[Federal Register: January 18, 2006 (Volume 71, Number 11)]
[Rules and Regulations]
[Page 2889-2895]
[DOCID:fr18ja06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0483; FRL-7754-9]

Thymol; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the thymol (5-methyl-2-isopropyl-1-
phenol) on honey, honeycomb, and honeycomb with honey when applied/used
as treatment to decrease the incidence of Varroa mite infestation in
the honey bee. Vita (Europe) Limited, c/o Landis International Limited,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of thymol (5-methyl-2-isopropyl-1-phenol).

DATES: This regulation is effective January 18, 2006. Objections and
requests for hearings must be received on or before March 20, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit X. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0483. All documents in the
docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November
25, 2005, by an enhanced Federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Andrew Bryceland, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180

is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

To access the OPPTS Harmonized Guidelines referenced in this document
go directly

to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of April 27, 2005 (70 FR 21773) (FRL-7707-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3F6752) by Vita (Europe) Limited c/o Landis International,
Inc., P.O. Box 5126, Valdosta, GA 31603-5126. The petition requested
that 40 CFR part 180 be amended by establishing a temporary exemption
from the requirement of a tolerance for residues of thymol (5-methyl-2-
isopropyl-1-phenol). This notice included a summary of the petition
prepared by the petitioner. A public comment has been received
objecting to ``any tolerance, exemption, or waiver allowing more than
zero residue of thymol on food.'' This objection was supported by the
arguments that:
    1. Embryonic chickens have multiple malformations following thymol
injection into the yolk or air sac, and;
    2. Switzerland has established an Maximum Residue Limit (MRL) of
0.8 milligram/kilogram (mg/kg). The commenter did not provide a
specific data citation for either of these arguments.
    The results from the chicken study are of questionable relevance to
mammals. Currently, EPA does not use chickens (or intrayolk or intra-
airsac exposure routes) as an animal model for developmental toxicity
because of the differences in developmental physiology and anatomy
between the two species. Developmental timing, duration, and potential
environmental effects on developing young are also different in mammals
and birds, again precluding this model for use in setting developmental
toxicity endpoints for the regulation of pesticides (Reference 13).
    Developmental malformations have not been found following thymol
exposure to other mammalian species such as mice, rats, hamsters, and
rabbits (Environmental Risk Management Agency of New Zealand, 2005). In
addition, Mortazavi et al. (2003) reported no external tissue
abnormalities in fetuses following dosing of female rats with an
infusion of the plant Satureja khuzestanica (which has the components
thymol and carvacrol).
    Regulatory limits have been set for thymol in other countries. The
Swiss Federal Department of the Interior has set a tolerance (MRL)
concentration for thymol in honey as an antiparasitic agent (0.8 mg/kg;
pharmacological substance active in nutrition or therapeutic
application; 817.021.23). This tolerance was derived to prevent
exceedance of the taste threshold for thymol in honey (1.1 - 1.3 mg/kg;
Bogdanov et al., 1999), not safety. Tolerances set by EPA are based on
``the reasonable certainty of no harm,'' FFDCA section
408(c)(2)(A)(ii), and therefore, are not constrained by criteria such
as taste.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take intoaccount the factors set forth in
section 408(b)(2)(C), which require 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. . . .''
Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues '' and ``other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information 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.
    Thymol is an essential oil that is extracted from thyme and
mandarine and tangerine oils and is FDA approved when used as a
synthetic flavoring (21 CFR 172.515), a preservative and indirect food
additive of adhesives (21 CFR 175.105). Additionally, the source plant
(thyme), from which thymol is extracted is acknowledged by FDA as
generally recognized as safe (GRAS) (21 CFR 182.10, 21 CFR 182.20).
Residues of thymol can be found in other food stuffs either naturally
such as that found in lime honey or intentionally added to foods such
as ice cream, non-alcoholic beverages, candy, baked goods, and chewing
gum. Information from the public literature documents that levels of
thymol residues in such foods are present at significantly higher
concentrations than those resulting from pesticidal treatments (Refs.
1, 3, 14, 15, 16, 17, and 18). End use products containing thymol as
the active ingredient will be used as a slow release treatment within
the beehive itself to decrease the incidence of Varroa mite infestation
in the honey bee.
    Toxicity data requirements were addressed by requests for data
waivers. The Agency granted data waivers based on publically available
information/data submitted by the registrant and reviewed by the
Agency.
    1. Acute oral toxicity waiver (OPPTS 870.1100, 152-10). The waiver
rationale submitted in support of the acute oral toxicity (870.1100)
data requirement is based on oral LD50s from the open
literature and reviewed by the Agency. The oral LD50 of
thymol has been reported to be 980, 640-1800, and 880 mg/kg in rats,
mice, and guinea pigs, respectively (Refs. 3 and 5). Thymol occurs in
various food stuffs and spices from 0.02 mg/kg to 100 mg/kg (Refs. 3,
14, 15, 16, 17, and 18). The lowest level in which there was an effect
from thymol was 640 mg/kg (Refs. 3 and 5). The amount in which thymol
causes an acute effect is approximately 6 times higher than the 100 mg/
kg found in the food stuff with the highest amount of thymol present.
The information/data described above support the waiver form the data
requirement for the acute oral toxicity study.
    2. Acute dermal toxicity data waiver (OPPTS 870.1200, 152.11). The
waiver rationale submitted in support of the acute dermal toxicity data
requirement is based upon information collected from a report by the
Environmental Risk Management Agency (ERMA, 2005) of New Zealand and
Anonymous (2000) which found dermal LD50's for thymol

greater than 2,000 mg/kg. Thymol occurs in various food stuffs and
spices from 0.02 mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16, 17, and 18).
Dermal exposure to thymol already occurs from contact with foodstuffs
and seasonings containing thymol as it is FDA approved when used as a
direct food additive and is generally recognized as safe by FDA as a
spice, natural oil, oleoresin, or natural extract and therefore, any
additional exposure resulting from dermal contact with thymol will not
result in any significant exposure. Thymol, when used as a pesticide,
is to be applied to the inside of beehives. Data from U.S. and European
field trials demonstrate maximum residue concentrations of 2.59 mg/kg
thymol in honey (at 30 days following treatment in U.S. trials) and
4.61 mg/kg thymol in honey (at 2 days following treatment in European
trials) demonstrate that, following good agricultural practices (as
specified in the tolerance exemption), the amount of thymol residues
remaining in the beehive after application will be well below the
dermal LD50 and within the range of those thymol residues
already present in food stuffs (MRID No.'s: 460435-10, 11, 12, and 13).
Based on this information, the Agency therefore concludes that the
information/data described above support the waiver from the data
requirement for the acute dermal toxicity study.
    Classification: Acceptable.
    3. Acute inhalation toxicity waiver (OPPTS 870.1300, 152-12). The
waiver rationale submitted in support of the acute inhalation toxicity
data requirment is based upon information from the U.S. Food and Drug
Administration Center for Drug Evaluation and Research (Ref. 19).
Thymol is added to the anesthetic halothane as a preservative (0.01%)
and is considered inactive at this concentration (Ref. 19). Halothane
is used to anesthetize dogs, cats, and other non-food animals for
periods sometimes exceeding 4 hours (Ref. 19). Anesthetic induction
concentrations can typically reach approximately 5% (Ref. 19).
Calculation of the exposure from these factors yields a thymol
atmospheric concentration of 5 milligram/liter (mg/L). Thymol is for
application to the inside of beehives. Thymol occurs in various food
stuffs and spices from 0.02 mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16,
17, and 18). Inhalation exposure to thymol already occurs from contact
with foodstuffs and seasonings containing thymol as it is FDA approved
when used as a direct food additive and is generally recognized as safe
by FDA as a spice, natural oil, oleoresin, or natural extract and
therefore, any additional exposure resulting from inhalation contact
with thymol will not result in any significant exposure The
information/data described above support the waiver from the data
requirement for the acute inhalation toxicity study.
    Classification: Acceptable.
    4. Skin hypersensitivity study waiver (OPPTS 870.2600, 152.15). The
waiver rationale for skin hypersensitivity is based on publically
available information (Ref. 20). Using quantitative structure activity
relationships, from the public literature, it was predicted that thymol
is a dermal sensitizer (Ref. 20). Thymol is for application to the
inside of beehives. Thymol occurs in various food stuffs and spices
from 0.02 mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16, 17, and 18). Dermal
exposure to thymol already occurs from contact with foodstuffs and
seasonings containing thymol as it is FDA approved when used as a
direct food additive and is generally recognized as safe by FDA as a
spice, natural oil, oleoresin, or natural extract and therefore, any
additional exposure resulting from dermal contact with thymol will not
result in any significant exposure. The information/data described
above support the waiver from the data requirement for the skin
hypersensitivity study.
    Classification: Acceptable.
    The information/data described above support the waiver from the
data requirement for the skin hypersensitivity study. However, the
registrant is obliged under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) section 6(a)(2) to notify the Agency in the
events of such incidents.
    Classification: Acceptable.
    5. Genotoxicity and mutagenicity study waivers, Master Record
Identification Numbers (MRIDs) 46282801 and 46282802 (OPPTS 870.2300,
870.5195; 152-17, and 152.19). Genotoxicity and mutagenicity studies
submitted on September 18th of 2003 (MRIDs 462828-01 and -02),
presumably as waiver rationales for genotoxicity (870.5000) and other
peer-reviewed publications retrieved by EPA (Refs. 3, 6, 7, 8, 9, 10,
and 11), were used to support the waivers from the data requirements.
These data demonstrate that thymol is not genotoxic and/or mutagenic.
The information/data described above support the waivers from the data
requirements for the genotoxicity and mutagenicity studies.
    Classification: Acceptable.
    6. Immune response study waiver (OPPTS 870.3550, 152.18). The
waiver rationale for immune response (870.3550) is based upon
information presented in a peer-reviewed publication (Ref. 21). No
effects were shown in this data (Ref. 21). The information/data
described above support the waiver form the data requirement for the
acute inhalation toxicity study.
    Classification: Acceptable.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    1. Food. Thymol is already found naturally in food stuffs such lime
honey and cooking herbs and/or food stuffs derived from cranberry and
mandarin and tangerine oils. Thymol is also added to food stuffs
commonly consumed by humans such as ice cream, non-alcoholic beverages,
candy, baked goods, and chewing gum. It is FDA approved when used as a
synthetic flavoring, (21 CFR 172.515), a preservative and indirect food
additive of adhesives (21 CFR 175.105) and the source plant (thyme),
from which thymol is extracted is acknowledged by FDA as generally
recognized as safe (GRAS) (21 CFR 182.10, 21 CFR 182.20). The
information and/or data reviewed in support of this tolerance exemption
demonstrate that the levels of thymol already present in foods or
intentionally added to food stuffs will at concentrations significantly
higher that those levels expected from the use of thymol as a
pesticidal product. Because thymol is already present, either naturally
or intentionally added to various food stuffs, there is a great
likelihood of exposure to thymol for most, if not all individuals,
including infants and children. Even if there is a significant increase
in exposure to thymol due to it's use as a pesticide, the acute
toxicity information from the public literature demonstrating
relatively low mammalian toxicity indicate that any possible risk
associated with acute exposures by the oral route would below to non-
existent.
    2. Drinking water exposure. No exposure to thymol residues in
drinking water is expected since the use of this product is limited to
application within the hive box in which the product is contained in a
dispenser tray, where the

product is rapidly volatilized or redistributed. Because thymol has
relatively low toxicity, has been approved for food use by FDA as a
direct food additive and is generally recognized as safe by FDA, even
if exposure through drinking water were to occur, the exposure would be
far less than the exposure that humans already get from consumption of
thymol thru the diet and therefore, no risk is anticipated.

B. Other Non-Occupational Exposure

    The potential for non dietary exposure to residues of thymol for
the general population, including infants and children, is unlikely
because the uses are limited to application to certain agricultural
crops within the hive box containing the bees and there is no honey
present in the bee hive. Thymol is consumed by humans thru the diet and
for this reason, from a dietary exposure standpoint, has been
determined to have relatively low toxicity. Therefore, while the
likelihood of exposure exists for most if not all individuals, any
increased exposure due to the proposed product would not add any
significant risks.
    1. Dermal exposure. Dermal exposure to thymol already occurs from
contact with foodstuffs and seasonings containing thymol as it is FDA
approved when used as a direct food additive and is generally
recognized as safe by FDA as a spice, natural oil, oleoresin, or
natural extract and therefore, any additional exposure resulting from
dermal contact with thymol will not result in any significant risk.
    2. Inhalation exposure. Inhalation exposure to thymol already
occurs from contact with foodstuffs and seasonings containing thymol as
it is FDA approved when used as a direct food additive and is generally
recognized as safe by FDA as a spice, natural oil, oleoresin, or
natural extract and therefore, any additional exposure resulting from
dermal contact with thymol will not result in any significant risk.

V. Cumulative Effects

    Thymol has a novel mode of cellular action (GABAA receptor, sodium,
potassium, and calcium channel modulator) compared to other currently
registered active ingredients (Ref. 1). In addition, there is no
indication that toxic effects of thymol would be cumulative (Ref. 1).
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider available information concerning the cumulative effects of a
particular pesticide's residues and other substances that have a common
mechanism of toxicity.
    EPA does not have, at this time, available data to determine
whether thymol has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to thymol and
any other substances and thymol does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that thymol has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

VI. Determination of Safety for U.S. Population, Infants and Children

    1. U.S. population. The Agency has determined that there is a
reasonable certainty that no harm will result from aggregate exposure
to residues of thymol to the U.S. population. This includes all
anticipated dietary exposures and other non-occupational exposures for
which there is reliable information. The Agency arrived at this
conclusion based on the relatively low levels of mammalian dietary
toxicity associated with thymol, its FDA approval as a direct food
additive, a preservative and indirect food additive of adhesives and
GRAS listing as a spice, natural oil, oleoresin, or natural extract and
information and/or data which demonstrate that the U.S. population is
potentially exposed to 938 times more thymol from the consumption of
foodstuff such as ice cream, cola beverages and candy, to which thymol
is intentionally added, than from thymol consumed in honey (Refs. 22,
23, and MRID 46043510). These data indicate that thymol residues found
in food and foodstuffs exist at significantly higher concentrations
that those residues levels resulting from the use of thymol as a
pesticide. For these reasons, the Agency has determined that thymol
residues in honey will not pose any significant dietary risk under
reasonable foreseeable circumstances residue.
    2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of exposure (safety) for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base unless the EPA
determines that a different margin of exposure (safety) will be safe
for infants and children. Based on all the reliable available
information the Agency reviewed on thymol, the Agency concludes that
there are no residual uncertainties for prenatal/postnatal toxicity
resulting from thymol and that thymol has relatively low toxicity to
mammals from a dietary standpoint, including infants and children thus,
there are no threshold effects of concern and an additional margin of
safety is not necessary to protect infants and children.

VII. Other Considerations

A. Endocrine Disruptors

    No studies illustrating thymol-induced immune and endocrine
toxicity were submitted by the registrant.
    EPA is required under FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases for including, as part of the program, the
androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may
help determine whether a substance may have an effect in humans, FFDCA
has authority to require the wildlife evaluations. As the science
develops and resources allow, screening of additional hormone systems
may be added to the Endocrine Disruptor Screening Program (EDSP). When
the appropriate screening and/or testing protocols being considered
under the Agency's EDSP have been developed, thymol may be subjected to
additional screening and/or testing to better characterize effects
related to endocrine

disruption. Based on available data, no endocrine system-related
effects have been identified with consumption of thymol. Information
submitted from the public literature and reviewed by the Agency
however, describe immunological endpoints in relation to short-term and
chronic dosing. No effects were seen in the thymus, spleen, lymph
nodes, white cell counts, red cell counts, hemoglobin counts, or
hematocrits following the dosing of rats with 1,000 or 10,000 mg/kg of
food grade thymol for 19 weeks. (MRID 46282803; Ref. 21). This
information does not however, provide evidence to suggest that thymol
affects the immune system, functions in a manner similar to any known
hormone, or that it acts as an endocrine disruptor.

B. Analytical Method(s)

    An analytical method for measuring thymol in honey and beeswax was
submitted and reviewed by the Agency and found to be acceptable.

C. Codex Maximum Residue Level

    The are no CODEX maximum residues levels for thymol.

VIII. Conclusions

    Based on the information/data submitted and other information
available to the Agency, there is a reasonable certainty that no harm
will result from aggregate exposure to residues of thymol to the U.S.
population, including infants and children, under reasonable
foreseeable circumstances, when the biochemical pesticide is used in
accordance with the product label directions. This includes all
anticipated dietary exposures and all other non-occupational exposures
for which there is reliable information. The Agency has arrived at this
conclusion based on the information/data submitted (and publically
available) demonstrating relatively low toxicity of thymol. As a
result, EPA is establishing an exemption from the tolerance
requirements pursuant to FFDCA 408(c) and (d) for residues of thymol in
or on honey, honeycomb and honeycomb with honey.

IX. References

    1. 12/7/05 Agency review memorandum; From Dr. Kent Carlson,
Biologist; Through Dr. Russell Jones, Senior Biologist; To Andrew
Bryceland, Regulatory Action Leader; Subject: Addendum to the 7/19/05
Agency review memorandum and Review of Response to Deficiency Letter,
Waiver Rationales, and Product Chemistry.
    2. 7/19/05 Agency review memorandum; From Dr. Kent Carlson,
Biologist; Through Dr. Russell Jones, Senior Biologist; To Andrew
Bryceland, Regulatory Action Leader; Review of Response to Deficiency
Letter, Waiver Rationales, and Product Chemistry.
    3. Environmental Risk Management Authority (ERMA). 2005. Form HS1,
Application for approval to import or manufacture any hazardous
substance for release (for APILIFE VAR). http://www.ermanz.govt.nz.

    4. Mortazavi, S.H.R., Ebrahimi, M., Salehnia, A., and M. Abdollahi.
2003. Effects of satureja khuzestanica on reproduction potency of
female rats. Neurotoxicology and Teratology. 25. 381-397.
    5. Sax, N.I., 1984. Dangerous properties of industrial materials.
6th edition. New York, NY. Van Nostrand Reinhold. p2580.
    6. Anonymous. 2000. Thymol. Toxikologische Bewertung. Heidleberg,
Berufsgenossenschaft der chemischen Industrie Vol:259 (2000) 38p.
    7. Azizan, A. and R.D. Blevins. 1995. Mutagenicity and
antimutagenicity testing of six chemicals associated with the pungent
properties of specific spices as revealed by the Ames Salmonella/
microsomal assay. Arch. Environ. Contam. Toxicol. 28: 248-258.
    8. Stammati, A., Bonsi, P., Zucco, F., Moezelaar, R., Alakomi, H.-
L., and A. von Wright. 1999. Toxicity of selected plant volatiles in
microbial and mammalian short-term assays. Food and Chemical
Toxicology. 37: 813-823.
    9. Zani, F., Massimo, G., Benvenuti, S., Bianchi, A., Albasini, A.,
Melegari, M., Vampa, G., Bellotti, A., and P. Mazza. 1990. Studies on
the genotoxic properties of essential oils with Bacillus subtilis rec-
assay and Salmonella/microsome reversion assay. Planta Med. 57:237-241.
    10. Tsutsui, T., Suzuki, N., Kobayashi, Y., Suzuki, H., Fukuda, S.,
and H. Maizumi. 1987. Assessment of the carcinogenic hazard of 27
substances used in dental practices. Japanese Journal of Pharmacology.
43 (suppl). 132P.
    11. Grant, W.F. 1982. Chromosome aberration assays in Allium. A
report of the U.S. Environmental Protection Agency Gene-Tox program.
Mutat. Res. 99(3). 273-291.
    12. Environmental Protection Agency. 2001. Risk assessment guidance
for superfund volume I: Human health evaluation manual (Part E,
Supplemental Guidance for Dermal Risk Assessment) Interim. EPA/540/R/
99/005, OSWER 9285.7-02EP, PB99-963312.
    13. EPA Health Effects Guidelines (OPPTS.7300, Prenatal development
toxicity study, pg.1 (e)(1)).
    14. FR Notice 7308-1, Vol.68, No. 109, Friday June 6, 2003.
    15. Fenaroli's Handbook of Flavoring ingredients. Vol 2. Edited,
translated and revised by T.E. Furia and Bellanca. 2\nd\ edition.
Cleeland: The Chemical Rubber Co., 1975., p536.
    16. De Vincenzi, M., Maialetti, F., and M. Di Pasquale. 1991.
Monographs on botanical flavoring substances used in food; Part 1.
Fitoterapia. 62(1). 47-63.
    17. Piasenzotto, L., Gracco, L., Conte, L.S., and S. Bodenov. 2002.
Application of solid phase microextraction to evaluate traces of thymol
in honey. Apidologie. 33. 545-552.
    18. Council of Europe. 2000. Council of Europe Publishing, F-67075
Strousburg Cedex, Koelblin-Fortuna-Dick, p. 85.
    19. Food and Drug Administration, April 10, 1997, NADA, Freedom of
Information Summary, p3.
    20. Hostynek, J.J. and P.S. Magee. 1997. Fragrance allergens:
Classification and ranking by QSAR. Toxicology In Vitro. 11. 377-384.
    21. Hagan, E.C., Hansen, W.H., Fitzhugh, O.G., Jenner, P.M., Jones,
W.I., Taylor, J.M., Long, E.L., Nelson, A.A., and J.B. Brouwer. 1967.
Food flavourings and compounds of related structure. II. Subacute and
Chronic Toxocity. Fd. Cosmet. Toxicol. 5. 141-157.
    22. USEPA NCEA-ORD. 1997. Exposure Factors Handbook, Chapter 7 Body
Weight Studies, at http://cfpub.epa.gov/ncea/cfm/

recordisplay.cfm?deid= 12464CFID=17826586 &CFTOKEN=20588395.
    23. Food and Drug Administration. FDA Total Diet Study. 1990. FDA
Total Diet Study. 2003. TDS Diets, Version 1 (1990 food list + 1987-88
NFCS data), at http://www.cfsan.fda.gov/~comm/tds-hist.html#fca.

X. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by the FQPA, any person
may file an objection to any aspect of this regulation and may also
request a hearing on those objections. The EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. Although the procedures in those regulations
require some modification to reflect the amendments made to FFDCA by
the FQPA, EPA will continue to use those procedures, with appropriate
adjustments, until the necessary modifications can be made. The new
section 408(g) of FFDCA provides essentially the same process for
persons to ``object '' to a regulation setting an exemption from the
requirement of a

tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2005-0483 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before March 20,
2006.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is<PHONE_NUMBER>.
    2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number EPA-HQ-OPP-2005-0483, to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to<EMAIL_ADDRESS>
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance
requirement under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations

that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 30, 2005.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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

0
2. Section 180.1240 is amended by redesignating the existing text as
paragraph (a) and adding a new paragraph (b) to read as follows:

Sec.  180.1240  Thymol; exemption from the requirement of a tolerance.

* * * * *
    (b) An exemption from the requirement of tolerance is established
for residues of Thymol (5-methyl-2-isopropyl-1-phenol in or on honey,
honeycomb, and honeycomb with honey when used in accordance with good
agricultural practices.

[FR Doc. 06-436 Filed 1-17-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: December 3, 2007 (Volume 72, Number 231)]
[Notices]
[Page 67988]
[DOCID:fr03de07-123]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56843; File No. SR-ISE-2007-71]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Order Approving a Proposed Rule Change Relating to Fee Changes on
a Retroactive Basis

November 27, 2007.
    On October 2, 2007, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change, pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder,\2\ to retroactively apply a fee reduction that was
implemented on September 4, 2007, as discussed below. The proposed rule
change was published for comment in the Federal Register on October 22,
2007.\3\ The Commission received no comments on the proposal. This
order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 56662 (October 16,
2007), 72 FR 59576.
---------------------------------------------------------------------------

    On September 4, 2007, the Exchange implemented a fee reduction to
the Schedule of Fees, effective for the month of September 2007, with
respect to Electronic Access Member (``EAM'') Trading Application
Software Fees (``Software Fees'').\4\ Consequently, the Software Fees
are as follows:
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 56379 (September 10,
2007), 72 FR 52591 (September 14, 2007) (SR-ISE-2007-79) (notice of
filing and immediate effectiveness of a proposed rule change
relating to fee changes).
---------------------------------------------------------------------------

     Equity EAMs are charged $250 for each of the first and
second connections and $50 for each additional connection thereafter,
regardless of whether the Equity EAM is connected via Financial
Information eXchange (``FIX'') or Application Programming Interface
(``API'').\5\
---------------------------------------------------------------------------

    \5\ ISE uses an open API, which members program to in order to
develop applications that send trading commands and/or queries to
and receive broadcasts and/or transactions from the trading system.
FIX is an industry-wide messaging standard protocol.
---------------------------------------------------------------------------

     Options EAMs that connect via API are charged $250 for
each of the first five connections and $100 for each additional
connection.
     Options EAMs that connect via FIX are charged $250 for
each of the first and second connections and $50 for each additional
connection thereafter.
    The Exchange now seeks to apply retroactively these reduced fees to
the time period of July 1, 2007 to August 31, 2007 (``Retroactive
Period'').
    The Commission finds that the proposed rule change is consistent
with the requirements of Section 6 of the Act \6\ and the rules and
regulations thereunder applicable to a national securities exchange. In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\7\ in that it will reduce
the Software Fees during the Retroactive Period and result in an
equitable allocation of reasonable dues, fees, and other charges among
the Exchange's members and other persons using its facilities.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78(f)(b).
    \7\ 15 U.S.C. 78f(b)(4).
    \8\ In approving this rule change, the Commission notes that it
has considered the proposal's impact on efficiency, competition, and
capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\9\ that the proposed rule change (SR-ISE-2007-71) be, and hereby
is, approved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Nancy M. Morris,
Secretary.
[FR Doc. E7-23318 Filed 11-30-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Rules and Regulations]
[Page 6902]
[FR Doc No: 2015-02465]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 200

[Release No. 33-9273A, 34-65686A, 39-2480A, IA-3310A and IC-29855A]

Rescission of Outdated Rules and Forms, and Amendments To Correct
References

AGENCY: Securities and Exchange Commission.

ACTION: Technical amendment.

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SUMMARY: The Securities and Exchange Commission (``SEC'' or
``Commission'') is making technical amendments to update control
numbers assigned to information collection requirements of the
Commission by the Office of Management and Budget pursuant to the
Paperwork Reduction Act of 1980.

DATES: Effective date: February 9, 2015.

FOR FURTHER INFORMATION CONTACT: Daniel K. Chang, Senior Counsel, at
(202) 551-6792, Office of Regulatory Policy, Division of Investment
Management, U.S. Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-8549.

SUPPLEMENTARY INFORMATION: The Commission published a final rule at 76
FR 71872, on November 21, 2011, which rescinded rules and forms adopted
under the Public Utility Holding Company Act (``PUHCA''),\1\ revised
other rules and forms to correct outdated references to PUHCA,
corrected outdated references due to enactment of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010 (``the Dodd-Frank
Act''), and made other ministerial corrections.\2\ Congress repealed
PUHCA effective 2006, and the Dodd-Frank Act amended various provisions
of the federal securities laws and removed references to PUHCA from
those laws.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 79 (repealed effective 2006).
    \2\ Public Law 111-203, 124 Stat. 1376 (2010).
---------------------------------------------------------------------------

    The final rule contained a typographical error that prevented an
amendment to the Code of Federal Regulations.\3\ This technical
amendment is being published so that the table in 17 CFR 200.800(b) can
be updated to reflect that amendment.
---------------------------------------------------------------------------

    \3\ The final rule incorrectly referenced 17 CFR 200.80(b) of
Subpart M, rather than 17 CFR 200.800(b) of Subpart N. As a result
of the incorrect reference, the table in 17 CFR 200.800(b) of
Subpart N was not amended.
---------------------------------------------------------------------------

List of Subjects in 17 CFR Part 200

    Administrative practice and procedure, Authority delegations
(Government agencies), Classified information, Conflicts of interest,
Government employees, Organization and functions (Government agencies).

Text of the Amendments

    For the reasons set out in the preamble, Title 17, Chapter II of
the Code of Federal Regulations is amended as follows:

PART 200--ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND
REQUESTS

Subpart N--Commission Information Collection Requirements Under the
Paperwork Reduction Act: OMB Control Numbers

0
1. The authority citation for part 200, subpart N, continues to read as
follows:

    Authority: 44 U.S.C. 3506; 44 U.S.C. 3507.

Sec.  200.800  [Amended]

0
2. In Sec.  200.800(b), in the table, remove the following entries:
Form ET, wherever it appears; Rule 1(a); Rule 1(b); Rule 1(c); Rule 2;
Rule 3; Rule 7; Rule 7(d); Rule 20(b); Rule 20(c); Rule 20(d); Rule 23;
Rule 24; Rule 26; Rule 29; Rule 44; Rule 45; Rule 47(b); Rule 52; Form
53; Rule 54; Rule 57(a); Rule 57(b); Rule 58; Rule 62; Rule 71(a); Rule
72; Rule 83; Rule 87; Rule 88; Rule 93; Rule 94; Rule 95; Rule 100(a);
Uniform System of Accounts for Mutual Service Companies and Subsidiary
Service Companies, Public Utility Holding Company Act of 1935;
Preservation and Destruction of Records of Registered Public Utility
Holding Companies and of Mutual and Subsidiary Service Companies; Form
U5A; Form U5B; Form U5S; Form U-1; Form U-13-1; Form U-6B-2; Form U-57;
Form U-9C-3; Form U-12(I)-A; Form U-12(I)-B; Form U-13E-1; Form U-R-1;
Form U-13-60; Form U-3A-2; Form U-3A3-1; Form U-7D; Form U-33-S; Form
ID, 259.602, 3235-0328; and Form SE., 259.603, 3235-0327.

    Dated: February 3, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-02465 Filed 2-6-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]
[Page 66966-66967]
[DOCID:fr17de09-34]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9093-3]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA'' or the ``Act''), 42 U.S.C. 7413(g), notice is hereby
given of a proposed consent decree to address a lawsuit filed by
WildEarth Guardians and San Juan Citizens Alliance in the United States
District Court for the District of Columbia: WildEarth Guardians, et
al. v. Jackson, No. 1:09-CV-00089-CKK (D. D.C.). On January 14, 2009,
Plaintiffs filed a complaint alleging that EPA failed to meet its
obligations under sections 111(b)(1)(B), 112(d)(6) and 112(f)(2) of the
Clean Air Act (``CAA'') to take actions relative to the review/revision
of the New Source Performance Standards and the National Emission
Standards for Hazardous Air Pollutants with respect to the Oil and
Natural Gas production source category. The proposed consent decree
establishes deadlines for EPA's proposed and final actions for meeting
these obligations.

DATES: Written comments on the proposed consent decree must be received
January 19, 2010.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2009-0918, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Amy Branning, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    Under sections 111(b)(1)(B), 112(d)(6) and 112(f)(2) of the CAA,
EPA has a mandatory duty to take actions relative to the review/
revision of new source performance standards (``NSPS'') and national
emission standards for hazardous air pollutants (``NESHAP'') within
eight years of the issuance of the standards. The proposed consent
decree would resolve a deadline suit filed by Plaintiffs for EPA's
failure to take the above actions within eight years of issuing NSPS
and NESHAP for the Oil and Natural Gas production source category. The
proposed Consent Decree requires that EPA sign by January 31, 2011
proposed standards and/or determinations not to issue standards
pursuant to sections 111(b)(1)(B), 112(d)(6) and 112(f)(2), and that
EPA finalize its proposals by November 30, 2011. The proposed Consent
Decree authorizes EPA to sign by January 31, 2011 a final determination
not to review the NSPS pursuant to section 111(b)(1)(B) without issuing
a proposal for such determination. The approach of determining not to
review is not available for actions under section 112. The proposed
Consent Decree further requires that, within 15 business days following
signature, EPA shall deliver a notice of such action to the Office of
the Federal Register for prompt publication. The proposed consent
decree states that, after EPA fulfills its obligations under the
decree, the case shall be dismissed with prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines, based on any comment submitted, that consent to
this consent decree should be withdrawn, the terms of the decree will
be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How Can I Get A Copy of the Consent Decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2009-0918) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center 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 OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use http://www.regulations.gov to
submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number then select
``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or on paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and To Whom Do I Submit Comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://
www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: December 10, 2009.
Richard B. Ossias,
Associate General Counsel.
[FR Doc. E9-30044 Filed 12-16-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Notices]
[Page 6465]
[DOCID:fr08fe06-74]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-284-000]

SR Energy, LLC; Notice of Issuance of Order

February 1, 2006.
    SR Energy, LLC (SR Energy) filed an application for market-based
rate authority, with an accompanying rate schedule. The proposed
market-based rate schedule provides for sales of energy, capacity and
ancillary services at market-based rates. SR Energy also requested
waivers of various Commission regulations. In particular, SR Energy
requested that the Commission grant blanket approval under 18 CFR part
34 of all future issuances of securities and assumptions of liability
by SR Energy.
    On January 31, 2006, the Commission granted the request for blanket
approval under Part 34, subject to the following:
    Any person desiring to be heard or to protest the blanket approval
of issuances of securities or assumptions of liability by SR Energy
should file a motion to intervene or protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protests, is March 2, 2006.
    Absent a request to be heard in opposition by the deadline above,
SR Energy is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
SR Energy, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approval of SR Energy's issuances of securities or
assumptions of liability.
    Copies of the full text of the Commission's Order are available
from the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
[FR Doc. E6-1667 Filed 2-7-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50636-50637]
[FR Doc No: 2015-20561]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2099]

Lisa Marie Coroniti: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Lisa Coroniti from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Ms. Coroniti was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product. Ms. Coroniti was given notice of the
proposed permanent debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Ms. Coroniti failed to
request a hearing.

Ms. Coroniti's failure to request a hearing constitutes a waiver of her
right to a hearing concerning this action.

DATES: This order is effective August 20, 2015.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement,
Office of Enforcement and Import Operations, Office of Regulatory
Affairs (ELEM-4144), Food and Drug Administration, 12420 Parklawn
Drive, Element Bldg., Rm. 4144, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the regulation of any drug product under the FD&C Act.
    On April 8, 2014, the U.S. District Court for the Eastern District
of Virginia entered judgment against Ms. Coroniti for one count of
introducing misbranded drugs into interstate commerce, in violation of
sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and
333(a)(2)).
    FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows: Ms. Coroniti was a sales representative for Gallant Pharma
International Inc. (Gallant Pharma) between June 2011 and August 2013,
and was responsible for selling injectable cosmetic drugs and devices,
and intravenous chemotherapy drugs, to doctors and hospitals in
Philadelphia, Pennsylvania. Some of the drugs Ms. Coroniti facilitated
the sale of were misbranded within the meaning of the FD&C Act.
    Ms. Coroniti admitted that she sold drugs which were not approved
by the FDA for use on patients in the United States. She further
admitted that the drugs she sold on behalf of Gallant Pharma were
misbranded in that they did not bear adequate directions for use and
were not subject to an exemption from that requirement, and they were
accompanied by non-FDA approved packaging and inserts.
    Between June 2011 and August 2013, Ms. Coroniti admitted to selling
misbranded drugs to 15 distinct doctors and medical practices in
Pennsylvania and generated more than $1.1 million in illegal proceeds
from these sales. She admitted that, as of April 26, 2013, she became
willfully blind to the illegality of Gallant Pharma's business.
Nonetheless, she continued her sales activity with Gallant Pharma until
her arrest in August 2013.
    Between April 26, 2013, and August 7, 2013, Ms. Coroniti personally
sold more than $367,000 in misbranded drugs and devices to doctors and
medical practices in the Philadelphia, Pennsylvania, area. On or about
July 30, 2013, Ms. Coroniti sold five vials of misbranded BOTOX to a
doctor in Philadelphia, Pennsylvania, in exchange for $1,900.00,
thereby causing a misbranded drug to be introduced into interstate
commerce. She further admitted that the loss amount attributable to her
personal sales was between $200,000 and $400,000.
    As a result of her conviction, on March 25, 2015, FDA sent Ms.
Coroniti a notice by certified mail proposing to permanently debar her
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
the finding, under section 306(a)(2)(B) of the FD&C Act, that Ms.
Coroniti was convicted of a felony under Federal law for conduct
related to the regulation of a drug product. FDA determined that Ms.
Coroniti's felony conviction was related to the regulation of drug
products because the conduct underlying her conviction, including
intentionally introducing into interstate commerce misbranded drug
products, undermined FDA's regulatory oversight over drug products
marketed in the United States. The proposal also offered Ms. Coroniti
an opportunity to request a hearing, providing her 30 days from the
date of receipt of the letter in which to file the request, and advised
her that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. The proposal was received on May 1, 2015. Ms. Coroniti failed
to respond within the timeframe prescribed by regulation and has,
therefore, waived her opportunity for a hearing and has waived any
contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of
the FD&C Act, under authority delegated to the Director (Staff Manual
Guide 1410.35), finds that Lisa Marie Coroniti has been convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C.
335a(c)(2)(A)(ii)) requires that Ms.Coroniti's debarment be permanent.
    As a result of the foregoing findings, Lisa Marie Coroniti is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or
382), or under section 351 of the Public Health Service Act (42 U.S.C.
262), effective (see DATES) (see section 201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B),
and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug
product application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Lisa Marie Coroniti, in
any capacity during her debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Ms. Coroniti provides services in any capacity to a person with an
approved or pending drug product application during her period of
debarment she will be subject to civil money penalties (section
307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7))). In addition, FDA
will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Lisa Marie Coroniti during her
period of debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C.
335a(c)(1)(A))).
    Any application by Ms. Coroniti for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) should be identified with Docket No. FDA-2014-N-2099 and
sent to the Division of Dockets Management (see ADDRESSES). All such
submissions are to be filed in four copies. The public availability of
information in these submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20561 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Rules and Regulations]
[Pages 22868-22870]
[FR Doc No: 2021-08853]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0285]
RIN 1625-AA87

Security Zone, Christina River, Newport, DE

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a security zone for the
protection of persons under the protection of the United States Secret
Service (USSS) as they transit by vehicle on the route 141 bridge over
the Christina River near Newport, Delaware. The security zone will be
enforced intermittently and only during times necessary to protect
persons under the protection of the USSS as they transit over the
bridge and will restrict vessel traffic while the zone is being
enforced. Only vessels or people specifically authorized by the Captain
of the Port, Delaware Bay, or designated representative, may enter or
remain in the regulated area.

DATES: This rule is effective without actual notice from April 30, 2021
through May 17, 2021. For the purposes of enforcement, actual notice
will be used from 2 p.m. on April 23, 2021 until April 30, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0285 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Edmund Ofalt, Sector Delaware Bay,
Waterways Management Division, U.S. Coast Guard; telephone 215-271-
4814, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard was not notified by
the United States Secret Service of the visit with sufficient time to
publish a NPRM prior to the arrival of persons under the protection of
the USSS. Delay in promulgating this rule would be impracticable
because a security zone is required to be in place by April 23, 2021,
to protect these persons under the protection of the USSS in the
vicinity of

this waterway. The presence of these persons creates unique safety and
security concerns.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register for the same reasons
discussed above.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Delaware Bay
(COTP) has determined that persons under the protection of the USSS
transits starting April 23, 2021 present a potential target for
terrorist acts, sabatoge, or other subversive acts, accidents, or other
causes of a similar nature. Due to the roadway passing over the
Christina River, this security zone is necessary to protect these
persons, the public, and the surrounding waterway.

IV. Discussion of the Rule

    This rule establishes a temporary security zone from 2 p.m. on
April 23, 2021, through 11:59 p.m. on May 17, 2021, on certain waters
of the Christina River near Newport, Delaware. The security zone is
bounded on the east by a line drawn from 39[deg]42.55' North Latitude
(N), 075[deg]35.88' West Longitude (W), thence southerly to
39[deg]42.50' N, 075[deg]35.87' W proceding from shoreline to shoreline
on the Christina River in a westerly direction where it is bounded by
the South James Street Bridge at 39[deg]42.63' N, 075[deg]36.53' W.
    This zone will be enforced intermittently during the effective
dates. Enforcement of this zone will be broadcast via Broadcast Notice
to Mariners on VHF-FM marine channel 16, as well as actual notice via
on scene Coast Guard Personnel.
    No vessel or person will be permitted to enter or remain within
this zone without permission from the COTP or a designated
representative.

V. Regulatory Analyses

    We developed this 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 rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the location,
duration and time of year of the security zone. Vessel traffic on this
portion of the Christina River is typically limited to recreational
traffic. The zone will be enforced intermittently and broadcast via
VHF-FM channel 16 allowing vessel traffic time to trainsit outside of
enforcement times. The time of year of this security zone has limited
recreational traffic due to weather and the potential presence of ice.

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 rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
security zone may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    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 rule. If the 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.
    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.

C. Collection of Information

    This rule will 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 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 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.

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

F. Environment

    We have analyzed this 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 determined 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 rule involves a
security zone which will be

intermittently enforced over the course of approximately 24 days. It is
categorically excluded from further review under paragraph L[60a] of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

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.

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 amends
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: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0285 to read as follows:

Sec.  165.T05-0285  Security Zone; Christina River, Newport, DE.

    (a) Location. The following area is a security zone: All waters of
the Christina River, from shoreline to shoreline bounded on the east by
a line drawn from 39[deg]42.55' North Latitude (N), 075[deg]35.88' West
Longitude (W), thence southerly to 39[deg]42.50' N, 075[deg]35.87' W
thence along the Christina River in a westerly direction and bounded by
the South James Street Bridge at 39[deg]42.63' N, 075[deg]36.53' W.
These coordinates are based on North American Datum 83 (NAD83).
    (b) Definitions. As used in this section--
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been designated by the Captain of the
Port Delaware Bay (COTP) to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of the regulations in this section.
    Official patrol vessel means any Coast Guard, Coast Guard
Auxiliary, State, or local law enforcement vessel assigned or approved
by the COTP.
    USSS protectee means any person for whom the United States Secret
Service (USSS) requests implementation of a security zone in order to
supplement protection of said person(s).
    (c) Regulations. (1) In accordance with the general regulations
contained in Sec.  165.33, entry into or movement within this zone is
prohibited unless authorized by the COTP, Sector Delaware Bay, or
designated representative.
    (2) Only vessels or people specifically authorized by the Captain
of the Port, Delaware Bay, or designated representative, may enter or
remain in the regulated area. To request permission to enter or remain
in the regulated area contact the COTP or the COTP's representative on
VHF-FM channel 13 or 16. Vessel operators and persons within the
security zone must comply with all lawful orders or directions given to
them by the COTP or the COTP's designated representative. No person may
swim upon or below the surface of the water of this security zone
unless authorized by the COTP or his designated representative.
    (3) Upon being hailed by an official patrol vessel or the
designated representative, by siren, radio, flashing light, or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with lawful direction may result in expulsion from the regulated
area, citation for failure to comply, or both.
    (d) Enforcement. (1) This security zone is effective without actual
notice from April 30, 2021 through May 17, 2021. For the purposes of
enforcement, actual notice will be used from 2 p.m. on April 23, 2021
until April 30, 2021.
    (2) This security zone will be enforced with actual notice by the
U.S. Coast Guard representatives on scene, as well as other methods
listed in Sec.  165.7. The Coast Guard will enforce the security zone
created by this section only when it is necessary for the protection of
persons under the protection of the USSS traveling across the route 141
bridge in Newport, Delaware. The U.S. Coast Guard may be additionally
assisted in the patrol and enforcement of the zone by Federal, State,
and local agencies.

    Dated: April 23, 2021.
Leon McClain, Jr.,
Captain, U.S. Coast Guard, Acting Captain of the Port, Delaware Bay.
[FR Doc. 2021-08853 Filed 4-29-21; 8:45 am]
BILLING CODE 9110-04-P