[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Rules and Regulations]
[Page 27463-27469]
[DOCID:fr16my07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0203; FRL-8126-2]

Acetochlor; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises and separates the tolerances for
acetochlor in 180.470 into paragraphs (a) through (d) and reassigns
many of the current entries from paragraph (a) to paragraph (d), which
applies to tolerances for indirect and inadvertent residues. This
regulation also establishes several new tolerances and amends several
existing tolerances under paragraph (a). It further establishes several
new tolerances under paragraph (d); and amends and revises two
tolerances moved to that paragraph. Details of these changes are
outlined in Unit II. of this document. The Acetochlor Registration
Partnership (ARP) and Monsanto Company requested these changes as
submitted by petitions to EPA pursuant to the Federal Food, Drug and
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 16, 2007. Objections and
requests for hearings must be received on or before July 16, 2007, 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-2006-0203. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

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

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

FOR FURTHER INFORMATION CONTACT: Vickie Walters, 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 those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be

affected by this action. Other types of entities not listed in this
unit could also be affected. The North American Industrial
Classification System (NAICS) codes have been provided to assist you
and others in determining whether this action might apply to certain
entities. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

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

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

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

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0203 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before July 16, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0203, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

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

II. Petition for Tolerance

    In the Federal Register of February 7, 2007 (72 FR 5706) (FRL-8111-
8, EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
1F6263, 4F4505, 6F4791) by the Acetochlor Registration Partnership
(ARP) and Monsanto Company, 1300 ``I'' St., NW., Washington, DC 20005,
and PP 5F6918 by Monsanto Company, 1300 ``I'' St., NW., Suite 450 East,
Washington, DC 20005. The petitions requested that 40 CFR 180.470(a) be
amended by establishing tolerances for residues of the herbicide,
acetochlor [2-chloro-2-methyl-6-ethyl-N-ethoxymethylacetamide) and its
metabolites containing the ethyl methyl aniline (EMA) moiety and the
hydroxyethyl methyl-aniline (HEMA) moiety, and expressed as acetochlor
equivalents in or on the food commodities corn, field, forage at 3.0
ppm (5F4505) corn, pop, grain at 0.05 part per million (ppm); corn,
pop, stover at 1.5 ppm (PP 1F6263); corn, sweet, fodder and forage at
1.5 ppm; and corn, sweet, kernels plus cob with husks removed at 0.05
ppm (6F4791); sorghum, forage at 1.0 ppm; sorghum, grain at 0.05 ppm;
and sorghum, grain, stover at 1.5 ppm (5F6918). These petitions also
requested that 40 CFR 180.470(d) be amended by establishing tolerances
for residues of the herbicide, acetochlor (2-chloro-2-methyl-6-ethyl-N-
ethoxymethylacetamide) and its metabolites containing the ethyl methyl
aniline (EMA) moiety and the hydroxyethyl methyl-aniline (HEMA) moiety,
and expressed as acetochlor equivalents in or on the food commodities
beet, sugar, root and tops/ pea and bean (except soybean) dried and
shelled (subgroup 6C)/potato/ and grain, cereal (except rice) (group
15),at 0.05 ppm; grain, grain, cereal (except rice), forage/fodder/
straw (group 16) forage at 0.5 ppm; grain, cereal (except rice) forage/
fodder/straw (group 16) hay at 2.0 ppm; grain, cereal (except rice)
forage/fodder/straw (group 16) stover at 0.1 ppm; grain, cereal (except
rice) forage/fodder/straw (group 16), straw at 0.3 ppm (1F6263); non-
grass animal feeds (group 18) forage at 1.3 ppm; and non-grass animal
feeds (group 18) hay at 3.5ppm (6F4791). That notice referenced a
summary of the petitions prepared by Acetochlor Registration
Partnership and Monsanto Company, the registrants, which have been
placed in the public docket, http://www.regulations.gov. There were no

comments received in response to the notice of filing.
    Based upon review of the data supporting the petitions EPA is
reassigning the entries for soybean, forage at 0.7 ppm; soybean, grain
at 0.1 ppm; soybean, hay at1.0 ppm; wheat, forage at 0.5 ppm; wheat,
grain at 0.02 ppm; and wheat, straw at 0.1 ppm; from 180.470(a) to
180.470(d) and establishing a tolerance for wheat, hay at 2.0 ppm under
40.CFR 180.470(d). The terminology for soybean, grain is being updated
to read soybean, seed to conform to Agency procedures. Additionally,
EPA is increasing the tolerance for corn, field, forage to 3.0 from 1.0
ppm. This tolerance will be listed in 180.470(a).
    Based upon review of the data submitted and Agency procedures
concerning commodity names, the Agency is correcting the terminology
for pending crops under 40 CFR 180.470(a) as follows: corn, field,
forage at 3.0 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at
1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.05 ppm;
corn, sweet, forage at 1.5 ppm; and sorghum, grain, grain at 0.05 ppm.
The Agency is also correcting the tolerance levels and terminology for
pending crops under 40 CFR 180.470(a) as follows: corn, sweet, stover
at 1.0 ppm; sorghum, grain, forage at 1.6 ppm; sorghum, grain, grain at
0.05 ppm; and sorghum, grain, stover at 1.7 ppm. The above listings for
corn, field, forage; sorghum, grain, forage; sorghum, grain, grain; and
sorghum, grain, stover; replace the current listings for corn, field
forage; sorghum, forage; sorghum, grain; and sorghum, grain, stover.
    The Agency also determined that the tolerance expression and
correct terminology for the pending crops under 40 CFR 180.470(d)
should be written as follows: Tolerances are also established for
indirect or inadvertent residues of acetochlor (2-chloro-2'-methyl-6-
ethyl-N-ethoxymethylacetamide) and its metabolites containing the ethyl
methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA)
moiety, to be analyzed as acetochlor and expressed as acetochlor
equivalents, in or on the following raw agricultural commodities when
present therein as a

result of application of acetochlor to growing crops listed in
paragraph (a) of this section: Animal feed, nongrass, group 18, forage
at 1.3 ppm; animal feed, nongrass, group 18, hay at 3.5 ppm; beet,
sugar, root at 0.05 ppm; beet, sugar, tops at 0.05 ppm; grain, cereal,
group 15 except for corn, grain sorghum, rice and wheat, grain at 0.05
ppm; grain, cereal, forage, fodder and straw, group 16 except for corn,
grain sorghum, rice and wheat, forage at 0.5 ppm; grain, cereal,
forage, fodder and straw, group 16,except corn, grain sorghum, rice and
wheat, hay at 2.0 ppm; grain, cereal, forage, fodder and straw, Group
16, except corn, grain sorghum, rice and wheat, stover at 0.1 ppm;
grain, cereal, forage, fodder and straw, group 16, except corn, grain
sorghum, rice and wheat, straw at 0.3 ppm; pea and bean, dried shelled,
except soybean, subgroup 6C at 0.05 ppm; potato at 0.05; sunflower,
seed at 0.05 ppm and wheat, hay at 2.0 ppm.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerances
and amendments for tolerances for residues of acetochlor (2-chloro-2'-
methyl-6-ethyl-N-ethoxymethylacetamide) and its metabolites containing
the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl
aniline (HEMA) moiety, to be analyzed as acetochlor and expressed as
acetochlor equivalents.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by acetochlor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document is entitled ``Acetochlor-

RED Phase 2 Revised HED Chapter of the TRED'' and is available in the
docket (EPA-HQ-OPP-2005-0227 identified as document 0004.

B. Toxicological Endpoints

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

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

Acetochlor: Human Health Risk Assessment to Support the Proposed Uses
on Sorghum and Sweet Corn and Rotational Crops of Nongrass Animal Feeds
(Group 18), Sugar Beets, Dried Shelled Beans and Peas (Subgroup 6C),
Sunflowers, Potatoes Cereal Grains (Group 15), and Forage, Fodder and
Straw of Cereal Grains (Group 16) on page 11 in Docket ID EPA-HQ-OPP-
2006-0203.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetochlor, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetochlor tolerances in (40 CFR
180.470). EPA assessed dietary exposures from acetochlor in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. In estimating acute dietary
exposure, EPA used food consumption information from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances or for which tolerances are proposed, were treated
and contain tolerance-level residues. Experimentally derived processing
factors were used for cereal grain commodities. Default values were
used for all other processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998; Nationwide CSFII. As to residue levels in food, EPA chronic
dietary analysis included anticipated residues from field trial data
and assumed that all crop were treated. Experimentally derived
processing factors were used for cereal grain commodities. Default
values were used for all other processed commodities.
    iii. Cancer. Previously, EPA has treated acetochlor as a non-
threshold

carcinogen and conducted a linear low-dose quantitative cancer risk
assessment in evaluating its safety. The determination that a
quantitative linear low-dose cancer assessment was appropriate was
based on findings that acetochlor caused mouse lung tumors and
histiocytic sarcomas in female mice. The Agency has reexamined the data
and concluded they do not support use of a quantitative linear low-dose
cancer assessment. The Agency determined that the relationship of the
mouse lung tumors to treatment was equivocal, due to some
inconsistencies in dose-response between the two available mouse
studies, the relatively frequent occurrence of the tumor in older mice
and the lack of evidence of direct genotoxicity of acetochlor. Further
the Agency found that the increase in the histiocytic sarcomas in
female mice in one study was also equivocal. EPA concludes that this
equivocal evidence of cancer shows no greater than a negligible risk of
cancer. Nonetheless, acetochlor has been associated with nasal tumors
in the rats and these tumors remain as a tumor of concern for human
exposure to acetochlor. Because, however, the nasal tumors have been
found to be a threshold effect, EPA has not used quantitative linear
low-dose cancer assessment in assessing this cancer risk. Rather, EPA
has relied on the chronic risk assessment because the chronic Reference
Dose (cRfD), which is based on a NOAEL of 2 milligrams/kilograms/day
(mg/kg/day), is considered to be protective of nasal tumors for which a
point of departure of 10 mg/kg/day was identified. EPA has used the
same exposure assumptions in assessing cancer risk as in assessing
other chronic risks.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) of FFDCA require that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by section 408(b)(2)(E) of FFDCA and authorized under
section 408(f)(1) of FFDCA. Data will be required to be submitted no
later than 5 years from the date of issuance of this tolerance.
    2. Dietary exposure from drinking water. The drinking water values
used in the dietary risk assessments were based on information provided
by the Acetochlor Registration Partner ship water monitoring program to
support the current use on field corn. The Agency has determined that
the new uses of acetochlor are not likely to result in concentrations
exceeding those seen in the field corn monitoring data; therefore this
data can be used to estimate drinking water concentrations resulting
from the new uses on sweet corn and sorghum. In the monitoring data,
exposure to acetochlor parent was significantly higher in the surface
water monitoring sites than the ground water monitoring sites;
therefore, the concentration used in the acute dietary assessment was
from a surface water monitoring site that produced the highest
concentration of 0.01821 ppm. The drinking water value used in the
chronic dietary risk assessment was from a surface water monitoring
site that produced the highest time-weighted annualized mean (TWAM)
concentration for a single year of 0.00143 ppm.
    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). Acetochlor is not
registered for use on any sites 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.''
    Acetochlor is a member of the chloroacetanilide cumulative
assessment group (CAG) which includes alachlor and butachlor. The
Agency previously conducted a cumulative risk assessment for the CAG
based on a common mode of action for the production of tumors of the
nasal olfactory epithelium in rats. Butachlor was determined to be part
of the CAG, however, there are currently no U.S. registrations for the
chemical; therefore, it was excluded from the cumulative risk
assessment. This risk assessment is fully discussed in the document:
Cumulative Risks from Chloroacetanilide Pesticides dated March 6, 2006
identified as document EPA-HQ-OPP-2005-0050-0061 which is available on
the internet at http://www.regulaions.gov in docket number EPA-HQ-OPP-

2005-0050. Based on that cumulative risk assessment (CRA), the Agency
concluded that the cumulative risks from alachlor and acetochlor did
not exceed the Agency's level of concern since cumulative MOEs were
above 13,000 for all populations compared to a cumulative level of
concern of 100.
    For this risk assessment the Agency believes that the cumulative
risk from these new uses in addition to the current existing uses of
acetochlor and alachlor will not exceed The Agency's level of concern.
Individual risk assessments were conducted based on a point of
departure of 10 mg/kg/day for nasal tumors. Anticipated residues based
on field trial data and 100% crop treated was assumed for all existing
and new uses for acetochlor. The individual acetochlor assessment from
food resulted in MOEs raging from 49,000 for children 1-2 years old and
children 3-5 years old to 179,000 for adults 50+. The addition of water
to the assessment using surrogate data from the corn monitoring
studies, resulted in MOEs ranging from 40,000 for children 1-2 years
old to 116,000 for adults 50+. The MOEs for the General U.S. population
were 111,000 from food and 83,000 from both food and water.
    As noted in the March, 2006 cumulative risk assessment for the
chloroacetanilide chemicals, alachlor is the index chemical and
acetochlor is included in the assessment with a relative potency of 1/
20th of alachlor. Further, as noted in the cumulative risk assessment,
acetochlor commodities were not considered to be risk drivers in the
chloroacetanilide CRA; therefore given the individual MOEs for
acetochlor, it is unlikely that the addition of the new uses for
acetochlor will cause an unacceptable cumulative risk when considered
with the existing alachlor and acetochlor uses.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional (``10X'') tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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. This additional margin of
safety is commonly referred to as the FQPA safety factor. In applying
this provision, EPA either retains the default value of 10X when
reliable data do not support the choice of a different

factor, or, if reliable data are available, EPA uses a different
additional FQPA safety factor value based on the use of traditional
uncertainty/safety factors and/or special FQPA safety factors, as
appropriate.
    2. Prenatal and postnatal sensitivity. Concern for prenatal and
postnatal susceptibility is low for acetochlor since toxicity to
offspring was observed only at maternal toxic doses in developmental
toxicity studies in the rat and rabbit and in three multi-generation
reproductive toxicity studies in the rat. In addition, clear NOAELS
were established in all of these three studies.
    3. Conclusion. A 10X FQPA safety factor was applied to the acute
dietary risk in the form of a database uncertainty factor to account
for the lack of a developmental neurotoxicity study. The following
findings support this determination.
    i. The toxicity database for acetochlor is not complete at this
time. A developmental neurotoxicity study is required based on
neurological observations, primarily in the dog or an alternative test
which addresses the sensitivity of the dog to neurological effects. In
addition, submission of positive control studies for validation of the
laboratory methodology used in the acute and subchronic rat oral
neurotoxicity screening studies is required as confirmatory data and to
upgrade those studies to acceptable.
    ii. Evidence of neurotoxicity from exposure to acetochlor was
observed in several studies. Salvation and other clinical signs
(anogential staining, diarrhea) were reported in some studies in both
the rat (two developmental studies) and the dog (subchronic and chronic
oral). The dog appears to be more sensitive than the rat or mouse to
effects on the nervous system, in that salivation occurred at lower
dose levels and frank neuropathology of the brain was observed in one
study. In the 1-year oral toxicity study in the dog pronounced
neurological signs (ataxia, abnormal head movements, tremor, depressed
righting, hoping and flexor reflexes, exaggerated tonic neck reflex and
stiffness and rigidity of the hindlimbs) were observed at the high dose
and were associated with degenerative lesions of the cerebellum. Other
evidence of neurotoxicity is discussed on page 46 of the document
entitled ``Acetochlor-RED Phase 2 Revised HED Chapter of the TRED''
which is available on the internet at http://www.regulaions.gov in the

docket identified as EPA-HQ-OPP-2005-0227 document 0004.
    iii. The acute dietary endpoint of concern for the general
population including females 13-49 years of age, was derived from an
acute oral neurotoxicity screening study in rats (NOAEL of 150 mg/kg/
day based on decreased motor activity in females. Given the likely
dosing in the developmental neurotoxicity study, it is possible that
this study could lower the acute RfD by a factor of 10.
    EPA has determined that reliable data show that it would be safe
for infants and children to reduce the FQPA safety factor to 1X for the
chronic dietary risk. That decision is based on the following findings.
     The toxicity database for acetochlor is complete other
than the lack of a developmental neurotoxicity study.
     Given likely dosing in the developmental neurotoxicity
study, it is unlikely that this study would lower the cRFD. The chronic
dietary endpoint of concern for all populations was derived from the
chronic oral toxicity study in dogs with a NOAEL of 2 mg/kg/day based
on the increased salivation and histopathology in testes, kidney and
liver at 10 mg/kg/day. The cRFD of 2.0 mg/kg/day is less than the
NOAELs in the reproductive study of 21 mg/kg/day. A developmental
neurotoxicity study will likely be conducted at dose levels similar to
those of the 2-generation rat reproduction study. No evidence of
neuropathology or overt neurobehavioral effects were observed in the 2-
generation reproductive study with rats.
     There is no evidence that acetochlor results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The FQPA safety factor was reduces to 1X.
     There are no residual uncertainties identified in the
chronic exposure database. The chronic dietary food exposure assessment
was based on the assumption of all crops treated and anticipated
residues from acceptable field trial data for all commodities. For
chronic dietary food exposure assessments, experimentally derived
processing factors were used for cereal grain commodities and default
processing factors were used for all other processed commodities. The
drinking water values used in the dietary risk assessments were based
on information provided by the Acetochlor Registration Partnership
water monitoring program to support the current use on field corn.
These assessments will not underestimate the exposure and risks posed
by acetochlor.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability
of additional cancer cases given aggregate exposure. Short-,
intermediate, and long-term risks are evaluated by comparing aggregate
exposure to the LOC to ensure that the MOE called for by the product of
all applicable uncertainty/safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to acetochlor will occupy < 1% of the aPAD at the 95th percentile for
the U.S. population and 2.6% of the aPAD at the 95th percentile for all
infants, the population subgroup receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
acetochlor from food and water will utilize < 1% of the cPAD for the
U.S. population and 1.2 % of the cPAD for children 1-2 years old, the
population subgroup receiving the greatest exposure. There are no
residential uses for acetochlor that result in chronic residential
exposure to acetochlor.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Acetochlor is not registered for use on any sites that would result
in residential exposure. Therefore, an aggregate risk assessment for
this duration is not appropriate.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Acetochlor is not registered for use on any sites that would result
in residential exposure. Therefore, an aggregate risk assessment for
this duration is not appropriate.
    5. Aggregate cancer risk for U.S. population. As explained above,
in Unit III.C.iii., the cRfD is considered to be protective of any
cancer risk posed by acetochlor and as discussed in Unit E2, EPA has
found that chronic acetochlor exposure does not exceed the cRfD;
therefore, aggregate cancer risks are not of concern.

    6. 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 acetochlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate high performance liquid chromatography with oxidative
coulometric electrochemical detector (HPLC/OCED) method is available
for enforcing new tolerances for acetochlor and its metabolites in
sweet corn, sorghum, and rotational crops. This method is listed as
Method I for plants in PAM Vol. II.

B. International Residue Limits

    There are no Codex Maximum Residue Levels established for
acetochlor on agricultural commodities.

V. Conclusion

    Therefore, tolerances are established for residues of acetochlor
(2-chloro-2'-methyl-6-ethyl-N-ethoxymethylacetamide) and its
metabolites containing the ethyl methyl aniline (EMA) moiety and the
hydroxyethyl methyl aniline (HEMA) moiety to be analyzed as acetochlor,
and expressed as acetochlor equivalents as discussed in Unit II.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 8, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--AMENDED

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

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

0
2. Section 180.470 is revised to read as follows:

Sec.  180.470  Acetochlor; tolerances for residues.

    (a) General. Tolerances are established for residues of acetochlor;
2-chloro-2'-methyl-6-ethyl-N-ethoxymethylacetanilide, and its
metabolites containing the ethyl methyl aniline (EMA) moiety and the
hydroxyethyl methyl aniline (HEMA) moiety, to be analyzed as acetochlor
and expressed as acetochlor equivalents, in or on the following raw
agricultural commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage..................................                3.0
Corn, field, grain...................................               0.05
Corn, field, stover..................................                1.5
Corn, pop, grain.....................................               0.05
Corn, pop, stover....................................                1.5
Corn, sweet, forage..................................                1.5
Corn, sweet, kernels plus cob with husks removed.....               0.05
Corn, sweet, stover..................................                1.0
Sorghum, grain, forage...............................                1.6
Sorghum, grain, grain................................               0.05
Sorghum, grain, stover...............................                1.7
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. [Reserved].
    (d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of acetochlor; 2-chloro-2'-methyl-
6-ethyl-N-ethoxymethylacetanilide, and its metabolites containing the
ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline
(HEMA) moiety, to be analyzed as acetochlor and expressed as acetochlor
equivalents, in or on the following raw agricultural commodities when
present therein as a result of application of acetochlor to the growing
crops in paragraph (a) of this section:

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage...............               1.3
Animal feed, nongrass, group 18, hay..................               3.5
Beet, sugar, root.....................................              0.05
Beet, sugar, tops.....................................              0.05
Grain, cereal, forage, fodder and straw, group 16,                   0.5
 except corn, grain sorghum, rice and wheat, forage...
Grain, cereal, forage, fodder and straw, group 16,                   2.0
 except corn, grain sorghum, rice and wheat, hay......
Grain, cereal, forage, fodder and straw, group 16,                   0.1
 except corn, grain sorghum, rice and wheat, stover...
Grain, cereal, forage, fodder and straw, group 16,                   0.3
 except corn, grain sorghum, rice and wheat, straw....
Grain, cereal, group 15, except corn, grain sorghum,                0.05
 rice, and wheat, grain...............................
Pea and bean, dried shelled, except soybean, subgroup               0.05
 6C...................................................
Potato................................................              0.05
Soybean, forage.......................................               0.7
Soybean, hay..........................................               1.0
Soybean, seed.........................................               0.1
Sunflower, seed.......................................              0.05
Wheat, forage.........................................               0.5
Wheat, grain..........................................              0.02
Wheat, hay............................................               2.0
Wheat, straw..........................................               0.1
------------------------------------------------------------------------

[FR Doc. E7-9430 Filed 5-15-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Notices]
[Page 25290-25291]
[DOCID:fr27my09-96]

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

[Investment Company Act Release No. 28726; File No. 812-13649]

Main Street Capital Corporation, et al.; Notice of Application

May 19, 2009.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 23(c)(3) of
the Investment Company Act of 1940 (the ``Act'') for an exemption from
section 23(c) of the Act.

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

Summary of the Application: Applicants, Main Street Capital Corporation
(the ``Company''), Main Street Mezzanine Fund, LP (``MSMF''), Main
Street Capital Partners, LLC (the ``Adviser'') and Main Street
Mezzanine Management, LLC (the ``GP''), request an order to amend a
prior order (the ``Prior Order'') that permits the Company to issue
restricted shares of its common stock (``Restricted Stock'') under the
terms of its employee and director compensation plan, the Main Street
Capital Corporation 2008 Equity Incentive Plan (the ``Plan'').\1\
Applicants seek to amend the Prior Order in order to permit the
Company, pursuant to the Plan, to engage in certain transactions that
may constitute purchases by the Company of its own securities within
the meaning of section 23(c) of the Act.
---------------------------------------------------------------------------

    \1\ Main Street Capital Corporation, et al., Investment Company
Act Release Nos. 28082 (Dec. 21, 2007) (notice) and 28120 (Jan 16,
2008) (order). MSMF, the GP and the Adviser are each, directly or
indirectly, wholly owned by the Company.
---------------------------------------------------------------------------

    Filing Dates: The application was filed on April 3, 2009 and
amended on May 13, 2009 and May 18, 2009.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicant with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on June 15, 2009, and should be accompanied by proof of
service on applicant, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090. Applicants, c/o Jason B.
Beauvais, General Counsel, Main Street Capital Corporation, 1300 Post
Oak Boulevard, Suite 800, Houston, TX 77056.

FOR FURTHER INFORMATION CONTACT: Jaea F. Hahn, Senior Counsel, at (202)
551-6870, or Janet M. Grossnickle, Assistant Director, at (202) 551-
6821, (Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Company is an internally managed, non-diversified, closed-
end investment company that has elected to be regulated as a business
development company (``BDC'') under the Act. The Company is currently
permitted to issue shares of Restricted Stock under the terms of its
Plan in reliance on the Prior Order. Applicants seek to amend the Prior
Order in order to permit the Company, pursuant to the Plan, to withhold
shares of the Company's common stock or purchase shares of the
Company's common stock from executive officers or employees
(``Participants'') to satisfy tax withholding obligations related to
the vesting of Restricted Stock or the exercise of stock options that
were or will be granted pursuant to the Plan. In addition, the Company
seeks to amend the Prior Order to permit Participants to pay the
exercise price of options that were or will be granted to them pursuant
to the Plan with shares of the Company's common stock already held by
them or pursuant to a net share settlement feature.\2\ The Applicants
will continue to comply with all of the terms and conditions of the
Prior Order.
---------------------------------------------------------------------------

    \2\ Net share settlement allows the Company to deliver only gain
shares (i.e., shares of its common stock with a fair market value,
as the term is defined in the Plan, equal to the option spread upon
exercise) directly to the optionee without the need for the optionee
to sell shares of the Company's common stock on the open market or
borrow cash from third parties in order to exercise his or her
options.
---------------------------------------------------------------------------

    2. The Plan authorizes the issuance to Participants of shares of
Restricted Stock and options to purchase shares of the Company's common
stock, subject to certain forfeiture restrictions. On the date
Restricted Stock vests, shares of the Restricted Stock are released to
the Participant and are available for sale or

transfer and the value of the vesting shares is deemed to be
compensation for a Participant.\3\ As discussed more fully in the
application, certain exercises of options result in a Participant being
deemed to have received compensation in the amount by which the fair
market value of the shares of the Company's common stock, determined as
of the date of exercise, exceeds the exercise price. Applicants state
that any compensation income recognized by a Participant generally is
subject to federal withholding for income and employment tax purposes.
Accordingly, arrangements must be made to satisfy the necessary
withholding tax obligations.
---------------------------------------------------------------------------

    \3\ During the restriction period (i.e., prior to the lapse of
the forfeiture restrictions), the Restricted Stock may not be sold,
transferred, hypothecated, margined, or otherwise encumbered by the
Participant.
---------------------------------------------------------------------------

    3. The Company's stockholders approved the terms and provisions of
the Plan on June 17, 2008. The Plan explicitly permits the Company to
withhold shares of the Company's common stock or purchase shares of the
Company's common stock from the Participants to satisfy tax withholding
obligations related to the vesting of Restricted Stock or the exercise
of options granted pursuant to the Plan. The Plan further provides that
Participants may pay the exercise price of options to purchase shares
of the Company's stock with shares of the Company's stock already held
by such Participants or pursuant to net share settlement.

Applicants' Legal Analysis

    1. Section 23(c) of the Act, which is made applicable to BDCs by
section 63 of the Act, generally prohibits a BDC from purchasing any
securities of which it is the issuer except in the open market,
pursuant to tender offers or under other circumstances as the
Commission may permit to ensure that the purchase is made on a basis
that does not unfairly discriminate against any holders of the class or
classes of securities to be purchased. Applicants state that the
withholding or purchase of shares of Restricted Stock and common stock
in payment of applicable withholding tax obligations or of common stock
in payment for the exercise price of a stock option might be deemed to
be purchases by the Company of its own securities within the meaning of
section 23(c) and therefore prohibited by the Act.
    2. Section 23(c)(3) provides that the Commission may issue an order
that would permit a BDC to repurchase its shares in circumstances in
which the repurchase is made in a manner or on a basis that does not
unfairly discriminate against any holders of the class or classes of
securities to be purchased. Applicants believe that the requested
relief meets the standards of section 23(c)(3).
    3. Applicants state that these purchases will be made on a basis
which does not unfairly discriminate against the stockholders of the
Company because all purchases of the Company's stock will be at the
closing price of the common stock on the NASDAQ Global Select Market
(or any primary exchange on which the shares are traded) on the
relevant date (i.e., the public market price on the date the Restricted
Stock vests or the date of the exercise of any options). Applicants
further state that no transactions will be conducted pursuant to the
requested order on days where there are no reported market transactions
involving the Company's shares. Applicants submit that because all
transactions would take place at the public market price for the
Company's common stock, the transactions would not be significantly
different than could be achieved by any stockholder selling in a market
transaction.
    4. Applicants submit that the proposed purchases do not raise
concerns about preferential treatment of the Company's insiders because
the Plan is a bona fide compensation plan of the type that is common
among corporations generally. Further, the vesting schedule is
determined at the time of the initial grant of the Restricted Stock
while the option exercise price is determined at the time of the
initial grant of the options. Applicants represent that all purchases
will be made only as permitted by the Plan, which was approved by the
Company's stockholders. Applicants argue that granting the requested
relief would be consistent with precedent and the Commission's
recognition of the important role that equity compensation can play in
attracting and retaining qualified personnel with respect to certain
types of investment companies, including BDCs.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-12219 Filed 5-26-09; 8:45 am]

BILLING CODE 8010-01-P


MEMORANDUM

SUBJECT: 	Technical Support Document for Approval of a Missouri State Implementation Plan Revision relating to Restriction of Emissions Credit for Reduced Pollutant Concentrations from the Use of Dispersion Techniques

FROM: 		Steven Brown
                  ARD/AQPB/CPPS

TO: 			EPA-R07-OAR-2022-0285; MO-433

THROUGH:  	Andy Hawkins, Branch Chief
                  ARD/AQPB

SUMMARY:
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Missouri State Implementation Plan (SIP) received from the Missouri Department of Natural Resources (MoDNR) as a SIP revision submission on January 30, 2020.

Specifically, the revisions are to the existing rule, Title 10, Division 10 of the Code of State Regulations, (10 CSR 10-6.140) "Restriction of Emissions Credit for Reduced Pollutant Concentrations from the Use of Dispersion Techniques", with a restructured version of the same rule. The rule was SIP approved in 40 CFR § 52.1320(c) on March 31, 1989 (54 FR 13184). The purpose of the state regulation is to limit the use of dispersion techniques rather than emission reductions to meet ambient air quality standards in the vicinity of major sources of air pollution. The use of certain dispersion techniques is prohibited by Section 123 of the Clean Air Act.

These proposed revisions restructure the rule to the MoDNR standard rule organizational format, amend the applicability section by adding a new reference, add definitions
specific to this rule and remove unnecessary words.

RULE REVISIONS:
Below is EPA's description of the changes made to each rule section and the text of the revised rule.
Revisions that are additions to MoDNR's existing approved SIP rule text are bold. Revisions that are deletions to the existing approved SIP rule text are stricken through. The rule text with changes is listed first and is followed by a summary of the EPA's review of the changes. In some sections there may be an EPA notation at the beginning of the section explaining rearrangement of language.

      10 CSR 10-6.140 Restriction of Emissions Credit for Reduced Pollutant
      Concentrations from the Use of Dispersion Techniques

(1) Applicability.

(A) This rule shall apply applies to the procedures to account for emission dispersion techniques used in the calculation of any emission limitation or any revision of any limitation to be established by the director or to be considered for establishment by the Missouri Air Conservation Commission (MACC). This rule also requires that all emission limitations established by the director or by the MACC after December 31, 1970 be reviewed for compliance with this rule.

(B) 40 CFR 51, Appendix W, promulgated as of July 1, 2017 shall apply and is hereby incorporated by reference in this rule, as published by the Office of the Federal Register. Copies can be obtained from the
U.S. Publishing Office Bookstore, 710 N. Capitol Street NW, Washington DC 20401. This rule does not incorporate any subsequent amendments or additions.

(C) Exemptions. The provisions of section (3) of this rule do not apply to emission limitation credits from --

 Stack heights on which construction commenced on or before December 31, 1970, except where pollutants are being emitted from the stacks by source operations which were constructed, reconstructed, or on which major modifications were carried out after December 31, 1970; or

 Dispersion techniques implemented before December 31, 1970, except where these dispersion techniques are being applied to source operations which were constructed, reconstructed, or on which major modifications were carried out after December 31, 1970.

EPA Analysis:  The revisions to section (1) (A)(B)(C) are administrative in nature and do not affect the stringency of the SIP.  See below for explanation of changes.

Applicability (A): This revision is a minor word change from shall apply to applies.

Applicability (B):  This revision adds a reference to the provisions of 40 CFR 51, Appendix W- Guideline on Air Quality Models.

Applicability (C)1-2:  The unchanged language was removed from the "Exemptions" section (3)(A)(B) in the SIP approved rule and placed in the "Applicability" section (C)1 (C)2 in the revised rule.

EPA Notation (addresses the following section): The "General" provisions text in section (2), are stricken through and removed from this section, but the unchanged language is moved down to section (3) in this revised rule. Due to this move, section (2) now becomes, the "Definitions" section.

(2) General

(A) The degree of emission limitation required of any installation for control of any air pollutant must not be affected by that portion of any installation's stack height that exceeds good engineering practice (GEP) or by any dispersion technique, except as provided in section (3) of this rule.

(B) Before the director or the MACC establishes an emission limitation that is based on a GEP stack height that exceeds the formula GEP height allowed by 10 CSR 10-6.020(2)(G)3.B., the director must notify the public of the availability of the demonstration study
and must provide opportunity for public hearing on it.

(C) This rule does not restrict the actual stack height of any installation or the use of any dispersion technique by any
installation.

(2) Definitions.

  Commence -- For the purposes of major stationary source construction or major modification, the owner or operator has all necessary preconstruction approvals or permits and --
 Began, or caused to begin, a continuous program of actual on- site construction of the source, to be completed within a reasonable time; or
 Entered into binding agreements or contractual obligations, which cannot be canceled or modified without substantial loss to the owner or operator, to undertake a program of actual construction of the source to be completed within a reasonable time.

   Dispersion technique --
 Any technique designed to affect the concentration of a pollutant in the ambient air by --
 Using that portion of a stack which exceeds good engineering practice stack height;
 Varying the rate of emission of a pollutant according to atmospheric conditions or ambient concentrations of that pollutant; or
C. Increasing final exhaust gas plume rise by manipulating source process parameters, exhaust gas parameters, stack parameters, or combining exhaust gases from several existing stacks into one (1) stack; or other selective handling of exhaust gas streams so as to increase the exhaust gas plume rise; and
       This definition does not include:
                 The reheating of a gas stream, following use of a pollution control system, for the purpose of returning the gas to the temperature at which it was originally discharged from the installation generating the gas stream;
                 The merging of exhaust gas streams where --
 The installation owner or operator demonstrates that the installation was originally designed and constructed with the merged gas streams;
 After July 8, 1985, the merging is part of a change in operation at the installation that includes the installation of emissions control equipment and is accompanied by a net reduction in the allowable emissions of a pollutant. This exclusion from the definition of dispersion technique shall apply only to the emission limitation for the pollutant affected by a change in operation; or
                   Before July 8, 1985, the merging was part of a
change in operation at the installation that included the
installation of emissions control equipment or was carried out for sound economic or engineering reasons. Where there was an increase in the emission limitation or in the event that no emission limitation was in existence prior to the merging, the director shall presume that merging was significantly motivated by an intent to gain emissions credit for greater dispersion. Without a demonstration by the source owner or operator that merging was not significantly motivated by that intent, the director shall deny credit for the effects of merging in calculating the allowable emissions for the source;

 Smoke management in agricultural or silvicultural prescribed burning programs;
 Episodic restrictions on residential woodburning and open burning; or
 Techniques under subparagraph (2)(B)1.C. of this rule which increase final exhaust gas plume rise where the resulting allowable emissions of sulfur dioxide from the installation do not exceed five thousand (5,000) tons per year.

 Emission limitation -- A regulatory requirement, permit condition, or consent agreement which limits the quantity, rate, or concentration of emissions on a continuous basis, including any requirement which limits the level of opacity, prescribes equipment, sets fuel specifications, or prescribes operation or maintenance procedures for an installation to assure continuous emission reduction.

       Excessive concentration --
 For installations seeking credit for reduced ambient pollutant concentrations from stack height exceeding that defined in paragraph (2)(E)2. of this rule, an excessive concentration is a maximum ground-level concentration due to emissions from a stack due in whole or part to downwash, wakes, or eddy effects produced by nearby structures or nearby terrain features which are at least forty percent (40%) in excess of the maximum concentration experienced in the absence of the downwash, wakes, or eddy effects, and that contributes to a total concentration due to emissions from all installations that is greater than an ambient air quality standard. For installations subject to the prevention of significant deterioration program as set forth in 10 CSR 10-6.060(8), an excessive concentration means a maximum ground-level concentration due to emissions from a stack due to the same conditions as mentioned previously and is greater than a prevention of significant deterioration increment. The allowable emission rate to be used in making demonstrations under this definition shall be prescribed by the new source performance regulation as referenced by 10 CSR 10-6.070 for the source category unless the owner or operator demonstrates that this emission rate is infeasible. Where demonstrations are approved by the director, an alternative emission rate shall be established in consultation with the source owner or operator;
 2. For installations seeking credit after October 11, 1983, for increases in stack heights up to the heights established under paragraph (2)(E)2. of this rule, an excessive concentration is either --
 A maximum ground-level concentration due in whole or part to downwash, wakes, or eddy effects as provided in paragraph (2)(D)1. of this rule, except that the emission rate used shall be the applicable emission limitation (or, in the absence of this limit, the actual emission rate); or
 The actual presence of a local nuisance caused by the stack, as determined by the director; and
 3. For installations seeking credit after January 12, 1979, for a stack height determined under paragraph (2)(E)2. of this rule where the director requires the use of a field study of fluid model to verify good engineering practice stack height, for installations seeking stack height credit after November 9, 1984, based on the aerodynamic influence of cooling towers, and for installations seeking stack height credit after December 31, 1970, based on the aerodynamic influence of structures not represented adequately by the equations in paragraph (2)(E)2. of this rule, a maximum ground level concentration due in whole or part to downwash, wakes, or eddy effects that is at least forty percent (40%) in excess of the maximum concentration experienced in the absence of downwash, wakes, or eddy effects.

 Good engineering practice (GEP) stack height -- The greater of --
 Sixty-five meters (65 m) measured from the ground-level elevation at the base of the stack;
 For stacks on which construction commenced on or before January 12, 1979, and for which the owner or operator had obtained all applicable permits or approvals required under 40 CFR 51 and 52,

                         Hg = 2.5H

 provided the owner or operator produces evidence that this equation was actually relied on in establishing an emission limitation; and for all other stacks,

                         Hg = H + 1.5L

             Where:
 Hg = GEP stack height, measured from the ground-level elevation at the base of the stack;
 H = height of nearby structure(s) measured from the ground-level elevation at the base of the stack; and

 L = lesser dimension, height, or projected width of the nearby structure(s). Provided that the director may require the use of a field study or fluid model to verify GEP stack height for the installation; or
 3. The height demonstrated by a fluid model or field study approved by the director, which ensures that the emissions from a stack do not result in excessive concentrations of any air pollutant as a result of atmospheric downwash, wakes, or eddy effects created by the source itself, nearby structures, or nearby terrain features.

 Major modification -- Any physical change or change in the method of operation at an installation or in the attendant air pollution control equipment that would result in a significant net emissions increase of any pollutant. A physical change or a change in the method of operation, unless previously limited by enforceable permit conditions, shall not include:
 Routine maintenance, repair, and replacement of parts;
  Use of an alternative fuel or raw material by reason of an order under sections 2(a) and (b) of the Energy Supply and Environmental Coordination Act of 1974, a prohibition under the Power Plant and Industrial Fuel Use Act of 1978, or by reason of a natural gas curtailment plan pursuant to the Federal Power Act;
  Use of an alternative fuel or raw material, if prior to January 6, 1975, the source was capable of accommodating the fuel or material, unless the change would be prohibited under any enforceable permit condition which was established after January 6, 1975;
  An increase in the hours of operation or in the production rate unless the change would be prohibited under any enforceable permit condition which was established after January 6, 1975; or
  Use of an alternative fuel by reason of an order or rule under section 125 of the Clean Air Act.

 Nearby -- Nearby, as used in the definition good engineering practice (GEP) stack height in paragraph (2)(E)2. of this rule, is defined for a specific structure or terrain feature --
  For purposes of applying the formula provided in paragraph (2)(E)2. of this rule, nearby means that distance up to five (5) times the lesser of the height or the width dimension of a structure, but not greater than one-half (1/2) mile; and
 For conducting fluid modeling or field study demonstrations under paragraph (2)(E)3. of this rule, nearby means not greater than one-half (1/2) mile, except that the portion of a terrain feature may be considered to be nearby which falls within a distance of up to ten (10) times the maximum height of the feature, not to exceed two (2) miles if feature achieves a height one-half (1/2) mile from the stack that is at least forty percent (40%) of the GEP stack height determined by the formula provided in paragraph (2)(E)2. of this rule, or twenty-six meters (26 m), whichever is greater, as measured from the ground-level elevation at the base of the stack. The height of the structure or terrain feature is measured from the ground-level elevation at the base of the stack.

 Stack -- Any spatial point in an installation designed to emit air contaminants into ambient air. An accidental opening such as a crack, fissure, or hole is a source of fugitive emissions, not a stack.

 Definitions of certain terms in this rule, other than those
specified in this rule section, may be found in 10 CSR 10-6.020.

EPA Analysis: The revisions to section (2) by adding definitions specific to this rule are administrative in nature. EPA reviewed these definitions and concluded they do not substantively change any existing statutory or regulatory requirement or impact the stringency of the SIP or air quality, nor do they impact the State's ability to attain or maintain the National Ambient Air Quality Standards.

EPA Notation (addresses the following section): The "Exemptions" provision text in section (3) are stricken through and removed from this section, but the unchanged language was moved to the "Applicability" section (1)(C) in this revised rule. Due to this move, section (3) now becomes, the "General Provisions" section.

(3) Exemptions. The provisions of section (2) of this rule shall not
apply to:
     (A) Emission limitation credits from stack heights on which construction commenced on or before December 31, 1970, except where pollutants are being emitted from such stacks by source operations which were constructed, or reconstructed, or on which major modifications were carried out after December 31, 1970; or

     (B) Emission limitation credits from dispersion techniques implemented before December 31, 1970, except where such dispersion techniques are being applied to source operations which were constructed or reconstructed, or on which major modifications were carried out after December 31, 1970.

       General Provisions.

  The degree of emission limitation required of any installation for control of any air pollutant must not be affected by that portion of any installation's stack height that exceeds good engineering practice (GEP) or by any other dispersion technique, except as provided in section (1).

 Before the director or the MACC establishes an emission limitation that is based on a GEP stack height that exceeds the formula GEP height allowed by this rule, the director must notify the public of the availability of the demonstration study and must provide opportunity for public hearing on it.

 This rule does not restrict the actual stack height of any installation or the use of any dispersion technique by any installation.

(4) Reporting and Recordkeeping. (Not applicable)

(5) Test Methods. (Not applicable)

EPA Analysis:  The revisions to section (3)(A)(B)(C) are administrative in nature and do not affect the stringency of the SIP.

General Provisions (3)(A)(B)(C):  The unchanged language was moved from section (2) "General" to section (3) in the SIP approved rule.  Section (3) now becomes the "General Provisions" section.


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46614-46615]
[DOCID:fr11au08-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13140-000]

Tidewalker Associates; Notice of Preliminary Permit Applications
Accepted for Filing and Soliciting Comment, Motions To Intervene, and
Competing Applications

August 5, 2008.
    On March 11, 2008, Tidewalker Associates each filed an application,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Quoddy Roads Project, to be located on Lubec
Narrows in Washington County, Maine.
    The proposed Quoddy Roads Project consists of: (1) 179 proposed 210

kilowatt sea-current generating units having a total installed capacity
of 37.95 megawatts, (2) a proposed transmission line, and (3)
appurtenant facilities. The Tidewalker Associates, project would have
an average annual generation of 82.34 gigawatt-hours and be sold to a
local utility.
    Applicant Contact: Mr. Norman Laberge, Tidewalker Associates, 46
Place Cove Road, Trescott, ME, phone<PHONE_NUMBER>.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13140) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-18463 Filed 8-8-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Page 41072]
[FR Doc No: 2018-17761]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-192-000]

North Carolina Electric Membership Corporation v. Duke Energy
Progress, LLC; Notice of Complaint

    Take notice that on August 10, 2018, pursuant to section 206 of the
Federal Power Act, 16 U.S.C. 824e, Rule 206 of the Federal Energy
Regulatory Commission's (Commission) Rules of Practice and Procedure,
18 CFR 385.206 (2018), and section 16.1 of the Fifth Amended and
Restated Power Supply and Coordination Agreement between Duke Energy
Progress, LLC (DEP or Respondent) and the North Carolina Electric
Membership Corporation (NCEMC or Complainant), FERC Rate Schedule No.
182, NCEMC filed a formal complaint against DEP alleging that the
Respondent's Fixed Demand Rate, Variable Demand Rate, and the formula
production rate that will go into effect January 1, 2020, are
excessive, unjust and unreasonable, and not cost-based as required by
the Respondent's Market-Based Rate Tariff, as more fully explained in
the complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent listed on the Commission's list of
Corporate Officials and on the North Carolina Utilities Commission and
the South Carolina Public Service Commission.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 30, 2018.

    Dated: August 13, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-17761 Filed 8-16-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 2, 2009 (Volume 74, Number 39)]
[Notices]
[Page 9098-9099]
[DOCID:fr02mr09-40]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2008-0333]

Delaware River and Bay Oil Spill Advisory Committee; Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting.

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

SUMMARY: The Delaware River and Bay Oil Spill Advisory Committee
(DRBOSAC) will meet in Philadelphia, PA to discuss various issues to
improve oil spill prevention and response strategies for the Delaware
River and Bay. This meeting will be open to the public.

DATES: The Committee will meet on Wednesday, March 18, 2009, from 10
a.m. to 1 p.m. Written material and requests to make oral presentations
should reach the Coast Guard on or before March 11, 2009. Requests to
have a copy of your material distributed to each member of the
committee should reach the Coast Guard on or before March 11, 2009.

ADDRESSES: The Committee will meet at Coast Guard Sector Delaware Bay,
1 Washington Ave., Philadelphia, PA 19147. Send written material and
requests to make oral presentations to Gerald Conrad, liaison to the
Designated Federal Officer (DFO) of the DRBOSAC, at the address above.
This notice and

any documents identified in the Supplementary Information section as
being available in the docket may be viewed online, at http://
www.regulations.gov, using docket number USCG-2008-0333.

FOR FURTHER INFORMATION CONTACT: Gerald Conrad, liaison to the DFO of
the DRBOSAC, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).

Agenda of the Meeting

    The agenda for the meeting will be as follows:
    (1) Opening comments.
    (2) Introductions.
    (3) Administrative announcements.
    (4) Debriefs from each DRBOSAC Sub-committee.
    (5) Future Committee business.
    (6) Closing.

More information and detail on the meeting will be available at the
committee Web site, located at http://www.uscg.mil/d5/sectDelawarebay/
DRBOSAC.asp. Additional detail may be added to the agenda up to March
11, 2009.

Procedural

    This meeting will be open to the public. All persons entering the
building will have to present identification and may be subject to
screening. Please note that the meeting may close early if all business
is finished.
    The public will be able to make oral presentations during the
meeting when given the opportunity to do so. The public may file
written statements with the committee; written material should reach
the Coast Guard no later than March 11, 2009. If you would like a copy
of your material distributed to each member of the committee in advance
of the meeting, please submit 35 copies to the liaison to the DFO no
later than March 11, 2009.
    Please register your attendance with the liaison to the DFO no
later than March 11, 2009.

Information on Services for Individuals With Disabilities

    For information on facilities, or services for individuals with
disabilities, or to request special assistance at the meeting, contact
the Liaison to the DFO as soon as possible.

    Dated: February 22, 2009.
David L. Scott,
Captain, U.S. Coast Guard, Commander, Sector Delaware Bay, Designated
Federal Officer.
[FR Doc. E9-4351 Filed 2-27-09; 8:45 am]

BILLING CODE 4910-15-P


VOLUME 4– Resistance Monitoring Data for 2005 / 2006 Larval
Populations

DATA OBJECTIVES:

	Data from 2005 and 2006 annual resistance monitoring program using
established methods based on collection, culturing and bioassaying of
larval populations collected throughout Arizona should be provided.
Data should be compared to previous years to determine whether there are
any shifts in susceptibility to Cry1 Ac and Cry2 Ab2.

CONTENTS ADDRESSING OBJECTIVES:

 1. DOCUMENT 1	Preliminary Report on Susceptibility of Southwestern Pink
Bollworm to Bt Toxins Cry1AC and Cry2Ab2 in 2005.

(15 pages; attached & labeled)

2. DOCUMENT 2	Susceptibility to Bt Toxins Cry1AC and Cry2Ab2 of
Southwestern Pink Bollworm in 2004.

(21 pages; attached & labeled)

3. DOCUMENT 3	Susceptibility of Southwestern Pink Bollworm to Bt Toxins
Cry1AC and Cry2Ab2:  Final Results of 2003 Season Studies.

(23 pages; attached & labeled)

4. DOCUMENT 4	Susceptibility of Southwestern Pink Bollworm to Cry2Ab:
Baseline Responses in 2001 and 2002.

(12  pages; attached & labeled)


[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7742-7744]
[FR Doc No: 2018-03604]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2029]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Practices and Procedures; Formal
Evidentiary Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on administrative practices and procedures;
formal evidentiary public hearing.

DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-2029 for ``Administrative Practices and Procedures; Formal
Evidentiary Public Hearing.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the

docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35,
and 10.85); Formal Evidentiary Public Hearing (21 CFR 12.22 and 12.45)

(OMB Control Number 0910-0191)--Extension

    The Administrative Procedures Act (5 U.S.C. 553(e)) provides that
every Agency shall give an interested person the right to petition for
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30)
sets forth the format and procedures by which an interested person may
submit to FDA, in accordance with Sec.  10.20 (21 CFR 10.20), a citizen
petition requesting the Commissioner of Food and Drugs (the
Commissioner) to issue, amend, or revoke a regulation or order, or to
take or refrain from taking any other form of administrative action.
    The Commissioner may grant or deny such a petition, in whole or in
part, and may grant such other relief or take other action as the
petition warrants. Respondents are individuals or households, State or
local governments, and not-for-profit institutions or groups.
    Section 10.33 (21 CFR 10.33), issued under section 701(a) of the
Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)),
sets forth the format and procedures by which an interested person may
request reconsideration of part or all of a decision of the
Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of
administrative proceedings). A petition for reconsideration must
contain a full statement in a well-organized format of the factual and
legal grounds upon which the petition relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner. The respondent must submit a petition no later
than 30 days after the decision involved. However, the Commissioner
may, for good cause, permit a petition to be filed after 30 days. An
interested person who wishes to rely on information or views not
included in the administrative record shall submit them with a new
petition to modify the decision. FDA uses the information provided in
the request to determine whether to grant the petition for
reconsideration. Respondents to this collection of information are
individuals of households, State or local governments, not-for-profit
institutions, and businesses or other for-profit institutions who are
requesting from the Commissioner of FDA a reconsideration of a matter.
    Section 10.35 (21 CFR 10.35), issued under section 701(a) of the
FD&C Act, sets forth the format and procedures by which an interested
person may request, in accordance with Sec.  10.20, the Commissioner to
stay the effective date of any administrative action.
    Such a petition must do the following: (1) Identify the decision
involved; (2) state the action requested, including the length of time
for which a stay is requested; and (3) include a statement of the
factual and legal grounds on which the interested person relies in
seeking the stay. FDA uses the information provided in the request to
determine whether to grant the petition for stay of action.
    Respondents to this information collection are interested persons
who choose to file a petition for an administrative stay of action.
    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the
FD&C Act, sets forth the format and procedures by which an interested
person may request, in accordance with Sec.  10.20, an advisory opinion
from the Commissioner on a matter of general applicability. When making
a request, the petitioner must provide a concise statement of the
issues and questions on which an opinion is requested, and a full
statement of the facts and legal points relevant to the request.
Respondents to this collection of information are interested persons
seeking an advisory opinion from the Commissioner.
    FDA has developed a method for electronic submission of citizen
petitions. The Agency still allows for non-electronic submissions;
however, electronic submissions of a citizen petition to a specific
electronic docket presents a simpler and more straightforward approach.
FDA has created a single docket on https://www.regulations.gov, the
U.S. Government's consolidated docket website for Federal Agencies, for
the initial electronic submission of all citizen petitions. The
advantage to this change is that it ensures efficiency and ease in
communication, quicker interaction between citizen petitioners and FDA,
and easier access to FDA to seek input through the citizen petition
process.
    The regulations in 21 CFR 12.22, issued under section 701(e)(2) of
the FD&C Act, set forth the instructions for filing objections and
requests for a hearing on a regulation or order under Sec.  12.20(d)
(21 CFR 12.20(d)). Objections and requests must be submitted within the
time specified in Sec.  12.20(e). Each objection, for which a hearing
has been requested, must be separately numbered and specify the
provision of the regulation or the proposed order. In addition, each
objection must include a detailed description and analysis of the
factual information and any other document, with some exceptions,
supporting the objection. Failure to include this information
constitutes a waiver of the right to a hearing on that objection. FDA
uses the description and analysis to determine whether a hearing
request is justified. The description and

analysis may be used only for the purpose of determining whether a
hearing has been justified under 21 CFR 12.24 and does not limit the
evidence that may be presented if a hearing is granted.
    Respondents to this information collection are those parties that
may be adversely affected by an order or regulation.
    Section 12.45 (21 CFR 12.45), issued under section 701 of the FD&C
Act, sets forth the format and procedures for any interested person to
file a petition to participate in a formal evidentiary hearing, either
personally or through a representative. Section 12.45 requires that any
person filing a notice of participation state their specific interest
in the proceedings, including the specific issues of fact about which
the person desires to be heard. This section also requires that the
notice include a statement that the person will present testimony at
the hearing and will comply with specific requirements in 21 CFR 12.85,
or, in the case of a hearing before a Public Board of Inquiry,
concerning disclosure of data and information by participants (21 CFR
13.25). In accordance with Sec.  12.45(e) the presiding officer may
omit a participant's appearance.
    The presiding officer and other participants will use the collected
information in a hearing to identify specific interests to be
presented. This preliminary information serves to expedite the
prehearing conference and commits participation.
    The respondents are individuals or households, State or local
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
10.30--Citizen petition.........             220               1             220              24           5,280
10.33--Administrative                          6               1               6              10              60
 reconsideration of action......
10.35--Administrative stay of                  6               1               5              10              50
 action.........................
10.85--Requests for Advisory                   4               1               4              16              64
 opinions.......................
12.22--Filing objections and                   5               1               5              20             100
 requests for a hearing on a
 regulation or order............
12.45--Notice of participation..               5               1               5               3              15
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,569
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for this collection of information are based
on Agency records and experience over the past 3 years. The increase in
burden hours is due to an increase in the number of respondents under
several provisions.

    Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03604 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P