[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Rules and Regulations]
[Pages 33458-33465]
[FR Doc No: 2014-13233]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0411; FRL-9910-52]

Spirodiclofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends a tolerance for residues of
spirodiclofen in or on citrus, oil. Bayer CropScience requested this
tolerance amendment under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective June 11, 2014. Objections and
requests for hearings must be received on or before August 11, 2014,
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-2013-0411, 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: Lois Rossi, 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-2013-0411 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
August 11, 2014. 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-2013-0411, 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 February 4, 2010 (75 FR 5790) (FRL-8807-
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
9E7632) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.608 be amended by
establishing tolerances for residues of the insecticide spirodiclofen,
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-
dimethylbutanoate), in or on bushberry subgroup 13-07B at 4.0 parts per
million (ppm). The petition additionally requested to revise the
tolerance expression under paragraphs (a)(1) and (a)(2) to read as
follows: ``(a)(1). Tolerances are established for residues of the
insecticide spirodiclofen, including its metabolites and degradates.
Compliance with the tolerance levels specified is to be determined by
measuring only spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate)''; and ``(a)(2).
Tolerances are established for residues of the insecticide
spirodiclofen, including its metabolites and degradates. Compliance
with the tolerance levels specified is to be determined by measuring
only the sum of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate) and its metabolite,
3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one,
calculated

as the stoichiometric equivalent of spirodiclofen.'' That notice
referenced a summary of the petition prepared on behalf of IR-4 by
Bayer CropScience, the registrant, which is available in the docket,
http://www.regulations.gov.
    In the Federal Register of March 29, 2011 (76 FR 17374) (FRL-8867-
4), 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
0E7820) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.608 be amended by establishing
tolerances for residues of the insecticide spirodiclofen, (3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate), in or on sugar apple, cherimoya, atemoya, custard
apple, ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu,
starfruit, passionfruit, persimmon and acerola at 0.45 ppm; and lychee,
longan, Spanish lime, rambutan and pulasan at 3.5 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by
Bayer CropScience, the registrant, which is available in the docket,
http://www.regulations.gov.
    Finally, in the Federal Register of July 19, 2013 (78 FR 43115)
(FRL-9392-9), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 3F8152) by Bayer CropScience, 2 TW Alexander Dr., Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.608 be
amended by amending the established tolerance for residues of the
insecticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on citrus, oil
from 20 ppm to 35 ppm. That document referenced a summary of the
petition prepared by Bayer CropScience, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    IR-4 has since withdrawn PPs 9E7632 and 0E7820 due to
unresolved labeling issues regarding pollinators. However, the EPA has
determined that the proposed changes to the tolerance expression under
the notice for PP 9E7632 are appropriate. Additionally, EPA is
relying upon the risk assessments supporting those actions in order to
amend the citrus, oil tolerance, since the higher citrus, oil level was
considered in these assessments. Therefore, risk estimates
characterized in the underlying assessments for those actions are
considered overestimations of risk, because the uses associated with
PPs 9E7632 and 0E7820 have since been withdrawn; however,
those assessments will support the amended citrus, oil tolerance.

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 spirodiclofen including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spirodiclofen
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.
    Spirodiclofen has a low acute toxicity via the oral, dermal and
inhalation routes. It is not an eye or dermal irritant; however, it is
a potential skin sensitizer. Following repeated exposures, the primary
target organs identified are the adrenal glands in both sexes and
testes in males. Increased cytoplasmic vacuolation in the Zona
fasciculate of the adrenal cortex was observed in several subchronic
and chronic studies in rats, mice and dogs of both sexes. Female rats
and dogs appeared to be the more sensitive to adrenal effects, with the
dog as the most sensitive species. The effects on the adrenal glands
generally coincided with increased adrenal weight. Other organs with
histopathology findings reported in male dogs included the testes
(vacuolation and hypertrophy/activation of Leydig cells), epididymis
(degeneration and/or immaturity of germinal epithelium, oligo- and
aspermia), prostate (immaturity signs), and thymus (atrophy). Increased
liver weights were also reported in male dogs along with decreases in
prostate weights.
    The effects reported in chronic dog studies were similar to
subchronic studies and occurred at lower administered oral doses of
spirodiclofen. As with subchronic studies, histopathology of the
adrenal gland revealed an increased incidence of cortical vacuolation
in the Zona fasciculata of both sexes. In the testes, increased
incidences of Leydig cell vacuolation, slight Leydig cell hypertrophy,
and tubular degeneration were observed in males. Other effects reported
in chronic studies included decreases in cholesterol and triglycerides,
decreased body weights and body-weight gains, increased APh levels and
increased vacuolated jejunum enterocytes in rats, and increased
incidences of Leydig cell hyperplasia in rats and mice.
    There was no evidence of developmental toxicity in the rabbit
developmental toxicity study. The rat developmental toxicity study
resulted in developmental toxicity (an increased incidence of slight
dilatation of the renal pelvis) at the highest dose tested; a dose
which did not cause maternal toxicity. In the 2-generation reproductive
toxicity study in rats, developmental effects were observed in
F1 males (delayed sexual maturation, decreased testicular
spermatid and epididymal sperm counts/oligospermia; and atrophy of the
testes, epididymides, prostate, and seminal vesicles) and F1
females (increased severity of ovarian luteal cell vacuolation/
degeneration), but at a higher dose than the systemic effects seen for
parents and offspring.
    There was no evidence of neurotoxicity in the acute and subchronic
neurotoxicity studies for spirodiclofen. In a developmental
neurotoxicity (DNT) study, a decrease in retention was observed in the
memory phase of the water maze for postnatal day 60 female offspring at
all doses. In this DNT study, the morphometric measurements were not
performed at the low- and mid-dose; therefore,

another DNT study was conducted using identical experimental conditions
as the previous study. The results of the second DNT study demonstrated
no treatment-related neurotoxicity, but the two DNT studies for
spirodiclofen suggest increased susceptibility of offspring. An
acceptable immunotoxicity study, which was reviewed by the EPA after
the risk assessment was finalized, showed no treatment related systemic
or immunotoxic related effects up to the highest dose tested.
    Chronic toxicity and carcinogenicity studies showed an increased
incidence of uterine adenocarcinoma in female rats, Leydig cell adenoma
in male rats, and liver tumors in mice. The EPA has classified
spirodiclofen as ``likely to be carcinogenic to humans'' by the oral
route based on evidence of Leydig cell adenomas in male rat testes,
uterine adenomas and/or adenocarcinoma in female rats, and liver tumors
in mice. Results of genotoxicity testing were negative.
    Specific information on the studies received and the nature of the
adverse effects caused by spirodiclofen 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 in the document,
``Spirodiclofen. Human-Health Risk Assessment for Proposed Uses in/on
Sugar Apple, Cherimoya, Atemoya, Custard Apple, Ilama, Soursop, Biriba,
Lychee, Longan, Spanish Lime, Rambutan, Pulasan, Guava, Feijoa,
Jaboticaba, Wax Jambu, Starfruit, Passionfruit, Persimmon, and
Acerola.'' At pages 28-30 in docket ID number EPA-HQ-OPP-2013-0411.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spirodiclofen used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Spirodiclofen 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
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations,      An appropriate endpoint attributable to a single dose was not identified.
 including infants and children).             Therefore, an acute dietary assessment was not performed.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 1.38 mg/kg/    Chronic RfD = 0.014  Chronic Oral Toxicity Study in
                                    day.                  mg/kg/day.           Dogs
                                   UFA = 10x...........  cPAD = 0.014 mg/kg/  LOAEL = 4.7 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased relative adrenal
                                   FQPA SF = 1x........                        weights in both sexes, increased
                                                                               relative testis weights in males
                                                                               and histopathology findings in
                                                                               adrenal glands of both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)   Classification: ``Likely to be Carcinogenic to Humans''; Q1* (mg/kg/day)-1 =
                                                                    1.49 x 10-2.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. mg/kg/day = milligram/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spirodiclofen, EPA considered exposure under the
petitioned-for tolerances as well as all existing spirodiclofen
tolerances in 40 CFR 180.608. EPA assessed dietary exposures from
spirodiclofen 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 spirodiclofen; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA utilized average field trial residues;
experimentally determined processing factors for citrus fruit, pome
fruit and grape; and Dietary Exposure Evaluation Model (DEEM (ver
7.81)) default processing factors for the remaining processed
commodities. The assessment also utilized percent crop treated for new
uses (PCTn) on hops and blueberry, and percent crop treated (PCT)
estimates for several other registered commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, Cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode

of action is available, a threshold or nonlinear approach is used and a
cancer RfD is calculated based on an earlier noncancer key event. If
carcinogenic mode of action data are not available, or if the mode of
action data determines a mutagenic mode of action, a default linear
cancer slope factor approach is utilized. Based on the data summarized
in Unit III.A., EPA has concluded that spirodiclofen should be
classified as ``Likely to be Carcinogenic to Humans'' and a linear
approach has been used to quantify cancer risk. Cancer risk was
quantified using the same food residue estimates as discussed in Unit
III.C.1.ii.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: Almond,
5%; apple, 5%; apricot, 5%; cherry, 2%; grapefruit, 50%; grape, raisin,
10%; grape, table, 30%; grape, wine, 5%; hazelnuts, 2%; lemon, 1%;
nectarine, 10%; orange, 10%; peach, 5%; pear, 10%; pecan, 2%;
pistachio, 1%; plum/prune, 5%; and walnut, 5%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (USDA/NASS), proprietary market
surveys, and the National Pesticide Use Database for the chemical/crop
combination for the most recent 6-7 years. EPA uses an average PCT for
chronic dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than one. In those cases, 1% is used as the average PCT and 2.5%
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the highest observed maximum
value reported within the recent 6 years of available public and
private market survey data for the existing use and rounded up to the
nearest multiple of 5%.
    The Agency estimated the PCT for new uses as follows: Blueberry,
2%; and hops, 92%.
    In the Federal Register of May 7, 2008 (73 FR 25533) (FRL-8362-2),
the Agency estimated the PCT for the proposed use of spirodiclofen on
hops to be 92%. Since spirodiclofen has only been registered on hops
since 2008, EPA relied on the previously estimated PCT for hops.
    The EPA estimate of the percent PCT for these new uses of
spirodiclofen represents the upper bound of use expected during the
pesticide's initial five years of registration; that is, the PCT for
spirodiclofen is a threshold of use that EPA is reasonably certain will
not be exceeded for this registered use site. The PCT recommended for
use in the chronic dietary assessment is calculated as the average PCT
of the miticide with the highest usage (i.e., the miticides with the
greatest PCT) on that crop over the three most recent years of
available data. The PCT recommended for use in the chronic dietary
assessment is 2% for blueberries and 92% for hops. Comparisons are only
made among pesticides of the same pesticide type (i.e., the miticide
with the highest usage on the use crop is selected for comparison with
a new miticide). The highest miticide PCT included in the estimation
may not be the same for each year since different miticides may have
the highest usage in different years.
    Typically, EPA uses USDA/NASS surveys as the source data because
they are publicly available and directly report values for PCT. When a
specific use crop is not reported by USDA/NASS, EPA uses proprietary
data and calculates the PCT based on reported data on acres treated and
acres grown. If no proprietary data are available, EPA may extrapolate
PCT for new uses from other crops if the production area and pest
spectrum are substantially similar.
    A retrospective analysis to validate this approach shows few cases
where the PCT for the highest miticides were exceeded (EPA, 2006).
Further review of these cases identified factors contributing to the
exceptionally high use of a new pesticide. To evaluate whether the PCT
for spirodiclofen could be exceeded, EPA considered whether or not
there may be unusually high pest pressure, as indicated in emergency
exemption requests for spirodiclofen, the pest spectrum of the new
pesticide in comparison with the highest miticides, whether or not the
highest miticides are well-established for that use and whether or not
pest resistance issues with past miticides provide spirodiclofen with
significant market potential. Given currently available information,
the Agency concludes that it is unlikely that actual PCT for
spirodiclofen will exceed the estimated PCT for new uses during the
next five years.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, 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 b and c, 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 reliable information on the regional consumption of
food to which spirodiclofen may be applied in a particular area.
    2. Dietary exposure from drinking water. EPA concluded that the
residues of concern in drinking water for purposes of risk assessment
are spirodiclofen and its three metabolites

(BAJ 2510, BAJ 2740-dihydroxy, and BAJ 2740-ketohydroxy). Therefore,
the Agency used screening level water exposure models in the dietary
exposure analysis and risk assessment for spirodiclofen and its
metabolites in drinking water. These simulation models take into
account data on the physical, chemical, and fate/transport
characteristics of spirodiclofen and its metabolites. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
spirodiclofen and its metabolites for chronic exposures for non-cancer
assessments are estimated to be 4.99 parts per billion (ppb) for
surface water and 0.44 ppb for ground water. The EDWCs for chronic
exposures for cancer assessments are estimated to be 1.67 ppb for
surface water and 0.44 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 4.99 ppb was used to
assess the contribution to drinking water. For cancer dietary risk
assessment, the water concentration of value 1.67 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). Spirodiclofen is not
registered for any specific use patterns that would result in
residential exposure.
    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
spirodiclofen to share a common mechanism of toxicity with any other
substances, and spirodiclofen does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that spirodiclofen does
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://www.epa.gov/pesticides/cumulative.

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 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. The spirodiclofen toxicity
database is adequate to evaluate the potential increased susceptibility
of infants and children, and includes developmental toxicity studies in
rat and rabbit, a 2-generation toxicity study in rat, and two rat DNT
studies. There is no evidence of increased susceptibility in the rabbit
developmental toxicity study or in the 2-generation rat reproductive
toxicity study following in utero/pre- and postnatal exposures of
spirodiclofen. However, evidence for quantitative susceptibility was
observed in a rat developmental toxicity study, where an increased
incidence of slight dilatation of the renal pelvis was observed at the
highest dose tested (1,000 mg/kg/day) in the absence of maternal
toxicity. Additionally, two rat DNT studies are available. The first
study demonstrated increased quantitative susceptibility of offspring
based on the observed decreased retention in the memory phase of the
water maze for postnatal day 60 female offspring at all doses and
changes in brain morphometric parameters at the highest dose tested of
135.9 mg/kg/day (including caudate putamen, parietal cortex,
hippocampal gyrus, and dentate gyrus); there was no maternal toxicity
noted at any dose. EPA requested information concerning the brain
morphometric parameters in the low- and mid doses with the petitioner
indicating that the brain tissues were not appropriately preserved and
analysis was therefore not possible. As a result, a second rat DNT
study was submitted which also indicated increased susceptibility in
offspring based on decreased pre-weaning body weight and body weight
gain in males and females and decreased post-weaning body weights in
males. The second rat DNT demonstrated no treatment-related
neurotoxicity in the offspring.
    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 spirodiclofen is complete. Changes to
40 CFR Part 158 require immunotoxicity testing (OPPTS Guideline
870.7800) for pesticide registration. At the time of the last completed
risk assessment for spirodiclofen, which was finalized on November 11,
2011, an immunotoxicity study was a data gap in the toxicity database.
However, since the time of the risk assessment, EPA has received and
reviewed an acceptable immunotoxicity study for spirodiclofen. Upon
review of the study, the Agency has determined that there is no
treatment related systemic or immunotoxic related effects. Therefore,
the immunotoxicity study does not impact the findings of the 2011 risk
assessment. Additionally, EPA has determined a subchronic inhalation
toxicity study is not required for spirodiclofen at this time. This
approach considered all of the available hazard and exposure
information for spirodiclofen, including: (1) Its low acute inhalation
toxicity; (2) the lowest short- and intermediate-term MOEs calculated
using an oral POD are 6,200 and 1,000 respectively; and (3) its
physical and chemical properties, including its low volatility.
Therefore, an additional UF is not needed to account for the lack of
this study.
    ii. Two DNT studies have been submitted and reviewed by the EPA.
The Agency has determined that there is no concern for the increased
quantitative susceptibility seen in the first DNT study because the
results were not reproduced in the second DNT study conducted using
identical doses and experimental conditions. The second DNT provided no
evidence of neurotoxicity, and concern for the increased quantitative
susceptibility (slight changes in body weights) noted in this study is
low because there is a well-established NOAEL, only marginal
developmental toxicity was noted, and all developmental/functional
parameters were comparable to controls. In addition, doses selected for
risk assessment of spirodiclofen are much lower than the dose where the
effects in

the second DNT were noted. Finally, there was no evidence of
neurotoxicity or neuropathology in the acute and subchronic
neurotoxicity studies. Therefore, there is no need for an additional UF
to account for neurotoxicity. Additional information about the two DNT
studies can be found at http://www.regulations.gov in the Federal
Register of May 7, 2008 (http://www.epa.gov/fedrgstr/EPA-PEST/2008/May/Day-07/p9826.htm).
    iii. Quantitative susceptibility was noted in the developmental
toxicity study in rats. However, EPA determined that the degree of
concern is low for the noted effects because the increased incidence of
slight renal pelvic dilation was observed only at the highest dose
tested, in the absence of statistical significance and dose response.
Additionally, renal pelvic dilation was considered to be a
developmental delay and not a severe effect for developmental toxicity.
The low background incidences in this study may also be idiosyncratic
to this strain (Wistar) of rats since renal pelvic dilations are
commonly seen at higher incidences in other strains (Sprague-Dawley or
Fisher) of rats. Furthermore, there is a well-established NOAEL at
which all developmental/functional parameters were comparable to
controls, and lower doses are being used for the risk assessment of
spirodiclofen. As noted above, concern is low for the increased
quantitative susceptibility noted in offspring in the DNT studies.
There was no evidence of increased susceptibility in the developmental
toxicity study in rabbits or the 2-generation reproduction study in
rats. Therefore, there are no residual concerns regarding developmental
effects in the young.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic and cancer dietary exposure assessments were
refined, utilizing average field trial residues; experimentally
determined processing factors for citrus fruit, pome fruit, and grape;
and DEEM (ver. 7.81) default processing factors for the remaining
processed commodities. The assessment also included PCTn estimates for
hops and blueberry and PCT data for several additional registered
commodities. EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
spirodiclofen and its metabolites in drinking water. These assessments
will not underestimate the exposure and risks posed by spirodiclofen.

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,
spirodiclofen is 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
spirodiclofen from food and water will utilize 3.2% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for spirodiclofen.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). A short- and
intermediate-term adverse effect was identified; however, spirodiclofen
is not registered for any use patterns that would result in short- or
intermediate-term residential exposure. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposure plus chronic dietary exposure. Because there are no short- or
intermediate-term residential exposures and chronic dietary exposure
has already been assessed under the appropriately protective cPAD
(which is at least as protective as the POD used to assess short- and
intermediate-term risk), no further assessment of short- or
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for spirodiclofen.
    4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in Unit III.C.1.iii., EPA has concluded the
cancer risk from food and water for all existing and proposed
spirodiclofen uses will result in a lifetime cancer risk of 3 x
10-6. EPA generally considers cancer risks in the range of
10-6 or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the log scale; for example,
risks falling between 3 x 10-7 and 3 x 10-6 are
expressed as risks in the range of 10-6. Considering the
precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above in this unit, cancer risk should generally
not be assumed to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment.
    For the following reasons, EPA concludes that there are
conservatisms in the spirodiclofen exposure assessment. Based on a
critical commodity analysis conducted in DEEM-Food Commodity Intake
Database (DEEM-FCID)TM, the major contributors to the cancer
risk were hops (44% of the total exposure) and water (21% of the total
exposure). EPA notes the following conservative assumptions, which were
incorporated into the cancer analysis for hops and water:
    i. Hops. DEEM-FCIDTM assumes that 100% of the residues
in hops are transferred to beer during the brewing process (no residues
remain in/on the spent hops). Since spirodiclofen has low water
solubility, this is a conservative assumption. Additionally, the
assessment assumed a PCT estimate of 92% for hops; PCT estimates for
new uses are designed to provide a conservative estimate of the actual
PCT estimates; and
    ii. Drinking water. The water residue estimate assumed 87% of the
basin is cropped with 100% of the crops treated at the maximum labeled
rate.
    Therefore, EPA concludes that the cancer risk estimate provided in
this assessment is conservative and actual cancer risk will be lower
than the estimate provided in this document.
    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 spirodiclofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a liquid chromatography/mass
spectrometry/mass spectrometry (LC/

MS/MS) method, is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for spirodiclofen in or on
citrus oil.

V. Conclusion

    Therefore, a tolerance for residues of spirodiclofen, 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate, in or on citrus, oil is amended from 20 ppm to 35
ppm. Additionally, the tolerance expression is amended for
spirodiclofen in order to clarify (1) that, as provided in FFDCA
section 408(a)(3), the tolerance covers metabolites and degradates of
spirodiclofen not specifically mentioned; and (2) that compliance with
the specified tolerance levels is to be determined by measuring only
spirodiclofen.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 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 FFDCA section 408(d), 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 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 final rule. In addition,
this final 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) (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 of 1995 (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: June 2, 2014.
Lois Rossi,
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. Section 180.608 is amended by:
0
a. Revising the introductory text of paragraphs (a)(1) and (a)(2); and
0
b. Revising the commodity ``Citrus, oil'' in the table in paragraph
(a)(1) to read as follows:

Sec.  180.608  Spirodiclofen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
spirodiclofen, including its metabolites and degradates, in or on the
commodities listed below. Compliance with the following tolerance
levels is to be determined by measuring only spirodiclofen (3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate).

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

                                * * * * *
Citrus, oil...............................  35

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

    (2) Tolerances are established for residues of spirodiclofen,
including its metabolites and degradates, in or on the commodities
listed below. Compliance with the following tolerance levels is to be
determined by measuring only spirodiclofen (3-(2,4-dichlorophenyl)-2-
oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) and its
metabolite 3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5] dec-3-en-2-
one, calculated

as the stoichiometric equivalent of spirodiclofen.
* * * * *
[FR Doc. 2014-13233 Filed 6-10-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 11, 2009 (Volume 74, Number 111)]
[Notices]
[Page 27856-27858]
[DOCID:fr11jn09-114]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60048; File No. SR-CBOE-2009-035]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Temporary Membership Status and Interim Trading
Permit Access Fees

June 4, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on May 29, 2009, the Chicago
Board Options Exchange, Incorporated (``CBOE'' or the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the CBOE. The Commission is publishing this
notice to

solicit comments on the proposed rule change from interested parties.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to adjust (i) the monthly access fee for persons
granted temporary CBOE membership status (``Temporary Members'')
pursuant to Interpretation and Policy .02 under CBOE Rule 3.19 (``Rule
3.19.02'') and (ii) the monthly access fee for Interim Trading Permit
(``ITP'') holders under CBOE Rule 3.27. The text of the proposed rule
change is available on the Exchange's Web site (http://www.cboe.org/
Legal/), at the Exchange's Office of the Secretary, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, CBOE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The CBOE has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The current access fee for Temporary Members under Rule 3.19.02 \2\
and the current access fee for ITP holders under Rule 3.27 \3\ are both
$9,014 per month. Both access fees are currently set at the indicative
lease rate (as defined below) for May 2009. The Exchange proposes to
adjust both access fees effective at the beginning of June 2009 to be
equal to the indicative lease rate for June 2009 (which is $10,171).
Specifically, the Exchange proposes to revise both the Temporary Member
access fee and the ITP access fee to be $10,171 per month commencing on
June 1, 2009.
---------------------------------------------------------------------------

    \2\ See Securities Exchange Act Release No. 56458 (September 18,
2007), 72 FR 54309 (September 24, 2007) (SR-CBOE-2007-107) for a
description of the Temporary Membership status under Rule 3.19.02.
    \3\ See Securities Exchange Act Release No. 58178 (July 17,
2008), 73 FR 42634 (July 22, 2008) (SR-CBOE-2008-40) for a
description of the Interim Trading Permits under Rule 3.27.
---------------------------------------------------------------------------

    The indicative lease rate is defined under Rule 3.27(b) as the
highest clearing firm floating monthly rate \4\ of the CBOE Clearing
Members that assist in facilitating at least 10% of the CBOE
transferable membership leases.\5\ The Exchange determined the
indicative lease rate for June 2009 by polling each of these Clearing
Members and obtaining the clearing firm floating monthly rate
designated by each of these Clearing Members for that month.
---------------------------------------------------------------------------

    \4\ Rule 3.27(b) defines the clearing firm floating monthly rate
as the floating monthly rate that a Clearing Member designates, in
connection with transferable membership leases that the Clearing
Member assisted in facilitating, for leases that utilize that
monthly rate.
    \5\ The concepts of an indicative lease rate and of a clearing
firm floating month rate were previously utilized in the CBOE rule
filings that set and adjusted the Temporary Member access fee. Both
concepts are also codified in Rule 3.27(b) in relation to ITPs.
---------------------------------------------------------------------------

    The Exchange used the same process to set the proposed Temporary
Member and ITP access fees that it used to set the current Temporary
Member and ITP access fees. The only difference is that the Exchange
used clearing firm floating monthly rate information for the month of
June 2009 to set the proposed access fees (instead of clearing firm
floating monthly rate information for the month of May 2009 as was used
to set the current access fees) in order to take into account changes
in clearing firm floating monthly rates for the month of June 2009.
    The Exchange believes that the process used to set the proposed
Temporary Member access fee and the proposed Temporary Member access
fee itself are appropriate for the same reasons set forth in CBOE rule
filing SR-CBOE-2008-12 with respect to the original Temporary Member
access fee.\6\ Similarly, the Exchange believes that the process used
to set the proposed ITP access fee and the proposed ITP access fee
itself are appropriate for the same reasons set forth in CBOE rule
filing SR-CBOE-2008-77 with respect to the original ITP access fee.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 57293 (February 8,
2008), 73 FR 8729 (February 14, 2008) (SR-CBOE-2008-12), which
established the original Temporary Member access fee, for detail
regarding the rationale in support of the original Temporary Member
access fee and the process used to set that fee, which is also
applicable to this proposed change to the Temporary Member access
fee as well.
    \7\ See Securities Exchange Act Release No. 58200 (July 21,
2008), 73 FR 43805 (July 28, 2008) (SR-CBOE-2008-77), which
established the original ITP access fee, for detail regarding the
rationale in support of the original ITP access fee and the process
used to set that fee, which is also applicable to this proposed
change to the ITP access fee as well.
---------------------------------------------------------------------------

    Each of the proposed access fees will remain in effect until such
time either that the Exchange submits a further rule filing pursuant to
Section 19(b)(3)(A)(ii) of the Act \8\ to modify the applicable access
fee or the applicable status (i.e., the Temporary Membership status or
the ITP status) is terminated. Accordingly, the Exchange may, and
likely will, further adjust the proposed access fees in the future if
the Exchange determines that it would be appropriate to do so taking
into consideration lease rates for transferable CBOE memberships
prevailing at that time.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    The procedural provisions of the CBOE Fee Schedule related to the
assessment of each proposed access fee are not proposed to be changed
and will remain the same as the current procedural provisions relating
to the assessment of that access fee.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and furthers the
objectives of Section 6(b)(4) of the Act,\10\ in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among persons using its facilities.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing rule change establishes or changes a due,
fee, or other charge imposed by the Exchange, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and subparagraph (f)(2)
of Rule 19b-4 \12\ thereunder. At any time within 60 days of the filing
of the proposed rule change, the Commission may summarily abrogate such
rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors,

or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-035 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2009-035. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-CBOE-2009-035 and should be
submitted on or before July 2, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-13722 Filed 6-10-09; 8:45 am]

BILLING CODE 8010-01-P


                                 Docket Index
Notice of Proposed Rulemaking  -  Findings of Failure to Attain the 1997 PM2.5 Standards; California; San Joaquin Valley (Docket No. EPA-R09-OAR-2016-0494)

A.  Rulemaking Documents
 Findings of Failure to Attain the 1997 PM2.5 Standards; California; San Joaquin Valley, proposed rule, prepublication version, signed September 23, 2016.
 81 FR 69448, Findings of Failure to Attain the 1997 PM2.5 Standards; California; San Joaquin Valley, proposed rule, proposed rule (October 6, 2016).
 Federal Register Notices and EPA Guidance Documents
 52 FR 24634, Revisions to the National Ambient Air Quality Standards for Particulate Matter, final rule (July 1, 1987).

 62 FR 38652, National Ambient Air Quality Standards for Particulate Matter, final rule (July 18, 1997).

 70 FR 944, Air Quality Designations and Classifications for the Fine Particles (PM2.5) National Ambient Air Quality Standards, final rule (January 5, 2005).

 71 FR 61144, National Ambient Air Quality Standards for Particulate Matter, final rule (October 17, 2006).

 76 FR 69896, Approval and Promulgation of Implementation Plans; California; 2008 San Joaquin Valley PM2.5 Plan and 2007 State Strategy, final rule (November 9, 2011).

 78 FR 3086, National Ambient Air Quality Standards for Particulate Matter, final rule (January 15, 2013).

 79 FR 31566, Identification of Nonattainment Classification and Deadlines for Submission of State Implementation Plan (SIP) Provisions for the 1997 Fine Particle (PM2.5) National Ambient Air Quality Standard (NAAQS) and 2006 PM2.5 NAAQS, final rule (June 2, 2014).

 80 FR 1482, Designation of Areas for Air Quality Planning Purposes; California; San Joaquin Valley; Reclassification as Serious Nonattainment for the 1997 PM2.5 Standards, proposed rule (January 12, 2015).

 80 FR 15340, Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements, proposed rule (March 23, 2015).

 80 FR 18528, Designation of Areas for Air Quality Planning Purposes; California; San Joaquin Valley; Reclassification as Serious Nonattainment for the 1997 PM2.5 Standards, final rule (April 7, 2015).

 81 FR 6936, Approval and Disapproval of California Air Plan; San Joaquin Valley Serious Area Plan and Attainment Date Extension for the 1997 PM2.5 NAAQS, proposed rule (February 9, 2016).

 81 FR 58010, Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements, final rule (August 24, 2016).
C. Correspondence
 Letter from Deborah Jordan, Director, Air Division, EPA Region IX, to James Goldstene, Executive Officer, CARB, transmitting findings of technical systems audit, dated October 22, 2012.
 Letter from Meredith Kurpius, Manager, EPA Region 9, Air Quality Analysis Office, to Sheraz Gill, Director of Strategies and Incentives, SJVUAPCD, dated December 28, 2015.
 Letter from Jon Klassen, Program Manager, SJVUAPCD, to Deborah Jordan, Director, Air Division, EPA Region 9, certifying calendar year 2015 ambient air quality data and quality assurance data, dated May 9, 2016.
 Letter from Ravi Ramalingam, Chief, Consumer Products and Air Quality Assessment Branch, CARB, to Elizabeth Adams, Acting Director, Air Division, EPA Region 9, certifying calendar year 2015 ambient air quality data and quality assurance data, dated May 10, 2016.
D. Other Documents
 EPA maintains a list of designated FRMs and FEMs on the web at: http://www.epa.gov/ttn/amtic/criteria.html.
 EPA, Air Quality Criteria for Particulate Matter, No. EPA/600/P - 99/002aF, October 2004.
 EPA, Air Quality Criteria for Particulate Matter, No. EPA/600/P - 99/002bF, October 2004
 Natural Resources Defense Council v. EPA, 706 F.3d 428 (D.C. Cir. 2013).
 CARB, The California Almanac of Emissions and Air Quality, Chapter 4: Regional Trends and Forecasts, 2013 Edition.
 EPA, design value workbook, worksheets "Table 3a" and "Table 3b," dated August 28, 2014.
 SJVUAPCD, 2015 Air Monitoring Network Plan, August 28, 2015.
 EPA, fact sheet, "San Joaquin Valley Fine Particulate Matter," June 29, 2016.
 EPA, AQS Design Value Report, Report Request ID: 1463864, July 15, 2016.
 EPA, AQS Design Value Report, Report Request ID: 1463865, July 15, 2016.
 EPA, AQS Raw Data Qualifier Report, Report Request ED: 1464417, July 18, 2016.
 EPA, design value xl workbook, including "Table 5. PM2.5 Site Listing, 2013-2015," dated July 29, 2016.
 Denial of Request for Extension of Attainment Date for 1997 PM2.5 NAAQS; California; San Joaquin Valley Serious Nonattainment Area, final rule, prepublication version, dated September 23, 2016.


[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Proposed Rules]
[Page 45373]
[FR Doc No: 2023-15003]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-1025; Airspace Docket No. 18-AEA-7]
RIN 2120-AA66

Amendment of Area Navigation (RNAV) Route T-299, and
Establishment of T-318 and T-360; Eastern United States

AGENCY: Federal Aviation Administration (FAA) DOT.

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The FAA is withdrawing the NPRM published in the Federal
Register on December 28, 2018, proposing to amend United States Area
Navigation (RNAV) route T-299, and establish T-318 and T-360 in support
of transitioning the National Airspace System (NAS) from ground-based
to satellite-based navigation.

DATES: Effective as of 0901 UTC, July 17, 2023, the proposed rule
published December 28, 2018 (83 FR 67160), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Reason for Withdrawal

    The FAA published a notice of proposed rulemaking in the Federal
Register for Docket No. FAA-2018-1025 (83 FR 67160; December 28, 2018).
The NPRM proposed to amend RNAV route T-299 and establish routes T-318
and T-360 to support the transition of the NAS to satellite-based
navigation. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal. No
comments were received. Subsequent to the NPRM, other airway docket
actions rendered this proposal unnecessary.

Conclusion

    The FAA determined that the NPRM published on December 28, 2018, is
unnecessary. Therefore, the FAA withdraws that NPRM.

    Issued in Washington, DC, on July 11, 2023.
Karen L. Chiodini,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-15003 Filed 7-14-23; 8:45 am]
BILLING CODE 4910-13-P


Reducing Power Plant Emissions:

EPA's New Proposed Rules For Mercury William H. Maxwell Combustion Group U. S. Environmental Protection Agency Office of Air Quality Planning and Standards Research Triangle Park, North Carolina Presentation to the North Carolina DENR/ DAQ Mercury/ CO 2 Workshop April 20, 2004 Raleigh, NC Tuesday, April 20 8: 00: Coffee and Networking 8: 28 NC Specific Mercury Topics and Issues   Session 2  ( Hg 2)   Moderator   Steve Schliesser, Senior Environmental Engineer, NC DAQ ( Question to Be Answered: What Mercury reductions are possible, and what makes sense in NC?)

8: 29 USEPA s Proposed Mercury MACT and Alternate Proposals for Mercury Reduction Trading Options  A Summary of Options and Schedule for Comments and Final Regulations: Bill Maxwell/ Bob Wayland, USEPA ( subject to daily developments)

9: 15 Performance and Costs of Mercury Control Technology for Bituminous Coals   Dr. Michael Durham, President, ADA Environmental Solutions 9: 44 BREAK 10: 00/ Achieving CSA System wide Reductions in ( NOx & SO2) Emissions at Duke Energy Facilities and Reactions to Achieving EPA s MACT/ Trading Proposals for Mercury ( Including limited comments on options for new technologies, etc.)   Robert A McMurry, Duke Energy 10: 35 Achieving CSA System wide Reductions in ( NOx & SO2) Emissions at Progress Energy Facilities and Reactions to Achieving EPA s MACT/ Trading Proposals for Mercury   Ben White, Progress Energy 11: 05 Estimated Emission Reductions in NC from Co control as a Result of CSA, Using EPA Tool to Estimate NC Coal Fired Power Plant Mercury Emissions   Paul Grable & Steve Schliesser, Environmental Engineers, NC DAQ 11: 25 Developing Policy Options That Can Result in Integration of CO2 and Mercury Reductions and State Implementation Plan Credits; Alden Hathaway, Environmental Resources Trust, Inc. Washington, DC North Carolina Department of Environment and Natural Resources, Division of Air Quality Mercury/ CO2 Workshop Held at the Jane S. McKimmon Center,

North Carolina State University,

Raleigh, North Carolina April 19   21, 2004 EPA Proposes to Reduce Utility Emissions through Current CAA Authorities

° Interstate Air Quality Rule ( IAQR) to address the contribution of transported SO2/ NOx emissions to ozone ( smog) and fine particle ( PM2.5) nonattainment problems in the Eastern U. S.

° Standards to Reduce Mercury Emissions and Deposition   Section 112 standards ° Maximum achievable control technology ( MACT)

° Command and control ° Take comment on trading options   State implemented section 111 standards ° Emissions Guidelines and New Source Performance Standards ° Market based, cap and trade program Coal Fired Power Plants   There are about 530 power plants with 305 GW of capacity that consist of about 1,300 units, of which 1,150 would be covered.

  Coal plants generate the vast majority of power sector emissions:

 100% Hg  95% SO 2  90% of NOx  83% of CO 2 EPA uses the Integrated Planning Model ( IPM) to consider the emissions, costs, and fuel impacts of controlling pollution from these plants and all other fossil fuel fired generating units in the lower 48 States. The Agency adapted this commercial capacity planning tool for application to pollution control strategies. It was used in the WRAP process, by FERC for restructuring issues, by environmental groups, and power companies. Power Generation Is a Major Source of Emissions 2000 Sulfur Dioxide 2000 Nitrogen Oxides * Other stationary combustion includes residential and commercial sources.

1999 Mercury Fuel Combustionelectric utilities Other stationary combustion * Industrial Processing Transportation Miscellaneous Utilities ( 63%)

Utilities ( 40%) Utilities ( 22%)   Nitrogen Oxides ( NO x) contribute to the formation of both particulate matter ( PM) and ground level ozone.

  Sulfur Dioxide ( SO 2) contributes to particulate matter.

  Ozone and PM have been linked with premature death,

serious illnesses such as chronic bronchitis and heart attacks, and respiratory illnesses such asthma exacerbations.

  NO x and SO 2 are also linked with acid rain, eutrophication of water bodies including estuaries such as the Chesapeake Bay, and regional haze.

  Mercury has been linked to potential reproductive, immune and nervous system effects, with special concerns for pregnant women and young children.

Pollutants and Concerns Mercury Contamination in Fish   Currently 44 states have issue fish consumption advisories for some or all of their waters due to contamination from mercury.*

States with Fish Advisories Due to Mercury * Note: For more information about the relationship between fish advisories and human exposure to mercury, see the EPA Report   America's Children and the Environment: Measures of Contaminants, Body Burdens, and Illnesses

available at http:// yosemite. epa. gov/ o chp/ ochpweb. nsf/ content/

publications. htm Mercury Advisories by Type Advisories for specific waterbodies only Statewide freshwater advisory only Statewide coastal advisory No mercury advisory Statewide freshwater advisory +

advisories for specific waterbodies Proposal to Reduce Mercury Emissions from the Power Sector Proposed Alternatives to Reduce Mercury Emissions from the Power Sector   3 individual approaches outlined in the January 30,

2004 proposal   Propose traditional, command and control section 112 MACT requirements for utility units   Reduces mercury emissions from 48 to 34 tons by January 2008   Propose cap and trade approach under guidelines outlined in section 112( n)( 1)( A)

  Propose market based, cap and trade approach under section 111   Revises December 20, 2000 finding that it is   appropriate and necessary  to regulate Utility Units under section 112   Caps mercury emissions at 15 tons in 2018; interim cap for 2010 proposed to encourage early reductions in SO 2 and NO x, generating additional Hg emissions reductions   Final approach to be determined following completion of public hearings and close of public comment period   Final rule signed on/ before December 15, 2004 Section 112 MACT ° Affected source definition   Electric Utility Steam Generating Unit ( Utility Unit)

  Any fossil fuel fired combustion unit of more than 25 MWe that serves a generator that produces electricity for sale   Cogeneration Utility Unit   unit that generates steam and electricity and supplies more than one third of its potential electric output capacity and more than 25 MWe output to any utility power distribution system for sale   Cogeneration is defined as the simultaneous production of power ( electricity) and another form of useful thermal energy ( usually steam or hot water) from a single fuel consuming process   Non Utility Units, not subject to this rule   Any unit that meets the above definition, but combusts natural gas > 98% of the time   Simple and combined cycle turbine units   Industrial boilers Existing Source MACT Limits 4.1 0.38 Coal refuse fired 200 19.0 IGCC 98 9.2 Lignite fired 61 5.8 Subbituminous fired 21 2.0 Bituminous fired Hg ( 10 6 lb/ MWh) 1 Hg ( lb/ TBtu) 1 Subcategory 1   Based on a 12 month rolling average 0.002 210 Oil fired Ni ( lb/ MWh) 2 Ni ( lb/ TBtu) 2 Subcategory 2   Based on a not to exceed annual limit NOTE: Output based standards are referenced to a baseline efficiency ( 32% for existing units). New Source MACT Limits 1.1 Coal refuse fired 20 3 IGCC 62 Lignite fired 20 Subbituminous fired 6.0 Bituminous fired Hg ( 10 6 lb/ MWh) 1 Subcategory 1   Based on a 12 month rolling average 3   Based on a 90% reduction for beyond the floor control 0.0008 Oil Fired Ni ( lb/ MWh) 2 Subcategory 2   Based on a not to exceed annual limit NOTE: Output based standards are referenced to a baseline efficiency ( 35% for new units). Fuel Blending ° Coal Blending   Unit classified by the predominate coal burned during the compliance period   Unit classified by a   weighted emission limit  based on the proportion of energy output ( in Btu) contributed by each coal rank burned during the compliance period ° If non regulated fuels are used ( e. g., petroleum coke, Tire derived Fuel [ TDF], etc.), the compliance calculation would include:

  Energy output ( in Btu) of all fuels   Hg emissions considered would be all measured by the stack monitor   However, the blended emission limitation is based only on the regulated fuels Monitoring and Compliance ° Hg Testing and Monitoring Requirements   12 month rolling average Hg emission level   Options for Hg monitoring ° Continuous Emission Monitors ( CEM)

  Proposed Performance Specification 12A ( PS 12A)

° Carbon Absorption Tube   Proposed Reference Method 324 ° Manual Stack Test   ASTM Method D6784 02 (" Ontario Hydro")

  EPA Reference Method 29 ° Emissions Averaging Provision for Hg   Demonstrate compliance through averaging Hg emissions from multiple ( two or more) affected units located at a common, contiguous facility site   Leads to a single applicable facility wide emission limit ° Ni Testing and Monitoring Requirements   Maximum allowable emission limit; not to be exceeded   Options for Ni monitoring ° EPA Reference Method 29 Section 111 Proposal ° Section 111( b)   New Source Performance Standards ( NSPS)

  Requires EPA to promulgate standards of performance for emissions of air pollutants from new sources   Monitoring and compliance requirements are similar to the section 112 MACT requirements 0.00082 Oil fired 1.11 Coal refuse fired 201 IGCC 621 Lignite fired 201 Subbituminous fired 6.01 Bituminous fired Emission Limit ( 10 6 lb/ MWh)

Subcategory 1   Hg emissions 2   Ni emissions Section 111 Proposal ( continued)

° Section 111( d)   Emission Guidelines ( EG)

  Requires EPA to prescribe regulations that outline a procedure by which each State shall submit plans which create standards of performance for existing sources for which air quality criteria have not been set but for which NSPS have been established   Cap and Trade program reduces the overall amount of emissions by:

° Requiring sources to hold allowances to cover their emissions on a one for one basis ° Limiting overall allowances so that they cannot exceed specified levels ( i. e., the " cap level")

° Reducing the cap to less than the amount of emissions actually emitted, or allowed to be emitted, at the inception of the program ° Allowing for a declining cap over time ° Creating market based incentives for early reductions Section 111 Proposal ( continued)

° Section 111   Regulatory Approach   Primary goal is to reduce Utility Unit Hg emissions from current levels   2018 cap is permanent   Effectively becoming more stringent as more plants are required to keep their collective emissions below 15 tons   Near term interim cap in 2010   Level will reflect the maximum level of Hg reductions achievable through FGD and SCR installations ( for SO 2 and NO x emission reductions) on units covered under the IAQR   Level is not prescribed in current proposal because of uncertainties associated with the ability of these controls to reduce Hg emissions   EPA seeks comment and technical information on the Phase I cap level   EPA believes that a carefully designed   multi pollutant  approach   a program designed to control NO x, SO 2, and Hg at the same time   is the most effective way to reduce emissions from the electric power sector ° Details of section 111 trading program are outlined in a Supplemental Notice of Proposed Rulemaking ( SNPR), which was published on March 16, 2004 SNPR: Hg Program Requirements Under Section 111   Each State must submit a plan that demonstrates it will meet its assigned statewide Hg emissions budget   States may join the trading program by adopting or referencing the model trading rule in State regulations; or, adopting regulations that mirror the necessary components of the model trading rule   States can choose not to join the federal trading program and meet their budget through intra state trading or no trading   States can also choose to implement more stringent Hg emissions requirements   EPA has taken comment on a proposal to promulgate, under section 112( n)( 1)( A), a cap

andtrade program for Hg from coal fired utility units   Trading program would be federally implemented with the EPA, instead of states, serving as the permitting authority SNPR: Monitoring Hg Emissions   Monitoring of Hg will resemble current monitoring of SO 2 and NO x under the Acid Rain and NO x SIP Call programs   A comprehensive QA/ QC program ensures the adequacy of emissions data   Current monitoring in the Acid Rain and NO x SIP Call programs averages over 98% availability   A petition process enables monitoring flexibility and facilitates the resolution of issues   Commensurate with the SO 2 and NO x cap and trade programs, regulated sources would have the flexibility of using alternative monitoring approaches as long as such approaches meet the performance requirements in the rule Summary   Recent proposals are based on 3 major points regarding public health   Science continues to tell us to move aggressively on fine particles   There is growing evidence that ozone may be a larger problem than previously expected   Mounting scientific evidence and public concern/ interest indicate that Hg emissions must be controlled   Administration strongly prefers the Clear Skies Act legislation instead of controlling NO x, SO 2 and Hg under the existing CAA   EPA will stay with the current package of proposals, absent any movement on the legislation   EPA is committed to action   Power sector is not the only industrial sector EPA is looking towards to make significant reductions   Petroleum refining, car/ truck/ engine manufacturing, and construction equipment industries are making reductions through the Tier II, Heavy Duty Diesel, and Non road Diesel rules   EPA is also requiring a variety of industries to meet new MACT standards,

which will create emission reductions of both criteria and air toxics pollutants Next Steps   Supplemental Notice on Mercury Rule March 16, 2004   Hold Public Hearings February 25 26, 2004   Philadelphia, PA   Chicago, IL   Research Triangle Park, NC   Denver, CO March 30, 2004   Public Comment Periods Close April 30, 2004   Supplemental Notice on Interstate Air Quality Rule April 2004   Finalize Mercury Rule December 2004   Finalize Interstate Air Quality Rule December 2004