[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Rules and Regulations]
[Pages 64322-64330]
[FR Doc No: 2014-25732]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0659; FRL-9917-30]

Prallethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide prallethrin, including its metabolites and degradates, in
or on all food commodities from use of prallethrin in food handling
establishments where food and food products are held, processed,
prepared and/or served, or as a wide-area mosquito adulticide at 1.0
part per million (ppm). McLaughlin Gormley King Company requested these
tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 29, 2014. Objections and
requests for hearings must be received on or before December 29, 2014,
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-2013-0659, 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: Daniel J. Rosenblatt, Registration
Division (RD) (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0659 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
December 29, 2014. 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-2013-0659, 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.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to section 408(d)(3) of FFDCA,
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F8090) by McLaughlin Gormley King Company, 8810 Tenth Avenue,
Minneapolis, MN 55427. The petition requested that 40 CFR 180.545 be
amended by establishing a tolerance of 1.0 ppm for residues of the
insecticide prallethrin, including its metabolites and degradates, in
or on all raw agricultural commodities and processed food, and food
products in food handling establishments where food and food products
are held, processed, prepared and/or served, or as a wide-area mosquito
adulticide. That document referenced a summary of the petition prepared
by McLaughlin Gormley King Company, the registrant, which is available
in the docket, http://www.regulations.gov. There were no comments
received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Prallethrin is a member of the pyrethroid class of insecticides.
Pyrethroids have historically been classified into two groups, Type I
and Type II, based upon chemical structure and neurotoxicological
effect. Type I pyrethroids lack an alpha-cyano moiety and induce a
syndrome consisting of aggressive sparring, altered sensitivity to
external stimuli, and fine tremor progressing to whole-body tremor and
prostration in rats. These Type I pyrethroid-specific behaviors are
collectively described as the T-syndrome. Type II pyrethroids contain
an alpha-cyano moiety and produce a syndrome that includes pawing,
burrowing, salivation, and coarse tremors leading to choreoathetosis in
rats. These Type II pyrethroid-specific behaviors are collectively
described as the CS-syndrome (Verschoyle and Aldridge 1980; Lawrence
and Casida 1982). Prallethrin is structurally similar to Type I
pyrethroids. The adverse outcome pathway (AOP) shared by pyrethroids
involves the ability to interact with voltage-gated sodium channels
(VGSCs) in the central and peripheral nervous system, leading to
changes in neuron firing, and ultimately neurotoxicity.
    Prallethrin has been evaluated for a variety of toxic effects in
experimental toxicity studies. Neurotoxicity was observed throughout
the database and is the most sensitive endpoint. Effects were seen
across species, sexes, and routes of administration. In the acute rat
neurotoxicity study, decreased exploratory behavior was seen at the
time of peak effect. Reduced motor activity and transient tremors were
also observed in the study. In the subchronic rat neurotoxicity study,
a higher arousal rate was observed in animals at the highest dose
tested. Clinical signs of neurotoxicity were also observed in other
toxicity studies (subchronic and chronic oral studies in dogs,
developmental toxicity studies in the rat and rabbit, 21-day dermal and
28-day inhalation studies in rats). No neurotoxic effects were observed
in rats in the chronic toxicity study.
    Effects were also observed in the liver (rats, mice, and dogs),
heart (dogs), and thyroid gland (rats). Some effects were also seen in
the kidney (mice and rats). However, neurotoxicity was the most
sensitive endpoint in the toxicology database, and other effects were
generally seen in the presence of neurotoxicity and/or at higher doses.
Liver effects observed included increased weight, elevated serum
cholesterol and alkaline phosphatase

activity, centrilobular hepatocyte vacuolation, histiocytic
infiltration, enlarged liver, and perilobular hepatocellular
hypertrophy. In dogs, myocardial fiber degeneration was seen in females
in the subchronic study at the highest dose tested. Heart effects were
also seen in one mid-dose female in the chronic study (hemorrhage and
red discoloration). However, there was no dose response for the
observed heart lesions in the study. Thyroid effects were observed in
rats and consisted of increases in the number of small follicles and
follicular cell hypertrophy and hyperplasia. The thyroid effects were
seen in short-term studies in the presence of liver effects. Kidney
effects observed were increased weights and histopathology.
    Developmental and reproduction studies are available for
prallethrin. There was no evidence of increased quantitative or
qualitative susceptibility in any of the studies. In the developmental
studies, no toxic effects were noted in fetuses up to the highest doses
tested. Maternal effects in the studies included tremors, salivation,
exaggerated reflexes, and chromorhinorrhea. In the reproduction study,
decreased pup body weights were seen during the lactation period.
Effects seen in parental animals were decreased body weights and body
weight gains, increased liver weights and microscopic findings in the
liver, kidney, thyroid, and pituitary.
    Prallethrin is classified as ``Not Likely to be Carcinogenic to
Humans.'' No tumors were observed in rat and mouse carcinogenicity
studies up to the highest doses tested. In both the rat and mouse
studies, the animals could have tolerated higher dose levels; however,
EPA determined that dose levels were adequate to assess potential
carcinogenicity.
    Prallethrin tested negative in the majority of the genotoxicity
studies. It also tested negative in an in vitro chromosomal aberration
study in Chinese Hamster Ovary (CHO K1) cells without metabolic
activation, but tested positive at all doses with metabolic activation.
However, clastogenicity was not clearly dose-related, was seen at
nontoxic and slightly toxic doses, and was not expressed in in vivo
studies and structure-activity comparisons with the other pyrethroids
revealed no correlations with clastogenicity. Other gene mutation,
chromosomal aberration, and unscheduled DNA synthesis (UDS) studies
were negative; therefore, there is no concern for genotoxicity.
    Acute lethality studies conducted with prallethrin indicate
moderate acute toxicity via the oral and inhalation routes of
administration (Category II) and low acute toxicity via the dermal
route (Categories IV). It is not irritating to the skin (Category IV)
but is minimally irritating to the eye (Category IV). It is not a
dermal sensitizer. The weight of evidence from the available guideline,
non-guideline, mechanism of action, and pharmacokinetics studies
supports characterizing the toxicological profile of pyrethroids,
including prallethrin, as being rapid in onset and associated with
acute, peak exposures. Also, there is no apparent increase in hazard
from repeated/chronic exposures to prallethrin.
    Specific information on the studies received and the nature of the
adverse effects caused by prallethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect
level (LOAEL) from the toxicity studies can be found in the document
titled ``Prallethrin: Human Health Risk Assessment for the Tolerance
Petition to Amend the Section 3 Mosquito Adulticide Registration to
Include Use of the Insecticide Over All Crops,'' dated September 15,
2014, by going to http://www.regulations.gov. The referenced document
is available in the docket established by this action, which is
described under ADDRESSES. Locate and click on the hyperlink for docket
ID number EPA-HQ-OPP- 2013-0659. Double-click on the document to view
the referenced information.

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 (LOC) 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 are identified (the
LOAEL). Uncertainty/safety factors are used in conjunction with the POD
to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for prallethrin used for
human risk assessment are shown in Tables 1 and 2 of this unit. Based
on the proposed use patterns for prallethrin, endpoints and points of
departure were selected for dietary (acute only), dermal, inhalation,
and incidental oral exposures.
    For oral exposures (acute dietary and incidental oral), the
endpoint and POD were selected from a chronic dog study in which
neurotoxicity was observed within 4 weeks of dosing and was considered
to have potentially resulted from a single dose, based on a weight-of-
the-evidence. For dermal assessment, the endpoint was selected from the
route-specific 21-day dermal study in the rat, in which clinical signs
were observed within 1 to 3 days of dosing. The endpoints being used to
assess oral and dermal exposures are the same (neurotoxicity);
therefore, risks from those routes of exposure were combined. Although
the LOAEL for inhalation is also based on neurotoxicity, derivation of
the human equivalent concentrations (HECs) used for inhalation risk
assessment shows that assessing inhalation exposure based on the
portal-of-entry effects is protective of the systemic endpoints,
including neurotoxicity. As a result, inhalation exposure was not
combined with either the dermal or the oral routes of exposure.
    A chronic dietary risk assessment was not conducted for
prallethrin. Given what is known about pyrethroid toxicokinetics/
dynamics, in general, and as there is no apparent increase in hazard
from repeated/chronic exposures to prallethrin, the acute dietary
exposure assessment is protective of chronic dietary exposures. Based
on the toxicity profile, intermediate- or long-term exposure
assessments were not conducted for adults or children.

  Table 1--Summary of Toxicological Doses and Endpoints for Prallethrin for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessments
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                                    Point of departure
        Exposure/scenario          and uncertainty/FQPA   RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (Children >=6 years  NOAEL = 2.5 mg/kg/    Acute RfD = 0.025    Chronic dog study (capsule). LOAEL
 old and Adults).                   day.                  mg/kg/day.           = 5 mg/kg/day based on clinical
                                   UFA = 10x...........  aPAD= 0.025 mg/kg/    signs of neurotoxicity.
                                   UFH = 10x...........   day..
                                   FQPA SF = 1x........
Acute Dietary (Children <6 years   NOAEL = 2.5 mg/kg/    Acute RfD = 0.025
 old).                              day.                  mg/kg/day.
                                   UFA = 10x...........  aPAD= 0.008 mg/kg/
                                   UFH = 10x...........   day.
                                   FQPA SF = 3x........
Incidental Oral Short-Term (1 to   NOAEL = 2.5 mg/kg/    Residential LOC for
 30 days).                          day.                  MOE = 300.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 3x........
Dermal Short-term (1 to 30 days)   Dermal NOAEL = 30 mg/ Residential LOC for  21-day Dermal Rat. LOAEL = 150 mg/
 (Children <6 years old).           kg/day.               MOE = 300.           kg/day based on observed clinical
                                   UFA = 10x...........                        signs of toxicity (fixation,
                                   UFH = 10x...........                        abnormal gait, tremors,
                                   FQPA SF = 3x........                        sensitivity to external stimuli,
                                                                               vocalization, twitching and
                                                                               writhing spasms), all beginning
                                                                               between days 1 and 3 of a 21-day
                                                                               dermal study in rats.
Dermal Short-term (1 to 30 days)   Dermal NOAEL = 30 mg/ Residential LOC for
 (Children >=6 years old and        kg/day.               MOE = 100.
 Adults).                          UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
Inhalation Short-term (1 to 30     Inhalation NOAEL =    Residential LOC for  28-Day Inhalation Rat. LOAEL =
 days) (Children <6 years old).     0.001 mg/L.           MOE = 100.           0.0044 mg/L based on irregular
                                   UFA = 3x............                        respiration, decreased
                                   UFH = 10x...........                        spontaneous activity, salivation,
                                   FQPA SF = 3x........                        incontinence, and nasal
                                   HEC/HED calculations                        discharge.
                                    used for risk
                                    assessment (see
                                    below).
Inhalation Short-term (1 to 30     Inhalation NOAEL =    Residential LOC for
 days) (Children >=6 years old      0.001 mg/L.           MOE = 30.
 and Adults).                      UFA = 3x............
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                   HEC/HED calculations
                                    used for risk
                                    assessment.
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aPAD = acute population adjusted dose. FQPA SF = FQPA Safety Factor. HEC = human equivalent concentration. HED =
  human equivalent dose. LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of
  exposure. NOAEL = no observed adverse effect level. Point of Departure (POD) = A data point or an estimated
  point that is derived from observed dose-response data and used to mark the beginning of extrapolation to
  determine risk associated with lower environmentally relevant human exposures. RfD = reference dose. UF =
  uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
  sensitivity among members of the human population (intraspecies).

  Table 2--Summary of Toxicological Doses and Endpoints for Prallethrin for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessments
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                                        Residential              HECs                        HEDs
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Residential HECs and HEDs........  Handler/Outdoor Post- 0.00020 mg/L.......  0.006 mg/kg/day.
                                    application.
Residential LOC for MOE = 100      Indoor Post-          0.00014 mg/L.......  N/A.
 (Children <6 years old).           application without
                                    air ventilation.
Residential LOC for MOE = 30       Indoor Post-          Adults: 0.00004 mg/  N/A.
 (Children >=6 years old and        application with      L.
 Adults).                           air ventilation.     Children: 0.00003
                                                          mg/L..
                                   Bystander...........  0.00002 mg/L.......  N/A.
                                  ------------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)           Classification: ``Not Likely to be Carcinogenic to Humans.''
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HEC = human equivalent concentration. HED = human equivalent dose. Kg = kilogram. LOC = level of concern. L =
  Liter. Mg = milligram. MOE = margin of exposure. N/A = Not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to prallethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing prallethrin tolerances in 40 CFR
180.545. Acute and chronic aggregate dietary (food and drinking water)
exposure assessments were conducted using the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption
data from the U.S. Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA).
    i. Acute exposure. The acute dietary risk assessment is partially
refined, and is based on the assumption that as a result of potential
use in food handling establishments (FHEs), most commodities will have
residues at one-half the limit of quantification (LOQ) of the
analytical method used in the FHE residue trials (0.05 ppm). It was
also based on the assumptions that all flour food forms will contain
residues at the highest level found in the FHE residue trials on flour,
and that tree nuts and peanuts will contain residues at the highest
level found in the FHE residue trials on peanuts. Based on residue
data, the highest residue value (0.0045 ppm) was used for all crops as
a result of treatment from the mosquito adulticide use.
    The percent FHE value of 4.65% was applied to the FHE residue
values, and the adulticide residues were incorporated at a level of
100% (i.e., all foods could potentially have residues resulting from
the mosquito adulticide use). Residues from food handling (modified by
the % FHE estimate) and mosquito adulticide treatments were combined.
    ii. Chronic exposure. A chronic dietary risk assessment was not
conducted. However, a chronic exposure assessment was conducted to
determine background levels of dietary exposure for estimating
aggregate risk. The exposure estimates are based on the highest residue
value from the FHE residue trials for tree nuts, peanuts, and all flour
food forms; and on the LOQ of the method used in the FHE trials (0.10
ppm). The data were treated in the same manner as the data in the acute
dietary risk assessment, with the exception that the average residue
value from the adulticide trials (0.0007 ppm) was used instead of the
highest residue value (0.0045 ppm).
    For the chronic exposure assessment, EPA applied a percent FHE
value of 4.65% to the FHE residue values and assumed 100 percent crop
treated (PCT) for the proposed mosquito adulticide use, just as we have
done for the acute exposure assessment. This value is considered to be
an overestimate of the potential for the mosquito adulticide to drift
onto growing crops. Residues from the FHE and adulticide uses were then
combined. Processing factors were not used because the assumption was
made that foods in an FHE could be treated after processing.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that prallethrin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(F) of FFDCA states that EPA to states that the Agency
may use data on the actual percent of food treated for assessing
chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimates a maximum 4.65% probability that a food a
person consumes contains residues as a result of treatment in an FHE at
some point with any pesticide (i.e., it is not specific to
prallethrin). This value was derived by taking into account the daily
probability of treatment and the percent of expenditures resulting in
potential residues in restaurants, commercial kitchens, food
warehouses, and food processors. For both the acute and chronic
assessments, this value was used for the FHE component of the residue
for all commodities with the exception of drinking water.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including

several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available reliable information on the
regional consumption of food to which prallethrin may be applied in a
particular area.
    Specific information on the methodology to estimate PCT can be
found in the document entitled ``Prallethrin: Upper Bound Estimate of
the Likelihood of Insecticide Residues on Food Resulting from Treatment
in Food Handling Establishments,'' dated September 7, 2014, by going to
http://www.regulations.gov.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for prallethrin. These simulation models take into account
data on the physical, chemical, and fate/transport characteristics of
prallethrin. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), Tier II
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), and the Pesticide Flooded Application Model (PFAM), the surface
water estimated drinking water concentration (EDWC) value of 0.591
parts per billion (ppb) was used in the acute assessment and that the
annual average surface water EDWC value of 0.0375 ppb was used in the
chronic assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Prallethrin is currently registered for the following uses that
could result in residential exposures: A variety of residential pet,
indoor and outdoor uses for pests found on turf, and in homes and
commercial settings, including food handling establishments. However,
for purposes of this assessment, only registered residential products
and use sites with the highest application rates or percent active
ingredient (a.i.) were assessed because they are representative of the
worst case exposure scenarios for the exposed populations.
    EPA assessed potential residential handler exposure scenarios
resulting from mixing/loading/applying sprays to lawns using hose-end
and backpack sprayers because exposure from treating lawns were higher
than from other application methods and sites. A quantitative
assessment was not required for handling of total release fogger
products since the labels state that the room/house must be vacated
immediately by the user once initiated.
    EPA assessed post-application dermal exposure for adults and
children as well as incidental oral (i.e., hand-to-mouth) exposure for
children resulting from contact with residues deposited on turf and
indoor surfaces following application with aerial and truck-mounted
fogger mosquito vector control applications, hand-held spray
applications on turf and lawn, and indoor aerosol foggers,
respectively. Adult and child post-application inhalation exposure
resulting from both aerial and truck-mounted mosquito vector control
applications were also assessed. A quantitative post-application
inhalation exposure assessment was not performed for turf or indoor
aerosol foggers because inhalation exposure from these application
methods is anticipated to be negligible. Further information regarding
EPA standard assumptions and generic inputs for residential exposures
may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    The Agency has determined that the pyrethroids and pyrethrins share
a common mechanism of toxicity (go to http://www.regulations.gov and
search under document ID number EPA-HQ-OPP-2008-0489-0006). The members
of this group share the ability to interact with voltage-gated sodium
channels ultimately leading to neurotoxicity. The cumulative risk
assessment for the pyrethroids/pyrethrins was published on November 9,
2011, and is available at http://www.regulations.gov under EPA-HQ-OPP-
2011-0746. No cumulative risks of concern were identified, allowing the
Agency to consider new uses for pyrethroids. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity, and to evaluate the cumulative effects of this class of
chemicals, see EPA's Web site at http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.
    Prallethrin is included in the pyrethroids/pyrethrins cumulative
risk assessment. No dietary, residential or aggregate risk estimates of
concern have been identified in the single chemical assessment. In the
cumulative assessment, residential exposure was the greatest
contributor to the total exposure. An existing residential turf use for
prallethrin was evaluated to determine the potential contribution it
would have on the cumulative risk assessment. Although the turf use was
considered the main contributor for residential exposure, the turf
assessment indicated that exposure from turf would not impact the
residential component of the cumulative risk estimates for the
pyrethroids.
    Therefore, since the proposed mosquito adulticide contributes far
less exposure than the registered turf uses, there will be no impact on
the residential component of the cumulative risk estimates.
    Dietary exposures make a minor contribution to the total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid cumulative was much more highly refined than that performed
for prallethrin. In addition, for the prallethrin risk assessment, the
most sensitive apical endpoint in the prallethrin database was selected
to derive the POD. Further, the POD selected for prallethrin is
specific to prallethrin, whereas the POD selected for the cumulative
assessment was based on common mechanism of action data that are
appropriate for all 20 pyrethroids included in the cumulative
assessment. Dietary exposure to prallethrin residues resulting from the
proposed mosquito adulticide use over all crops will contribute very
little to the dietary exposure to prallethrin alone; therefore, the
proposed use will make an insignificant contribution to dietary risk to
the pyrethroids as a whole.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines,

based on reliable data, that a different margin of safety will be safe
for infants and children. This additional margin of safety is commonly
referred to as the Food Quality Protection Act Safety Factor (FQPA SF).
In applying this provision, EPA either retains the default value of
10x, or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prallethrin toxicity
database includes developmental toxicity studies in the rat and rabbit,
and a reproduction study in the rat. No evidence of increased
qualitative or quantitative susceptibility was noted in any of these
studies. This lack of susceptibility is consistent with the results of
guideline developmental and reproduction studies with other pyrethroid
pesticides.
    High-dose studies assessing what dose results in lethality to 50%
of the tested population (LD50) in the scientific literature
indicate that pyrethroid exposure can result in increased quantitative
sensitivity in the young, specifically in the form of neurotoxicity.
Examination of pharmacokinetic and pharmacodynamic data indicates that
the sensitivity observed at high doses is related to pyrethroid age-
dependent pharmacokinetics, which is the activity of enzymes associated
with the metabolism of pyrethroids. With otherwise equivalent
administered doses for adults and juveniles, predictive pharmacokinetic
models indicate that the differential adult-juvenile pharmacokinetics
will result in a 3x greater dose at the target organ in juveniles
compared to adults. No evidence of increased quantitative or
qualitative susceptibility was seen in the pyrethroid scientific
literature related to pharmacodynamics (the effect of pyrethroids at
the target tissue) both with regard to interspecies differences between
rats and humans and to differences between juveniles and adults.
Specifically, there are in vitro pharmacodynamic data and in vivo data
indicating similar responses between adult and juvenile rats at low
doses and data indicating that the rat is a conservative model compared
to the human based on species-specific pharmacodynamics of homologous
sodium channel isoforms in rats and humans.
    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 3x for infants and children less than 6 years
of age. For the general population, including children greater than 6
years of age, EPA is reducing the FQPA SF to 1x. These decisions are
based on the following findings:
    i. The toxicology database for prallethrin is considered complete
with respect to guideline toxicity studies for prallethrin; however,
the Agency lacks additional information to fully characterize the
potential for juvenile sensitivity to the neurotoxic effects of
pyrethroids. In light of the literature studies indicating a
possibility of increased sensitivity in juvenile rats at high doses,
EPA identified a need, and requested proposals for, additional non-
guideline studies to evaluate the potential for sensitivity in juvenile
rats. A group of pyrethroid registrants is currently conducting those
studies. Pending the results of those studies, however, the available
toxicity studies for prallethrin can be used to characterize toxic
effects including potential developmental and reproductive toxicity, as
well as neurotoxicity. Acceptable developmental toxicity studies in
rats and rabbits, reproduction studies in rats, neurotoxicity studies
(acute, subchronic, and developmental) in rats are available. In
addition, route-specific dermal and inhalation toxicity studies are
available. The Immunotoxicity study has been waived. As discussed in
Unit IV.D.2., EPA concludes that the 3x FQPA SF will be adequate for
protecting infants and children less than 6 years old.
    ii. After reviewing the extensive body of data and peer-reviewed
literature on pyrethroids, the Agency has reached a number of
conclusions regarding fetal and juvenile sensitivity for pyrethroids,
including the following:
     Based on an evaluation of over 70 guideline toxicity
studies for 24 pyrethroids submitted to the Agency, including prenatal
developmental toxicity studies in rats and rabbits, and pre- and
postnatal multi-generation reproduction toxicity studies and DNTs in
rats in support of pyrethroid registrations, there is no evidence that
pyrethroids directly impact developing fetuses. None of the studies
show any indications of fetal toxicity at doses that do not cause
maternal toxicity.
     Increased susceptibility was seen in offspring animals in
the DNT study with the pyrethroid zeta-cypermethrin (decreased pup body
weights) and DNT and reproduction studies with another pyrethroid beta-
cyfluthrin (decreased body weights and tremors). However, the
reductions in body weight and the other non-specific effects occur at
higher doses than neurotoxicity, the effect of concern for pyrethroids.
The available developmental and reproduction guideline studies in rats
with zeta-cypermethrin did not show increased sensitivity in the young
to neurotoxic effects. Overall, findings of increased sensitivity in
juvenile animals in pyrethroid studies are rare. Therefore, the
residual concern for the postnatal effects is reduced.
     High-dose LD50 studies (studies assessing what
dose results in lethality to 50% of the tested population) in the
scientific literature indicate that pyrethroids can result in increased
quantitative sensitivity to juvenile animals. Examination of
pharmacokinetic and pharmacodynamic data indicates that the sensitivity
observed at high doses is related to pyrethroid age-dependent
pharmacokinetics--the activity of enzymes associated with the
metabolism of pyrethroids. Furthermore, a rat physiologically-based
pharmacokinetic (PBPK) model predicts a 3-fold increase of pyrethroid
concentration in juvenile brain compared to adults at high doses.
     In vitro pharmacodynamic data and in vivo data indicate
that adult and juvenile rats have similar responses to pyrethroids at
low doses and therefore juvenile sensitivity is not expected at
relevant environmental exposures. Further, data also show that the rat
is a conservative model compared to the human based on species-specific
pharmacodynamics of homologous sodium channel isoforms.
    iii. There are no residual uncertainties with regard to dietary
exposure. The dietary exposure assessments are based on highly
conservative residue levels for the mosquito adulticide use and for the
FHE uses. Furthermore, conservative, upper-bound assumptions were used
to determine exposure through drinking water and residential sources,
such that these exposures have not been underestimated.
    Taking all of this information into account, EPA has reduced the
FQPA SF for women of child-bearing age because there is no evidence in
the over 70 guideline toxicity studies submitted to the Agency that
pyrethroids directly impact developing fetuses. In addition, none of
the studies show any indications of fetal toxicity at doses that do not
cause maternal toxicity. Because there remains some uncertainty as to
juvenile sensitivity due to the findings in the high-dose
LD50 studies, EPA is retaining a 3x FQPA SF for infants and
children less than 6 years of age. By age 6, the metabolic system is
expected to be at or near adult levels thus reducing concerns for
potential age-dependent sensitivity related to pharmacokinetics;
therefore for children over 6, a 1x factor

is appropriate. Although EPA is seeking additional data to further
characterize the potential neurotoxicity for pyrethroids, EPA has
reliable data that show that reducing the FQPA SF to 3x will protect
the safety of infants and children less than 6 years old. These data
include:
    a. Data from developmental and reproductive toxicity guideline
studies with prallethrin that show no sensitivity.
    b. Data showing that the potential sensitivity at high doses is
likely due to pharmacokinetics.
    c. A rat PBPK model predicting a 3-fold increase of pyrethroid
concentration in the juvenile brain compared to adults at high doses
due to age-dependent pharmacokinetics.
    d. Data indicating that the rat is a conservative model compared to
the human based on species-specific pharmacodynamics of homologous
sodium channel isoforms.
    iv. Although EPA has required additional data on transferable
residues from treated turf for prallethrin, EPA is confident that it
has not underestimated turf exposure due to the conservativeness of the
default turf transfer value and conservative assumptions in the short-
term turf assessment procedures (e.g., assuming residues do not degrade
over the thirty day assessment period and assuming high-end activities
on turf for every day of the assessment period). The additional data on
turf transferable residues have been required in case requirement of
exposure assessments is needed on the future, and to further EPA's
general understanding of the availability of pesticide residues on
turf.
    For several reasons, EPA has determined that reliable data show
that a 3x factor is protective of the safety of infants and children
less than 6 years of age. First, it is likely that the extensive
guideline studies with pyrethroids, which indicate that increased
sensitivity in juvenile animals in pyrethroid studies is rare, better
characterize the potential sensitivity of juvenile animals than the
LD50 studies. The high doses that produced juvenile
sensitivity in the literature studies are well above normal dietary or
residential exposure levels of pyrethroids to juveniles and lower
levels of exposure anticipated from dietary and residential uses are
not expected to overwhelm the juvenile's ability to metabolize
pyrethroids, as occurred with the high doses used in the literature
studies. The fact that a greater sensitivity to the neurotoxicity of
pyrethroids is not found in guideline studies following in utero
exposures (based on more than 70 studies for 24 pyrethroids) supports
this conclusion, despite the relatively high doses used in the studies.
Second, in vitro data indicate similar pharmacodynamic response to
pyrethroids between juvenile and adult rats. Finally, as indicated,
pharmacokinetic modeling only predicts a 3x difference between
juveniles and adults. Therefore, the FQPA SF of 3x is protective of
potential juvenile sensitivity.
    Specific information about the reevaluation of the FQPA SF for
pyrethroids may be found in document ID number EPA-HQ-OPP-2011-0746-
0011.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Acute aggregate risk from exposure to prallethrin
results from exposure to residues in food and drinking water alone. The
acute dietary exposure analysis included both food and drinking water;
therefore, acute aggregate risk estimates are equivalent to the acute
dietary risk estimates. The acute risk estimate for the general U.S.
population is 10% of the aPAD. The population subgroup with the highest
acute dietary risk estimate is children 1-2, which uses 76% of the
aPAD. Acute aggregate risk is not of concern for the general U.S.
population or any other population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit, there is no increase in hazard with increasing dose duration;
therefore, the acute aggregate assessment is protective of potential
chronic aggregate exposures.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). The short-
term aggregate risk assessments resulted in MOEs of 620 for children,
and 1,600 for adult females and the general U.S. population. The adult
and children's MOEs are greater than their respective LOCs of 100 and
300. As a result, the short-term aggregate risk estimates are not of
concern for the general U.S. population or any population subgroup.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
prallethrin is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Units III.A. and III.C.1.iii., EPA has concluded that
prallethrin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to prallethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A method based on gas chromatography with electron capture
detection (GC/ECD), ID #262, is adequate for the enforcement of
tolerances for residues of prallethrin in or on crop commodities. The
reported limits of quantitation (LOQs) are 0.01 to 0.10 ppm, depending
on the commodity. The limits of detection (LODs) were reported to be
0.004 to 0.06 ppm, depending on the commodity. Multiresidue methods
testing for prallethrin have not been conducted, and is not required,
based on previous Agency discussions with the petitioner on November 3,
2010.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by section
408(b)(4) of FFDCA. The Codex Alimentarius is a joint

United Nations Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, section
408(b)(4) of FFDCA requires that EPA explain the reasons for departing
from the Codex level. The Codex has not established a MRL for
prallethrin.

V. Conclusion

    Therefore, tolerances are established for residues of the
insecticide prallethrin, including its metabolites and degradates, in
or on all raw agricultural commodities and processed food from use of
prallethrin in food handling establishments where food and food
products are held, processed, prepared and/or served, or as a wide-area
mosquito adulticide at 1.0 part per million (ppm). Compliance with the
tolerance level specified is to be determined by measuring only
prallethrin, 2-methyl-4-oxo-3-(2-propyn-1-yl)-2-cyclopenten-1-yl-2,2-
dimethyl-3-(2-methyl-1-propen-1-yl)cyclopropanecarboxylate.
    EPA is revising 40 CFR 180.545 to clarify the tolerance. EPA is
merging paragraphs (a)(1) and (2) together into a new paragraph (a).
EPA is removing paragraphs (a)(3) and (4) as they contain language that
is more appropriately regulated under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) as use directions on the label.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under section 408(d) of FFDCA in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. 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: October 17, 2014.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Revise Sec.  180.545 to read as follows:

Sec.  180.545  Prallethrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide prallethrin, including its metabolites and degradates, in
or on all raw agricultural commodities and processed food from use of
prallethrin in food handling establishments where food and food
products are held, processed, prepared and/or served, or as a wide-area
mosquito adulticide at 1.0 part per million (ppm). Compliance with the
tolerance level specified is to be determined by measuring only
prallethrin, 2-methyl-4-oxo-3-(2-propyn-1-yl)-2-cyclopenten-1-yl-2,2-
dimethyl-3-(2-methyl-1-propen-1-yl)cyclopropanecarboxylate.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2014-25732 Filed 10-28-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Proposed Rules]
[Pages 45109-45112]
[FR Doc No: 2023-14843]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1311; Project Identifier MCAI-2022-00624-E]
RIN 2120-AA64

Airworthiness Directives; Safran Helicopter Engines, S.A. (Type
Certificate Previously Held by Turbomeca, S.A.) Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM).

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

SUMMARY: The FAA is revising a notice of proposed rulemaking (NPRM)
that would have applied to all Safran Helicopter Engines, S.A. (Safran)
(type certificate previously held by Turbomeca, S.A.) Model Arriel 2D
and Arriel 2E engines. This action revises the NPRM by proposing to
require updating the airworthiness limitation section (ALS) of the
existing engine maintenance manual (EMM) or instructions for continued
airworthiness (ICA) and the existing approved maintenance or inspection
program, as applicable, by incorporating the actions and associated
thresholds and intervals, including life limits, as specified in a
European Union Aviation Safety Agency (EASA) airworthiness directive
(AD), which is proposed for incorporation by reference (IBR). The FAA
is proposing this AD to address the unsafe condition on these products.
Since these actions would revise the required actions proposed in the
NPRM, the agency is requesting comments on this SNPRM.

DATES: The FAA must receive comments on this SNPRM by August 28, 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-2022-1311; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains the NPRM, this SNPRM, 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 service information identified that is proposed for
IBR in this SNPRM, contact EASA, KonradAdenauer-Ufer 3, 50668 Cologne,
Germany; phone: +49 221 8999 000; email: [email protected]. You may
find this material on the EASA website at ad.easa.europa.eu. It is also
available at regulations.gov under Docket No. FAA-2022-1311.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kevin Clark, Aviation Safety Engineer,
FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (781)
238-7088; 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-2022-1311; Project Identifier MCAI-2022-00624-E'' 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 again revise 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 SNPRM.

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 SNPRM 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 SNPRM, 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 SNPRM. Submissions containing CBI should
be sent to Kevin Clark, Aviation Safety Engineer, FAA, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590. 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 an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to all Safran Model Arriel 2D and Arriel 2E engines. The
NPRM published in the Federal Register on October 31, 2022 (87 FR
65535). The NPRM proposed to supersede AD 2021-08-02 (86 FR 26651, May
17, 2021) (AD 2021-08-02). The NPRM was prompted by EASA AD 2022-0083,
dated May 11, 2022 (EASA AD 2022-0083), issued by EASA, which is the
Technical Agent for the Member States of the European Union (referred
to after this as the MCAI), which supersedes EASA AD 2018-0273, dated
December 13, 2018 (EASA AD 2018-0273). The MCAI states that the
manufacturer published a revised ALS introducing new and more
restrictive maintenance tasks and airworthiness limitations. These new
or more restrictive maintenance tasks and airworthiness limitations
include initial and repetitive inspections for clogging of the power
turbine air pressurization pipe.
    AD 2021-08-02 requires replacing certain critical parts before
reaching their published in-service life limits, performing scheduled
maintenance tasks before reaching their published periodicity, and
performing unscheduled maintenance tasks when the engine meets certain
conditions. As a terminating action, AD 2021-08-02 requires operators
to revise the ALS of their existing approved maintenance or inspection
program by incorporating the revised airworthiness limitations and
maintenance tasks.
    In the NPRM, the FAA proposed to supersede AD 2021-08-02 and
require revisioning the ALS of the operator's existing approved
maintenance or inspection program, as applicable, to incorporate new
and more restrtictive airworthiness limitations. These new or more
restrictive airworthiness limitations and maintenance tasks include
initial and repetitive inspections for clogging of the power turbine
air pressurization pipe. The FAA proposed this AD to prevent failure of
the engine. This unsafe condition, if not addressed, could result in
uncontained release of a critical part, damage to the engine, and
damage to the helicopter. See EASA AD 2022-0083 for additional
background information.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1311.

Actions Since the NPRM Was Issued

    Since the FAA issued the NPRM, the FAA discovered an inaccurate
reference to a certain paragraph of EASA AD 2022-0083 in paragraph (g)
of the NPRM and determined that a reduced compliance time of 90 days is
necessary. This SNPRM was prompted by the FAA's determination that the
revised airworthiness limitations and new maintenance procedures are
necessary and the need to correct an inaccurate paragraph reference.
The FAA is proposing this AD to address the unsafe condition on these
products.

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2022-0083, which specifies instructions
for accomplishing the actions specified in the applicable ALS,
including performing maintenance tasks, replacing life-limited parts,
and revising the existing approved AMP by incorporating the
limitations, tasks, and associated thresholds and intervals described
in the ALS.
    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 ADDRESSES.

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 this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI described above. The FAA is issuing this SNPRM after
determining that the unsafe condition described previously is likely to
exist or develop on other products of the same type design. Certain
changes described above expand the scope of the NPRM. As a result, it
is necessary to reopen the comment period to provide additional
opportunity for the public to comment on this SNPRM.

Proposed AD Requirements in This SNPRM

    This proposed AD would retain none of the requirements of AD 2021-
08-02. This proposed AD would require revising the ALS of the existing
EMM or instructions for continued airworthiness and the existing
approved maintenance or inspection program, as applicable, to
incorporate the actions specified in paragraph (1) of the MCAI,
described previously, except as discussed under ``Differences Between
this SNPRM and the MCAI.'' The owner/operator (pilot) holding at least
a private pilot certificate may revise the ALS of the existing EMM or
ICA and the existing approved maintenance or inspection program, as
applicable for the engine, and must enter compliance with the
applicable paragraphs of this proposed AD into the engine maintenance
records in accordance with 14 CFR 43.9(a) and 91.417(a)(2)(v). The
record must be maintained as required by 14 CFR 91.417, 121.380, or
135.439. This action could be performed equally well by a pilot or a
mechanic. This is an exception to the FAA's standard maintenance
regulations.

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 since
coordinated with other manufacturers and CAAs to use this process. As a
result, the FAA proposes to incorporate by reference EASA AD 2022-0083
in the FAA final rule. Service information required by the EASA AD for
compliance will be available at regulations.gov under Docket No. FAA-
2022-1311 after the FAA final rule is published.

Differences Between This SNPRM and the MCAI

    EASA AD 2022-0083 applies to Arriel 2D, 2E, 2H, 2L2, and 2N model
turboshaft engines, whereas this proposed AD would only apply to Arriel
2D and Arriel 2E model turboshaft engines. Arriel 2H, 2L2, and 2N
engines are not U.S. type certificated.
    Paragraph (1) of EASA AD 2022-0083 specifies to replace each
component before exceeding the applicable life limit and, within the
thresholds and intervals, accomplishing all applicable maintenance
tasks after its effective date. This proposed AD would instead require
revising the ALS of the existing EMM or ICA and the existing approved
maintenance or inspection program, as applicable, by incorporating the
requirements specified in paragraph (1) of EASA AD 2022-0083 within 90
days after the effective date of this AD.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 426 engines installed on helicopters of U.S. Registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS of the existing EMM or   1 work-hours x $85 per                $0             $85         $36,210
 ICA and the existing approved           hour = $85.
 maintenance or inspection program.
----------------------------------------------------------------------------------------------------------------

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 Directive 2021-08-02, Amendment 39-21496 (86
FR 26651, May 17, 2021); and
0
b. Adding the following new airworthiness directive:

Safran Helicopter Engines, S.A. (Type Certificate Previously Held by
Turbomeca, S.A.): Docket No. FAA-2022-1311; Project Identifier MCAI-
2022-00624-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 28, 2023.

(b) Affected ADs

    This AD replaces AD 2021-08-02, Amendment 39-21496 (86 FR 26651,
May 17, 2021) (AD 2021-08-02).

(c) Applicability

    This AD applies to Safran Helicopter Engines, S.A. (type
certificate previously held by Turbomeca, S.A.) Model Arriel 2D and
Arriel 2E engines.

(d) Subject

    Joint Aircraft Service Component (JASC) Code 7250, Turbine
section.

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the
airworthiness limitations section (ALS) of the existing engine
maintenance manual (EMM) to introduce new or more restrictive tasks
and limitations for certain life-limited parts. The FAA is issuing
this AD to prevent failure of life-limited parts. The unsafe
condition, if not addressed, could result in uncontained release of
a critical part, damage to the engine, and damage to the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Within 90 days after the effective date of this AD, revise
the ALS of the existing EMM or instructions for continued
airworthiness and the existing approved maintenance or inspection
program, as applicable, by incorporating the actions

specified in paragraph (1) of European Union Aviation Safety Agency
(EASA) AD 2022-0083, dated May 11, 2022 (EASA AD 2022-0083).
    (2) The owner/operator (pilot) holding at least a private pilot
certificate may perform the action required by paragraph (g)(1) of
this AD for your engine and must enter compliance with the
applicable paragraphs of this AD into the engine maintenance records
in accordance with 14 CFR 43.9(a) and 91.417(a)(2)(v). The record
must be maintained as required by 14 CFR 91.417, 121.380, or
135.439.

(h) Provisions for Alternative Actions and Intervals

    After the actions required by paragraph (g) of this AD have been
done, no alternative actions and associated thresholds and
intervals, including life limits, are allowed unless they are
approved as specified in the provisions of the ``Ref Publication''
section of EASA AD 2022-0083.

(i) 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the certification office, send it to the
attention of the person identified in paragraph (j) of this AD and
email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Additional Information

    For more information about this AD, contact Kevin Clark,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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 the AD specifies otherwise.
    (i) European Union Aviation Safety Agency AD 2022-0083, dated
May 11, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0083, contact EASA, KonradAdenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]. You may find this material on the EASA website
at ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) 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 July 6, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-14843 Filed 7-13-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Rules and Regulations]
[Pages 32635-32636]
[FR Doc No: 2014-13240]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-1041; Notice No. 25-546-SC]

Special Conditions: Bombardier Aerospace, Models BD-500-1A10 and
BD-500-1A11 Series Airplanes; Electronic Flight Control System: Control
Surface Awareness and Mode Annunciation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final Special Conditions.

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

SUMMARY: These special conditions are issued for the Bombardier
Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes. These
airplanes will have a novel or unusual design feature associated with
control surface awareness and mode annunciation of the electronic
flight control system. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: Effective Date: July 7, 2014.

FOR FURTHER INFORMATION CONTACT: Joe Jacobsen, FAA, Airplane and
Flightcrew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On December 10, 2009, Bombardier Aerospace applied for a type
certificate for their new Models BD-500-1A10 and BD-500-1A11 series
airplanes (hereafter collectively referred to as ``CSeries''). The
CSeries airplanes are swept-wing monoplanes with an aluminum alloy
fuselage sized for 5-abreast seating. Passenger capacity is designated
as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11.
Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and
144,000 pounds for the Model BD-500-1A11.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.17, Bombardier Aerospace must show that the CSeries airplanes
meet the applicable provisions of 14 CFR part 25 as amended by
Amendments 25-1 through 25-129 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the CSeries airplanes because of a
novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the CSeries airplanes must comply with the fuel vent and
exhaust emission requirements of 14 CFR part 34 and the noise
certification requirements of 14 CFR part 36, and the FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The CSeries airplanes will incorporate the following novel or
unusual design features: A fly-by-wire electronic flight control system
(EFCS) and no direct coupling from the flightdeck controller to the
control surface. As a result, the pilot is not aware of the actual
control surface position as envisioned under current airworthiness
standards.

Discussion

    These special conditions require that the flightcrew receive a
suitable flight control position annunciation when a flight condition
exists in which nearly full surface authority (not crew-commanded) is
being used. Suitability of such a display must take into account that
some pilot-demanded maneuvers (e.g., rapid roll) are necessarily
associated with intended full performance, which may saturate the
surface. Therefore, simple alerting systems function in both intended
and unexpected control-limiting situations. As a result, they must be
properly balanced between providing necessary crew awareness and being
a potential nuisance to the flightcrew. A monitoring system that
compares airplane motion and surface deflection with the demand of the
pilot side stick controller could help reduce nuisance alerting.
    These special conditions also address flight control system mode
annunciation. Suitable mode annunciation must be provided to the
flightcrew for events that significantly change the operating mode of
the system but do not merit the classic ``failure warning.''
    These special conditions establish a level of safety equivalent to
that provided by a conventional flight control system and existing
regulations.

Discussion of Comments

    Notice of proposed special conditions No. 25-13-40-SC for the
Bombardier CSeries airplanes was published in the Federal Register on
December 12, 2013 (78 FR 75511). No comments were received, and the
special conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions are applicable to the
Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier
Aerospace apply at a later date for a change to the type certificate to
include another model incorporating the same novel or unusual design
feature, the special conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on two model series of airplanes. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Bombardier Aerospace Models BD-
500-1A10 and BD-500-1A11 series airplanes.

Electronic Flight Control System: Control Surface Awareness and Mode
Annunciation

0
1. In addition to the requirements of Sec. Sec.  25.143, 25.671, and
25.672, the following requirements apply:
    a. The system design must ensure that the flightcrew is made
suitably aware whenever the primary control means nears the limit of
control authority.

    Note: The term ``suitably aware'' indicates annunciations
provided to the flightcrew are appropriately balanced between
nuisance and that necessary for crew awareness.

    b. If the design of the flight control system has multiple modes of
operation, a means must be provided to indicate to the flightcrew any
mode that significantly changes or degrades the normal handling or
operational characteristics of the airplane.

    Issued in Renton, Washington, on April 22, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-13240 Filed 6-5-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9384-9385]
[FR Doc No: 2019-04713]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0012]

Proposed Modification to the List of Appropriate NRTL Program
Test Standards

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA proposes to add a test standard to the
NRTL Program's List of Appropriate Test Standards.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before April 15, 2019. All submissions must bear a postmark or
provide other evidence of the submission date.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at: http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2013-0012,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210;
telephone:<PHONE_NUMBER>. Deliveries (hand, express mail, messenger,
and courier service) are accepted during the Docket Office's normal
business hours, 10:00 a.m. to 3:00 p.m., ET. Note that security
procedures may result in significant delays in receiving submissions
sent by regular mail. Contact the OSHA Docket Office for information
about security procedures concerning delivery of materials by regular
or express mail, hand delivery, or messenger (courier) service.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the website. All submissions,
including copyrighted material, are available for inspection at the
OSHA Docket Office. You may also

contact Kevin Robinson at the below address.
    Instructions: All submissions must include the agency name and OSHA
docket number (OSHA-2013-0012). All comments, including any personal
information you provide, are placed in the public docket without
change, and may be made available online at http://www.regulations.gov.
Therefore, the agency cautions commenters about submitting statements
they do not want made available to the public, or submitting comments
that contain personal information (either about themselves or others)
such as Social Security numbers, birth dates, and medical data. For
further information on submitting comments, see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.
    Extension of comment period: Submit requests for an extension of
the comment period on or before April 15, 2019 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW, Room N-3653, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, Room N-3647, telephone:
(202) 693-1999; email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson, NRTL
Program, Occupational Safety and Health Administration, U.S. Department
of Labor, telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
OSHA's web page includes information about the NRTL Program (see http://www.osha.gov).
    Copies of this Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This Federal Register notice, as well as other relevant information, is
also available on OSHA's web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The NRTL Program recognizes organizations that provide product-
safety testing and certification services to manufacturers. These
organizations perform testing and certification, for purposes of the
NRTL Program, to U.S. consensus-based product-safety test standards.
The products covered by the NRTL Program consist of those items for
which OSHA safety standards require ``certification'' by a NRTL. The
requirements affect electrical products and 38 other types of products.
OSHA does not develop or issue these test standards, but generally
relies on standards development organizations (SDOs) which develop and
maintain the standards using a method that provides input and
consideration of views of industry groups, experts, users, consumers,
governmental authorities and others having broad experience in the
safety field involved.

Addition of Test Standards to the NRTL List of Appropriate Test
Standards

    Periodically, OSHA will propose to add new test standards to the
NRTL List of Appropriate Test Standards following an evaluation of the
test standard document. To qualify as an appropriate test standard, the
agency evaluates the document to (1) verify it represents a product
category for which OSHA requires certification by a NRTL, (2) verify
the document represents an end product and not a component, and (3)
verify the document defines safety test specifications (not
installation or operational performance specifications). OSHA becomes
aware of new test standards through various avenues. For example, OSHA
may become aware of new test standards by: (1) Monitoring notifications
issued by certain Standards Development Organizations; (2) reviewing
applications by NRTLs or applicants seeking recognition to include new
test standard in their scopes of recognition; and (3) obtaining
notification from manufacturers, manufacturing organizations,
government agencies, or other parties. OSHA may determine to include a
new test standard in the list, for example, if the test standard is for
a particular type of product that another test standard also covers or
it covers a type of product that no standard previously covered.

II. Proposal To Add a Test Standard to the NRTL Program's List of
Appropriate Test Standards

    In this notice, OSHA proposes to add one new test standard to the
NRTL Program's List of Appropriate Test Standards. Table 1, below,
lists the test standard that is new to the NRTL Program. OSHA
preliminarily determined that this test standard is an appropriate test
standard and proposes to include it in the NRTL Program's List of
Appropriate Test Standards. OSHA seeks public comment on this
preliminary determination.

 Table 1--Test Standard OSHA Proposes To Add to the NRTL Program's List
                      of Appropriate Test Standards
------------------------------------------------------------------------
    Proposed test standard to be added           Test standard title
------------------------------------------------------------------------
ANSI/CPLSO 14-2016........................  Crane Insulators.
------------------------------------------------------------------------

III. Public Participation

    Comments should consist of pertinent written documents and
exhibits. Commenters needing more time to comment must submit a request
in writing, stating the reasons for the request, by the due date for
comments. OSHA will limit any extension to 10 days unless the requester
justifies a longer time period. OSHA may deny a request for an
extension if it is not adequately justified.
    To obtain or review copies of comments submitted to the docket,
contact the Docket Office, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address. These
materials will also be available online at http://www.regulations.gov
under Docket No. OSHA-2013-0012.
    OSHA staff will review all comments to the docket submitted in a
timely manner and, after addressing the issues raised by these
comments, will make a recommendation to the Assistant Secretary for
Occupational Safety and Health regarding the addition of one test
standard to the NRTL Program's List of Appropriate Test Standards. The
Assistant Secretary will make the final decision. In making this
decision, the Assistant Secretary may undertake other proceedings
prescribed in Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of this final decision in the
Federal Register.

V. Authority and Signature

    Loren Sweatt, Acting Assistant Secretary of Labor for Occupational
Safety and Health, authorized the preparation of this notice.
Accordingly, the agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2)), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on March 7, 2019.
Loren Sweatt,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2019-04713 Filed 3-13-19; 8:45 am]
 BILLING CODE 4510-26-P