[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Page 17645]
[FR Doc No: 2014-06847]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2014-0014]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated January 23, 2014, the Texas State Railroad (TSRR) has petitioned
the Federal Railroad Administration (FRA) for a waiver of compliance
from certain provisions of the Federal railroad safety regulations
contained at Title 49 CFR part 232, Brake System Safety Standards for
Freight and Other Non-Passenger Trains and Equipment; End-of-Train
Devices. FRA assigned the petition Docket Number FRA-2014-0014.
    TSRR is a tourist railroad that operates between Rusk and
Palestine, Texas, for 25 miles and at a track speed of 20 mph. TSRR
owns and operates passenger equipment that is equipped with the UC and
L types of brake valves. Specifically, TSRR requests relief from 49 CFR
232.17(b)(2) to extend the time interval from 1 year to 2 years to
perform the clean, oil, test, and stencil inspection for the passenger
equipment operated and equipped with UC and L types of brake valves.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov/. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by May 12, 2014 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2014-06847 Filed 3-27-14; 8:45 am]
BILLING CODE 4910-06-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request: U. S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, Chemical Emergency Preparedness and Planning Office 2. OMB control number b.

None a. 2050  0144 3. Type of information collection ( check one) a.

New collection b. Revision of a currently approved collection c.  Extension of a currently approved collection d.

Reinstatement, without change, of a previously approved collection for which approval has expired e.

Reinstatement, with change, of a previously approved collection for which approval has expired f.

Existing collection in use without an OMB control number 4. Type of review requested ( check one) a.

Regular b.

Emergency  Approval requested by: / / c.

Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities?

Yes

No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.

Three years from approval date b.

Other Specify: / /___

7. Title: Information Collection Requirements for Registration and Documentation of Risk Management Plans under Section 112r of the Clean Air Act.

8. Agency form number( s) ( If applicable) ICR 1656.09 9. Keywords: Clean Air Act Amendments, Accidental Release Prevention, Registration, Documentation, Risk Management Plans, Risk Management Programs.

10. Abstract: Under Section 112r of the Clean Air Act, as amended, sources must register, document risk management programs, and submit risk management plans to EPA by June 21, 1999. The plans shall include information on a source's hazard assessment, prevention program, and emergency response program. The regulations, codified in 40 CFR part 68, also include requirements for a petitioner to submit sufficient information in support of a petition to scientifically support the request to add or delete a chemical from the list of regulated substances. The Agency will use this information in making the decision to grant or deny a petition.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. __ Farms b. P Business or other for profit e.

Federal Government c. Not for profit institutions f.

State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a.

Voluntary b.

Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 16,650 b. Total annual responses 5,550 1. Percentage of these responses collected electronically 90 % c. Total hours requested 97,160 d. Current OMB inventory 109,800 e. Difference  12,640 f. Explanation of difference 1. Program Change 0 2. Adjustment  12,640 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 6 c. Total annualized cost requested 6 d. Current OMB inventory 9 e. Difference  3 f. Explanation of difference 1. Program change 0 2. Adjustment  3 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a.

Recordkeeping b.

Third party disclosure c.

Reporting 1.

On occasion 2.

Weekly 3.

Monthly 4.

Quarterly 5.

Semi annually 6.

Annually 7.

Biannually 8.

Other ( describe) every 5 years 17. Statistical methods Does this information collection employ statistical methods?

Yes

No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Sicy Jacob Phone: 202 564 8019 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Evaluation ( OPPE) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57580-57581]
[DOCID:fr03oc05-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER05-667-003]

Midwest Independent Transmission System Operator, Inc.; Notice of
Filing

September 27, 2005.
    Take notice that on September 23, 2005, the Midwest Independent
Transmission System Operator, Inc. (Midwest ISO) tendered for filing, a
redline version of a March 2, 2005, unexecuted Large Generator
Interconnection Agreement among

Dakota Wind Harvest, LLC, the Midwest ISO, and Montana-Dakota Utilities
Company. Midwest ISO explains that this redline version compares the
unexecuted agreement with the pro forma Large Generator Interconnection
Agreement in effect at the time the March 2 unexecuted agreement was
filed.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on October 4, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5400 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44718-44725]
[FR Doc No: 2019-18386]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0088; FRL-9997-10]

Emamectin Benzoate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
emamectin benzoate (referred to as emamectin in this document) in or on
multiple commodities which are identified and discussed later in this
document. Interregional Research Project No. 4 (IR-4) and Syngenta Crop
Protection, LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 27, 2019. Objections and
requests for hearings must be received on or before October 28, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0088, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0088 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 28, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0088, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8644) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of emamectin, including its
metabolites and degradates in or on the raw agricultural commodities:
Artichoke, globe at 0.06 parts per million (ppm), Brassica, leafy
greens, subgroup 4-16B at 0.050 ppm, Celtuce at 0.100 ppm, Cherry
subgroup 12-12A at 0.10 ppm, Fennel, Florence at 0.100 ppm, Fruit,
pome, group 11-10 at 0.025 ppm, Herb subgroup 19A at 0.50 ppm, Kohlrabi
at 0.050 ppm, Leafy greens subgroup 4-16A at 0.100 ppm, Leaf petiole
vegetable subgroup 22B at 0.100 ppm, Nut, tree, group 14-12 at 0.02
ppm, Vegetable, brassica, head and stem, group 5-16 at 0.050 ppm, and
Vegetable, fruiting, group 8-10 at 0.020 ppm. The petition also
proposed to amend 40 CFR 180.505 by removing the tolerances for
residues of emamectin, including its metabolites and degradates, in or
on the raw agricultural commodities: Fruit, pome, group 11 at 0.025
ppm, Nut, tree, group 14 at 0.02 ppm, Pistachio at 0.02 ppm, Turnip,
greens at 0.050 ppm, Vegetable, leafy, except brassica, group 4 at
0.100 ppm, Vegetable, brassica, leafy, group 5 at 0.050 ppm, and
Vegetable fruiting, group 8 at 0.020 ppm.
    That document referenced a summary of the petition prepared by
Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F8640) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR part 180 be amended
by establishing a tolerance for residues of emamectin, including its
metabolites and degradates in or on vegetable, cucurbit, group 9 at
0.03 ppm. That document referenced a summary of the petition prepared
by Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested,
as authorized under FFDCA section 408(d)(4)(A)(i). EPA's explanation
for those variations are contained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for emamectin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with emamectin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The main target organ for emamectin is the nervous system;
treatment-related clinical signs (tremors, ptosis, ataxia, mydriasis,
and hunched posture) and neuropathology (neuronal degeneration in the
brain and in peripheral nerves and muscle fiber degeneration) were
found in most of the emamectin studies in rats, dogs, rabbits, and
mice. Decreased body weight was also a frequent finding.
    Integral to the dose-response assessment in mammals for this class
of compounds is the role of P-glycoprotein (P-gp) in target tissues. P-
gp is a member of the adenosine triphosphate (ATP)

binding cassette transporter protein class/group, which reside in the
plasma membrane and function as a transmembrane efflux pump, moving
xenobiotics from the intracellular to the extracellular domain. P-gp is
found in the canalicular surface of hepatocytes, the apical surface of
proximal tubular cells in the kidneys, brush border surface of
enterocytes, luminal surface of blood capillaries of the brain (blood
brain barrier), placenta, ovaries, and the testes. As an efflux
transporter, P-gp acts as a protective barrier to keep xenobiotics out
of the body by excreting them into bile, urine, and intestinal lumen,
and prevents accumulation of these compounds in the brain and gonads,
as well as in the fetus. Therefore, test animals with genetic
polymorphisms that compromise P-gp expression are particularly
susceptible to emamectin and abamectin induced neurotoxicity.
    In this connection, some CF-1 mice have a polymorphism for the gene
encoding P-gp and are either devoid (homozygous) or have diminished
(heterozygous) levels of P-gp. These mice are found to be uniquely
sensitive to the neurotoxic effects of emamectin and abamectin. In
addition, the neonatal rat is also particularly sensitive to emamectin
and abamectin as P-gp is undetectable in the neonatal rat brain. The
first detection of P-gp is on post-natal day (PND) 7 and does not reach
adult levels until approximately PND 28. As shown in the reproductive
and DNT studies, neonatal rats are sensitive to the effects of
abamectin-induced pup body weight reductions and death. In contrast, in
the developing human fetus, the presence of P-gp was found as early as
22 weeks of gestation. Based on the difference in the ontogeny of P-gp
in neonatal rats and human newborns, the Agency does not believe that
the early post-natal findings in the rat are relevant to human newborns
or young children, at this time.
    The human multidrug resistance (MDR-1) gene encoding P-gp and
polymorphism of MDR-1 gene are well studied. The literature data are
inconclusive with respect to the functional significance of the genetic
variance in P-gp in humans. Currently, the reported cases of
polymorphism of the MDR-1 gene in human populations have not been shown
to result in a loss of P-gp function similar to that found in CF-1
mice. Given the ontogeny of P-gp and the lack of convincing evidence
from the literature on human polymorphism of MDR-1 gene resulting in
diminished P-gp function, the Agency considers the results of the
studies with CF-1 mice not relevant for human health risk assessment.
Therefore, the Agency is using results from toxicological studies
conducted in the species that do not have diminished P-gp function for
selecting toxicity endpoints and PODs for risk assessment. Among the
test animals with fully functional P-gp, the beagle dog is the most
sensitive species.
    Emamectin did not elicit increased fetal sensitivity in
developmental toxicity studies in rats and rabbits. In the reproductive
toxicity study, emamectin produced neuronal degeneration in the brain
and spinal in parental and offspring animals at similar dose level (1.8
mg/kg/day), and no increase in quantitative sensitivity was found in
the pup with respect to the neurotoxicity. However, in the
developmental neurotoxicity study in rats, there was an increase in
both quantitative and qualitative sensitivity in the pups as no adverse
effect was seen at the highest dose tested (3.6/2.5 mg/kg/day) in
parental animals, while at 0.6 mg/kg/day, the pups showed a dose-
related decrease in open field motor activity at post-natal day 17.
Body tremors, hind-limb extension, and auditory startle were also
observed in the high dose pups (3.6/2.5 mg/kg/day).
    The carcinogenicity and mutagenicity studies provide no indication
that emamectin is carcinogenic or mutagenic. Emamectin is classified as
``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by emamectin as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Emamectin (Emamectin
Benzoate). Human Health Risk Assessment in Support of Establishing
Permanent Tolerances on Globe Artichoke, Cherry Subgroup 12-12A, Herb
Subgroup 19A, and Crop Group Conversions and Expansions to include Pome
Fruit Group 11-10, Tree Nut Group 14-12, Brassica Vegetable Head and
Stem Group 5-16, Brassica Leafy Greens Subgroup 4-16B, Leafy Greens
Subgroup 4-16A, Leaf Petiole Vegetable Subgroup 22B, Fruiting Vegetable
Group 8-10, and individual tolerances for Florence Fennel, Kohlrabi,
Celtuce, and Cucurbit Vegetables Group 9'' on pages 42-48 in docket ID
number EPA-HQ-OPP-2018-0088.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for emamectin used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Emamectin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety  factors      risk assessment
----------------------------------------------------------------------------------------------------------------
Dietary, all durations...........  NOAEL = 0.25 mg/kg/   Acute RfD = 0.0025   Subchronic and chronic oral
(General population including       day.                  mg/kg/day.           toxicity studies in dogs.
 infants and children).            UFA = 10x...........  aPAD = 0.0025 mg/kg/ Subchronic LOAEL = 0.5 mg/kg/day
                                   UFH = 10x...........   day.                 based skeletal muscle atrophy and
                                   FQPA SF = 1x........  Chronic RfD =         white matter multifocal
                                                          0.0025 mg/kg/day.    degeneration in the brains of
                                                         cPAD = 0.0025 mg/kg/  both sexes and white matter
                                                          day.                 multifocal degeneration in the
                                                                               spinal cords of males.
                                   ....................  ...................  Chronic LOAEL=0.5 mg/kg/day based
                                                                               on axonal degeneration in the
                                                                               pons, medulla, and peripheral
                                                                               nerves (sciatic, sural, and
                                                                               tibial); whole body tremors;
                                                                               stiffness of the hind legs,
                                                                               spinal cord axonal degeneration,
                                                                               and muscle fiber degeneration.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Not Likely to be carcinogenic to humans based on the absence
                                    of significant increase in tumor incidence in two adequate rodent
                                    carcinogenicity studies
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to emamectin, EPA considered exposure under the petitioned-for
tolerances as well as all existing emamectin tolerances in 40 CFR
180.505. EPA assessed dietary exposures from emamectin in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for emamectin. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, a refined acute assessment was conducted. The
assessment relied upon percent crop treated (PCT) data, and a
combination of monitoring data from the Pesticide Data Program (PDP)
and field trial data. For hog meat, a tolerance level residue was
assumed. For all other livestock commodities, anticipated residue
values were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, a refined chronic
assessment was conducted. The assessment relied upon the same data as
above, except for using mean field trial data for cottonseed, tree
nuts, globe artichoke, cherry subgroup 12-12A, and herb subgroup 19A.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that emamectin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Specific values used in the acute assessment for percent crop
treated are: 10% almonds, 20% apples, 20% broccoli, 40% brussels
sprouts, 25% cabbage, 20% cauliflower, 40% celery, 10% chicory, 2.5%
cotton, 20% lettuce, 20% pears, 15% peppers, 2.5% pistachios, 10%
spinach, 20% tomatoes, and 2.5% walnuts.
    Specific values used in the chronic assessment for percent crop
treated are: 2.5% almonds, 10% apples, 5% broccoli, 20% brussels
sprouts, 10% cabbage, 5% cauliflower, 20% celery, 5% chicory, 10%
lettuce, 5% pears, 5% peppers, 2.5% pistachios, 5% spinach, 15%
tomatoes, and 2.5% walnuts.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use

less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for emamectin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of emamectin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC), the estimated
drinking water concentrations (EDWCs) of emamectin for acute exposures
are estimated to be 1.5 parts per billion (ppb) for surface water and
EDWCs for chronic exposures are estimated to be 1.15 ppb for surface
water. No groundwater concentrations are predicted for emamectin, as
the model (PRZM-GW; pesticide root zone model--groundwater) indicates
emamectin will not break through into groundwater over the 100-year
course of the modeled scenario.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 1.5 ppb was used to assess
the contribution to drinking water and for the chronic dietary risk
assessment, the water concentration of value 1.15 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Residential exposures are not anticipated from the proposed uses of
emamectin, nor are they anticipated from existing uses of emamectin
since they are agricultural uses, restricted use products (i.e.,
restricted to use by certified applicators only), or are limited to
non-residential areas (i.e., commercial and industrial areas) with the
exception of a gel bait product. The ready-to-use (RTU) gel bait
product is registered for use in multiple locations, including in
residential areas. As the RTU product requires no mixing/loading, the
only potential for residential handler exposure is via application.
When applying this product according to use directions, bait points and
bait beads are intended to be placed in cracks and crevices where
direct contact by adults is anticipated to be negligible. Post-
application exposures for adults and children are also unlikely due to
the nature of the application method, and the location of the bait
placement. Therefore, a residential exposure assessment has not been
conducted and there are no residential risk estimates recommended for
use in the aggregate risk assessment for emamectin.
    4. Cumulative effects from substances with a common mechanism of
toxicity. The Agency is required to consider the cumulative risks of
chemicals sharing a common mechanism of toxicity. In 2016, EPA's Office
of Pesticide Programs released a guidance document entitled Pesticide
Cumulative Risk Assessment: Framework for Screening Analysis (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides guidance
on how to screen groups of pesticides for cumulative evaluation using a
two-step approach beginning with the evaluation of available
toxicological information and if necessary, followed by a risk-based
screening approach. This framework supplements the existing guidance
documents for establishing common mechanism groups (CMGs) and
conducting cumulative risk assessments (CRA).
    The Agency has utilized this framework for abamectin and determined
that abamectin along with emamectin form a candidate CMG of the
avermectin macrocyclic lactones. This group of pesticides is considered
a candidate CMG because they share characteristics to support a
testable hypothesis for a common mechanism of action and while there
are sufficient toxicological data to suggest a common pathway, there
are not adequate data to establish those key events in a pathway as
described in the mode of action/adverse outcome pathway (MOA/AOP)
framework (e.g., lack of dose or temporal concordance of proposed key
events).
    In 2017, the Agency conducted a screening-level cumulative exposure
analysis consistent with the guidance described in the cumulative
screening framework. The screening-level cumulative assessment for the
avermectin macrocyclic lactones, abamectin and emamectin, indicated
that cumulative aggregate dietary and residential exposures for
abamectin and emamectin were below the Agency's levels of concern.
    Based upon updated use information (i.e., new uses), the Agency has
updated its screening-level cumulative exposure analysis for the
avermectin macrocyclic lactones, including abamectin and emamectin.
This updated screening-level cumulative exposure assessment for the
avermectin macrocyclic lactones, abamectin and emamectin, indicated
that that cumulative aggregate dietary and residential exposures for
abamectin and emamectin were below the Agency's levels of concern. The
screening memo, titled ``Avermectin Macrocyclic Lactones, Abamectin and
Emamectin. Cumulative Screening Risk Assessment'' can be found in
docket ID number EPA-HQ-OPP-2018-0088 at http://www.regulations.gov.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Emamectin did not elicit
increased fetal sensitivity in developmental toxicity studies in rats
and rabbits. In the reproductive toxicity study, emamectin produced
neuronal degeneration in the brain and spinal cord in parental and
offspring animals at a similar dose level (1.8 mg/kg/day), and no
increase in quantitative sensitivity was found in the pup with respect
to the neurotoxicity. However, in the developmental neurotoxicity study
in rats, there was an increase in both quantitative and qualitative
sensitivity in the pups as no adverse effect was seen at the highest
dose tested (3.6/2.5 mg/kg/day) in parental animals, while at 0.6 mg/
kg/day, the pups showed a dose-related decrease in open field motor
activity at post-natal day 17. Body tremors, hind-limb extension, and
auditory startle

were also observed in the high dose pups (3.6/2.5 mg/kg/day).
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for emamectin is complete.
    ii. The proposed MOA is interaction with GABA receptors leading to
neurotoxicity. The clinical signs observed in the emamectin database
are consistent with the proposed MOA. Following emamectin exposure,
neurotoxicity has been seen across multiple studies and species of test
animals. Neurotoxic effects seen in various studies are consistent with
the MOA of emamectin, and the selected toxicity endpoints and POD is
protective of the neurotoxic effects in the data.
    iii. As discussed above, the developmental neurotoxicity study
showed an increase in both quantitative and qualitative sensitivity in
the pups as indicated by a dose-related decrease in open field motor
activity at post-natal day 17 at 0.6 mg/kg/day. Body tremors, hind-limb
extension, and auditory startle were also observed in the high dose
pups (2.5 mg/kg/day), while no adverse effects were seen in the
parental animals at the highest tested dose (3.6 mg/kg/day). However,
the toxicity endpoint and POD (0.25 mg/kg/day) selected for risk
assessment are protective of the effects seen in the pups.
    iv. There are no residual uncertainties for emamectin with respect
to the exposure databases. Although the dietary exposure estimates are
partially refined, anticipated residue estimates for most commodities
were derived from field trials which are still considered conservative
since field trials are conducted under maximum use conditions (maximum
allowed application rate and number of applications, minimum pre-
harvest interval, etc.). Monitoring data were used for apples in the
acute assessment since apple juice had a significant impact on
exposure. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to emamectin in
drinking water. There are no anticipated exposures to residential
handlers, or for post-application exposure of adults and children.
These assessments will not underestimate the exposure and risks posed
by emamectin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to emamectin will occupy 26% of the aPAD for children 1 to 2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk: Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
emamectin from food and water will utilize 3.4% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
emamectin is not expected.
    3. Short-term risk. A short-term adverse effect was identified;
however, emamectin is not registered for any use patterns that would
result in short-term residential exposure. Short-term risk is assessed
based on short-term residential exposure plus chronic dietary exposure.
Because there is no short-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short-term risk is necessary, and
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for emamectin.
    4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, emamectin is not registered for any use patterns
that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for emamectin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, emamectin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to emamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods (Method 244-92-3 and Method 244-92-3, Revision 1)
are available for the enforcement of tolerances on plants. The methods
determine residues of emamectin and its regulated isomers and
degradates/metabolites using high performance liquid chromatography
with fluorescence detection (HPLC/FLD).
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for emamectin on various commodities
that are different than the tolerances established for emamectin in the
United States.

    The U.S. and Codex residue definitions are not harmonized. The U.S.
residue definition for emamectin includes the sum of emamectin and its
metabolites (8,9-isomer) for plants and livestock. The Codex residue
definition includes only emamectin for plants and livestock
commodities.
    Codex has MRLs for residues of emamectin on tomato, tomatillo, bell
pepper, and non-bell pepper, the representative commodities of the
fruiting vegetable group 8-10 at 0.02 ppm each. The U.S. tolerance at
0.02 ppm for residues on crop group 8-10 is being harmonized with these
Codex MRLs.
    Codex has an MRL for residues of emamectin on mustard greens, the
representative commodity for Brassica leafy greens subgroup 4-16B at
0.2 ppm. The U.S. tolerance on subgroup 4-16B is being harmonized with
Codex mustard greens, the representative commodity, at 0.20 ppm.
    Codex has MRLs for residues of emamectin on head lettuce at 1 ppm
and leaf lettuce at 0.7 ppm. The current U.S. tolerance is 0.1 ppm for
subgroup 4-16A, which has head lettuce, leaf lettuce, and spinach as
the representative commodities. EPA is therefore harmonizing the
tolerance for subgroup 4-16A with Codex head lettuce at 1 ppm.
    Codex has MRLs for apple and pear at 0.02 ppm each. EPA harmonizing
the tolerance on pome fruit, group 11-10 with these MRLs at 0.02 ppm.
    For tree nut crop group 14-12, the Codex MRLs for residues on the
representative commodities of this group is 20x lower than the U.S.
tolerances being established in this rulemaking. Lowering the tolerance
could cause U.S. growers to have violative residues when following
label instructions; therefore, EPA is not harmonizing the tolerance
with the Codex MRLs.
    For all other commodities, Codex does not have established MRLs.

C. Revisions to Petitioned-For Tolerances

    For new uses on globe artichoke, herb subgroup 19A, and cherry
subgroup 12-12A, the tolerances differ slightly from those proposed by
IR-4 due to differences in calculating parent equivalents of emamectin
metabolites from the residue data.
    The currently established tolerance on crop group 11 and the
proposed tolerance on crop group 11-10 are both at 0.025 ppm. The
tolerance for pome fruit crop group 11-10 is being established at 0.02
ppm to harmonize with Codex MRLs on apple and pear.
    The tolerance on Brassica leafy greens subgroup 4-16B is being set
at 0.2 ppm instead of the proposed level at 0.050 ppm and the tolerance
on leafy greens subgroup 4-16A is being set at 1 ppm instead of 0.1 ppm
to harmonize with Codex.
    For the proposed tolerance on fennel, Florence, the commodity
definition was corrected to be Fennel, florence, fresh leaves and
stalk.
    For the other commodities and crop groups, the tolerances differ
from the petitioned-for tolerances due to the use of HED rounding class
practice.
    The proposed tolerance for emamectin on vegetable, cucurbit, group
9 at 0.03 ppm is not necessary because the available data support the
existing tolerance of 0.02 ppm for that crop group.

V. Conclusion

    Therefore, tolerances are established for residues of emamectin,
including its metabolites and degradates in or on the raw agricultural
commodities Artichoke, globe at 0.05 ppm; Brassica, leafy greens,
subgroup 4-16B at 0.2 ppm; Celtuce at 0.1 ppm; Cherry subgroup 12-12A
at 0.09 ppm; Fennel, florence, fresh leaves and stalk at 0.1 ppm;
Fruit, pome, group 11-10 at 0.02 ppm; Herb subgroup 19A at 0.4 ppm;
Kohlrabi at 0.05 ppm; Leaf petiole vegetable subgroup 22B at 0.1 ppm;
Leafy greens subgroup 4-16A at 1 ppm; Nut, tree, group 14-12 at 0.02
ppm; Vegetable, brassica, head and stem, group 5-16 at 0.05 ppm; and
Vegetable, fruiting, group 8-10 at 0.02 ppm.
    Additionally, the following existing tolerances are removed as
unnecessary due to the establishment of the above tolerances: Fruit,
pome, group 11 at 0.025; Nut, tree, group 14 at 0.02 ppm; Pistachio at
0.02 ppm; Turnip, greens at 0.050 ppm; Vegetable, brassica, leafy,
group 5 at 0.050 ppm; Vegetable fruiting, group 8 at 0.020 ppm; and
Vegetable, leafy, except brassica, group 4 at 0.100 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 180

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

    Dated: August 8, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.505, amend the table in paragraph (a)(1) as follows:
0
i. Add alphabetically the entries ``Artichoke, globe''; ``Brassica,
leafy greens, subgroup 4-16B''; ``Celtuce''; ``Cherry subgroup 12-
12A''; ``Fennel, florence, fresh leaves and stalk''; ``Fruit, pome,
group 11-10''; ``Herb subgroup 19A''; ``Kohlrabi''; ``Leaf petiole
vegetable subgroup 22B''; ``Leafy greens subgroup 4-16A''; ``Nut, tree,
group 14-12''; ``Vegetable, brassica, head and stem, group 5-16''; and
``Vegetable, fruiting, group 8-10'';
0
ii. Remove the entries for ``Fruit, pome, group 11''; ``Nut, tree,
group 14''; ``Pistachio''; ``Turnip, greens''; ``Vegetable, brassica,
leafy, group 5''; ``Vegetable fruiting, group 8''; and ``Vegetable,
leafy, except brassica, group 4''.
    The additions read as follows:

Sec.  180.505  Emamectin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
------------------------------------------------------------------------
Artichoke, globe........................................            0.05
Brassica, leafy greens, subgroup 4-16B..................             0.2
Celtuce.................................................             0.1
Cherry subgroup 12-12A..................................            0.09

                                * * * * *
------------------------------------------------------------------------
Fennel, florence, fresh leaves and stalk................             0.1
Fruit, pome, group 11-10................................            0.02

                                * * * * *
------------------------------------------------------------------------
Herb subgroup 19A.......................................             0.4
Kohlrabi................................................            0.05
Leaf petiole vegetable subgroup 22B.....................             0.1
Leafy greens subgroup 4-16A.............................               1
Nut, tree, group 14-12..................................            0.02

                                * * * * *
------------------------------------------------------------------------
Vegetable, brassica, head and stem, group 5-16..........            0.05

                                * * * * *
------------------------------------------------------------------------
Vegetable, fruiting, group 8-10.........................            0.02
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-18386 Filed 8-26-19; 8:45 am]
 BILLING CODE 6560-50-P


John Poole < rs@ refsols. com> 06/ 13/ 2006 11: 29 AM To Dave Godwin/ DC/ USEPA/ US@ EPA cc Subject RE: FW: RS 24 & RS 44 SNAP LISTINGS Hello Dave,

Thanks for this message. I will try & answer the questions you raise as follows:

( 1) We are planning to sell the ASHRAE composition RS 24 for auto a/ c & intend to use the same fittings for the old blend ( 2) No, we have not sold ( the old RS 24 formulation) into MAC yet.

( 3) ASHRAE tolerances for RS 24 are:

Component Tolerances % R134a + 1.0,  1.0 R125 + 1.0,  1.0 R600 + 0.1,  0.2 R601a + 0.1,  0.2 These tolerances appear to cover the old RS 24 formulation, except in the case of R601a ( isopentane) where the new blend contains 0.6% & the old blend 0.75%.

But, I think you are right in that both formulation fall within ARI 700 Standard tolerances.

( 4) No problem with your wording of with regard to disclosure of the old blend.

( 5) R424A has at last been published in May  & copy of the notice is attached.

( 6) R426A: after the Chicago meetings last January where RS 24 received this designated ASHRAE number, this was put out for public comment. No comments have been received, & copy of this position is attached in e0mail dated 8 May from ASHRAE. O guess we go to the next stage of the process now, & I will let you know if anything happens at the Quebec meetings.

I hope this answers your queries but please contact me if you need anything more. Best regards John John Poole Refrigerant Solutions Ltd. 8 Muriestion Road, Hale, Altrincham, Cheshire, WA15 9ST Tel: (+ 44) ( 0) 161 926 9876 Fax: (+ 44) ( 0) 161 926 9875 Email: rs@ refsols. com Web: www. refsols. com  Original Message From: Godwin. Dave@ epamail. epa. gov [ mailto: Godwin. Dave@ epamail. epa. gov] Sent: 12 June 2006 22: 02 To: John Poole Cc: Sheppard. Margaret@ epamail. epa. gov; Glover. Hillary@ epamail. epa. gov Subject: RE: FW: RS 24 & RS 44 SNAP LISTINGS Hi John.

We are drafting our next Federal Register notice that will include notification of the change in composition of RS 24 and RS 44 and our findings of acceptability for the new compositions. One sticky point that arises is the issue of RS 24 as a substitute for CFC 12 in motor vehicle air conditioning. When we approved the original composition ( http:// www. epa. gov/ ozone/ snap/ regs/ 67fr77927. pdf), we included information that you provided on the unique fittings ( quick connect) and unique labels ( gold with black text) that we require for all acceptable refrigerants in automobile air conditioning. Technically, we would require another set of unique fittings for a new refrigerant, but that certainly seems not warranted in this case. So, some questions to help us get around this:

* Do you plan to sell the new RS 24 composition ( i. e., R 426A) for use in auto air conditioning? If so, do you plan on using the same fittings and labels as previously designed for the old composition?

* Did you sell any of the OLD composition of RS 24 for use in auto AC, or do you know of any such use?

* What tolerances were set by ASHRAE ( or voted for public review by ASHRAE) for the mass percent composition of the R 426A blend? It might be that the old composition falls within the ASHRAE tolerance range, or if not, I'm guessing it would fall within typical ARI Standard 700 tolerances.

* If we discuss these tolerance issues, how much information on the old composition may we divulge? We plan to keep the old composition confidential per your request, so we want to know if saying something like " the old composition falls within the tolerances proposed in the ASHRAE designation of R 426A" goes too far. We won't have our Federal Register notice ready until after the upcoming ASHRAE meeting in Quebec, so we'd appreciate any update you have after that meeting with regards to the designations  whether R 424A ( RS 44) was finalized and published and whether R 426A ( RS 24) was voted by the ASHRAE Board of Directors for publication ( or recommended by SSPC 34 for publication).

Thanks again.

Best regards,

 Dave John Poole < rs@ refsols. com> To 02/ 21/ 2006 01: 23 Dave Godwin/ DC/ USEPA/ US@ EPA PM cc Subject RE: FW: RS 24 & RS 44 SNAP LISTINGS Yes, please Dave  could you hold the old compositions confidential.

Thanks and regards John  Original Message From: Godwin. Dave@ epamail. epa. gov [ mailto: Godwin. Dave@ epamail. epa. gov] Sent: 21 February 2006 17: 59 To: John Poole Subject: RE: FW: RS 24 & RS 44 SNAP LISTINGS Thanks John. One more question:

When we originally approved RS 24 and RS 44, we held the exact compositions confidential. Is it ok to say what those old compositions were, or do you want them held confidential? For the new versions, we will indicate the ASHRAE numbers and the corresponding composition.

 Dave John Poole < rs@ refsols. com> To 02/ 15/ 2006 05: 05 Dave Godwin/ DC/ USEPA/ US@ EPA PM cc Subject RE: FW: RS 24 & RS 44 SNAP LISTINGS Hello Dave,

You are right. It looks as though I had the wrong e mail address for the first message, but glad that this has now reached you.

Let me try and answer the queries you have raised:

( 1) RS 44 ASHRAE number: yes, you are correct. This was sent out for Public comment after the meetings in Denver, Colorado last June and no comments were received. I understand that publication is estimated for March.

( 2) RS 24 ASHRAE number: again, you are correct. Standard 34 committee accepted a classification of A1 for RS 24, which now has to go through the same public comments process.

( 3) United Suppliers of America ( USA): yes, they are an authorized dealer For both RS 24 & RS 44. In the case of RS 44, they made the submission to ASHRAE for a refrigerant number, but they are not another manufacturer & will Not be selling the same blend under another name. Same position applies to RS 24.

Hope this answers your questions but please let me know if you need any More information.

Best regards John John Poole Refrigerant Solutions Ltd. 8 Muriestion Road, Hale, Altrincham, Cheshire, WA15 9ST Tel: (+ 44) ( 0) 161 926 9876 Fax: (+ 44) ( 0) 161 926 9875 Email: rs@ refsols. com Web: www. refsols. com  Original Message From: Godwin. Dave@ epamail. epa. gov [ mailto: Godwin. Dave@ epamail. epa. gov] Sent: 15 February 2006 21: 20 To: John Poole Cc: Sheppard. Margaret@ epamail. epa. gov Subject: Re: FW: RS 24 & RS 44 SNAP LISTINGS Hi John,

Thanks; this email came through. I'm not sure what happened to the 3 February one. The message says it was addressed to Godwin. Dave@ epamail. gov  that address probably doesn't work but Godwin. Dave@ epamail. epa. gov or Godwin. Dave@ epa. gov should both work.

I believe your emails will suffice for the formulation and company name change and are all that SNAP needs. We are in the process of publishing a new SNAP Notice of Acceptability in the U. S. Federal Register. If it's not too late, we may be able to include this formulation change in that notice. If not that one, then the next one. After we publish the Notice, we will update our website ( www. epa. gov/ ozone/ snap/) accordingly. As always, if any of your customers have any questions regarding the legality of a particular blend/ composition, they can contact the US EPA directly.

I had just a couple questions. My understanding was that ASHRAE has approved for publication the R 424A ( A1 rating) designation, but has only recommended for public review the R 426A ( A1 rating) designation. Is that correct? Not that I expect any issues, but just so we're clear in the Notice.

Also, I believe the application to ASHRAE for R 424A came under the name " USA United Suppliers of America" or the like. How are they related to Refrigerant Solutions Ltd.? Are they an authorized dealer for you, or are they another refrigerant producer that will make and sell the same blend? If the latter, will they use any other designations besides R 424A and RS 44? Will R 426A ( RS 24) also be sold by USA United Suppliers of America?

Thank you for your diligence in informing us about these changes.

Best regards,

 Dave David S. Godwin, P. E. Environmental Engineer U. S. Environmental Protection Agency Office of Air and Radiation Office of Atmospheric Programs Stratospheric Protection Division Alternatives and Emissions Reduction Branch Mailing Address: 1200 Pennsylvania Avenue, NW; Mail Code 6205J; Washington, D. C. 20460; USA Deliveries / Office Location: 1310 L Street, NW; Room 802K; Washington, D. C. 20005; USA Phone: 1 202 343 9324 Fax: 1 202 343 2363 Godwin. Dave@ epa. gov John Poole < rs@ refsols. com> To 02/ 14/ 2006 01: 33 Dave Godwin/ DC/ USEPA/ US@ EPA PM cc Subject FW: RS 24 & RS 44 SNAP LISTINGS Hello Dave,

Further to our telephone conversation today, I am re sending my e mail of 3 February as discussed. I think this covers most of the background to the marginal changes in compositions of RS 24 & RS 44 but please let me know if you need any more information or clarification,

I confirm that we will continue to use the unique set of fittings for motor vehicle air conditioning that are currently used with RS 24 as formulated and SNAP listed.

As requested, I am also attaching copies of submissions made to ASHRAE Standards 34 committee for RS 24 & RS 44.

Please could you confirm receipt of this e mail.

Thanks and regards John John Poole Refrigerant Solutions Ltd. 8 Muriestion Road, Hale, Altrincham, Cheshire, WA15 9ST Tel: (+ 44) ( 0) 161 926 9876 Fax: (+ 44) ( 0) 161 926 9875 Email: rs@ refsols. com Web: www. refsols. com From: John Poole [ mailto: rs@ refsols. com] Sent: 03 February 2006 15: 18 To: ' Godwin. Dave@ epamail. gov' Subject: RS 24 & RS 44 SNAP LISTINGS Dear Dave,

We were SNAP listed for RS 24 and RS 44 refrigerants in 2002 and 2003 respectively, and you handled our applications at that time. I do not know if you are still involved with SNAP applications, so forgive me if you are not in which case maybe you could provide me with a suitable contact.

We were Refrigerant Products Ltd at the time of these applications, since when we have changed to Refrigerant Solutions Ltd. The reason that I am contacting you is to do with the formulations of these 2 refrigerant blends which have been marginally changed as follows:

RS 24 % Component SNAP listing Revised blend R134a 93 93 R125 5 5.1 R600 Butane 1,25 1.3 R601a Isopentane 0.75 0.6 R600a Isobutane Total hydrocarbon 2.0 1.9 RS 44 % Component SNAP listing Revised blend R134a 47 47 R125 50 50.5 R600 Butane 2.7 1 R601a Isopentane 0.3 0.6 R600a Isobutane 0.9 Total hydrocarbon 3.0 2.5 The reason that we are making these slight adjustments to the blends is because of ASHRAE numbers which have been designated as follows:

Product Designated ASHRAE number Date RS 24 R426A January 2006 RS 44 R424A June 2005 Both RS 24 & RS 44 have been classified by ASHRAE as A1, namely low toxicity & non flammable under all conditions of fractionation.

As you can see, the hydrocarbon content of each blend has been marginally reduced & the HFC contents are virtually unchanged.

Do our current SNAP listings remain unchanged, or do we need to make revised submissions incorporating these minor changes? I guess, also, do we need to register the change of name of the company?.

Thanks and best regards John Poole Refrigerant Solutions Ltd. 8 Muriestion Road, Hale, Altrincham, Cheshire, WA15 9ST Tel: (+ 44) ( 0) 161 926 9876 Fax: (+ 44) ( 0) 161 926 9875 Email: rs@ refsols. com Web: www. refsols. com


[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Proposed Rules]
[Page 8763-8766]
[DOCID:fr26fe09-28]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1221]
RIN 1625-AA00

Safety Zone; Blue Water Resort and Casino Spring Classic;
Colorado River, Parker, AZ

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes establishing a temporary safety zone
within the Lake Moolvalya region of the navigable waters of the
Colorado River in Parker, Arizona for the Blue Water Resort and Casino
Spring Classic. This temporary safety zone is necessary to provide for
the safety of the participants, crew, spectators, participating
vessels, and other vessels and users of the waterway. Persons and
vessels are prohibited from entering into, transiting through, or
anchoring within this safety zone unless authorized by the Captain of
the Port, or his designated representative.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before March 30,
2009 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2008-1221 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. For
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Petty Officer Kristen Beer, USCG, Waterways Management, U.S.

Coast Guard Sector San Diego at<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-1221), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2008-1221'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2008-1221 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. You may also visit
either the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays; or the U.S. Coast Guard
Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101 between 8
a.m. and 3 p.m., Monday through Friday, except Federal holidays. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    The Southern California Speedboat Club is sponsoring the Blue Water
Resort and Casino Spring Classic, which is held on the Lake Moolvalya
region on the Colorado River in Parker, Arizona. This proposed
temporary safety zone is necessary to provide for the safety of the
participants, crew, spectators, sponsor vessels, and other users of the
waterway. This event involves powerboats racing along a circular
course. The size of the boats varies from ten to 21 feet in length.
Approximately 70 to 100 boats will be participating in this event. The
sponsor will provide two patrol and rescue boats and two river closure
boats.

Discussion of Proposed Rule

    The Coast Guard proposes establishing a safety zone that will be
enforced from 6 a.m. to 6 p.m. on April 17, 2009 through April 19,
2009. This safety zone is necessary to provide for the safety of the
crews, spectators, participants, and other vessels and users of the
waterway. Persons and vessels will be prohibited from entering into,
transiting through, or anchoring with this safety zone unless
authorized by the Captain of the Port, or his designated
representative. The limits of this temporary safety zone are the
portion of the Colorado River from Headgate Dam to 0.5 miles north of
Blue Water Marina, Parker, Arizona.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. We expect the economic
impact of this proposed rule to be so minimal that a full Regulatory
Evaluation is unnecessary. This determination is based on the size and
location of the safety zone. Commercial vessels will not be hindered by
the safety zone. Recreational vessels will not be allowed to transit
through the established safety zone during the specified times unless
authorized to do so by the Captain of the Port or his designated
representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: the owners or operators of vessels
intending to transit or anchor in a portion of the Colorado River from
6 a.m. to 6 p.m. on April 17, 2009 through April 19, 2009.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons.
Although the safety zone would apply to the entire width of the river,
traffic would be allowed to pass through the zone with the permission
of the Coast Guard patrol commander. Before the effective period,

the Coast Guard will publish a local notice to mariners (LNM).
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Petty Officer Kristen Beer,
USCG, Waterway Management, U.S. Coast Guard Sector San Diego at (619)
278-7262. The Coast Guard will not retaliate against small entities
that question or complain about this proposed rule or any policy or
action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this proposed rule would not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

    This proposed rule would not effect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 5100.1 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
made a preliminary determination under the Instruction that this action
is not likely to have a significant effect on the human environment. An
environmental analysis checklist supporting this preliminary
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add a new temporary zone Sec.  165.T11-136 to read as follows:

Sec.  165.T11-136  Safety Zone; Blue Water Resort and Casino Spring
Classic; Colorado River, Parker, AZ.

    (a) Location. The limits of this temporary safety zone are the
portion of the Colorado River from Headgate Dam to 0.5 miles north of
the Bluewater Marine in Parker, Arizona.
    (b) Enforcement Period. This section will be enforced from 6 a.m.
to 6 p.m. on April 17, 2009 through April 19, 2009. If the event
concludes prior to the scheduled termination time, the Captain

of the Port will cease enforcement of this safety zone and will
announce that fact via Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander. The
Patrol Commander may be contacted on VHF-FM Channel 83.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: February 11, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-4070 Filed 2-25-09; 8:45 am]

BILLING CODE 4910-15-P