[Federal Register Volume 80, Number 114 (Monday, June 15, 2015)]
[Rules and Regulations]
[Pages 34065-34070]
[FR Doc No: 2015-14647]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0176; FRL-9928-63]

Di-n-butyl carbonate; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of di-n-butyl carbonate (CAS Reg. No. 542-
52-9) when used as an inert ingredient (solvent) in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest, and animals, and when used as an inert ingredient in
antimicrobial pesticide formulations in food-contact surfaces sanitizer
products at a maximum level

in the end-use concentration of 15,000 ppm (1.5%). Exponent Inc., on
behalf of Huntsman Corp., submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of di-n-butyl carbonate.

DATES: This regulation is effective June 15, 2015. Objections and
requests for hearings must be received on or before August 14, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0176, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0176 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 14, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0176, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-
55), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10683) by
Exponent Inc., 1150 Connecticut Ave. NW., Suite 1100, Washington, DC
20036, on behalf of Huntsman Corporation, 8600 Gosling Road, The
Woodlands, TX 77381. The petition requested that 40 CFR 180.910,
180.930, and 180.940 be amended by establishing an exemption from the
requirement of a tolerance for residues of di-n-butyl carbonate (CAS
Reg. No. 542-52-9) when used as an inert ingredient (solvent) in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals, and when used as an inert
ingredient in antimicrobial formulations in food-contact surface
sanitizer products. That document referenced a summary of the petition
prepared by Exponent Inc., on behalf of Huntsman Corp., the petitioner,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.
    Based on a review of the data submitted in support of this
petition, EPA has modified the exemption requested by limiting the
amount of di-n-butyl carbonoate allowed in food contact sanitizing
solutions to a maximum 15,000 ppm (1.5%). This limitation is based on
the Agency's risk assessment which can be found at http://www.regulations.gov in document ``Di-n-Butyl Carbonate; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations,'' in docket ID number EPA-HQ-OPP-
2014-0176.

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(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 di-n-butyl carbonate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with di-n-butyl carbonate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by di-n-butyl carbonate as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
    Di-n-butyl carbonate acute toxicity testing indicate that it has
low acute oral, dermal and inhalation toxicity (acute oral and dermal
LD50 > 2,000 milligrams/kilogram (mg/kg); acute inhalation
LC50 >8 mg/Liter (mg/L) and is non-irritating to the eyes
and negative for dermal sensitization. Di-n-butyl carbonate is
irritating to the skin. In a combined repeated dose toxicity study with
the reproductive and developmental toxicity screening test, di-n-butyl
carbonate was administered daily to rats by gavage. The di-n-butyl
carbonate test material did not result in any test material related
mortality or clinical observations in the parental animals. No effects
were observed in the functional observational battery, hematology and
clotting parameters, clinical chemistry parameters, or organ weights.
No macroscopic findings related to the test item were observed. No
histopathological effects were reported in neurological tissues
(cerebrum, cerebellum, pons, peripheral nerve, spinal cord) (cervical,
midthoracic and lumbar sections) or any immunological tissues (bone
marrow, thymus, spleen, lymph nodes).
    The NOAEL of di-n-butyl carbonate in rats is 500 mg/kg bw/day for
parental animals (males and females) and 500 mg/kg bw/day for embryo-
fetal toxicity. The LOAEL is 750 mg/kg bw/day based on decreased body
weight gain in male and female paternal animals and embryo-fetal
toxicity at 750 mg/kg bw/day as evidenced by increased pre- and post-
implantation losses and decreased total number of pups.
    If ingested di-n-butyl carbonate would be readily hydrolyzed by
esterases in the gut to generate two molar equivalents of n-butanol and
one molar equivalent of carbonic acid. EPA has stated for the n-butanol
tolerance reassessment that once absorbed, n-butanol disappears rapidly
from the blood. The carbonic acid rapidly dissociates into
CO2 and water.
    Di-n-butyl carbonate was negative in an OCSPP Harmonized Test
Guideline Bacterial Reverse Mutation Assay (at concentrations ranging
from 1.5 to 5,000 ug per plate); no positive mutagenic response was
observed.
    There are no carcinogenicity studies available for di-n-butyl
carbonate. Based on predicted rapid metabolism and excretion, the lack
of specific target organ toxicity in the OCSPP Harmonized Test
Guideline 870.3650 study, the results of genotoxicity testing being
negative, and a Quantitative Structure Activity Relationship (QSAR)
expert model, DEREK Nexus, that indicates no structural alerts for
carcinogenicity, di-n-butyl carbonate is not expected to be
carcinogenic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No acute toxicological endpoints have been identified for di-n-
butyl carbonate; therefore no acute exposure assessments are warranted.

    The overall NOAEL for di-n-butyl carbonate was established at 500
mg/kg/day. The chronic risk assessment for di-n-butyl carbonate is
based on this endpoint and the chronic reference dose (cRfD) is
therefore 5.0 mg/kg/day. The cRfD incorporates a 10X interspecies
factor and a 10X intraspecies factor. Since the FQPA SF has been
reduced to 1X, the cPAD is also 5.0 mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to di-n-butyl carbonate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from di-n-butyl carbonate in food as follows:
    The Agency assessed the dietary exposures to di-n-butyl carbonate
as an inert ingredient for use in pesticide formulations applied to
growing crops, raw agricultural commodities, and livestock, as well as
an inert ingredient for use in food-contact surface sanitizing
solutions. In the case of dietary exposures to di-n-butyl carbonate as
an inert ingredient used in pesticide formulations applied to growing
crops, raw agricultural commodities, and livestock, a chronic dietary
exposure assessment was conducted using the Dietary Exposure Evaluation
Model/Food Commodity Intake Database (DEEM-FCID) TM, Version 3.16. EPA
used food consumption information from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA). This dietary survey was conducted from
2003 to 2008. As to residue levels in food, no residue data were
submitted for di-n-butyl carbonate. 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 ingredient.
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 general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
    In the case of the proposed use of di-n-butyl carbonate as an inert
ingredient in food-contact sanitizing pesticide products, EPA has
utilized a conservative, health-protective method of estimating dietary
intake that is based upon conservative assumptions related to the
amount of residues that can be transferred to foods as a result of the
proposed use. This same methodology has been utilized by EPA in
estimating dietary exposures to antimicrobial pesticides used in food-
handling settings. A complete description of the approach used to
assess dietary exposures resulting from food contact sanitizing
solution uses of di-n-butyl carbonate can be found at http://www.regulations.gov in document ``Di-n-Butyl Carbonate; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations,'' pp. 12-23 in docket ID number
EPA-HQ-OPP-2014-0176.
    The exposures from food and food contact sanitizing are then added
together for the final dietary exposure assessment.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for di-n-butyl carbonate,
a conservative drinking water concentration value of 100 parts per
billions (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. 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., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    There are no current or proposed residential uses for di-n-butyl
carbonate; however, it is possible that di-n-butyl carbonate may be
used as an inert ingredient in pesticide products. A highly
conservative residential exposure assessment was performed in which it
was assumed that all residential use pesticide products would contain
di-n-butyl carbonate as an inert ingredient. A complete description of
the approach used to assess possible residential exposures from di-n-
butyl carbonate can be found in http://www.regulations.gov in document
``Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological
Effects Assessment to Support Proposed Exemption from the Requirement
of a Tolerance When Used as an Inert Ingredient in Pesticide
Formulations,'' pp. 16 in docket ID number EPA-HQ-OPP-2014-0176.
    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 di-n-butyl carbonate to share a common mechanism
of toxicity with any other substances, and di-n-butyl carbonate does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that di-n-butyl carbonate does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is evidence for
qualitative susceptibility in the OECD 422 study. In this study,
embryo-fetal toxicity was manifested as evidenced by increased pre- and
post-implantation losses and decreased total number of pups in the
presence of maternal toxicity (decreased in body weights). However,
considering the overall toxicity profile and the toxicity endpoints and
doses selected for di-n-butyl carbonate, the degree of concern for the
effects observed in the di-n-butyl carbonate reproductive and
developmental toxicity screening study

is low. There is a clear NOAEL for the offspring effects, and endpoints
and regulatory doses were selected for use in the dietary risk
assessment to be protective of these effects.
    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 di-n-butyl carbonate summarize the
studies included in the database. EPA concludes that these data are
sufficient for assessing the effects of di-n-butyl carbonate on infants
and children.
    ii. There is no indication that di-n-butyl carbonate is a
neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. Although there is some evidence that di-n-butyl carbonate
results in increased susceptibility in rats, the degree of concern for
these effects is low for the reasons explained in Unit IV.D.2.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues as well as conservative
assumptions regarding exposures from food-contact sanitizer uses. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to di-n-butyl carbonate in
drinking water. These assessments will not underestimate the exposure
and risks posed by di-n-butyl carbonate.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
di-n-butyl carbonate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
di-n-butyl carbonate from food and water will utilize 21% of the cPAD
for the U.S. population and 94% of the cPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). While di-n-butyl
carbonate is not currently used as an inert ingredient in pesticide
products that are registered for uses that could result in short- or
intermediate-term residential exposure, it is possible that di-n-butyl
carbonate could be used in such products and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with potential short-and intermediate-term residential exposures
to n-butyl benzoate.
    Using the exposure assumptions described in this unit for short-and
intermediate-term exposures, EPA has concluded the combined food,
water, and residential exposures result in aggregate short- and
intermediate-term MOEs of 320 for adults and 100 for children (1-2
years old). EPA's level of concern for n-butyl benzoate is a MOE of 100
or below; however, these MOEs are not of concern based on the highly
conservative assumptions made regarding residential and dietary
exposures to n-butyl benzoate.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit
IV.A., di-n-butyl carbonate is not expected to pose a cancer risk to
humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to di-n-butyl carbonate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required for
di-n-butyl carbonate in pesticide formulations which include uses on
crops for pre- and post-harvest, and on animals, since the Agency is
establishing an exemption from the requirement of a tolerance without
any numerical limitation.
    An analytical method is also not required for enforcement purposes
for di-n-butyl carbonate on food-contact surfaces in antimicrobial
applications since the Agency is not establishing a numerical tolerance
for residues of di-n-butyl carbonate in or on any food commodities. EPA
is establishing a limitation on the amount of di-n-butyl carbonate that
may be used in food-contact surface antimicrobial applications. That
limitation will be enforced through the pesticide registration process
under the Federal Insecticide, Fungicide, and Rodenticide Act
(``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any food-
contact surface antimicrobial applications for sale or distribution
that contains greater than 15,000 ppm (1.5%) of di-n-butyl carbonate by
weight.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance is
established under 40 CFR 180.910, 180.930, and 180.940(a) for di-n-
butyl carbonate (CAS Reg. No. 542-52-9) when used as an inert
ingredient (solvent) in pesticide formulations applied to growing
crops, raw agricultural commodities after harvest, and animals, and
when used as an inert ingredient in antimicrobial formulations in food-
contact surface sanitizer products at a maximum level in the end-use
concentration of 15,000 ppm.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action 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 action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions 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 action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency

has determined that this action will not have a substantial direct
effect on States or tribal governments, on the relationship between the
national government and the States or tribal governments, or on the
distribution of power and responsibilities among the various levels of
government or between the Federal Government and Indian tribes. Thus,
the Agency has determined that Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000) do not apply to this
action. In addition, this action does not impose any enforceable duty
or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 5, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.910, add alphabetically the inert ingredient to the
table 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
------------------------------------------------------------------------

                                * * * * *
Di-n-butyl carbonate (CAS Reg. No.    ...............  Solvent.
 542-52-9).

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

0
3. In Sec.  180.930, add alphabetically the inert ingredient to the
table to read as follows:

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

* * * * *

------------------------------------------------------------------------
          Inert ingredients                Limits             Uses
------------------------------------------------------------------------

                                * * * * *
Di-n-butyl carbonate (CAS Reg. No.    ...............  Solvent.
 542-52-9).

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

0
4. In Sec.  180.940(a), add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------

                              * * * * * * *
Di-n-butyl carbonate...........        542-52-9  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed
                                                  15,000 ppm.

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

* * * * *
[FR Doc. 2015-14647 Filed 6-12-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: September 14, 2009 (Volume 74, Number 176)]
[Notices]
[Page 47038-47039]
[DOCID:fr14se09-97]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Eighth Plenary Meeting, Special Committee 214/EUROCAE: Standards
for Air Traffic; Data Communication Services, Working Group 78 (WG-78)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 214, Standards for Air Traffic
Data Communication Services.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of the RTCA Special Committee 214, Standards for Air Traffic
Data Communication Services.

DATES: The meeting will be held September 21-25, 2009 from 9 a.m.-5
p.m.

ADDRESS: The meeting will be held at AIRBUS, Sites Cl[eacute]ment Ader,
Jean-Luc Lagard[eacute]re, Avenue d'A[eacute]roconstellation, 31700
Blagnac, Toulouse, France.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 214, Standards for Air Traffic
Data Communication Services meeting. The agenda will include:

Meeting Objectives

 Acceptance of the following documents to complete further SPR
work by Dec 09:
     First draft of D-TAXI Graphic OSD
     First draft of 4DTRAD OSD
     First draft of FLIPINT OSD
     First draft of D-RVR
     First draft of D-HXWZ
 Acceptance of the proposed resolution of WP1 Open issues
 Review of Oceanic position paper
 Review ATS functions Section position paper
 Review the ATSA-ITP position paper
 Progress on WP2 OSA & OPA
 Progress on WP2 Material integration into Integrated SPR
 Progress on interoperability material
 Review and update the work plan as required

Agenda

Day 1: Joint Sub-Group Meetings

Morning & Afternoon
     Sub-Groups coordination
     SG meetings

Days 2, 3: SG Comment Resolution Working Sessions

Morning & Afternoon
 WP1 Sub-group
     D-TAXI Graphics OSD sub-Group
     WP1 Open issues sub-group
 WP2 Sub-Group:
     WP2 OSA & OPA sub-group
     WP2 material Integration sub-group
 Interop Sub-Group

Day 4: Plenary

 Welcome/Introductions/Administrative Remarks
     Election of European Co-Chair
 Approval of the Agenda
 Approval of the Minutes of Plenary 7
     Review Actions
 Review of the work so far
     SC-214/WG-78 Work Plan and TORs
     SC-206/WG-76 Coordination
     SC-186/WG-51 Coordination
 Sub-Group Progress reports
 Review of Oceanic Position paper
 Review of ATS Function definition Position paper
 Review of ATSA-ITP Position paper
 Subgroups progress reports
 Document Approvals
 Review Committee Plan--Master Schedule
 Review Dates, Location and Agenda for Next Meeting
 Any Other Business (GOLD paper)

Day 5: SGs Meetings

Morning & Afternoon
 Implementation of Plenary agreed actions

    Additional Information: All the documents to be reviewed can be
found at the Web site http://www.faa.gov/go/SC214 under the Plenary 8
folder.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 8, 2009.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. E9-22026 Filed 9-11-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: May 23, 2007 (Volume 72, Number 99)]
[Notices]
[Page 28966-28967]
[DOCID:fr23my07-59]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0235; FRL-8122-4]

Aliphatic Esters Reregistration Eligibility Decision; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY:  This notice announces the availability of EPA's
Reregistration Eligibility Decision (RED) for the pesticide aliphatic
esters, and opens a public comment period on this document. The
Agency's risk assessments and other related documents also are
available in the aliphatic esters Docket. The aliphatic esters case
contains six active ingredients, but only one active ingredient, the
methyl esters of fatty acids, is registered and in only one product.
The methyl esters of fatty acids are used as a pinching agent and
applied as a foliar spray on ornamentals kept inside and outside of
greenhouses. EPA has reviewed the aliphatic esters through a modified
public participation process that the Agency uses to involve the public
in developing pesticide reregistration decisions. Through this process,
EPA is ensuring that all pesticides meet current health and safety
standards.

DATES:  Comments must be received on or before June 22, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0235, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0235. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://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 regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either 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
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Cathryn O'Connell, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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. Since others also may be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. 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. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. 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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register  date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards. EPA
has completed a Reregistration Eligibility Decision (RED) for the
pesticide, aliphatic ester under section 4(g)(2)(A) of FIFRA. The
aliphatic esters case contains six active ingredients, but only one
active ingredient, the methyl esters of fatty acids, is registered and
in only one product. The methyl esters of fatty acids are used as a
pinching agent and applied as a foliar spray on ornamentals, mostly
azaleas, kept inside and outside of greenhouses. In the risk assessment
a potential concern of chemical pneumonia for handlers was identified.
As a result, EPA is requiring the use of an organic-vapor respirator
during mixing, loading, and application of the product and increasing
the restricted entry interval (REI) from 4 hours to 12 hours.
    EPA has determined that the data base to support reregistration is
substantially complete and that products containing the aliphatic
esters are eligible for reregistration, provided the risks are
mitigated in the manner described in the RED. Upon submission of any
required product specific data under section 4(g)(2)(B) and any
necessary changes to the registration and labeling (either to address
concerns identified in the RED or as a result of product specific
data), EPA will make a final reregistration decision under section
4(g)(2)(C) for products containing aliphatic esters.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration. The Agency's Pesticide Tolerance
Reassessment and Reregistration; Public Participation Process,
published in the Federal Register on May 14, 2004, (69 FR 26819)(FRL-
7357-9) explains that in conducting these programs, EPA is tailoring
its public participation process to be commensurate with the level of
risk, extent of use, complexity of issues, and degree of public concern
associated with each pesticide. Due to its uses, risks, and other
factors, the aliphatic esters was reviewed through the modified 4-Phase
process. Through this process, EPA worked extensively with stakeholders
to reach the regulatory decisions for the aliphatic esters.
    The reregistration program is being conducted under Congressionally
mandated time frames, and EPA recognizes the need both to make timely
decisions and to involve the public. The Agency is issuing the
aliphatic esters RED for public comment. This comment period is
intended to provide an opportunity for public input and a mechanism for
initiating any necessary amendments to the RED. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
Agency Docket for the aliphatic esters. Comments received after the
close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. If any comment significantly affects the
document, EPA also will publish an amendment to the RED in the Federal
Register. In the absence of substantive comments requiring changes, the
aliphatic esters RED will be implemented as it is now presented.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, the Administrator
shall determine whether pesticides containing such active ingredient
are eligible for reregistration, before calling in product specific
data on individual end-use products and either reregistering products
or taking other ``appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: May 10, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-9834 Filed 5-22-07; 8:45 am]

BILLING CODE 6560-50-S


FQPA Publicly Releasable Summary of the Petition for the Establishment
of a Exemption from the Requirement of a Tolerance on all Raw
Agricultural Commodities

A. Introduction

Falcon Lab, LLC, 1103 Norbee Drive, Wilmington, DE 19803, has submitted
to the EPA a petition to exempt, pursuant to 408(d) of the FFDCA, from
the requirement of a tolerance ammonium salts of higher fatty acids
[C8-C18 saturated and C8-C12 unsaturated] on all food uses.  This
petition is being submitted after the failure to finalize a proposed
rule to exempt ammonium salts of higher fatty acids, originally
published in 1996 (61FR10233-36).  The final rule is to be published at
40 CFR 180.1166.

The petition contains data or information regarding the elements set
forth in 408(d)(2) of the FFDCA; however EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition.

B. Residue Chemistry

Residue Chemistry.  There have been no analytical procedures conducted
to ascertain residual ammonium salts of fatty acids on treated food
crops.  Ammonium salts of fatty acids have been used on food crops since
1982 with no adverse effects.  Naturally occurring fatty acids
constitute a significant part of the normal daily diet and are of low
toxicity when taken orally and pose no known health risks.  The residues
of these salts of fatty acids from pesticide use are not likely to
exceed levels of naturally occurring fatty acids in commonly eaten
foods.  Salts of fatty acids are generally recognized as safe (GRAS) by
the U.S. Food and Drug Administration and potassium salts of fatty acids
have been previously exempted from the requirement of a tolerance (40
CFR 180.1068).

C. Toxicological Profile

In the 1992 Reregistration Eligibility Document (RED): Soap Salts, the
Agency concluded that the soap salt toxicological database on file was
adequate to support reregistration.  This conclusion is supported by the
extensive study and summary data for fatty acids, fatty acid salts
(potassium) and esters of fatty acids.  Because the toxicity of ammonium
salts of fatty acids is low, no exposure data was required by the
Agency.  Even though exposure could be expected to be significant to
applicators, because of the low toxicity of ammonium salts of fatty
acids, pesticide use in accordance with label directions will not
present a hazard.  Protective eyewear is required for ammonium salts of
fatty acids to mitigate potential ocular exposure and irritation.

Acute Toxicity.  A battery of acute studies on fatty acids (nonanoic
acid, C9), fatty acid esters, an end use product containing ammonium
salts of fatty acids resulted in acute oral and acute dermal LD50 >5000
mg/kg, respectively.  Fatty acids and their ammonium salt-containing
product were mild to moderately irritating on rabbit skin.  Nonanoic
acid was severely irritating to human skin, while an end-use product
containing ammonium nonanoate was moderately irritating to rabbit skin
when 20 mg was applied for 4 hours.  The ammonium salt of nonanoic acid
was severely irritating to rabbit eyes.  As described in the 1992 RED,
and supported with data and summaries of data, the acute toxicity
effect/categories for ammonium salts of fatty acids are: Acute Oral,
Category IV; Acute Dermal, Category IV; Primary Eye Irritation, Severely
Irritatating;  Primary Skin, Mild-Moderate Irritation; and Acute
Inhalation, Category III.

Subchronic toxicity.   A waiver has been requested for the 90-day
feeding study.  A 14-day range finding study with nonanoic acid (C9)
found no systemic toxicity with either sex at the high dose tested
(20,000 ppm, or 1,834 mg/kg/day), and no adverse effects were observed
with respect to survival, clinical signs, body weight gain, food
consumption, hematology, clinical chemistry or gross pathology.   Based
on these results of the range finding study, and the natural occurrence
of fatty acids in the human diet, the Agency waived the requirement for
the 90-day feeding study.   Naturally occurring fatty acids constitute a
significant part of the normal daily diet and are of low toxicity when
taken orally and pose no known health risks.  The residues of these
salts of fatty acids from pesticide use are not likely to exceed levels
of naturally occurring fatty acids in commonly eaten foods.  Fatty acids
are normally metabolized by the cells, where they are oxidized to simple
compounds for use as energy sources and as structural components
utilized in all living cells.  Potassium, sodium and ammonium are
normally part of the body’s metabolism and electrolyte balance.

Chronic Toxicity/Oncogenicity.   Not required due to the evidenced low
toxicity of ammonium salts of fatty acids.

Reproductive and Developmental Toxicity  A waiver has been requested for
the teratogenicity study based on published findings of a developmental
toxicity study with nonanoic acid: “In a developmental toxicity study
in rats, MRID 43843508 the treatment had no adverse effects on clinical
signs, body weights, weight gain, or food/water consumption.  No fetal
toxicity was observed between the treated or the untreated controls.
Moreover, the mean number of viable fetuses, early or late resporptions,
implantation sites, corpora lutea, pre- and post-implantation losses,
sex ratios and fetal body weights were comparable to those of the
control group.  The no observed effect level (NOEL) for maternal and
developmental toxicity was 1,500 mg/kg/day with the lowest observed
toxicity level (LOEL) greater than 1,500 mg/kg/day.

DNA inhibition was reported with 600 μmol/l of the sodium salt of
caprylic acid, tested with guinea pig kidney cells.  Unscheduled DNA
synthesis was found in mouse cells with 35 mg/kg of oleic acid.
Cytogenetic analysis was positive for 2500 μg/l of oleic acid with
hamster fibroblasts and for 100 mg/l with Saccaromyces cerevisiae.

Animal metabolism.  Fatty acids are normally metabolized by the cells,
where they are oxidized to simple compounds for use as energy sources
and as structural components utilized in all living cells.  Potassium,
sodium and ammonium are normally part of the body’s metabolism and
electrolyte balance.

D. Aggregate Exposure

Dietary exposure. Salts of fatty acids are food additives (21 CFR
172.863).  Residue chemistry data requirements are not applicable to the
proposed tolerance exemption.  While there are registered food uses of
for ammonium salts of fatty acids, there is neither a tolerance nor a
tolerance exemption under 40 CFR 180.  In the 1991 RED the Agency
pledged to correct this discrepancy by proposing a tolerance exemption.
This action was carried out in 1996 (61FR19233-36) but the proposed rule
was never finalized even though no comments were received from the
public.  The herewith submitted petition to exempt ammonium salts of
fatty acids, from the requirement of a tolerance for all food uses,
seeks to re-propose and finalize this tolerance exemption.

4.  Non-Dietary Exposure.  The only non-dietary exposure to ammonium
salts of fatty acids will be occupational and residential exposure.
Ammonium salts of fatty have been, or are currently used as a rabbit and
deer repellent on forage and grain crops; vegetables and field crops,
non-crop areas, nursery stock and ornamentals, flowers, roses shrubs,
fruit trees and vines.  The labels for products whose active ingredient
is a higher soap salt of a fatty acid bear the signal word “WARNING”
due to potential eye irritation and require that users wear protective
eyewear, i.e. glasses, goggles, or faceshield, to protect against ocular
exposure.  The products may also cause allergic skin reactions in some
individuals, however, no measures are recommended to reduce skin
exposure because the Agency believes the allergic reactions are uncommon
and transient.

E.  Cumulative Effects

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.'' Studies of fatty acids and fatty acid
salts previously submitted to the Agency, indicate that the half-life of
fatty acids is less than one (1) day (MRID 00157476).  As can be
expected, there is very rapid microbial degradation of fatty acids in
soil.  Fatty acids and their salts are excellent substrates for
microbial growth, serving both as carbon sources and energy sources.
The active ingredient cannot totally dissipate from soil, because there
is a natural content of fatty acids in soil resulting from plant
metabolism and by formation of microbial organisms.  Fatty acids
constitute a significant portion of the normal daily diet of mammals
(including humans, birds, and invertebrates since they are found in
large amounts in the form of lipids in all living tissues (including
seeds).  Microbial metabolism of fatty acids has the effect of either
converting the degradates to CO2 and ester (if used as an energy source)
or converting the carbon content of the fatty acid to any of the
thousands of naturally occurring organic substances produced by the soil
microflora (if used as a carbon source).  Based on these known facts of
the role of fatty acids in the environment and in food and feed, there
should be no concern for cumulative effects of ammonium salts of fatty
acids used as pesticides.

F. Safety Determination

U.S. Population.  As described above in D., fatty acids are a necessary
and normal component of the human diet.  Dietary exposure from
pesticidal use would be very low compared to the everyday normal dietary
exposure.

Infants and children. Fatty acids are a necessary and normal part of the
diet of infants and children.  For the same reasons as for the general
U.S. population, dietary exposure to ammonium salts of fatty acids due
to pesticidal use would be of minimal concern.

G. Proposed Tolerance Exemption

Falcon Lab, LLC, is requesting that the Agency grant and exemption from
the requirement of a tolerance for ammonium salts of higher fatty acids
[C8-C18, saturated, and C8-C12, unsaturated].  This action is consistent
with the Agency’s pledge to formalize food use approval for ammonium
salts of fatty acids as stated in the 1992 RED: Soap Salts, by exempting
ammonium salts of higher fatty acids from the requirement of a
tolerance.  The Agency began this process in 1996 with the publication
of a proposed rule to exempt ammonium salts of fatty acids from the
requirement of a tolerance: “the Agency is now proposing to establish
an exemption from the requirement of a tolerance for all food uses under
FFDCA section 408 for ammonium soap salts of fatty acids because a
tolerance is not needed to protect the public health.”  The Agency
proposed to establish the exemption from the requirement of a tolerance
at 40 CFR 180.1166.  Although no comments were received during the
public comment period, the rule was not finalized, and has languished
since.  Falcon Lab is now petitioning the Agency to establish a
permanent exemption from the requirement of a tolerance for all food
uses for ammonium salts of higher fatty acids due to the demonstrated,
very low acute oral and dermal toxicity of these ammonium salts and
because residues from pesticide uses are not likely to exceed levels of
naturally occurring or intentionally added fatty acids in commonly
consumed foods.  In the 1992 RED, and the recently published
Biopesticide Registration Document for Ammonium Nonanoate, the agency
found that the risks to applicators and consumers of treated foods with
ammonium salts of fatty acids to be negligible.

H. International Tolerances

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There are no international tolerances or exemptions from the
requirement of a tolerance for residues of ammonium salts of fatty acids
in food or animal feed.  Therefore, harmonization is not an issue.


[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Proposed Rules]
[Pages 74530-74535]
[FR Doc No: 2022-26472]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1573; Project Identifier MCAI-2022-00671-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2020-22-16, AD 2021-16-01, and AD 2022-04-03, which apply to certain
Airbus SAS Model A318, A320 and A321 series airplanes; and Model A319-
111, -112, -113, -114, -115, -131, -132, -133, -151N, and -153N
airplanes. AD 2020-22-16, AD 2021-16-01, and AD 2022-04-03 require
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations. Since
the FAA issued AD 2020-22-16, AD 2021-16-01, and AD 2022-04-03, the FAA
has determined that new or more restrictive airworthiness limitations
are necessary. This proposed AD would continue to require the actions
in AD 2020-22-16, AD 2021-16-01, and AD 2022-04-03, and would require
revising the existing maintenance or inspection program, as applicable,
to incorporate additional new or more restrictive airworthiness
limitations, as specified in a European Union Aviation Safety Agency
(EASA) AD, which is proposed for incorporation by reference (IBR). The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by January 20,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1573; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For the EASA ADs identified in this NPRM, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999
000; email [email protected]; website easa.europa.eu. You may find
this material on the EASA website at ad.easa.europa.eu. It is also
available in the AD docket at regulations.gov under Docket No. FAA-
2022-1573 may view this material at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Hyeyoon Jang, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1573; Project Identifier
MCAI-2022-00671-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Hyeyoon Jang, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines, WA
98198; telephone<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2020-22-16, Amendment 39-21312 (85 FR 70439,
November 5, 2020) (AD 2020-22-16) for certain Airbus SAS Model A318
series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, -
133, -151N, and -153N airplanes; Model A320 series airplanes; and Model
A321 series airplanes. AD 2020-22-16 was prompted by an MCAI originated
by EASA, which is the Technical Agent for the Member States of the
European Union. EASA issued AD 2020-0067, dated March 23, 2020 (EASA AD
2020-0067) (which corresponds to FAA AD 2020-22-16) to correct an
unsafe condition. AD 2020-22-16 requires revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. The FAA issued AD 2020-22-
16 to address a safety-significant latent failure (that is not
annunciated), which, in combination with one or more other specific
failures or events, could result in a hazardous or catastrophic failure
condition.
    The FAA issued AD 2021-16-01, Amendment 39-21662 (86 FR 47212,
August 24, 2021) (AD 2021-16-01), for certain Airbus SAS Model A318
series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, -
133, -151N, and -153N airplanes; Model A320 series airplanes; and Model
A321 series airplanes. AD 2021-16-01 was prompted by EASA AD 2020-0219,
dated October 12, 2020 (EASA AD 2020-0219) (which corresponds to FAA AD
2021-16-01) to correct an unsafe condition. AD 2021-16-01 requires
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations. The
FAA issued AD 2021-16-01 to address safety-significant latent failure
(that is not annunciated), which, in combination with one or more other
specific failures or events, could result in a hazardous or
catastrophic failure condition. AD 2021-16-01 specifies that
accomplishing the revision required by that AD terminates the
corresponding requirements of AD 2020-22-16, for the tasks identified
in the service information referred to in EASA AD 2020-0219, dated
October 12, 2020, only.
    The FAA issued AD 2022-04-03, Amendment 39-21944 (87 FR 10064,
February 23, 2022) (AD 2022-04-03), for certain Airbus SAS Model A318
series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, -
133, -151N, and -153N airplanes; and Model A320 and A321 series
airplanes. AD 2022-04-03 was prompted by EASA AD 2021-0108, dated April
20, 2021 (EASA AD 2021-0108) (which corresponds to FAA AD 2022-04-03).
AD 2022-04-03 requires revising the existing maintenance or inspection
program, as applicable, to incorporate new or more restrictive
airworthiness limitations. The FAA issued AD 2022-04-03 to address a
safety-significant latent failure (that is not annunciated), which, in
combination with one or more other specific failures or events, could
result in a hazardous or catastrophic failure condition. AD 2022-04-03
specifies that accomplishing the revision required by that AD
terminates the limitations of Task<PHONE_NUMBER>1-1-C, as required by
paragraph (i) of AD 2020-22-16, for airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before January 17, 2020 only.

Actions Since AD 2020-22-16, AD 2021-16-01, and AD 2022-04-03 Were
Issued

    Since the FAA issued AD 2020-22-16, AD 2021-16-01, and AD 2022-04-
03, EASA superseded ADs 2020-0067, 2020-0219, and 2021-0108; and issued
EASA AD 2022-0091, dated May 20, 2022 (EASA AD 2022-0091) (also
referred to as the MCAI), for certain Model A318 series, A319 series,
A321 series, and Model A320-211, -212, -214, -215, -216, -231, -232, -
233, -251N, -252N, -253N, -271N, -272N, and -273N airplanes. Model
A320-215 airplanes are not certificated by the FAA

and are not included on the U.S. type certificate data sheet; this
proposed AD therefore does not include those airplanes in the
applicability.
    Airplanes with an original airworthiness certificate or original
export certificate of airworthiness issued after February 18, 2022 must
comply with the airworthiness limitations specified as part of the
approved type design and referenced on the type certificate data sheet;
this AD therefore does not include those airplanes in the
applicability.
    The FAA is proposing this AD to address a safety-significant latent
failure (that is not annunciated), which, in combination with one or
more other specific failures or events, could result in a hazardous or
catastrophic failure condition. You may examine the MCAI in the AD
docket at regulations.gov under Docket No. FAA-2022-1573.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0091 specifies new or more restrictive airworthiness
limitations for certification maintenance requirements.
    This proposed AD would also require EASA AD 2020-0067, dated March
23, 2020; which the Director of the Federal Register approved for
incorporation by reference as of December 10, 2020 (85 FR 70439,
November 5, 2020).
    This proposed AD would also require EASA AD 2020-0219, dated
October 12, 2020, which the Director of the Federal Register approved
for incorporation by reference as of September 28, 2021 (86 FR 47212,
August 24, 2021).
    This proposed AD would also require EASA AD 2021-0108, dated April
20, 2021, which the Director of the Federal Register approved for
incorporation by reference as of March 30, 2022 (87 FR 10064, February
23, 2022).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI described above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would retain the requirements of AD 2020-22-16, AD
2021-16-01, and AD 2022-04-03. This proposed AD would also require
revising the existing maintenance or inspection program, as applicable,
to incorporate additional new or more restrictive airworthiness
limitations, which are specified in EASA AD 2022-0091 described
previously, as proposed for incorporation by reference. Any differences
with EASA AD 2022-0091 are identified as exceptions in the regulatory
text of this AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance (AMOC) according to
paragraph (s)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to retain the IBR of EASA ADs 2020-0067, 2020-0219, and
2021-0108, and incorporate EASA AD 2022-0091 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA ADs 2022-0091, 2020-0067, 2020-0219, and 2021-0108 through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this proposed AD. Using common terms that are
the same as the heading of a particular section in EASA ADs 2022-0091,
2020-0067, 2020-0219, or 2021-0108 does not mean that operators need
comply only with that section. For example, where the AD requirement
refers to ``all required actions and compliance times,'' compliance
with this AD requirement is not limited to the section titled
``Required Action(s) and Compliance Time(s)'' in EASA ADs 2022-0091,
2020-0067, 2020-0219, or 2021-0108. Service information required by
EASA ADs 2022-0091, 2020-0067, 2020-0219, and 2021-0108 for compliance
will be available at  regulations.gov under Docket No. FAA-2022-1573
after the FAA final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections) may be used unless the actions and intervals are approved
as an AMOC in accordance with the procedures specified in the AMOCs
paragraph under ``Additional AD Provisions.'' This new format includes
a ``New Provisions for Alternative Actions and Intervals'' paragraph
that does not specifically refer to AMOCs, but operators may still
request an AMOC to use an alternative action or interval.

Costs of Compliance

    The FAA estimates that this proposed AD affects 1,680 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2020-22-16, AD 2021-16-01, and AD 2022-04-03 to be
$7,650 (90 work-hours x $85 per work-hour) per AD.
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their

affected fleet(s), the FAA has determined that a per-operator estimate
is more accurate than a per-airplane estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directives (AD) 2020-22-16, Amendment 39-
21312 (85 FR 70439, November 5, 2020); AD 2021-16-01, Amendment 39-
21662 (86 FR 47212, August 24, 2021); and AD 2022-04-03, Amendment 39-
21944 (87 FR 10064, February 23, 2022).
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-1573; Project Identifier MCAI-2022-
00671-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 20, 2023.

(b) Affected ADs

    This AD replaces the ADs specified in paragraphs (c)(1) through
(3) of this AD.
    (1) AD 2020-22-16, Amendment 39-21312 (85 FR 70439, November 5,
2020) (AD 2020-22-16).
    (2) AD 2021-16-01, Amendment 39-21662 (86 FR 47212, August 24,
2021) (AD 2021-16-01).
    (3) AD 2022-04-03, Amendment 39-21944 (87 FR 10064, February 23,
2022) (AD 2022-04-03).

(c) Applicability

    This AD applies to the Airbus SAS airplanes specified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category, with an original airworthiness certificate or original
export certificate of airworthiness issued on or before February 18,
2022.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, -133, -
151N, -153N, and -171N airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N, -
252N, -253N, -271N, -272N, and -273N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX,
and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address to address a safety significant latent
failure (that is not annunciated), which, in combination with one or
more other specific failures or events, could result in a hazardous
or catastrophic failure condition.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Revision of the Existing Maintenance or Inspection Program
From AD 2020-22-16, With No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2020-22-16, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before January 17, 2020, except for Model
A319-171N airplanes: Except as specified in paragraph (h) of this
AD: Comply with all required actions and compliance times specified
in, and in accordance with, European Union Aviation Safety Agency
(EASA) AD 2020-0067, dated March 23, 2020 (EASA AD 2020-0067).
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (o) of this AD terminates the
requirements of this paragraph.

(h) Retained Exceptions to EASA AD 2020-0067 With No Changes

    This paragraph restates the exceptions specified in paragraph
(j) of AD 2020-22-16, with no changes.
    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0067 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2020-0067 specifies revising ``the
AMP'' within 12 months after its effective date, but this AD
requires revising the existing maintenance or inspection program, as
applicable, to incorporate the ``tasks and associated thresholds and
intervals'' specified in paragraph (3) of EASA AD 2020-0067 within
90 days after December 10, 2020 (the effective date of AD 2020-22-
16).
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2020-0067 is at the applicable ``associated
thresholds'' specified in paragraph (3) of EASA AD 2020-0067, or
within 90 days after December 10, 2020 (the effective date of AD
2020-22-16), whichever occurs later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2020-0067 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2020-0067 does not apply
to this AD.

(i) Retained Restrictions on Alternative Actions and Intervals From AD
2020-22-16, With a New Exception

    This paragraph restates the requirements of paragraph (k) of AD
2020-22-16, with a new exception. Except as required by paragraph
(o) of this AD, after the maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals are allowed unless they are
approved as specified in the provisions of the ``Ref. Publications''
section of EASA AD 2020-0067.

(j) Retained Revision of the Existing Maintenance or Inspection Program
From AD 2021-16-01 With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2021-16-01, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 10, 2020, except for Model
A319-171N airplanes: Revise the existing maintenance or inspection
program, as applicable, by incorporating task(s) and associated
thresholds and intervals specified in paragraph (3) of EASA AD 2020-
0219, dated October 12, 2020 (EASA AD 2020-0219), except you are
required to incorporate task(s) and associated thresholds and
intervals within 90 days after September 28, 2021 (the effective
date of AD 2021-16-01). Record a compliance time for the initial
tasks of either the applicable ``thresholds'' incorporated by the
requirements of paragraph (3) of EASA AD 2020-0219 or 90 days after
September 28, 2021 (the effective date of AD 2021-16-01), whichever
would occur later. Accomplishing the revision of the existing
maintenance or inspection program required by paragraph (o) of this
AD terminates the requirements of this paragraph.

(k) Retained Restrictions on Alternative Actions and Intervals From AD
2021-16-01, With a New Exception

    This paragraph restates the requirements of paragraph (h) of AD
2021-16-01, with a new exception. Except as required by paragraph
(o) of this AD, after the existing maintenance or inspection program
has been revised as required by paragraph (j) of this AD, no
alternative actions (e.g., inspections) and intervals are allowed
unless they are approved as specified in the provisions of the
``Ref. Publications'' section of EASA AD 2020-0219.

(l) Retained Revision of the Existing Maintenance or Inspection Program
From AD 2022-04-03, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2022-04-03, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before December 9, 2020, except for Model
A319-171N airplanes: Except as specified in paragraph (m) of this
AD: Comply with all required actions and compliance times specified
in, and in accordance with, EASA AD 2021-0108, dated April 20, 2021
(EASA AD 2021-0108). Accomplishing the revision of the existing
maintenance or inspection program required by paragraph (o) of this
AD terminates the requirements of this paragraph.

(m) Retained Exceptions to EASA AD 2021-0108, With No Changes

    This paragraph restates the exceptions specified in paragraph
(h) of AD 2022-04-03, with no changes.
    (1) Where EASA AD 2021-0108 refers to its effective date, this
AD requires using March 30, 2022 (the effective date of AD 2022-04-
03).
    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0108 do not apply to this AD.
    (3) Paragraph (3) of EASA AD 2021-0108 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after March 30, 2022 (the effective
date of AD 2022-04-03).
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA 2021-0108 is at the applicable ``thresholds''
as incorporated by the requirements of paragraph (3) of EASA AD
2021-0108, or within 90 days after March 30, 2022 (the effective
date of AD 2022-04-03), whichever occurs later.
    (5) The provisions specified in paragraphs (4) of EASA AD 2021-
0108 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2021-0108 does not apply
to this AD.

(n) Retained Restrictions on Alternative Actions and Intervals From AD
2022-04-03, With a New Exception

    This paragraph restates the requirements of paragraph (i) of AD
2022-04-03, with a new exception. Except as required by paragraph
(o) of this AD, after the existing maintenance or inspection program
has been revised as required by paragraph (l) of this AD, no
alternative actions (e.g., inspections) and intervals are allowed
unless they are approved as specified in the provisions of the
``Ref. Publications'' section of EASA AD 2021-0108.

(o) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (p) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with EASA AD 2022-0091, dated May 20, 2022 (EASA AD 2022-
0091). Accomplishing the revision of the existing maintenance or
inspection program required by this paragraph terminates the
requirements of paragraphs (g) (j), and (l) of this AD.

(p) Exceptions to EASA AD 2022-0091

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2022-0091 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2022-0091 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2022-0091 is at the applicable ``associated
thresholds'' as incorporated by the requirements of paragraph (3) of
EASA AD 2022-0091, or within 90 days after the effective date of
this AD, whichever occurs later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2022-0091 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2022-0091 does not apply
to this AD.

(q) Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (o) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2022-0091.

(r) Terminating Action for Certain Requirements of AD 2020-22-16

    (1) Accomplishing the actions required by paragraph (j) of this
AD terminates the corresponding requirements of AD 2020-22-16, for
the tasks identified in the service information referred to in EASA
AD 2020-0219 only.
    (2) Accomplishing the actions required by paragraph (l) of this
AD terminates the limitations of Task<PHONE_NUMBER>1-1-C, as required
by paragraph (i) of AD 2020-22-16, for airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before January 17, 2020 only.

(s) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (t) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(t) Additional Information

    For more information about this AD, contact Hyeyoon Jang,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(u) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.

    (3) The following service information was approved for IBR on
[DATE 35 DAYS AFTER PUBLICATION OF THE FINAL RULE].
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0091,
dated May 20, 2022.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
December 10, 2020 (85 FR 70439, November 5, 2020).
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0067,
dated March 23, 2020.
    (ii) [Reserved]
    (5) The following service information was approved for IBR on
September 28, 2021 (86 FR 47212, August 24, 2021).
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0219,
dated October 12, 2020.
    (ii) [Reserved]
    (6) The following service information was approved for IBR on
March 30, 2022 (87 FR 10064, February 23, 2022).
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0108,
dated April 20, 2021.
    (ii) [Reserved]
    (7) For EASA ADs 2022-0091, 2020-0067, 2020-0219, and 2021-0108,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; website
easa.europa.eu. You may find these EASA ADs on the EASA website at
ad.easa.europa.eu.
    (8) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (9) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 1, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-26472 Filed 12-5-22; 8:45 am]
BILLING CODE 4910-13-P