[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]
[Page 37571-37578]
[DOCID:fr29jy09-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0131; FRL-8424-6]

Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives;
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of alkyl alcohol alkoxylate phosphate
derivatives when used as inert ingredients in growing crops under 40
CFR 180.920 and for residues of alkyl alcohol alkoxylate sulfate
derivatives when used as inert ingredients in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals under 40 CFR 180.910 and 40 CFR 180.930. The Joint Inerts
Task Force (JITF), Cluster Support Team Number 2 (CST 2) submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of alkyl alcohol alkoxylate phosphate and sulfate
derivatives.

DATES: This regulation is effective July 29, 2009. Objections and
requests for hearings must be received on or before September 28, 2009,
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-2009-0131. 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: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address: leifer.kerry @epa.gov.

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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents 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 part180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0131 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 September 28, 2009.
    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-2009-0131, 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. Background

    In the Federal Register of April 15, 2009 (74 FR 17487) (FRL-8409-
7), 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
9E7533) by JITF, CST 2, c/o CropLife America, 1156 15\th\ St., NW.,
Suite 400, Washington, DC 20005, The petition requested that 40 CFR
180.910, 40 CFR 180.920, and 40 CFR 180.930 be amended by establishing
exemptions from the

requirement of a tolerance for residues of various alkyl alcohol
alkoxylate phosphate and sulfate derivatives when used as inert
ingredients in pesticide formulations applied to raw agricultural
commodities, growing crops, and animals. The petition specifically
requested the establishment of an exemption from the requirement of a
tolerance under 40 CFR 180.920 for residues of [alpha]-alkyl (minimum
C6 linear, branched, saturated and/or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer with or without polyoxypropylene,
mixture of di- and monohydrogen phosphateesters and the corresponding
ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and
zinc salts of the phosphate esters; minimum oxyethylene content is 2
moles; minimum oxypropylene content is 0 moles (Chemical Abstract
Service Registry numbers (CAS Nos.) 9046-01-9, 39464-66-9, 50643-20-4,
52019-36-0, 68071-35-2, 68458-48-0, 68585-36-4, 68815-11-2, 68908-64-5,
68511-37-5,68130-47-2, 42612-52-2, 58318-92-6, 60267-55-2, 68070-99-5,
68186-36-7, 68186-37-8, 68610-65-1, 68071-17-0, 936100-29-7, 936100-30-
0, 73038-25-2, 78330-24-2, 154518-39-5, 317833-96-8, 108818-88-8,
873662-29-4, 61837-79-4, 68311-02-4, 68425-73-0, 37280-82-3, 68649-29-
6, 67711-84-6, 68891-13-4); and the establishment of an exemption from
the requirement of a tolerance under 40 CFR 180.910 and 40 CFR 180.930
for residues of [alpha]-alkyl(C6-C15)-[omega]-
hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium,
potassium, sodium, and zinc salts, poly(oxyethylene) content averages
2-4 moles (CAS Nos. 9004-82-4, 68585-34-2, 68891-38-3, 9004-84-6,
13150-00-0, 26183-44-8, 68611-55-2, 68511-39-7, 3088-31-1, 9004-82-4,
25446-78-0, 32612-48-9, 50602-06-7, 62755-21-9, 68424-50-0, 73665-22-
2). For ease of reading, the alkyl alcohol alkoxylate phosphate and
sulfate derivatives are referred to throughout this document as AAAPDs
and AAASDs respectively, and collectively as AAAPSDs. That notice
referenced a summary of the petition prepared by JITF, CST 2, the
petitioner which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    This petition, which also included a limitation of the
concentration of alkyl alcohol alkoxylate phosphate and sulfate
derivatives to not exceed 30% by weight of the pesticide formulation,
was submitted in response to a final rule of August 9, 2006 (71 FR
45415) (FRL-8084-1) in which the Agency revoked, under FFDCA section
408(e)(1) the existing exemptions from the requirement of a tolerance
for residues of certain inert ingredients because of insufficient data
to make the determination of safety required by FFDCA section
408(b)(2). The expiration date for the tolerance exemptions subject to
revocation was August 9, 2008, which was later extended to August 9,
2009, by a document published in the Federal Register issue of August
4, 2008 (73 FR 45312) (FRL-8372-7) to allow for data to be submitted to
support the establishment of tolerance exemptions for these inert
ingredients prior to the effective date of the tolerance exemption
revocation.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide chemical residues. First, EPA
determines the toxicity of pesticide chemicals. Second, EPA examines
exposure to the pesticide chemical through food, drinking water, and
through other exposures that occur as a result of the pesticide
chemical use in residential settings.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for exemption
from the requirement of a tolerance for residues of AAAPSDs when used
as inert ingredients in pesticide formulations applied to growing
crops, raw agricultural commodities and food-producing animals. EPA's
assessment of exposures and risks associated with establishing
tolerances 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 AAAPSDs are not acutely toxic by the oral and dermal routes of
exposure under normal use conditions; however, concentrated materials
are generally moderate to severe eye and skin irritants and may be skin
sensitizers. Following subchronic exposure to rats, gastrointestinal
irritation (increased incidences of hyperplasia, submucosal edema, and
ulceration) was observed, but no specific target organ toxicity or
neurotoxicity was seen. No neurotoxicological effects were detected in
a functional observational battery or a motor activity assessment. No
reproductive effects were noted in the database. There was a
qualitative increase in susceptibility to pups seen in a rat
developmental/reproductive toxicity screening study; however, effects
were seen only in one study and were in the presence of maternal
toxicity. Further, a clear no-observed-adverse-effect-level (NOAEL) was

established for the developmental effects and this NOAEL is
significantly higher than the toxicological points of departure
selected for risk assessment. There are no carcinogenicity concerns
based on structure activity modeling. Points of departure for chronic
dietary, incidental oral, inhalation, and dermal exposure were selected
from a 2-generation reproduction and fertility effects study in rats.
The endpoint was decreased absolute and relative liver weights and
increased incidence in the number of animals with minimal hepatocyte
necrosis in males.
    Sufficient data were provided on the chemical identity of the
AAAPSDs; however, limited data are available on the metabolism and
environmental degradation of these compounds. The Agency relied
collectively on information provided on the representative chemical
structures, the submitted physicochemical data, structure activity
relationship (SAR) information, as well as information on other
surfactants and chemicals of similar size and functionality to
determine the residues of concern for the AAAPSDs. The Agency has
concluded that since metabolites and environmental degradates are not
likely to be more toxic than the parent compounds, a risk assessment
based on the parent compounds is not likely to underestimate risk.
    Specific information on the studies received and the nature of the
adverse effects caused by the AAAPSDs as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document Alkyl Alcohol
Alkoxylate Phosphate and Sulfate Derivatives (AAAPDs and AAASDs--JITF
CST 2 Inert Ingredients). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide, pages 11-17 in docket ID number EPA-HQ-
OPP-2009-0131.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as 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) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD 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
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    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
greater than that 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 AAAPSDs used for human
risk assessment is shown in Table 1 of this unit.

       Table 1.--Summary of Toxicological Doses and Endpoints for AAAPSDs for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario              Uncertainty/ Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                             No appropriate endpoint was identified for acute dietary assessment
 (all populations)...................
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 87 millgrams/     Chronic RfD = 0.87 mg/   Reproduction/fertility
(all populations)....................   kilograms/day (mg/kg/    kg/day                   effects in male rats
                                        day)                    cPAD = 0.87 mg/kg/day..   (Master Record
                                       UFA = 10x..............                            Identification number
                                       UFH = 10x..............                            (MRID) 47060903))
                                       FQPA SF = 1x...........                           LOAEL = 223 mg/kg/day
                                                                                based on a dose-
                                                                                related decrease in
                                                                                absolute and relative
                                                                                liver weight and an
                                                                                increased incidence in
                                                                                the number of animals
                                                                                with ``minimal''
                                                                                hepatocyte necrosis in
                                                                                males in the high-dose
                                                                                group compared to
                                                                                control group
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term             NOAEL= 87 mg/kg/day      LOC for MOE = 100......  Reproduction/fertility
(1 to 30 days) and intermediate-term   UFA = 10x..............                            effects in male rats
 (1 to 6 months).                      UFH = 10x..............                            (MRID 47060903)
                                       FQPA SF = 1x...........                           LOAEL = 223 mg/kg/day
                                                                                based on a dose-
                                                                                related decrease in
                                                                                absolute and relative
                                                                                liver weight and an
                                                                                increased incidence in
                                                                                the number of animals
                                                                                with ``minimal''
                                                                                hepatocyte necrosis in
                                                                                males in the high-dose
                                                                                group compared to
                                                                                control group
----------------------------------------------------------------------------------------------------------------

Dermal and inhalation                  Oral study NOAEL = 87    LOC for MOE = 100        Reproduction/fertility
(all durations)......................   mg/kg/day (dermal                                 effects in male rats
                                        absorption rate = 5%                              (MRID 47060903)
                                        (inhalation absorption                           LOAEL = 223 mg/kg/day
                                        rate = 100%)                                      based on a dose-
                                       UFA = 10x..............                            related decrease in
                                       UFH = 10x..............                            absolute and relative
                                       FQPA SF = 1x...........                            liver weight and an
                                                                                increased incidence in
                                                                                the number of animals
                                                                                with ``minimal''
                                                                                hepatocyte necrosis in
                                                                                males in the high-dose
                                                                                group compared to
                                                                                control group.
----------------------------------------------------------------------------------------------------------------
Cancer                                    Classification: No animal toxicity data available for an assessment;
(oral, dermal, inhalation)...........      based on SAR analysis, AAAPSDs are not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = FQPA 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 AAAPSDs, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from AAAPSDs in food as follows:
    i. Acute and chronic exposure. In conducting the acute and chronic
dietary exposure assessments, EPA used food consumption information
from the United States Department of Agriculture (USDA) 1994-1996 and
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, no residue data were submitted
for the AAAPSDs. In the absence of specific residue data EPA has
developed an approach which uses surrogate information to derive upper
bound exposure estimates for the subject inert ingredients. Upper bound
exposure estimates are based on the highest tolerance for a given
commodity from a list of high-use insecticides, herbicides, and
fungicides. A complete description of the dietary exposure and risk
assessment can be found at http://www.regulations.gov in Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts in
docket ID number EPA-HQ-OPP-2008-0738.
    In the assessment, the Agency assumed that the residue level of the
inert ingredient would be no higher than the highest tolerance for a
given commodity. Implicit in this assumption is that there would be
similar rates of degradation (if any) between the active and inert
ingredient and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50% of the product and often can be much higher.
Further, pesticide products rarely have a single inert ingredient;
rather there is generally a combination of different inert ingredients
used which additionally reduces the concentration of any single inert
ingredient in the pesticide product in comparison with the active
ingredient. In the case of AAAPSDs, EPA made a specific adjustment to
the dietary exposure assessment to account for the use limitations of
the amount of AAAPSDs that may be in formulations (no more than 30%)
and assumed that the AAAPSDs are at the maximum limitations rather than
at equal quantities with the active ingredient. This remains a very
conservative assumption because surfactants are generally used at
levels far below these percentages. For example, EPA examined several
of the pesticide products associated with the tolerance/commodity
combination which are the driver of the risk assessment and found that
these products did not contain surfactants at levels greater than 2.25%
and that none of the surfactants were AAAPSDs.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In sum, EPA chose a
very conservative method for estimating what level of inert residue
could be on food, and then used this methodology to choose the highest
possible residue that could be found on food and assumed that all food
contained this residue. No consideration was given to potential
degradation between harvest and consumption even though monitoring data
shows that tolerance level residues are typically one to two orders of
magnitude higher than actual residues in food when distributed in
commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    ii. Cancer. The Agency used a qualitative SAR database, DEREK11, to
determine if there were structural alerts for potential carcinogenicity
of a

representative AAAPSD. No structural alerts for carcinogenicity were
identified and the AAAPSDs are not expected to be carcinogenic.
Therefore a quantitative cancer exposure assessment is not necessary to
assess cancer risk.
    iii. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue or PCT information in
the dietary assessment for AAAPSDs. Tolerance level residues or 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for AAAPSDs in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of AAAPSDs. 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.
    A screening level drinking water analysis, based on the Pesticide
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of AAAPSDs. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of the AAAPSDs were conducted. Modeled acute drinking water values
ranged from 0.001 parts per billion (ppb) to 41 ppb. Modeled chronic
drinking water values ranged from 0.0002 ppb to 19 ppb. Further details
of this drinking water analysis can be found at http://
www.regulations.gov in document Alkyl Amine Polyalkoxylates (JITF CST 4
Inert Ingredients). Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations, pages 18 and 70-72 in docket ID
number EPA-HQ-OPP-2008-0738.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for AAAPSDs, a conservative drinking water concentration
value of 100 ppb based on screening level modeling was used to assess
the contribution to drinking water for both the acute and chronic
dietary risk assessments. These values were directly entered into the
dietary exposure model.
    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). AAAPSDs are used as
inert ingredients in pesticide products that are registered for
specific uses that could result in indoor residential exposures and may
have uses as inert ingredients in pesticide products that may result in
outdoor residential exposures.
     A screening level residential exposure and risk assessment was
completed for products containing AAAPSDs as inert ingredients. In this
assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected. For
each of the use scenarios, the Agency assessed residential handler
(applicator) inhalation and dermal exposure for use scenarios with high
exposure potential (i.e., exposure scenarios with high-end unit
exposure values) to serve as a screening assessment for all potential
residential pesticides containing AAAPSDs. Similarly, residential
postapplication dermal and oral exposure assessments were also
performed utilizing high-end exposure scenarios. Further details of
this residential exposure and risk analysis can be found at http://
www.regulations.gov in document JITF Inert Ingredients. Residential and
Occupational Exposure Assessment Algorithms and Assumptions Appendix
for the Human Health Risk Assessments to Support Proposed Exemption
from the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations in docket ID number EPA-HQ-OPP-2008-0710.
    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 AAAPSDs to share a common mechanism of toxicity
with any other substances, and AAAPSDs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that AAAPSDs do not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database
consists of OPPTS Harmonized Guideline 870.3650 (combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test) studies in rats conducted with representative AAAPDs, as well as
a 2-generation rat reproduction toxicity (OPPTS Harmonized Guideline
870.3800) study and a rat developmental toxicity study conducted with a
representative AAASD.
    In an OPPTS Harmonized Guideline 870.3650 study conducted with a
representative AAAPD, no increased susceptibility to the offspring of
rats following prenatal and postnatal exposure was observed. In a
second OPPTS Harmonized Guideline 870.3650 study conducted with another
representative AAAPD, there was evidence of increased qualitative
susceptibility as indicated by the increased number of stillborn pups
and pups dying within lactation day (LD) 4/5 and clinical observations
(coldness to the touch, discolored heads, and a lack of nesting
behavior) at 800 mg/kg/day where lesions in the forestomach and thymus
atrophy was observed in the parental animals. However, this qualitative
susceptibility seen in the OPPTS Harmonized Guideline 870.3650 study
does not indicate a heightened risk for infants and children because a
clear NOAEL (200 mg/kg/day) was established for developmental effects
and an additional margin of safety is provided since the point of
departure selected from the 2-generation rat reproduction study for
chronic exposure is 87 mg/kg/day.
    In a rat developmental study with AAASD, no maternal or
developmental toxicity was observed at the limit dose. In the 2-
generation reproduction study with AAASD, the only significant effects
observed were liver effects

characterized by dose-related decrease in absolute and relative liver
weight and an increased incidence in the number of animals with
``minimal'' hepatocyte necrosis in males. No treatment-related effects
were observed on reproduction or in the offspring.
    There are no residual uncertainties identified in the exposure
databases. The food exposure assessments are considered to be
conservative. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children.
    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 AAAPSDs is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit IV.D.2.).
    ii. No susceptibility was demonstrated in the offspring in the
reproductive/developmental screening test portion of an OPPTS
Harmonized Guideline 870.3650 study with one AAAPD following prenatal
and postnatal exposure at 800 mg/kg/day.
    iii. Although increased qualitative susceptibility was demonstrated
in the offspring in a reproductive/developmental screening test portion
of an OPPTS Harmonized Guideline 870.3650 study with another AAAPD, the
Agency did not identify any residual uncertainties after establishing
toxicity endpoints and traditional UFs to be used in the risk
assessment of the AAAPSDs.
    iv. There is no indication that AAAPSDs are neurotoxic chemicals
and thus there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100
PCT is assumed for all crops. EPA also made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to AAAPSDs in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by AAAPSDs.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    In conducting this aggregate risk assessment, the Agency has
incorporated the petitioner's requested use limitations of AAAPSDs as
inert ingredients in pesticide product formulations into its exposure
assessment. Specifically the petition includes a use limitation of
AAAPSDs at not more than 30% by weight in pesticide formulations.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effects attributable to a single exposure to
the AAAPSDs were seen in the toxicity databases, therefore, AAAPSDs are
not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure, and the use limitations of not more than 30% by
weight in pesticide formulations, the chronic dietary exposure from
food and water to AAAPSDs is 13% of the cPAD for the U.S. population
and 43% of the cPAD for children 1-2 yrs old, the most highly exposed
population subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    AAAPSDs are used as inert ingredients in pesticide products that
are currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to AAAPSDs.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of 130
and 140, for adult males and females respectively, for a combined high-
end dermal and inhalation handler exposure with a high-end
postapplication dermal exposure and an aggregate MOE of 110 for
children for a combined turf dermal exposure with hand-to-mouth
exposure.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    AAAPSDs are used as inert ingredients in pesticide products that
are currently registered for uses that could result in intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
intermediate-term residential exposures to AAAPSDs.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 270 and 280, for adult males and females
respectively, for a combined high-end dermal and inhalation handler
exposure with a high-end postapplication dermal exposure and an MOE of
110 for children for a combined high-end dermal exposure with hand-to-
mouth exposure.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts for carcinogenicity, AAAPSDs are not expected to pose
a cancer risk to humans.
    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 residues of AAAPSDs.

V. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for
AAAPSDs nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.

VI. Conclusion

    Therefore, exemptions from the requirement of a tolerance are
established for residues of AAAPDs when used as inert ingredients in
pesticide formulations applied to growing crops only under 40 CFR
180.920 and residues of AAASDs when used as inert ingredients in raw
agricultural commodities, growing crops, and animals under 40 CFR
180.910, 40 CFR 180.920, and 40 CFR 180.930.

VII. 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) (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).

VIII. 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: July 20, 2009.
G. Jeffrey Herndon,
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. In Sec.  180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-Alkyl(C6-C15)-[omega]-    Not to exceed 30%   Surfactants,
 hydroxypoly(oxyethylene)sulfate   of pesticide        related adjuvants
 , and its ammonium, calcium,      formulation.        of surfactants
 magnesium, potassium, sodium,
 and zinc salts,
 poly(oxyethylene) content
 averages 2-4 moles (CAS Reg.
 Nos. 3088-31-1, 9004-82-4, 9004-
 84-6, 13150-00-0, 25446-78-0,
 26183-44-8, 32612-48-9, 50602-
 06-7, 62755-21-9, 68424-50-0,
 68511-39-7, 68585-34-2, 68611-
 55-2, 68891-38-3, 73665-22-2).
                                * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.920, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-Alkyl (minimum C6         Not to exceed 30%   Surfactants,
 linear, branched, saturated and/  of pesticide        related adjuvants
 or unsaturated)-[omega]-          formulation.        of surfactants
 hydroxypolyoxyethylene polymer
 with or without
 polyoxypropylene, mixture of di-
  and monohydrogen phosphate
 esters and the corresponding
 ammonium, calcium, magnesium,
 monoethanolamine, potassium,
 sodium, and zinc salts of the
 phosphate esters; minimum
 oxyethylene content is 2 moles;
 minimum oxypropylene content is
 0 moles (CAS Reg. Nos. 9046-01-
 9, 37280-82-3, 39464-66-9,
 42612-52-2, 50643-20-4, 52019-
 36-0, 58318-92-6, 60267-55-2,
 61837-79-4, 67711-84-6, 68070-
 99-5, 68071-35-2, 68071-17-0,
 68130-47-2, 68186-37-8, 68186-
 36-7, 68311-02-4, 68425-73-0,
 68458-48-0, 68511-37-5, 68610-
 65-1, 68585-36-4, 68649-29-6,
 68815-11-2, 68908-64-5, 68891-
 13-4, 73038-25-2, 78330-24-2,
 108818-88-8, 154518-39-5,
 317833-96-8, 873662-29-4,
 936100-29-7, 936100-30-0).
                                * * * * *
------------------------------------------------------------------------

0
4. In Sec.  180.930, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-Alkyl(C6-C15)-[omega]-    Not to exceed 30%   Surfactants,
 hydroxypoly(oxyethylene)sulfate   of pesticide        related adjuvants
 , and its ammonium, calcium,      formulation.        of surfactants
 magnesium, potassium, sodium,
 and zinc salts,
 poly(oxyethylene) content
 averages 2-4 moles (CAS Reg.
 Nos. 3088-31-1, 9004-82-4, 9004-
 84-6, 13150-00-0, 25446-78-0,
 26183-44-8, 32612-48-9, 50602-
 06-7, 62755-21-9, 68424-50-0,
 68511-39-7, 68585-34-2, 68611-
 55-2, 68891-38-3, 73665-22-2).
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-18033 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Rules and Regulations]
[Pages 40227-40228]
[FR Doc No: 2019-17371]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0358; Airspace Docket No. 19-AEA-7]
RIN 2120-AA66

Establishment of Class E Airspace; Minersville, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace extending upward from
700 feet above the surface at Primrose Heliport, Minersville, PA, to
accommodate new area navigation (RNAV) global positioning system (GPS)
standard instrument approach procedures serving this heliport.
Controlled airspace is necessary for the safety and management of
instrument flight rules (IFR) operations at this heliport.

DATES: Effective 0901 UTC, October 10, 2019. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11C, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave., College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E airspace extending upward from 700 feet above
the surface for Primrose Heliport, Minersville, PA, to accommodate new
area navigation (RNAV) global positioning system (GPS) standard
instrument approach procedures serving this heliport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 26377, June 6, 2019) for Docket No. FAA-2019-0358 to
establish Class E airspace extending upward from 700 feet above the
surface for Primrose Heliport, Minersville, PA.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11C, Airspace Designations and
Reporting Points, dated August 13, 2018, and effective September 15,
2018. FAA Order 7400.11C is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11C lists Class A,
B, C, D, and E

airspace areas, air traffic service routes, and reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace extending upward from 700 feet
above the surface within a 6-mile radius at Primrose Heliport,
Minersville, PA, providing the controlled airspace required to support
the new RNAV (GPS) standard instrument approach procedures for IFR
operations at the heliport.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018,
effective September 15, 2018, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Minersville, PA [New]

Primrose Heliport, PA
    (Lat. 40[deg]41'21'' N, long. 76[deg]16'47'' W)

    That airspace extending upward from 700 feet above the surface
within a 6-mile radius of Primrose Heliport.

    Issued in College Park, Georgia, on August 7, 2019.
Matt Cathcart,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2019-17371 Filed 8-13-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 12, 2008 (Volume 73, Number 219)]
[Notices]
[Page 66895]
[DOCID:fr12no08-84]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0692; FRL-8740-1]
RIN 2040-ZA02

Drinking Water: Preliminary Regulatory Determination on
Perchlorate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Reopening of public comment period.

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SUMMARY: EPA announced on October 10, 2008, its preliminary regulatory
determination that a national primary drinking water regulation for
perchlorate would not present ``a meaningful opportunity for health
risk reduction for persons served by public water systems.'' In
response to requests from several stakeholders, this action reopens the
public comment period for an additional 15 days.

DATES: EPA must receive your comments on or before November 28, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2008-0692, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Mail: Water Docket, Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: Water Docket, EPA Docket Center (EPA/DC)
EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2008-
0692. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Eric Burneson, Office of Ground Water
and Drinking Water, Standards and Risk Management Division, at (202)
564-5250 or e-mail<EMAIL_ADDRESS>For general information
contact the EPA Safe Drinking Water Hotline at<PHONE_NUMBER> or e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Safe Drinking Water Act requires EPA to
make determinations every five years of whether to regulate at least
five contaminants on the Contaminant Candidate List (CCL). EPA included
perchlorate on the first and second CCLs that were published in the
Federal Register on March 2, 1998 (63 FR 10273) and February 24, 2005
(70 FR 9071). Most recently, EPA presented final regulatory
determinations regarding 11 contaminants on the second CCL in a notice
published in the Federal Register on July 30, 2008. On October 10, 2008
(73 FR 60262), EPA presented supporting rationale and requested public
comment on its preliminary determination not to regulate perchlorate
(please note that EPA has issued a new RIN number for this action which
is 2040-AF02). EPA will make a final regulatory determination for
perchlorate after considering comments and information provided in the
comment period following this notice. The original comment deadline was
November 10, 2008. Several stakeholders have requested a reopening to
the comment period in order to evaluate EPA's findings, review the
scientific literature and prepare comments. This action reopens the
comment period for 15 days.

    Dated: November 6, 2008.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. E8-26945 Filed 11-10-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Page 56656]
[FR Doc No: 2022-19986]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2955-011]

City of Watervliet; Notice of Waiver Period for Water Quality
Certification Application

    On September 6, 2022, the City of Watervliet submitted to the
Federal Energy Regulatory Commission (Commission) a copy of its
application for a Clean Water Act section 401(a)(1) water quality
certification filed with New York State Department of Environmental
Conservation (New York DEC), in conjunction with the above captioned
project. Pursuant to 40 CFR 121.6 and section 4.34(b)(5) of the
Commission's regulations,\1\ we hereby notify the New York DEC of the
following:
---------------------------------------------------------------------------

    \1\ 18 CFR 4.34(b)(5).
---------------------------------------------------------------------------

    Date of Receipt of the Certification Request: September 2, 2022.
    Reasonable Period of Time to Act on the Certification Request: One
year (September 2, 2023).
    If New York DEC fails or refuses to act on the water quality
certification request on or before the above date, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: September 9, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19986 Filed 9-14-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Rules and Regulations]
[Page 71613]
[FR Doc No: 2016-25169]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 33

[EPA-HQ-OA-2016-0457; FRL-9954-30-OA]
RIN 2090-AA40

Participation by Disadvantaged Business Enterprises in
Procurements Under EPA Financial Assistance Agreements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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

SUMMARY: Because EPA received comments which could be construed as
adverse, we are withdrawing the direct final rule to amend Part 33--
Participation by Disadvantaged Business Enterprises in Procurements
under EPA Financial Assistance Agreements published on July 28, 2016.

DATES: Effective October 18, 2016 the rule published in the Federal
Register of July 28, 2016 (81 FR 49539) (FRL-9946-27-OA) is withdrawn.

FOR FURTHER INFORMATION CONTACT: Teree Henderson, Office of the
Administrator, Office of Small Business Programs (mail code: 1230A),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-0548; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 28, 2016, we published a direct
final rule (81 FR 49539) and a parallel proposal (81 FR 49591) amending
the provisions for Part 33--Participation by Disadvantaged Business
Enterprises in Procurements under EPA Financial Assistance Agreements.
These amendments were issued as a direct final rule, along with a
parallel proposal to be used as the basis for final action in the event
EPA received any adverse comments on the direct final amendments.
Because EPA received comments which could be construed as adverse, we
are withdrawing the direct final rule to amend the general provisions
for part 33 published on July 28, 2016.
    We stated in the direct final rule that if we received adverse
comment by August 29, 2016, the direct final rule would not take effect
and we would publish a timely withdrawal in the Federal Register. We
subsequently received comments that could be construed as adverse on
that direct final rule. We will address those comments in a subsequent
final action based on the parallel proposal published on July 28, 2016
(81 FR 49591). As stated in the direct final rule and the parallel
proposed rule, we will not institute a second comment period on this
action.

List of Subjects in 40 CFR Part 33

    Environmental protection, Grant programs.

    Dated: October 12, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2016-25169 Filed 10-17-16; 8:45 am]
BILLING CODE 6560-50-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Issued by the Department of Transportation on August 26, 2002

NOTICE OF ACTION TAKEN – DOCKET OST-2000-8052

________________________________________________________________________
____________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of AIRTRAN AIRWAYS, INC. filed 08/08/2002  for:

XX  Renewal of exemption for two years under 49 U.S.C. §40109 to
provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between Atlanta, Georgia, and Freeport (Grand Bahama Island),
Commonwealth of the Bahamas.

Applicant rep: Edwin O. Bailey<PHONE_NUMBER>   DOT Analyst: Keith A.
Glatz<PHONE_NUMBER>

                                                            D I S P O S
I T I O N

XX Granted (see below)

The above action was effective when taken: August  26, 2002 through
August  26, 2004.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX   The authority granted is consistent with the overall state of
aviation relations between the United States and the Commonwealth of the
Bahamas.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificate of public convenience and necessity

		XX  Standard Exemption Conditions (attached)

_________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this order is available on the World Wide Web
at

 http://dms.dot.gov//reports/reports_ aviation.asp

											Attachment

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with the applicable requirements of the Federal Aviation
Administration Regulations, and with all U.S. Government requirements
concerning security; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

 PAGE


[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41310-41312]
[FR Doc No: 2022-14795]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0490; FRL-9966-01-OCSPP]

Petition To Revoke Tolerances and Cancel Registrations for
Certain Organophosphate Uses; Notice of Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is seeking public comment on a November 18, 2021 petition
filed by the United Farm Workers, United Farm Workers Foundation,
Earthjustice, California Rural Legal Assistance Foundation, Farmworker
Association of Florida, Farmworker Justice, GreenLatinos, Labor Council
for Latin American Advancement, League of United Latin American
Citizens, Learning Disabilities Association of America, Pesticide
Action Network North America, and Pineros y Campesinos Unidos del
Noroeste (the Earthjustice Petition). The petitioners request that the
Agency revoke all tolerances and cancel all associated registrations
for food uses of

the following organophosphate pesticides (OPs): Acephate, Densulide,
Chlorethoxyfos, Chlorpyrifos-methyl, Diazinon, Dichlorvos, Dicrotophos,
Dimethoate, Ethoprop, Malathion, Naled, Phorate, Phosmet, Terbufos, and
Tribufos. In addition, the petitioners request that the Agency take
actions to protect workers from potential risks of exposure to OPs,
update its risk assessments to include a protective regulatory endpoint
for children, and complete registration review on the OP class of
chemicals by October 1, 2022. The petition was submitted pursuant to
the Federal Food, Drug and Cosmetic Act (FFDCA), the Administrative
Procedure Act (APA), and the First Amendment.

DATES: Comments must be received on or before August 11, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0490, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anna Romanovsky, Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets#tips.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

B. How can I get copies of this document and other related information?

    A copy of the Earthjustice Petition, Petition to Revoke Food
Tolerances and Cancel Registrations for Harmful Organophosphate Uses,
is available in the docket under Docket ID No. EPA-HQ-OPP-2022-0490.

II. What action is the Agency taking?

    EPA seeks public comment during the next 30 days on a petition
dated November 18, 2021 (available in docket number EPA-HQ-OPP-2022-
0490 at https://www.regulations.gov) from the United Farm Workers,
United Farm Workers Foundation, Earthjustice, California Rural Legal
Assistance Foundation, Farmworker Association of Florida, Farmworker
Justice, GreenLatinos, Labor Council for Latin American Advancement,
League of United Latin American Citizens, Learning Disabilities
Association of America, Pesticide Action Network North America, and
Pineros y Campesinos Unidos del Noroeste. The petitioners request that
the Agency revoke all tolerances and cancel all associated
registrations for food uses of OPs that its risk assessments determine
to be unsafe, update its risk assessments to use neurodevelopmental
toxicity instead of 10% red blood cell acetylcholinesterase inhibition
as a regulatory endpoint that is protective for children, and cancel
registrations for uses that have unreasonable adverse effects on
workers. The petitioners further request that the Agency accomplish the
foregoing no later than October 1, 2022. The petition was submitted
pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq.,
and the First Amendment.
    The OPs are a group of pesticides with a broad range of uses and
are one of the most widely used class of pesticides in U.S.
agriculture. The OPs are a class of chemicals with a common mechanism
of toxicity: inhibition of the acetylcholinesterase (AChE) enzyme.
There are currently 20 OPs going through registration review. EPA's
risk assessments and other registration review materials for the OPs
included in the Earthjustice Petition are contained in the dockets for
each of the respective registration review cases, as listed here:
     Acephate (EPA-HQ-OPP-2008-0915).
     Bensulide (EPA-HQ-OPP-2008-0022).
     Chlorethoxyfos (EPA-HQ-OPP-2008-0843).
     Chlorpyrifos-methyl (EPA-HQ-OPP-2010-0119).
     Diazinon (EPA-HQ-OPP-2008-0351).
     Dichlorvos (EPA-HQ-OPP-2009-0209).
     Dicrotophos (EPA-HQ-OPP-2008-0440).
     Dimethoate (EPA-HQ-OPP-2009-0059).
     Ethoprop (EPA-HQ-OPP-2008-0560).
     Malathion (EPA-HQ-OPP-2009-0317).
     Naled (EPA-HQ-OPP-2009-0053).
     Phorate (EPA-HQ-OPP-2007-0674).
     Phosmet (EPA-HQ-OPP-2009-0316).

     Terbufos (EPA-HQ-OPP-2008-0119).
     Tribufos (EPA-HQ-OPP-2008-0883).
    On December 2, 2021, the Agency released an updated schedule for
registration review for the cases for which interim registration review
decisions will be issued after October 2022. The schedule can be found
on the EPA website at https://www.epa.gov/pesticide-reevaluation/upcoming-registration-review-actions.
    Authority: 21 U.S.C. 346a.

    Dated: July 6, 2022.
Mary Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2022-14795 Filed 7-11-22; 8:45 am]
BILLING CODE 6560-50-P


                          CHOLINE CHLORIDE TECHNICAL

ACTIVE INGREDIENT
      Acetyl Choline.............. . . . . . . . . . ................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98.0%
OTHER INGREDIENTS  . . . . . . . . . . . . . . . . . . . . ..................... . . . . . . . . . . . . . . . . . . . .. . . .2.0%
       TOTAL  . . . . . . . . . . . . .................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . l00.0%

                         NET WEIGHT: 55 LBS. (25 KG.)

                         KEEP OUT OF REACH OF CHILDREN

CAUTION

            SEE BACK PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
                     AND STATEMENT OF PRACTICAL TREATMENT

FIRST AID
                                  IF IN EYES:
> Hold eye open and rinse slowly and gently with water for 15-20 minutes.
> Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.
> Call a poison control center or doctor for further treatment advice.
                                  IF INHALED:
> Move person to fresh air
> If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.
> Call a poison control center or doctor for further treatment advice.
                            IF ON SKIN OR CLOTHING:
> Take off contaminated clothing.
> Rinse skin immediately with plenty of water for 15-20 minutes.
> Call a poison control center or doctor for further treatment advice.
HOTLINE NUMBER
Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact the National Pesticide Information Center at<PHONE_NUMBER> for general or medical information.

              EPA REG. NO.  88031-XX			EPA EST. NO.  88031-CA-001

                                BATCH NUMBER:

                           PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION

Harmful if swallowed.  Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum or using tobacco. Remove contaminated clothing and wash before reuse.

ENVIRONMENTAL HAZARDS

Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge Do not discharge effluent containing this product into sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA.

	STORAGE AND DISPOSAL

Do not contaminate water, food or feed by storage or disposal.
PESTICIDE STORAGE: Keep containers tightly closed when not in use.
PESTICIDE DISPOSAL:  Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility.
CONTAINER DISPOSAL: Non-refillable container. Do not reuse or refill this container. Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty residue into application equipment. Then offer for recycling, if available, or dispose of liner in a sanitary landfill or by incineration or, if allowed by state and local authorities, by burning. If burned, stay out of smoke.

	DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. For use only in formulating agricultural plant growth regulators product formulations. It is the responsibility for formulators using this product to register all formulations made from it with the EPA as a plant growth regulator product. Before using this product to formulate any agricultural plant growth regulator product be sure to consult the technical manual, which is available from the manufacturer.

WARRANTY STATEMENT

To the fullest extent permitted by law, CP Bio, Inc. warrants that the product conforms to the chemical description on the label and is reasonably fit for the purposes set forth on the label when used according to directions under normal use conditions. There are no other warranties, express or implied, including a warranty of fitness for a particular purpose. This warranty does not extend to the handling or use of this
product contrary to label instructions
                              WARRANTY STATEMENT

To the fullest extent permitted by law, CP Bio, Inc. warrants that the product conforms to the chemical description on the label and is reasonably fit for the purposes set forth on the label when used according to directions under normal use conditions. There are no other warranties, express or implied, including a warranty of fitness for a particular purpose. This warranty does not extend to the handling or use of this
product contrary to label instructions
              CP Bio, Inc., 4802 Murrieta Street, Chino, CA 91710


[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22942-22943]
[FR Doc No: 2013-08955]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0092; Notice 2]

Pilkington North America, Inc., Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Grant of Petition for Inconsequential Noncompliance.

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

SUMMARY: Pilkington North America, Inc. (Pilkington) has determined
that certain replacement rear windows manufactured for model year 2006
through 2009 Honda Civic two-door coupe passenger cars manufactured on
April 16, 2008, do not fully comply with paragraphs S6.2 and S6.3 of
Federal Motor Vehicle Safety Standard (FMVSS) No. 205 Glazing
Materials. Pilkington

has filed an appropriate report pursuant to 49 CFR Part 573, Defect and
Noncompliance Responsibility and Reports, dated February 4, 2009.
    Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule
implementing those provisions at 49 CFR part 556, Pilkington has
petitioned for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential to motor vehicle safety. Notice of
receipt of Pilkington's petition was published, with a 30-day public
comment period, on May 20, 2009, in the Federal Register (74 FR 23775).
No comments were received. To view the petition, and all supporting
documents log onto the Federal Docket Management System (FDMS) Web site
at: http://www.regulations.gov/. Then follow the online search
instructions to locate docket number ``NHTSA-2009-0092.''
    For further information on this decision, contact Mr. Luis
Figueroa, Office of Vehicle Safety Compliance, NHTSA, telephone (202)
366-5298, facsimile<PHONE_NUMBER>.
    Equipment Involved: Affected are approximately 206 replacement rear
windows (National Auto Glass Specifications (NAGS) part number
FB22692GTY) for model year 2006 through 2009 Honda Civic two-door coupe
passenger cars that were manufactured at Pilkington's Versailles,
Kentucky plant on April 16, 2008.
    Summary of Pilkington's Analysis and Arguments: Pilkington explains
that the noncompliance for the 205 replacement rear windows exists due
to Pilkington's failure to label the replacement rear windows with the
marks required by section 7 of ANSI/SAE Z26.1-1996, the symbol ``DOT,''
and its NHTSA assigned manufacturer code mark. As of the time of the
petition,
    Paragraphs S6.2 and S6.3 of FMVSS No. 205 require in pertinent
part:
    S6.2 A prime glazing manufacturer certifies its glazing by adding
to the marks required by section 7 of ANSI/SAE Z26.1 1996, in letters
and numerals of the same size, the symbol ``DOT'' and a manufacturer's
code mark that NHTSA assigns to the manufacturer. NHTSA will assign a
code mark to a manufacturer after the manufacturer submits a written
request to the Office of Vehicle Safety Compliance, National Highway
Traffic Safety Administration, * * *
    S6.3 A manufacturer or distributor who cuts a section of glazing
material to which this standard applies, for use in a motor vehicle or
camper, must (a) Mark that material in accordance with section 7 of
ANSI/SAE Z26.1 1996; and (b) Certify that its product complies with
this standard in accordance with 49 U.S.C. 30115.
    Pilkington states that it believes that this noncompliance is
inconsequential to motor vehicle safety for the following reasons:
    (1) The noncompliances relate solely to product monograms or
markings and the noncompliant rear windows. Pilkington has tested a
number of the parts in its possession and confirmed that they meet or
exceed all other applicable performance requirements in FMVSS No. 205.
    (2) NHTSA has previously granted other exemptions for noncompliant
product labeling. In the past, the agency has recognized that the
failure to meet labeling requirements often is inconsequential to motor
vehicle safety.
    (3) The information contained in the noncompliant product markings
is not required in order for consumers to operate their vehicles
safely.
    Pilkington also stated its belief that the noncompliance will not
interfere with any future tracing of the windows because Pilkington is
only one of three manufacturers of rear windows for this particular
Honda Civic, the other two being PGW (Pittsburgh Glass Works, formerly
known as PPG) and Auto Temp, Inc. Given that the windows produced by
the two other manufacturers will be properly marked, Pilkington's
unlabeled rear windows should easily be identified and traced, if
necessary, should any future defects or noncompliances be discovered.
    Discussion: NHTSA has reviewed and accepts Pilkington's analyses
that this noncompliance is inconsequential to motor vehicle safety.
Pilkington has provided documentation that the windows do comply with
all other safety performance requirements of the standard, except the
labeling. This documentation is a surrogate for the certification
labeling. NHTSA believes that the lack of labeling would not result in
inadvertent replacement of the windows with the wrong glazing. Broken
tempered glass can readily be identified as tempered glass, rather than
plastic or laminated glass. Anyone who intended to replace the window
with an identical tempered glass window would have to contact
Pilkington for the proper part, since tempered glass windows cannot be
easily manufactured by small field facilities. At that point,
Pilkington, or their representative, would be able to provide the
correct replacement window by use of their parts system.
    NHTSA Decision: In consideration of the foregoing, NHTSA has
decided that Pilkington has met its burden of persuasion that the FMVSS
No. 205 noncompliance in the noncompliant windows described in
Pilkington's Noncompliance Information Report is inconsequential to
motor vehicle safety. Accordingly, Pilkington's petition is hereby
granted and the petitioner is exempted from the obligation of providing
notification of, and a remedy for, that noncompliance under 49 U.S.C.
30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the 206 noncompliant windows that Pilkington no longer
controlled at the time that it determined that a noncompliance existed
in the subject vehicles.

    Authority: 49 U.S.C. 30118, 30120; delegations of authority at
49 CFR 1.95 and 501.8.

    Issued On: April 11, 2013.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2013-08955 Filed 4-16-13; 8:45 am]
BILLING CODE 4910-59-P