[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Rules and Regulations]
[Pages 52985-52989]
[FR Doc No: 2014-21068]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0445; FRL-9915-32]

Flazasulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flazasulfuron in or on tree nut group 14-12. ISK Biosciences
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 5, 2014. Objections and
requests for hearings must be received on or before November 4, 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-2013-0445, 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: Lois Rossi, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-7090; 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/Title40/40tab02.tpl. To access the
OCSPP test guidelines referenced in this document electronically,
please go to http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0445 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
November 4, 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-2013-0445, 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 30, 2013 (78 FR 79361) (FRL-
9903-69), 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
3F8173) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, Ohio 44077. The petition requested that 40 CFR 180.655 be
amended by establishing tolerances for residues of the herbicide
flazasulfuron, N-[[4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide, in or on tree nut group 14-12
at 0.01 parts per million (ppm). That document referenced a summary of
the petition prepared by ISK Biosciences Corporation, 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
added a tolerance for almond, hulls. 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 flazasulfuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flazasulfuron
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.
    Flazasulfuron exhibits low acute toxicity via oral, dermal and
inhalation routes of exposure. It is not irritating to the skin or eyes
and is not a dermal sensitizer. Subchronic studies in animals indicated
decreased body weight gain, slight anemia in rats, and liver
abnormalities in dogs. Dermal or systemic toxicity was not seen in a
subchronic dermal study in rabbits at dose levels up to the limit dose.
    In the longer-term mammalian toxicity studies, the kidney and liver
were the primary target organs of flazasulfuron toxicity. Observed
effects included adverse changes in kidney function (chronic
nephropathy) and kidney physiology (enlargement, dark color of kidney),
increases in liver weight and hepatocellular hypertrophy, increases in
inflammatory cell infiltration, hepatocellular necrosis, hepatocellular
swelling, and bile duct proliferation.
    Developmental toxicity was observed in both rats and rabbits.
Reduced fetal weights and delays in ossification were seen in a
developmental toxicity study with Sprague-Dawley rats; an increased
incidence of visceral malformations (intraventricular septal defect)
was seen in a developmental study with Wistar rats. The developmental
study in rabbits showed high incidences of abortion at the highest dose
tested. Decreases in body weight and chronic nephropathy were observed
in offspring in a 2-generation rat reproduction toxicity study. The
effects on offspring in these studies occurred at dose levels which
were also toxic to the parents.
    A transient decrease in motor activity 5 hours post-dosing on Day 0
was observed at the mid-dose in an acute neurotoxicity study. This
observation may be associated with a systemic effect and not with
neurotoxicity since there was no corroborating indication of
neurotoxicity in the subchronic neurotoxicity study. There are no
indications of immunotoxicity potential from the repeated dose studies
in the toxicity database. In addition, preliminary assessment of the
available immunotoxicity study (currently under detailed review) shows
no immunotoxicity in female mice when tested up to levels near the
limit dose. Therefore, there are no concerns for immunotoxicity.
    There was no evidence of carcinogenicity in the mouse oncogenicity
study or the combined chronic toxicity/carcinogenicity study in the rat
and no evidence of genotoxic potential in in vitro and in vivo
mutagenicity studies. Based on the results of these studies, EPA has
classified flazasulfuron as ``no evidence of carcinogenicity to
humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by flazasulfuron 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 document ``Flazasulfuron: Human Health Risk
Assessment for Proposed Uses on Tree Nuts,'' at p. 28 in docket ID
number EPA-HQ-OPP-2013-0445.

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 flazasulfuron used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Flazasulfuron 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 = 50 mg/kg/day...  Acute RfD = 0.5 mg/kg/   Acute neurotoxicity
 including females, 13-49 years of     UFA = 10x..............   day.                     (rat) LOAEL = 1,000 mg/
 age).                                 UFH = 10x..............  aPAD = 0.5 mg/kg/day...   kg/day based on
                                       FQPA SF = 1x...........                            transient decrease in
                                                                                motor activity
                                                                                observed at Day 0 (5
                                                                                hours post-dosing).

Chronic dietary......................  NOAEL= 1.3 mg/kg/day...  Chronic RfD = 0.013 mg/  Combined Chronic
(All populations)....................  UFA = 10x..............   kg/day.                  Toxicity/
                                       UFH = 10x..............  cPAD = 0.013 mg/kg/day.   Carcinogenicity in
                                       FQPA SF = 1x...........                            rats LOAEL = 13.3 mg/
                                                                                kg/day based on
                                                                                adverse change in
                                                                                kidney function
                                                                                (chronic nephropathy).
Incidental oral short-term...........  NOAEL= 2 mg/kg/day.....  LOC for MOE = 100......  90-Day Oral Toxicity
(1 to 30 days) and Intermediate Term   UFA = 10x..............                            (dog) LOAEL = 10 mg/kg/
 (1 to 6 months).                      UFH = 10x..............                            day based on changes
                                       FQPA SF = 1x...........                            in liver (increase in:
                                                                                Deposition of brown
                                                                                pigments, glutamic
                                                                                pyruvic transaminase,
                                                                                creatine
                                                                                phosphokinase,
                                                                                inflammatory cell
                                                                                infiltration,
                                                                                microgranulomas).
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Dermal short-term....................    No hazard was identified at the limit dose following dermal exposure.
(1 to 30 days) and Intermediate-Term
 (1 to 6 months).
                                      --------------------------------------------------------------------------
Inhalation short-term................  NOAEL= 2 mg/kg/day.....  LOC for MOE = 100......  90-Day oral toxicity
(1 to 30 days) and Intermediate-Term   UFA = 10x..............                            (dog) LOAEL = 10 mg/kg/
 (1 to 6 months).                      UFH = 10x..............                            day based on changes
                                       FQPA SF =1x............                            in liver (increase in:
                                                                                Deposition of brown
                                                                                pigments, glutamic
                                                                                pyruvic transaminase,
                                                                                creatine
                                                                                phosphokinase,
                                                                                inflammatory cell
                                                                                infiltration,
                                                                                microgranulomas).
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Cancer (Oral, dermal, inhalation)....  Classification: No evidence of carcinogenicity to humans based on lack of
                                          carcinogenic effects in the rat and mouse carcinogenicity studies and
                                                             lack of a mutagenicity concern.
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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). 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 flazasulfuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing flazasulfuron
tolerances in 40 CFR 180.655. EPA assessed dietary exposures from
flazasulfuron 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 flazasulfuron. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA). As to residue levels in food, EPA assumed
tolerance level residues and 100% of the crop was treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture's National Health and Nutrition Examination Survey, What
We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA
made the same assumptions (tolerance level residues and 100 PCT) as in
the acute dietary exposure assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flazasulfuron does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flazasulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flazasulfuron. 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 Tier II PRZM-EXAMS--Index Reservoir model and PRZM-GW
model, the estimated drinking water concentrations (EDWCs) of
flazasulfuron for acute exposures are estimated to be 26.9 parts per
billion (ppb) for surface water and 90.8 ppb for ground water and for
chronic exposures for non-cancer assessments are estimated to be 4.67
ppb for surface water and 55.6 ppb for 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 90.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 55.6 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). There are no
residential uses being requested at this time. Therefore, residential
handler and post-application scenarios were not assessed for the
proposed tree nut use. However, there are existing residential uses
that have been previously assessed and are used in the aggregate
assessment presented in this document. Flazasulfuron is currently
registered for the following uses that could result in residential
exposures: Golf courses, sod farms, professionally managed athletic

fields, commercial lawns, Christmas trees, and industrial vegetation
management areas. EPA assessed residential exposure using the following
assumptions:
    i. Residential Handler Exposures. Residential short-term (1-30
days) dermal and inhalation exposures are expected from flazasulfuron
handler activities associated with the residential spot treatment use.
Since no hazard was identified for the dermal route of exposure, dermal
risks were not assessed. A MOE greater than 100 for the inhalation
route is deemed adequate to protect residential flazasulfuron handlers.
Handler scenarios resulted in MOEs ranging from 27,000 to 6,800,000 for
inhalation exposures and, therefore are not of concern.
    ii. Residential Post-application Exposures. Since the use sites
include recreational parks, there is a potential for short-term dermal
and incidental oral exposures to occur for children from the broadcast
use of flazasulfuron. When determining the potential for residential
exposure, the Agency considers residues, leaf to skin/hand residue
transfer, children's hand-to-mouth transfer, and exposure time. Since
no hazard was identified for the dermal route of exposure, dermal risks
were not assessed. All children post-application scenarios resulted in
MOEs ranging from 2,900 to 1,300,000 for incidental oral exposures and,
therefore are not of concern.
    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.'' EPA has not found
flazasulfuron to share a common mechanism of toxicity with any other
substances, and flazasulfuron does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that flazasulfuron 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. The pre- and postnatal
toxicity database for flazasulfuron includes developmental toxicity
studies in rats (Sprague-Dawley and Wistar) and rabbits and a 2-
generation reproduction toxicity study in rats.
    There was no evidence of increased quantitative susceptibility of
fetuses or offspring to flazasulfuron in any of the developmental or
reproductive toxicity studies, since the effects on offspring occurred
at dose levels which were also toxic to the parents. There is a
potential concern for increased qualitative susceptibility of offspring
based on the intraventricular septal defect seen in offspring at
minimally toxic maternal dose levels in the Wistar rat developmental
toxicity study; however, this effect was not seen in the developmental
study in Sprague-Dawley rats tested up to the limit dose, and this
concern is further addressed by the presence of clear NOAELs and
LOAELs, and by the selection of regulatory endpoints that are
protective of this effect. Therefore, EPA has no concerns for increased
qualitative susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for flazasulfuron is complete.
    ii. There is no concern for increased quantitative or qualitative
susceptibility in offspring.
    iii. There are no neurotoxicity concerns.
    iv. There are no residual uncertainties regarding exposure.

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 flazasulfuron will occupy 3% of the aPAD for infants less than one
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
flazasulfuron from food and water will utilize 23% of the cPAD for
infants less than one year 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
flazasulfuron 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). The short-
term aggregate exposure for adults, which accounts for inhalation
exposure while treating turf and dietary exposure from food and water,
resulted in an MOE of 1,600 and is not of concern. The short-term
aggregate exposure for children ages 1<2, which accounts for incidental
oral exposure from hand-to-mouth activities on treated turf and dietary
exposure from food and water, resulted in an MOE of 810 and is 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). Since intermediate-term residential exposures are not likely to
occur, intermediate-term aggregate risks were not assessed.
    5. Aggregate cancer risk for U.S. population. Because there was no
evidence of carcinogenicity in the rat and mouse carcinogenicity
studies,

flazasulfuron 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 flazasulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography/tandem mass spectrometry with multiple reaction
monitoring (HPLC/MS-MS/MRM) is available to enforce the tolerance
expression.

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 flazasulfuron.

C. Revisions to Petitioned-For Tolerances

    EPA has added a tolerance for almond, hulls. Almond hulls are
listed separately as a raw agricultural commodity for almonds in Table
1 of OCSPP 860.1000, and are included in Table 1 Feedstuffs (June
2008); therefore, a tolerance is required for almond hulls.

V. Conclusion

    Therefore, tolerances are established for residues of
flazasulfuron, N-[[4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide, in or on tree nut group 14-12
at 0.01 ppm and on almond hulls at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 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 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 final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of 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 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: August 27, 2014.
Lois Rossi,
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.  180.655, add alphabetically the following commodities to
the table in paragraph (a), to read as follows:

Sec.  180.655  Flazasulfuron; tolerance for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.01

                                * * * * *
Nut, tree, group 14-12.....................................         0.01

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

* * * * *
[FR Doc. 2014-21068 Filed 9-4-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Rules and Regulations]
[Pages 44216-44217]
[FR Doc No: 2020-15746]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2018-0074; FRL-10012-57-OAR]
RIN 2060-AT86

National Emission Standards for Hazardous Air Pollutants: Organic
Liquids Distribution (Non-Gasoline) Residual Risk and Technology
Review; Corrections

AGENCY: Environmental Protection Agency (EPA).

ACTION: Correcting amendments.

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

SUMMARY: On July 7, 2020, the U.S. Environmental Protection Agency
(EPA) revised the National Emission Standards for Hazardous Air
Pollutants: Organic Liquids Distribution (Non-Gasoline) Residual Risk
and Technology Review. A set of amendatory instructions and one
reference to a standard approved for incorporation by reference were
removed during the review and publication process but the related
standard reference was not removed. In addition, subsequent amendatory
instructions were not properly revised to reflect the edits. This
document corrects the final regulations.

DATES: This final rule is effective on July 22, 2020. The incorporation
by reference (IBR) of certain publications listed in the rule was
approved by the Director of the Federal Register as of July 7, 2020.

FOR FURTHER INFORMATION CONTACT: Mr. Neil Feinberg, Sector Policies and
Programs Division (E143-01), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rule published on July 7, 2020
(85 FR 40740), the EPA removed the instructions to redesignate a series
of paragraphs in 40 CFR 63.14 (the centralized IBR section) to add ASTM
D6378-18a, Standard Test Method for Determination of Vapor Pressure
(VPX) of Petroleum Products, Hydrocarbons, and Hydrocarbon-Oxygenate
Mixtures (Triple Expansion Method), approved December 1, 2018, but did
not remove the standard from use in 40 CFR 63.2406. As a result, not
only was the standard improperly added to 40 CFR 63.2046, but revisions
to two existing paragraphs in 40 CFR 63.14 (to ASTM D6420-99
(Reapproved 2004), Standard Test Method for Determination of Gaseous
Organic Compounds by Direct Interface Gas Chromatography-Mass
Spectrometry (Approved October 1, 2004) and ASTM D6420-18, Test Method
for Determination of Gaseous Organic Compounds by Direct Interface Gas
Chromatography/Mass Spectrometry (Approved November 1,

2018)) could not be carried out. This document corrects the centralized
IBR section at 40 CFR 63.14 by restating the instruction that could not
be applied to the CFR and removes ASTM D6378-18a from 40 CFR 63.2046.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements.

Karl Moor,
Deputy Assistant Administrator.

    For the reasons set forth in the preamble, the EPA amends 40 CFR
part 63 as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart A--General Provisions

0
2. Section 63.14 is amended by:
0
a. Redesignating paragraphs (h)(90) through (h)(102) as paragraphs
(h)(91) through (h)(103).
0
b. Adding and reserving new paragraph (h)(90); and
0
c. Revising newly redesignated paragraphs (h)(92) and (94).
    The addition and revisions read as follows:

Sec.  63.14  Incorporations by reference.

* * * * *
    (h) * * *
    (90) [Reserved]
* * * * *
    (92) ASTM D6420-99 (Reapproved 2004), Standard Test Method for
Determination of Gaseous Organic Compounds by Direct Interface Gas
Chromatography-Mass Spectrometry (Approved October 1, 2004), IBR
approved for Sec. Sec.  63.457(b), 63.772(a), 63.772(e), 63.1282(a) and
(d), and table 8 to subpart HHHHHHH.
* * * * *
    (94) ASTM D6420-18, Test Method for Determination of Gaseous
Organic Compounds by Direct Interface Gas Chromatography/Mass
Spectrometry (Approved November 1, 2018), IBR approved for Sec. Sec.
63.987(b), 63.997(e), 63.2354(b), and table 5 to subpart EEEE.
* * * * *

Sec.  63.2406  [Amended]

0
3. In Sec.  63.2406, amend the definition ``Annual average true vapor
pressure,'' by adding ``or'' to the end of paragraph (1) and removing
and reserving paragraph (2).

[FR Doc. 2020-15746 Filed 7-21-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 136 (Tuesday, July 20, 2021)]
[Rules and Regulations]
[Pages 38232-38233]
[FR Doc No: 2021-15326]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2020-0004]
RIN 1218-AD36

Occupational Exposure to COVID-19; Emergency Temporary Standard

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

ACTION: Interim final rule; extension of comment period.

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

SUMMARY: The period for submitting public comments is being extended by
30 days to allow stakeholders interested in the emergency temporary
standard (ETS) additional time to review the ETS and collect
information and data necessary for comment.

DATES: The comment period for the interim final rule (ETS) that was
published June 21, 2021, at 86 FR 32376, effective June 21, 2021, is
extended. Comments on any aspect of the ETS and whether the ETS should
be adopted as a permanent standard must be submitted by August 20,
2021.

ADDRESSES:
    Written comments: You may submit comments and attachments,
identified by Docket No. OSHA-2020-0004, electronically at
www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the online instructions for making electronic submissions.
    Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2020-0004). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public or
submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
    Docket: To read or download comments or other material in the
docket, go to Docket No. OSHA-2020-0004 at www.regulations.gov. All
comments and submissions are listed in the www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that website. All comments and
submissions, including copyrighted material, are available for
inspection through the OSHA Docket Office. Documents submitted to the
docket by OSHA or stakeholders are assigned document identification
numbers (Document ID) for easy identification and retrieval. The full
Document ID is the docket number (OSHA-2020-0004) plus a unique four-
digit code (e.g., OSHA-2020-0004-1033). When citing materials in the
docket, OSHA includes the term ``Document ID'' followed by the last
four digits of the Document ID number (e.g., Document ID 1033).
Document ID numbers are used to identify docket materials in this
notice. However, OSHA identified supporting information in the ETS (86
FR 32376) by author name and publication year, when appropriate. The
agency has also provided a spreadsheet in the docket that identifies
the full Document ID for each reference cited in the ETS (see Document
ID 1042). This information can be used to search for a supporting
document in the docket at http://www.regulations.gov. Contact the OSHA
Docket Office at<PHONE_NUMBER> (TTY number:<PHONE_NUMBER>) for assistance
in locating docket submissions.

FOR FURTHER INFORMATION CONTACT:
    General information and press inquiries: Contact Frank Meilinger,
Director, Office of Communications, U.S. Department of Labor; telephone
(202) 693-1999; email<EMAIL_ADDRESS>    For technical inquiries: Contact Andrew Levinson, Directorate of
Standards and Guidance, U.S. Department of Labor; telephone (202) 693-
1950.

SUPPLEMENTARY INFORMATION: On June 21, 2021, OSHA issued an ETS to
protect healthcare and healthcare support service workers from
occupational exposure to COVID-19 in settings where people with COVID-
19 are reasonably expected to be present.
    The public comment period for the ETS was to close on July 21,
2021, 30 days after publication of the ETS. However, OSHA received
requests from several stakeholders to extend the comment period by an
additional 30 days, through August 20, 2021 (Document ID 1078; 1079;
1080; 1082; 1083; 1086; 1088; 1089). These stakeholders explained that
they need additional time to thoroughly review the ETS, gather input
from members, and prepare informed comments (see, e.g., Document ID
1078; 1079; 1080; 1082; 1083; 1086; 1087; 1088; 1089).
    OSHA agrees to an extension and believes a 30-day extension of the
public comment period is sufficient and appropriate in order to address
these stakeholder requests. Therefore, the public comment period will
be extended until August 20, 2021.

Authority and Signature

    James S. Frederick, Acting Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Avenue NW, Washington, DC 20210, authorized the
preparation of this document pursuant to the following authorities:
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor's Order 8-2020 (85 FR
58393 (Sept. 18, 2020)); 29 CFR part 1911; and 5 U.S.C. 553.

    Signed at Washington, DC, on July 12, 2021.
James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-15326 Filed 7-19-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Rules and Regulations]
[Page 18441-18442]
[DOCID:fr04ap08-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 526, and 558

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of NADAs; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of
seven new animal drug applications (NADAs) because FDA is withdrawing
approval of the NADAs.

DATES:  This rule is effective April 4, 2008.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the seven NADAs listed below because the
products are no longer manufactured or marketed:

------------------------------------------------------------------------
                                                         21 CFR Cite
         Sponsor              NADA Number Product     Affected  (Sponsor
                                    (Drug)            Drug Labeler Code)
------------------------------------------------------------------------
Eon Labs Manufacturing,    NADA 65-063,              520.2345a (000185)
 Inc.,                     Tetracycline capsules
227-15 North Conduit
 Ave.,
Laurelton, NY 11413

                           NADA 65-345,              520.390b (000185)
                           Chloramphenicol capsules
------------------------------------------------------------------------
G.C. Hanford               NADA 65-465,              526.1696a (010515)
 Manufacturing Co.,        AQUA-MAST
P.O. Box 1017,             (penicillin G procaine)
Syracuse, NY 13201
------------------------------------------------------------------------
International Nutrition,   NADA 95-551,              558.625 (043733)
 Inc.,                     TYLAN 5 Premix
7706 ``I'' Plaza,          (tylosin phosphate)
Omaha, NE 68127

                           NADA 109-688,             558.274 (043733)
                           HYGROMIX 2.4 Premix
                           (hygromycin B)

                           NADA 109-816,             558.630 (043733)
                           TYLAN 10 SULFA-G Premix
                           (tylosin phosphate and
                            sulfamethazine)
------------------------------------------------------------------------
Pfizer, Inc.,              NADA 103-758,             Not codified
235 East 42d St.,          TERAMIX-10 Premix
New York, NY 10017         (oxytetracycline)
------------------------------------------------------------------------

    Following the withdrawal of approval of these NADAs, Eon Labs
Manufacturing, Inc., is no longer sponsor of an approved application.
Therefore, 21 CFR 510.600(c) is amended to remove entries for this
sponsor.
    As provided below, the animal drug regulations are amended to
reflect the withdrawal of approvals. The regulations for penicillin G
procaine

intramammary dosage forms (21 CFR 526.1696a) are also amended to
correct several errors and to reflect a current format.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520 and 526

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 526, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Eon Labs Manufacturing, Inc.''; and in the table in paragraph
(c)(2) remove the entry for ``000185''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.390b  [Amended]

0
4. In Sec.  520.390b, in paragraph (b)(1), remove ``, 000185,''.

Sec.  520.2345a  [Amended]

0
5. In Sec.  520.2345a, remove paragraph (b)(3).

PART 526--INTRAMAMMARY DOSAGE FORMS

0
6. The authority citation for 21 CFR part 526 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
7. Revise Sec.  526.1696a to read as follows:

Sec.  526.1696a  Penicillin G procaine.

    (a) Specifications. Each 10-milliliter single-dose syringe contains
penicillin G procaine equivalent to 100,000 units of penicillin G.
    (b) Related tolerances. See Sec.  556.510 of this chapter.
    (c) Sponsors. See Nos. 010515 and 050604 in Sec.  510.600(c) of
this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse one 10-
milliliter dose into each infected quarter. Treatment may be repeated
at 12-hour intervals for not more than three doses, as indicated by
clinical response.
    (2) Indications for use. For the treatment of mastitis caused by
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating
cows.
    (3) Limitations. Milk that has been taken from animals during
treatment and for 60 hours after the latest treatment must not be used
for food. Animals must not be slaughtered for food during treatment or
within 3 days after the latest treatment.
    (e) Conditions of use in dry cows--(1) Amount. Infuse one 10-
milliliter dose into each infected quarter at time of drying-off.
    (2) Indications of use. For the treatment of mastitis caused by
Streptococcus agalactiae in dry cows.
    (3) Limitations. Discard all milk for 72 hours (6 milkings)
following calving, or later as indicated by the marketable quality of
the milk. Animals must not be slaughtered for food within 14 days
postinfusion.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
8. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.274  [Amended]

0
9. In Sec.  558.274, amend paragraph (a)(2) by removing ``Nos. 043733
and'' and adding in its place ``No.''.

Sec.  558.625  [Amended]

0
10. In Sec.  558.625, remove and reserve paragraph (b)(3).

Sec.  558.630  [Amended]

0
11. In Sec.  558.630, amend paragraph (b)(10) by removing ``043733,''.

    Dated: March 26, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-7103 Filed 4-3-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: May 7, 2009 (Volume 74, Number 87)]
[Rules and Regulations]
[Page 21246-21249]
[DOCID:fr07my09-2]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1214; Directorate Identifier 2007-NM-259-AD;
Amendment 39-15897; AD 2009-10-02]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited
(Jetstream) Model 4101 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is superseding an existing airworthiness directive
(AD), which applies to all BAE Systems (Operations) Limited (Jetstream)
Model 4101 airplanes. That AD currently requires operators to determine
the number of flight cycles accumulated on each component of the main
landing gear (MLG) and the nose landing gear (NLG), and to replace each
component that reaches its life limit with a serviceable component. The
existing AD also requires operators to revise the Airworthiness
Limitations (AWL) section of the Instructions for Continued
Airworthiness (ICA) in the aircraft maintenance manual to reflect the
new life limits for structurally significant items. This new AD
requires a new revision of the AWL section of the ICA to incorporate
revised life limits for structurally significant items,

operational and functional tests of certain systems, and instructions
to retain critical ignition source prevention features during
configuration changes. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country. We are issuing this AD to prevent failure of certain
structurally significant items, including the MLG and the NLG, which
could result in reduced structural integrity of the airplane; and to
prevent fuel vapor ignition sources, which could result in fuel tank
explosion and consequent loss of the airplane.

DATES: This AD becomes effective June 11, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of June 11,
2009.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications as of October 26, 2005 (70 FR
55230, September 21, 2005).

ADDRESSES: For service information identified in this AD, contact BAE
Systems Regional Aircraft, 13850 McLearen Road, Herndon, Virginia
20171; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet http://www.baesystems.com/Businesses/RegionalAircraft/
index.htm.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to include an AD that supersedes AD 2005-19-15, amendment
39-14280 (70 FR 55230, September 21, 2005). The existing AD applies to
all BAE Systems (Operations) Limited (Jetstream) Model 4101 airplanes.
That NPRM was published in the Federal Register on November 17, 2008
(73 FR 67817). That NPRM proposed to continue to require operators to
determine the number of flight cycles accumulated on each component of
the main landing gear and the nose landing gear, and to replace each
component that reaches its life limit with a serviceable component.
That NPRM also proposed to continue to require operators to revise the
Airworthiness Limitations (AWL) section of the Instructions for
Continued Airworthiness (ICA) in the aircraft maintenance manual to
reflect the new life limits for structurally significant items. That
NPRM also proposed to require a new revision of the AWL section of the
ICA to incorporate revised life limits for structurally significant
items, operational and functional tests of certain systems, and
instructions to retain critical ignition source prevention features
during configuration changes.

Comments

    We provided the public the opportunity to participate in the
development of this AD. No comments have been received on the NPRM or
on the determination of the cost to the public.

Conclusion

    We have carefully reviewed the available data and determined that
air safety and the public interest require adopting the AD as proposed.

Costs of Compliance

    The following table provides the estimated costs for U.S. operators
to comply with this AD.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
             Action                  Work hour     Average labor     Cost per       registered      Fleet cost
                                                   rate per hour     airplane        airplanes
----------------------------------------------------------------------------------------------------------------
AWL revision (required by AD                   1             $80             $80               3            $240
 2005-19-15)....................
AWL revision (new action).......               1              80              80               3             240
----------------------------------------------------------------------------------------------------------------

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 have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-14280 (70 FR 55230, September 21, 2005) and by
adding the following new airworthiness directive (AD):

2009-10-02 BAE Systems (Operations) Limited (Formerly British
Aerospace Regional Aircraft): Amendment 39-15897. Docket No. FAA-
2008-1214; Directorate Identifier 2007-NM-259-AD.

Effective Date

    (a) This AD becomes effective June 11, 2009.

Affected ADs

    (b) This AD supersedes AD 2005-19-15.

Applicability

    (c) This AD applies to all BAE Systems (Operations) Limited
Model Jetstream 4101 airplanes, certificated in any category.

Unsafe Condition

    (d) This AD results from mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country. We are issuing this AD to prevent failure of certain
structurally significant items, including the main landing gear and
the nose landing gear, which could result in reduced structural
integrity of the airplane; and to prevent fuel vapor ignition
sources, which could result in fuel tank explosion and consequent
loss of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Certain Requirement of AD 2005-19-15: Revise Aircraft Maintenance
Manual (AMM)

    (f) Within 30 days after October 26, 2005 (the effective date of
AD 2005-19-15): Revise the Airworthiness Limitations (AWL) section
of the Instructions for Continued Airworthiness of the BAE Systems
(Operations) Limited J41 AMM to include the life limits of the
components listed in Chapter 05-10-10, Airworthiness Limitations--
Description and Operation Section, Revision 23, dated February 15,
2005, of the AMM. This may be accomplished by inserting a copy into
the AWL section of the Instructions for Continued Airworthiness.
Thereafter, except as provided in paragraph (i) of this AD, no
alternative replacement times may be approved for any affected
component.

New Requirements of This AD: Revise AWL Section of Instructions for
Continued Airworthiness

    (g) Within 90 days after the effective date of this AD: Revise
the AWL section of the Instructions for Continued Airworthiness by
incorporating the instructions of Subjects 05-10-10, ``Airworthiness
Limitations,'' 05-10-20, ``Certification Maintenance Requirements,''
and 05-10-30, ``Critical Design Configuration Control Limitations
(CDCCL)--Fuel System'' of the BAE Systems (Operations) Limited
Jetstream Series 4100 AMM, Revision 31, dated February 15, 2009.
Thereafter, except as provided in paragraph (i) of this AD, no
alternative replacement times or inspection intervals may be
approved for any affected component. The revised Chapter 05-10-10
replaces the corresponding chapter specified in paragraph (f) of
this AD.
    (h) Where paragraph 2.A.(2) of Subject 05-10-10 of the BAE
Systems (Operations) Limited Jetstream Series 4100 AMM, Revision 31,
dated February 15, 2009, specifies that certain landing gear units
``must be removed before 31st March 2008,'' this AD requires
compliance within 60 days after the effective date of this AD.

Alternative Methods of Compliance (AMOCs)

    (i) 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.
Send information to ATTN: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1175; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.

Related Information

    (j) European Aviation Safety Agency airworthiness directive
2008-0094, dated May 16, 2008, also addresses the subject of this
AD.

Material Incorporated by Reference

    (k) You must use the service information contained in Table 1 of
this AD to do the actions required by this AD, unless the AD
specifies otherwise.

                                 Table 1--All Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
               Document                               Revision                               Date
----------------------------------------------------------------------------------------------------------------
BAE Systems (Operations) Limited J41    23.................................  February 15, 2005.
 (AMM).
Subject 05-10-10 of the BAE Systems     31.................................  February 15, 2009.
 (Operations) Limited Jetstream Series
 4100 AMM.
Subject 05-10-20 of the BAE Systems     31.................................  February 15, 2009.
 (Operations) Limited Jetstream Series
 4100 AMM.
Subject 05-10-30 of the BAE Systems     31.................................  February 15, 2009.
 (Operations) Limited Jetstream Series
 4100 AMM.
----------------------------------------------------------------------------------------------------------------

    Chapter 05 of the BAE Systems (Operations) Limited Jetstream
Series 4100 AMM contains the following effective pages:

                                                         Table 2--Effective Pages of Chapter 05
                                                                [List of effective pages]
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Page title/description                         Page number(s)                           Revision number                Date shown on page(s)
--------------------------------------------------------------------------------------------------------------------------------------------------------
AMM Title Page.....................  None shown.....................................  Not shown on page*..............  February 15, 2009
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              AMM Publications Transmittal
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     1..............................................  31..............................  February 15, 2009.
                                     2-3............................................  Not shown on page*..............  February 15, 2009.

Chapter 05 Airworthiness             1-2............................................  Not shown on page*..............  February 15, 2009.
 Limitations List of Effective
 Pages.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Subject 05-10-10: Airworthiness Limitations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     1-4............................................  Not shown on page*..............  September 15, 2004.
                                     5..............................................  Not shown on page*..............  February 15, 2006.
                                     6-10...........................................  Not shown on page*..............  February 15, 2005.
                                     12, 16, 18-40, 45..............................  Not shown on page*..............  February 15, 2009.
                                     11, 13-15, 17, 41[dash]44, 46, 47..............  Not shown on page*..............  February 15, 2007.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Subject 05-10-20: Certification Maintenance Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     1, 5...........................................  Not shown on page*..............  December 1, 1997.
                                     2-3............................................  Not shown on page*..............  September 15, 2004.
                                     4..............................................  Not shown on page*..............  October 15, 1999.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                Subject 05-10-30: Critical Design Configuration Control Limitations (CDCCL)--Fuel System
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     1-2............................................  Not shown on page*..............  February 15, 2008.
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Page 1 of the Publications Transmittal of the BAE Systems (Operations) Limited Jetstream Series 4100 AMM is the only page that shows the revision level
  of this document.

    (1) The Director of the Federal Register approved the
incorporation by reference of Subject 05-10-10, Subject 05-10-20,
and Subject 05-10-30 of the BAE Systems (Operations) Limited
Jetstream Series 4100 AMM, Revision 31, dated February 15, 2009,
under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) The Director of the Federal Register previously approved the
incorporation by reference of the BAE Systems (Operations) Limited
J41 AMM, Revision 23, dated February 15, 2005, on October 26, 2005
(70 FR 55230, September 21, 2005).
    (3) For service information identified in this AD, contact BAE
Systems Regional Aircraft, 13850 McLearen Road, Herndon, Virginia
20171; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet http://www.baesystems.com/Businesses/RegionalAircraft/
index.htm.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (5) You may also review copies of the 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, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on April 27, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-10425 Filed 5-6-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Proposed Rules]
[Pages 76402-76403]
[FR Doc No: 2015-30947]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-4076; Directorate Identifier 2015-NE-30-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Rolls-Royce plc (RR) RB211-22B and RB211-524 turbofan engines
with low-pressure turbine (LPT) support roller bearing, part number (P/
N) LK30313 or P/N UL29651, installed. This proposed AD was prompted by
a report of a breach of the turbine casing and release of engine
debris. This proposed AD would require removal of certain LPT support
roller bearings installed in RR RB211-22B and RB211-524 engines. We are
proposing this AD to prevent failure of the LPT support roller bearing,
loss of radial position following LPT blade failure, uncontained part
release, damage to the engine, and damage to the airplane.

DATES: We must receive comments on this proposed AD by February 8,
2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<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-2015-
4076; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Brian Kierstead, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
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-2015-4076;
Directorate Identifier 2015-NE-30-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
with FAA personnel concerning this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2015-0187, dated September 9, 2015 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    An RB211-524G2-T engine experienced an in-service event that
resulted in breach of a turbine casing and some release of core
engine debris through a hole in the engine nacelle. The
investigation of the event determined the primary cause to have been
fracture and release of a Low Pressure (LP) turbine stage 2 blade.
The blade release caused secondary damage to the LP turbine,
producing significant out-of-balance forces. The event engine was
fitted with an LP turbine support bearing where the roller retention
cage is constructed from two halves that are riveted together. The
LP turbine imbalance resulted in an overload of the LP turbine
support bearing and caused separation of the riveted, two-piece
roller retention cage. Radial location of the LP turbine shaft was
lost, allowing further progression of the event that resulted in a
breach of the IP turbine casing.

    RR introduced a modified LPT support roller bearing that can
withstand greater loads when an LPT turbine blade release occurs,
thereby preventing LPT rotor movement. You may obtain further
information by examining the MCAI in the AD docket on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2015-4076.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the European Community, EASA
has notified us of the unsafe condition described in the MCAI. We are
proposing this AD because we evaluated all information provided by EASA
and determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design. This proposed AD
would require removal from service of the affected LPT support
bearings.

Costs of Compliance

    We estimate that this proposed AD affects 9 engines installed on
airplanes of U.S. registry. We also estimate it would take 0 hours to
comply with this proposed AD since the proposed actions required by the
AD would be performed during a shop visit, when major engine flanges
are separated, which requires the removal of the LPT support roller
bearing. Therefore, no additional time is needed to remove it. Parts
would cost about $8,184 per engine. The average labor rate is $85 per
hour. Based on these figures, we estimate the cost of this proposed AD
on U.S. operators to be $73,656.

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 to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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):

Rolls-Royce plc: Docket No. FAA-2015-4076; Directorate Identifier
2015-NE-30-AD.

(a) Comments Due Date

    We must receive comments by February 8, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Rolls-Royce plc RB211-22B-02, RB211-22B (MOD
72-8700), RB211-524B-02, RB211-524B-B-02, RB211-524B2-19, RB211-
524B2-B-19, RB211-524B3-02, RB211-524B4-02, RB211-524B4-D-02, RB211-
524C2-19, RB211-524C2-B-19, RB211-524D4-19, RB211-524D4-B-19, RB211-
524D4X-19, RB211-524D4X-B-19, RB211-524D4-39, RB211-524D4-B-39,
RB211-524G2-19, RB211-524G3-19, RB211-524-G2-T-19, RB211-524G3-T-19,
RB211-524H-36, RB211-524H2-19, RB211-524H-T-36, and RB211-524H2-T-19
turbofan engines, all serial numbers, with low-pressure turbine
(LPT) support roller bearing, part number (P/N) LK30313 or P/N
UL29651, installed.

(d) Reason

    This AD was prompted by a report of a breach of the turbine
casing and release of engine debris through a hole in the engine
nacelle. We are issuing this AD to prevent failure of the LPT
support roller bearing, loss of radial position following LPT blade
failure, uncontained part release, damage to the engine, and damage
to the airplane.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done. At the next shop visit or within 24 months
after the effective date of this AD, whichever occurs first, remove
from service LPT support roller bearing, P/N LK30313 or P/N UL29651,
and replace with a part eligible for installation.

(f) Installation Prohibition

    After the effective date of this AD, do not install an LPT
support roller bearing, P/N LK30313 or P/N UL29651, onto any engine.

(g) Definition

    For the purpose of this AD, a ``shop visit'' is defined as
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine flanges, except that the
separation of engine flanges solely for the purposes of
transportation without subsequent engine maintenance does not
constitute an engine shop visit.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(i) Related Information

    (1) For more information about this AD, contact Brian Kierstead,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2015-0187,
dated September 9, 2015, for more information. You may examine the
MCAI in the AD docket on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2015-4076.

    Issued in Burlington, Massachusetts, on December 2, 2015.
Colleen M. D'Alessandro,
Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-30947 Filed 12-8-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32380-32381]
[FR Doc No: 2011-13857]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17Ac3-1(a) and SEC File No. 270-96; OMB Control No. 3235-
0151; Form TA-W (1669).

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget requests for approval of extension on the following rule and
form: Rule 17Ac3-1(a) (17 CFR 240.17Ac3-1(a)) and Form TA-W (17 CFR
249b.101) under the Securities Exchange Act of 1934 (15 U.S.C. 78a et
seq.).
    Section 17A(c)(4)(B) of the Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.) authorizes transfer agents registered with an
appropriate regulatory agency (``ARA'') to withdraw from registration
by filing with the ARA a written notice of withdrawal and by agreeing
to such terms and conditions as the ARA deems necessary or appropriate
in the public interest, for the protection of investors, or in the
furtherance of the purposes of Section 17A.
    In order to implement Section 17A(c)(4)(B) of the Exchange Act the
Commission, on September 1, 1977, promulgated Rule 17Ac3-1(a) and
accompanying Form TA-W. On January 11, 2007, the Commission amended
Rule 17Ac3-1(a) and accompanying Form TA-W to require that the form be
filed in electronic format through EDGAR. Rule 17Ac3-1(a) provides that
notice of withdrawal of registration as a transfer agent with the
Commission shall be filed on Form TA-W. Form TA-W requires the
withdrawing transfer agent to provide the Commission with certain
information, including: (1) The locations where transfer agent
activities are or were performed; (2) the reasons for ceasing the
performance of such activities; (3) disclosure of unsatisfied judgments
or liens; and (4) information regarding successor transfer agents.
    The Commission uses the information disclosed on Form TA-W to
determine whether the registered transfer agent applying for withdrawal
from registration as a transfer agent should be allowed to deregister
and, if so, whether the Commission should attach to the granting of the
application any terms or conditions necessary or appropriate in the
public interest, for the protection of investors, or in furtherance of
the purposes of Section 17A of the Exchange Act. Without Rule 17Ac3-
1(a) and Form TA-W, transfer agents registered with the Commission
would not have a means to voluntarily deregister when necessary or
appropriate to do so.
    Respondents file approximately 50 TA-Ws with the Commission
annually. A Form TA-W filing occurs only once, when a transfer agent is
seeking deregistration. Respondents file approximately 50 TA-Ws with
the Commission annually. A Form TA-W filing occurs only once, when a
transfer agent is seeing deregistration. Approximately 80 percent of
Form TA-Ws are completed by the transfer agent or its employees and
approximately 20 percent of Forms TA-W are completed by an outside
filing agent that is hired by the registrant to prepare the form and
file it electronically. In view of the readily-available information
requested by Form TA-W, its short and simple presentation, and the
Commission's experience with the filers, we estimate that approximately
30 minutes is required to complete and file Form TA-W, which consists
primarily of external

labor costs plus a nominal and unquantifiable amount of computer
operations/maintenance cost (because the Forms must be filed
electronically through the Commission's EDGAR system). For transfer
agents that complete Form TA-W themselves, we estimate the cost per
filing is $25 (.5 hours times $50 average hourly rate for clerical
staff time), which is an internal labor cost. We estimate that outside
filing agents charge $100 to complete and file at TA-W on behalf of a
registrant, reflecting an external cost to respondents.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid Office of Management and Budget (OMB) control number.
    Background documentation for this information collection may be
viewed at the following link, http://www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an e-mail to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312, or send an e-mail to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    May 31, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-13857 Filed 6-3-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Rules and Regulations]
[Pages 15710-15711]
[FR Doc No: 2020-05211]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2020-D-0988]

Required Warnings for Cigarette Packages and Advertisements:
Small Entity Compliance Guide; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``Required
Warnings for Cigarette Packages and Advertisements: Small Entity
Compliance Guide.'' This guidance is intended to help small businesses
understand and comply with FDA's document entitled ``Tobacco Products:
Required Warnings for Cigarette Packages and Advertisements,'' which
establishes new required cigarette health warnings for cigarette
packages and advertisements.

DATES: March 18, 2020.

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-2020-D-0988 for ``Required Warnings for Cigarette Packages and
Advertisements: Small Entity Compliance Guide.'' 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.govinfo.gov/content/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)).
    Submit written requests for single copies of the guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Lauren Belcher or Annette Marthaler,
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002, 1-877-287-1373, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Required Warnings for Cigarette Packages and Advertisements:
Small Entity Compliance Guide.'' FDA is issuing this guidance to help
small businesses understand and comply with the final rule, codified at
21 CFR part 1141, entitled ``Tobacco Products: Required Warnings for
Cigarette Packages and Advertisements'', that establishes new required
cigarette health warnings for cigarette packages

and advertisements and is published elsewhere in this edition of the
Federal Register. The final rule implements a provision of the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub.
L. 111-31) that requires FDA to issue regulations requiring color
graphics depicting the negative health consequences of smoking to
accompany new textual warning label statements. The Tobacco Control Act
amends the Federal Cigarette Labeling and Advertising Act (FCLAA) (15
U.S.C. 1333) to require each cigarette package and advertisement to
bear one of the new required warnings. Additionally, as required under
the FCLAA, the rule establishes marketing requirements that include the
random and equal display and distribution of the required warnings on
cigarette packages and quarterly rotation of the required warnings in
cigarette advertisements. FDA has prepared this Small Entity Compliance
Guide in accordance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104-121).

II. Significance of Guidance

    FDA is issuing this guidance consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on assisting small businesses to understand and
comply with FDA's final rule, ``Tobacco Products: Required Warnings for
Cigarette Packages and Advertisements.'' 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to collections of information described in
FDA's rule on ``Tobacco Products; Required Warnings for Cigarette
Packages and Advertisements,'' which this guidance is intended to
interpret. 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. 3501-3521). The information collection
provisions in the final rule have been submitted to OMB for review as
required by section 3507(d) of the Paperwork Reduction Act of 1995.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05211 Filed 3-17-20; 8:45 am]
 BILLING CODE 4164-01-P