[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Rules and Regulations]
[Pages 26722-26727]
[FR Doc No: 2016-10389]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0014; FRL-9944-82]

Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection,
LLC., requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 4, 2016. Objections and
requests for hearings must be received on or before July 5, 2016, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0014, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0014 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0014, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8323) by Syngenta Crop Protection, LLC., 410 Swing Road, Greensboro,
NC 27419. The petition requested that 40 CFR 180.546

be amended by establishing tolerances for residues of the fungicide
mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-
alaninate, in or on rapeseed crop subgroup 20A at 0.05 parts per
million (ppm). That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for mefenoxam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with mefenoxam 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. Mefenoxam is the enriched R-enantiomer of metalaxyl which is
a racemic mixture that contains approximately 50% each of the R- and S-
enantiomers. EPA conducted side-by-side comparison of the available
toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam
has similar toxicity to that of metalaxyl. Therefore, the metalaxyl
data may be used to support regulatory actions for mefenoxam.
    The Agency reassessed the toxicity databases for metalaxyl and
mefenoxam in accordance with current policies and determined that many
of the effects previously noted in several toxicological studies are no
longer considered to be adverse (i.e. body weight gain without changes
in absolute body weight; hepatocyte hypertrophy without necrosis;
enzyme leakage to bloodstream or disruption of lipid homeostasis). In
rat and dog repeat dose (i.e., subchronic and chronic) oral toxicity
studies, there were no indications of adverse effects up to the highest
dose tested (HDT).
    Adverse effects were only observed from acute exposure to rats. In
the rat developmental toxicity study of metalaxyl, maternal toxicity
consisted of dose-related increased incidence of convulsions that
occurred shortly after dosing, as well as other clinical signs. In a
range-finding acute neurotoxicity study of mefenoxam, females showed
abnormal functional observation battery (FOB) findings at lower doses
than males. However, there was no indication of toxicity up to the HDT
in the mefenoxam subchronic neurotoxicity study, which confirms the
lack of adverse effects observed in all other repeated-dose studies.
    There was no indication of developmental toxicity in studies of
mefenoxam or metalaxyl. There was no indication of immunotoxicity in a
mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have
been classified as ``not likely to be carcinogenic in humans'' based on
the results for metalaxyl in the carcinogenicity study in mice and the
combined chronic toxicity and carcinogenicity study in rats.
    Specific information on the studies received and the nature of the
adverse effects caused by mefenoxam 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 ``Mefenoxam, Human Health Risk
Assessment'' at pages 14-17 in docket ID number EPA-HQ-OPP-2015-0014.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for mefenoxam used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Mefenoxam for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Metalaxyl Prenatal Developmental
 including infants, children, and  UFA = 10x...........   kg/day.              Toxicity--Rat
 females 13-50 years of age.       UFH = 10x...........  aPAD = 0.5 mg/kg/    LOAEL = 250 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 dose-related increases in
                                                                               clinical signs of toxicity (e.g.,
                                                                               post-dosing convulsions).
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  No endpoint was identified. No systemic toxicity was observed in any toxicity
                                    study where the animals were administered metalaxyl or mefenoxam in the
                                    diet. Acute dietary assessment is protective of all other durations of
                                    exposure.
                                  ------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Metalaxyl Prenatal Developmental
 30 days) and intermediate-term    UFA = 10x...........                        Toxicity--Rat
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 250 mg/kg/day based on
                                   FQPA SF = 1x........                        dose-related increases in
                                                                               clinical signs of toxicity (e.g.,
                                                                               post-dosing convulsions).
                                  ------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   No endpoint was identified. No systemic toxicity was observed at the limit
 and intermediate-term (1 to 6      dose (1,000 mg/kg/day) in rabbits treated with metalaxyl during a 21-day
 months).                           dermal toxicity study.
                                   For converting oral to dermal doses for risk assessment, the Dermal
                                    Absorption Factor (DAF) = 35%.
                                  ------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Metalaxyl Prenatal Developmental
 days) and intermediate-term (1    UFA = 10x...........                        Toxicity--Rat
 to 6 months).                     UFH = 10x...........                       LOAEL = 250 mg/kg/day based on
                                   FQPA SF = 1x........                        dose-related increases in
                                   Note: Toxicity via                          clinical signs of toxicity (e.g.,
                                    the inhalation and                         post-dosing convulsions).
                                    oral routes are
                                    assumed to be
                                    equivalent..
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
                                    absence of treatment-related increases in tumor incidence in adequately
                                    conducted carcinogenicity studies in rats and mice treated with metalaxyl.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mefenoxam, EPA considered exposure under the petitioned-for
tolerances as well as all existing mefenoxam tolerances in 40 CFR
180.546 and metalaxyl tolerances 40 CFR 180.408. EPA assessed dietary
exposures from mefenoxam/metalaxyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for mefenoxam. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA conducted a somewhat refined acute
dietary exposure assessment for the proposed food use of mefenoxam on
the rapeseed subgroup 20A and the existing uses of both metalaxyl and
mefenoxam. Residues were assumed to be present at tolerance levels in
plant commodities, with additional factors applied to certain plant
commodities to include all residues of concern for risk assessment.
Tolerance-level residues adjusted upward to account for metalaxyl/
mefenoxam residues of concern in livestock commodities were used and
based on data from metabolism studies on goats and hens. DEEM default
and empirical processing factors were used as available. It was assumed
that 100% of the crops were treated (100% CT).
    ii. Chronic exposure. No such effects were identified in the
toxicological studies for mefenoxam; therefore, a quantitative chronic
dietary exposure assessment is unnecessary.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that mefenoxam does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for mefenoxam. Tolerance-level residues and/or 100%
CT were assumed for all food commodities
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for mefenoxam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of mefenoxam. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-

and-assessing-pesticide-risks/about-water-exposure-models-used-
pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and the
Pesticide Root Zone Model-Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of mefenoxam for acute exposures
are estimated to be 741 parts per billion (ppb) for surface water and
3,700 ppb for ground water. These modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Mefenoxam is currently registered for the following uses that could
result in residential exposures: Residential turf and ornamentals,
including nonbearing citrus trees. EPA assessed residential exposure
using the following assumptions: Residential handler exposure is
expected to be short-term in duration. Intermediate-term exposures are
not likely because of the intermittent nature of applications by
homeowners. Residential post-application exposure was assessed based on
short-term incidental oral risk estimates for children 1 < 2 years old.
Dermal post-application risk assessments were not conducted because an
adverse systemic dermal hazard was not identified for mefenoxam.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 mefenoxam
to share a common mechanism of toxicity with any other substances, and
mefenoxam does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that mefenoxam does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that
mefenoxam results in increased susceptibility from in utero exposure to
rats or rabbits in the prenatal developmental studies or exposure to
young rats in the 2-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for metalaxyl and mefenoxam is complete.
    ii. In the rat prenatal developmental toxicity with metalaxyl,
maternal animals exhibited clinical signs indicative of neurobehavioral
effects as previously discussed.
    In the range-finding acute neurotoxicity study with mefenoxam,
females exhibited abnormal functional observation battery (FOB)
findings at doses lower than in males. In the subchronic neurotoxicity
study with mefenoxam, there were no indications of neurotoxicity up to
the HDT. In metalaxyl and mefenoxam treated adult animals, clinical
signs and abnormal FOB findings were noted. However, a developmental
neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam
because (1) there are no indications of increased susceptibility for
infants or children; (2) the convulsions observed in the rat prenatal
developmental toxicity study occurred in the maternal animals with no
effects being observed in the young; (3) the convulsions occurred only
after a bolus dose; (4) the available developmental and range-finding
acute neurotoxicity studies provided clear NOAELs and LOAELs for
evaluating effects; (5) the current POD is below the level at which any
effects were seen in either study, and (6) there were no other
indications of neurotoxicity in the mefenoxam or metalaxyl databases,
which include a subchronic (adult rat) neurotoxicity study for
mefenoxam. Therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. In metalaxyl and mefenoxam treated animals, there was no
evidence of increased susceptibility following pre-/postnatal exposure
in the prenatal developmental toxicity studies or the reproduction and
fertility effects study. There is no evidence that mefenoxam results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance levels or upper bound residue estimates. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to mefenoxam in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by mefenoxam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. The acute aggregate risk assessment considers
exposure estimates from dietary consumption of mefenoxam (food and
drinking water). Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
mefenoxam will occupy 95% of the aPAD for children <1 years old, the
population group

receiving the greatest exposure, but this is below the level of
concern.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account chronic exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from repeated exposure was
identified and no chronic dietary endpoint was selected. Therefore,
mefenoxam is not expected to pose a chronic risk.
    3. Short-term and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account both short-term
and intermediate-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level).
Mefenoxam is currently registered for uses that could result in short-
term and intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate short-term and
intermediate-term residential exposures to mefenoxam. Using the
exposure assumptions described in this unit for short-term and
intermediate-term exposures, EPA has concluded the combined short-term
and intermediate-term food, water, and residential exposures result in
aggregate MOEs of 79,000 for adult; and 1,000 for children 1 < 2 years
old. Because EPA's level of concern for mefenoxam is a MOE of 100 or
below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, mefenoxam is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Several methods are available for enforcing tolerances: (1) A gas-
liquid chromatography procedure employing an alkali flame ionization
detector (GLC/AFID); (2) a method using GLC/nitrogen phosphorus
detection; and (3) a multi-residue method in PAM, Vol 1.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for mefenoxam for the rapeseed
crop subgroup 20A.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam,
methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on
rapeseed subgroup 20A at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: April 21, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.546, add alphabetically the entry for ``Rapeseed
subgroup 20A'' to the table in paragraph (a) to read as follows:

Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) * * *

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

                                * * * * *
Rapeseed subgroup 20A......................................        0.05

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

* * * * *
[FR Doc. 2016-10389 Filed 5-3-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Page 30068]
[FR Doc No: 2015-12611]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9070-002]

Bypass Limited; Bypass Limited, LLC; Notice of Transfer of
Exemption

    1. By letter filed April 24, 2015,\1\ William B. Conway, Jr.,
Counsel for Enel Green Power North America, Inc. (EGPNA),\2\ informed
the Commission that the exemption from licensing for the Bypass
Project, FERC No. 9070, originally issued September 26, 1985,\3\ has
been transferred to Bypass Limited, LLC, an affiliate of Enel Green
Power. The project is located on the Main Canal at its intersection
with the Bypass Canal in Jerome County, Idaho. The transfer of an
exemption does not require Commission approval.
---------------------------------------------------------------------------

    \1\ Seventeen other exempted projects which are to be
transferred were included in the April 24, 2015 letter. These
exemptions will be handled under separate proceedings.
    \2\ Enel Green Power North America, Inc. is a wholly owned
subsidiary of Enel Green Power. Enel Green Power is a well-
capitalized publicly traded company.
    \3\ 32 FERC ] 62,661, Order Granting Exemption From Licensing
for a Conduit Hydroelectric Project (1985).
---------------------------------------------------------------------------

    2. Bypass Limited, LLC is now the exemptee of the Bypass Project,
FERC No. 9070. All correspondence should be forwarded to: Bypass
Limited, LLC, c/o Enel Green Power North America, Inc., Attn: General
Counsel, 1 Tech Drive, Suite 220, Andover, MA 01810.

    Dated: May 19, 2015.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-12611 Filed 5-22-15; 8:45 am]
 BILLING CODE 6717-01P


[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Notices]
[Pages 64584-64585]
[FR Doc No: 2018-27236]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4115]

Clarification of Radiation Control Regulations for Manufacturers
of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Clarification of
Radiation Control Regulations for Manufacturers of Diagnostic X-Ray
Equipment.'' This draft guidance provides clarification to industry and
FDA staff of the Federal regulations that relate to diagnostic x-ray
systems and their major components. These regulations pertain to the
recordkeeping, reporting, manufacturing, importing, and installation of
``electronic products,'' as defined in FDA regulations. This draft
guidance, when finalized, will supersede FDA's guidance entitled
``Clarification of Radiation Control Regulations for Diagnostic X-Ray
Equipment.'' This draft guidance is not final nor is it in effect at
this time.

DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-4115 for ``Clarification of Radiation Control Regulations
for Manufacturers of Diagnostic X-Ray Equipment.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Clarification of Radiation Control Regulations for Manufacturers of
Diagnostic X-Ray Equipment'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Scott Gonzalez, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4276, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides clarification to industry and FDA
staff of the Federal regulations that relate to diagnostic x-ray
systems and their major components. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) defines diagnostic x-ray systems as both a
medical device, under section 201(h) of the FD&C Act (21 U.S.C.
321(h)), and an electronic product, under section 531 of the FD&C Act
(21 U.S.C. 360hh). As such, these devices are subject to the provisions
of the FD&C Act that apply to medical devices (e.g., sections 510

and 520 of the FD&C Act (21 U.S.C. 360 and 360j)), and their
implementing regulations as well as the provisions of the FD&C Act
(sections 531 through 542 of the FD&C Act (21 U.S.C. 360hh through
360ss)) that apply to electronic products, known as the Electronic
Product Radiation Control (EPRC) and their implementing regulations.
These regulations pertain to the recordkeeping, reporting,
manufacturing, importing, and installation of ``electronic products''
as defined under 21 CFR 1000.3(j). This draft guidance, when finalized,
will supersede FDA's guidance entitled ``Clarification of Radiation
Control Regulations for Diagnostic X-Ray Equipment'' (HHS Publication
FDA 89-8221 issued in March 1989).
    This draft guidance addresses only the requirements that apply to
diagnostic x-ray equipment under the EPRC provisions of the FD&C Act
and the regulations implementing those provisions. This draft guidance
does not address requirements that may apply to such equipment as
medical devices under provisions of the FD&C Act and its implementing
regulations.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Clarification of Radiation Control Regulations for Manufacturers of
Diagnostic X-Ray Equipment.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Clarification of
Radiation Control Regulations for Manufacturers of Diagnostic X-Ray
Equipment'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 1500029 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

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

------------------------------------------------------------------------
                                                            OMB control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
1002, 1005, 1010, 1020, 1030,       Reporting and              0910-0025
 1040, and 1050.                     Recordkeeping for
                                     Electronic
                                     Products--General
                                     Requirements.
------------------------------------------------------------------------

    Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27236 Filed 12-14-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Rules and Regulations]
[Pages 49892-49893]
[FR Doc No: 2015-20299]

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

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2015-2002; Special Conditions No. 25-593-SC]

Special Conditions: Bombardier Inc. Model BD-700-2A12 and BD-700-
2A13 Airplanes; Flight Envelope Protection, High-Speed Limiting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Bombardier Inc.
Model BD-700-2A12 and BD-700-2A13 airplanes. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: This action is effective on Bombardier Inc. on August 18, 2015.
We must receive your comments by October 2, 2015.

ADDRESSES: Send comments identified by docket number FAA-2015-2002
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 8 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

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

SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for prior public comment on, these special conditions is
impracticable because these procedures would significantly delay
issuance of the design approval and thus delivery of the affected
airplanes.
    In addition, the substance of these special conditions has been
subject to the public-comment process in several prior instances with
no substantive comments received. The FAA therefore finds that good
cause exists for making these special conditions effective upon
publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On May 30, 2012, Bombardier Aerospace Inc. applied for a type
certificate for their new Model BD-700-2A12 and BD-700-2A13 airplanes.
These airplanes are derivatives of the Model BD-700 series airplanes.
These two models are marketed as the Bombardier Global 7000 and Global
8000, respectively. These are ultra-long-range, executive-interior
business jets, with a maximum certified passenger capacity of 19.
    The Global 7000 and Global 8000 airplanes will be assembled without
a completed interior in Toronto, Ontario, and flight tested at the
Bombardier Flight Test Center in Wichita, Kansas. Like the existing BD-
700 airplanes, Global 7000 and Global 8000 custom passenger interiors
and airplane delivery will be provided from Montreal, Quebec, via
supplemental type certificate.
    The Global 7000 and Global 8000 share an identical supplier base
and significant design-element commonality, the highlights of which
are:

 Two GE PassportTM 20 aft-mounted engines
 New high-speed transonic wing
 Fly-by-wire control system with side-stick controls
 Pro Line Fusion[supreg] avionics suite

    Both the Model BD-700-2A12 and -2A13 airplanes have a wingspan of
104.1 feet, a height of 26.7 feet, a maximum operating altitude of
51,000 feet, a maximum operating speed of 340 knots, and a maximum
fuselage diameter of 8.84 feet. The BD-700-2A12 is 111.9 feet long,
with a maximum take-off weight of 106,250 pounds; and the -2A13 is
102.9 feet in length at 104,800 pounds.
    The longitudinal control-law design of both airplane designs
incorporate a high-speed protection system in the normal mode; this
would prevent the pilot from inadvertently or intentionally exceeding a
speed approximately equivalent to VFC or attaining
VDF. Current Title 14, Code of Federal Regulations (14 CFR)
part 25 sections do not relate to a high-speed limiter that might
preclude or modify flying-qualities assessments in the high-speed
region.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, Bombardier Inc. must show
that the Model BD-700-2A12 and BD-700-2A13 airplanes meet the
applicable provisions of part 25 as amended by Amendments 25-1 through
25-129.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model BD-700-2A12 and BD-700-2A13
airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply
with the fuel-vent and exhaust-emission requirements of 14 CFR part 34,
and the noise-certification requirements of 14 CFR part 36; and the FAA
must issue a finding of regulatory adequacy under Sec.  611 of Public
Law 92-574, the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes will
incorporate the following novel or unusual design feature:
    An electronic flight-control system that contains fly-by-wire
control laws, including envelope protections, for high-speed protection
functions. Current part 25 requirements do not contain appropriate
standards for high-speed protection systems.

Discussion

    Model BD-700-2A12 and BD-700-2A13 airplanes are equipped with a
high-speed protection system, which, when the system detects airspeed
exceeding a small tolerance above VMO/MMO,
employs a high-speed limiter to automatically deploy multifunction
spoilers (MFS) as speed brakes. The MFS retract automatically when the
system detects that airspeed is sufficiently reduced.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes. Should
Bombardier Inc. apply at a later date for a change to the type
certificate to include another model incorporating the same novel or
unusual design feature, these special conditions would apply to that
model as well.

Conclusion

    This action affects only certain novel or unusual design features
on Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes. It is not a
rule of general applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, because a delay would
significantly affect the certification of the airplane, the FAA has
determined that prior public notice and comment are unnecessary and
impracticable, and good cause exists for adopting these special
conditions upon publication in the Federal Register. The FAA is
requesting comments to allow interested persons to submit views that
may not have been submitted in response to the prior opportunities for
comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

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

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Bombardier Model BD-700-2A12 and BD-
700-2A13 airplanes. The requirements of Sec.  25.253 (high-speed
characteristics), and its related policy, are applicable to the Model
BD-700-2A12 and BD-700-2A13 airplanes, and are not affected by these
special conditions.
    In addition to Sec.  25.143, the following requirement applies:
    Operation of the high-speed limiter during all routine and descent
procedure flight must not impede normal attainment of speeds up to
high-speed warning.

    Issued in Renton, Washington, on August 7, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-20299 Filed 8-17-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)]
[Rules and Regulations]
[Pages 75948-75951]
[FR Doc No: 2015-30798]

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

ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1501 and 1502

[EPA-HQ-OARM-2015-0244; FRL-9925-90-OARM]

Environmental Protection Agency Acquisition Regulation (EPAAR);
Ratification of Unauthorized Commitments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) amends the EPA
Acquisition Regulation (EPAAR) to address minor non-substantive changes
in one subpart and one definition. The direct final rule updates
``Ratification of Unauthorized Commitments'' and revises the definition
of Chief of the Contracting Office (CCO). EPA does not anticipate any
adverse comments.

DATES: This rule is effective on February 5, 2016 without further
notice, unless adverse comment is received January 6, 2016. If adverse
comment is received, the EPA will publish a timely withdrawal of the
rule in the Federal Register.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OARM-2015-0244 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: EPA-HQ-OARM-2015-0244, OEI Docket, Environmental
Protection Agency, 2822T, 1200 Pennsylvania Ave. NW., Washington, DC
20460. Please include a total of three (3) copies.
     Hand Delivery: EPA Docket Center--Attention OEI Docket,
EPA West, Room B102, 1301 Constitution Ave. NW., Washington, DC 20004.
Such

deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OARM-
2015-0244. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Government
Property-Contract Property Administration Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER> and the telephone number for the EPA
Docket Center is<PHONE_NUMBER>. This Docket Facility is open from 8:30
a.m. to 4:30 p.m. Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Rodney Neely, Policy, Training, and
Oversight Division, Acquisition Policy and Training Service Center
(3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

    1. Do not submit Classified Business Information (CBI) to EPA Web
site http://www.regulations.gov or email. Clearly mark the part or all
of the information that you claim to be CBI. For CBI information in a
disk or CD-ROM that you mail to EPA, mark the outside of the disk or
CD-ROM as CBI, and then identify electronically within the disk or CD-
ROM the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) Part or section number.
     Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
    3. Make sure to submit your comments by the comment period deadline
identified.

I. Background

    The EPA is revising EPAAR subpart 1501.602-3 Ratification of
Unauthorized Commitments to the approval authorities and levels to be
consistent with the Federal Acquisition Regulations (FAR). The Senior
Procurement Executive (SPE) is responsible for ratification approvals
for $25,000 and above. The CCO is the approval authority for
ratifications below $25,000. The procedures of this subpart are
clarified, along with minor editorial changes. 1502.100 Definitions is
revised to update the definition of CCO.

II. Final Rule

    This final rule makes the following changes:
    1. Revise EPAAR subpart 1501.602-3 to update approval authorities
and levels, remove procedures, and execute minor editorial changes.
    2. Revise EPAAR 1502.100 to modify the definition of Chief of the
Contracting Office.

Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under the E.O. 12866 and 13563
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act (RFA), As Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et.
seq.

    The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute; unless the agency certifies that the rule will not have
a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions. For purposes of assessing the
impact of

today's final rule on small entities, ``small entity'' is defined as:
(1) A small business that meets the definition of a small business
found in the Small Business Act and codified at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a government of a city, county,
town, school district or special district with a population of less
than 50,000; or (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field. After considering the economic impacts of this
rule on small entities, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, because the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities'' 5 U.S.C. 503
and 604. Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule. This
action revises current EPAAR clauses and will not have a significant
economic impact on substantial number of small entities. We continue to
be interested in the potential impacts of the proposed rule on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, and tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of Sections 202 or 205 of the UMRA. This
action is also not subject to the requirements of section 203 of UMRA
because it contains no regulatory requirements that might significantly
or uniquely affect small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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, as
specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this action. In the spirit of Executive Order 13132, and
consistent with EPA policy to promote communications between EPA and
State and local governments, EPA specifically solicits comment on this
proposed action from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Thus, Executive
Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045, entitled ``Protection of Children from
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997),
applies to any rule that: (1) Is determined to be economically
significant as defined under E.O. 12886, and (2) concerns an
environmental health or safety risk that may have a proportionate
effect on children. This rule is not subject to E.O. 13045 because it
is not an economically significant rule as defined by E.O. 12866, and
because it does not have a proportionate effect on children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28335
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This action
does not involve technical standards. Therefore, EPA is not considering
the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. EPA has determined that this final
rule will not have disproportionately high and adverse human health or
environmental effects on minority or low-income populations because it
does not affect the level of protection provided to human health or the
environment in the general public.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 804 exempts from section 801 the following types
of rules (1) rules of particular applicability; (2) rules relating to
agency management or personnel; and (3) rules of Agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required
to submit a rule report regarding today's action under section 801
because this is a rule of agency organization, procedure, or practice
that does not substantially affect the rights or obligations of non-
agency parties.

List of Subjects in 48 CFR Parts 1501 and 1502

    Environmental protection, Government procurement.

    Dated: November 12, 2015.
John R. Bashista,
Director, Office of Acquisition Management.
    For the reasons stated in the preamble, Chapter 15 of Title 48 Code

of Federal Regulations, parts 1501 and 1502 are amended as set forth
below:

0
1. The authority citation for parts 1501 and 1502 continues to read as
follows:

    Authority: 5 U.S.C. 301; Sec. 205(c), 63 Stat. 390, as amended,
40 U.S.C. 486(c); and 41 U.S.C. 418b.

PART 1501--GENERAL

0
2. Amend 1501.602-3 by revising paragraph (b) to read as follows:

1501.602-3  Ratification of unauthorized commitments.

* * * * *
    (b)(1) Ratification Approval. The Senior Procurement Executive
(SPE) as defined in 1502.100 is the ratifying official for all
ratification actions $25,000 and above.
    (2) The Chief of the Contracting Office (CCO) as defined in
1502.100 is delegated authority to be the ratifying official for all
ratification actions below $25,000.
    (3) The CCOs defined in 1502.100 for purposes of ratification
authority only must meet the following criteria:
    (i) Must possess a contracting officer's warrant and be in the 1102
job series;
    (ii) Are prohibited from re-delegating their ratification
authority;
    (iii) Are prohibited from approving a ratification if he/she acted
as a contracting officer in preparing the determination and findings
required under paragraph (c)(3) of this section; and
    (iv) Must abide by the other limitations on ratification of
unauthorized commitments set forth in FAR 1.602-3(c) and the EPAAR.
* * * * *

PART 1502--DEFINITION OF WORDS AND TERMS

0
3. Amend 1502.100 by revising the definition of ``Chief of the
Contracting Office (CCO)'' to read as follows:

1502.100  Definitions.

    Chief of the Contracting Office (CCO) means the Office of
Acquisition Management Division Directors at Headquarters, Research
Triangle Park and Cincinnati. For purposes of ratification authority
only, CCO also includes Regional Acquisition Managers. (See 1501.602-
3(b)(3) for the criteria for this ratification authority).
* * * * *
[FR Doc. 2015-30798 Filed 12-4-15; 8:45 am]
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[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24736-24737]
[FR Doc No: 2014-09911]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0154]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for EDURANT 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 drug 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 drug product EDURANT
(rilpivirine hydrochloride). EDURANT is indicated in combination with
other antiretroviral agents for the treatment of human immunodeficiency
virus (HIV-1) infection in treatment-na[iuml]ve adult patients.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for EDURANT (U.S. Patent No.
7,125,879) from Janssen Pharmaceutica N.V., and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 10, 2012, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of EDURANT represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
EDURANT is 2,396 days. Of this time, 2,094 days occurred during the
testing phase of the regulatory review period, while 302 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: October 29, 2004. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on October 29, 2004.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: July 23,
2010. FDA has verified the applicant's claim that the new drug
application (NDA) for EDURANT (NDA 202022) was submitted on July 23,
2010.

    3. The date the application was approved: May 20, 2011. FDA has
verified the applicant's claim that NDA 202022 was approved on May 20,
2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 768 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 30, 2014. 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 October 28, 2014. To meet its burden, the petition must
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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09911 Filed 4-30-14; 8:45 am]
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