

Store/maintain/submit information

0

0

3.5

3.5

147

Totals

6

23.6

3.5

33.1

1,811

Are there other costs that should be accounted for that may have been
missed?

CO	There have been training costs incurred as we learned the new
streamlined submission process, and participated in various meetings and
discussions prior to the final rule change.

MI	Are you including the costs of only issuing the Section 18 without
any enforcement or follow-up costs?  If so, these are costs with the
section 18 that are potentially missed. Also if there is any special
conditions in the granting document (eg monitoring).

NY	No costs have been missed.

(6)  	Miscellaneous – Response to Emergency Exemption Process
Revisions

	How has the streamlined application process impacted your Division?

As it pertains to recertification of certain repeat emergency exemptions

CO	The streamlined process has greatly reduced the effort required to
prepare repeat requests.  This year we put together four of these in one
day (2 hours each).  Under the old system repeat requests would take
less time and effort than the initial application, perhaps 24 hours
instead of the 40 hour average.

MI	The streamlined process has actually lessened the time of the
technical expert in responding to section 18 requests.

NY	The streamlined process has been a significant savings in time and
money.

As it pertains to the criteria used to determine when a potential
emergency condition is expected to cause a significant economic loss and
the data requirements used to document the loss

Has the application and review process for submitting repeat emergency
exemptions improved since the regulation went into effect March 28,
2006?

CO	This has also made preparation of section 18 requests substantially
easier.  It also makes it easy to know when a situation will not qualify
and clarifies for extension specialists what type of information is
needed.  This may reduce EPA’s workload in ways that they may not be
directly aware of, since we will not submit a request if it doesn’t
meet the very clear criteria that have now been spelled out for us.

The application process for submitting repeat exemptions has improved
since the regulations took effect in March of 2006.  It is still too
early to see if the turn-around time on EPA’s side has been reduced.

MI 	In a few instances, we have needed to seed the help of an
agricultural economist to deal with a tier 3 economic analysis.   Since
the new the regulation went into effect we have been able to turn around
section 18 submissions faster and receive approval quicker from EPA.

NY 	As it pertains to the criteria used to determine when a potential
emergency condition is expected to cause a significant economic loss and
the data requirements used to document the loss.  The information and
time required for this is similar to what was required previously. Yes,
the application and review process for submitting repeat emergency
exemptions have improved since the regulation went into effect March 28,
2006.

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment G

EPA Form No. 8570-4

Confidential Statement of Formula

This attachment is available as part of the electronic in the docket
EPA-HQ-OPP-2007-0320.  he form is also available electronically via the
Internet at   HYPERLINK "http://www.epa.gov/opprd001/forms/8570-4.pdf"
http://www.epa.gov/opprd001/forms/8570-4.pdf

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment H

Methodology for Estimating OPP ICR Wage Rates for Industry, State and
EPA Labor Costs; Memo From Richard Keigwin, Director Biological and
Economic Analysis Division, to OPP Division Directors, July 2006. This
attachment is available only as part of the electronic in the docket
EPA-HQ-OPP-2007-0320.

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment I

Display Related to OMB Control No. 2070-0032

Listings of Related Regulations in 40 CFR 9.1

ATTACHMENT I

Display Related to OMB Control #2070-0032 - Listings of

Related Regulations in 40 CFR 9.1

	As of May 10, 1993, the OMB approval numbers for EPA regulations in
Chapter I of Title 40 of the Code of Federal Regulations (CFR) appear in
a listing in 40 CFR 9.1 (58 FR 27472).  This listing fulfills the
display requirements in section 3507(f) of the Paperwork Reduction Act
(PRA) for EPA regulations.  The listing at 40 CFR 9.1 displays this OMB
Control number for the following regulations:

Program
Ti汴㐉‰䙃⁒楣慴楴湯഍䔍數灭楴湯漠敆敤慲湡
瑓瑡杁湥楣獥映牯ഠ獕景倠獥楴楣敤⁳湕敤⁲浅
牥敧据⁹潃摮瑩潩獮ㄉ㘶㈮രउउउ††ठ㘱⸶㈳ऍउ
उ ††ㄉ㘶㐮ളउउउ††ठ㘱⸶〵̍഍ഄ̍഍ഄ഍
഍

഍

഍഍഍

഍

഍഍഍

഍

഍഍


[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]
[Page 47613]
[DOCID:fr06au10-97]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1925-DR; Docket ID FEMA-2010-0002]

Kentucky; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-1925-DR), dated July 23, 2010,
and related determinations.

DATES: Effective Date: July 30, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective July 30, 2010.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-19455 Filed 8-5-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 2 (Tuesday, January 4, 2011)]
[Rules and Regulations]
[Page 255]
[FR Doc No: 2010-33171]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0829; Directorate Identifier 2010-NE-23-AD;
Amendment 39-16524; AD 2010-24-05]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Canada Corp. (P&WC)
PW305A and PW305B Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: The FAA is correcting an airworthiness directive (AD) that
published in the Federal Register. That AD applies to the products
listed above. The agency docket No. and the engine type in the subject
heading and paragraph (c) in the Summary section and the Regulatory
text are incorrect. This document corrects that error. In all other
respects, the original document remains the same.

DATES: This final rule is effective January 3, 2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, 12 New England Executive Park,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Airworthiness Directive 2010-24-05,
amendment 39-16524 (75 FR 72653, November 26, 2010), currently requires
updating the airworthiness limitations section of the engine
maintenance manuals for Pratt & Whitney Canada (P&WC) PW305A and PW305B
turbofan engines.
    As published, the agency docket No. in the Summary section and the
engine type in the Summary section and in the Regulatory text are
incorrect.
    No other part of the preamble or regulatory information has been
changed; therefore, only the changed portion of the final rule is being
published in the Federal Register.
    The effective date of this AD remains January 3, 2011.

Correction of Non-Regulatory Text

    In the Federal Register of November 26, 2010, AD 2010-24-05;
Amendment 39-16524 is corrected as follows:
    On page 72653, in the third column, on line 19 under 14 CFR Part
39, change ``Docket No. FAA-2010-0892'' to ``Docket No. FAA-2010-
0829''.
    On page 72653, in the third column, on line 25 under 14 CFR Part
39, change ``PW305A and PW305B Turboprop'' to ``PW305A and PW305B
Turbofan''.

Correction of Regulatory Text

Sec.  39.13  [Corrected]

0
In the Federal Register of November 26, 2010, on page 72655, in the
first column, paragraph (c) of AD 2010-24-05 is corrected to read as
follows:
* * * * *
    (c) This AD applies to Pratt & Whitney Canada Corp. (P&WC)
PW305A and PW305B turbofan engines with certain impellers, part
numbers (P/Ns) 30B2185, 30B2486, 30B2858-01, or 30B4565-01
installed. These engines are installed on, but not limited to,
Hawker-Beech Corporation BAe.125 series 1000A, 1000B, and Hawker
1000 airplanes and Learjet Inc. Learjet 60 airplanes.
* * * * *

    Issued in Burlington, Massachusetts, on December 22, 2010.
Peter A. White,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2010-33171 Filed 1-3-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Page 69486]
[FR Doc No: 2010-28451]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63208A; File No. SR-DTC-2010-13]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Implement a Disincentive Fee Associated With the Deposit Automation
Management System

November 5, 2010.

Correction

    In FR Document No. 2010-27856 beginning on page 68013 for Thursday,
November 4, 2010, the paragraph under which The Depository Trust
Company (``DTC'') filed the proposed rule change was incorrectly
identified as section 19(b)(3)(A)(iii) of the Securities Exchange Act
of 1934 (``Exchange Act'') and Rule 19b-4(f)(3) thereunder. The correct
paragraph under which DTC filed the proposed rule change is section
19(b)(3)(A)(ii) of the Exchange Act and Rule 19b-4(f)(2).

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-28451 Filed 11-10-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Page 4997]
[FR Doc No: 2023-01488]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15272-000]

Premium Energy Holdings, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On March 31, 2022, Premium Energy Holdings, LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Whale Rock Pumped Storage Hydro Project to be located approximately 0.5
miles east of Cayucos, California in San Luis Obispo County. The sole
purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed closed-loop project would consist of the following:
(1) a new upper reservoir with a normal maximum operating elevation of
1,788 feet average mean sea level, a surface area of 87 acres, and a
total storage capacity of 4,780 acre-feet; (2) an existing lower
reservoir (Whale Rock Reservoir completed in 1961); (3) a 0.68-mile-
long headrace tunnel, 0.16-mile-long vertical shaft, 4.76-mile-long
horizontal tunnel, 0.07-mile-long penstock, and 0.99-mile-long tailrace
tunnel with a maximum head of 1,558 feet connecting the reservoirs to
the powerhouse; (4) a new powerhouse located on land owned by the State
of California that would house 4 new pump-turbines rated at 150
megawatts each; (5) a new substation constructed on the southern shore
of Lake Nacimiento near the powerhouse connected to the regional
electrical utility with either, (6) 7 miles of existing line
(upgraded), interconnecting the Morro--Solar 230-kilovolt (kV)
transmission line, or 7 miles of existing line (upgraded),
interconnecting the Morro--Diablo 230-kV transmission line and 0.5
miles of new right-of-way south of the Baywood substation for the new
tap interconnection; and (7) appurtenant facilities. The estimated
annual power generation at the Whale Rock Pumped Storage Project would
be 1,200,000 megawatt-hours.
    Applicant Contact: Victor M. Rojas, Managing Director, Premium
Energy Holdings, LLC. 355 South Lemon Ave., Suite A, Walnut, California
91789; phone:<PHONE_NUMBER>; [email protected].
    FERC Contact: Benjamin Mann; email: [email protected]; phone:
(202) 502-8127.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-15272.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-15272) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: January 19, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-01488 Filed 1-25-23; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I had tried to quit smoking analog cigarettes for years.  I tried patches and gum to no avail.  Upon extensive research on smokeless delivery systems I decided to give the vapor delivery system a try.  I have met with great success.  I have gone from smoking a pack and a half of analogs a day to no analogs at all in two weeks.  I am sincerely grateful to the vaping community for helping me quit a habit that I sincerely thought I would never quit.  I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation. This issue is extremely important to all those that see vaping as a lifesaving alternative to the deadly analog industry.

I appreciate your consideration of my request and am happy to discuss this issue with you further.