[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Proposed Rules]
[Pages 53009-53013]
[FR Doc No: 2014-21101]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0008; FRL-9914-98]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before October 6, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW. Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(703) 305-7090; email address<EMAIL_ADDRESS>Lois Rossi,
Registration Division (RD) (7505P), main telephone number: (703) 305-
7090; email address<EMAIL_ADDRESS>The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

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:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).

    [emsp14]Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed at the end of
the pesticide petition summary of interest.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. The Agency is taking public comment on
the requests before responding to the petitioners. EPA is not proposing
any particular action at this time. EPA has determined that the
pesticide petitions described in this document contain the data or
information prescribed in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petitions. After
considering the public comments, EPA intends to evaluate whether and
what action may be warranted. Additional data may be needed before EPA
can make a final determination on these pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerances

    1. PP 2E8098. (EPA-HQ-OPP-2014-0303). Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC 27419, requests to establish a
tolerance in 40 CFR part 180 for residues of the herbicide,
bicyclopyrone: 4-hydroxy-3-(2-[(2-methoxyethoxy) methyl)-6-
(trifluoromethyl)-3-pyridylcarbonyl) bicyclo [3.2.1]oct-3-en-2-one.],
in or on sugarcane, stalks at 0.01 parts per million (ppm). The Direct
Analysis and Common Moiety Method were used to measure and evaluate the
chemical bicyclopyrone. (RD)
    2. PP 3F8205. (EPA-HQ-OPP-2013-0758). Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC 27419, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide,
thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite[N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, in or on alfalfa,
seed at 1 parts per million (ppm); buckwheat, grain at 0.9 ppm; corn,
field, grain at 0.03 ppm; corn, pop, forage at 0.10 ppm; corn, pop,
stover at 0.05 ppm; millet, pearl, forage at 0.02 ppm; millet, pearl,
stover at 0.02 ppm; millet, proso, forage at 0.02 ppm; millet, proso,
stover at 0.02 ppm; millet, proso, straw at 0.02 ppm; oat, grain at 0.9
ppm; rice, straw at 2 ppm; rice, grain at 6 ppm; rye, grain at 0.9 ppm;
sorghum, forage at 0.02 ppm; sorghum, grain, stover at 0.02 ppm;
soybean at 0.02 ppm; sunflower, seed at 0.4 ppm; teosinte at 0.02 ppm;
triticale, grain at 0.9ppm; vegetable, legume, subgroup 6A at 0.9 ppm;
vegetable, legume, subgroup 6B at 0.5 ppm; vegetable, legume, subgroup
6C at 0.2 ppm; vegetable, foliage of legume, subgroup 7A at 4 ppm;
wheat, grain at 0.5 ppm; wheat, aspirated grain fraction at 2.5 ppm;
wheat, bran at 0.5 ppm; wheat, germ at 0.5 ppm; wild rice at 0.02 ppm.
Syngenta Crop Protection, LLC., has submitted practical analytical
methodology for detecting and measuring levels of thiamethoxam in or on
raw agricultural commodities. This method is based on crop specific
cleanup procedures and determination by liquid chromatography with
either ultraviolet ray (UV) or MS detections. The limit of detection
(LOC) for each analyte of this method is 1.25 nanogram (ng) injected
for samples analyzed by UV and 0.25 ng injected for samples analyzed by
MS, and the limit quantification (LOQ) is 0.005 ppm for milk and
juices; 0.01 ppm for all other substrates. (RD)
    3. PP 3F8225. (EPA-HQ-OPP-2014-0355). Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC 27419, requests to establish a
tolerance in 40 CFR part 180 for residues of the herbicide,
bicyclopyrone: 4-hydroxy-3-(2-[(2-methoxyethoxy) methyl)-6-
(trifluoromethyl)-3-pyridylcarbonyl) bicyclo [3.2.1]oct-3-en-2-one in
or on field corn, forage at 0.4 parts per million (ppm); field corn,
grain, at 0.02 ppm; field corn, stover at 0.5 ppm; popcorn,

grain, at 0.02 ppm, popcorn, stover at 0.5 ppm; sweet corn, forage at
0.40 ppm; sweet corn, ears at 0.04 ppm; sweet corn, stover at 0.50 ppm;
and cattle liver at 0.06 ppm. An analytical method of liquid
chromatography with tandem mass spectroscopy detection method (LC-MS/
MC) was used to measure and evaluate the chemical bicyclopyrone. (RD)
    4. PP 4E8236. (EPA-HQ-OPP-2014-0134). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of streptomycin in or on grapefruit at 0.15 parts per million
(ppm); grapefruit, dried pulp at 0.63 ppm; and fruit, pome, group 11-10
at 0.25 ppm; a laboratory working method based on USDA Food Safety and
Inspection Service SOP No: CLG-AMG1.02, ``Confirmation of
Aminoglycosides by HPLC-MS/MS'' is available. Modifications were made
to improve the performance of the method for the various crop
fractions. (RD)
    5. PP 4E8273. (EPA-HQ-OPP-2014-0506). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of the fungicide cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-
2-pyrimidinamine, in or on artichoke, globe at 4.0 parts per million
(ppm); acerola at 1.5 ppm; feijoa at 1.5 ppm; guava at 1.5 ppm;
jaboticaba at 1.5 ppm; passionfruit at 1.5 ppm; starfruit at 1.5 ppm;
wax jambu at 1.5 ppm; fruit, stone group 12-12 at 2.0 ppm; and
pomegranate at 7.0 ppm. The Syngenta Crop Protection Method AG-631B is
used to measure and evaluate the chemical cyprodinil. (RD)
    6. PP 4E8274. (EPA-HQ-OPP-2014-0470). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of the fungicide, difenoconazole, 1-[2-[2-chloro-4-(4-
chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole, in or on ginseng at 0.50 parts per million (ppm); artichoke,
globe at 1.5 ppm; fruit, stone, group 12-12 at 2.5 ppm; and nut, tree,
group 14-12 at 0.03 ppm. The liquid chromatography tandem mass
spectrometry (LC-MS/MS) method is used to measure and evaluate the
chemical difenoconazole. (RD)
    7. PP 4F8231. (EPA-HQ-OPP-2014-0373). Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish
a tolerance in 40 CFR part 180 for residues of the fungicide,
difenoconazole, in or on pea, and bean, dried shelled, except soybean,
subgroup 6C at 0.2 parts per million (ppm); pea, vine at 10 ppm; pea,
hay at 40 ppm; and bushberry, subgroup 13-07B at 3.0 ppm. A practical
analytical method for detecting and measuring levels of difenoconazole
in or on food with a limit of quantitation (LOQ) that allows monitoring
of food with residues at or above the levels set in the proposed
tolerances. Residues are qualified by liquid chromatography/mass
spectrometry (LC-MS/MS). (RD)
    8. PP 3F88189. (EPA-HQ-OPP-2014-0601). BASF Corporation on behalf
of Whitmire Micro-Gen Research Laboratories, Inc., 3568 Tree Court
Industrial Blvd., St. Louis, MO 63122-6682, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide, Alpha-
Cypermethrin, in or on food/feed handling establishments at 0.05 parts
per million (ppm). The gas chromatography with electron capture
detection or GC/ECD, HPLC-UV and LC/MS/MS methods is used to measure
and evaluate the chemical 0.01 mg/kg (LOQ). (RD)

Amended Tolerances

    1. PP 3F8205. (EPA-HQ-OPP-2013-0758). Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC 27419, requests to amend the
tolerances in 40 CFR 180.565 for residues of the insecticide,
thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite[N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, by increasing the
existing tolerances in or on alfalfa, forage from 0.05 to 10 parts per
million (ppm); alfalfa, hay from 0.12 to 8 ppm; barley, hay from 0.40
to 1.5 ppm; barley, straw from 0.40 to 3 ppm; barley, grain from 0.4 to
0.9 ppm; corn, field, forage from 0.10 to 4 ppm; corn, field, stover
from 0.05 to 4 ppm; corn, sweet forage from 0.10 to 5 ppm; corn, sweet,
kernel plus cob with husks removed from 0.02 to 0.03 ppm; corn, sweet,
stover from 0.05 to 4 ppm; wheat, forage from 0.50 to 3 ppm; wheat, hay
from 0.02 to 8 ppm; wheat, straw from 0.02 to 6 ppm. Concurrently,
Syngenta Crop Protection, LLC., requests to amend the tolerances in 40
CFR 180.565 by removing tolerances for residues of the insecticide,
thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) in or on grain, cereal, group 15,
except barley at 0.02 ppm; sunflower at 0.02 ppm; and vegetable,
legume, group 6 at 0.02 ppm, upon approval of the tolerances listed
under ``New Tolerances'' for PP 3F8205. Syngenta Crop Protection, LLC.,
has submitted practical analytical methodology for detecting and
measuring levels of thiamethoxam in or on raw agricultural commodities.
This method is based on crop specific cleanup procedures and
determination by liquid chromatography with either ultra-violet (UV) or
mass spectrometry (MS) detections. The limit of detection (LOC) for
each analyte of this method is 1.25 nanogram (ng) injected for samples
analyzed by UV and 0.25 ng injected for samples analyzed by MS, and the
limit quantification (LOQ) is 0.005 ppm for milk and juices, and 0.01
ppm for all other substrates. (RD)
    2. PP 4E8236. (EPA-HQ-OPP-2014-0134). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to amend the tolerances in 40 CFR 180.245 for residues
of the residues of streptomycin as follows: (1) moving the existing
tolerances for streptomycin on celery, pepper, and tomato from
paragraph (a)(2), and potato from paragraph (a)(3) to the table in
(a)(1); (2) modifying the existing tolerance for tomato from 0.25 ppm
to 0.5 ppm; (3) removing the existing time limited tolerances for
grapefruit and grapefruit, dried pulp in paragraph (b) upon
establishment of the permanent tolerances for grapefruit and
grapefruit, dried pulp; (4) removing the existing tolerance for fruit,
pome, group 11 upon establishment of the tolerance for fruit, pome,
group 11-10; and (5) modifying the tolerance expression and creating a
single paragraph and table under 180.245 (a) to read as follows:
General. Tolerances are established for residues of the fungicide
streptomycin, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only streptomycin (O-
2-Deoxy-2-(methylamino)-a-L-glucopyranosyl-(1-2)-O-5-deoxy-3-C-formyl-
a-L-lyxofuranosyl-(1-4)-N,N'-bis(aminoiminomethyl)-D-streptamine) in or
on the commodity. A laboratory working method based on USDA Food Safety
and Inspection Service SOP No: CLG-AMG1.02, ``Confirmation of
Aminoglycosides by HPLC-MS/MS'' is available. Modifications were made
to improve the performance of the method for the various crop
fractions. (RD)
    3. PP 4E8273. (EPA-HQ-OPP-2014-0506). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to remove the tolerance in 40 CFR 180.532 for residues
of the fungicide, cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-
pyrimidinamine, in or on fruit, stone, group 12 at 2.0 parts per
million (ppm). The Syngenta Crop Protection Method AG-631B is used to

measure and evaluate the chemical cyprodinil. (RD)
    4. PP 4E8274. (EPA-HQ-OPP-2014-0470). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to remove the tolerances in 40 CFR 180.475 for residues
of the fungicide, difenoconazole, 1-[2-[2-chloro-4-(4-
chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole, in or on fruit, stone, group 12 at 2.5 parts per million
(ppm); nut, tree, group 14 at 0.03 ppm; and pistachio at 0.03 ppm. The
liquid chromatography (LC) tandem mass spectrometry (MS)/(MS) method is
used to measure and evaluate the chemical difenoconazole. (RD)
    5. PP 4F8262. (EPA-HQ-OPP-2014-0441). Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC 27419-8300, requests to amend the
tolerance in 40 CFR part 180 for residues of the herbicide, fluazifop-
p-butyl in or on sweet potato roots from 0.05 parts per million (ppm);
to 1.5 ppm. The PAM Vol. II, Method II is used to measure and evaluate
the chemical fluazifop-p-butyl. (RD)
    6. PP 4F8279. (EPA-HQ-OPP-2014-0489). Dow AgroSciences, LLC., 9330
Zionsville Road, Indianapolis, IN 46268-1054, requests to amend the
tolerances in 40 CFR 180.417 to include residues of the herbicide,
triclopyr choline salt as triclopyr, [(3,5,6-trichloro-2-pyridinyl)oxy]
acetic acid, including its metabolites and degradates, in or on the raw
agricultural commodities listed. An analytical method using electron
capture gas chromatography is used to measure and evaluate the chemical
triclopyr. (RD)

New Tolerance Exemptions

    1. PP 3E8217. (EPA-HQ-OPP-2014-0374). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, New
Jersey 08540, on behalf of BetaTec Hop Products, Inc., 5185 MacArthur
Blvd. NW., Suite 300, Washington, DC 20016, requests to establish an
exemption from the requirement of a tolerance for residues of the
biochemical pesticide potassium salts of hop beta acids, in or on honey
and honeycomb. The petitioner believes no analytical method is needed
because it is not required for a tolerance exemption. (BPPD)
    2. PP IN-10671. (EPA-HQ-OPP-2014-0514). BASF, EPA Company Number
71840, 26 Davis Drive, Research Triangle Park, NC 27709, requests to
establish an exemption from the requirement of a tolerance for residues
of polyethylene glycol alkyl ether sulfosuccinate disodium salts (CAS
Nos. 68954-91-6 and 68815-56-5), for use as an inert ingredient in seed
treatment formulations in accordance with 40 CFR 180.920. The
petitioner believes no analytical method is needed because it is not
required for the establishment of a tolerance exemption for inert
ingredients. (RD)
    3. PP IN-10674. (EPA-HQ-OPP-2014-0217). Spring Trading Company,
10805 West Timberwagon Circle, Spring, TX 77380-4030, on behalf of
Croda, Inc., 315 Cherry Lane, New Castle, DE 19720, requests to
establish an exemption from the requirement of a tolerance for residues
of the polyoxyalkylated sorbitan fatty acid esters with C6
through C22 aliphatic alkanoic and/or alkenoic fatty acids,
branched or linear, the resulting polyoxyalkylene sorbitan esters
having a minimum molecular weight of 1,000 (CAS Nos. 81776-11-6, 87090-
31-1, 88895-72-1; 1472661-05-4, 161026-53-5, 103171-31-9, 1472661-17-8,
1472668-03-3, 1472655-32-5, 1472663-59-4, 1472663-64-1, 1472663-66-3,
1472663-92-5, 1472654-83-3, 1472644-84-0, 1472644-85-1, 1472644-87-3,
1472644-88-4, 1472644-80-6, 1472644-81-7) when used as a pesticide
inert ingredient in pesticide formulations as dispersants, emulsifiers,
surfactants, and related adjuvants of surfactants. The petitioner
believes no analytical method is needed because it is not required for
the establishment of a tolerance exemption for inert ingredients. (RD)
    4. PP IN-10690. (EPA-HQ-OPP-2014-0467). Spring Trading Company,
LLC., 10805 West Timberwagon Circle, Spring, Texas 77380, on behalf of
Croda Inc., 315 Cherry Lane, New Castle DE, 19720, requests to amend an
exemption from the requirement of a tolerance in 40 CFR 180.910 and
180.930 for residues of the alkyl alcohol alkoxylate phosphate and
sulfate derivatives (AAAPD and AAASD respectively), (CAS Nos. 37281-86-
0, 51325-10-1, 52019-38-2, 58206-38-5, 58857-49-1, 62482-61-5, 63887-
54-7, 66020-37-9, 66281-20-7, 68332-75-2, 68400-75-9, 70844-96-1,
78041-18-6, 82465-25-6, 84843-37-8, 95014-34-9, 99924-51-3, 120913-45-
3, 123339-53-7, 129208-04-4, 144336-75-4, 146815-57-8, 151688-56-1,
159704-69-5, 172027-16-6, 172274-69-0, 176707-42-9, 181963-82-6,
188741-55-1, 191940-53-1, 210993-53-6, 290348-69-5. 290348-70-8,
340681-28-9, 422563-26-6, 522613-09-8, 717140-06-2, 717140-09-5,
717827-29-7, 762245-80-7, 762245-81-8, 866538-89-8, 866538-90-1,
913068-96-9, 1087209-87-7, 1174313-54-2, 1205632-03-6, 1233235-49-8,
1451002-50-8, 1456802-88-2, 1456802-89-3, 1456803-12-5, 3694-74-4,
9086-52-6, 15826-16-1, 25446-78-0, 27731-61-9, 55901-67-2, 61894-66-4,
63428-85-3, 65104-74-7, 65122-38-5, 67762-19-0, 67762-21-4, 67923-90-4,
68611-29-0, 119432-41-6, and 219756-63-5) when used as a pesticide
inert ingredient in pesticide formulations for post-harvest use on
agricultural crops and when applied to animals. The petitioner believes
no analytical method is needed because it is not required for the
establishment of a tolerance exemption for inert ingredients. (RD)
    5. PP IN-10704. (EPA-HQ-OPP-2014-0418). Loveland Products, Inc.,
3005 Rocky Mountain Avenue, Loveland, CO 80538, requests to establish
an exemption from the requirement of a tolerance for residues of the
phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl- (CAS No. 23328-53-
2) when used as a pesticide inert ingredient in pesticide formulations
as a ultra-violet (UV) stabilizer not to exceed 10% weight/weight (w/w)
in pesticide formulations under 40 CFR 180.920 (pre-harvest uses). The
petitioner believes no analytical method is needed because CAS No.
23328-53-2 is currently approved for use at no more than 0.6% in
pesticide formulations. (RD)
    6. PP IN-10705. (EPA-HQ-OPP-2014-0481). Akzo Nobel Surface
Chemistry, LLC., 525 West Van Buren Street, Chicago, IL 60607-3823,
requests to establish an exemption from the requirement of a tolerance
for residues of 2-propenoic acid, 2-methyl-, phenylmethyl ester,
polymer with 2-propenoic acid, peroxydisulfuric acid ([(HO)S(O)2]2O2)
sodium salt (1:2)-initiated, compounds with diethanolamine; (CAS
No.1574486-33-1) with a minimum number average molecular weight (in
amu) of 2,000, when used as a pesticide inert ingredient in pesticide
formulations under 40 CFR 180.960. The petitioner believes no
analytical method is needed because it is not required for an exemption
from the requirement of a tolerance. (RD)

List of Subjects in 40 CFR Part 180

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

     Dated: August 22, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2014-21101 Filed 9-4-14; 8:45 am]
BILLING CODE 6560-50-P


Lydia Wegman/RTP/USEPA/US

10/04/2007 12:33 PM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> cc

<EMAIL_ADDRESS><EMAIL_ADDRESS>Zachary Pekar/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

CASAC letter on second draft of lead NAAQS exposure and risk assessments

As promised.


[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6841-6842]
[FR Doc No: 2011-2660]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0170; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
2006 and 2007 Aston Martin Vantage Passenger Cars Are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt of petition for decision that nonconforming
2006 and 2007 Aston Martin Vantage passenger cars are eligible for
importation.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2006 and 2007 Aston Martin Vantage passenger cars that were not
originally manufactured to comply with all applicable Federal Motor
Vehicle Safety Standards (FMVSS) are eligible for importation into the
United States because they are substantially similar to vehicles that
were originally manufactured for importation into and sale in the
United States and that were certified by their manufacturer as
complying with the safety standards (the U.S.-certified version of the
2006 and 2007 Aston Martin Vantage passenger cars,) and they are
capable of being readily altered to conform to the standards.

DATES: The closing date for comments on the petition is March 10, 2011.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
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 DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a

motor vehicle originally manufactured for importation into and sale in
the United States, certified under 49 U.S.C. 30115, and of the same
model year as the model of the motor vehicle to be compared, and is
capable of being readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC (``JK''), of Baltimore, Maryland (Registered
Importer 90-006) has petitioned NHTSA to decide whether nonconforming
2006 and 2007 Aston Martin Vantage passenger cars are eligible for
importation into the United States. The vehicles which JK believes are
substantially similar are 2006 and 2007 Aston Martin Vantage passenger
cars that were manufactured for sale in the United States and certified
by their manufacturer as conforming to all applicable FMVSS.
    The petitioner states that it compared non-U.S. certified 2006 and
2007 Aston Martin Vantage passenger cars to their U.S.-certified
counterparts, and found the vehicles to be substantially similar with
respect to compliance with most FMVSS.
    JK submitted information with its petition intended to demonstrate
that non-U.S. certified 2006 and 2007 Aston Martin Vantage passenger
cars, as originally manufactured, conform to many FMVSS in the same
manner as their U.S. certified counterparts, or are capable of being
readily altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 2006
and 2007 Aston Martin Vantage passenger cars are identical to their
U.S. certified counterparts with respect to compliance with Standard
Nos. 102 Transmission Shift Lever Sequence, Starter Interlock, and
Transmission Braking Effect, 103 Windshield Defrosting and Defogging
Systems, 104 Windshield Wiping and Washing Systems, 106 Brake Hoses,
109 New Pneumatic Tires, 113 Hood Latch System, 116 Motor Vehicle Brake
Fluids, 124 Accelerator Control Systems, 135 Light Vehicle Brake
Systems, 201 Occupant Protection in Interior Impact, 202 Head
Restraints, 204 Steering Control Rearward Displacement, 205 Glazing
Materials, 206 Door Locks and Door Retention Components, 207 Seating
Systems, 209 Seat Belt Assemblies, 210 Seat Belt Assembly Anchorages,
212 Windshield Mounting, 214 Side Impact Protection, 216 Roof Crush
Resistance, 219 Windshield Zone Intrusion, 225 Child Restraint
Anchorage Systems, 302 Flammability of Interior Materials, and 401
Interior Trunk Release.
    The petitioner also contends that the vehicles are capable of being
readily altered to meet the following standards, in the manner
indicated:
    Standard No. 101 Controls and Displays: Replacement of the
instrument cluster with a conforming U.S.-model component.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Installation of the following conforming U.S.-model
components on vehicles not already so equipped: (a) Front and rear side
marker lamps and reflex reflectors; (b) headlamps; (c) tail lamps; and
(d) a high mounted stop lamp.
    Standard No. 110 Tire Selection and Rims: Installation of a tire
information placard.
    Standard No. 111 Rearview Mirrors: Installation of a conforming
U.S.-model passenger side rearview mirror, or inscription of the
required warning statement on the face of that mirror.
    Standard No. 114 Theft Protection: Installation of a supplemental
key warning buzzer to ensure that the theft protection system meets the
requirements of this standard.
    Standard No. 118 Power-Operated Window, Partition, and Roof Panel
Systems: Installation of U.S.-model software to ensure that the power-
operated window system meets the requirements of this standard.
    Standard No. 208 Occupant Crash Protection: Installation of: (a) A
seat belt warning buzzer and associated software; (b) airbag warning
labels; (c) a replacement front passenger's seat frame base
incorporating four occupant classification system (OCS) sensors and
associated electronic control module (The connection for the OCS
already exists in the vehicle wiring system.); (d) a child restraint
tether anchorage on the front passenger's seat; (e) revised software in
the restraint control module (RCM) so that the OCS connection and
redundant Passenger Airbag Cut Off Switch (PACOS) is recognized; and
(f) revised software in the central electronic module (CEM) for system
compatibility and to reconfigure the vehicle settings to ensure that
the occupant restraint systems meet the requirements of this standard.
    In addition, the petitioner states that the passenger airbag cut
off switch (PACOS) must be deactivated.
    The petitioner included a parts list in its petition that it
obtained from the original manufacturer of the vehicle listing the
components that must be installed in the nonconforming vehicle.
    The petitioner also states that the occupant restraint systems used
in vehicle includes conforming combination lap and shoulder belts at
the outboard front seating positions as well as the rear outboard
seating positions that are self-tensioning and released by means of a
single red pushbutton.
    Standard No. 301 Fuel System Integrity: Installation of U.S.-model
software to ensure that the system meets the requirements of this
standard.
    The petitioner additionally states that a vehicle identification
plate must be affixed to the vehicles near the left windshield post to
meet the requirements of 49 CFR Part 565.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: February 2, 2011.
Claude H. Harris,
Acting Associate Administrator for Enforcement.
[FR Doc. 2011-2660 Filed 2-7-11; 8:45 am]
BILLING CODE 4910-59-P


Notes from Teleconference with Members of pesticide Poisoning Victims
United

and Consultant Mr. Stuart Turner

May 6, 2010

Participants

On site (EPA):  Carol Stangel, Deborah Smegal, Faruque Khan , Jeff
Dawson, Kathy Davis,

Margaret Rice, Margarita Collantes, Jill Bloom

On the phone:  Erin Koch (EPA); Day Owen, Neila Owen, Maya Gee
(Pesticide Poisoning Victims United), Stuart Turner (consultant)

Introductory remarks

EPA mostly in a listening role (no decisions)

(Mr. Owen)  Thanks for meeting.  Petition requests three things; today
focus on establishment of appropriate buffer.  Pesticide applications of
concern are helicopter-applied; take place on mountains, under damp and
foggy conditions.  Residents live in valleys.

(Maya Gee) Organic farmer—dairy, eggs, produce.  In October 2007
exposed to drift from application one mile away.  Suffered difficulty
breathing, rapid heartbeat, joint pain, headaches, nausea, diarrhea;
took one year of detoxification to feel better.

Stuart Turner

Many years experience with forestry practices, aerial applications.

Because of the physical geography of the region (Coastal Range),
applications are made 75-100’ above the target area.  Applications
mostly herbicides to aid establishment of new trees.  Large droplet
size. Even in a field of new trees, there are standing snags that
dictate how high the helicopter must fly.  Most applications not in
conformance with law, labels say apply 10-15’ above canopy.  Cited the
example of Oust, DuPont product containing 75% sulfometuron methyl.
(Subsequent review: label includes language “Application more than 10
ft above the canopy increases the potential for spray drift,” no
direct prohibitions)  Cited Acu-flo nozzle

Timing is critical because preferred species are mostly tolerant of
herbicides when they are not actively growing; spraying occurs from late
February to May, with April being the peak; may even occur over snow.
Location gets a lot of rain.  Areas on average 35% slope, but up to 65%.

Applications at 75-100’—need 60-75’ to clear snags by 10’,
because of slope inside boom is 75’off the ground, outside boom 100’
 Helicopters fly on the contours—even without snags outside boom at
least 20’ above ground.

Many of the sprayed areas contain or are close to intermittent streams.

In the area of concern, microinversions, which prevent vertical mixing
of air, are not uncommon.  Air will come down the mountains and pool in
the valleys, where the topography of criss-cross ridges slows drainage,
and could contribute to a build-up of atmospheric pollutants over the
course of several days

One of the herbicides commonly used by the timber companies is
sulfometuron, which can be phytotoxic to non-target plants at very low
doses  Herbicides account for 95% of the pesticides applied; commonly
used herbicides contain sulfometuron, hexazinone, triclopyr, and 2,4-D.
The herbicides are mainly used in the first five years of a planting.
Typical pattern might be:

1.  First application for site-prep on clear-cut or near clear-cut
areas, to suppress “trash trees”

2.  Second application after “conifer release,” planting of Douglas
fir, spruce, Western red cedar; seedlings when planted are 1-3 years old

3.  In the first five years, herbicides may be applied once or twice
more.

Frequent fog-helicopters do apply when fog is present.  The swirling fog
travels at 2-4 mph due to predominant winds and currents. In Spring, fog
is present on about 90% of the days. On a foggy day, visibility between
applications at upper reaches of mountain and bottom 1000’ is limited.
 There is some evidence that pesticides move with the fog (per work of
Dr. Norman Akesson).

Mr. Turner will provide a video showing helicopter applications in the
Coastal Range.

Pesticides also applied over snow.  Potential for pesticides to appear
in snow-melt and run-off.  There are many seasonal or ephemeral streams
in the area where water may flow through August.

Jeff Dawson asked:  Are there technologies, nozzles, adjuvants that can
reduce drift in these situations? Mr. Turner replied that these
technologies are not adequate to limit drift under these particular
conditions, and that buffer zones are the only way.

Alternate application methods:  Applications of herbicides can be made
with the “hack and squirt” method, whereby the bark of the
undesirable trees is cut and herbicide is spray into the cut.
Applications via helicopter may be 250,000 A/year and big companies
think the crews to do this work are not cost-effective.  Owners of small
woodlot tend toward the backpack applications.  Applicators are supposed
to “use as directed” but labels are lacking in specifics that might
reduce drift.

Day Owen

Even though a lumber company doesn’t clearcut (then start a new crop
of trees) every area every year, from his house one can always spot a
clearcut in the surrounding mountains.

Neila Owen

Encountered pesticide drift from application by Roseberg Timber Company
on October 12, 2007; took her over a year to recover.

 PAGE

 PAGE   2


[Federal Register Volume 88, Number 113 (Tuesday, June 13, 2023)]
[Proposed Rules]
[Pages 38413-38416]
[FR Doc No: 2023-12642]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0269]
RIN 1625-AA00

Safety Zone; Heavy Weather and Natural or Other Disasters in San
Juan Captain of the Port Zone, San Juan, Puerto Rico

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a safety zone that
would restrict vessels from transiting through certain navigable waters
in the San Juan Captain of the Port (COTP) zone during periods of
experienced or expected gale force winds (of 34 knots/39 mph or
greater) and reduced visibility due to anticipated heavy weather
periods, e.g., tropical storm, hurricane or due to any natural or other
disasters where the restriction of vessel traffic is deemed appropriate
by the COTP. This proposed rulemaking would prohibit vessel traffic
transiting or remaining in the regulated areas unless authorized by the
COTP, San Juan, Puerto Rico, or a designated representative. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 28, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0269 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LCDR Carlos M. Ortega-P[eacute]rez,
the Waterways Management Division Chief, Sector San Juan Prevention
Department, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
MTS Maritime Transportation System
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    The purpose of the proposed regulation is to ensure the safety of
the port and life on navigable waters of the United States by
restricting movement of vessels and barges over 500 gross tons (GT) in
the event of heavy weather conditions or any natural or other disasters
anticipated to affect the San Juan Captain of the Port (COTP) zone. The
COTP has determined that reduced or restricted visibility and gale
force winds which may occur during heavy weather periods and other
disasters affecting Puerto Rico and the U.S. Virgin Islands,
constitutes a safety concern for the navigable waters and waterfront
facilities within the San Juan COTP zone. This proposed regulation
would ensure safety of vessels and navigable waters within the safety
zone before, during, and after heavy weather conditions, e.g., tropical
storms, hurricanes and any natural or other disasters to minimize
potential danger to the inbound, outbound, and transiting vessels.
Additionally, both natural and other disasters may occur that are
outside of the scope of the previously mentioned events, that would
require the restriction of vessel movements within the COTP zone to
protect life, property and the Maritime

Transportation System (MTS) of Puerto Rico and the U.S. Virgin Islands.
The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone on certain
navigable waters within the Sector San Juan COTP zone in response to
anticipated heavy weather periods (e.g., tropical storms and
hurricanes) and any natural or other disasters that would restrict
movement of vessels when the COTP sets specific Port Conditions, or
deems such restrictions necessary, if the situation threatens the
safety of vessels and mariners entering, departing, and transiting
through ports located within the San Juan COTP zone. The movement of
vessels and barges over 500 GT within navigable waters of the San Juan
COTP zone, i.e., ports of Puerto Rico and the U.S. Virgin Islands would
be affected by this rule. Vessel movement restrictions would only apply
to ports identified by the COTP forecast to experience gale force winds
within an established threshold. The proposed rule would give the COTP
flexibility in controlling and reconstituting vessel traffic during
periods of heavy weather and allows for expediting resumption of the
MTS following disasters and severe weather.
    The proposed rule includes safety zones that would have vessel
movement limitation determined by each Hurricane Port Condition when
established by the COTP while in hurricane season or while anticipating
gale force winds, and any natural or other disasters within the San
Juan COTP zone. Hurricane Port Conditions (WHISKEY, X-RAY, YANKEE, and
ZULU) are standardized states of operation instituted by the COTP and
shared with all major ports, facilities, and members of MTS) within the
COTP zone. All stakeholders are required to work in unison to safeguard
the MTS when faced with the annual challenges posed by tropical storms,
hurricanes as well as other unforeseen disasters.
    Notice of Port Conditions and their requirements will be given via
Marine Safety Information Bulletins, online at https://homeport.uscg.mil/port-directory/san-juan, Broadcast Notice to
Mariners, and during Port Coordination meetings.
    The regulatory text we are proposing appears at the end of this
document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    We expect the economic impact of this proposed rule to be not
significant for the following reasons: (1) Vessel traffic and
facilities will be impacted by this rule only during limited times
while heavy weather or other disaster is expected to impact the Sector
San Juan COTP zone; (2) vessel traffic would be secured only during
port conditions Yankee and Zulu, and only in port areas potentially
affected by gale force winds; and (3) the Coast Guard would issue
updates on https://homeport.uscg.mil/port-directory/san-juan, Broadcast
Notice to Mariners, and during Port Coordination meetings.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed 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.
    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. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. 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.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. 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 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone of limited duration implemented during heavy weather events e.g.,
tropical storms, hurricanes, or other natural disasters where a safety
zone implementation is deemed appropriate by the COTP. Normally such
actions are categorically excluded from further review under paragraph
L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning
Implementing Procedures 5090.1. A preliminary Record of Environmental
Consideration 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.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0269 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov. Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

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 is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR
1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 00170.1, Revision No. 01.3.

0
2. Add Sec.  165.791 to read as follows:

Sec.  165.791  Safety Zones; Heavy Weather and Natural or Other
Disasters in San Juan Captain of the Port Zone.

    (a) Location. The following area is a safety zone: All navigable
waters, as defined in 33 CFR 2.36, within Sector San Juan Captain of
the Port (COTP) zone, San Juan, Puerto Rico, as described in 33 CFR
3.35-25, during specified conditions. (b) Definitions. (1) As used in
this section, designated representative means a Coast Guard Patrol
Commander, including a Coast Guard coxswain, petty officer, or other
officer operating a Coast Guard vessel and a Federal, State, and local
officer designated by or assisting the COTP San Juan in the enforcement
of the safety zone.
    (b) Definitions.
    (1) Gale force winds means sustained surface winds, or frequent
gusts, of 34 knots (39 mph) or more usually seen in coastal regions.
    (2) Port Condition WHISKEY means a condition set by the COTP when
gale force winds are expected to make landfall at the port within 72
hours.
    (3) Port Condition X-RAY means a condition set by the COTP when
gale force winds are expected to make landfall at the port within 48
hours.
    (4) Port Condition YANKEE means a condition set by the COTP when
gale force winds are expected to make landfall at the port within 24
hours.
    (5) Port Condition ZULU means a condition set by the COTP when gale
force winds are expected to make landfall at the port within 12 hours.
    (c) Regulations. (1) Port Condition WHISKEY. Open to all commercial
traffic. All oceangoing vessels over 500 (GT) to report their intention
to depart or remain in port. All oceangoing vessels over 500 GT
intending to remain in port must contact the COTP prior to setting port
condition X-Ray. All vessel and port facilities must exercise due
diligence in preparation for potential storm impacts. Slow-moving
vessels may be ordered to depart to ensure safe avoidance of the
incoming storm upon the anticipation of the setting of Port Condition
X-RAY. Ports and waterfront facilities must begin removing all debris
and securing potential flying hazards. Container stacking plans must be
implemented. Waterfront facilities that are unable to reduce container-
stacking height to no more than four high must submit a container
stacking protocol to the COTP.
    (2) Port Condition X-RAY. Open to all commercial traffic. Remain in
port applications will no longer be accepted without a COTP waiver.
Vessels remaining in port may be issued COTP Orders to depart
immediately. All vessels and port facilities must ensure that potential
flying debris is removed or secured. Hazardous materials/pollution
hazards must be secured in a safe manner and away from waterfront
areas. Facilities must continue to implement container-stacking
protocol. Containers must not exceed four tiers, unless previously
approved by the COTP. Containers carrying hazardous materials may not
be stacked above the second tier. All oceangoing commercial vessels
greater than 500-gross tons must prepare to depart ports and anchorages
within the affected regulated area. These

vessels must depart immediately upon the setting of Port Condition
YANKEE. During this condition, slow-moving vessels may be ordered to
depart to ensure safe avoidance of the incoming storm. Vessels that are
unable to depart the port must contact the COTP to request and receive
permission to remain in the port. Vessels with COTPs permission to
remain in the port must implement their pre-approved mooring
arrangement. Terminal operators must prepare to terminate all cargo
operations. The COTP may require additional precautions to ensure the
safety of the ports and waterways.
    (3) Port Condition YANKEE. The port is closed to all inbound vessel
traffic except unless specifically authorized by the COTP. All
oceangoing vessels greater than 500-gross tons without approved
applications to remain in port shall depart designated ports within the
Sector San Juan COTP zone at this time. Final mooring arrangements for
vessels remaining in port. Appropriate container stacking protocol must
be completed. Terminal operators must terminate all cargo operations
not associated with storm preparations. Cargo operations associated
with storm preparations include moving cargo within or off the port for
securing purposes, crane and other port/facility equipment
preparations, and similar activities, but do not include moving cargo
onto the port or vessel loading/discharging operations unless
specifically authorized by the COTP. All facilities must continue to
operate in accordance with approved Facility Security Plans and comply
with the requirements of the Maritime Transportation Security Act.
    (4) Port Condition ZULU. The port is closed to all vessel traffic
except unless specifically authorized by the COTP. Cargo operations are
suspended, including bunkering and lightering. except final
preparations that are expressly permitted by the COTP as necessary to
ensure the safety of the ports and facilities. Waivers maybe granted
unless Cargo of Particular Hazard or Certain Dangerous Cargo is
involved. Coast Guard Port Assessment Teams will conduct final port
assessments.
    (5) Emergency Regulation for Other Disasters. Any natural or other
disasters that are anticipated to affect the Sector San Juan COTP zone
will result in the prohibition of facility operations and vessel
traffic transiting or remaining in the affected port.
    (6) Persons and vessels desiring to enter, transit through, anchor
in, or remain in the regulated area may contact the COTP via telephone
at<PHONE_NUMBER>, or a designated representative via VHF radio on
channel 16, to request authorization. If authorization to enter,
transit through, anchor in, or remain in the regulated area is granted
by the COTP or a designated representative, all persons and vessels
receiving such authorization must comply with the instructions of the
COTP or a designated representative.
    (7) Coast Guard Sector San Juan will attempt to notify the maritime
community of periods during which these safety zones will be in effect
via Broadcast Notice to Mariners or by on-scene designated
representatives.

    Dated: June 8, 2023.
Robert M. Pirone,
Captain, U.S. Coast Guard, Alternate Captain of the Port, San Juan.
[FR Doc. 2023-12642 Filed 6-12-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47399-47400]
[FR Doc No: 2016-17187]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0406]

Determination of Regulatory Review Period for Purposes of Patent
Extension; QUTENZA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for QUTENZA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
September 19, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by January 17,
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-E-0406 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; QUTENZA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

redacted/blacked out, will be available for public viewing and posted
on http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
    Although only a portion of a regulatory review period may count
toward the actual amount of extension that the Director of USPTO may
award (for example, half the testing phase must be subtracted as well
as any time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product QUTENZA
(capsaicin). QUTENZA is indicated for management of neuropathic pain
associated with postherpetic neuralgia. Subsequent to this approval,
the USPTO received a patent term restoration application for QUTENZA
(U.S. Patent No. 6,239,180) from NeurogesX, Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration and also requested that FDA determine the
product's regulatory review period. In a letter dated June 23, 2016,
FDA advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of QUTENZA represented
the first permitted commercial marketing or use of the product.
Thereafter, FDA also determined the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
QUTENZA is 2,944 days. Of this time, 2,547 days occurred during the
testing phase of the regulatory review period, while 397 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: October 27, 2001. The applicant claims September 27, 2001,
as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was October 27, 2001, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
16, 2008. The applicant claims October 13, 2008, as the date the new
drug application (NDA) for QUTENZA was initially submitted. However,
FDA records indicate that NDA 22-395 was submitted on October 16, 2008.
    3. The date the application was approved: November 16, 2009. FDA
has verified the applicant's claim that NDA 22-395 was approved on
November 16, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,687 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17187 Filed 7-20-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Rules and Regulations]
[Page 54947-54950]
[DOCID:fr24se08-7]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2008-0761]
RIN 1625-AA08

Special Local Regulations for Marine Events; St. Leonard Creek,
Patuxent River, Calvert County, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing special local regulations
during the ``War of 1812 North American Grand Tactical'', a marine
event to be held September 21, 2008 on the waters of St. Leonard Creek
and Patuxent River, Calvert County, MD. These special local regulations
are necessary to provide for the safety of life on navigable waters
during the event. This action is intended to temporarily

restrict vessel traffic in a portion of St. Leonard Creek and the
Patuxent River during the event.

DATES: This rule is effective from 7 a.m. to 3:30 p.m. on September 21,
2008.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0761 and are available online at
www.regulations.gov. This material is also available for inspection or
copying at two locations: the 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, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays and the Fifth
Coast Guard District, Prevention Division, Room 416, 431 Crawford
Street, Portsmouth, VA 23704 between 10 a.m. and 2 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Dennis Sens, Project Manager, Fifth Coast Guard
District, Inspections and Investigations Branch, at<PHONE_NUMBER>. If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On August 7, 2008, we published a notice of proposed rulemaking
(NPRM) entitled Special Local Regulations for Marine Events; St.
Leonard Creek, Patuxent River, Calvert County, MD in the Federal
Register (73 FR 45919). We received no letters commenting on the
proposed rule. No public meeting was requested, and none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The Coast Guard received notice of
the event on July 18, 2008. The NPRM published on August 7, 2008, and
the comment period expired on September 8, 2008. Delaying the effective
date would be contrary to the public interest, since immediate action
is needed to ensure the safety of the event participants, support
vessels, spectator craft and other vessels transiting the event area.
However advance notifications will be made to users of the Patuxent
River and St. Leonard Creek via marine information broadcast, local
notice to mariners, commercial radio stations and area newspapers.

Background and Purpose

    On September 21, 2008, the Jefferson Patterson Park and Museum will
sponsor ``War of 1812 North American Grand Tactical'' on the waters of
St. Leonard Creek and the Patuxent River, Calvert County, MD. The event
will consist of four tall ships and several small boats that will re-
enact sea battles in Maryland during the War of 1812. The regulated
area originates along the northern shore of St. Leonard Creek, thence
west to Petersons Point thence northwest along the shoreline of the
Patuxent River adjacent to Jefferson Patterson Park and Museum and
extends outward over the water within an approximately 500 yard arc.
Due to the need for vessel control during the event, the Coast Guard
will temporarily restrict vessel traffic in the event area to provide
for the safety of participants, spectators and other transiting
vessels.

Discussion of Comments and Changes

    The Coast Guard did not receive comments in response to the notice
of proposed rulemaking (NPRM) published in the Federal Register.
Accordingly, the Coast Guard is establishing temporary special local
regulations on specified waters of the Patuxent River, and St. Leonard
Creek, Calvert County, MD.

Regulatory Analyses

    We developed this 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 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.
    Although this regulation will prevent traffic from transiting a
portion of St. Leonard Creek and Patuxent River during the event, the
effect of this regulation will not be significant due to the limited
duration that the regulated area will be in effect and the extensive
advance notifications that will be made to the maritime community via
the Local Notice to Mariners, marine information broadcasts, and area
newspapers, so mariners can adjust their plans accordingly.
Additionally, the regulated area has been narrowly tailored to impose
the least impact on general navigation yet provide the level of safety
deemed necessary. Vessel traffic may be able to transit the regulated
area at slow speed when event activity is halted, when the Coast Guard
Patrol Commander deems it is safe to do so.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on a substantial number of small
entities. This 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 the effected portion of St. Leonard Creek and
Patuxent River during the event.
    Although this regulation prevents traffic from transiting a small
segment of St. Leonard Creek and the Patuxent River during the event,
this rule would not have a significant economic impact on a substantial
number of small entities for the following reasons. This rule would be
in effect for only a limited period. Vessel traffic may be able to
transit the regulated area when event activity is halted, when the
Coast Guard Patrol Commander deems it is safe to do so. Before the
enforcement period, we will issue maritime advisories so mariners can
adjust their plans accordingly.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call

1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate
against small entities that question or complain about this rule or any
policy or action of the Coast Guard.

Collection of Information

    This rule calls 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 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 rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this 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 concluded
under the Instruction that there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(h), of the Instruction, from further
environmental documentation.
    Under figure 2-1, paragraph (34)(h), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 100

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 100 as follows:

PART 100--REGATTAS AND MARINE PARADES

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Add a temporary Sec.  100.35-T05-0761 to read as follows:

Sec.  100.35-T05-0761  St. Leonard Creek, Patuxent River, Calvert
County, MD.

    (a) Definitions: The following definitions apply to this section:
(1) Coast Guard Patrol Commander means a commissioned, warrant, or
petty officer of the Coast Guard who has been designated by the
Commander, Coast Guard Sector Baltimore to act on his behalf.
    (2) Official Patrol means any vessel assigned or approved by
Commander, Coast Guard Sector Baltimore with a commissioned, warrant,
or petty officer on board and displaying a Coast Guard ensign.
    (3) Participant includes all vessels participating in the War of
1812 Grand Tactical re-enactment under the auspices of a Marine Event
Permit issued to the event sponsor and approved by Commander, Coast
Guard Sector Baltimore.
    (b) Regulated area includes the waters of the Patuxent River and
St. Leonard Creek, Calvert County, MD, within the general vicinity of
Petersons Point. The area is bounded on the east by a line drawn along
longitude 076[deg]30[min]00[sec] West, bounded on the south by a line
drawn along latitude 38[deg]23[min]00[sec] North, bounded on the west
by a line drawn along longitude 076[deg]31[min]20[sec] West and bounded
on the north by the Patuxent River shoreline. All coordinates reference
Datum NAD 1983.
    (c) Special local regulations: (1) Except for event participants
and persons or vessels authorized by the Coast Guard Patrol Commander,
no person or vessel may enter or remain in the regulated area.
    (2) The operator of any vessel in the regulated area shall: (i)
Stop the vessel immediately when directed to do so by any Official
Patrol.

    (ii) Proceed as directed by any Official Patrol.
    (iii) When authorized to transit the regulated area, all vessels
shall proceed at the minimum speed necessary to maintain a safe course
that minimizes wake near the event area.
    (d) Effective period. This section will be enforced from 7 a.m. to
3:30 p.m. on September 21, 2008.

    Dated: September 15, 2008.
Fred M. Rosa, Jr.,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. E8-22429 Filed 9-23-08; 8:45 am]

BILLING CODE 4910-15-P