[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Rules and Regulations]
[Pages 38981-38986]
[FR Doc No: 2015-16523]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0284; FRL-9927-85]

S-metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective July 8, 2015. Objections and
requests for hearings must be received on or before September 8, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0284, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 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 FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0284 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
September 8, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0284, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E8248) by IR-4 500 College Road East, Suite 201 W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of S-metolachlor in or on the raw agricultural commodity
lettuce at 1.5 parts per million (ppm); vegetable, cucurbit group 9 at
0.50 ppm; vegetable, fruiting, group 8-10, except tabasco pepper at
0.10 ppm; low growing berry subgroup 13-07G except cranberry at 0.40
ppm; and sunflower subgroup 20B at 0.50 ppm and the concurrent deletion
of the existing tolerances for okra; vegetable, fruiting, group 8
except tabasco pepper; cucumber; melon subgroup 9A; pumpkin; squash,
winter; and sunflower, seed. That document referenced a summary of the
petition prepared by Syngenta Crop Protection, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established. The reason for these changes are explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for S-metolachlor including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with S-metolachlor
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The existing toxicological database is primarily comprised of
studies conducted with metolachlor. However, bridging studies indicate
that the metolachlor toxicology database can be used to assess toxicity
for S-metolachlor. In subchronic (metolachlor and S-metolachlor) and
chronic (metolachlor) toxicity studies in dogs and rats decreased body
weight and body weight (bw) gain were the most commonly observed
effects. No systemic toxicity was observed in rabbits when metolachlor
was administered dermally. There was no evidence of neurotoxic effects
in the available toxicity studies, and there is no evidence of
Immunotoxicity in the submitted mouse Immunotoxicity study.
    Prenatal developmental studies in the rat and rabbit with both
metolachlor and S-metolachlor revealed no evidence of a qualitative or
quantitative susceptibility in fetal animals. A 2-generation
reproduction study with metolachlor in rats showed no evidence of
parental or reproductive toxicity. There are no residual uncertainties
with regard to pre- and/or postnatal toxicity.
    Metolachlor has been evaluated for carcinogenic effects in the
mouse and the rat. Metolachlor did not cause an increase in tumors of
any kind in mice. In rats, metolachlor caused an increase in benign
liver tumors in rats, but this increase was seen only at the highest
dose tested and was statistically significant compared to controls only
in females. There was no evidence of mutagenic or cytogenetic effects
in vivo or in vitro. Based on this evidence, EPA has concluded that
metolachlor does not have a common mechanism of carcinogenicity with
acetochlor and alachlor, compounds that are structurally similar to
metolachlor. Metolachlor has been classified as a Group C, possible
human carcinogen, based on liver tumors in rats at the highest dose
tested (HDT).
    Taking into account the qualitatively weak evidence on carcinogenic
effects and the fact that the increase in benign tumors in female rats
occurs at a dose 1,500 times the chronic reference dose (cRfD), EPA has
concluded that the cRfD is protective of any potential cancer effect.
    Specific information on the studies received and the nature of the
adverse effects caused by S-metolachlor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``S-metolachlor--Risk Assessment
for Establishment of Tolerances for New Uses on Lettuce, Low Growing
Berry Subgroup 13-07G, except Cranberry; Vegetable, Cucurbit, Group 9;
Sunflower subgroup 20B; Vegetable, Fruiting, Group 8-10; except Tabasco
Pepper and Okra'' on pp. 40 in docket ID number EPA-HQ-OPP-2014-0284.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
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 S-metolachlor used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for S-metolachlor for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (General population    NOAEL = 300 mg/kg/day.  Acute RfD = 3.0 mg/kg/  Developmental Toxicity
 including infants and children).                             day.                    Study--Rat (metolachlor).
                                     UFA = 10x               aPAD = 3.0 mg/kg/day..  LOAEL = 1,000 mg/kg/day
                                     UFH = 10x.............                           based increased incidence
                                     FQPA SF = 1x..........                           of death, clinical signs
                                                                                (clonic and/or tonic
                                                                                convulsions, excessive
                                                                                salivation, urine-stained
                                                                                abdominal fur and/or
                                                                                excessive lacrimation),
                                                                                and decreased body weight
                                                                                gain.
Chronic dietary (All populations)..  NOAEL= 9.7 mg/kg/day..  Chronic RfD = 0.097 mg/ One Year Chronic Toxicity--
                                                              kg/day.                 Dog (metolachlor).
                                     UFA = 10x               cPAD = 0.097 mg/kg/day  LOAEL = 33 mg/kg/day based
                                     UFH = 10x.............                           decreased body weight gain
                                     FQPA SF = 1x..........                           in females.

Incidental oral short-term (1 to 30  NOAEL= 50 mg/kg/day...  LOC for MOE = 100.....  Developmental Toxicity
 days).                                                                               Study--Rat (S-
                                                                                metolachlor).
                                     UFA = 10x               ......................  LOAEL = 500 mg/kg/day based
                                     UFH = 10x.............                           on increased incidence of
                                     FQPA SF = 1x..........                           clinical signs, decreased
                                                                                body weight/body weight
                                                                                gain, food consumption and
                                                                                food efficiency seen in
                                                                                maternal animals.
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 1,000...  Developmental Toxicity
 days).                               study NOAEL= 50 mg/kg/                          Study--Rat (S-
                                      day (inhalation                                 metolachlor).
                                      absorption rate =
                                      100%).
                                     UFA = 10x               ......................  LOAEL = 500 mg/kg/day based
                                     UFH = 10x.............                           on increased incidence of
                                     FQPA SF = 10x UFDB....                           clinical signs, decreased
                                                                                body weight/body weight
                                                                                gain, food consumption and
                                                                                food efficiency seen at
                                                                                the LOAEL in maternal
                                                                                animals.
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Cancer (all routes)................  Metolachlor has been classified as a Group C carcinogen with risk
                                      quantitated using a non-linear RfD approach.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. Mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to S-metolachlor, EPA considered exposure under the
petitioned-for tolerances as well as all existing S-metolachlor
tolerances in 40 CFR 180.368. EPA assessed dietary exposures from S-
metolachlor in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for S-metolachlor. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture's (USDA) National Health and Nutrition
Examination Survey/What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA assumed tolerance level residues and 100
percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance level
residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to S-metolachlor. Therefore, a separate quantitative cancer
exposure assessment is unnecessary since the chronic dietary risk
estimate will be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for S-
metolachlor. Tolerance level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for S-metolachlor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of S-metolachlor. 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.
    The Agency assessed parent metolachlor, and the metabolites CGA-
51202 (metolachlor-OA), CGA-40172, and CGA-50720 together in the
drinking water assessment using a total toxic residues (TTR) approach
where half-lives were recalculated to collectively account for the
parent and the combined residues of concern.
    Based on the Surface Water Concentration Calculator (SWCC), the
Pesticide Root Zone Model Ground Water (PRZM GW), and the Screening
Concentration in Ground Water (SCI-GROW), the estimated drinking water
concentrations (EDWCs) of S-metolachlor and its metabolites for acute
exposures are estimated to be 371 parts per billion (ppb) for surface
water and 1,060 ppb for ground water, and for chronic exposures are
estimated to be 43.70 ppb for surface water and 14.3 ppb in ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1,060 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 43.70 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticide, and flea and tick control on pets).
    S-metolachlor is currently registered for the following uses that
could result in residential exposures: On commercial (sod farm) and
residential warm-season turf grasses and other non-crop land including
golf courses, sports fields, and ornamental gardens. EPA assessed
residential exposure using the following assumptions: For residential
handlers, short-term inhalation exposure is

expected. The following scenarios were evaluated:
     Mixing/loading/applying gardens/trees with manually-
pressurized hand wand, hose-end sprayer, backpack, and sprinkler can
equipment.
     Mixing/loading/applying lawns/turf with manually-
pressurized hand wand, hose-end sprayer, backpack, and sprinkler can
equipment.
    For residential post-application, there is the potential for short-
term incidental oral exposure for individuals exposed as a result of
being in an environment that has been previously treated with S-
metolachlor. The quantitative exposure/risk assessment for residential
post-application exposures is based on the following scenario:
     Hand-to-mouth incidental oral exposure of children 1-2
years old playing on turf treated with S-metolachlor.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found S-metolachlor to share a common mechanism of
toxicity with any other substances, and S-metolachlor does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that S-
metolachlor does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act 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. There was no evidence of
increased quantitative or qualitative fetal susceptibility in the
prenatal developmental studies in rats and rabbits or in the
reproductive toxicity study in rats, with either metolachlor or S-
metolachlor. In general, significant developmental toxicity was not
seen in rats or rabbits with either compound. The only effects observed
in fetal animals were in the rat prenatal developmental study and
included slightly decreased number of implantations per dam, decreased
number of live fetuses/dam, increased number of resorptions/dam and
significant decrease in mean fetal bw. These effects occurred at
maternally toxic doses (1,000 milligram/kilogram/day (mg/kg/day)).
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x for all scenarios except inhalation. For
inhalation scenarios a 10x database uncertainty factor (UF) still
applies. This decision is based on the following findings:
    i. The toxicology database for metolachlor and S-metolachlor is
complete, with the exception of a required subchronic inhalation study
for metolachlor. As noted above, a 10x data base UF will be applied
only for assessing risk for inhalation exposure scenarios.
    ii. There is no indication that S-metolachlor is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that S-metolachlor results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to S-metolachlor in drinking water. EPA used
similarly conservative assumptions to assess post-application
incidental oral exposure of children 1<2 years old. These assessments
will not underestimate the exposure and risks posed by S-metolachlor.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to S-metolachlor will occupy 6.1% of the aPAD for all infants (less
than 1 year old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
S-metolachlor from food and water will utilize 6.8% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
S-metolachlor is not expected.
    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).
    S-metolachlor is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to S-metolachlor. Potential
short-term residential risk scenarios anticipated include adult
inhalation handler exposure to turf via backpack sprayer and post-
application incidental oral exposure of children playing on treated
lawns.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 10,400 for adults
and 1,100 for children 1-2 years old. Because EPA's levels of concern
for S-metolachlor is a

MOE of 1,000 or below for inhalation scenarios (adults) and 100 or
below for incidental oral scenarios (children 1-2 years old), these
MOEs are not of concern.
    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).
    An intermediate-term adverse effect was identified; however, S-
metolachlor is not registered for any use patterns that would result in
intermediate-term residential exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for S-metolachlor.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A, the chronic dietary risk assessment is protective of any
potential cancer effects. Based on the results of that assessment, EPA
concludes that S-metolachlor 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 S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methodology is available for enforcing the established and
recommended tolerances. PAM Vol. II, Pesticide Regulation Section
180.368, lists a gas chromatography with nitrogen-phosphorus detector
(GC/NPD) method (Method I) for determining residues in/on plant
commodities and a gas chromatography with mass selective detector (GC/
MSD) method (Method II) for determining residues in livestock
commodities. These methods determine residues of metolachlor and its
metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.
Adequate data are also available on the recovery of metolachlor through
FDA's Multiresidue Method Testing Protocols which indicate that
metolachlor is completely recovered through Method 302.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint 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, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for S-metolachlor.

C. Revisions to Petitioned-For Tolerances

    The tolerance being established for the sunflower subgroup 20B is
1.0 ppm, not 0.50 ppm as proposed. This is due to the Agency using the
Organization for Economic Cooperation and Development (OECD) Tolerance
Calculation procedures, which determined that a tolerance of 1.0 ppm is
appropriate based on entry of the 4 field trials for pre-emergence
application.

V. Conclusion

    Therefore, tolerances are established for residues of S-metolachlor
in or on lettuce at 1.5 ppm; the low growing berry subgroup 13-07G,
except cranberry at 0.40 ppm; the sunflower subgroup 20B at 1.0 ppm;
the vegetable, cucurbit group 9 at 0.50 ppm; and the vegetable,
fruiting, group 8-10, except tabasco pepper at 0.10 ppm. Additionally,
due to the establishment of the tolerances listed above, the existing
tolerances for vegetable, fruiting, group 8, except tabasco pepper;
cucumber; melon subgroup 9A; okra; pumpkin; squash, winter; and
sunflower, seed are removed as they are unnecessary.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

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: June 26, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.368:
0
a. Remove the entries ``Cucumber,'' ``Melon subgroup 9A,'' ``Okra,''
``Pumpkin,'' ``Squash, winter,'' ``Sunflower, seed,'' and ``Vegetable,
fruiting, group 8, except tabasco pepper,'' in paragraph (a)(2).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(2).
    The amendments read as follows:

Sec.  180.368  Metolachlor; tolerances for residues.

    (a) * * *
    (2) * * *

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

                                * * * * *
Lettuce.................................................             1.5
Low growing berry subgroup 13-07G, except cranberry.....            0.40

                                * * * * *
Sunflower subgroup 20B..................................             1.0

                                * * * * *
Vegetable, cucurbit group 9.............................            0.50

                                * * * * *
Vegetable, fruiting, group 8-10, except tabasco pepper..            0.10

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

* * * * *
[FR Doc. 2015-16523 Filed 7-7-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60888-60889]
[FR Doc No: 2015-25617]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 77-276]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Application for Temporary Variance of
Minimum Flow Requirement.
    b. Project No.: 77-276.
    c. Date Filed: September 30, 2015.
    d. Applicant: Pacific Gas and Electric Company (licensee).
    e. Name of Project: Potter Valley Project.
    f. Location: Eel River and East Fork Russian River in Lake and
Mendocino Counties, California.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Matthew Joseph, License Coordinator,
Pacific Gas and Electric Company, Mail Code: N13E, P.O. Box 770000, San
Francisco, CA 94177,<PHONE_NUMBER>.
    i. FERC Contact: Mr. John Aedo,<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, protests,
and recommendations is October 19, 2015. The Commission strongly
encourages electronic filing. Please file motions to intervene,
protests, comments, or recommendations using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. Please include the project number (P-
77-276) on any comments, motions to intervene, protests, or
recommendations filed.
    k. Description of Request: The licensee requests a temporary
variance of the minimum flow requirement in the East Branch Russian
River. The licensee states that it is planning to conduct repairs to
reconstruct the lower woodstave conduit and replace some adjoining
piping above the Potter Valley powerhouse. The licensee states that it
needs to dewater the lower portion of the water conveyance system to
conduct this work. In order to complete the work, the licensee is
requesting a temporary variance of its Normal water year minimum flow
requirement of 35 cubic feet per second (cfs) between November 1, 2015
and March 15, 2016. During this time, the licensee proposes to release
flows through a conduit into a seasonal creek that is a tributary to
the East Branch Russian River immediately downstream of the project
powerhouse. The licensee states that during the repair period, it would
release a minimum flow of 20 cfs from the conduit into the East Branch
Russian River, which would include the release of up to 5 cfs for the
Potter Valley Irrigation District. The licensee states that if site
conditions reach a Critically Dry water year status, it would instead,
maintain the license-required minimum flow of 5 cfs. Finally, the
licensee proposes to regularly monitor the interim flows in the
seasonal tributary. Upon completion of construction, the licensee
states that it would notify the resource agencies and return to the
license-required flows.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license surrender.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: October 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-25617 Filed 10-7-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Proposed Rules]
[Pages 10545-10549]
[FR Doc No: 2016-04288]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-3983; Directorate Identifier 2015-NM-009-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A330-200 Freighter series airplanes; Model A330-
200 and A330-300 series airplanes; Model A340-200 and A340-300 series
airplanes; Model A340-500 series airplanes; and Model A340-600 series
airplanes. This proposed AD was prompted by a report indicating that,
during an operational test of a ram air turbine (RAT), the RAT did not
deploy in automatic mode. This proposed AD would require identification
of the manufacturer, part number, and serial number of the RAT, and re-
identifying and modifying the RAT if necessary. We are proposing this
AD to prevent non-deployment of the RAT, which, if preceded by a total
engine flame-out, or during a total loss of normal electrical power
generation,

could result in reduced control of the airplane.

DATES: We must receive comments on this proposed AD by April 15, 2016.

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 http://www.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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For Airbus service information identified in this NPRM, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. For Hamilton Sundstrand service information identified
in this AD, contact Hamilton Sundstrand, Technical Publications, Mail
Stop 302-9, 4747 Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-
7002; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.hamiltonsundstrand.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3983; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-3983;
Directorate Identifier 2015-NM-009-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0008, dated January 15, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A330-200 Freighter series airplanes; Model A330-200, and A330-300
series airplanes; Model A340-200, and A340-300 series airplanes; Model
A340-500 series airplanes; and Model A340-600 series airplanes. The
MCAI states:

    During a scheduled Ram Air Turbine (RAT) operational test on an
A330 aeroplane, the RAT did not deploy in automatic mode. The
subsequent investigation conducted by the RAT manufacturer Hamilton
Sundstrand (HS) and Arkwin Industries, revealed that this failure to
deploy was due to an inadequate stroke margin in the manufacturing
shimming procedure of the actuator deployment solenoids.
    This condition, if not corrected, could possibly result in
reduced control of the aeroplane, particularly if occurring
following a total engine flame out, or during a total loss of normal
electrical power generation.
    Prompted by this unsafe condition, Airbus issued Service
Bulletin (SB) A330-29-3126, SB A340-29-4097 and SB A340-29-5025,
providing instructions to identify the manufacturer, part number (P/
N) and serial number (s/n) of the RAT actuator, and to modify the
shimming procedure for the affected RAT actuator.
    For the reasons described above, this [EASA] AD requires
identification of the affected RAT actuators and, depending on its
configuration (modified or not), the accomplishment of applicable
corrective actions [modifying the RAT actuator. Additional actions
include re-identifying the RAT actuator part number and RAT part
number, as applicable.]

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3983.

Related ADs

    EASA and the FAA have issued additional ADs related to the RAT. FAA
AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012, which
corresponds to EASA AD 2011-0197, dated October 10, 2011), requires an
inspection of the RAT anti-stall valve in the pump housing for correct
setting, re-identification of the RAT pump, performing a functional
ground test of the RAT, and replacement of the RAT pump or the RAT
assembly with a serviceable part if necessary. FAA AD 2012-21-19 is
applicable to all Airbus Model A330-200 Freighter series airplanes;
Model A330-200 and -300 series airplanes; and Model A340-200 and -300
series airplanes.
    The FAA also issued AD 2012-21-20, Amendment 39-17236 (77 FR 65799,
October 31, 2012), which corresponds to EASA AD 2011-0204, dated
October 14, 2011. FAA AD 2012-21-20 requires identification of the
supplier, part number, and serial number of the RAT actuator; and re-
identification of the RAT actuator and RAT, or replacement of the RAT
actuator with a serviceable unit and re-identification of the RAT, if
necessary. FAA AD 2012-21-20 is applicable to certain Airbus Model
A330-200 Freighter series airplanes, Model A330-200 and -300 series
airplanes, and Model A340-200, -300, -500, and -600 series airplanes.
    In addition, the FAA issued AD 2015-26-02, Amendment 39-18350 (80
FR 81174, December 29, 2015), which corresponds to EASA AD 2013-0274,
dated November 15, 2013. FAA AD 2015-26-02 requires, for certain
airplanes, identification of the part number, serial number, and
standard of the RAT pump, RAT module, RAT actuator, and RAT lower
gearbox assembly; and corrective actions if necessary. For certain
other airplanes, AD 2015-26-02 requires re-identification or
replacement of the RAT module.

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information, which
describes

procedures for identifying the supplier, part number, and serial number
of the installed RAT actuator; modifying the RAT; and re-identifying
the RAT actuator and RAT.
     Service Bulletin A330-29-3126, dated June 12, 2014.
     Service Bulletin A340-29-4097, dated June 12, 2014.
     Service Bulletin A340-29-5025, dated June 16, 2014.
    Hamilton Sundstrand has issued Service Bulletins ERPS06M-29-21,
dated May 27, 2014; and ERPS33T-29-7, dated June 6, 2014. This service
information describes procedures for identifying the affected RAT
actuator and RAT part numbers and serial numbers, modifying affected
actuators, and re-identifying affected RAT actuators and RATs.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 84 airplanes of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $7,140, or $85 per
product.
    In addition, we estimate that any necessary follow-on actions would
take about 14 work-hours and require parts costing $427,301, for a cost
of $428,491 per product. We have no way of determining the number of
aircraft that might need actions.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus: Docket No. FAA-2016-3983; Directorate Identifier 2015-NM-
009-AD.

(a) Comments Due Date

    We must receive comments by April 15, 2016.

(b) Affected ADs

    This AD affects AD 2012-21-19, Amendment 39-17235 (77 FR 65812,
October 31, 2012); AD 2012-21-20, Amendment 39-17236 (77 FR 65799,
October 31, 2012); and AD 2015-26-02, Amendment 39-18350 (80 FR
81174, December 29, 2015).

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
through (c)(7) of this AD, certificated in any category.
    (1) Airbus Model A330-223F and -243F airplanes, all manufacturer
serial numbers; except those on which Airbus Modification 204067 has
been embodied in production.
    (2) Airbus Model A330-201, -202, -203, -223, and -243 airplanes,
all manufacturer serial numbers; except those on which Airbus
Modification 204067 has been embodied in production.
    (3) Airbus Model A330-301, -302, -303, -321, -322, -323,- 341, -
342, and -343 airplanes, all manufacturer serial numbers; except
those on which Airbus Modification 204067 has been embodied in
production.
    (4) Airbus Model A340-211, -212, and -213, airplanes, all
manufacturer serial numbers.
    (5) Airbus Model A340-311, -312, and -313 airplanes, all
manufacturer serial numbers.
    (6) Airbus Model A340-541 airplanes, all manufacturer serial
numbers.
    (7) Airbus Model A340-642 airplanes, all manufacturer serial
numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic
Power.

(e) Reason

    This AD was prompted by a report indicating that, during an
operational test of a ram air turbine (RAT), the RAT did not deploy
in automatic mode. We are issuing this AD to prevent non-deployment
of the RAT, which, if preceded by a total engine flame-out, or
during a total loss of normal electrical power generation, could
result in reduced control of the airplane.

(f) Compliance

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

(g) Identification and Replacement for Certain Airbus Model A330, and
A340-200 and -300 Airplanes

    For Airbus Model A330-200 Freighter series airplanes, Model
A330-200 and -300 series airplanes, and Model A340-200 and -300
series airplanes: Within 30 months after the effective date of this
AD, identify the supplier, part number, and serial number of the
installed RAT actuator, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-29-3126, dated June 12,
2014; or Airbus Service Bulletin A340-29-4097, dated June 12, 2014;
as applicable.

    (1) If the supplier identified is Arkwin Industries, and the
identified RAT actuator part number and serial number are listed in
Hamilton Sundstrand Service Bulletin ERPS06M-29-21, dated May 27,
2014, and the serial number is included in table 2 of Hamilton
Sundstrand Service Bulletin ERPS06M-29-21, dated May 27, 2014, with
a description of ``correctly shimmed:'' Within 30 months after the
effective date of this AD, re-identify the actuator and the RAT, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A330-29-3126, dated June 12, 2014; or Airbus Service
Bulletin A340-29-4097, dated June 12, 2014; as applicable.
    (2) If the supplier identified is Arkwin Industries, and the
identified actuator RAT part number and serial number are listed in
Hamilton Sundstrand Service Bulletin ERPS06M-29-21, dated May 27,
2014, and the serial number is included in table 2 of Hamilton
Sundstrand Service Bulletin ERPS06M-29-21, dated May 27, 2014, with
a description of ``incorrectly shimmed:'' Within 30 months after the
effective date of this AD, modify the RAT actuator and re-identify
the RAT, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A330-29-3126, dated June 12, 2014; or Airbus
Service Bulletin A340-29-4097, dated June 12, 2014; as applicable.
    (3) If the supplier identified is Arkwin Industries, and the
identification plate for the RAT actuator is missing, or the part
number and serial number are not listed in Hamilton Sundstrand
Service Bulletin ERPS06M-29-21, dated May 27, 2014: Within 30 months
after the effective date of this AD, modify the RAT actuator and re-
identify the RAT, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A330-29-3126, dated June 12, 2014; or
Airbus Service Bulletin A340-29-4097, dated June 12, 2014; as
applicable.

(h) Identification and Replacement for Certain Airbus Model A340-500
and -600 Airplanes

    For Airbus Model A340-500 and -600 airplanes: Within 30 months
after the effective date of this AD, identify the part number and
serial number of the installed RAT actuator, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A340-29-5025,
dated June 16, 2014.
    (1) If the identified RAT actuator part number and serial number
are listed in Hamilton Sundstrand Service Bulletin ERPS33T-29-7,
dated June 6, 2014, and the serial number is included in table 2 of
Hamilton Sundstrand Service Bulletin ERPS33T-29-7, dated June 6,
2014, with a description of ``correctly shimmed:'' Within 30 months
after the effective date of this AD, re-identify the actuator and
the RAT, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A340-29-5025, dated June 16, 2014.
    (2) If the identified RAT actuator part number and serial number
are listed in Hamilton Sundstrand Service Bulletin ERPS33T-29-7,
dated June 6, 2014, and the serial number is included in table 2 of
Hamilton Sundstrand Service Bulletin ERPS33T-29-7, dated June 6,
2014, with a description of ``incorrectly shimmed:'' Within 30
months after the effective date of this AD, modify the RAT actuator
and re-identify the RAT, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A340-29-5025, dated June 16,
2014.
    (3) If the identification plate for the RAT actuator is missing,
or the part number and serial number are not listed in Hamilton
Sundstrand Service Bulletin ERPS33T-29-7, dated June 6, 2014: Within
30 months after the effective date of this AD, modify the RAT
actuator and re-identify the RAT, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A340-29-5025,
dated June 16, 2014.

(i) Terminating Action for Certain Requirements of Other ADs

    (1) For Airbus Model A330-200 Freighter, A330-200, and A330-300
series airplanes; and Model A340-200 and -300 series airplanes:
Accomplishment of the actions required by paragraph (g)(1), (g)(2),
or (g)(3) of this AD constitutes compliance with the requirements of
paragraph (g)(1) of AD 2012-21-19, Amendment 39-17235 (77 FR 65812,
October 31, 2012); paragraph (g) of AD 2012-21-20, Amendment 39-
17236 (77 FR 65799, October 31, 2012); and paragraphs (g), (h), and
(i) of AD 2015-26-02, Amendment 39-18350 (80 FR 81174, December 29,
2015), for that airplane only.
    (2) For Airbus Model A340-500 and -600 series airplanes:
Accomplishment of the actions required by paragraphs (h)(1), (h)(2),
and (h)(3) of this AD constitutes compliance with the requirements
of paragraphs (h)(1) and (h)(2) of AD 2012-21-20, Amendment 39-17236
(77 FR 65799, October 31, 2012); and paragraph (j) of AD 2015-26-02,
Amendment 39-18350 (80 FR 81174, December 29, 2015), for that
airplane only.

(j) Parts Installation Limitations

    As of the effective date of this AD, no person may install any
RAT actuator or any RAT having a part number identified in table 1
to paragraph (j) of this AD, on any airplane, unless it meets the
conditions specified in paragraph (j)(1) or (j)(2) of this AD, as
applicable.

       Table 1 to Paragraph (j) of This AD--Affected Part Numbers
------------------------------------------------------------------------
                                                       RAT actuator part
 Affected Airbus airplane models    RAT part number         number
------------------------------------------------------------------------
Model A330-200 and -300 series    1720934C,             5912958, 5915768
 airplanes.                        1720934D,
                                   766351A, 768084A,
                                   770379A, 770952C,
                                   770952D, 770952E.
Model A330-200 Freighter series   1720934C,             5912958, 5915768
 airplanes.                        1720934D,
                                   766351A, 768084A,
                                   770379A, 770952C,
                                   770952D, 770952E.
Model A340-200 and -300 series    1720934C,             5912958, 5915768
 airplanes.                        1720934D,
                                   766351A, 768084A,
                                   770379A, 770952C,
                                   770952D, 770952E.
Model A340-500 and -600 series    772722H, 772722J,     5912536, 5915769
 airplanes.                        772722L.
------------------------------------------------------------------------

    (1) For Airbus Model A330-200 Freighter series airplanes; Model
A330-200, and A330-300 series airplanes; and Model A340-200 and -300
series airplanes: The RAT actuator or RAT has a serial number listed
as affected and modified in Hamilton Sundstrand Service Bulletin
ERPS06M-29-21, dated May 27, 2014, and the RAT has been re-
identified in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A330-29-3126, dated June 12, 2014; or Airbus
Service Bulletin A340-29-4097, dated June 12, 2014.
    (2) For Airbus Model A340-500 and -600 series airplanes: The RAT
actuator or the RAT has a serial number listed as affected and
modified in Hamilton Sundstrand Service Bulletin ERPS33T-29-7, dated
June 6, 2014, and the RAT has been re-identified in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A340-29-
5025, dated June 16, 2014.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): If any Airbus service
information contains procedures or tests that are identified as RC,
those procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2015-0008, dated January 15,
2015, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-3983.
    (2) For Airbus service information identified in this proposed
AD, contact Airbus SAS, Airworthiness Office--EAL, 1 Rond Point
Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93
36 96; fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. For Hamilton
Sundstrand service information identified in this AD, contact
Hamilton Sundstrand, Technical Publications, Mail Stop 302-9, 4747
Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-7002; telephone
860-654-3575; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://www.hamiltonsundstrand.com. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 19, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-04288 Filed 2-29-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30720-30721]
[FR Doc No: 2019-13687]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5372]

Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers.'' This final guidance
provides detailed recommendations for manufacturers seeking marketing
clearance of diagnostic ultrasound systems and transducers, and
includes guidance describing the types of modifications to a diagnostic
ultrasound device for which FDA does not intend to enforce the
requirement for a new premarket notification (510(k)).

DATES: The announcement of the guidance is published in the Federal
Register on June 27, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5372 for ``Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Shahram Vaezy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4227A, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Keith Wear, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2114,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides detailed recommendations for manufacturers
seeking marketing clearance of diagnostic ultrasound systems and
transducers. This guidance supersedes FDA's guidance entitled
``Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers'' dated September 9,
2008, regarding FDA's approach to the regulation of certain diagnostic
ultrasound devices.
    In addition to outlining regulatory approaches for certain
diagnostic ultrasound devices, this guidance describes the types of
modifications to a diagnostic ultrasound device for which FDA does not
intend to enforce the requirement for a new 510(k). As

before, manufacturers who submit 510(k)s and receive marketing
clearance will continue to be exempt from the Electronic Product
Radiation Control reporting requirements in 21 CFR 1002.12, for
diagnostic ultrasound devices, as described in the notice to industry
entitled ``Exemption from Reporting under 21 CFR 1002'' dated February
24, 1986.\1\
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmitting ProductsandProcedures/
MedicalImaging/UCM509874.pdf.
---------------------------------------------------------------------------

    FDA considered comments received on the draft guidance that
appeared in the Federal Register of October 2, 2017 (82 FR 45856). FDA
revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on information for manufacturers seeking
marketing clearance of diagnostic ultrasound systems and transducers.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 560 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
801...............................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
1002 and 1010.....................  Reporting and              0910-0025
                                     Recordkeeping for
                                     Electronic
                                     Products--General
                                     Requirements.
814, subpart A-E..................  Premarket Approval         0910-0231
                                     of Medical Devices.
513(f)(2) FD&C Act................  De Novo                    0910-0844
                                     Classification
                                     Process (Evaluation
                                     of Automatic Class
                                     III Designation).
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
------------------------------------------------------------------------

    Dated: June 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13687 Filed 6-26-19; 8:45 am]
 BILLING CODE 4164-01-P