[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Rules and Regulations]
[Pages 80665-80672]
[FR Doc No: 2015-32168]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0727; FRL-9933-41]

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spinosad in or on multiple commodities that are identified and
discussed later in this document. In addition, this regulation removes
a number of existing tolerances for residues of spinosad that are
superseded by tolerances being established in this action.
Interregional Research Project #4 (IR-4) requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 28, 2015. Objections and
requests for hearings must be received on or before February 26, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0727, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0727 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 26, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0727, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 30, 2013 (78 FR 79359) (FRL-
9903-69), and November 4, 2015 (80 FR 68289) (FRL-9936-13), EPA issued
a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing and subsequent filing of an amendment to
pesticide petition (PP 3E8204) by IR-4, 500 College Road East, Suite
201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.495
be amended by establishing tolerances for residues of the insecticide
spinosad, a fermentation product of Saccharopolyspora spinosa,
consisting of two related active ingredients: Spinosyn A (Factor A: CAS
Registry No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione; and Spinosyn D (Factor D; CAS Registry No. 131929-63-0) or 2-
[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on the raw
agricultural commodities: Coffee, green bean at 0.2 parts per million
(ppm); coffee, instant at 0.4 ppm; coffee, roasted bean at 0.4 ppm;
cottonseed subgroup 20C at 0.02 ppm; caneberry subgroup 13-07A at 0.7
ppm; bushberry subgroup 13-07B, except lingonberry at 0.25 ppm; fruit,
small, vine climbing, except fuzzy kiwifruit subgroup 13-07F at 0.5
ppm; berry, low growing, subgroup 13-07G, except blueberry, lowbush,
and cranberry at 1.0 ppm; fruit, pome group 11-10 at 0.2 ppm;
vegetable, fruiting, group 8-10 at 0.4 ppm; fruit, citrus, group 10-10
at 0.3 ppm; fruit, stone, group 12-12 at 0.2 ppm; onion, bulb, subgroup
3-07A at 0.1 ppm; onion, green, subgroup 3-07B at 2.0 ppm; and nuts,
tree, group 14-12 at 0.1 ppm. In addition, the petitioner proposes
based upon establishment of the new tolerances above, to remove the
following established tolerances that are superseded by this action:
bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A at 0.70 ppm;
fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20 ppm;
fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm; Juneberry at
0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at 0.10 ppm; okra
at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10 ppm; quinoa,
grain at 1.0 ppm; salal at 0.25 ppm; strawberry at 1.0 ppm; vegetable,
bulb, group 3, except green onion at 0.10 ppm; vegetable, fruiting
group 8 at 0.4 ppm; and cotton, undelinted seed at 0.02 ppm. That
document referenced a summary of the petition prepared by Dow
AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filings.
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has made
certain modifications to the petitioned-for tolerances. The reasons for
these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.
    Spinosad and spinetoram are considered by EPA to be toxicologically
identical for human health risk assessment based on their very similar
chemical structures and similarity of the toxicological databases for
currently available studies. The primary toxic effect observed from
exposure to spinosad or spinetoram was histopathological changes in
multiple organs (specific target organs were not identified).
Vacuolization of cells and/or macrophages was the most common
histopathological finding noted across both toxicological databases
with the dog being the most sensitive species. In addition to the
numerous organs observed with histopathological changes, anemia was
noted in several studies.
    There was no evidence of increased quantitative or qualitative
susceptibility from spinosad or spinetoram exposure. In developmental
studies, no maternal or developmental effects were seen in rats or
rabbits. In the rat reproduction toxicity studies, offspring toxicity
was seen in the presence of parental toxicity at approximately the same
dose for both chemicals (75-100 mg/kg/day). Parental toxicity was
evidenced by increased organ weights, mortality, and histopathological
findings in several organs. Offspring effects included decreased litter
size, survival, and body weights with spinosad while an increased
incidence of late resorptions and post-implantation loss was seen with
spinetoram. Dystocia and/or other parturition abnormalities were
observed with both chemicals.
    Spinosad and spinetoram are classified as having low acute toxicity
via the oral, dermal, and inhalation routes of exposure. Neither
chemical is an eye or dermal irritant. Spinetoram was found to be a
dermal sensitizer. No hazard was identified for dermal exposure;
therefore a quantitative dermal assessment is not needed. In acute and
subchronic neurotoxicity studies, there was no evidence of
neurotoxicity from exposure to spinosad or spinetoram. In an
immunotoxicity study with spinosad, systemic effects (decreased body
weights, increased liver weights, and abnormal hematology results) were
seen at the highest dose tested (141 mg/kg/day); however, there was no
evidence of immunotoxicity.
    Spinosad and spinetoram are classified as ``not likely to be
carcinogenic to humans'' based on lack of evidence of carcinogenicity
in mice and rats and negative findings in mutagenicity assays.
    Specific information on the studies received and the nature of the
adverse effects caused by spinetoram as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in documents including: (1) ``Spinosad and
Spinetoram--Human Health Risk Assessment to Support the Section 3
Registration Request for Application to Coffee and for Updates to
Several Crop Group/Subgroup Commodity Definitions'', dated March 15,
2015 at page 31, and (2) ``Spinosad/Spinetoram. Addendum to Human
Health aggregate Risk assessment D415812 (T. Bloem et al., March 10,
2015) to Support a New Use on Quinoa'', dated November 19, 2015 in
docket ID number EPA-HQ-OPP-2013-0727.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    Spinosad and spinetoram should be considered toxicologically
identical in the same manner that metabolites are generally considered
toxicologically identical to the parent. Although, as stated above, the
doses and endpoints for spinosad and spinetoram are similar, they are
not identical due to variations in dosing levels used in the spinetoram
and spinosad toxicological studies. EPA compared the spinosad and
spinetoram doses and endpoints for each exposure scenario and selected
the lower of the two doses for use in human risk assessment.
    A summary of the toxicological endpoints for spinosad/spinetoram
used for human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Spinosad/Spinetoram for Use in Human Health Risk
                                                   Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations)..  A dose and endpoint of concern attributable to a single dose was not
                                    observed.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.49 mg/kg/    Chronic RfD =        Chronic Toxicity--Dog Study (with
                                    day.                  0.0249 mg/kg/day.    spinetoram)
                                   UFA = 10x...........  cPAD = 0.0249 mg/kg/ LOAEL = 5.36/5.83 mg/kg/day (males/
                                   UFH = 10x...........   day.                 females) based on arteritis and
                                   FQPA SF = 1x........                        necrosis of the arterial walls of
                                                                               the epididymides in males and of
                                                                               the thymus, thyroid, larynx, and
                                                                               urinary bladder in females.
Incidental oral short-term (1 to   NOAEL= 4.9 mg/kg/day  Residential LOC for  Subchronic Oral Toxicity--Dog
 30 days) and intermediate-term    UFA = 10x...........   MOE <100.            Study (with spinosad)
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 9.73 mg/kg/day based on
                                   FQPA SF = 1x........                        microscopic changes in multiple
                                                                               organs, clinical signs of
                                                                               toxicity, decreases in body
                                                                               weights and food consumption, and
                                                                               biochemical evidence of anemia
                                                                               and liver damage.

Inhalation short-term............  Inhalation (or oral)  Residential LOC for  Subchronic Oral Toxicity--Dog
(1 to 30 days) and Intermediate-    study NOAEL= 4.9 mg/  MOE <100.            Study (with spinosad)
 Term (1-6 months).                 kg/day (inhalation                        LOAEL = 9.73 mg/kg/day based on
                                    assumed equivalent                         microscopic changes in multiple
                                    to oral).                                  organs, clinical signs of
                                   UFA = 10x...........                        toxicity, decreases in body
                                   UFH = 10x...........                        weights and food consumption, and
                                   FQPA SF = 1x........                        biochemical evidence of anemia
                                                                               and liver damage.
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Cancer (Oral, dermal, inhalation)            Classified as ``not likely to be carcinogenic to humans''.
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LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE =
  margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
  chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinosad and spinetoram, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinosad tolerances
in 40 CFR 180.495 and existing spinetoram tolerances. EPA assessed
dietary exposures from spinosad and spinetoram 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.
    No such effects were identified in the toxicological studies for
spinosad or spinetoram; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
    ii. Chronic exposure. Spinosad is registered for application to all
of the same crops as spinetoram, with similar pre-harvest and
retreatment intervals, and application rates greater than or equal to
spinetoram. Further, both products control the same pest species. For
this reason, EPA has concluded it would overstate exposure to assume
that residues of both spinosad and spinetoram would appear on the same
food. Rather, EPA aggregated exposure by either assuming that all
commodities contain spinosad residues (because side-by-side spinetoram
and spinosad residue data indicated that spinetoram residues were less
than or equal to spinosad residues).
    In conducting the chronic dietary exposure assessment for
spinetoram, EPA used the Dietary Exposure Evaluation Model--Food
Consumption Intake Database (DEEM-FCID, ver. 3.16) which incorporates
food consumption data from the United States Department of Agriculture
(USDA) National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA; 2003-2008). The chronic analysis assumed 100
percent crop treated (PCT), average field-trial residues or tolerance-
level residues for crop commodities, average residues from the
livestock feeding studies, residue estimates for fish/shellfish,
experimental processing factors when available, and modeled drinking
water estimates.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spinosad does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and 100 percent crop treated (PCT)
information were used. Section 408(b)(2)(E) of FFDCA authorizes EPA to
use available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spinosad and spinetoram in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of spinosad. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and
Screening Concentration in Ground Water (SCIGROW) models, the estimated
drinking water concentrations (EDWCs) of spinosad for acute exposures
are estimated to be 25.0 ppb for surface water and 1.1 ppb for ground
water. For chronic exposures for non-cancer assessments, EDWCs of
spinosad are estimated to be 21.7 ppb for surface water and 1.1 ppb for
ground water. EDWCs of spinetoram for acute exposures are estimated to
be 8.6 parts per billion (ppb) for surface water and 0.072 ppb for
ground water. For chronic exposures for non-cancer assessments, EDWCs
of spinetoram are estimated to be 5.9 ppb for surface water and 0.072
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 21.7 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control,

indoor pest control, termiticides, and flea and tick control on pets).
    Spinosad and spinetoram are currently registered for uses that
could result in residential exposures including lawns, gardens,
turfgrass, ornamentals, fire ant mounds, and spot-on pet applications.
There is potential for residential handler and post-application
exposures to both spinosad and spinetoram. Since spinosad and
spinetoram control the same pests, EPA concludes that these products
will not be used for the same uses in combination with each other and
thus combining spinosad and spinetoram residential exposures would
overstate exposure. EPA assessed residential exposure for both spinosad
and spinetoram using the most conservative residential exposure
scenarios for either chemical.
    EPA assessed residential exposure using the following assumptions:
Residential handler (short-term inhalation exposures) and post-
application (short-term incidental oral) exposures are expected as a
result of the following registered uses: (1) application of spinosad to
gardens, turfgrass, ornamentals and fire ant mounds; (2) application of
spinetoram to lawns, gardens, and ornamentals; and (3) spot-on
application of spinetoram to cats and kittens. The Agency determined
the ``worst-case'' scenarios for handler and post-application exposures
as: (1) adult residential handler inhalation exposure from mixing/
loading/applying liquid formulations to turf via backpack sprayer, and
(2) child (1-<2 years) residential post-application incidental oral
(hand-to-mouth) exposure from liquid formulation on turf/home gardens/
ornamentals. These worst-case exposure estimates were used in the
aggregate assessment of residential exposure to spinosad and
spinetoram.
    Aggregating exposure resulting from the turf and pet uses was not
conducted as the products control different pests and, therefore,
application on the same day is unlikely. Use survey data indicate that
concurrent use of separate pesticide products that contain the same
active ingredient to treat the same or different pests does not
typically occur. Furthermore, a number of issues are considered when
combining residential exposure scenarios, including whether aggregating
additional uses is appropriate in light of the already conservative
assumptions inherent in the assessment. When assessing individual
short-term residential postapplication exposure scenarios, EPA assumes
exposure occurs to zero-day residues (i.e., day of application
residues) day after day. EPA also assumes that an individual performs
the same postapplication activities, intended to represent high end
exposures as described in the Residential SOPS, day after day for the
same amount of time every day (i.e., no day to day variation), although
doing intense contact activities on the day of application subsequent
to application for multiple chemicals would not be anticipated. Once
calculated, these exposure estimates are then compared to points of
departure that are typically based on weeks of dosing in test animals.
For spinosad/spinetoram, the short-term risk assessment has the
additional conservatism of basing the level of concern for short-term
exposure (30-days) on a toxicity study involving continuous exposure
over 90 days.
    Current EPA policy requires assessment for residential post-
application exposures of short- (1 to 30 days), intermediate- (1 to 6
months), and long-term (greater than 6 months) exposures from spot-on
products due to the preventative nature of these products and the
potential for extended usage in more temperate parts of the country.
However, for spinetoram, there is no progression of toxicity with time;
therefore, the short-term assessment is protective of intermediate- and
long-term exposure.
    Available turf transferable residue (TTR) data on spinosad in
support of the turf uses and spinetoram data on dislodgeable residues
from petting after topical administration to cats were incorporated
into the exposure assessment. Spinosad and spinetoram dislodgeable-
foliar residue (DFR) studies are unnecessary at this time as there is
no hazard via the dermal route of exposure.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticides-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    EPA has not found spinosad or spinetoram to share a common
mechanism of toxicity with any other substances, and neither spinosad
nor spinetoram appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that spinosad and spinetoram do not have 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
EPA's Web site at http://www2.epa.gov/pesticides-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative susceptibility of rat and rabbit
fetuses to in-utero exposure to spinetoram or spinosad. In
developmental studies, no maternal or developmental effects were seen
in rats or rabbits. In the rat reproduction toxicity studies, offspring
toxicity was seen in association with parental toxicity at
approximately the same dose for both spinetoram and spinosad.
Therefore, there is no evidence of increased susceptibility and there
are no concerns or residual uncertainties for pre-natal and/or post-
natal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spinosad and spinetoram is complete.
There is no evidence of neurotoxicity, developmental/reproductive
toxicity, immunotoxicity, mutagenicity, or carcinogenicity from
spinetoram or spinosad exposure. Therefore, no additional database
uncertainty factor (UF) is needed.
    ii. There is no indication of spinosad or spinetoram neurotoxicity
from available acute and subchronic

neurotoxicity studies in rats and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinosad or spinetoram results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the spinosad
and spinetoram exposure databases. The dietary exposure assessment is
conservative as it assumes 100 PCT and residue estimates are based on
field trial data and fish nature of the residue studies. Moreover, EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to spinosad and spinetoram in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by spinosad and spinetoram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spinosad and spinetoram are not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spinosad and spinetoram from food and water will utilize 64% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
spinosad and spinetoram is not expected.
    3. Short- and Intermediate-term risks. Short-term aggregate
exposure takes into account short-term residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level).
    Spinosad and spinetoram are currently registered for uses that
could result in short-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to spinosad and
spinetoram.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 220 for children
1-2 years old and 1,000 for adults 20-49 years old. Because EPA's level
of concern for spinosad and spinetoram is a MOE of 100 or below, these
MOEs are not of concern.
    EPA has concluded that the combined intermediate-term and long-term
food, water, and residential exposures result in aggregate MOEs that
will not fall below the short-term aggregate MOEs since there is no
progression of spinetoram toxicity with time. Because EPA's level of
concern for spinetoram and spinosad is a MOE of 100 or below, these
MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, spinosad is not expected to pose a cancer risk to humans.
    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 spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method RES 94025 (GRM 94.02) is a
high-performance liquid chromatography method with ultraviolet
detection (HPLC/UV)) is available to enforce the tolerance expression.
Additional methods have also been determined to be adequate for
tolerance enforcement purposes.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex maximum residue limits (MRLs) for spinosad are currently
established in or on several of the relevant crops or crop groups or
subgroups affected by this action. EPA harmonizes with existing Codex
MRLs whenever feasible. The recommended fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F and raisin tolerances and the
Codex MRLs are harmonized. But harmonization with the Codex MRLs for
the following tolerances is inappropriate as doing so may result in
exceedances of the tolerances when the pesticide is applied using the
labeled instructions: Fruit, pome, group 11-10; nut, tree, group 14-12;
and cottonseed, subgroup 20C. Harmonization with the currently
established vegetable, fruiting, group 8-10 Codex MRL is inappropriate
as the Codex MRL is too high to allow for enforcement of the labeled
instructions.

C. Response to Comments

    In response to the notice of filing, EPA received two (2) comments
on December 4, 2015. One comment was received from a private citizen in
support of EPA's regulatory initiatives to control potentially harmful
substances in order to protect human health and the environment.
    The other comment was from the Center for Biological Diversity and
concerned endangered species, specifically stating that EPA cannot
approve these new uses prior to completion of consultations with the
U.S. Fish and Wildlife Service and the National Marine Fisheries
Service (``the Services''). This comment is not relevant to the
Agency's evaluation of the safety of the spinosad tolerances;

section 408 of the FFDCA focuses on potential harms to human health and
does not permit consideration of effects on the environment.

D. Revisions to Petitioned-For Tolerances

    Based on the available field-trial and processing data and the OECD
tolerance calculation procedure, EPA: (1) concludes that proposed
tolerances in or on coffee processed commodities are unnecessary; (2)
made revisions to proposed tolerance values in order to harmonize with
Canada and/or Codex MRLs where supporting data allowed; (3) made
revisions to the commodity definitions to conform with current Agency
practices, and (4) is reducing the requested tolerance for coffee,
green bean from 0.2 ppm to 0.04 ppm. Also, although a spinosad
tolerance in/on quinoa, grain was requested at 1.0 ppm for the purpose
of harmonizing with the Codex cereal grain MRL, EPA is establishing a
tolerance at 0.02 ppm. EPA considered the fact that the Codex MRL is
based on post-harvest treatment and, therefore, is not reflective of
the proposed foliar-only quinoa application scenario. Based on the
available wheat grain data and adjusting these data for the proposed
application rate, EPA concluded that a 0.02-ppm spinosad tolerance in/
on quinoa grain is appropriate.
    In addition, the Agency is updating the tolerance expression for
spinosad as follows to reflect current EPA policies: Tolerances are
established for residues of the insecticide spinosad, including its
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only the sum of spinosyn A (Factor A: CAS #
131929-60-7; (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-
tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione); and spinosyn D (Factor D;
CAS # 131929-63-0; (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione), calculated as the
stoichiometric equivalent of spinosad.

V. Conclusion

    Therefore, EPA is establishing tolerances for residues of the
insecticide spinosad, including its metabolites and degradates, in or
on the following commodities. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
spinosyn A (Factor A: CAS # 131929-60-7;
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione; and spinosyn D (Factor D;
CAS # 131929-63-0; (2S,3aR,5aS,5bS,9S,13S, 14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione, calculated as the
stoichiometric equivalent of spinosad, in or on berry, low growing,
subgroup 13-07G, except cranberry at 0.90 ppm; bushberry, subgroup 13-
07B at 0.40 ppm; caneberry subgroup 13-07A at 1.0 ppm; coffee, green
bean at 0.04 ppm; cottonseed subgroup 20C at 0.02 ppm; fruit, citrus,
group 10-10 at 0.30 ppm; fruit, pome, group 11-10 at 0.20 ppm; fruit,
small, vine climbing, subgroup13-07F, except fuzzy kiwifruit at 0.50
ppm; fruit, stone 12-12 at 0.20 ppm; nut, tree, group 14-12 at 0.10
ppm; onion, bulb, subgroup 3-07A at 0.10 ppm; onion, green, subgroup 3-
07B at 4.0 ppm; quinoa, grain at 0.02 ppm; and vegetable, fruiting,
group 8-10 at 0.40 ppm. In addition, EPA is removing the following
existing spinosad tolerances that are superseded by this action
including: Bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A
at 0.70 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11
at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm;
Juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at
0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10
ppm; strawberry at 1.0 ppm; vegetable, bulb, group 3, except green
onion at 0.10 ppm; vegetable, fruiting group 8 at 0.4 ppm; and cotton,
undelinted seed at 0.02 ppm. In addition, EPA is increasing the
existing tolerance for grape, raisin to 1.0 ppm.

VI. Statutory and Executive Order Reviews

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

Agency consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 15, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.495, paragraph (a):
0
a. Revise the introductory text.
0
b. Remove the entries in the table for ``Bushberry subgroup 13B'';
``Caneberry subgroup 13A''; ``Cotton, undelinted seed''; ``Fruit,
citrus, group 10''; ``Fruit, pome, group 11''; ``Fruit, stone, group
12''; ``Grape''; ``Juneberry''; ``Lingonberry''; ``Nut tree, group
14''; ``Okra''; ``Onion, green''; ``Pistachio''; ``Salal'';
``Strawberry''; ``Vegetable, bulb, group 3, except green onion''; and
``Vegetable, fruiting, group 8''.
0
c. Revise the entry in the table for ``Grape, raisin''.
0
d. Add alphabetically entries to the table for ``Berry, low growing,
subgroup 13-07G, except cranberry''; ``Bushberry subgroup 13-07B'';
``Caneberry subgroup 13-07A''; ``Coffee, green bean''; ``Cottonseed
subgroup 20C''; ``Fruit, citrus, group 10-10''; ``Fruit, pome, group
11-10''; ``Fruit, small, vine climbing, subgroup13-07F, except fuzzy
kiwifruit''; ``Nut, tree, group 14-12''; ``Onion, bulb, subgroup 3-
07A''; ``Onion, green, subgroup 3-07B''; ``Quinoa, grain''; and
``Vegetable, fruiting, group 8-10''.
    The additions and revision read as follows:

Sec.  180.495  Spinosad; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide spinosad, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
spinosyn A (Factor A: CAS # 131929-60-7;
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione; and spinosyn D (Factor D;
CAS # 131929-63-0; (2S,3aR,5aS,5bS,9S,13S, 14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione, calculated as the
stoichiometric equivalent of spinosad.

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

                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry.......        0.90

                                * * * * *
Bushberry subgroup 13-07B...................................        0.40
Caneberry subgroup 13-07A...................................         1.0

                                * * * * *
Coffee, green bean..........................................        0.04

                                * * * * *
Cottonseed subgroup 20C.....................................        0.02

                                * * * * *
Fruit, citrus, group 10-10..................................        0.30
Fruit, pome, group 11-10....................................        0.20
Fruit, small, vine climbing, subgroup13-07F, except fuzzy           0.50
 kiwifruit..................................................
Fruit, stone 12-12..........................................        0.20

                                * * * * *
Grape, raisin...............................................         1.0

                                * * * * *
Nut, tree, group 14-12......................................        0.10

                                * * * * *
Onion, bulb, subgroup 3-07A.................................        0.10
Onion, green, subgroup 3-07B................................         4.0

                                * * * * *
Quinoa, grain...............................................        0.02

                                * * * * *
Vegetable, fruiting, group 8-10.............................        0.40

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-32168 Filed 12-24-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Rules and Regulations]
[Pages 37603-37604]
[FR Doc No: 2012-15266]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG 2012-0416]

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

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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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 33 CFR 165.1191 will be enforced from 9 a.m.
on July 3, 2012 through 10:15 p.m. on July 4, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ensign William Hawn, Sector San Francisco Waterways
Safety Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, 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, 2012 through 10:15 p.m. on July 4, 2012.
    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, 2012, and
will take place at Pier 50 in San Francisco, CA. Towing of the barge
from Pier 50 to the display location is scheduled to take place from 8
p.m. until 8:45 p.m. on July 4, 2012. During the 25 minute fireworks
display, scheduled to take place from 9:30 p.m. until 9:55 p.m. on July
4, 2012, the fireworks barge will be located 1,000 feet off of Pier 39
in position 37[deg]48'49'' N, 122[deg]24'46'' W (NAD 83) for the San

Francisco Independence Day Fireworks Display in 33 CFR 165.1191. This
safety zone will be in effect from 9 a.m. on July 3, 2012 to 10:15 p.m.
on July 4, 2012.
    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, 2012,
the safety zone will apply to the navigable waters around and under the
fireworks launch site within a radius of 1,000 feet in position
37[deg]48'38'' N, 122[deg]25'28'' W (NAD 83) for the San Francisco
Independence Day Fireworks Display in 33 CFR 165.1191. This safety zone
will be in effect from 9:30 p.m. to 10:15 p.m. on July 4, 2012.
    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: June 6, 2012.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2012-15266 Filed 6-21-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Rules and Regulations]
[Page 78192-78196]
[DOCID:fr22de08-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0472; FRL-8755-1]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Stafford County Reasonably Available Control Technology Under
the 8-Hour Ozone National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by theCommonwealth of Virginia. This SIP revision fulfills
Virginia's reasonably available control technology (RACT) requirements
under the Clean Air Act (CAA or the Act) with respect to the 8-hour
ozone national ambient air quality standard (NAAQS) in Stafford County.
Virginia has fulfilled these requirements by submitting a certification
that 1-hour ozone NAAQS RACT controls for sources in the Commonwealth
subject to control technology guidelines (CTGs) and for a single major
source not subject to any CTG, continue to represent RACT under the 8-
hour NAAQS, and submitting a negative declaration demonstrating that no
facilities exist in Stafford County that are subject to certain
enumerated CTGs that have not been adopted by Virginia.

DATES: Effective Date: This final rule is effective on January 21,
2009.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2008-0472. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
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 andwill be publicly
available only in hard copy form. Publicly available docket materials
are available either electronically through http://www.regulations.gov
or in hard copy for public inspection during normal business hours at
the Air Protection Division, U.S. Environmental Protection Agency,
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies
of the State submittal are available at the Virginia Department of
Environmental Quality, 629 East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On August 7, 2008 (73 FR 45925), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Virginia. The NPR proposed
approval of Stafford County's requirements of RACT under the 8-hour
ozone NAAQS set forth by the CAA. The formal SIP revision was submitted
by the Virginia Department of Environmental Quality on April 21, 2008.

II. Summary

    Sections 172(c)(1) and 182(b)(2) of the CAA require that all SIPs
satisfy the nitrogen oxides (NOX) and volatile organic
compounds (VOCs) RACT requirements that apply in areas that have not
attained the NAAQS for ozone. See 42 U.S.C. 7502(c)(1), 42 U.S.C.
7511a(b)(2), and 42 U.S.C. 7511a(f). EPA has determined that States
that have RACT provisions approved in their SIPs for 1-hour ozone
nonattainment areas have several options for fulfilling the RACT
requirements for the 8-hour ozone NAAQS. If a State meets certain
conditions, it may certify that previously adopted 1-hour ozone RACT
controls in the SIP continue to represent RACT control levels for
purposes of fulfilling 8-hour ozone RACT requirements. See Final Rule
To Implement the 8-Hour Ozone National Ambient Air Quality Standard--
Phase 2; Final Rule To Implement Certain Aspects of the 1990 Amendments
Relating to New Source Review and Prevention of Significant
Deterioration as They Apply in Carbon Monoxide, Particulate Matter and
Ozone NAAQS; Final Rule for Reformulated Gasoline (Phase 2 Rule) 70 FR
71612, 71655, November 29, 2005. Alternatively, a State may adopt new
or more stringent regulations that represent RACT control levels,
either in lieu of or in conjunction with a certification.
    The Commonwealth of Virginia has submitted a certification that
previously adopted RACT controls in Virginia's SIP that were approved
by EPA under the 1-hour ozone NAAQS continue to represent RACT for the
8-hour implementation purposes. This previously adopted RACT consists
of Virginia's adoption of EPA promulgated CTGs for those source
categories that apply to existing sources in Stafford County. Virginia
has also submitted a negative declaration demonstrating that no
facilities exist in Stafford County for

those CTGs that have not been adopted by Virginia.
    Virginia has also certified, based on consideration of additional
research, that the 1-hour ozone NAAQS RACT determination for the only
major stationary source located in Stafford County not covered by a CTG
continues to represent RACT under the 8-hour ozone NAAQS. Other
specific requirements of RACT and the rationale for EPA's proposed
action are explained in the NPR and will not be restated here.
    On September 8, 2008, EPA received adverse comments from State of
New Jersey Department of Environmental Protection on the NPR. A summary
of the comments submitted and EPA's response is provided in Section III
of this document.

III. Summary of Public Comments and EPA Responses

    Comment: The commenter opposes the approval of the SIP revision
submitted by Virginia for Stafford County. The commenter notes that
Stafford County is a moderate ozone nonattainment area, and is required
to implement RACT on all major VOC and NOX sources, and all
sources covered by a CTG. The commenter also states that in the final
rule to implement the 8-hour ozone standard (i.e., the Phase 2 Rule)
EPA indicates that States may rely on existing CTGs and the prior 1-
hour RACT determinations as presumptive RACT. The comment also states
that most CTGs and prior 1-hour RACT determinations were done over a
decade ago, and asserts that the emission limits are no longer RACT
because of advancements in air pollution control technology. This is
especially the case, it argues, for nitrogen oxides. Additionally, the
commenter appears to believe that section 108 of the Act requires EPA
to review, modify and reissue control technology in a timely fashion,
that EPA has failed to do so, and that this failure to do so prevents
EPA from allowing States the discretion of certifying that previous 1-
hour ozone RACT determinations fulfill obligations under the 8-hour
ozone NAAQS. The commenter also asserts that it is adversely affected
because it is a downwind state. Finally, the commenter notes that and
sections 110(a)(2)(D) and Part D of the CAA require upwind states to
include adequate controls in their SIPs prohibiting interstate
transport of air pollutants in amounts that contribute to nonattainment
in any downwind state.
    Response: The commenter correctly notes that Stafford County is a
moderate ozone nonattainment area and is required to implement RACT on
all major VOC and NOX sources, and all sources covered by a
CTG. The RACT provisions of the CAA are set forth in sections 172(c)(1)
and 182(b)(2) of Part D of the Act. 42 U.S.C. 7502(c)(1), 42 U.S.C.
7511a(b)(2). Section 172 applies to RACT in so-called ``subpart 1''
areas. Stafford County is not a ``subpart 1'' area. RACT, as it applies
in moderate or above ozone nonattainment areas, or within the OTR,
i.e., to Stafford County, is a specific requirement set forth in
Section 182(b)(2) of Part D of the Act. Section 182(b)(2) identifies
the categories of sources to which RACT applies. Section 182(b)(2) does
not specify the level of control required to meet the RACT requirement.
    The commenter also correctly acknowledges that the Phase 2 Rule, 70
FR 71612, explicitly addressed whether, and the circumstances under
which, states may continue to rely on existing CTGs and the prior 1-
hour RACT determinations. Specifically, in the Phase 2 Rule, EPA
determined that States may certify that ``previously required RACT
controls represent RACT for 8-hour implementation purposes.'' 70 FR at
71652.
    The commenter does not allege that EPA's approval of the SIP
revision is inconsistent with the provisions of the Phase 2 Rule. The
final action establishing those provisions was taken by EPA, not in
today's action, but in the Federal Register notice for the Phase 2 Rule
published on November 29, 2005, 70 FR 71612. Challenges to the Phase 2
Rule have been brought by commenter and others in the U.S. Court of
Appeals for the District of Columbia. Natural Resources Defense Council
v. EPA (D.C. Cir. No. 06-1045 and consolidated cases).
    The Phase 2 Rule, in fact, explicitly addresses the State's
obligation to consider new information when deciding whether to certify
that prior RACT determinations remain valid for the 8-hour ozone NAAQS.
The commenter does not allege that the State has failed to satisfy that
obligation, or that it has not met any other requirements in the Phase
2 Rule for certifying that its prior RACT determinations remain valid
for the 8-hour ozone NAAQS. Thus, while we agree with commenter that
many of the CTGs have not been revised since they were issued, we do
not agree that it is therefore improper for EPA to approve this SIP
revision. In the Phase 2 Rule, EPA specifically addressed concerns
arising from our recognition that ``the CTGs/ACTs * * * may not provide
the most accurate picture of current control options.'' 70 FR at 71655.
    In response, we decided that ``States and other interested parties
should consider available information that may supplement the CTG and
ACT documents. In cases where additional information is presented, for
example, as part of notice-and-comment rulemaking on a RACT SIP
submittal, States (and EPA) would necessarily consider the additional
data in reviewing what control obligation is consistent with RACT.'' 70
FR at 71655. Only after conducting this review may a State certify that
a 1-hour ozone RACT determination continues to represent an appropriate
RACT level of control for the 8-hour ozone program. Id. Absent data
indicating that the previous RACT determination is no longer
appropriate, the State may certify that the existing 1-hour RACT
determination fulfills the requirement for 8-hour ozone RACT, and the
State need not submit in its SIP a new RACT requirement for those
sources. Id.
    Although the commenter broadly alleges that the CTGs no longer
reflect RACT because they have not been updated recently, the commenter
does not identify any specific deficiencies or indicate which, if any,
of the particular CTGs adopted by Virginia it believes to be defective.
Furthermore, no evidence in the record indicates that Virginia either
determined--or that anyone brought to its attention during the notice
and comment rulemaking for this SIP submission--that evidence existed
to cast doubt on the appropriateness under the 8-hour ozone NAAQS of
any of the previously adopted and SIP-approved CTGs. A commenter bears
some burden of bringing to an agency's attention at least some
particulars of an alleged defect in a rulemaking. See, International
Fabricare Inst. v. EPA, 972 F.2d 384, 391 (D.C. Cir. 1992).
    In sum, the commenter has not identified any new information that
has become available, but that the State did not consider and has not
even alleged that any particular CTG actually adopted into the Virginia
SIP fails to represent RACT under the 8-hour ozone NAAQS. Thus, under
the specific terms of the Phase 2 ozone implementation rule, Virginia
is entitled to rely on that Rule's presumption that absent evidence to
the contrary, a state may certify that CTGs previously adopted to meet
1-hour ozone NAAQS continue to meet the requirements for RACT under the
8-hour ozone NAAQS. See 70 FR at 71652, 71654-55.
    With respect to the single major source in Stafford County that is
not subject to a CTG, Virginia took reasonable steps to seek out
additional information to assure that the 1-hour

ozone NAAQS source-specific RACT determination for this source
continues to represent RACT under the 8-hour ozone NAAQs. This is
consistent with our determination in the Phase 2 Rule that the
certification must be submitted with appropriate supporting
information, including the consideration of new data. In all cases
where additional information is presented, States (and EPA) must
consider the additional information as part of that rulemaking, and
absent such information, the State may certify existing RACT as meeting
the 8-hour ozone requirements. 70 FR at 71655.
    Virginia reviewed EPA's RACT/BACT/LAER clearinghouse for sources
within the same Standard Industrial Classification code as the sole
major non-CTG source in Stafford County, and determined that there was
no information to indicate that the 8-hour ozone RACT determination
should be different from the August 10, 1998 1-hour ozone RACT
determination for this facility, which has been approved by EPA. See 66
FR 8, January 2, 2001. Based on the forgoing, the low potential
emissions from the facility, and the even lower actual emissions from
the facility, Virginia determined in its SIP submission, consistent
with the Phase 2 Rule, that the existing 1-hour RACT determination
could be certified as fulfilling the 8-hour ozone RACT requirements. As
with our analysis with respect to the CTG RACT certification, we
believe that Virginia is entitled to rely on the Phase 2 Rule's
presumption that absent evidence to the contrary, a state may certify
this 1-hour ozone NAAQS determination as meeting the requirements for
RACT under the 8-hour ozone NAAQS.
    We also do not agree with commenter's apparent beliefs regarding
section 108 of the Clean Air Act. With respect to that section, the
commenter states that ``[a]ccording to Section 108(c) of the Clean Air
Act, EPA has an obligation to review, modify and reissue control
techniques'' and that ``USEPA has failed to do so in a timely
fashion.'' Section 108 of the Act provides that ``the Administrator
shall from time to time review, and as appropriate, modify or reissue
any criteria or information on control techniques. * * *'' Section 108
does not establish time frames for the Administrator to review, modify,
or reissue control techniques. Furthermore, section 108 provides that
the review, modification or reissuance of a RACT is only to be done
``as appropriate.'' EPA believes that Congress left the decision
whether to review, modify or reissue a control technique to the
Administrator's discretion.
    Finally, with respect to the comments related to requirements of
section 110(a)(2)(D) and Part D of the Act, EPA agrees with the
commenter that section 110(a)(2)(D) requires, among other things, that
a State's SIP needs to contain provisions to regulate the interstate
transport of air pollution that significantly contributes to
nonattainment or interferes with maintenance of a NAAQS in another
State. 42 U.S.C. 7411(a)(2)(D). Although Title I, Part D of the Act
does not contain similar language, section 184 is within Title I, Part
D of the Act. Section 184 contains specific provisions to address
interstate transport of ozone and its precursors within the Ozone
Transport Region (OTR) (which includes both New Jersey and Stafford
County). This comment, however, is not relevant to the present action
because EPA is not taking action here to determine whether Virginia has
satisfied the requirements of CAA sections 110(a)(2)(D) or 184. EPA has
never interpreted the RACT provisions in section 172(c)(1) or 182(b)(2)
as requiring States to address interstate transport issues. Indeed, EPA
has expressly stated in the Phase 2 Rule that we ``believe [] that
section 172(c) is not the appropriate section of the CAA to address the
transport of ozone and ozone precursors * * *'' 70 FR at 71653. We
believe, based on the forgoing, that the section 182(b)(2) RACT
requirements also are not intended as a mechanism for addressing
interstate transport of pollutants.

IV. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) That are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. * * *'' The opinion
concludes that ``[r]egarding (10.1-1198, therefore, documents or other
information needed for civil or criminal enforcement under one of these
programs could not be privileged because such documents and information
are essential to pursuing enforcement in a manner required by Federal
law to maintain program delegation, authorization or approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at

any time invoke its authority under the CAA, including, for example,
sections 113, 167, 205, 211 or 213, to enforce the requirements or
prohibitions of the state plan, independently of any state enforcement
effort. In addition, citizen enforcement under section 304 of the CAA
is likewise unaffected by this, or any, state audit privilege or
immunity law.

IV. Final Action

    EPA is approving the SIP revision submitted to EPA by the
Commonwealth of Virginia on April 21, 2008. This SIP revision contains
the requirements of RACT set forth by the CAA under the 8-hour ozone
NAAQS.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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 action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 20, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action.
    This action, pertaining to the Stafford County RACT under the 8-
hour ozone NAAQS, may not be challenged later in proceedings to enforce
its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: December 11, 2008.
Donald S. Welsh,
Regional Administrator, Region III.

0
40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

     Authority: 42 U.S.C. 7401 et seq.

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (e) is amended by adding
the entry for RACT under the 8-hour ozone NAAQS-Stafford County at the
end of the table to read as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
    Name of non-regulatory SIP          Applicable           State                                Additional
             revision                geographic area    submittal date   EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
RACT under the 8-Hour NAAQS......  Stafford County....       4/21/2008  [Insert Federal
                                                                         Register page
                                                                         number where the
                                                                         document begins
                                                                         and date].
----------------------------------------------------------------------------------------------------------------

 [FR Doc. E8-30212 Filed 12-19-08; 8:45 am]

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