[Federal Register: February 6, 2008 (Volume 73, Number 25)]
[Rules and Regulations]
[Page 6851-6856]
[DOCID:fr06fe08-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0280; FRL-8346-9]

Clothianidin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
clothianidin in or on sugar beet roots, tops and molasses. Bayer
CropScience requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 6, 2008. Objections and
requests for hearings must be received on or before April 7, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0280. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:

(703) 306-0415; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0280 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 as required by 40 CFR part 178 on or
before April 7, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0280, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 30, 2007 (72 FR 21263) (FRL-8124-
5), 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 petition (PP
6F7159) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that 40 CFR 180.586 be amended
by establishing a tolerance for residues of the insecticide
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on beet, sugar, root at 0.02 parts per million
(ppm); beet, sugar, tops at 0.04 ppm; and beet, sugar, molasses at 0.06
ppm. That notice referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in

response to the notice of filing.
    Upon completing review of the current clothianidin database, the
Agency concluded that the appropriate tolerance levels for clothianidin
residues in or on pending crops should be established as follows: Beet,
sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and beet,
sugar, dried pulp at 0.03 ppm. The Agency no longer considers sugar
beet tops to be a significant livestock feedstuff; therefore, a
separate tolerance for tops is not required.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of clothianidin on beet, sugar, roots at 0.02 ppm, beet,
sugar, molasses at 0.05 ppm and beet, sugar, dried pulp at 0.03. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information

concerning the variability of the sensitivities of major identifiable
subgroups of consumers, including infants and children. Specific
information on the studies received and the nature of the adverse
effects caused by clothianidin as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The risk assessment is available in the docket

established by this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2007-0280 in that docket.
    Clothianidin does not appear to exhibit toxicity towards a
consistent specific target organ. Decreases in body weight and body
weight gain were observed in rats, dogs, and mice. In single-dose
studies, mice (acute toxicity category II) appear more sensitive than
rats (category IV). Clinical signs of neurotoxicity were exhibited in
both mice (decreased motor activity, tremors, and deep respirations at
50 milligram/kilogram (mg/kg)) and rats (transient signs of decreased
arousal, motor activity, and locomotor activity at 100 mg/kg) in acute
neurotoxicity studies following exposure by gavage; however, no
indications of neurotoxicity were observed following dietary exposure
in the subchronic neurotoxicity study in rats. In a developmental
neurotoxicity study in rats, decreased body weights, body weight gains,
motor activity, and acoustic startle response amplitude (females) were
seen in offspring at doses lower than those resulting in maternal
toxicity. Although the NOAELs were similar for the subchronic and
chronic feeding studies in the rat, a greater spectrum of effects was
observed in the chronic study (decreased body weight, body weight gain,
and food consumption plus additional observations in the liver, ovary,
and kidney) versus the subchronic study (effects only on body weight
and food consumption). In the rat, administration via the oral route
appears to be more toxic than via the dermal route. In longer term
studies, dogs exhibited clinical signs of anemia. The only observed
effects in mice following chronic dietary administration were increases
in vocalization and decreases in body weight and body weight gain.
Clothianidin has been classified as not likely to be carcinogenic to
humans.
    There was no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit offspring in developmental studies;
however, increased quantitative susceptibility of rat pups was seen in
both the reproduction and developmental neurotoxicity studies. The
degree of concern for both of these studies is low because the observed
effects are well characterized, and there are clear NOAELs and LOAELs.
The NOAEL for the effects of concern identified in the reproduction
study (decreased mean body weight gain and absolute thymus weights in
pups, delayed sexual maturation, and an increase in still births) is
the basis for the endpoint selected for the chronic dietary and short-
term, intermediate-term and long-term non-dietary risk assessments.
    In adult rats, a guideline immunotoxicity study shows no
clothianidin-mediated immunotoxicity at doses lower than those
resulting in generalized signs of toxicity (e.g., decreases in body
weight); however, it cannot be concluded that a similar lack of effects
will occur in offspring. Based on evidence of decreased absolute and
adjusted organ weights of the thymus and spleen in multiple studies in
the clothianidin data base and on evidence of increased quantitative
susceptibility of juvenile rats, compared to adults, in the 2-
generation reproduction study to these effects, a developmental
immunotoxicity (DIT) study has been required.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the LOC to take into account uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic risks by
comparing aggregate exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the LOC by all applicable UFs.
Short-term, intermediate-term, and long-term risks are evaluated by
comparing aggregate exposure to the LOC to ensure that the margin of
exposure (MOE) called for by the product of all applicable UFs is not
exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for clothianidin used for
human risk assessment can be found at http://www.regulations.gov in

document ``Clothianidin: Human Health Risk Assessment for Proposed Use
on Sugar Beet'' at pages 18-20 in docket ID number EPA-HQ-OPP-2007-
0280.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clothianidin, EPA considered exposure under the petitioned-
for tolerances as well as all existing clothianidin tolerances in (40
CFR 180.586). EPA assessed dietary exposures from clothianidin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). The acute assessment is based on maximum residues of
clothianidin observed in clothianidin and thiamethoxam field trials and
assumes 100 percent crop treated (%CT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. The chronic assessment is based on average residues
from clothianidin and thiamethoxam field trials and assumes 100% CT.
    iii. Cancer. Because clothianidin is not expected to pose a cancer
risk, a quantitative dietary exposure assessment for the purposes of
assessing cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must pursuant
to FFDCA section 408(f)(1) require that

data be provided 5 years after the tolerance is established, modified,
or left in effect, demonstrating that the levels in food are not above
the levels anticipated. For the present action, EPA will issue such
data call-ins as are required by FFDCA section 408(b)(2)(E) and
authorized under FFDCA section 408(f)(1). Data will be required to be
submitted no later than 5 years from the date of issuance of this
tolerance.
    The Agency used PCT information as follows:
    The acute assessment is based on maximum residues of clothianidin
observed in clothianidin field trials and assumes 100% crop treated.
The chronic assessment is based on average residues from clothianidin
field trials and also assumes 100% CT.
    The Agency believes that the three conditions listed in Unit III.
have been met. With respect to Condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which clothianidin
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for clothianidin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of clothianidin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of clothianidin for acute
exposures are estimated to be 7.29 parts per billion (ppb) for surface
water and 5.84 ppb for ground water. The EECs for chronic exposures are
estimated to be 1.35 ppb for surface water and 5.84 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 7.29 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.84 ppb was used to
access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Clothianidin is currently registered for the following residential
non-dietary sites: Turfgrass. EPA assessed residential exposure using
the following assumptions: The following exposure scenarios were
assessed for residential post-application risks: Toddlers playing on
treated turf, adults performing yard work on treated turf, and adults
and youths playing golf on treated turf.
    Additional information on residential exposure assumptions can be
found at http://www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0280, pages 26

through 27).
    4. Cumulative effects from substances with a common mechanism of
toxicity. 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.''
    Clothianidin is a member of the neonicotinoid class of pesticides
and is a metabolite of another neonicotinoid, thiamethoxam. Structural
similarities or common effects do not constitute a common mechanism of
toxicity. Evidence is needed to establish that the chemicals operate by
the same, or essentially the same sequence of major biochemical events
(EPA, 2002). Although clothianidin and thiamethoxam bind selectively to
insect nicotinic acetylcholine receptors (nAChR), the specific binding
site(s)/receptor(s) for clothianidin, thiamethoxam, and the other
neonicotinoids are unknown at this time. Additionally, the commonality
of the binding activity itself is uncertain, as preliminary evidence
suggests that clothianidin operates by direct competitive inhibition,
while thiamethoxam is a non-competitive inhibitor. Furthermore, even if
future research shows that neonicotinoids share a common binding
activity to a specific site on insect nicotinic acetylcholine
receptors, there is not necessarily a relationship between this
pesticidal action and a mechanism of toxicity in mammals. Structural
variations between the insect and mammalian nAChRs produce quantitative
differences in the binding affinity of the neonicotinoids towards these
receptors, which, in turn, confers the notably greater selective
toxicity of this class towards insects, including aphids and
leafhoppers, compared to mammals. While the insecticidal action of the
neonicotinoids is neurotoxic, the most sensitive regulatory endpoint
for clothianidin is based on unrelated effects in mammals, including
changes in body and thymus weights, delays in sexual maturation, and
still births. Additionally, the most sensitive toxicological effect in
mammals differs across the neonicotinoids (e.g., testicular tubular
atrophy with thiamethoxam; mineralized particles in thyroid colloid
with imidaclopid). Thus, there is currently no evidence to indicate
that neonicotinoids share common mechanisms of toxicity, and EPA is not
following a cumulative risk approach based on a common mechanism of
toxicity for the neonicotinoids. 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 concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism released by EPA's Office of Pesticide Programs on
EPA's website at http://www.epa.gov/pesticides/cumulative/.

    Note that because clothianidin is a major metabolite of
thiamethoxam, EPA has combined exposure to clothianidin resulting both
from thiamethoxam use and from use of clothianidin as an active
ingredient and has compared this aggregate exposure estimate to
relevant endpoints for clothianidin. EPA has taken the further
conservative step of assuming that, in instances where both
thiamethoxam and clothianidin are

registered for use on a crop, both pesticides will, in fact, be used on
that crop.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. In the developmental
neurotoxicity study, toxicity in the offspring was observed at a lower
dose level than the dose that caused toxicity in the maternal animals.
Maternal effects included decreased body weights, body weight gains,
and food consumption. Effects seen in the offspring included decreased
body weights, body weight gains, motor activity, and acoustic startle
response in the females. However, EPA determined that the degree of
concern for the developmental neurotoxicity study is low and there are
no residual uncertainties for prenatal and/or postnatal toxicity due to
the results of the developmental neurotoxicity study because the
observed effects are well characterized and there are clear NOAELs/
LOAELs.
    In the 2-generation reproduction study, offspring toxicity
(decreased body weight gains, delayed sexual maturation in males,
decreased absolute thymus weights in F1 pups of both sexes, and an
increase in stillbirths in both generations) was seen at a lower dose
than the dose that caused parental toxicity. Based on evidence of
decreased absolute and adjusted organ weights of the thymus and spleen
in multiple studies in the clothianidin data base and on evidence of
increased quantitative susceptibility of juvenile rats, compared to
adults, in the 2-generation reproduction study to these effects. EPA
has required that testing be conducted to assess immune system function
in adults and in young animals following exposure during the period of
organogenesis. No quantitative or qualitative susceptibility was
observed in either of the developmental rat or rabbit studies. In the
rat, no developmental toxicity was observed at the highest dose tested,
although this dose level induced decreases in body weight gain and food
consumption in the dams. In the rabbit, premature deliveries, decreased
gravid uterine weights, an increase in litter incidence of a missing
lobe of the lung, and a decrease in the litter average for ossified
sternal centra per fetus were noted at a dose level in which maternal
death, a decrease in food consumption, and clinical signs (scant feces
and orange urine) were observed. Since the developmental effects
observed in the rabbit study were seen in the presence of maternal
toxicity, they are not considered to be qualitatively more severe than
the maternal effects.
    3. Conclusion. The exposure data for clothianidin are complete or
are estimated based on data that reasonably accounts for potential
exposures. The acute dietary exposure assessment is based on maximum
residues of clothianidin observed in clothianidin and thiamethoxam
field trials and assumes 100% CT. The chronic assessment is based on
average residues from clothianidin and thiamethoxam field trials and
also assumes 100% CT. For water, the highest acute estimate from
conservative models was used for both the acute and the chronic dietary
exposure analyses. By using these conservative assessments, acute and
chronic exposures/risks will not be underestimated. The residential
exposure assessment utilizes residential standard operation procedures
(SOPs) to assess post-application exposure to children as well as
incidental oral ingestion by toddlers. The residential SOPs are based
on reasonable worst-case assumptions and will not likely underestimate
exposure/risk. These assessments are unlikely to underestimate the
potential exposure to 74,800 infants and children resulting from the
use of clothianidin.
    The toxicology data base for clothianidin, however, is not complete
for FQPA purposes. A complete complement of acceptable developmental,
reproduction, developmental neurotoxicity, mammalian neurotoxicity and
special neurotoxicity studies are available; however, due to evidence
of decreased absolute and adjusted organ weights of the thymus and
spleen in multiple studies in the clothianidin database, and because
juvenile rats in the two-generation reproduction study appear to be
more susceptible to these effects, EPA has determined that testing
should be conducted to assess immune system function in adults and in
young animals following developmental exposures. Given the levels at
which this testing should be conducted it could result in selection of
a more protective (i.e., lower) regulatory endpoint.
    Due to the uncertainty with regard to potential effects on immune
system function in young animals, EPA cannot conclude that there are
reliable data supporting selection of a children's safety factor
different from the presumptive 10X factor. Therefore, the 10X FQPA
children's safety factor will be retained. This safety factor will be
in the form of a database uncertainty factor to account for the lack of
the testing with regard to immune system function with clothianidin.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to clothianidin will occupy 45% of the aPAD for the population group
(children 1-2 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
clothianidin from food and water will utilize 16% of the cPAD for the
population group (children 1-2 years old). Based on the use pattern,
chronic residential exposure to residues of clothianidin is not
expected.
    3. Short-term / Intermediate-term risk. Short-term aggregate and
intermediate-term aggregate exposures take into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Clothianidin is currently registered for use(s) that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for clothianidin.
    EPA has determined that, for clothianidin, the toxicological
effects

are the same across oral, dermal, and inhalation routes of exposure and
has selected the same endpoint and dose for short-term and
intermediate-term exposure scenarios. Therefore, the exposures are
simply summed (combined/aggregated) for use in risk calculations.
Short- and intermediate aggregate risk estimates range from an MOE of
1,100 for toddlers (food + water + treated turf + treated soil +
dermal) to 22,000 for youth golfers (food + water + post-application
treated turf). The short-term and intermediate-term aggregate risks
associated with the registered and proposed uses of clothianidin do not
exceed the Agency's LOC for the general U.S. population or any
population subgroup.
    4. Aggregate cancer risk for U.S. population. Clothianidin has been
classified as a ``not likely human carcinogen.'' It is not expected to
pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromotography/mass spectrometry/mass spectrometry
(LC/MS/MS) methods are available for both collecting data and enforcing
tolerances for clothianidin residues in plant (Bayer Methods 00552 and
109240-1) and animal (Bayer Method 00624) commodities. The validated
limit of quantitation (LOQ) for clothianidin in plant commodities is
0.010 ppm, except for wheat straw (0.020 ppm), and the validated LOQs
are 0.010 ppm in milk and 0.020 ppm in animal tissues. All three of
these methods have been reviewed by EPA's Analytical Chemistry
Laboratory (ACL), approved for tolerance enforcement, and forwarded to
FDA for inclusion in PAM Volume II.

B. International Residue Limits

    There are no established or proposed Canadian, Mexican, or Codex
maximum residue limits (MRLs) for clothianidin residues on sugar beet
commodities.

V. Conclusion

    Therefore, the tolerance is established for residues of (E)-1-(2-
chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on
beet, sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and
beet, sugar, dried pulp at 0.03.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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, 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) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). 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., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: January 22, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.586 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Beet, sugar, dried pulp..............................               0.03
Beet, sugar, molasses................................               0.05
Beet, sugar, roots...................................               0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-1784 Filed 2-5-08; 8:45 am]

BILLING CODE 6560-50-S


COMPANY NOTICE OF FILING -  FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE (7/1/2006)

Docket ID Number: EPA-HQ-OPP-2017-0400

EPA Registration Division contact: Tony Kish, PM 22<PHONE_NUMBER>

Interregional Research Project Number 4

Pesticide Petition (PP) Number 7E8575

EPA has received a pesticide petition (PP No. 7E8575) from Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W., Princeton, New Jersey  08540, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR Part 180.503 by establishing a tolerance for residues of the fungicide cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-(methoxyimino) acetamide, in or on the raw agricultural commodities Carrot, roots at 0.03 parts per million (ppm); Ginseng at 0.02 ppm; Mango at 0.02 ppm; Brassica, leafy greens, subgroup 4-16B at 15.0 ppm; Leafy greens subgroup 4-16A at 19.0 ppm; Leaf petiole vegetable subgroup 22B at 6.0 ppm; Vegetable, tuberous and corm, subgroup 1C at 0.05 ppm; Vegetable, fruiting, group 8-10 at 0.2 ppm; Arugula at 19.0 ppm; Upland cress at 19.0 ppm; Garden cress at 19.0 ppm; Celtuce at 6.0 ppm; and Fennel, Florence at 6.0 ppm.

Additionally, a regional tolerance for residues of the fungicide cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-(methoxyimino) acetamide, is proposed for Bean, succulent at 0.05 ppm.

Remove established tolerances for residues of the fungicide cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-(methoxyimino) acetamide, in or on the raw agricultural commodities Cilantro, leaves at 19.0 ppm; Leafy greens, subgroup 4A at 19.0 ppm; Leaf petioles, subgroup 4B at 6.0 ppm; Potato at 0.05 ppm; Vegetable, fruiting, group 8 at 0.2 ppm.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.

The plant metabolism of cymoxanil is adequately understood in three diverse crops: potatoes, tomatoes, and lettuce. The results of these plant metabolism studies indicate that cymoxanil degrades extensively to primarily the amino acid glycine, with subsequent re-incorporation into other naturally-occurring products, such as glucose.

	2. Analytical method.

An analytical enforcement method is available for determining these plant residues by high performance level chromatography (HPLC) with ultraviolet (UV) detection. The limit of quantitation allows monitoring of crops with cymoxanil residues at or above the levels proposed in these tolerances.  The LOQ is 0.05 ppm for cymoxanil.

	3. Magnitude of residues.

Carrot - Magnitude of residue data were collected from field trials conducted in California (region 10), Georgia, South Carolina (region 2), Texas (region 6), Ohio (region 5) and Washington (region 12).  Residues of cymoxanil ranged from <0.02 to 0.024 ppm.

Ginseng - Magnitude of residue data were collected from field trials conducted in Wisconsin (region 5).  Residues of cymoxanil were all <0.02 ppm.

Mango - Magnitude of residue data were collected from field trials conducted in Florida (region 13).  Residues of cymoxanil were all <0.02 ppm.

Mustard Greens - Magnitude of residue data were collected from field trials conducted in California (region 10), Georgia, North Carolina, South Carolina (region 2), Florida (region 3), Tennessee (region 4), Texas (region 6) and Michigan (region 5).  Residues of cymoxanil ranged from <0.05 to 8.4 ppm (no washing or trimming).

Lima beans - Magnitude of residue data were collected from field trials conducted in Ohio (region 1), Georgia, South Carolina, Maryland and New Jersey (region 2), Tennessee (region 4), and Wisconsin (region 5).  Residues of cymoxanil in seeds without pods were <0.05 ppm and ranged from <0.05 to 0.40 ppm in plants with pods.

B. Toxicological Profile

	1. Acute toxicity.

A battery of acute toxicity tests on technical cymoxanil places it in the following Toxicity Categories:

Oral LD50		Rat			285-960 mg/kg	Category II-III
Dermal LD50		Rabbit			>2000 mg/kg		Category III
Inhalation LC50	Rat			>5.06 mg/L		Category IV
Eye irritation		Rabbit			Mild-slight irritant	Category III-IV
Dermal irritation	Rabbit			Slight irritant		Category IV
Dermal sensitization	Guinea Pig		Not a sensitizer

An acute neurotoxicity study with cymoxanil was not required based on adequate information in the database to identify a dose and endpoint for single-exposure dietary effects.

	2. Genotoxicty.

Cymoxanil was tested in a battery of assays to evaluate genotoxicity with the following results.  Based on the weight-of-evidence, cymoxanil is not considered to be genotoxic.

Bacterial gene mutation           			Salmonella typhimurium    	Negative
Mammalian gene mutation in vitro  		CHO/HGPRT           		Negative
Mammalian chromosome aberrations in vitro		Hyman lymphocytes               	Positive
Mammalian chromosome aberrations in vivo 		Mouse micronucleus  		Negative
Unscheduled DNA synthesis in vitro     		Primary rat hepatocytes	Positive
Unscheduled DNA synthesis in vivo     		Primary rat hepatocytes 	Negative
                             				and spermatocytes

	3. Reproductive and developmental toxicity.

In rat two-generation reproduction studies, EPA concluded the parental NOAELs to range from 31.6-42.8 mg/kg/day based on reduced body weight, body weight gain, and food consumption. The offspring NOAELs ranged from 6.5-14.9 mg/kg/day based on decrease early postnatal pup survival/viability and decreased pup weights.

EPA has selected a developmental NOAEL in rabbits of 8 mg/kg/day as the point of departure for the ARfD for females 13-49 years of age based cleft palate and hydrocephalus.

In a developmental neurotoxicity study, EPA has selected a maternal NOAEL of 100 mg/kg/day, the highest dose tested, based on the lack of adverse effects and an offspring NOAEL of 5 mg/kg/day based on decreased pup survival during post-natal days 2-5 at 50 mg/kg/day.

	4. Subchronic toxicity.

Subchronic (90-day) feeding studies were conducted with rats, mice, and dogs.  In addition, the following subchronic feeding studies were conducted: A 90-day in rats to evaluate neurotoxicity and 28-day feeding studies in rats and mice to evaluate immunotoxicity.   A 28-day dermal study was also conducted in rats.

In a subchronic toxicity/neurotoxicity study in rats with cymoxanil, the NOAEL was 47.6 mg/kg/day in males and 59.9 mg/kg/day in females based on the following changes at higher concentrations: decreased body weights in both sexes, decreased food efficiency in females, and minimal to mild testicular and epididymal changes in males.  In a concurrent 90-day rat neurotoxicity study, there was no evidence of neurotoxicity at any level.  The neurotoxicity NOAEL was 3000 ppm (224 mg/kg/day), the highest dose tested.

The subchronic NOAEL for male mice administered cymoxanil was 82.4 mg/kg/day based on body weight and weight gain effects at 294 mg/kg/day and above.  The NOAEL for females was 121 mg/kg/day based on increases in spleen and liver weights at 433 mg/kg/day and above.

Based on subchronic studies in dogs, EPA selected a NOAEL of 5 mg/kg/day due to decreased body weight and reduced RBC values at a LOAEL of 10 mg/kg/day.

Subchronic 28-day studies were conducted in rats and mice to evaluate the immunotoxicity potential of cymoxanil.   Cymoxanil was not immunotoxic up to and including the highest dose tested which was 1,600 ppm in rats (108 and 117 mg/kg/day in males and females, respectively), 1,200 ppm (218 mg/kg/day) in male mice, and 2,400 ppm (552 mg/kg/day) in female mice.

In a 28-day dermal study in rats there were no effects at any dose tested. The 28-day dermal NOAEL was 1,000 mg/kg/day, the highest dose tested.

	5. Chronic toxicity.

Chronic studies with cymoxanil were conducted on rats, mice, and dogs to determine oncogenic potential and/or chronic toxicity of the compound.  Effects generally similar to those observed in the 90-day studies were seen in the chronic studies.

Cymoxanil was not oncogenic in lifetime feeding studies in rats and mice.  EPA has classified cymoxanil as Not Likely to be Carcinogenic to Humans.  The chronic NOAEL for cymoxanil in rats was 4.1 mg/kg/day in males and 5.4 mg/kg/day in females based on body weight and nutritional changes and non-neoplastic lesions in several organs (lungs, liver, testes, eye, sciatic nerve) at higher dietary concentrations.  In mice, the chronic NOAELs for cymoxanil were 4.2 and 5.8 mg/kg/day for males and females, respectively, based on changes in organ weights, gastrointestinal effects in females and liver, testes, and epididymal effects in males at the LOAEL.  There was no evidence of carcinogenicity.

The lowest NOAEL for chronic toxicity in dogs selected by EPA was 3.0 mg/kg/day based on body weight changes at 5.6 mg/kg/day.

	6. Animal metabolism.

When administered by gavage to rats, cymoxanil was readily absorbed and eliminated.  A rapid and almost complete elimination was observed in the urine and feces. The majority of radioactivity was recovered within 96 hours, mainly in urine but also in feces. Radioactivity in the tissues and carcass was less than 1%.  In the urine and feces, the majority of the radioactivity was free and/or conjugated glycine. 2-Cyano-2-methoxyimino-acetic acid was also found in low levels in the urine and trace levels in the feces. Intact cymoxanil was less than 1% in feces and not detected in the urine. The metabolic pathway involves hydrolysis of cymoxanil and the degradation to glycine, which in turn is incorporated into natural constituents or further metabolized.

	7. Metabolite toxicology.

There are no metabolites of toxicological significance to mammals.

	8. Endocrine disruption.

Chronic, lifespan, and multi-generational bioassays in mammals and acute and subchronic studies on aquatic organisms and wildlife did not reveal endocrine effects. Any endocrine-related effects would have been detected in this definitive array of required tests. The probability of any such effect due to agricultural uses of cymoxanil is negligible.

C. Aggregate Exposure

Cymoxanil is a fungicide currently registered in the United States for use on cucurbits, head lettuce, peppers, potatoes, tomatoes, grapes, hops, caneberries, bulb vegetables, leafy vegetables, and cilantro. In addition, tolerances have been approved for cymoxanil on imported grapes. This tolerance petition proposes the following new uses in the United States: carrot, roots; ginseng; mango; brassica, leafy greens, subgroup 4-16B; and bean, succulent (East of the Rocky Mountains). There are no residential uses.

	1. Dietary exposure.

The chronic dietary RfD of 0.03 mg/kg/day is based on the one-year dog study and a total uncertainty factor of 100.  EPA selected an acute dietary population adjusted dose (PAD) of 0.08 mg/kg/day for females 13-49 based on a rabbit developmental tox study and an acute PAD of 0.50 for the general population (including infants and children) from a rat developmental neurotox study.

	i. Food and Drinking Water.

Chronic Dietary Exposure Assessment

Chronic dietary cymoxanil exposure risk resulting from the proposed and registered uses of cymoxanil was estimated using the Dietary Exposure Evaluation Model with the Food Commodity Intake Database (DEEM-FCID[TM], Version 4.02). The analysis employed overall-mean field-trial values and a very conservative assumption of 100% crop treated for all crops.  A worst case estimated chronic drinking water concentration was included in the assessment of chronic aggregate exposure (food and water) for cymoxanil.

For the general U.S. population and all sub-populations, the estimated chronic dietary exposure to cymoxanil from food and drinking water is well below 100% of the chronic RfD.  This chronic dietary risk estimate for cymoxanil shows that an adequate margin of safety exists for all population subgroups and that no effects would result from dietary exposure to cymoxanil.

Acute Dietary Exposure

The acute dietary exposure analysis resulting from the proposed and registered uses of cymoxanil was conducted with the acute module of the DEEM-FCID[TM] software.  The acute dietary (food and drinking water) analysis used field trial residue data, processing factors and a very conservative assumption of 100% crop treated for all crops.  A worst case estimated acute drinking water concentration was included in the assessment of acute aggregate exposure (food and water) for cymoxanil.

 The results of the acute dietary exposure analysis (food and drinking water) for cymoxanil indicate that the predicted exposure, is well below the relevant PADs for the US population, adult females and all sub-populations, demonstrating that an adequate margin of safety exists for all populations.  Cymoxanil clearly meets the Food Quality Protection Act (FQPA) standard of reasonable certainty of no harm.

	2. Non-dietary exposure.

Cymoxanil products are not labeled for residential non-food uses, thereby eliminating the potential for residential exposure. Non-occupational, non-dietary exposure for cymoxanil has not been estimated because the proposed products are limited to commercial crop production. Therefore, the potential for non-occupational exposure is insignificant.

D. Cumulative Effects

 EPA's consideration of a common mechanism of toxicity is not necessary at this time because there is no indication that toxic effects of cymoxanil should be cumulative with those of any other chemical compounds or with each other. Cymoxanil is a unique cyanoacetamide and is chemically unrelated to any other commercial plant disease control agent. Its biochemical mode of action on fungi appears to be unique; it is theorized to act through inhibition of multiple cellular processes, but a definitive mechanism has not been completely elucidated. Similarly, the mechanism of action underlying observed toxicological effects in mammals is not fully characterized and there is no reliable information to suggest that cymoxanil has a mechanism of toxicity in common with any other compound.

Given the distinct chemical and toxicological profile of cymoxanil, its low acute toxicity, absence of genotoxic, oncogenic, developmental, or reproductive effects, and low exposure potential, the expression of cumulative human health effects with any other natural or synthetic pesticide is not anticipated.

E. Safety Determination

	1. U.S. population.

Based on the completeness and reliability of the toxicity data and the conservative exposure assessments, there is reasonable certainty that no harm will result from the aggregate exposure of residues of cymoxanil.  No additional safety factors are warranted.

	2. Infants and children.

Based on the completeness and reliability of the toxicity data base, the lack of toxicological endpoints of special concern, the lack of any indication that children are more sensitive than adults to cymoxanil, and the conservative exposure assessment, there is a reasonable certainty that no harm will result to infants and children from the aggregate exposure of residues of cymoxanil, including all anticipated dietary exposure and all other non-occupational exposures. Accordingly, there is no need to apply an additional safety factor for infants and children.

F. International Tolerances

1. EU

MRL's established for cymoxanil are available at the following link:
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=pesticide.residue.CurrentMRL&language=EN

2. Canada

Cymoxanil MRL's are established by Canada and are available in the link below:
http://www.pmra-arla.gc.ca/english/legis/maxres-e.html - proposedmrls

3.  Japan

MRL's established for cymoxanil are available at the following link:
http://www.m5.ws001.squarestart.ne.jp/foundation/agrdtl.php?a_inq=33300


[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Rules and Regulations]
[Pages 34895-34896]
[FR Doc No: 2013-13751]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0347]

Safety Zone; San Francisco Independence Day Fireworks Display,
San Francisco Bay, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the safety zones for the San
Francisco Independence Day Fireworks Display in the Captain of the
Port, San Francisco area of responsibility during the dates and times
noted below. This action is necessary to protect life and property of
the maritime public from the hazards associated with the fireworks
display. During the enforcement period, unauthorized persons or vessels
are prohibited from entering into, transiting through, or anchoring in
the safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in this notice will be enforced from 9 a.m. on
July 3, 2013 through 10:15 p.m. on July 4, 2013.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Junior Grade William Hawn, Sector San
Francisco Waterways Safety Division, U.S. Coast Guard; telephone 415-
399-7442, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the San
Francisco Independence Day Fireworks Display safety zones from 9 a.m.
on July 3, 2013 through 10:15 p.m. on July 4, 2013.
    For Location 1, during the loading of the fireworks barges, while
the barges are being towed to the display location, and until the start
of the fireworks display, the safety zone applies to the navigable
waters around and under the fireworks barges within a radius of 100
feet. Loading of the pyrotechnics onto the fireworks barges is
scheduled to take place from 9 a.m. until 2 p.m. on July 3, 2013, and
will take place at Pier 50 in San Francisco, CA. Towing of the barges
from Pier 50 to the display location is scheduled to take place from 8
p.m. until 8:45 p.m. on July 4, 2013. During the 25 minute fireworks
display, scheduled to take place from 9:30 p.m. until 9:55 p.m. on July
4, 2013, the fireworks barge will be located 1,000 feet off of Pier 39
in approximate position 37[deg]48'49'' N, 122[deg]24'46'' W (NAD 83).
Pursuant to 33 CFR 165.1191, Table 1, Item number 8, this safety zone
will be in effect from 9 a.m. on July 3, 2013 to 10:15 p.m. on July 4,
2013.
    For Location 2, the fireworks will be launched from the San
Francisco Municipal Pier. During the 25 minute fireworks display,
scheduled to take place from 9:30 p.m. until 9:55 p.m. on July 4, 2013,
the safety zone will apply to the navigable waters around and under the
fireworks launch site within a radius of 1,000 feet in approximate
position 37[deg]48'38'' N, 122[deg]25'28'' W (NAD 83). Pursuant to 33
CFR 165.1191, Table 1, Item number 8, this safety zone will be in
effect from 9:30 p.m. to 10:15 p.m. on July 4, 2013. Under the
provisions of 33 CFR 165.1191, unauthorized persons or vessels are
prohibited from entering into, transiting through, or anchoring in the
safety zone during all applicable effective dates and times, unless
authorized to do so by the PATCOM. Additionally, each person who
receives notice of a lawful order or direction issued by an official
patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: May 18, 2013.
Gregory G. Stump,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2013-13751 Filed 6-10-13; 8:45 am]
BILLING CODE 9110-04-P