[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20537-20542]
[FR Doc No: 2011-8550]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0063; FRL-8867-5]

Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project
4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 13, 2011. Objections and
requests for hearings must be received on or before June 13, 2011, 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-2010-0063. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0063 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 13, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0063, 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 Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7675)
by IR-4, Rutgers, The State University of New Jersey, 500 College Road
East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40
CFR part 180 be amended by establishing tolerances for residues of the
miticide/ovicide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-
dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on peppers,
African eggplant, eggplant, martynia, okra, pea eggplant, pepino,
roselle, and scarlet eggplant at 0.20 ppm; Crop Group 9: Cucurbit
vegetables at 0.20 ppm; Subgroup 13-07A: Caneberry at 1.1 ppm; Subgroup
13-07F: Small fruit vine climbing subgroup except fuzzy kiwi at 0.50
ppm; Subgroup 13-07G: Low-growing berry subgroup at 0.50 ppm and
avocado, papaya, star apple, black sapote, mango, sapodilla, canistel,
and mamey sapote at 0.20 ppm; and tea at 15 ppm. The petition also
proposed to delete the established tolerances in or on strawberry,
grape, cucumber, and vegetable, cucurbit subgroup 9A since

they would be covered by the proposed new tolerances. That notice
referenced a summary of the petition prepared by Valent, the
registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being set and
is setting a subgroup tolerance instead of separate tolerances for some
commodities. It was also determined that the proposed deletion of the
cucurbit subgroup 9A and establishment of a tolerance for the cucurbit
vegetables crop group 9 could not be done due to differences in
tolerance levels between subgroups 9A and 9B. Finally, the tolerance
expression is being revised to be consistent with current Agency
policy. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The existing etoxazole data indicate that it possesses low acute
toxicity via all routes of exposure. It is not an eye or dermal
irritant or a dermal sensitizer. No toxicity was seen at the limit dose
in a 28-day dermal toxicity study in rats.
    The liver is the main target organ in mice, rats and dogs. In a 90-
day toxicity study in dogs, increased liver weights and centrilobular
hepatocellular swelling in the liver were observed. Similar effects
were observed in a chronic toxicity study in dogs at similar doses,
indicating that systemic effects (mainly liver effects) occur at
similar dose levels following short- through long-term exposure without
increasing in severity. In a 90-day toxicity study in mice,
hepatotoxicity (increased relative liver weight, liver enlargement, and
centrilobular hepatocellular swelling) was observed at high doses.
Similar effects were observed at the high dose in a mouse
carcinogenicity study. Subchronic and chronic toxicity studies in rats
produced similar effects (increased liver weights, centrilobular
hepatocellular swelling, etc.) to those seen in mice and dogs. In
addition, slight increases in thyroid weights and incisors were
observed in subchronic and chronic toxicity studies in rats at high
doses and at terminal stages of the study. Toxicity was not observed at
the highest dose tested (HDT) in another carcinogenicity study in mice.
There is no evidence of immunotoxicity or neurotoxicity in any of the
submitted studies.
    Two studies in mice showed no evidence of carcinogenicity up to the
HDT. In a rat carcinogenicity study, which was deemed unacceptable due
to inadequate dosing, benign interstitial cell tumors (testis) and
pancreas benign islet cell adenomas were observed (in females) at the
high dose. These effects were not observed in an acceptable
carcinogenicity study in rats at higher doses. In special mechanistic
male rat studies there were no observable changes in serum hormone
levels (estradiol, luteinizing hormone (LH), prolactin and
testosterone) or reproductive effects (interstitial cell proliferation
or spermatogenesis) noted. EPA classified etoxazole as ``not likely to
be carcinogenic to humans.'' Etoxazole is not mutagenic.
    The toxicology data for etoxazole provides no indication of
increased susceptibility, as compared to adults, of rat and rabbit
fetuses to in utero exposure in developmental studies. The rabbit
developmental toxicity study included maternal toxic effects (liver
enlargement, decreased weight gain, and decreased food consumption) at
the same dose as developmental effects (increased incidences of 27
presacral vertebrae and 27 presacral vertebrae with 13th ribs). In the
2-generation reproduction study conducted with rats, offspring toxicity
was more severe (pup mortality) than parental toxicity (increased liver
and adrenal weights) at the same dose, indicating increased qualitative
susceptibility.
    Specific information on the studies received and the nature of the
adverse effects caused by etoxazole as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-0063 in the
document titled Etoxazole; ``Human Health Risk Assessment for Proposed
Tolerances and Uses on Peppers (Bell and Non-bell); Squash/Cucumbers
(Subgroup 9B); Avocado; Tropical and Subtropical Fruits (Inedible
Peel); Caneberry Subgroup 13-07A; Small Fruit Vine Climbing, Except
Kiwifruit, Subgroup 13-07F; Low-growing Berry, Subgroup 13-07G; and
Tea,'' pp. 29-31.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency

estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for etoxazole used for
human risk assessment is shown in the following Table:

    Table--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (Females 13-50 years of  A dose and endpoint attributable to a single dose were not identified in
 age and general population including   the database including the developmental toxicity studies.
 infants and children).
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Chronic dietary (All populations)....  NOAEL = 4.62 mg/kg/day   Chronic RfD = 0.046 mg/  Chronic Oral Toxicity
                                        UFA = 10x.               kg/day.                  Study-Dog LOAEL = 23.5
                                       UFH = 10x..............  cPAD = 0.046 mg/kg/day.   mg/kg/day based upon
                                       FQPA SF = 1x...........                            increased alkaline
                                                                                phosphatase activity,
                                                                                increased liver
                                                                                weights, liver
                                                                                enlargement (females),
                                                                                and incidences of
                                                                                centrilobular
                                                                                hepatocellular
                                                                                swelling in the liver.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFDB = to account for the absence of data or other data deficiency.
  FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).
  RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in 40 CFR
180.593. EPA assessed dietary exposures from etoxazole in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
etoxazole; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys for Food Intake by Individuals (CSFII). As
to residue levels in food, an unrefined, chronic dietary exposure
assessment was performed for the general U.S. population and various
population subgroups using tolerance-level residues for all
agricultural commodities and 100 percent crop treated (PCT).
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, Cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or non-linear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that etoxazole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etoxazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etoxazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of etoxazole for
chronic exposures for non-cancer assessments are estimated to be 4.761
parts per billion (ppb) for surface water and 0.318 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 4.761 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Etoxazole is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found etoxazole to share a common mechanism of toxicity
with any other substances, and etoxazole does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that etoxazole does not
have a

common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10x, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicology data for
etoxazole provides no indication of increased susceptibility, as
compared to adults, of rat and rabbit fetuses to in utero exposure in
developmental studies. In a rat reproduction study, offspring toxicity
was more severe (pup mortality) than parental toxicity (increased liver
and adrenal weights) at the same dose; thereby indicating increased
qualitative susceptibility. Based on the concerns in this unit, a
Degree of Concern Analysis was performed by EPA, which concluded that
concern is low since:
    i. The effects in pups are well-characterized with a clear NOAEL;
    ii. The pup effects occur at the same dose as parental toxicity;
and
    iii. The doses selected for various risk assessment scenarios are
lower (~3000-fold lower) than the doses that caused offspring toxicity
in the rat 2-generation reproduction study. Therefore, the endpoints
selected for risk assessment are protective of the effects seen in the
rat reproduction study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for etoxazole is complete except for acute
and subchronic neurotoxicity and immunotoxicity studies. Changes to 40
CFR 180.158 make acute and subchronic neurotoxicity testing (OPPTS
Guideline 870.6200), and immunotoxicity testing (OPPTS Guideline
870.7800) required for pesticide registration. Although these studies
are not yet available for etoxazole, the available data do not show any
evidence of treatment-related effects on the immune system. Further,
there is no evidence of neurotoxicity in any study in the toxicity
database for etoxazole. Therefore, EPA does not believe that conducting
neurotoxicity and immunotoxicity studies will result in a NOAEL lower
than the NOAEL of 4.62 mg/kg/day already established for etoxazole.
Consequently, an additional database uncertainty factor does not need
to be applied.
    ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased
susceptibility of offspring (pup mortality) compared to less severe
parental effects (increased liver and adrenal weights) at the same dose
in the rat multi-generation reproduction study, the Agency did not
identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs (10x for interspecies variation and 10x
for intraspecies variation) to be used in the risk assessment.
Therefore, there are no residual concerns regarding developmental
effects in the young.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to etoxazole in drinking water. These assessments
will not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 11% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for etoxazole.
    3. Short and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    A short- and/or intermediate-term adverse effect was identified;
however, etoxazole is not registered for any use patterns that would
result in short- and/or intermediate-term residential exposure. Short-
and/or intermediate-term risk is assessed based on short- and/or
intermediate term residential exposure plus chronic dietary exposure.
Because there is no short- and/or intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess short- and/or intermediate-term risk), no
further assessment of short- and/or intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short- and/or intermediate-term risk for etoxazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, etoxazole is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) and gas chromatography/mass selective
detection (GC/MSD) methods) are available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical

Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

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

C. Response to Comments

    EPA received a comment from a private citizen expressing concerns
for genetically modified vegetables and undue risks from pesticides.
However, this action does not involve use of genetically modified
vegetables. Additionally, when new or amended tolerances are requested
for the presence of the residues of a pesticide and its toxicologically
significant metabolite(s) in food or feed, the Agency, as is required
by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA),
estimates the risk of the potential exposure to these residues by
performing an aggregate risk assessment. Such a risk assessment
integrates the individual assessments that are conducted for food,
drinking water, and residential exposures. Additionally, the Agency, as
is further required by section 408 of the FFDCA, considers available
information concerning what are termed the cumulative toxicological
effects of the residues of that pesticide and of other substances
having a common mechanism of toxicity with it. The Agency has concluded
after this assessment that there is a reasonable certainty that no harm
will result from exposure to the residues of interest. Therefore, the
proposed tolerances are found to be acceptable. These assessments
consider body residue loads of the pesticide, as well as available
information concerning the potential that other substances have a
common mechanism of toxicity, in reaching a conclusion as to whether or
not the reasonable certainty of no harm decision can be made.

D. Revisions to Petitioned-for Tolerances

    Upon review of the data supporting the petition, EPA revised the
tolerance for caneberry subgroup 13-07A from 1.1 ppm to 1.5 ppm based
on analysis of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data.
    The Agency also corrected the commodity definition from ``fruit,
small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit'' to
``fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-
07F.''
    EPA has also determined that the petitioned-for tolerance on tea at
15 ppm should be established as a tolerance with no U.S. registrations
on tea, dried at 15 ppm. At least one U.S. residue field trial study is
required to establish a domestic registration on tea; however, no U.S.
residue field trial data were submitted in support of the use of
etoxazole on tea. Therefore, the Agency has established a tolerance
with no U.S. registrations on tea, dried at 15 ppm.
    Additionally, IR-4 petitioned for individual tolerances on peppers,
African eggplant, eggplant, martynia, okra, pea eggplant, pepino,
roselle, and scarlet eggplant (PP 9E7675). In the Federal Register of
December 8, 2010 (75 FR 76284-76292) (FRL-8853-8), EPA issued a final
rule that revised the crop grouping regulations. As part of this
action, EPA retained the pre-existing Crop Group 8 and added a new
group titled ``Crop Group 8-10 Fruiting Vegetable Group.'' The new crop
group 8-10 added new commodities and created new subgroups (including a
subgroup consisting of the commodities requested in PP 9E7675). EPA
indicated in the December 8, 2010 final rule as well as the earlier
January 6, 2010 proposed rule (75 FR 807) (FRL-8801-2) that, for
existing petitions for which a Notice of Filing had been published, the
Agency would attempt to conform these petitions to the rule. Therefore,
consistent with this rule, EPA is establishing a tolerance on the
pepper/eggplant subgroup 8-10B. EPA concludes it is reasonable to
establish the tolerance on the newly created subgroup, since the
individual commodities for which tolerances were requested are
identical to those which comprise the pepper/eggplant subgroup 8-10B.
    Also, because of differences in the tolerance levels between
subgroup 9A (melon subgroup) and 9B (squash/cucumber subgroup), the two
cannot be combined into a single tolerance under Crop Group 9 Cucurbit
Vegetables as proposed in the petition. Accordingly, other than the
nomenclature change to the existing subgroup 9A tolerance noted below,
EPA is leaving the existing subgroup 9A tolerance intact and adding a
new tolerance for subgroup 9B. In order to use the correct
nomenclature, the existing tolerance for ``vegetable, cucurbit subgroup
9A'' is being re-named ``melon subgroup 9A.''
    Finally, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of etoxazole not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on pepper/eggplant subgroup 8-10B at 0.20 ppm;
tea, dried at15 ppm; berry, low growing, subgroup 13-07G at 0.50 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
0.50 ppm; squash/cucumber subgroup 9B at 0.02 ppm; avocado at 0.20 ppm;
papaya at 0.20 ppm; star apple at 0.20 ppm; sapote, black at 0.20 ppm;
mango at 0.20 ppm; sapodilla at 0.20 ppm; canistel at 0.20 ppm; sapote,
mamey at 0.20 ppm; and caneberry subgroup 13-07A at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under 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 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 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: April 1, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.593 is amended by:
0
i. Revising the introductory text in paragraph (a);
0
ii. Removing the commodities ``Cucumber,'' ``Grape'' and ``Strawberry''
from the table in paragraph (a);
0
iii. Revising the entry ``Vegetable, cucurbit subgroup 9A'' to read
``Melon subgroup 9A'' in the table; and
0
iv. Alphabetically adding the following commodities to the table in
paragraph (a) to read as follows:

Sec.  180.593  Etoxazole; tolerances for residues.

    (a) General. Tolerances are established for residues of etoxazole,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only etoxazole (2-(2,6-
difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole) in or on the commodity.

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

                                * * * * *
Avocado...................................................          0.20
Berry, low growing, subgroup 13-07G.......................          0.50
Caneberry subgroup 13-07A.................................          1.5
Canistel..................................................          0.20

                                * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.50
 subgroup 13-07F..........................................

                                * * * * *
Mango.....................................................          0.20
Melon subgroup 9A.........................................          0.20

                                * * * * *
Papaya....................................................          0.20
Pepper/eggplant subgroup 8-10B............................          0.20

                                * * * * *
Sapodilla.................................................          0.20
Sapote, black.............................................          0.20
Sapote, mamey.............................................          0.20

                                * * * * *
Squash/cucumber subgroup 9B...............................          0.02
Star apple................................................          0.20

                                * * * * *
Tea, dried *..............................................         15

                                * * * * *
------------------------------------------------------------------------
* There are currently no U.S. registrations for tea as of April 13,
  2011.

* * * * *
[FR Doc. 2011-8550 Filed 4-12-11; 8:45 am]
BILLING CODE 6560-50-P


  Short-Chain Chlorinated Paraffins (SCCPs) and Other Chlorinated
Paraffins

Action Plan

I. Overview

SCCPs are found world-wide in the environment, wildlife and humans. They
are bioaccumulative in wildlife and humans, are persistent and
transported globally in the environment, and toxic to aquatic organisms
at low concentrations. Based on these factors, as well as the
availability of viable substitutes for certain uses of SCCPs, EPA
intends to initiate action to address the manufacturing, processing,
distribution in commerce, and use of SCCPs.

EPA intends to further evaluate whether the manufacturing, processing,
distribution in commerce and/or use of medium chained chlorinated
paraffins (MCCPs) and long-chained chlorinated paraffins (LCCPs) should
also be addressed.

As part of the Agency's efforts to address SCCPs, EPA also intends to
evaluate the potential for disproportionate impact on children and other
sub-populations.

II. Introduction

As part of EPA’s efforts to enhance the existing chemicals program
under the Toxic Substances Control Act (TSCA)1, the Agency identified an
initial list of widely recognized chemicals, including SCCPs, for action
plan development based on their presence in humans; persistent,
bioaccumulative, and toxic (PBT)2 characteristics; use in consumer
products; production volume; or other similar factors. This Action Plan
is based on EPA’s initial review of readily available use, exposure,
and hazard information on SCCPs. EPA considered which of the various
authorities provided under TSCA and other statutes might be appropriate
to address potential concerns with SCCPs in developing the Action Plan.
The Action Plan is intended to describe the courses of action the Agency
plans to pursue in the near term to address its concerns. The Action
Plan does not constitute a final Agency determination or other final
Agency action. Regulatory proceedings indicated by the Action Plan will
include appropriate opportunities for public and stakeholder input,
including through notice and comment rulemaking processes.

III. Scope of Review

For the purposes of this action plan, SCCPs include the chlorinated
paraffins that meet the following definition:

CxH(2x-y+2)Cly

where x = 10-13;

y = 3-12; and

the average chlorine content ranges from approximately 40 to 70 percent
with the limiting molecular formulas set at C10H19Cl3 and C13Hl6Cl12.
Any individual chemical meeting this definition is considered an SCCP
and is covered by this action plan. Furthermore, this action plan covers
any chemical substance or mixture that contains a chemical that meets
the definition. For example, CAS registry number (CASRN) 63449-39-8
(Paraffin waxes and hydrocarbon waxes, chlorinated) denotes chlorinated
paraffin waxes of unspecified carbon chain length and unspecified degree
of chlorination. If a portion of that chemical substance falls within
the definition of SCCPs then the entire substance would be subject to
this action plan. Likewise, CASRN 71011-12-6 named (Alkanes, C12-13,
chloro) would only contain chemicals that meet the alkyl range described
in the definition and would be subject to the action plan if any of the
chlorine content were consistent with the 40 to 70 percent criteria.

1 15 U.S.C. 2 Information on PBT chemicals can be found on the EPA
website at      http://www.epa.gov/pbt/.

Medium chained chlorinated paraffins (MCCP; C14-17 alkyl chain) and
long-chained chlorinated paraffins (LCCP; generally C18 - 28) are also
discussed in this action plan.

Only four chlorinated fractions are on the TSCA Inventory [Alkanes,
C6-18, chloro (CASRN 68920-70-7); Alkanes, C12-13, chloro (CASRN
71011-12-6); Alkanes, chloro (CASRN: 61788-76-9); Paraffin waxes and
Hydrocarbon waxes, chloro (CASRN 63449-39-8)] (EPA, 2006). Other CASRNs
associated with SCCPs are not on the TSCA Inventory. The CASRNs
associated with certain MCCPs and LCCPs are also not on the TSCA
Inventory.

IV. Uses and Substitutes Summary

The current use of chlorinated paraffins (SCCP, MCCP, and LCCP) in the
United States is on the order of 150 million pounds per year. Production
of short-chain and medium-chained chlorinated paraffins (C9 to C17) was
100 million pounds in 2007. A very small fraction of that number is
attributable to import/export business. According to the Chlorinated
Paraffins Industry Association, MCCPs represent the largest production
and use of chlorinated paraffins in North America while SCCPs is only
half that volume (CPIA, 2009). Marketing and use of SCCP has been
restricted in the European Union (ECHA 2008a). In Canada, SCCPs are not
currently manufactured and use was approximately 3000 metric tons in
2000 and 2001, the latest figures reported (Environment Canada, 2008).
In the United States, Dover Chemical Corp. is the sole manufacturer of
chlorinated paraffins and several companies import SCCPs (EPA, 2006).

The largest use of SCCPs in the United States is as a component of
lubricants and coolants in metal cutting and metal forming operations.
The second-largest use is as both a secondary plasticizer and a flame
retardant in plastics, especially PVC. Other minor domestic SCCP uses
are as a plasticizer and a flame-retardant additive to a variety of
products including: rubber formulations, paints and other coatings, and
adhesives and sealants (CPIA, 2009). For safety reasons, other countries
(those in the European Union and Canada) have allowed SCCPs to be used
as a flame retardant in underground mining conveyor belts (rubber
formulations) and fire retardants in dam sealants (ECHA 2008a).

MCCPs are alternatives to SCCPs for many applications. Based on their
physical-chemical properties, MCCPs are also expected to be persistent
in the environment and several field surveys have shown they are present
in sediments and biota, demonstrating their release to and persistence
in the environment. Field-measured bioaccumulation factors (BAFs) that
are greater than 5000 and biomagnification factors (BMF) greater than 1
indicate that MCCPs are bioaccumulative in biota and can biomagnify in
food chains (UNEP, 2009). MCCPs have toxicity to sensitive aquatic
organisms that is similar to SCCPs. Canada has concluded that MCCPs are
“toxic” as defined by the Canadian Environmental Protection Act
(CEPA) (Government of Canada 2008). The European Union’s 2005 Risk
Assessment Report and 2007 draft update conclude that there is a need
for limiting the risks posed by certain uses of MCCPs in the production
of PVC and metal cutting (EC, 2005, 2007).

LCCPs appear to have been used as alternatives to SCCPs in some of the
more demanding metal working applications (HELCOM, 2002). LCCPs also
appear to have potential as an alternative in leather, paints and
coatings, sealants and rubber applications. LCCPs are expected to be
persistent and bioaccumulative in the environment based on their
physical-chemical properties and bioaccumulation modeling, respectively.
Canada has concluded that LCCPs up to C20 are “toxic” as defined by
CEPA (Government of Canada 2008).Canada has not made a determination of
whether LCCPs greater that C20 are toxic.

A number of other potential alternatives, e.g. nitroalkanes, alkyl
phosphate and sulfonated fatty acid esters and vegetable oil based
products, are available for specific applications. It is stated that
these alternatives are considered less harmful than chlorinated
paraffins (UNECE, 2006). These non-chlorinated paraffin alternatives are
often more expensive and may require special handling. A UK estimated
cost for completely converting SCCPs to non-SCCPs in metal working was
predicted to be four million

V. Hazard Identification Summary

Human Health Effects

Acute toxicity of SCCPs (C10-13) is very low (EC, 1999; UNEP, 2009).
SCCPs may cause skin and eye irritation upon repeated application, but
do not appear to induce skin sensitization (EC, 1999; UNEP, 2009). There
was no evidence of developmental effects in prenatal developmental
toxicity studies in rats and rabbits (EC, 1999; UNEP, 2009).

The liver, kidney and thyroid are major target organs in repeated-dose
studies with rats and mice. When administered by gavage, chlorinated
paraffins (C12, 60 percent chlorine) are carcinogenic in rats and mice
of both sexes (NTP, 1986a; 2005). The underlying mechanisms for the
carcinogenicity of SCCP in rats and mice are not clearly known. SCCPs
were not mutagenic to bacteria with or without metabolic activation (NTP
1986a, b). There are some indications that the SCCP-induced kidney
tumors in male rats are associated with alpha 2μ

There is no experimental evidence using human data that demonstrates the
carcinogenicity of SCCPs. In the 11th Report on Carcinogens, NCI lists
chlorinated paraffins (C12, 60 percent chlorine) as reasonably
anticipated to be human carcinogens based on sufficient evidence of
carcinogenicity in experimental animals (NTP, 2005). They are classified
by the IARC as Group 2B - possibly carcinogenic to humans based on
sufficient evidence of carcinogenicity in experimental animals and
mechanistic considerations (IARC, 1990).

Health Canada and Environment Canada have characterized all chlorinated
paraffins (SCCPs, MCCPs and LCCPs) as “toxic” under CEPA (Government
of Canada 2008).

A recent compilation of toxicity data indicates the acute toxicity of
MCCPs is low and they are not genotoxic. Prenatal developmental toxicity
studies in rats and rabbits showed reduced fetal body weight. A
reproductive toxicity study also showed postnatal developmental toxicity
as demonstrated by reduced pup body weight, as well as reduced pup
survival at higher doses; there was no evidence of reproductive
toxicity. Repeated-dose studies in rats and dogs showed effects on the
liver (ECHA, 2008a).

Environmental Effects

SCCPs are highly toxic to aquatic invertebrates following acute (48-hr
EC50 = 0.043 to 11 mg/L) and chronic (NOEC = 0.005 to 2 mg/L) exposures.
In fish high toxicity is associated with chronic exposures, but not for
acute exposures (96-hr LC50 = 300 to 10,000 mg/L and NOEC = 0.0096 to
0.05 mg/L). For aquatic plants, there is high toxicity associated with
both acute and chronic exposures to SCCPs (96-hr EC50s range from 0.043
to 0.39 mg/L and NOEC ranges from 0.012 to 0.39 mg/L) (UNEP, 2009).

Both Health Canada and Environment Canada have characterized all
chlorinated paraffins (SCCPs, MCCPs and LCCPs) as “toxic” under CEPA
(Government of Canada 2008).

VI. Physical-Chemical Properties and Fate Characterization Summary

EPA has gathered information on the water solubility, vapor pressure,
Henry’s Law constant, and partition coefficient (log Kow) data for
several different SCCP molecular formulae to characterize the SCCPs
category (Environment Canada, 2008; HSDB, 2008; UNEP, 2009). In general,
water solubility decreases and Henry’s Law Constant and log Kow of
SCCPs increase with increasing carbon chain length and increasing
chlorine content. Short- and medium- chain length chlorinated paraffins
are liquids while longer chain, higher chlorinated paraffins are solids.
The SCCPs are viscous liquids at room temperature and normal pressure.
Vapor pressure of chlorinated paraffins generally decreases with
increasing MW (a function of number of chlorine atoms). All chlorinated
paraffins have low to negligible water solubility but the lower
molecular weight chlorinated paraffins can be emulsified by adding an
organic co-solvent. The octanol-water partition coefficients (log Kow)
of chlorinated paraffins range from 4.5 to 12, with SCCPs log Kows
ranging from approximately 4.5 to 7.4. The log Kows are generally above
5, the criteria used by many national and international authorities to
indicate potential for bioaccumulation because it can be readily
measured and calculated on the basis of structure (UNEP, 2009).

SCCPs are persistent and bioaccumulative in the environment. The
Persistence Organic Pollutant Review Committee (POPRC) of the Stockholm
Convention has concluded that SCCPs fulfill the persistence and
bioaccumulation criteria put forth in Annex D of the Stockholm
Convention on Persistent Organic Pollutants (UNEP, 2009). The EU has
concluded that SCCPs meets its criteria for both persistent and
bioaccumulative (PB) substance and a very persistent, very
bioaccumulative (vPvB) substance (ECHA 2008b). Canada has also concluded
SCCPs are persistent and bioaccumulative (Environment Canada 2008).

SCCPs released to the atmosphere are expected to exist in the vapor and
particulate phase in the ambient atmosphere given the range of vapor
pressures reported for these substances. Vapor phase constituents are
degraded in air by reaction with hydroxyl radicals with half-lives of
less than one to slightly greater than ten days. A half-life greater
than about two days in the atmosphere can be a significant factor in
facilitating long-range transport of persistent chemicals.

SCCPs released to water are expected to adsorb to sediment and suspended
particulate matter based on log Koc values. They are stable to
hydrolysis and photolysis. Volatilization from water is expected to be
moderate based on estimated Henry’s Law constants of the individual
congeners; however, adsorption to suspended solids and sediment in the
water column may attenuate the rate of volatilization. No degradation
was observed in sediments under anaerobic conditions. Detection of SCCPs
in sediment cores dating back to the 1940s provides evidence that SCCPs
are persistent (UNEP, 2009).

SCCPs released to soil are expected to have low mobility given their log
Koc. Volatilization from moist soil surfaces is expected to be moderate
based on estimated Henry’s Law constants of the individual congeners;
however, adsorption may attenuate the rate of volatilization.

Measured data indicate SCCPs bioaccumulate in biota. High
bioconcentration factors (BCFs) have been measured, ranging from 1,000
to 50,000 for whole body and/or individual tissues in a variety of
freshwater and marine organisms (Environment Canada, 2008; UNEP, 2009).
Field-derived bioaccumulation factors (BAFs) over one million were
measured for vertebrate species collected from the Great Lakes and in
arctic marine mammals (Environment Canada, 2008; UNEP, 2009).

The Henry’s Law constant values for SCCPs imply partitioning from
water to air or from moist soils to air, depending on environmental
conditions and prevailing concentrations in each compartment. Evidence
that SCCPs undergo such transport is provided by findings that they are
globally dispersed in the environment and appear in the Arctic (H

VII. Exposure Characterization Summary

Releases

SCCPs have the greatest potential for environmental release and exposure
of the chlorinated paraffins. The likely sources of releases for SCCPs
are identified as manufacturing and lubricant applications. In 2000 and
2001, nearly all usage of SCCPs was reported to be in metalworking
applications. Losses from the use of SCCPs in paint and sealants are
generally regarded as much lower than those from metalworking. Releases
of SCCPs may occur during production, storage, transportation,
industrial and consumer use of chlorinated paraffin-containing products,
disposal and burning of waste, leaching, runoff or volatilization from
landfills, and sewage sludge or other waste disposal sites (Tomy et al.,
1998).

Major sources of releases of chlorinated paraffins into the environment
are likely the formulation and manufacturing of products containing
chlorinated paraffins and use in metalworking fluids as an extreme
pressure additive. EPA estimated releases of SCCPs during metalworking
fluid use using generic scenario methodology. Releases to wastewater
were estimated to be approximately 2,400 kg/site-yr from container
cleaning, dragout (fluid that remains on the part after shaping),
disposal of filter media and spent metalworking fluid. Releases to
landfill and incineration from these same release sources were estimated
to be approximately 900 kg/site-yr using the generic site methodology.
Incinerators would not be as significant a source.

The possible sources of releases to water from manufacturing include
spills, facility wash down and drum rinsing/disposal. Chlorinated
paraffins in metalworking/metal cutting fluids may also be released to
aquatic environments from drum disposal, carry-off and spent bath. These
releases often ultimately end up in the effluents of sewage treatment
plants. In comparison to river and lake sediments, concentrations of
SCCPs/MCCPs in sewage sludge are much higher, especially from waste
water treatment plants serving industrial areas.

Human Exposure

The primary non-occupational routes of exposure to SCCPs include
ingestion, both directly and through contaminated food, and dermal
contact with products. Chlorinated paraffins have been isolated from
human liver, kidneys, adipose tissue and breast milk. Due to their
potential for environmental transport, SCCP exposure may occur from
sources far from their use and release. For example, SCCPs have been
found in breast milk samples taken from Inuit women (UNEP, 2009).

There is potential for inhalation exposure to SCCPs in metalworking
fluids from mists generated during metal shaping operations. EPA
estimated that potential inhalation exposure ranges from 1.8 to 8.3
mg/day for this scenario. There is also potential inhalation exposure to
mists in uses where products containing SCCPs are spray applied such as
in paints, adhesives and sealants.

EPA estimated the potential for occupational dermal exposure for various
manufacturing, formulation and use scenarios to range up to 1800 mg/day.
These exposures could be mitigated by the use of personal protection
equipment, such as gloves that have been demonstrated to be effective in
preventing permeation by SCCPs and formulations containing SCCPs.

Environmental Exposure

In 1986, EPA/OPPT conducted a monitoring study of Sugar Creek near the
Dover Chemical manufacturing facility in Dover, Ohio (Murray et al.,
1988). SCCP concentrations of 0.21

As summarized in a draft Risk Profile prepared by the POPs Review
Committee of the Stockholm Convention, SCCPs have been measured in a
variety of environmental media including air, sediment, surface waters,
and wastewater in North America, Europe, Japan, and/or the Arctic (UNEP,
2009).

SCCPs have also been measured in a variety biota, including freshwater
aquatic species from North America, Europe and the Arctic, marine
mammals from several locations in Canada and the Arctic, and avian and
terrestrial wildlife in Europe. In addition, SCCPs have been detected in
samples of human breast milk from Canada and the United Kingdom, as well
as in a variety of food items from Japan and various regions of Europe
(UNEP, 2009).

VIII. Risk Management Considerations

SCCPs continue to be manufactured, imported, processed and used in
industrial applications in the United States. SCCPs are persistent,
bioaccumulative, and toxic to aquatic organisms at low concentrations.
The persistence and bioaccumulative properties of SCCPs increase the
probability and duration of exposure such that even relatively small
releases from individual facilities that manufacture, import, process or
use them or from waste management facilities have the potential to
accumulate over time to levels that cause significant adverse impacts on
the environment. Thus, a snapshot of industrial and other releases of
SCCPs will underestimate the environmental loadings and burden in biota,
and thus potential risks. Indeed, SCCPs have been measured in biota and
various environmental media, including in terrestrial as well as aquatic
organisms.

Other chlorinated paraffins such as MCCPs and LCCPs can be used as
substitutes for SCCPs. They are also persistent and bioaccumulative
although they have lower water solubilities than SCCPs. They have also
been measured in environmental media and biota. The toxicity of MCCPs
and LCCPs may appear to be lower based on their lower solubility and
bioavailability, however, their toxicity is generally not as well
characterized as for the SCCPs.

There are no specific impacts on children associated with chlorinated
paraffins.

IX. Next Steps

EPA is addressing the discrepancy between the specific chlorinated
paraffins companies are actually manufacturing or importing and those
listed on the TSCA Inventory. Only some of the chlorinated paraffin
fractions being manufactured or imported are on the TSCA Inventory. EPA
intends to require companies to submit Pre-Manufacture Notices for the
SCCPs, MCCPs, and LCCPs fractions that are not on the TSCA Inventory.
If appropriate, EPA will initiate action under TSCA section 5 to address
the risks posed by such SCCPs, and potential risks associated with MCCPs
and LCCPs.  EPA plans to explore these questions in the near future.

Concurrently, EPA intends to consider initiating action under TSCA
section 6(a) to ban or restrict the manufacture, import, processing or
distribution in commerce, export, and use of SCCPs based on the
persistence, bioaccumulation and toxicity of SCCPs and their presence in
the environment.  EPA will develop more detailed assessments to support
the TSCA section 6(a) “presents or will present an unreasonable
risk” findings.  If these more detailed assessments indicate that a
different approach to risk management is appropriate, EPA will consider
additional approaches.

EPA intends to further evaluate whether the manufacturing, processing,
distribution in commerce, use and/or disposal of MCCPs and LCCPs should
also be addressed under TSCA section 6(a).

As part of the Agency's efforts to address these chemicals of concern,
EPA intends to evaluate the potential for disproportionate impact on
children and other sub-populations.

X. References

CPIA. 2009. Chlorinated Paraffins Industry Association.  Chlorinated
Paraffins: A Status Report.
http://www.regnet.com/cpia/status_report.html (accessed Apr 1, 2009).

EC. 2008. European Commission. European Union Risk Assessment Report
Alkanes, C10-13, chloro, CAS No. 85535-84-8.  Volume 81.  EUR 23396 EN.
Office for Official Publications of the European Communities:
Luxembourg, 2008.

EC. 2007. European Commission. European Union Risk Assessment Report
Alkanes, C14-17, chloro, (Medium-Chain Chlorinated Paraffins), CAS No.
85535-85-9. Draft Environment Addendum of August 2007. R331_0807_env.

http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT
/ADDENDUM/mccp_add_331.pdf (accessed Dec 22, 2009).

EC. 2005. European Commission. Updated Risk Assessment of Alkanes,
C14-17, chloro, (MCCP), Part I Environment, CAS No. 85535-85-9.  Volume
58.  EUR 21640 EN. Office for Official Publications of the European
Communities:  Luxembourg, 2005.

EC. 1999. European Commission. European Union Risk Assessment Report
Alkanes, C10-13, chloro, CAS No. 85535-84-8.  Volume 4. EUR 19010EN.
Office for Official Publications of the European Communities:
Luxembourg, 2008.

ECHA. 2008a. European Chemicals Agency. Data on Manufacture, Import,
Export, Uses and Releases of Alkanes, C10-13, chloro, SCCPs.as well as
Information on Potential Alternatives to Its Use.
http://echa.europa.eu/doc/consultations/recommendations/tech_reports/tec
h_rep_alkanes_chloro.pdf (accessed Dec 11, 2009).

ECHA. 2008b. European Chemicals Agency. Agreement of the Member State
Committee on Identification of Alkanes, C10-13, chloro (SCCP) as a
Substance of Very High Concern.  Adopted on 8 October 2008.
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[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Proposed Rules]
[Pages 4090-4092]
[FR Doc No: 2013-01004]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0018; Directorate Identifier 2010-SW-060-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Eurocopter Deutschland GmbH (Eurocopter) Model MBB-BK 117 C-2
helicopters. This proposed AD would require determining if a certain
serial-numbered bevel gear is installed in the tailrotor intermediate
gear box (IGB). If such a bevel gear is installed in the IGB, this AD
would require recording the bevel gear's reduced life limit in the
Airworthiness Limitations section of the maintenance manual and on the
component history card or equivalent IGB record. If the bevel gear's
life limit has been reached or exceeded, this AD

would require, before further flight, replacing the bevel gear with an
airworthy bevel gear. This proposed AD is prompted by the discovery
that the tooth foot fillets in certain bevel gears fell below the
minimum dimensions required in the design documents to ensure safe
functioning of the bevel gear until reaching its approved life limit.
The proposed actions are intended to prevent failure of a bevel gear
before reaching its currently approved life limit, failure of the IGB,
and subsequent loss of helicopter control.

DATES: We must receive comments on this proposed AD by March 19, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Chinh Vuong, Aviation Safety Engineer,
Safety Management Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2010-0096, dated May 25, 2010, to correct an unsafe condition for
Eurocopter Model MBB-BK 117 C-2 helicopters. EASA advises that during a
recent review of the production documents for the bevel gears of the
IGB, it was discovered that certain production batch numbers have tooth
foot fillets below the required minimum values that would ensure the
approved life limits for this part.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information

    Eurocopter has issued Alert Service Bulletin No. MBB BK117 C-2-04A-
005, Revision 2, dated April 28, 2010 (ASB). The ASB specifies
determining whether certain serial-numbered bevel gears are installed
in the IGB. The ASB specifies recording the reduced life limit for each
affected bevel gear on the log card of the IGB and on the list of life-
limited parts. If a bevel gear has one of the serial numbers listed in
Table 1 of the ASB, the ASB specifies filling out a reply form and
copying and sending it to Eurocopter. The ASB also specifies sending
the IGB to a certified overhaul facility for replacing the bevel gear
if it has reached or exceeded its life limit. EASA classified this ASB
as mandatory and issued AD No. 2010-0096, dated May 25, 2010, to ensure
the continued airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would require, within 30 days after the effective
date of this AD:
     Determining if a certain part-numbered and serial-numbered
bevel gear is installed in the IGB, and recording the reduced life
limit of the bevel gear on the component history card or equivalent
record of the IGB.
     If the bevel gear life limit has been reached or is
exceeded, before further flight, replacing the bevel gear with an
airworthy bevel gear.
     Revising the Airworthiness Limitations section of the
maintenance manual by reducing the retirement life for each IGB bevel
gear, part number (P/N) 4639 310 065, having a serial number listed in
Table 1 of the ASB, to the life limit listed in Table 1 of the ASB.

Differences Between This Proposed AD and the EASA AD

    This proposed AD does not require sending a copy of the form in the
ASB to the manufacturer. This proposed AD does not require sending the
IGB to an overhaul facility. Also, this proposed AD does not specify a
single ferry flight not to exceed 20 hours time-in-service to a
maintenance facility if the bevel gear has exceeded the reduced life
limit.

Costs of Compliance

    We estimate that this proposed AD would affect 107 helicopters of
U.S. registry and that the labor rate would average $85 per work-hour.
We also estimate that it would take about a half hour to determine
whether the IGB is affected and to enter the reduced life limit on the
component history card or the equivalent record and to revise the
Airworthiness Limitations section of the maintenance manual. Based on
these figures, we estimate that the cost per helicopter would total
about $43, about $4,601 for the U.S. fleet.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Eurocopter Deutschland GmbH Helicopters: Docket No. FAA-2013-0018;
Directorate Identifier 2010-SW-060-AD.

(a) Applicability

    This AD applies to Model MBB-BK 117 C-2 helicopters with a bevel
gear, part number (P/N) 4639 310 065, installed in the tail rotor
intermediate gear box (IGB), P/N 4639 002 007, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of a bevel gear,
failure of the tail rotor IGB, and subsequent loss of control of the
helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(d) Required Actions

    Within 30 days, do the following:
    (1) Determine if a bevel gear with a serial number (S/N) listed
in Table 1 of Eurocopter Alert Service Bulletin MBB BK117 C-2-04A-
005, Revision 2, dated April 28, 2010 (ASB), is installed in the
IGB.
    (i) If a bevel gear listed in Table 1 of the ASB is installed in
the IGB, record the reduced life limit of the bevel gear onto the
component history card or equivalent record of the IGB.
    (ii) If the bevel gear life limit has been reached or is
exceeded, before further flight, replace the bevel gear with an
airworthy bevel gear.
    (2) Revise the Airworthiness Limitations section of the
maintenance manual by reducing the retirement life for each IGB
bevel gear, P/N 4639 310 065, that has a S/N listed in Table 1 of
the ASB to the life limit corresponding to that S/N.

(e) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Chinh Vuong, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(f) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency AD 2010-0096, dated May 25, 2010.

(g) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor
Gearbox.

    Issued in Fort Worth, Texas, on January 9, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-01004 Filed 1-17-13; 8:45 am]
BILLING CODE 4910-13-P