[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]
[Page 45403-45408]
[DOCID:fr09au06-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0582; FRL-8082-1]

Isophorone; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends existing exemption from the requirement
of a tolerance for residues of isophorone (CAS Reg. No. 78-59-1) to
limit the use to beets, ginseng, rice, spinach, sugar beets, and Swiss
chard. The Isophorone Task Group (ITG) requested this revised exemption
from the requirement of a tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996. This regulatory action contributes toward the Agency's
tolerance reassessment requirements under FFDCA section 408(q), as
amended by the FQPA of 1996. By law, EPA is required by August 2006 to
reassess the tolerances that were in existence on August 2, 1996. The
regulatory action in this document pertains to the revision of one
existing tolerance exemption which is counted as a tolerance
reassessment toward the August 2006 review deadline.

DATES: This regulation is effective August 9, 2006. Objections and
requests for hearings must be received on or before October 10, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0582. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

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

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

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0582 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 10, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0582, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

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

II. Background and Statutory Findings

    In the Federal Register of April 27, 2005 (70 FR 7951) (FRL-7710-
1), 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 4E6894)
The Isophorone Task Group (ITG) of the Ketones Panel of the American
Chemistry Council, 1300 Wilson Blvd., Arlington, VA 22209. The petition
requested that 40 CFR 180.920 be amended by limiting the existing
exemption from the requirement for isophorone (CAS Reg. No. 78-59-1) to
rice, spinach, and sugar beets. That notice included a summary of the
pesticide petition prepared by ITG, the petitioner. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.
    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. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for an exemption from the requirement of a
tolerance for residues of isophorone in or on beets, ginseng, rice,
spinach, sugar beets, and Swiss chard. EPA's assessment of exposures
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by isophorone are
discussed in the following Table 1 as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the reviewed toxicity studies.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 233.8/
                                   toxicity rodents    >311.8 milligram/
                                   (rats)              kilogram/day (mg/
                                                       kg/day) male/
                                                       female.
------------------------------------------------------------------------
                                                      LOAEL = 102.5 (M)/
                                                       not established
                                                       (F) mg/kg/day
                                                       based on M
                                                       decrease in body
                                                       weight
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 150 mg/kg/
                                   toxicity study in   day higest dose
                                   nonrodents (dogs)   tested (HDT)
                                                      LOAEL = cannot be
                                                       established
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       50 ppm
                                   (inhalation) in    LOAEL = 115 ppm
                                   rodents (mice)      based on
                                                       decreased
                                                       gestation day 18
                                                       body weight,
                                                       corrected for
                                                       uterine weight
                                                      Developmental
                                                       NOAEL = >115 ppm
                                                      Developmental
                                                       LOAEL = cannot be
                                                       established
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       25 ppm
                                   (inhalation) in    LOAEL = 50 ppm
                                   rodents (rats)      based on
                                                       increased
                                                       incidence of
                                                       clinical signs
                                                       (alopecia, ano-
                                                       genital and
                                                       cervical
                                                       staining)
                                                      Developmental
                                                       NOAEL = 115 ppm
                                                       HDT
                                                      Developmental
                                                       LOAEL = cannot be
                                                       established
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = 250/500 mg/
                                   (rats)              kg/day (M/F)
                                                      LOAEL = 500 (M)/
                                                       not established
                                                       (F) based on M =
                                                       increased
                                                       incidence of
                                                       preputial gland
                                                       carcinoma
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = 500 mg/kg/
                                   (mice)              day HDT
                                                      LOAEL = cannot be
                                                       established
------------------------------------------------------------------------

    Isophorone was evaluated as part of the International Programme on
Chemical Safety (ICPS). The IPCS is a joint venture of the United
Nations Environment Programme, the International Labour Organisation,
and the World Health Organization. The main objective of the IPCS is to
carry out and disseminate evaluations of the effects of chemicals on
human health and the quality of the environment.
    The ICPS Environmental Health Criteria monograph for isophorone
critically evaluated the available toxicity data on isophorone, which
included a consideration of the studies summarized in Table 1 as well
as other available toxicity data on isophorone. As part of the human
health risk assessment of isophorone, the ICPS monograph states that
``limited studies in rats and mice indicate that isophorone does not
affect fertility nor does it cause developmental toxicity in
experimental animals.'' Additionally in summarizing the results of
genotoxicity testing, the ICPS further concluded that ``the weight of
evidence of all mutagenicity data supports the contention that
isophorone is not a potent DNA-reactive compound.''

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL are identified
is sometimes used for risk assessment if no NOAEL was achieved in the
toxicology study selected. An uncertainty factor (UF) is applied to
reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases.
    A summary of the toxicological endpoints for isophorone used for
human risk assessment is shown in the following Table 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for isophorone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)....  NOAEL = 150 mg/kg/day
                                       UF = 1.000.............
                                       Chronic RfD = 0.2 mg/kg/
                                        day.
Special FQPA SF = 1..................  90-Day oral dog
cPAD = chronic RfD...................   toxicity study. No
Special FQPA SF = 0.2 mg/kg/day......   toxicity was seen at
                                        the HDT
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)....  NOAEL = 250 mg/kg/day    NA                       Increased incidence of
                                                                                preputial gland
                                                                                carcinomas in male
                                                                                rats Toxicology and
                                                                                Carcinogenesis Study
                                                                                of Isophorone in F344/
                                                                                N Rats
----------------------------------------------------------------------------------------------------------------
                                        Classification: Under the 1986 cancer classification scheme, isophorone
                                        was classified as Group C- Possible Human Carcinogen, with a linear low-
                                         dose extrapolation approach and a 3/4s interspecies scaling factor for
                                        human risk. The upper bound estimate of unit risk, Q1* is 6.08 x 10-4 in
                                                                    human equivalents
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. An exemption from the
requirement of a tolerances has been established (40 CFR 180.40 CFR
site) for the residues of isophorone, in or on beet, ginseng, rice,
spinach, sugar beet and Swiss chard commodities. Risk assessments were
conducted by EPA to assess dietary exposures from isophorone 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.
    Option 1. No such effects were identified in the toxicological
studies for isophorone; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
    ii. Chronic exposure.--Option 2. In conducting the chronic dietary
exposure assessment EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-
FCIDTM), which incorporates food consumption data as
reported by respondents in the United States Department of Agriculture
(USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake
by Individuals (CSFII), and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: The assessment was based on a screening level
dietary assessment that assumed residues of isophorone in beet,
ginseng, rice, spinach, sugar beet and Swiss chard commodities
corresponding to the highest established active ingredient tolerance
level residues for those commodities and 100% crop treated. The highest
established tolerance level active ingredient residue level is chosen
as ``worst-case'' chronic exposure scenario as it would be highly
unlikely that residues of isophorone in the above-listed crops would be
at such levels.
    iii. Cancer. The assessment assumed residues of isophorone in beet,
ginseng, rice, spinach, sugar beet and Swiss chard commodities
corresponding to the highest established active ingredient tolerance
level residues for those commodities and 100% crop treated. The highest
established tolerance level active ingredient residue level is chosen
as ``worst-case'' cancer exposure scenario as it would be highly
unlikely that residues of isophorone in the above-listed crops would be
at such levels.
    2. Dietary exposure from drinking water. Monitoring exposure data
are utilized to complete a dietary exposure

analysis and risk assessment for isophorone in drinking water. The
estimated drinking water concentration (EDWC) of isophorone of 10
[mu]g/L utilized for the purposes of this tolerance action is a value
equivalent to the highest measured concentration of isophorone in
drinking water sources in monitoring studies used by EPA to establish
ambient water quality criteria for isophorone. (EPA 440/5-80-056; NTIS
PB81-11767).
    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).
    Since the use of isophorone is limited to pesticide productswhich
are not registered for use on any sites that would result in
residential exposure, no residential exposures are expected and a
residential exposure assessment has not been conducted
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to isophorone and any other
substances and isophorone does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that isophorone has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased prenatal or postnatal susceptibility of isophorone following
in utero exposure to rats and mice.
    3. Conclusion. There is an adequate toxicity database for the
selection of doses and endpoints for use in risk assessment for
isophorone. Exposure data are complete or are estimated based on data
that reasonably account for potential exposures. The use of the IRIS
chronic reference dose (cRfD) utilizes an additional 10X UF beyond the
traditional UFs for intraspecies variability and interspecies
extrapolation of 100X . This is protective of any potential concerns
for increased susceptibility of infants and children to isophorone. The
additional 10X uncertainty factor incorporated into the IRIS RfD is
based on the use of a subchronic toxicity study, which, given the lack
of increased pre-natal and postnatal susceptibility of isophorone,
would address any potential concerns for increased susceptibility of
infants and children to isophorone, therefore the FQPA factor is
removed.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. As there were no toxic effects attributable to a
single dose, an endpoint of concern was not identified to quantitate
acute dietary risk to the general population or to the subpopulation
females 13-50 years old. No acute risk is expected from exposure to
isophorone
    2. Chronic risk. The chronic dietary exposure analysis is based on
a screening level dietary assessment that assumed residues of
isophorone in beets, ginseng, rice, spinach, sugar beet and Swiss chard
commodities corresponding to the highest established active ingredient
tolerance level residues for those commodities and 100% crop treated
Even with these highly conservative assumptions, the risk estimates are
well below the Agency's level of concern. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that exposure to isophorone from food and drinking water will
utilize 1.8% of the chronic population adjusted dose (cPAD) for the
U.S. population, and 4.4% of the cPAD for non-nursing infants, the most
highly exposed population subgroup. Based on the use pattern, chronic
residential exposure to residues of isophorone is not expected.
Drinking water was incorporated directly into the dietary assessment
using the concentration for drinking water given in unit III.C.2.
    3. Aggregate cancer risk for U.S. population. A non-threshold
(Q1*) approach is used to estimate estimate cancer risk. The
upper bound estimate of lifetime cancer risk for the U.S population is
2.14 x 10-6. This value is derived by multiplying the upper
bound estimate of unit risk, 6.08 x 10-4 by the chronic
dietary exposure (food + drinking water) for the U.S. general
population (0.003520 mg/kg/day). Drinking water was incorporated
directly into the dietary assessment using the concentration for
drinking water given in unit III.C.2. Since this upper bound estimate
of cancer risk is based on a very conservative exposure estimate, and
is within the range of one in one million cancer risk that is typically
considered to not be a concern. EPA therefore concludes that isophorone
is not expected to pose a carcinogenic risk to humans. If applicable,
insert text. There is no boilerplate for this section.
    4. 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, and to infants and children from aggregate
exposure to isophorone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    There are currently no Codex Maximum Residue Limits for isophorone

C. Response to Comments

    Ten comments were received regarding petition PP 4E6894. One
comment, from B. Sachau, regarded general opposition to Agency approval
of tolerances and exemptions other than zero, and general opposition to
any residue left on a treated crop. The Agency finds that this comment
contained no scientific data or evidence to rebut the Agency's
conclusion that there is a reasonable certainty that no harm will
result from aggregate exposure to isophorone including all anticipated
dietary exposures and other exposures for which there is reliable
information. This comment, as well as prior similar comments from B.
Sachau have been responded to by the Agency on several occasions. For
example, (October 29, 2004, 69 FR 63083), (January 7, 2005, 70 FR
1349), and (June 30, 2005, 70 FR 37683. The other nine comments
regarded the use of isophorone in desmedipham and phenmedipham
formulations for use on beets, Swiss chard and ginseng. These uses are
either part of existing section 24(c) registrations or section 18
emergency exemptions, with each of the commentors requesting that these
commodities be included in the reassessment of the isophorone tolerance
exemption. The Agency agrees that these commodities should be included
in the tolerance exemption expression for isophorone and has included
these commodities in the aggregrate risk assessment and safety
determination provided in Unit III.

V. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of the inert ingredient isophorone, in or on
beets, ginseng, rice, spinach, sugar beets, and Swiss chard.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 28, 2006.
Lois Rossi,
Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.920 is amended in the table by removing the entry
Isophorone.
0
Section 180.1270 is added to subpart D to read as follows:

Sec.  180.1270  Isophorone; exemption from the requirement of a
tolerance.

    Isophorone (CAS Reg. No. 78-59-1) is exempt from the requirement of
a tolerance when used as an inert ingredient in pesticide formulations
applied to beets, ginseng, rice, spinach, sugar beets, and Swiss chard.

[FR Doc. E6-12547 Filed 8-8-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66029-66031]
[FR Doc No: 2015-27413]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0001]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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

SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email)

<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Mitigation has resolved any
appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: October 8, 2015.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Chief executive officer of      Community map            Effective date of         Community
         State and county           Location and case No.           community                repository                modification              No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Idaho:
    Ada FEMA Docket No.: B-1512)..  City of Boise (14-10-  The Honorable David         City of Boise,         Aug. 3, 2015.................       160002
                                     2112P).                Bieter, Mayor, City of      Planning and
                                                            Boise, P. O. Box 500,       Development
                                                            Boise, ID 83701.            Services, City Hall,
                                                                                150 North Capital
                                                                                Boulevard, Boise, ID
                                                                                83701.
Illinois:
    DuPage (FEMA Docket No.: B-     City of Warrenville    The Honorable David L.      Warrenville City       Aug. 14, 2015................       170218
     1513).                          (15-05-1937P).         Brummel, Mayor, City of     Hall, 3S258 Manning
                                                            Warrenville, City Hall,     Avenue, Warrenville,
                                                            28W701 Stafford Place,      IL 60555.
                                                            Warrenville, IL 60555.
    DuPage (FEMA Docket No.: B-     Unincorporated areas   Mr. Dan Cronin, County      DuPage County          Aug. 14, 2015................       170197
     1513).                          of DuPage County (15-  Board Chairman, DuPage      Department of
                                     05-1937P).             County, Administration      Development and
                                                            Building, 421 North         Environmental
                                                            County Farm Road,           Concerns, 421 North
                                                            Wheaton, IL 60187.          County Farm Rd., 2nd
                                                                                Floor, Wheaton, IL
                                                                                60187.
    Kane FEMA Docket No.: B-1512).  City of Aurora (15-05- The Honorable Thomas        City Hall,             Aug. 6, 2015.................       170320
                                     0787P).                Weisner, Mayor, City of     Engineering
                                                            Aurora, 44 East Downer      Department, 44 East
                                                            Place, Aurora, IL 60505.    Downer Place,
                                                                                Aurora, IL 60505.
    Kane FEMA Docket No.: B-1512).  Unincorporated areas   The Honorable Christopher   Kane Village Hall,     Aug. 6, 2015.................       170896
                                     of Kane County (15-    Lauzen, Kane County         Main Street, P. O.
                                     05-0787P).             Chairman, Kane County       Box 167, Kane, IL
                                                            Government Center, 719      62054.
                                                            South Batavia Avenue,,
                                                            Building A, Geneva, IL
                                                            60134.
Indiana:
    Allen (FEMA Docket No.: B-      Unincorporated areas   The Honorable F. Nelson     1 East Main Street,    Aug. 25, 2015................       180302
     1513).                          of Allen County (14-   Peters, Allen County        Room 630, Fort
                                     05-9162P).             Commissioner, Citizens      Wayne, IN 46802.
                                                            Square, 200 East Berry
                                                            Street, Suite 410, Fort
                                                            Wayne, IN 46802.
Iowa:
    Poweshiek FEMA Docket No.: (B-  Unincorporated areas   The Honorable Lamoyne       P. O. Box 297, 4802    Jul. 16, 2015................       190902
     1506).                          of Poweshiek County    Gaard, Chairman,            Barnes City Road,
                                     (15-07-0505P).         Poweshiek County Board of   Montezuma, IA 50112.
                                                            Supervisors, 931 Summer
                                                            Street, Grinnell, IA
                                                            50112.
Massachusetts:
    Norfolk FEMA Docket No.: (B-    City of Quincy (15-01- The Honorable Thomas P.     1305 Hancock Street,   Jul. 17, 2015................       255219
     1506).                          0275P).                Koch, Mayor, City of        Quincy, MA 02169.
                                                            Quincy, Quincy City Hall,
                                                            1305 Hancock Street,
                                                            Quincy, MA 02169.
    Plymouth FEMA Docket No.: (B-   Town of Hingham (15-   Ms. Irma Lauter, Chair,     Town Hall, 210         Aug. 14, 2015................       250268
     1512).                          01-0904P).             Board of Selectman, Town    Central Street,
                                                            Hall, 210 Central Street,   Hingham, MA 02043.
                                                            Hingham, MA 02043.
Michigan:
    Macomb FEMA Docket No.: (B-     Township of            Mr. Dan O'Leary, Township   57900 Van Dyke         Aug. 3, 2015.................       260447
     1512).                          Washington (14-05-     Supervisor, Township of     Avenue, Washington,
                                     8670P).                Washington, 57900 Van       MI 48094.
                                                            Dyke Road, Washington, MI
                                                            48094.
    Oakland FEMA Docket No.: (B-    City of Novi (15-05-   The Honorable Bob Gatt,     45175 West Ten Mile    Aug. 31, 2015................       260175
     1518).                          3406P).                Mayor, City of Novi,        Road, Novi, MI 48375.
                                                            Civic Center, 45175 West
                                                            Ten Mile Road, Novi, MI
                                                            48375.

Minnesota:
    Clay (FEMA Docket No.: (B-      City of Moorhead (15-  The Honorable Del Rae       500 Center Avenue,     Aug. 14, 2015................       275244
     1512).                          05-0455P).             Williams, Mayor, City of    Moorhead, MN 56561.
                                                            Moorhead, Moorhead City
                                                            Hall, 500 Center Avenue,
                                                            Moorhead, MN 56561.
Missouri:
    Jefferson (FEMA Docket No.: (B- City of De Soto (15-   The Honorable Werner        17 Boyd Street, De     Aug. 7, 2015.................       295263
     1512).                          07-0329P).             Stichling, Mayor, City of   Soto, MO 63020.
                                                            De Soto, 17 Boyd Street,
                                                            De Soto, MO 63020.
    Jefferson (FEMA Docket No.: (B- Unincorporated areas   The Honorable Ken Waller,   300 Main Street, P.    Aug. 7, 2015.................       290808
     1512).                          of Jefferson County    Jefferson County            O. Box 100,
                                     (15-07-0329P).         Executive, Jefferson        Hillsboro, MO 63050.
                                                            County Administration
                                                            Center, 729 Maple Street,
                                                            Suite G30, Hillsboro, MO
                                                            63050.
Ohio:
    Delaware FEMA Docket No.: (B-   Unincorporated areas   The Honorable Gary          50 Channing Street,    Aug. 1, 2015.................       390146
     1513).                          of Delaware County     Merrell, President,         South Wing,
                                     (15-05-1599P).         Delaware County Board of    Delaware, OH 43015.
                                                            Commissioners, 101 North
                                                            Sandusky Street,
                                                            Delaware, OH 43015.
    Franklin FEMA Docket No.: (B-   City of Columbus (15-  The Honorable Michael B.    757 Carolyn Avenue,    Aug. 1, 2015.................       390170
     1513).                          05-1599P).             Coleman, Mayor, City of     Columbus, OH 43224.
                                                            Columbus, 90 West Broad
                                                            Street, 2nd Floor,
                                                            Columbus, OH 43215.
    Franklin FEMA Docket No.: (B-   City of Dublin (15-05- The Honorable Michael       5800 Shier-Rings       Aug. 1, 2015.................       390673
     1513).                          1599P).                Keenan, Mayor, City of      Road, Dublin, OH
                                                            Dublin, 5200 Emerald        43017.
                                                            Parkway, Dublin, OH 43017.
    Franklin FEMA Docket No.: (B-   Unincorporated areas   The Honorable Marilyn       280 East Broad         Aug. 1, 2015.................       390167
     1513).                          of Franklin County     Brown, President,           Street, Columbus, OH
                                     (15-05-1599P).         Franklin County Board of    43215.
                                                            Commissioners, 373 South
                                                            High Street, 26th Floor,
                                                            Columbus, OH 43215.
Virginia:
    Fairfax FEMA Docket No.: (B-    City of Fairfax (15-   The Honorable Scott         10455 Amstrong         Aug. 7, 2015.................       515524
     1512).                          03-0545P).             Silverthorne, Mayor, City   Street, Room 200,
                                                            of Fairfax, Fairfax City    Fairfax, VA 22030.
                                                            Hall, 10455 Amstrong
                                                            Street, Room 316,
                                                            Fairfax, VA 22030.
Wisconsin:
    Kenosha FEMA Docket No.: (B-    City of Kenosha (14-   The Honorable Keith G.      625 52nd Street,       Aug. 21, 2015................       550209
     1513).                          05-8669P).             Bosman, Mayor, City of      Kenosha, WI 53140.
                                                            Kenosha, 625 52nd Street,
                                                            Kenosha, WI 53140.
    Kenosha FEMA Docket No.: (B-    Village of Bristol     Mr. Michael Farrell,        19801 83rd Street,     Aug. 21, 2015................       550595
     1513).                          (14-05-8669P).         President, Village of       Bristol, WI 53104.
                                                            Bristol, 19801 83rd
                                                            Street, Bristol, WI 53104.
    Milwaukee FEMA Docket No.: (B-  City of Greenfield     The Honorable Michael J.    7325 West Forest Home  Aug. 21, 2015................       550277
     1513).                          (15-05-0082P).         Neitzke, Mayor, City of     Avenue, Greenfield,
                                                            Greenfield, 7325 West       WI 53220.
                                                            Forest Home Avenue,
                                                            Greenfield, WI 53220.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-27413 Filed 10-27-15; 8:45 am]
 BILLING CODE 9110-12-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

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

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:  Proposed rule.

SUMMARY:  EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia.  This SIP revision
pertains to the requirements in meeting the reasonably available control
technology (RACT) under the 8-hour ozone national ambient air quality
standard (NAAQS).  These requirements are based on (1) certification
that previously adopted RACT controls in Virginia’s SIP that were
approved by EPA under the 1-hour ozone NAAQS are based on the currently
available technically and economically feasible controls, and that they
continue to represent RACT for the 8-hour implementation purposes; (2) a
negative declaration demonstrating that no facilities exist in Stafford
County for the applicable control technology guideline (CTG) categories;
and (3) new RACT determinations.  This action is being taken under the
Clean Air Act (CAA).

DATES:  Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-

2008-0472 by one of the following methods:

A.    www.regulations.gov.  Follow the on-line instructions for
submitting comments.

B.    E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    Mail:  EPA-R03-OAR-2008-0472, Cristina Fernandez, Chief, Air
Quality Planning

Branch, Mailcode 3AP21, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.    Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2008-0472.  EPA's policy is that all comments received will
be included in the public docket without change, and

may be made available online at www.regulations.gov, including any
personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.  Do not submit
information that you consider to be CBI or otherwise protected through
www.regulations.gov or e-mail.  The www.regulations.gov website is an
(anonymous access( system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment.  If you send an e-mail comment directly to EPA without going
through  www.regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet.  If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit.  If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.  Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or

in hard copy 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:  On April 21, 2008, the Virginia Department
of Environmental Quality (VADEQ) submitted a revision to its SIP that
addresses Stafford County’s requirements of RACT under the 8-hour
ozone NAAQS set forth by the CAA.

I.  Background

Ozone is formed in the atmosphere by photochemical reactions between
volatile organic compounds (VOC), oxides of nitrogen (NOx) and carbon
monoxide (CO) in the presence of sunlight.  In order to reduce ozone
concentrations in the ambient air, the CAA requires all nonattainment
areas to apply control on VOC/NOx emission sources to achieve emission
reductions.  Among effective control measures, RACT controls are a major
group for reducing VOC and NOx emissions from stationary sources.

Since the 1970's, EPA has consistently interpreted RACT to mean the
lowest emission limit that a particular source is capable of meeting by
the application of the control technology that is reasonably available
considering technological and economic feasibility.  See, e.g., 72 FR
20586 at 20610 (April 25, 2007).   Section 182 of the CAA sets forth two
separate RACT requirements for ozone nonattainment areas.  The first
requirement, contained in section 182(a)(2)(A) of the CAA, and referred
to as RACT fix-up requires the correction of RACT rules for which EPA
identified deficiencies before the CAA was amended in 1990.  On March
31, 1994, EPA published a final rulemaking notice approving the
Commonwealth of Virginia’s SIP revision in order to correct the
Commonwealth’s VOC RACT regulations and establish and require the
implementation for revised SIP regulations to control VOCs (59 FR 15117,
March 31, 1994).

The second requirement, set forth in section 182(b)(2) of the CAA,
applies to moderate (or worse) ozone nonattainment areas as well as to
marginal and attainment areas in ozone transport region (OTR)
established pursuant to section 184 of the CAA, and requires these areas
to implement RACT controls on all major VOC and NOx emission sources and
on all sources and source categories covered by a control technique
guideline (CTG) issued by EPA.  On March 12, 1997, EPA published a final
rulemaking notice approving the Commonwealth of Virginia’s SIP
revision as meeting the CTG RACT provisions of the CAA (62 FR 11332,
March 12, 1997).  Further details of Virginia’s RACT requirements can
be found in a Technical Support Document (TSD) prepared for this
rulemaking.

The counties of Fairfax, Loudoun, Prince William, and Arlington, as well
as the cities of Fairfax, Alexandria, Manassas, Manassas Park, and Falls
Church (Northern Virginia Area), along with Stafford County, Virginia,
Washington, D.C., and portions of southern Maryland, are part of the
OTR.  Under the 1-hour ozone NAAQS, these jurisdictions, including
Stafford County, Virginia, Washington, D.C., and portions of southern
Maryland were originally classified as part of the Metropolitan
Washington serious 1-hour ozone nonattainment area located in OTR (56 FR
56694 at 56844, November 6, 1991).  As part of the planning process,
section 182(b)(2) of the CAA required the Commonwealth of Virginia to
implement RACT on all sources and source categories covered by a CTG
issued by EPA.  Point sources with the potential to emit 50 tons per
year or more of VOCs or 100 tons per year or more of NOx that were not
covered by a CTG were also required to implement RACT.  As a result of
failure to meet the attainment date of November 15, 1999, the
Metropolitan Washington area was reclassified as a severe nonattainment
area for the 1-hour standard (68 FR 3410 at 3425, January 24, 2003).  As
a result of the reclassification, the Commonwealth of Virginia was
required to perform RACT evaluations on point sources with the potential
to emit 25 tons per year for either VOC (62 FR 11334, March 12, 1997) or
NOx (69 FR 48150, August 9, 2004).

On July 18, 1997, EPA promulgated the new 8-hour NAAQS for ozone (62 FR
38856, July 18, 1997).  Under the 8-hour ozone NAAQS, the Metropolitan
Washington Area, with the exception of Stafford County, was designated
nonattainment for the 8-hour ozone standard and classified as a moderate
nonattainment area.  Stafford County was included as part of the
Fredericksburg area, and was designated as a moderate nonattainment area
for the 8-hour ozone NAAQS (69 FR 23858, April 30, 2004).  On May 2,
2005 and May 4, 2005, the Commonwealth of Virginia submitted a
redesignation request and maintenance plan for the Fredericksburg area,
respectively.  EPA issued a final rule approving Virginia’s
redesignation request and maintenance plan for the Fredericksburg area
on December 23, 2005 (70 FR 76165).

Although Stafford County is part of the Fredericksburg maintenance area,
the requirements of section 184 of the CAA must still be satisfied
because Stafford County is also part of the OTR. Section 184(b)(1)(B) of
the CAA, requires the implementation of RACT with respect to all sources
of VOC covered by a CTG.  Additionally, section 184(b)(2) of the CAA,
requires the implementation of major stationary source requirements as
if the area were a moderate nonattainment area on any stationary source
with a potential to emit of at least 50 tons per year of VOC or 100 tons
per year of NOx.  Virginia is therefore required to submit to EPA a SIP
revision that demonstrates how Stafford County meets the RACT
requirements under the 8-hour ozone standard.

 EPA requires under the 8-hour ozone NAAQS that states meet the CAA RACT
requirements, either through a certification that previously adopted
RACT controls in their SIP revisions approved by EPA under the 1-hour
ozone NAAQS represent adequate RACT control levels for 8-hour attainment
purposes, or through the adoption of new or more stringent regulations
that represent RACT control levels.  A certification must be accompanied
by appropriate supporting information such as consideration of
information received during the public comment period and consideration
of new data.  This information may supplement existing RACT guidance
documents that were developed for the 1-hour standard, such that the
State’s SIP accurately reflects RACTs for the 8-hour ozone standard
based on the current availability of technically and economically
feasible controls.  Adoption of new RACT regulations will occur when
states have new stationary sources not covered by existing RACT
regulations, or when new data or technical information indicates that a
previously adopted RACT measure does not represent a newly available
RACT control level.  Another 8-hour ozone NAAQS requirement for RACT is
to submit a negative declaration that there are no CTG major sources of
VOC and NOx emissions within Virginia.

II.  Summary of SIP Revision

Virginia’s SIP revision for Stafford County contains the requirements
of RACT set forth by the CAA under the 8-hour ozone NAAQS.  Virginia’s
SIP revision satisfies the 8-hour RACT requirements through (1)
certification that previously adopted RACT controls in Virginia’s SIP
that were approved by EPA under the 1-hour ozone NAAQS are based on the
currently available technically and economically feasible controls, and
that they continue to represent RACT for the 8-hour implementation
purposes; (2) a negative declaration demonstrating that no facilities
exist in Stafford County for the applicable CTG categories; and (3) new
RACT determinations.

VOC RACT Controls

Virginia’s Regulations and Statues, under 9 VAC 5 Chapter 40, contain
the Commonwealth’s VOC RACT controls that were implemented and
approved in the Virginia SIP under the 1-hour ozone NAAQS.

Table 1 lists Virginia’s VOC RACT controls.

Table 1	Virginia’s VOC RACT Controls

Regulation

9 VAC 5-40-	Existing Stationary Sources

	Title of Regulation	State Effective Date	Federal Register Date	Citation

460	Emission Standards for Synthesized Pharmaceutical Products
Manufacturing Operations	02/01/02	03/03/06	71 FR 10838

610	Emission Standards for Rubber Tire Manufacturing Operations	04/17/95
04/21/00	65 FR 21315

1400	Emission Standards for Petroleum Refinery Operations	04/17/95
04/21/00	65 FR 21315

3290	Emission Standards for Solvent Metal Cleaning Operations Using
Non-Halogenated Solvents	04/01/97	11/03/99	64 FR 59635

3590	Emission Standards for Large Appliance Coating Application Systems
04/17/95	04/21/00	65 FR 21315

3740	Emission Standards for Magnet Wire Coating Application Systems
04/17/95	04/21/00	65 FR 21315

3890	Emission Standards for Automobile and Light Duty Truck Coating
Application Systems	04/17/95	04/21/00	65 FR 21315

4040	Emission Standards for Can Coating Application Systems	04/17/95
04/21/00	65 FR 21315

4190	Emission Standards for Metal Coil Coating Application Systems
04/17/95	04/21/00	65 FR 21315

4340	Emission Standards for Paper and Fabric Coating Application Systems
04/17/95	04/21/00	65 FR 21315

4490	Emission Standards for Vinyl Coating Application Systems	04/17/95
04/21/00	65 FR 21315

4640	Emission Standards for Metal Furniture Coating Application Systems
04/17/95	04/21/00	65 FR 21315

4790	Emission Standards for Miscellaneous Metal Parts and Products
Coating Application Systems	04/17/95	04/21/00	65 FR 21315

4940	Emission Standards for Flatwood Paneling Coating Application
Systems	04/17/95	04/21/00	65 FR 21315

5080	Flexographic, Packaging Rotogravure, and Publication Rotogravure
Printing Lines	04/01/96	03/12/97	62 FR 11334

5230	Emission Standards for Petroleum Liquid Storage and Transfer
Operations – Stage I Vapor Control Systems – Gasoline Service
Stations	02/01/02	03/03/06	71 FR 10838

5230	Emission Standards for Petroleum Liquid Storage and Transfer
Operations – Tank Truck Gasoline Loading Terminals	02/01/02	03/03/06
71 FR 10838

5230	Emission Standards for Petroleum Liquid Storage and Transfer
Operations – Bulk Gasoline Plants	02/01/02	03/03/06	71 FR 10838

5230	Emission Standards for Petroleum Liquid Storage and Transfer
Operations – Petroleum Liquids in Fixed Roof Tanks	02/01/02	03/03/06
71 FR 10838

5230	Emission Standards for Petroleum Liquid Storage and Transfer
Operations – Petroleum Liquid Storage in External Floating Roof Tanks
02/01/02	03/03/06	71 FR 10838

5230	Emission Standards for Petroleum Liquid Storage and Transfer
Operations – Gasoline Tank Trucks and Vapor Collection Systems
02/01/02	03/03/06	71 FR 10838

5510	Emission Standards for Asphalt Paving Operations	03/24/04	04/27/05
70 FR 21625

6840	Emission Standards for Solvent Metal Cleaning Operations in the
Northern Virginia Volatile Organic Compound Emissions Control Area
03/24/04	06/09/04	69 FR 32277

Virginia also submitted a negative declaration certifying that the
following VOC CTG or non-CTG major sources do not exist in Stafford
County.

Table 2 lists Virginia’s negative declaration for VOC CTG major
sources.

Table 2 – Documents for which no Applicable Facilities Exist in
Stafford County

Document Title

Control of Volatile Organic Compound Leaks from Petroleum Refinery
Equipment

Control of Volatile Organic Compound Emissions form Large Petroleum Dry
Cleaners

Control of Volatile Organic Compound Emissions from Manufacture of High
Density Polyethylene, Polypropylene, and Polystyrene Resins

Control of Volatile Organic Compound Equipment Leaks form Natural
Gas/Gasoline Processing Plants

Control of Volatile Organic Compound fugitive Emission from Synthetic
Organic Chemical Polymer and Resin Manufacturing Equipment

Control of Volatile Organic Compound Emissions from Air Oxidation
Processes in Synthetic Organic Chemical Manufacturing Industry

SOCMI Distillation and Reactor Processes CTG

Wood Furniture

Shipbuilding/repair

Aerospace

NOx RACT Controls

The only facility in Stafford County considered to be a major stationary
source for either VOC or NOx is Cellofoam.  Because actual VOC emissions
from Cellofoam are significantly below the facility’s federally
enforceable limit, the Cellofoam source specific new RACT determination
is appropriate, and therefore, the existing RACT controls can be
recertified.  Further details can be found in a TSD prepared for this
rulemaking.

III.  Proposed Action

EPA is proposing to approve the Virginia SIP revision for Stafford
County that addresses the requirements of RACT under the 8-hour ozone
NAAQS, which was submitted on April 21, 2008.  This SIP revision is
based on a combination of (1) certification that previously adopted RACT
controls in Virginia’s SIP that were approved by EPA under the 1-hour
ozone NAAQS are based on the currently available technically and
economically feasible controls, and that they continue to represent RACT
for the 8-hour implementation purposes; (2) a negative declaration
demonstrating that no facilities exist in Stafford County for the
applicable CTG categories; and (3) new RACT determinations.  EPA is
soliciting public comments on the issues discussed in this document.
These comments will be considered before taking final action.

IV.  Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 Clean Air Act.  Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law.  For that reason, this proposed 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 FR 43255, 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 proposed rule, pertaining to the Stafford County, VA
RACT under the 8-hour ozone NAAQS, 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.

List of Subjects in 40 CFR Part 52

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

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

          7/25/08
                   /s/

_________________
____________________________

Dated:                             		   		Donald S. Welsh,

Regional Administrator,

Region III.

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