[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]
[Page 67082-67088]
[DOCID:fr18de09-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0009; FRL-8798-1]

Chlorimuron Ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
chlorimuron ethyl, including its metabolites and degradates, in or on
corn, field, forage; corn, field grain; corn, field, stover; grain,
aspirated fractions; soybean, forage; and soybean, hay. In addition,
the presently established tolerance term, ``soybean'' is being revised
to ``soybean, seed.'' E.I. du Pont de Nemours and Company requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and
requests for hearings must be received on or before February 16, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0009. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Beth Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0009 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before February 16, 2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0009, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs
8F7430 and 8F7439) by E.I. du Pont de Nemours and Company, Laurel Run
Plaza, P.O. Box 80038, Wilmington, DE 19880-0038. The petitions
requested that 40 CFR 180.429 be amended by establishing tolerances for
residues of the herbicide chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-
methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate], in or on (PP
8F7430) corn, field grain at 0.01 parts per million (ppm); corn, field,
forage at 0.5 ppm; corn, field, stover at 2.0 ppm; corn, field, meal at
0.014 ppm; corn, field, flour at 0.015 ppm; corn, aspirated grain
fractions at 1.28 ppm; and (PP 8F7439) soybean, seed at 0.01 ppm;
soybean, forage at 0.45 ppm; soybean, hulls at 0.04 ppm; soybean,
aspirated grain fractions at 2.79 ppm; and soybean, hay at 1.8 ppm.
That notice referenced a summary of the petition prepared by E.I. du
Pont de Nemours and Company, the registrant, which is available to the
public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that tolerances are not needed for residues of chlorimuron
ethyl on the following: Corn, field, meal; corn, field, flour; and
soybean, hulls. EPA has also determined that the presently established
tolerance of 0.05 ppm is appropriate for soybean in lieu of the
proposed tolerance of 0.01 ppm for soybean, seed. Because soybean, seed
is the designated EPA term for soybeans, the existing soybean tolerance
is being amended to use that term. Additionally, EPA has determined
that a single tolerance of 3.0 ppm should be established for grain,
aspirated fractions in lieu of the proposed separate tolerances on
corn, aspirated grain fractions; and soybean, aspirated grain
fractions. EPA has also revised the tolerance expression for
chlorimuron ethyl to clarify the chemical moieties that are covered by
the tolerances and specify how compliance with the tolerances is to be
measured. The reasons 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of chlorimuron ethyl, including its metabolites
and degradates on corn, field forage at 0.5 ppm; corn, field, grain at
0.01 ppm; corn, field, stover at 2.0 ppm; grain, aspirated fractions at
3.0 ppm; soybean,

forage at 0.45 ppm; and soybean, hay at 1.8 ppm. EPA's assessment of
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Chlorimuron ethyl has low or minimal acute toxicity via the oral,
dermal and inhalation routes of exposure. It is mildly irritating to
the eye and non-irritating to the skin; it is not a skin sensitizer.
    In subchronic toxicity studies with chlorimuron ethyl: No adverse
effects were observed up to the limit dose tested in mice; decreased
body weight gain and liver pathology (margination of hepatocyte
cytoplasmic content in the centrilobular areas) were observed in rats
(males only); and mild hemolytic anemia, atrophy of the thymus and
prostate and increased liver weights were seen in dogs. Chronic
exposure of dogs to chlorimuron ethyl also led to mild anemia
(decreased erythrocyte count, hematocrit, and hemoglobin
concentration), but atrophy of the thymus and prostate were not seen.
In rats, treatment-related effects observed were limited to decreased
body weight and body weight gain in both sexes after long-term
exposure. Prostatitis (males) and fatty replacement in the pancreas
(both sexes) were also observed but considered incidental occurrences.
Biliary hyperplasia/fibrosis seen in females was attributed to aging.
In mice, there were no treatment-related effects observed up to the
highest dose tested (216 milligrams/kilograms/day (mg/kg/day)). There
were no treatment-related increases in tumors in rat and mouse
carcinogenicity studies after exposure to chlorimuron ethyl.
Chlorimuron ethyl is classified as ``Not Likely to be Carcinogenic to
Humans.''
    In the developmental toxicity studies, decreases in maternal body
weight gain and delayed ossification in fetuses were observed in rats
at the same dose (150 mg/kg/day). In rabbits, decreases in maternal
body weight gain were seen at 300 mg/kg/day, while delayed ossification
was seen in fetuses at a lower dose of 48 mg/kg/day, indicating
increased quantitative susceptibility. In a guideline 2-generation
reproduction study in rats, decreased body weight and histopathology in
the cerebellum (cellular changes in the internal granular and external
germinal layers) were seen in pups at 177 mg/kg/day. These effects were
seen in the absence of maternal toxicity, indicating potential
increased quantitative susceptibility of the pups to chlorimuron ethyl.
However, these effects were not associated with any neurotoxicity or
neurobehavioral changes and were not observed in other reproduction
studies in rats. In a non-guideline reproduction toxicity study (1-
generation) in rats, decreased body weight (females) and liver
histopathology (males) were seen in parental animals at 173 mg/kg/day,
along with decreases in litter weights. In another reproduction study
(1-year interim sacrifice) in rats, decreases in maternal and pup body
weights were observed at 195 mg/kg/day.
    There is no indication of neurotoxicity in the toxicity database
for chlorimuron ethyl. In a 2-generation reproduction study in rats,
histopathological alterations were seen in the cerebellum (cellular
changes in the internal granular and external germinal layers) of F2
pups at 177 mg/kg/day; however, these findings were not associated with
any neurobehavioral changes or any indications of neurotoxicity. In
addition, these histopathological alterations were not observed in two
other reproduction studies, and there was no evidence of neurotoxicity
observed in other rat toxicity studies or toxicity studies in other
species (rabbits, mice, or dogs).
    Hematological changes (indicative of mild anemia) and atrophy of
the thymus were observed in dogs after subchronic exposure. However,
atrophy of the thymus was not associated with any histopathology and
not seen after chronic exposure. No other potential immunotoxic effects
were observed in the toxicology database.
    Specific information on the studies received and the nature of the
adverse effects caused by chlorimuron ethyl 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 ``Chlorimuron ethyl. Human Health Risk
Assessment for Proposed Uses on Field Corn and Soybean, PPs 8F7430 and
8F7439,'' page 45 in docket ID number EPA-HQ-OPP-2009-0009.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for chlorimuron ethyl used
for human risk assessment can be found at http://www.regulations.gov in
document ``Chlorimuron ethyl. Human Health Risk Assessment for Proposed
Uses on Field Corn and Soybean, PPs 8F7430 and 8F7439,'' page 20 in
docket ID number EPA-HQ-OPP-2009-0009.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorimuron ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing chlorimuron ethyl
tolerances in 40 CFR 180.429. EPA assessed dietary exposures from
chlorimuron ethyl 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. No such effects were identified in the toxicological
studies for chlorimuron ethyl; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT) for all existing and new uses of chlorimuron
ethyl.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified chlorimuron ethyl as ``Not Likely to be
Carcinogenic to Humans.'' Therefore, an exposure assessment for
evaluating cancer risk is not needed for this chemical.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for chlorimuron ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of chlorimuron ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of chlorimuron ethyl
were determined for acute exposures and chronic exposures for non-
cancer assessments assuming a maximum seasonal use rate of 0.25 lb
chlorimuron ethyl per acre. EDWCs for acute exposures are estimated to
be 11.98 parts per billion (ppb) for surface water and 6.99 ppb for
ground water. EDWCs for chronic exposures for non-cancer assessments
are estimated to be 5.02 ppb for surface water and 6.99 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the most conservative water concentration value of 6.99 ppb
was used to assess the contribution to chlorimuron ethyl dietary
exposure from drinking water. Acute dietary risk assessments were not
conducted since no toxicological endpoint attributable to a single dose
of chlorimuron ethyl has been identified. Cancer dietary risk
assessments were not conducted since there is no cancer concern for
chlorimuron ethyl.
    In a summary of results from a pilot monitoring program conducted
by the U.S. Geological Survey, data show that chlorimuron ethyl has
been detected in drinking water of water supply reservoirs, but only at
maximum concentrations magnitudes lower than those predicted by the
FIRST model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Chlorimuron ethyl is
not registered for any specific use patterns that would result in
residential exposure.
    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 chlorimuron ethyl to share a common mechanism of
toxicity with any other substances, and chlorimuron ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
chlorimuron ethyl 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 website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for chlorimuron ethyl includes guideline rat and
rabbit developmental toxicity studies and a 2-generation reproduction
toxicity study in rats, as well as two additional non-guideline
reproduction studies in rats (a 1-generation study and 1-year interim
sacrifice study). No evidence of increased prenatal or postnatal
susceptibility was seen in the developmental toxicity study in rats or
in the non-guideline reproduction toxicity studies in rats. In the
rabbit developmental study, delayed ossification was observed in
fetuses at 48 mg/kg/day, while maternal effects (decreased body weight
gain) were seen at 300 mg/kg/day, suggesting increased quantitative
susceptibility of fetuses. In the 2-generation rat reproduction study,
decreased body weight and histopathology findings in the cerebellum
were observed in pups at 177/214 mg/kg/day (male/female) in the absence
of maternal toxicity, also suggesting increased quantitative
susceptibility of the pups.
    Although the data suggest increased quantitative susceptibility in
the developmental rabbit study and the 2-generation rat reproduction
study, there are no residual uncertainties with regard to prenatal
toxicity following in utero exposure of rats or rabbits or prenatal
and/or postnatal exposures of rats. The fetal effect seen in rabbits
was limited to delayed ossification, and, although effects
(histopathology in the cerebellum) were seen in a rat reproduction
study, there was no evidence of increased susceptibility observed in
two additional reproduction studies in rats. Additionally, there are
clear NOAELs for the offspring effects seen in rabbits (NOAEL=13 mg/kg/
day) and rats (17 mg/kg/day). Finally, the NOAEL (9 mg/kg/day) used to
establish the chronic Reference Dose of 0.09 mg/kg/day is considered
protective of potential developmental effects observed at the higher
doses. Considering the overall toxicity database and doses selected for
risk assessment, the degree of concern for the effects observed in the
studies is low.
    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:
    The toxicity database for chlorimuron ethyl is adequate to
characterize potential prenatal and postnatal risk for infants and
children. Acceptable/guideline studies for developmental toxicity in
rats and rabbits and reproduction toxicity in rats are available for
FQPA assessment.

    On December 26, 2007, EPA began requiring functional immunotoxicity
testing and acute and subchronic neurotoxicity testing of all food and
non-food use pesticides. These studies are not yet available for
chlorimuron ethyl. In the absence of specific immunotoxicity and
neurotoxicity studies, EPA has evaluated the available chlorimuron
ethyl toxicity data and determined that an additional uncertainty
factor is not required to account for the lack of these studies. The
reasons for this determination are explained below:
    i. Hematological changes (indicative of mild anemia) and atrophy of
the thymus were observed in dogs following subchronic exposure to
chlorimuron-ethyl at a dose of 45.8/42.7 (M/F) mg/kg/day, indicating
potential immunotoxicity. However, atrophy of the thymus was not
associated with any histopathology and was not seen after chronic
exposure; and no other potential immunotoxic effects were observed in
the toxicology database. Therefore, EPA does not believe that
conducting immunotoxicity testing will result in a NOAEL less than the
NOAEL of 9 mg/kg/day already established for chlorimuron ethyl, and an
additional factor (UFDB) for database uncertainties is not needed to
account for potential immunotoxicity.
    ii. There is no indication in the toxicity database that
chlorimuron ethyl is a neurotoxic chemical. No signs indicative of
neurotoxicity were seen in subchronic and chronic studies conducted
with dogs, mice and rats. In a 2-generation reproduction study in rats,
histopathological alterations were seen in the cerebellum of F2 pups at
the high dose (177 mg/kg/day). However, these findings were not
associated with any neurobehavioral changes or any other indications of
neurotoxicity. In addition, these histopathological alterations were
not observed in two other reproduction studies with chlorimuron ethyl.
Based on these considerations, EPA does not believe that a
developmental neurotoxicity study is warranted at this time and there
is no need for an additional UF to account for the lack of acute and
subchronic neurotoxicity studies.
    iii. Although there is evidence of increased quantitative
susceptibility in the developmental rabbit study and the 2-generation
rat reproduction study, the degree of concern for the effects observed
in the studies is low, and there are no residual uncertainties with
regard to prenatal toxicity following in utero exposure of rats or
rabbits or prenatal and/or postnatal exposures of rats.
    iv. There are no residual uncertainties identified in the exposure
databases. The food exposure assessments were performed based on the
assumptions of 100 PCT and tolerance-level residues. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to chlorimuron ethyl in drinking
water. Chlorimuron ethyl is not registered for residential use. These
assessments will not underestimate the exposure and risks posed by
chlorimuron ethyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
chlorimuron ethyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
chlorimuron ethyl from food and water will utilize 1% or less of the
cPAD for the general population and all population subgroups, including
infants and small children. There are no residential uses for
chlorimuron ethyl.
    3. Short/intermediate-term risk. Short-term and intermediate-term
aggregate exposure take into account short-term or intermediate-term
residential exposure plus chronic exposure from food and water
(considered to be a background exposure level). Chlorimuron ethyl is
not registered for any use patterns that would result in residential
exposure. Therefore, the short-term or intermediate-term aggregate risk
is the sum of the risk from exposure to chlorimuron ethyl through food
and water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Based on a lack of
evidence for carcinogenicity in mice and rats following long-term
dietary administration, chlorimuron ethyl is not expected to pose a
cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to chlorimuron ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography (HPLC) using a photoconductivity detector with a method
limit of quantitation (LOQ) of 0.01 ppm (AMR-459-85)) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Codex or Mexican maximum
residue limits (MRLs) for residues of chlorimuron ethyl for corn or
soybean commodities; however, there is a Canadian MRL for soybeans
(0.05 mg/kg), which harmonizes with the current U.S. tolerance on
soybeans.

C. Revisions to Petitioned-For Tolerances

    EPA has determined that tolerances are not needed for the
following: Corn, field, meal; corn, field, flour; and soybean, hulls.
Tolerances for the processed commodities of corn, field, meal and corn,
field, flour are not needed because these commodities are not expected
to have residues greater than the tolerance on the raw agricultural
commodity, field corn grain. EPA has also determined that tolerances
for corn and soybean aspirated grain fractions will not be listed
individually, but will be combined under the single tolerance, grain,
aspirated fractions at 3.0 ppm based on the soybean aspirated grain
fraction data. The current tolerance for residues of chlorimuron ethyl
on soybeans at 0.05 ppm is not being amended as requested. Although
adequate residue data are available indicating that residues on soybean
were less than 0.01 ppm in/on all seed samples following an application
at the R1-R2 stage, the existing 0.05 ppm

tolerance will cover this use and is additionally required for
harmonization purposes with the Canadian MRL. However, the soybean
tolerance is being amended to change the commodity name to ``soybean,
seed'' which is the current EPA designated term for this commodity. A
tolerance for residues in/on soybean, hulls is not required as this
commodity will be covered by the existing 0.05 ppm tolerance on
soybean, seed.
    Finally, EPA is revising the tolerance expression for all new and
existing commodities to clarify the chemical moieties that are covered
by the tolerances and specify how compliance with the tolerances is to
be measured. The revised tolerance expression makes clear that the
tolerances cover ``residues of chlorimuron ethyl, including its
metabolites and degradates'' and that compliance with the tolerance
levels will be determined by measuring only chlorimuron ethyl, ethyl 2-
[[[[(4-chloro-6-methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate].
EPA has determined that it is reasonable to make this change final
without prior proposal and opportunity for comment, because public
comment is not necessary, in that the change has no substantive effect
on the tolerance, but rather is merely intended to clarify the existing
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of chlorimuron
ethyl, including its metabolites and degradates, in or on corn, field
grain at 0.01 ppm; corn, field, forage at 0.5 ppm; corn, field, stover
at 2.0 ppm; soybean, forage at 0.45 ppm; soybean, hay at 1.8 ppm, and
grain, aspirated fractions at 3.0 ppm. In addition, the presently
established tolerance term, ``Soybean'' is being revised to ``Soybean,
seed.'' Compliance with the tolerance levels will be determined by
measuring only chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-
methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate], in or on the
commodity.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 8, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.429 is amended by revising the introductory text to
paragraph (a), revising the tolerance term ``Soybean'' to read
``Soybean, seed'' and alphabetically adding the following commodities
to the table in paragraph (a) to read as follows:

Sec.  180.429  Chlorimuron ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide chlorimuron ethyl, including its metabolites and degradates,
in or on the commodities in the table below. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-
methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate] in or on the
following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, field, forage..................................                0.5
Corn, field, grain...................................               0.01
Corn, field, stover..................................                2.0
Grain, aspirated fractions...........................                3.0
                                * * * * *
Soybean, forage......................................               0.45
Soybean, hay.........................................                1.8
Soybean, seed........................................               0.05
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-30032 Filed 12-17-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2378-2380]
[FR Doc No: 2017-00095]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1196 and FDA-2016-E-1197]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ADYNOVATE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ADYNOVATE and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
10, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for

extension acted with due diligence during the regulatory review period
by July 10, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION
section for more information.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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 Nos.
FDA-2016-E-1196 and FDA-2016-E-1197 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ADYNOVATE.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these Acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product ADYNOVATE
(antihemophilic factor (recombinant), PEGylated). ADYNOVATE is
indicated in adolescent and adult patients (12 years and older) with
Hemophilia A (congenital Factor VIII deficiency) for: On-demand
treatment and control of bleeding episodes, and routine prophylaxis to
reduce the frequency of bleeding episodes. Subsequent to this approval,
the USPTO received patent term restoration applications for ADYNOVATE
(U.S. Patent Nos. 7,199,223 and 8,247,536) from Nektar Therapeutics,
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated July 12,
2016, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of ADYNOVATE
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ADYNOVATE is 1,061 days. Of this time, 707 days occurred during the
testing phase of the regulatory review period, while 354 days occurred
during the approval phase. These periods of

time were derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: December
19, 2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on December
19, 2012.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): November 25, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ADYNOVATE (BLA 125566) was initially submitted on November 25, 2014.
    3. The date the application was approved: November 13, 2015. FDA
has verified the applicant's claim that BLA 125566 was approved on
November 13, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 708 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00095 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-P


           EPA Region 10 Meeting with Idaho Petroleum Marketers and
               Idaho Department of Environmental Quality (IDEQ)
                               February 7, 2012

Attendees:
EPA Region 10: Erik Sirs

Idaho Petroleum Marketers:
Richard Wright, Jacksons
Kent Storer, Leonard Equipment
Bob DeNinno, Supervalu
Rick Rhodes, Northwest Technologies
Jim Holm, Northwest Technologies
Harold Whitman, Idaho Petroleum Eq.
Dudley Adams, Gom Stop
Dennis Riding, Maverik
Steve King, Leonard Petroleum Equipment
Gail Arnold, Stinker Stores
Hance Andreasen, Wheeler Tank testing
Kevin Robinson, Century Link
Rob Franklin, United Oil
Holly Claiborn, United Oil
Suzanne Bucye, SBS Assoc.
Mike Brush, PSTF
Dana Harper, Dales Service Inc.
F. Durham, Olympus Tech

State of Idaho:
Jackie McCloughan, Idaho Transportation Dept
Orville Green, IDEQ
Keith Donahue, IDEQ
Susan Hamlin, IDEQ
Christopher Bowe, IDEQ
Rick Varvis, IDEQ

EPA gave an overview of the proposed changes to the UST regulations and encouraged the participants to comment on the proposal.


[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Page 28913]
[FR Doc No: 2021-11291]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No.: OSHA-2020-0003]

Advisory Committee on Construction Safety and Health (ACCSH)

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

ACTION: Notice of ACCSH membership.

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

SUMMARY: On May 11, 2021, the Secretary selected 15 members to serve on
the Advisory Committee on Construction Safety and Health (ACCSH).

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    For general information about ACCSH and ACCSH membership: Mr. Damon
Bonneau, OSHA, Directorate of Construction; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    Copies of this Federal Register document: Electronic copies of this
Federal Register document are available at http://www.regulations.gov.
This document, as well as news releases and other relevant information,
are also available on the OSHA web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    ACCSH advises the Secretary of Labor and the Assistant Secretary of
Labor for Occupational Safety and Health (Assistant Secretary) in the
formulation of standards affecting the construction industry, and on
policy matters arising in the administration of the safety and health
provisions under the Contract Work Hours and Safety Standards Act
(Construction Safety Act (CSA)) (40 U.S.C. 3701 et seq.) and the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) (see also 29 CFR 1911.10 and 1912.3). In addition, the CSA and
OSHA regulations require the Assistant Secretary to consult with ACCSH
before the agency proposes any occupational safety and health standard
affecting construction activities (40 U.S.C. 3704); 29 CFR 1911.10.
    ACCSH operates in accordance with the Federal Advisory Committee
Act (FACA), as amended (5 U.S.C. App. 2), and its implementing
regulations (41 CFR 102-3 et seq.); and Department of Labor Manual
Series Chapter 1-900 (8/31/2020). ACCSH generally meets two to four
times a year.

II. Appointment of Committee Members

    ACCSH consists of 15 members appointed by the Secretary. ACCSH
members generally serve two-year terms, unless they resign, cease to be
qualified, become unable to serve, or the Secretary removes them (29
CFR 1912.3(e)). The Secretary may appoint ACCSH members to successive
terms. The allocation of members for each category of ACCSH membership
is:
     Five members who are qualified by experience and
affiliation to present the viewpoint of employees in the construction
industry;
     Five members who are similarly qualified to present the
viewpoint of employers in the construction industry;
     Two public members, qualified by knowledge and experience
to make a useful contribution to the work of ACCSH, such as those who
have professional or technical experience and competence with
occupational safety and health in the construction industry;
     Two representatives of State safety and health agencies;
and
     One representative designated by the Secretary of the
Department of Health and Human Services.
    OSHA received nominations of highly qualified individuals in
response to the agency's request for nominations (85 FR 79221, December
9, 2020). The Secretary appointed individuals to serve on the Committee
who have broad experience relevant to the issues to be examined by the
Committee. The ACCSH membership is as follows:

Employee Representatives

     Cheryl M. Ambrose, United Association of Journeymen and
Apprentices of the Plumbing and Pipe Fitting Industry of the U.S. and
Canada;
     Christina Trahan Cain, North America's Building Trades
Unions (ACCSH Chair);
     Wayne J. Creasap II, International Association of Bridge,
Structural, Ornamental and Reinforcing Iron Workers;
     Ryan Papariello, Laborers Health and Safety Fund of North
America; and
     David Wysocki, International Masonry Training and
Education Foundation.

Employer Representatives

     Kevin Cannon, The Associated General Contractors of
America;
     Julie Carter, Roy Anderson Corp;
     Fravel E. Combs, M.A. Mortenson, Company;
     Greg Sizemore, Associated Builders and Contractors; and
     Wesley L. Wheeler, National Electrical Contractors
Association.

Public Representatives

     Christopher Fought, Merck; and
     R. Ronald Sokol, Safety Council of Texas City.

State Representatives

     Christopher Scott Mabry, North Carolina Department of
Labor Occupational Safety and Health Division; and
     Charles Stribling, Kentucky Labor Cabinet Department of
Workplace Standards.

Federal Representative

     Dr. G. Scott Earnest, National Institute for Occupational
Safety and Health.

Authority and Signature

    James S. Frederick, Acting Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice pursuant to 29 U.S.C. 655, 40 U.S.C. 3704, Secretary's Order 8-
2020 (85 FR 58393), 5 U.S.C. App. 2, and 29 CFR part 1912.

    Signed at Washington, DC, on May 21, 2021.
James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-11291 Filed 5-27-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41990-41992]
[FR Doc No: 2020-14995]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0363]

Cancer Clinical Trial Eligibility Criteria: Patients With Human
Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus
Infections; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Cancer
Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B
Virus, or Hepatitis C Virus Infections.'' This guidance is one in a
series of guidances that provide recommendations regarding eligibility
criteria for clinical trials of drugs or biological products regulated
by the Center for Drug Evaluation and Research (CDER) and the Center
for Biologics Evaluation and Research (CBER) for the treatment of
cancer. Specifically, this guidance includes recommendations on the
inclusion of patients with human immunodeficiency virus (HIV),
hepatitis B virus (HBV) infections, and hepatitis C virus (HCV)
infections. Exclusion of patients with HIV, HBV, or HCV infections from
cancer clinical trials remains common in most studies of
investigational drugs. Expanding cancer clinical trial eligibility to
be more inclusive of patients with HIV, HBV, or HCV infections is
justified in many cases and may accelerate the development of effective
therapies in cancer patients with these chronic infections. This
guidance finalizes the draft guidance of the same title that published
on March 13, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on July 13, 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-2019-D-0363 for ``Cancer Clinical Trial Eligibility Criteria:
Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus
Infections.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with
HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.'' This
guidance provides recommendations on the inclusion of patients with
HIV, HBV, and HCV infections in clinical trials of drugs or biological
products regulated by CDER and CBER for the treatment of cancer.
    A clinical trial's eligibility criteria (for inclusion and
exclusion) are essential components of the trial, defining the
characteristics of the study population. Because there is variability
in investigational drugs and trial objectives, eligibility criteria
should be developed taking into consideration the mechanism of action
of the drug, the targeted disease or patient population, the
anticipated safety of the investigational drug, the availability of
adequate safety data, and the ability to recruit trial participants
from the patient population to meet the objectives of the clinical
trial. However, some eligibility criteria have become commonly accepted
over time or used as a template across trials without clear scientific
or clinical rationale. Unnecessarily restrictive eligibility criteria
may slow patient accrual, limit patients' access to clinical trials,
and lead to trial results that do not fully represent treatment effects
in the patient population that will ultimately use the drug. Broadening
cancer trial eligibility criteria can maximize the generalizability of
trial results and the ability to understand the therapy's benefit-risk
profile across the patient population likely to use the drug in
clinical practice and should be considered to avoid jeopardizing
patient safety.
    The guidance recommends that eligibility criteria regarding
patients with HIV, HBV, or HCV infections address requirements
regarding relevant concurrent antiviral and other therapies (e.g.,
antibiotic prophylaxis) and degree of immunocompetence appropriate for
a given cancer, investigational drug, and intended use population. The
recommendations for eligibility criteria for patients with cancer and
concurrent HIV infection are focused on evaluation of immune function
and HIV therapy. The recommendations for eligibility criteria for
cancer patients with evidence of chronic HBV or with history of chronic
HCV or virologically suppressed on HCV treatment are focused on liver-
related laboratories and HBV/HCV therapy.
    In the Federal Register of March 13, 2019 (84 FR 9130), FDA
announced the availability of the draft guidance of the same title. FDA
received comments and considered those comments as the guidance was
finalized. The final guidance includes additional detail on the
recommendations regarding

eligibility criteria related to HBV and HCV therapy, additional
references in the appendices for patients with HBV and HCV in cancer
trials, and clarifications.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cancer Clinical Trial Eligibility
Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus
Infections.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR 201.56 and 201.57 have been
approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14995 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Page 65691]
[FR Doc No: 2023-20736]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0853]

Yogurt Products Deviating From Standard of Identity; Amendment of
Temporary Marketing Permit

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) are amending
Chobani, LLC's temporary permit to market test lower-fat yogurt
products. The temporary permit is amended to allow the use of the test
product as an ingredient in other nonstandardized food applications
including drinkable beverages, dips, and sauces. This amendment will
allow the applicant to continue to test market the test product, as
ingredients, in whole or in part, in other nonstandardized foods and
collect data on consumer acceptance of the test product.

FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 28, 2023
(88 FR 18322), we issued a notice announcing that we issued a temporary
permit to Chobani, LLC, 200 Lafayette St., New York, NY 10012, to
market test lower-fat yogurt products deviating from the general
definition and standard of identity for yogurt with modified milkfat
and fat-containing flavoring ingredients, and yogurt deviating from the
yogurt standard of identity by using ultrafiltered nonfat milk as a
basic dairy ingredient. The permit allowed for the test product to be
manufactured at 3450 Kimberly Rd. East, Twin Falls, ID 83301 and 669
County Rd. 25, New Berlin, NY 13411.
    We issued the permit to facilitate market testing of products that
deviate from the requirements for the basic dairy ingredient provision
of the yogurt standard of identity under 21 CFR 131.200(b).
    Under our regulations at 21 CFR 130.17(f), we are amending the
temporary permit issued to Chobani, LLC, to allow the test product to
be used as ingredients, in whole or in part, in other nonstandardized
foods. All other conditions and terms of this permit remain the same.

    Dated: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20736 Filed 9-22-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Proposed Rules]
[Pages 51035-51038]
[FR Doc No: 2021-19608]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0729; Project Identifier MCAI-2021-00364-R]
RIN 2120-AA64

Airworthiness Directives; Bell Textron Canada Limited Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2021-06-06, which applies to certain Bell Textron Canada Limited Model
505 helicopters. AD 2021-06-06 requires repetitive fluorescent
penetrant inspections (FPIs) of the pilot collective stick and grip
assembly and revising the existing Rotorcraft Flight Manual (RFM) for
your helicopter. Since the FAA issued AD 2021-06-06, the pilot
collective stick and grip assembly has been redesigned. This proposed
AD would retain certain requirements of AD 2021-06-06, require
modifying your helicopter to include the improved pilot collective
stick tube and would add a terminating action for the repetitive FPIs.
This proposed AD would also prohibit installing any pilot collective
stick and grip assembly unless certain requirements of this proposed AD
were met. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by October 29,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Bell
Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4;
telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-433-0272; email
<EMAIL_ADDRESS>or at https://www.bellflight.com/support/contact-support. You may view the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0729; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
Transport Canada AD, any comments received, and other information. The
street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-
9167; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0729; Project Identifier
MCAI-2021-00364-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include

supporting data. The FAA will consider all comments received by the
closing date and may amend this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Hal
Jensen, Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2021-06-06, Amendment 39-21473 (86 FR 14366,
March 16, 2021) (AD 2021-06-06), for Bell Textron Canada Limited Model
505 helicopters, serial number (S/N) 65011 and subsequent. AD 2021-06-
06 requires, before further flight, revising the Limitations section of
the existing RFM for your helicopter to prohibit single pilot
operations from the right crew seat, require the pilot in command to
occupy the left crew seat for dual pilot operations, and depending on
configuration, prohibit the use of SPLIT-COM mode. AD 2021-06-06 also
requires, before further flight and thereafter at intervals not to
exceed 25 hours time-in-service (TIS), removing and cleaning the pilot
collective stick and grip assembly and performing an FPI for a crack as
specified in the manufacturers service information. AD 2021-06-06 also
requires removing any cracked pilot collective stick and grip assembly
from service before further flight, and within 10 days after the
discovery of any crack, reporting certain information to Bell Product
Support Engineering. AD 2021-06-06 also prohibits installing any pilot
collective stick and grip assembly on any helicopter unless it has
successfully passed the FPI requirements of AD 2021-06-06. Lastly, AD
2021-06-06 prohibits relief under any Master Minimum Equipment List or
Minimum Equipment List for the Audio Panel when the aircraft is
operated with a single pilot.
    AD 2021-06-06 was prompted by Canadian Emergency AD CF-2021-05R2,
dated March 4, 2021 (Transport Canada Emergency AD CF-2021-05R2),
issued by Transport Canada, which is the aviation authority for Canada,
to correct an unsafe condition for Bell Textron Canada Limited Model
505 helicopters, S/Ns 65011 and subsequent. Transport Canada advised
that FPIs findings showed that cracking of the pilot collective stick
and grip assembly could occur at very low flight hours. Transport
Canada also specified that Bell Textron Canada Limited revised its
service information to introduce a temporary revision to the RFM
prohibiting single pilot operations from the right crew seat. This
condition, if not addressed, could result in failure of the pilot
collective stick and grip assembly and subsequent loss of control of
the helicopter.
    Accordingly, Transport Canada Emergency AD CF-2021-05R2 prohibited
single pilot operations from the right crew seat in accordance with the
manufacturers service information. Transport Canada considered its AD
an interim action and stated that further AD action may follow.

Actions Since AD 2021-06-06 Was Issued

    Since the FAA issued AD 2021-06-06, Transport Canada issued AD CF-
2021-05R3, dated March 19, 2021 (Transport Canada AD CF-2021-05R3),
which supersedes Transport Canada Emergency AD CF-2021-05R2. Transport
Canada advises that since Transport Canada Emergency AD CF-2021-05R2
was issued, the pilot collective stick and grip assembly has been
redesigned to address the root cause of the cracking. Accordingly,
Transport Canada AD CF-2021-05-R3 retains the requirements of Transport
Canada Emergency AD CF-2021-05R2 and requires installing the newly
designed pilot collective stick and grip assembly, which is a
terminating action for the requirements of Transport Canada Emergency
AD CF-2021-05R2. Transport Canada AD CF-2021-05R3 also revises the
applicability to include only helicopters that have not incorporated
the redesigned pilot collective stick and grip assembly during
production.
    Finally, the FAA received one comment on AD 2021-06-06 from one
commenter. Advanced Helicopter Services requested additional
information about AD 2021-06-06, specifically whether performing
certain actions specified in Bell Alert Service Bulletin 505-21-20,
Revision C, dated March 11, 2021 (ASB 505-21-20 Rev C) would be
considered a terminating action for the inspections required by AD
2021-06-06.
    The FAA has determined that it is necessary to supersede AD 2021-
06-06. The proposed required actions, including required actions
performed in accordance with portions of ASB 505-21-20 Rev C, would
include a terminating action for the repetitive FPI inspections.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with Canada, Transport Canada, its
technical representative, has notified the FAA of the unsafe condition
described in its AD. The FAA is proposing this AD after evaluating all
known relevant information and determining that the unsafe condition
described previously is likely to exist or develop on other helicopters
of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed ASB 505-21-20 Rev C, which provides instructions
for an initial and recurring FPIs for cracks in the pilot collective
stick and grip assembly part number (P/N) M207-20M478-041/-043/-047 on
Bell Textron Canada Limited Model 505 helicopters, serial numbers 65011
through 65347. ASB 505-21-20 Rev C also specifies inserting a temporary
revision into the RFM that prohibits single pilot operations from the
right crew seat until further notice, and specifies that if the right
crew seat pilot collective stick and grip assembly was previously
confirmed serviceable following an FPI then the 25 flight hour
recurring FPI of the right crew seat pilot collective stick and grip
assembly is no longer required provided that the helicopter is only
operated

single pilot in command (PIC) from the left crew seat.
    The FAA also reviewed Bell 505 RFM TR for Pilot Collective (ASB
505-21-20), BHT-505-FM-1, Temporary Revision (TR-6) (BHT-505-FM-1, TR-
6) and Bell 505 RFM TR for Pilot Collective (ASB 505-21-20), BHT-505-
FM-2, Temporary Revision (TR-1), each dated March 3, 2021. These
temporary revisions specify changes to Section 1 of the RFM Limitations
Section that the minimum flight crew consists of one pilot that shall
operate from the left crew seat and that dual operation is approved
provide that the PIC occupies the left crew seat. BHT-505-FM-1, TR-6
also prohibits use of SPLIT-COM mode.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements in This NPRM

    This proposed AD would retain certain requirements from AD 2021-06-
06. This proposed AD would require, before further flight, revising
Section 1, the Limitations section of the existing RFM for your
helicopter to prohibit single pilot operations from the right crew
seat, require the PIC to occupy the left crew seat for dual pilot
operations, and depending on configuration, prohibit the use of SPLIT-
COM mode. This proposed AD would also require, before further flight
after the effective date of this AD, and thereafter at intervals not to
exceed 25 hours TIS, removing the pilot collective stick and grip
assembly and performing an FPI for a crack and depending on the
inspection results, removing a certain part from service. This proposed
AD would also require within 12 months after the effective date of this
AD, removing a certain part-numbered pilot collective stick tube from
service and installing an improved pilot collective stick tube in
accordance with the manufacturers service information and thereafter,
removing a certain part-numbered pilot collective stick tube from
service before it accumulates 300 total hours TIS. Additionally, this
proposed AD would consider certain proposed actions to be a terminating
action for other proposed actions. This proposed AD would also prohibit
installing any pilot collective stick and grip assembly unless certain
proposed actions are accomplished.
    This proposed AD would require revising the Limitations section of
the existing RFM for your helicopter. An owner/operator (pilot) may
incorporate the RFM revisions, and the owner/operator must enter
compliance with the applicable paragraphs of the AD into the aircraft
records in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR
91.417(a)(2)(v). This is an exception to the FAA's standard maintenance
regulations.

Differences Between This Proposed AD and the Transport Canada AD

    This proposed AD would prohibit relief under any Master Minimum
Equipment List or Minimum Equipment List for the Audio Panel when the
aircraft is operated with a single pilot, whereas Transport Canada AD
CF-2021-05R3 does not. Transport Canada AD CF-2021-05R3 requires the
repetitive FPIs if the aircraft is not flown solely from the left crew
seat whereas this proposed AD requires FPIs regardless.
    Transport Canada AD CF-2021-05R3 requires operators to ``advise all
flight crews'' of changes to the RFM, and thereafter to ``operate the
helicopter accordingly.'' However, this AD would not specifically
require those actions. 14 CFR 91.9 requires that no person may operate
a civil aircraft without complying with the operating limitations
specified in the RFM. Therefore, including a requirement in this
proposed AD to operate the helicopter according to the revised RFM
would be redundant and unnecessary. Further, compliance with such a
requirement in an AD would be impracticable to demonstrate or track on
an ongoing basis; therefore, a requirement to operate the helicopter in
such a manner would be unenforceable.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 98 helicopters of U.S. Registry. Labor rates are estimated at
$85 per work-hour. Based on these numbers, the FAA estimates the
following costs to comply with this proposed AD.
    Revising the existing RFM for your helicopter would take about 0.5
work-hour for an estimated cost of $43 per helicopter.
    Removing, cleaning, and performing an FPI of the pilot collective
stick and grip assembly would take about 3 work-hours for an estimated
cost of $255 per helicopter and $24,990 for the U.S. fleet per
inspection cycle.
    Installing an improved pilot collective stick tube would take about
5 work-hours and parts would cost about $1,256 for an estimated cost of
$1,681 per helicopter.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 2021-06-06, Amendment 39-21473 (86
FR 14366, March 16, 2021); and
0
b. Adding the following new airworthiness directive:

Bell Textron Canada Limited: Docket No. FAA-2021-0729; Project
Identifier MCAI-2021-00364-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) action by October 29, 2021.

(b) Affected ADs

    This AD replaces AD 2021-06-06, Amendment 39-21473 (86 FR 14366,
March 16, 2021) (AD 2021-06-06).

(c) Applicability

    This AD applies to Bell Textron Canada Limited Model 505
helicopters, serial number (S/N) 65011 through 65347 inclusive,
certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor
Control.

(e) Unsafe Condition

    This AD was prompted by a report of a cracked pilot collective
stick and grip assembly. The FAA is issuing this AD to detect a
cracked pilot collective stick and grip assembly. The unsafe
condition, if not addressed, could result in failure of the pilot
collective stick and grip assembly and subsequent loss of control of
the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Before further flight after the effective date of this AD,
revise the Limitations section of the existing Rotorcraft Flight
Manual (RFM) for your helicopter by inserting Bell 505 RFM Temporary
Revision (TR) for Pilot Collective (ASB 505-21-20), BHT-505-FM-1,
Temporary Revision (TR-6) or Bell 505 RFM TR for Pilot Collective
(ASB 505-21-20), BHT-505-FM-2, Temporary Revision (TR-1), each dated
March 3, 2021, as applicable to your helicopter. Using a different
document with information identical to the information for the
``Flight Crew'' and ``Configuration,'' as applicable to your
helicopter, in the RFM TR specified in this paragraph for your
helicopter is acceptable for compliance with the requirements of
this paragraph. This action may be performed by the owner/operator
(pilot) holding at least a private pilot certificate and must be
entered into the aircraft records showing compliance with this AD in
accordance with Sec.  43.9(a)(1) through (4) and Sec.
91.417(a)(2)(v). The record must be maintained as required by Sec.
91.417, Sec.  121.380, or Sec.  135.439.
    (2) Before further flight after the effective date of this AD,
and thereafter at intervals not to exceed 25 hours time-in-service
(TIS):
    (i) Remove the pilot collective stick and grip assembly from the
jackshaft assembly and clean the areas specified in Figure 2 of Bell
Alert Service Bulletin 505-21-20, Revision C, dated March 11, 2021
(ASB 505-21-20 Rev C) with a clean cloth C-516C or equivalent
moistened with dry cleaning solvent C-304 or equivalent.
    (ii) Perform a fluorescent penetrant inspection (FPI) for a
crack by following the Accomplishment Instructions, Part I,
paragraph 5. (but not paragraphs 5.a. and b.) of ASB 505-21-20 Rev
C. Perform this FPI in the areas specified in Figure 2 of ASB 505-
21-20 Rev C. If there is a crack, before further flight, remove the
pilot collective stick and grip assembly from service.
    (3) Within 12 months after the effective date of this AD, remove
the pilot collective stick tube from service and install pilot
collective stick tube part number (P/N) M207-20M301-043 by following
the Accomplishment Instructions, Part II, paragraphs 3. through 4.
of ASB 505-21-20 Rev C except where this service information
specifies discarding parts, you are required to remove those parts
from service instead. Thereafter, remove from service pilot
collective stick tube P/N M207-20M301-043 before it accumulates 300
total hours TIS
    (4) Completing the actions required in paragraph (g)(3) of this
AD constitutes a terminating action for the requirements in
paragraphs (g)(1) and (2) of this AD.
    (5) As of the effective date of this AD, do not install any
pilot collective stick and grip assembly on any helicopter unless
the actions required by paragraphs (g)(2) and (g)(3) of this AD have
been accomplished.
    (6) As of the effective date of this AD, relief under any Master
Minimum Equipment List or Minimum Equipment List for the Audio Panel
is prohibited when the aircraft is operated with a single pilot.

(h) Credit for Previous Actions

    If you performed an FPI of the pilot collective stick and grip
assembly before the effective date of this AD using Bell Alert
Service Bulletin 505-21-20, dated February 20, 2021, Bell Alert
Service Bulletin 505-21-20, Revision A, dated February 26, 2021, or
Bell Alert Service Bulletin 505-21-20, Revision B, dated March 3,
2021, you met the before further flight FPI requirement of paragraph
(g)(2) of this AD.

(i) Special Flight Permits

    A special flight permit to a maintenance facility may be granted
provided that:
    (1) There are no passengers on-board,
    (2) The helicopter is flown from the copilot seat only, and
    (3) The GMA (intercom) is operative.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k)(1) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact Bell
Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec
J7J1R4; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-433-
0272; email<EMAIL_ADDRESS>or at https://www.bellflight.com/support/contact-support. You may view this
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (3) The subject of this AD is addressed in Transport Canada AD
CF-2021-05R3, dated March 19, 2021. You may view the Transport
Canada AD on the internet at https://www.regulations.gov in Docket
No. FAA-2021-0729.

    Issued on September 2, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-19608 Filed 9-13-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 5, 2010 (Volume 75, Number 2)]
[Notices]
[Page 350-351]
[DOCID:fr05ja10-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13576-000]

FFP Qualified Hydro 19 LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

December 29, 2009.
    On September 4, 2009, FFP Qualified Hydro 19 LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act, proposing to study the feasibility of the GV
Montgomery Lock and Dam Project, located on the Tennessee-Tombigbee
Waterway, in Itawamba County, Mississippi. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of the following:
    (1) A 25-ft by 200-ft long power canal; (2) a 40-ft by 40-ft
powerhouse; (3) a new 3 MVA substation; (4) a 200-ft long transmission
line; (5) 100 feet of new access roads; and (6) appurtenant facilities.
The proposed GV Montgomery Lock and Dam Project would have an average
annual generation of 8 gigawatt-hours.
    Applicant Contact: Ramya Swaminathan, Free Flow Power Corporation,
33 Commercial Street, Gloucester, MA 01930.
    FERC Contact: Allyson Conner,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov/docs-filing/ferconline.asp)

under the ``eFiling'' link. For a simpler method of submitting text
only comments, click on ``Quick Comment.'' For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>call toll-
free at<PHONE_NUMBER>; or, for TTY, contact<PHONE_NUMBER>. Although
the Commission strongly encourages electronic filing, documents may
also be paper-filed. To paper-file, mail an original and eight copies
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13576) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-31326 Filed 1-4-10; 8:45 am]

BILLING CODE 6717-01-P