[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7466-7472]
[FR Doc No: 2016-02816]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0672; FRL-9939-59]

Diflubenzuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective February 12, 2016. Objections and
requests for hearings must be received on or before April 12, 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-2014-0672, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0672 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
April 12, 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-2014-0672, 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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
4E8306) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.377 be
amended by: (1) Establishing tolerances in for the combined residues of
the insecticide diflubenzuron N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide) and its metabolites 4-chlorophenlyurea and 4-
chloroaniline, in or on the raw agricultural commodities carrot, roots
at 0.2 ppm; peach subgroup 12-12B at 0.5 ppm; plum subgroup 12-12C at
0.5 ppm; plum, prune, dried at 0.5 ppm; nut, tree group 14-12 at 0.2
ppm; pepper/eggplant subgroup 8-10 B at 1.0 ppm, and cottonseed
subgroup 20C at 0.2 ppm; (2) upon the approval of these tolerances,
removing established tolerances in or on fruit, stone, group 12, except
cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm; pistachio at 0.06
ppm; pepper at 1.0 ppm; and cotton, undelinted seed at 0.2 ppm; (3)
establishing regional tolerances for the combined residues of
diflubenzuron and its metabolites 4-chlorophenlyurea and 4-
chloroaniline in or on the raw agricultural commodities alfalfa, forage
at 6 ppm; alfalfa, hay at 20 ppm; and alfalfa, seed at 0.9 ppm; and (4)
modifying the existing tolerances in or on the following raw
agricultural commodities: Egg from 0.05 to 0.15 ppm; poultry, fat from
0.05 to 0.15 ppm; and poultry, meat byproducts from 0.05 to 0.06 ppm.
That document referenced a summary of the petition prepared by Chemtura
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. A second notice of filing for the same petition
(PP 4E8306) and same uses was inadvertently published in the Federal
Register on December 2, 2015 (80 FR 75449) (FRL-9939-55). This notice
of filing contained the same information as the previously published
notice of filing. Comments were received in response to both notices of
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established. The reason for these changes are explained in Unit IV.D.

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 diflubenzuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with diflubenzuron
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.
    For diflubenzuron, the hemopoietic system is the target site with
effects including increased sulfhemoglobin and/or methemoglobin levels
in rat and dog studies. In subchronic and chronic feeding studies, the
primary endpoint of concern was methemoglobinemia and/or
sulfhemoglobinemia. These effects were evident in both sexes of mice,
rats, and dogs and were produced by more than one route of
administration in rats (i.e., oral, dermal and inhalation). The general
consequence of methemoglobinemia and/or sulfhemoglobinemia is the
impairment of the oxygen transportation capacity of the blood, which is
generally known to be caused by aromatic amines in both humans and
animals. Degradates of diflubenzuron with aromatic amines, CPU (4-
chlorophenylurea) and PCA (4-chloroaniline), are also included in the
diflubenzuron non-cancer risk assessment. Monuron, an analog of CPU,
does not affect methemoglobin formation but does produce tumors in the
liver and kidneys of male rats. The non-cancer toxicities of CPU and
PCA are understood. PCA is similar in potency to diflubenzuron on
methemoglobin formation, while CPU is less toxic than PCA. Therefore,
the non-cancer assessment will include diflubenzuron, CPU and PCA, and
additional toxicity studies are not required on CPU and PCA.
    The toxicity data provide no indication of an increased
susceptibility to rats or to rabbits from in utero or postnatal
exposure to diflubenzuron. Developmental and reproduction studies in
rats and rabbits indicate a very low hazard potential for adverse
effects. Developmental studies were tested at the limit dose of 1,000
milligrams/kilogram/day (mg/kg/day) without apparent effects in both
dams and the fetuses. The reproduction study indicated that effects in
offspring occurred at doses that were higher than the doses producing
effects in parents. The requirements for acute and subchronic
neurotoxicity studies were waived because there are no clear signs of
neurotoxicity following subchronic or chronic dosing in multiple
species in the diflubenzuron database. The toxicity profile of
diflubenzuron shows that the principal toxic effects are the formation
of methemoglobinemia and/or sulfhemoglobinemia in the blood. An
immunotoxicity study has been reviewed and immunotoxicity was not
observed above the limit dose.
    The Agency concluded that diflubenzuron is not carcinogenic in
humans based on lack of evidence of carcinogenicity in rats and mice.
PCA, a plant metabolite of diflubenzuron, tested positive for splenic
tumors in male rats and hepatocellular adenomas/carcinomas in male mice
in a National Toxicology Program (NTP) study.
    Therefore, EPA has classified PCA as a probable human carcinogen.
CPU is the major degradate found in water and is a significant
metabolite in milk. CPU is structurally related to monuron
(N,Ndimethyl-CPU), a compound producing tumors of the kidney and liver
in male rats. EPA has assumed CPU is a probable human carcinogen as
well. However, based on methemoglobinemia observed only at high doses
of monuron, a compound similar to CPU and PCA, the non-carcinogenic
risk assessment will include diflubenzuron, CPU, and PCA.
    Specific information on the studies received and the nature of the
adverse effects caused by diflubenzuron as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Diflubenzuron: Human
Health Risk Assessment for an Amended Section 3 Registration for
Carrot, Peach Subgroup 12-12B, Plum Subgroup 12-12C, Pepper/Eggplant
Subgroup 8-10B, Cottonseed Subgroup 20C, Alfalfa (Regional
Restrictions) and R175 Crop Group Conversion for Tree Nut Group 14-12''
on page 45 in docket ID number EPA-HQ-OPP-2014-0672.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for diflubenzuron used for
human risk assessment is discussed in Table 1 in Unit III.B. of the
final rule published in the Federal Register of January 31, 2014 (79 FR
5294) (FRL-9904-27).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to diflubenzuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing diflubenzuron
tolerances in 40 CFR 180.377. EPA assessed dietary exposures from
diflubenzuron 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 diflubenzuron; 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 United States
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, ``What We Eat in America'' (NHANES/WWEIA) from 2003
through 2008. As to residue levels in food, EPA used the assumption
that diflubenzuron residues are present in most commodities at
tolerance levels (including tolerances previously established as well
as those established in this action) and that 100% of all crops are
treated. Average field trial residues were assumed for grapefruit,
lemon, and orange. Tolerances include residues of diflubenzuron, PCA,
and CPU.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that diflubenzuron does not pose a cancer risk to humans.
However, the metabolites CPU and PCA are considered probable
carcinogens and have Q*s assigned to them. Individual cancer dietary
exposure analyses were conducted for each metabolite. For PCA, average
percent crop treated (PCT) was used for some commodities. One-half the
Limit of Quantitation (LOQ) was used for estimating PCA residues on the
majority of crops because most crops did not contain detectable
residues of PCA. Average field trial residue was used for mushrooms.
The CPU cancer dietary analysis focused on CPU residues in milk because
metabolism studies indicate that diflubenzuron metabolizes to CPU in
milk. EPA assumed that 100% of milk commodities contained CPU at \1/2\
the LOQ. One-half the LOQ was used since detectable residues of CPU
were not found in the feeding study.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    For the cancer dietary exposure analysis, the Agency estimated the
PCT for existing uses as follows:
    Soybeans (1%), peppers (2.5%), oranges (10%), tangerines (10%),
grapefruit (25%), pear (5%), apricot (10%), peach (5%), almond, (10%),
pecan (2.5%), rice (2.5%), wheat (1%), cotton (1%), artichoke (45%),
peanut (10%), lemon (1%), plum (5%), and walnut (2.5%).
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 to 7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which diflubenzuron may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for diflubenzuron and CPU in drinking water. PCA is only a
minor metabolite in the environment and residues are not expected to be
present in drinking water. These simulation models take into account
data on the physical, chemical, and fate/transport characteristics of
diflubenzuron. 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.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    Based on the Surface Water Concentration Calculator model (SWCC)
for surface water the Estimated Drinking Water Concentration (EDWC) of
1.3 microgram/Liter ([mu]g/L) (including diflubenzuron and CPU) was
used to assess chronic non-cancer dietary risk. Based on the Pesticide
Root Zone Model-Groundwater (PRZM-GW) model for ground water the cancer
risk for CPU was assessed using the EDWC of 8.02 [mu]g/L.
    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).
    Diflubenzuron 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 diflubenzuron to share a common mechanism of
toxicity with any other substances, and diflubenzuron does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
diflubenzuron does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. Based on the available
developmental toxicity studies in rats and rabbits and the reproduction
study, there is no increased susceptibility to fetuses exposed in
utero. There was no indication of abnormalities in fetal development in
the developmental toxicity studies in either rats or rabbits at the
maternal limit doses of 1,000 mg/kg/day. In addition, there was no
evidence of sensitivity following pre- and/or post-natal exposure in a
two-generation reproduction study in rats.
    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 toxicological database for diflubenzuron is adequate for
risk assessment. The non-cancer toxicity of CPU and PCA is well
understood. CPU is less toxic and does not affect methemoglobin. PCA
does cause methemoglobin formation but is similar in potency to
diflubenzuron. Therefore, assuming equal toxicity of CPU and PCA to
diflubenzuron is health protective, additional toxicity studies are not
required on the metabolites.
    ii. There are no clear signs of neurotoxicity following subchronic
or chronic dosing in multiple species in the diflubenzuron database;
therefore, there is no need for any neurotoxicity studies.
    iii. There is no evidence that diflubenzuron 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. The dietary exposure assessment uses conservative assumptions
which will not underestimate dietary exposure and EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to diflubenzuron in drinking water. These
assessments will not underestimate the exposure and risks posed by
diflubenzuron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
diflubenzuron 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
diflubenzuron from food and water will utilize 39% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for diflubenzuron.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified;
however, diflubenzuron is not registered for any use patterns that
would result in short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short-term risk), no further assessment of short- or
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for diflubenzuron.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, diflubenzuron is not expected to pose a cancer risk to humans.
However, the metabolites CPU and PCA are considered probable
carcinogens and have Q*s assigned to them. Individual cancer dietary
exposure analyses were conducted for each metabolite. The cancer
assessment for PCA includes food only (it is not expected to be present
in drinking water). The cancer assessment for CPU includes milk and
water only. For PCA, the cancer dietary exposure estimate for the U.S.
population is 1.3 x 10-6. For CPU, the cancer dietary
exposure estimate for the U.S. population is 2.8 x 10-6.
    EPA generally considers cancer risks in the range of
10-6 or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the log scale; for example,
risks falling between 3 x 10-7 and 3 x 10-6 are
expressed as risks in the range of 10-6.
    Considering the precision with which cancer hazard can be
estimated, the conservativeness of low-dose linear extrapolation, and
the rounding procedure described above, cancer risk should generally
not be assumed to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. Although the PCA and CPU
exposure risk assessment are refined, they retain significant
conservatism in that residues in food

were estimated at \1/2\ LOQ even though no residues were detected in
field trials and feeding studies, and for some commodities EPA assumed
100 PCT. Accordingly, EPA has concluded the cancer risk for all
existing diflubenzuron uses, and the uses associated with the
tolerances established in this action fall within the range of 1 x
10-6 and are thus negligible.
    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 diflubenzuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement analytical methods are available for the
enforcement of tolerances for residues of diflubenzuron and its
metabolites in crop and livestock commodities. Three enforcement
methods for diflubenzuron are published in PAM, Vol. II as Methods I,
II, and III. Method I is a GC/ECD method that determines diflubenzuron
in plants as derivatized 4-chloroaniline (PCA). Method II is a GC/ECD
method that can separately determine residues of diflubenzuron, 4-
chlorophenylurea (CPU) and PCA in eggs, milk, and livestock tissues,
each as derivatized PCA. Method III is an HPLC/UV method that
determines diflubenzuron per se in eggs, milk, and livestock tissues.
All three methods have undergone successful Agency validations.

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 established MRLs for diflubenzuron in or on peach and
nectarine at 0.5 ppm which is the same as the tolerance in the United
States for the peach subgroup 12-12B at 0.50 ppm; a tolerance on plums
at 0.5 ppm which is the same as the U.S. tolerance for the plum
subgroup 12-12C at 0.5 ppm; and a tolerance on tree nuts at 0.2 ppm
which is the same as the U.S. tolerance for the tree nut group 14-12 at
0.20 ppm, and which was raised to harmonize with Codex.
    The Codex has established MRLs for diflubenzuron on chili peppers
at 3 ppm, dried chili peppers at 20 ppm, and sweet peppers at 0.7 ppm
which are different from the tolerances established in the U.S. for
diflubenzuron on the pepper/eggplant subgroup 8-10B at 1.0 ppm. The
pepper/eggplant subgroup 8-10B covers both bell and non-bell peppers
and the Codex MRLs split them out into two separate tolerances which
the U.S. does not do because the petition was for the entire subgroup.
Based on the residue data submitted and reviewed for this action, it
would not be appropriate for the U.S. tolerance to harmonize with
either the chili pepper MRL of 3 ppm or the sweet pepper MRL of 0.7
ppm. Also, in regards to the dried chili pepper MRL, this is not
expected to be an issue since the U.S. does not set tolerances on dried
fruits and vegetables, but instead the processed food is considered to
be the whole processed commodity after compensating for or
reconstituting the commodity's normal moisture content.

C. Response to Comments

    One comment was received in response to the February 11, 2015
Notice of Filing, however, it related to a different chemical than
diflubenzuron and therefore is not relevant to this action. Two
comments were received in response to the December 2, 2015 Notice of
Filing. One commenter opposed residues of this pesticide on food and
argued that EPA should deny the petition. The Agency understands the
commenter's concerns and recognizes that some individuals believe that
pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework. The second
comment stated that ``without long term studies of its effects on the
environment and the toxic effects on aquatic invertebrates, then there
should be a slight reduction in ppm of diflubenzuron used on crops.''
This comment is not relevant to the Agency's evaluation of safety of
the diflubenzuron tolerances; section 408 of the FFDCA focuses on
potential harms to human health and does not permit consideration of
effects on the environment.

D. Revisions to Petitioned-For Tolerances

    Based on an evaluation of the residue data, the Agency modified the
levels at which tolerances were proposed for the existing tolerances
for egg, poultry fat, and poultry meat byproducts. In addition, the
Agency determined that a separate tolerance is not required for the
commodity ``plum, prune, dried'' since residues are not found to
concentrate on prunes. Lastly, some of the tolerances levels were
modified to reflect the correct significant figures.

V. Conclusion

    Therefore, tolerances are established, modified and removed for
residues of diflubenzuron N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide) and its metabolites 4-chlorophenlyurea and 4-
chloroaniline, as follows:
    Under 180.377(a)(1) a tolerance is established for the cottonseed
subgroup 20C at 0.20 ppm; existing tolerances are changed for egg to
0.07 ppm; poultry, fat to 0.10 ppm; and poultry, meat byproducts to
0.08 ppm; and the existing tolerance for cotton, undelinted seed at 0.2
ppm is removed as unnecessary.
    Under 180.377(a)(2), tolerances are established in or on the raw
agricultural commodities carrot, roots at 0.20 ppm; peach subgroup 12-
12B at 0.50 ppm; plum subgroup 12-12C at 0.50 ppm; nut, tree group 14-
12 at 0.20 ppm; the pepper/eggplant subgroup 8-10 B at 1.0 ppm; and the
following existing tolerances are removed as unnecessary: Fruit, stone,
group 12, except cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm;
pistachio at 0.06 ppm; and pepper at 1.0 ppm.
    Under 180.377(c) regional tolerances are established for the
combined residues of diflubenzuron and its metabolites 4-
chlorophenlyurea and 4-chloroaniline in or on the raw agricultural
commodities alfalfa, forage at 6 ppm; alfalfa, hay at 20 ppm; and
alfalfa, seed at 0.9 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: February 3, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.377:

0
a. Remove the entries in the table in paragraph (a)(1) for ``Cotton,
undelinted seed,'' ``Egg,'' ``Poultry, fat,'' and ``Poultry, meat
byproducts.''
0
b. Add alphabetically the entries for ``Cottonseed subgroup 20C,''
``Egg,'' ``Poultry, fat,'' and ``Poultry, meat byproducts'' to the
table in paragraph (a)(1).
0
c. Remove the entries in the table in paragraph (a)(2) for ``Fruit,
stone, group 12, except cherry,'' ``Nut, tree, group 14,'' ``Pepper,''
and ``Pistachio.''
0
d. Add alphabetically the entries for ``Carrot, roots,'' ``Peach
subgroup 12-12B,'' ``Pepper/Eggplant subgroup 8-10B,'' ``Plum subgroup
12-12C,'' and ``Nut, tree, group 14-12'' to the table in paragraph
(a)(2).
0
e. Revise paragraph (c).
    The additions and revision read as follows:

Sec.  180.377  Diflubenzuron; tolerances for residues.

    (a) General (1) * * *

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

                                * * * * *
Cottonseed subgroup 20C....................................         0.20
Egg........................................................         0.07

                                * * * * *
Poultry, fat...............................................         0.10
Poultry, meat byproducts...................................         0.08

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

    (2) * * *

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

                                * * * * *
Carrot, roots..............................................         0.20

                                * * * * *
Peach subgroup 12-12B......................................         0.50

                                * * * * *
Pepper/Eggplant subgroup 8-10B.............................          1.0

                                * * * * *
Plum Subgroup 12-12C.......................................         0.50
Nut, tree, group 14-12.....................................         0.20

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

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registration are established for residues of the insecticide
diflubenzuron (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide), in or on the commodities in the table below.
Compliance with the tolerance levels specified below is to be
determined by measuring only the sum of diflubenzuron (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide), 4-
chlorophenylyurea and 4-chloroaniline, calculated as the stoichiometric
equivalent of diflubenzuron, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................          6.0
Alfalfa, hay...............................................           20
Alfalfa, seed..............................................         0.90
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-02816 Filed 2-11-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 15, 2010 (Volume 75, Number 199)]
[Notices]
[Page 63452]
[DOCID:fr15oc10-51]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR11-67-001]

ONEOK Gas Storage, L.L.C.; Notice of Baseline Filing

October 7, 2010.
    Take notice that on October 1, 2010, ONEOK Gas Storage, L.L.C.
submitted a revised baseline filing of its Statement of Operating
Conditions for services provided under Section 311 of the Natural Gas
Policy Act of 1978 (``NGPA'').
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Wednesday, October 20, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25964 Filed 10-14-10; 8:45 am]
BILLING CODE 6717-01-P


Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Pseudomonas chlororaphis strain AFS009

                    Docket ID Number: EPA-HQ-OPP-2016-0284
                              Date: June 1, 2017

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (EPA) to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is "safe." Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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 . . . ." Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, for microbial pesticides, EPA determines the pathogenicity and toxicity potential of the pesticide in tiered testing. Second, EPA examines exposure to the pesticide through food, drinking water, and other exposures that occur as a result of pesticide use in residential settings, as well as other non-occupational exposure to the substance.
I. Summary of Petitioned-for Tolerance Exemption
In the Federal Register of June 22, 2016 (81 FR 40594), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5F8410) by AFS009 Plant Protection, Inc., 104 T.W. Alexander Dr., Building 18, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudomonas chlororaphis subsp. aurantiaca strain AFS009 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner AFS009 Plant Protection, Inc., which is available in Docket ID Number EPA-HQ-OPP-2016-0284 via http://www.regulations.gov. One general comment opposing the establishment of the exemption was received.
Since the time the original notice of filing was published, the petitioner provided additional data on the identity of the active ingredient to EPA. After reviewing these data, EPA now considers the correct identity of the active ingredient to be Pseudomonas chlororaphis strain AFS009 and not Pseudomonas chlororaphis subsp. aurantiaca strain AFS009. In order to give the public an opportunity to comment on this new information, EPA republished its receipt of this tolerance exemption petition filing with an updated and accurate description in the Federal Register of December 20, 2016 (81 FR 92758) and placed a revised petition from AFS009 Plant Protection, Inc. into the docket. No comments were received on this latter notice.

II. Toxicological Profile
Consistent with FFDCA section 408(b)(2)(D), EPA reviewed the available scientific data and other relevant information on Pseudomonas chlororaphis strain AFS009 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The overall conclusions from all toxicological information submitted by the petitioner are briefly described below. More in-depth synopses of study results can be found in the risk assessment (Ref. 1) and other supporting science document (Ref. 2).

A. Overview of Pseudomonas chlororaphis strain AFS009

Pseudomonas chlororaphis strain AFS009 is a Gram-negative, fluorescent, Pseudomonad bacterium originally isolated from cotton plant roots in Texas. Fluorescent Pseudomonads were discovered when wheat fields resistant to root rots, including from Pythium and "Take-all root rot" (Gaeumannomyces graminis), were found to harbor these microbes on their roots while susceptible fields lacked them. Ongoing research identified certain antifungal compounds known as phenazines, namely phenazine-1-carboxylic acid (CAS No. 2538-68-3), that strongly correlated with disease control (Ref. 3). Pseudomonas chlororaphis strain AFS009, like other fluorescent Pseudomonads, colonizes the roots of plants and competes for niches plant-pathogenic fungi may also occupy, in the process producing various inhibitory metabolites that also affect these fungi.

Environmental fluorescent Pseudomonas species, including Pseudomonas chlororaphis, occur naturally in the environment and on food, and no foodborne disease outbreaks or toxin production from Pseudomonas chlororaphis in food or feed have been reported. In fact, other strains of Pseudomonas chlororaphis have been investigated as inhibitors of foodborne pathogens.

B. Microbial Pesticide Toxicology Data Requirements

Acute toxicity (acute oral, inhalation, and dermal toxicity) and irritation tests (acute eye and
primary dermal irritation) performed with Pseudomonas chlororaphis strain AFS009 addressed potential routes of exposure to the active ingredient and reveal no toxicity or irritation attributed to Pseudomonas chlororaphis strain AFS009 (Toxicity Category IV) (Refs. 1 and 4). In the acute oral toxicity/pathogenicity study performed with Pseudomonas chlororaphis strain AFS009, there was no evidence of toxicity, pathogenicity, or infectivity when rats were administered 3.73 x 10[9] colony-forming units (CFU) per rat by oral gavage. Scientific rationale for the acute pulmonary toxicity/pathogenicity and the acute injection toxicity/pathogenicity data requirements was determined to be adequate to support waiving these two studies, based on the above findings and because the microbe grows best below 86°F (30°C) and in the presence of oxygen and is unlikely to grow or metabolize at higher temperatures or with oxygen limitations.

In light of the adequacy of the toxicological data, scientific rationale, and literature (Refs. 3, 5, and 6) provided by the petitioner, EPA did not require toxicological testing at higher tiers. Based on animal testing of Pseudomonas chlororaphis strain AFS009, no toxicity, irritation, infectivity, pathogenicity or other adverse effects attributed to Pseudomonas chlororaphis strain AFS009 are expected.

1. Acute Oral Toxicity/Pathogenicity  -  Rat (Harmonized Guideline 885.3050; Master Record Identification Number (MRID No.) 495680-02). An acceptable acute oral toxicity and pathogenicity study demonstrated that Pseudomonas chlororaphis strain AFS009 is not toxic, infective, or pathogenic by oral gavage of 3.73 x 109 CFU/rat. The test substance cleared from most tissues by day 14. While there was low detection in mesenteric lymph nodes of some animals on days 14 and 21, the 21-day study showed a distinct pattern of clearance from the gastrointestinal tract with no signs of infectivity, pathogenicity, or toxicity. (Ref. 1).

2. Acute Oral Toxicity  -  Rat (Harmonized Guideline 870.1100; MRID No. 495680-03). An acceptable acute oral toxicity study demonstrated Pseudomonas chlororaphis strain AFS009 is not toxic to female rats when dosed at 5,000 mg/Kg body weight. The oral no observed adverse effect level (NOAEL) for female rats was greater than 5,000 mg/Kg body weight (Toxicity Category IV). (Ref. 1).

3. Acute Inhalation Toxicity  -  Rat (Harmonized Guideline 870.1300; MRID No. 495680-05). In an acute inhalation toxicity study, groups of young adult Sprague-Dawley rats (5/sex/group) were exposed nose-only to Howler Technical containing 100% Pseudomonas chlororaphis strain AFS009 aerosolized for 4 hours at a concentration of 5.04 mg/L. The animals were observed for 14 days. All animals survived the study. Labored breathing was seen in all animals at one hour after the exposure period with recovery by day 1 in most animals. Labored breathing persisted in only one male after one hour and lasted until day 6. One animal exhibited hypoactivity for one hour post removal. On days 7-14, all animals were reported as active and healthy. All animals lost weight from the exposure but gained it back or surpassed their starting weight by days 3-7. At day 14, all animals showed normal weight gain. No observed abnormalities were noted at necropsy. The inhalation median lethal concentration (LC50), which is a statistically derived concentration that can be expected to cause death in 50% of test animals, for both male and female rats was greater than 5.04 mg/L (Toxicity Category IV). (Refs. 1 and 2).

It is generally observed that labored breathing, hunched posture, and hypoactivity are signs of receiving a dose by the inhalation route, especially if the dosing rate is at or near the limit dose (2-5 mg/L). There is also consideration of whether the clinical signs are reversible as this indicates recovery from any dosing effect. It is noted that mortality and morbidity are the sole endpoints for the proper assignment of toxicity category for this test. The most credible explanation for the labored breathing and hypoactivity seen in this acute inhalation toxicity test was a response to high concentrations of dosing material. These clinical signs are not considered indicative of a systemic toxicity due to the bacterial agent but due to a high concentration of test material in the test chamber (Ref. 2.)

4. Acute Pulmonary Toxicity/Pathogenicity and Acute Injection Toxicity/Pathogenicity (Harmonized Guidelines 885.3150 and 885.3200; MRID No. 495680-16). No acute pulmonary toxicity/pathogenicity or acute injection toxicity/pathogenicity studies were submitted; instead, a scientific rationale was submitted requesting waiver of these data requirements. The Agency determined that these data were not necessary and waived the requirements for these data based on the following: (1) the lack of evidence of adverse effects in the acute oral toxicity/pathogenicity study and the acute oral toxicity study; (2) the transience of the impacts in the acute inhalation toxicity study; and (3) the knowledge that the microbe grows best below 86°F (30°C) and in the presence of oxygen. Based on this information, EPA was able to assess the potential of Pseudomonas chlororaphis strain AFS009 to cause infection or pathogenicity by the pulmonary or injection routes of exposure. The temperature (below 30[o]C) and oxygen growth limitations of this microbe are not expected to lead to infection during an intravenous exposure study. There was adequate evidence from an acute oral toxicity/pathogenicity study that the microbe was not infectious. Natural exposures through food to Gram-negative microbes in general are already widespread and harmless if the microbes are not pathogens. Pseudomonas chlororaphis strain AFS009 is not identified as a mammalian pathogen in the scientific literature, and this status is supported by the acute oral toxicity/pathogenicity test results and a literature review. The results of the acceptable oral toxicity/pathogenicity study with a demonstrated pattern of clearance address the injection route of exposure and support waiving the acute injection toxicity/pathogenicity study. The results of the acute inhalation toxicity study with a 4-hour exposure and no mortalities address the inhalation endpoint and support waiving the acute pulmonary toxicity/pathogenicity study. (Ref. 1).

5. Acute Dermal Toxicity  -  Rat (Harmonized Guideline 870.1200; MRID No. 495680-04). An acceptable acute dermal toxicity study demonstrated that Pseudomonas chlororaphis strain AFS009 was not toxic to male and female rats when dosed at 5,000 mg/Kg of body weight for 24 hours. The dermal NOAEL for male and female rats was greater than 5,000 mg/Kg body weight (Toxicity Category IV). (Ref. 1).

6. Acute Eye Irritation  -  Rabbit (Harmonized Guideline 870.2400; MRID No. 495680-06). An acceptable acute eye irritation study demonstrated that Pseudomonas chlororaphis strain AFS009 was not irritating to the eye (Toxicity Category IV). (Ref. 1).

7. Primary Dermal Irritation  -  Rabbit (Harmonized Guideline 870.2500; MRID No. 495680-07). An acceptable primary dermal irritation study demonstrated that Pseudomonas chlororaphis strain AFS009 was not dermally irritating (Toxicity Category IV). (Ref. 1).

Based on the lack of toxicity, infectivity, or pathogenicity in any of the available studies, EPA has not identified any toxicological points of departure. Consequently, EPA's aggregate risk assessment of the Pseudomonas chlororaphis strain AFS009 is qualitative, rather than quantitative, in nature.

III. Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Food Exposure: Pseudomonas chlororaphis is naturally found in agricultural settings (i.e., in water, in soils and on plants), and use of Pseudomonas chlororaphis strain AFS009 as a pesticide on food is expected to result in residues in or on food. When consumers wash their produce, it is anticipated that levels of Pseudomonas chlororaphis strain AFS009 and its associated metabolites may be reduced.
Drinking Water Exposure: Since Pseudomonas chlororaphis is naturally present in soils and on plants, exposure to Pseudomonas chlororaphis from surface water and possibly ground water can be expected. Moreover, use of Pseudomonas chlororaphis strain AFS009 as a pesticide on food is expected to result in residues in or on drinking water. Water treatment processes should remove any Pseudomonas chlororaphis strain AFS009 present. Should this microbial pesticide be present, no adverse effects are expected from exposure to Pseudomonas chlororaphis strain AFS009 through drinking water, based on the results of the toxicological studies.
Other Non-Occupational Exposure: Since the Pseudomonas chlororaphis strain AFS009 end-use products allow for applications in residential settings, including to bedding plants, annuals and perennials, home gardens, and ornamental trees and shrubs, exposure to the bacterium from its pesticide use would be likely. Pseudomonads, however, are already present in soil and on plant roots, and exposures to Pseudomonas chlororaphis strain AFS009 from pesticidal applications do not present a risk concern, particularly in light of available data that demonstrate it is not toxic or irritating and is not likely to be infective or pathogenic:

 Dermal exposure. Pseudomonas chlororaphis strain AFS009 was shown to be non-toxic and is not irritating to the skin (acute dermal toxicity and primary dermal irritation data).
 Inhalation exposure. Pseudomonas chlororaphis strain AFS009 was shown to be non-toxic and is not likely to be pathogenic or infective. Initial high doses to the lungs caused transitory effects that cleared within all animals except one by 24 hours. These transitory clinical signs are not considered indicative of a systemic toxicity due to the bacterial agent but due to a high concentration of test material in the test chamber (Ref. 2). Inhalation of large quantities of Pseudomonas chlororaphis strain AFS009 is not expected for homeowner applications because a concentrated product is not used for purposes other than manufacture and repeated exposure of high doses of concentrated product in home and garden sites is not anticipated.

IV. 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, EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

Pseudomonas chlororaphis strain AFS009 is not toxic and does not have a common mechanism of toxicity with other substances. Consequently, FFDCA section 408(b)(2)(D)(v) does not apply.

V. Determination of Safety for the U.S. Population, Infants and Children

A. U.S. Population

For all of the reasons discussed previously, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Pseudomonas chlororaphis strain AFS009. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

B. Infants and Children

FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. 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.

No endpoints were identified based on the available data for Pseudomonas chlororaphis strain AFS009, and differential effects to infants and children are not expected. Pseudomonads, such as Pseudomonas chlororaphis strain AFS009, are already very commonly present on a wide range of foods, including those consumed raw or with minimal processing. Because there are no threshold levels of concern to infants and children from Pseudomonas chlororaphis strain AFS009, EPA concludes that no additional margin of safety is necessary to protect infants and children.

VI. Conclusion
EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Pseudomonas chlororaphis strain AFS009. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices.

VII. References

1. U.S. EPA. 2016. Howler products containing Pseudomonas chlororaphis strain AFS009. Memorandum from J.V. Gagliardi, Ph.D. through J.L. Kough, Ph.D. to S. Cerrelli dated November 15, 2016 (available as a "Supporting Document" within Docket ID Number EPA-HQ-OPP-2016-0251 at http://www.regulations.gov).

2. U.S. EPA. 2017. Comments on Acute Inhalation Toxicity Study (870.1300) for Microbial Pesticide Technical Pseudomonas chlororaphis AFS 009. Memorandum from J.L. Kough, Ph.D. and M. Perry to M. Mendelsohn dated May 9, 2017 (available as a "Supporting Document" within Docket ID Number EPA-HQ-OPP-2016-0251 at http://www.regulations.gov).

3. Khan, A., J.C. Sutton and B. Grodzinski. 2003. Effects of Pseudomonas chlororaphis on Pythium aphanidermatum and Root Rot in Peppers Grown in Small-scale Hydroponic Troughs. Biocontrol Science and Technology 13(6):615-630.

4. U.S. EPA. 2014. Chapter 7 of the Label Review Manual (Precautionary Statements) (Revised July 2014). Available from https://www.epa.gov/sites/production/files/2015-03/documents/chap-07-jul-2014.pdf.

5. Shen, X., M. Chen, H. Hu, W. Wang, H. Peng, P. Xu and X. Zhang. 2012. Genome Sequence of Pseudomonas chlororaphis GP72, a Root-Colonizing Biocontrol Strain. Journal of Bacteriology 194(5):1269-1270.

6. Tombolini, R., D.J. van der Gaag, B. Gerhardson and J.K. Jansson. 1999. Colonization Pattern of the Biocontrol Strain Pseudomonas chlororaphis MA 342 on Barley Seeds Visualized by Using Green Fluorescent Protein. Applied and Environmental Microbiology 65(8):3674-3680.


[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Rules and Regulations]
[Pages 72183-72186]
[FR Doc No: 2021-27511]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1077; Project Identifier MCAI-2020-00819-A;
Amendment 39-21842; AD 2021-24-21]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Embraer S.A. Model EMB-500 and EMB-505 airplanes. This AD was
prompted by a report that the

operational envelope does not contain airspeed limitations and
procedures for operating the airplane at static air temperatures below
-54 [deg]C. This AD requires revising the airplane flight manual (AFM)
to incorporate new and revised airspeed limitations and procedures. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective January 25, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 25,
2022.

ADDRESSES: For service information identified in this final rule,
contact Phenom Maintenance Support, Avenida Brigadeiro Faria Lima,
2170, P.O. Box 36/2, S[atilde]o Jos[eacute] dos Campos, 12227-901,
Brazil; phone: +55 12 3927 1000; email:
[email protected]; website: https://www.embraer.com.br/en-US/Pages/home.aspx. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-1077.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1077; 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 final rule, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aviation Safety
Engineer, FAA, General Aviation & Rotorcraft Section, International
Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone:
(816) 329-4165; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Embraer S.A. Model
EMB-500 and EMB-505 airplanes with certain engines installed. The NPRM
published in the Federal Register on August 2, 2021 (86 FR 41410). The
NPRM was prompted by MCAI originated by the Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC), which is the aviation authority for
Brazil. ANAC issued AD 2020-05-03, effective June 1, 2020 (ANAC AD
2020-05-03) (also referred to after this as ``the MCAI''), to correct
an unsafe condition on Embraer S.A. Model EMB-500 and EMB-505 airplanes
with certain engines installed. Although the affected airplanes were
designed for operation at temperatures below -54 [deg]C, the
operational envelope in the AFM does not contain the necessary
limitations and procedures to operate safely in these colder
temperatures. The MCAI states that operation of the affected airplanes
at static air temperatures below -54 [deg]C without these limitations
could cause several systems and components to operate inadequately,
resulting in multiple systems failures.
    Accordingly, the MCAI requires updating the AFM to incorporate a
modified operational envelope that establishes restrictions and minimum
airspeed required for each static temperature range. In the NPRM, the
FAA proposed to require revising the AFM to incorporate the new and
revised airspeed limitations and procedures specified in the
manufacturer's service information. The FAA is issuing this AD to
prevent inadequate operation below the allowable temperature, which
could result in multiple systems failures and compromise safe flight of
the airplane.
    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1077.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment on the NPRM from Embraer. The following
presents the comment received and the FAA's response to the comment.
    Embraer requested that the FAA change the final rule to allow
operators to revise the AFM using EMB-500 AFM 2656, Revision 24, dated
March 17, 2020, and EMB-505 AFM-2665, Revision 21, dated March 13,
2020, as well as future FAA-approved AFM revisions. Embraer stated that
the information in the service information proposed for incorporation
by reference has been included in the March 2020 AFM revisions for each
model type.
    The FAA agrees and has revised the AD to allow use of a different
document provided the language is identical to the language in the
service information incorporated by reference.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comment received, and determined that air safety requires adopting this
AD as proposed. Accordingly, the FAA is issuing this AD to address the
unsafe condition on these products. Except for the changes described
previously, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Embraer Phenom Operational Bulletin No. 500-001/
20, dated March 9, 2020; and Operational Bulletin No. 505-005/13,
Revision 1, dated March 9, 2020. This service information specifies
revising the AFM to incorporate limitations and procedures for the
minimum airspeed in the affected region of the operational envelope.
These documents are distinct since they apply to different airplane
models. 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.

Costs of Compliance

    The FAA estimates that this AD affects 590 airplanes of U.S.
registry.

                                      Estimated Costs for Revising the AFM
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
.5 work-hour x $85 per hour = $42.50.........................              $0           $42.50          $25,075
----------------------------------------------------------------------------------------------------------------

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

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2021-24-21 Embraer S.A.: Amendment 39-21842; Docket No. FAA-2020-
1077; Project Identifier MCAI-2020-00819-A.

(a) Effective Date

    This airworthiness directive (AD) is effective January 25, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Embraer S.A. Model EMB-500 and EMB-505
airplanes, all serial numbers, certificated in any category, with
Model PW617F-E or PW617F1-E engines (for Model EMB-500 airplanes) or
Model PW535E engines (for Model EMB-505 airplanes) installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 0200, Operations.

(e) Unsafe Condition

    This AD was prompted by a report that the operational envelope
does not contain airspeed limitations and procedures for operating
the airplane at static air temperatures below -54 [deg]C. The FAA is
issuing this AD to prevent inadequate operation below the allowable
temperature. The unsafe condition, if not addressed, could result in
multiple systems failures and compromise safe flight of the
airplane.

(f) Compliance

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

(g) Revision of the Airplane Flight Manual (AFM)

    Within 30 days after the effective date of this AD:
    (1) For Model EMB-500 airplanes: Revise Section 2 Limitations
and Section 5 Performance of the existing AFM for your airplane by
incorporating the information in ``V--OPERATING INFORMATION,'' of
Embraer Phenom Operational Bulletin No. 500-001/20, dated March 9,
2020. You may use a different document provided the language is
identical to the language in ``V--OPERATING INFORMATION,'' of
Embraer Phenom Operational Bulletin No. 500-001/20, dated March 9,
2020.
    (2) For Model EMB-505 airplanes: Revise Section 2 Limitations,
Section 5 Performance, and Supplement 2 of the existing AFM for your
airplane by incorporating the information in ``V--OPERATING
INFORMATION,'' of Embraer Phenom Operational Bulletin No. 505-005/
13, Revision 1, dated March 9, 2020. You may use a different
document provided the language is identical to the language in V--
OPERATING INFORMATION,'' of Embraer Phenom Operational Bulletin No.
505-005/13, Revision 1, dated March 9, 2020.

(h) 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. Send your request to the person
identified in paragraph (i)(1) of this AD and email: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspection, the manager
of the local Flight Standards District Office.

(i) Related Information

    (1) For more information about this AD, contact Jim Rutherford,
Aviation Safety Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301,
Kansas City, MO 64106; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].
    (2) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil AD
2020-05-03, effective June 1, 2020, for related information. This
MCAI may be found in the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1077.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Embraer Phenom Operational Bulletin No. 500-001/20, dated
March 9, 2020.
    (ii) Embraer Phenom Operational Bulletin No. 505-005/13,
Revision 1, dated March 9, 2020.
    (3) For service information identified in this AD, contact
Phenom Maintenance Support, Avenida Brigadeiro Faria Lima, 2170,
P.O. Box 36/2, S[atilde]o Jos[eacute] dos Campos, 12227-901, Brazil;
phone: +55 12 3927 1000; email: [email protected];

website: https://www.embraer.com.br/en-US/Pages/home.aspx.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 19, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-27511 Filed 12-20-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Page 17121]
[FR Doc No: 2011-7219]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9286-7; Docket ID No. EPA-HQ-ORD-2011-0050]

Draft Integrated Science Assessment for Ozone and Related
Photochemical Oxidants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of extension of public comment.

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SUMMARY: EPA is announcing an extension of the public comment period
for the first external review draft of a document titled, ``First
External Review Draft Integrated Science Assessment for Ozone and
Related Photochemical Oxidants'' (EPA/600/R-10/076A). The original
Federal Register notice announcing the public comment period was
published on February 28, 2011 (76 FR 10893). This assessment document
was developed by the National Center for Environmental Assessment
(NCEA) within EPA's Office of Research and Development as part of the
review of the national ambient air quality standards (NAAQS) for ozone.

DATES: The public comment period began on February 28, 2011, and ends
May 5, 2011. Comments must be received by EPA by May 5, 2011.

ADDRESSES: The ``First External Review Draft Integrated Science
Assessment for Ozone and Related Photochemical Oxidants'' will be
available primarily via the Web page under the Recent Additions and
Publications menus at http://www.epa.gov/ncea. A limited number of CD-
ROM or paper copies will be available. Contact Ms. Debbie Wales by
phone<PHONE_NUMBER>), facsimile<PHONE_NUMBER>), or e-mail
<EMAIL_ADDRESS>to request either of these, and please provide
your name, your mailing address, and the document title, ``First
External Review Draft Integrated Science Assessment for Ozone and
Related Photochemical Oxidants'' (EPA/600/R-10/076A) to facilitate
processing of your request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Dr.
James Brown, NCEA; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or
e-mail<EMAIL_ADDRESS>    Comments may be submitted electronically via http://www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of Federal Register Notice (76 FR
10893).
    For information on submitting comments to the docket, please
contact the Office of Environmental Information Docket; telephone: 202-
566-1752; facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
    Dated: March 22, 2011.
Darrell A. Winner,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2011-7219 Filed 3-25-11; 8:45 am]
BILLING CODE 6560-50-P


environmentally important natural resources such as wetlands,
significant agricultural lands, aquifer recharge zones, coastal zones,
barrier islands, wild and scenic rivers, and significant fish or
wildlife habitat.

Substantially same as current Part 6, § 6.108(c), (e)(3) and (4), and
(g), and §6.605(b)(2) and (5), with clarifications regarding conditions
of applicability; consolidated to clarify applicability to all EPA
actions subject to NEPA.

(x) The proposed action in conjunction with related federal, state or
local government, or federally-recognized Indian tribe projects is
likely to produce significant cumulative impacts.

Substantially the same as current Part 6, § 6.509(b); consolidated to
clarify applicability to all EPA actions subject to NEPA.

(xi) The proposed action is likely to significantly affect the pattern
and type of land use (industrial, commercial, recreational, residential)
or growth and distribution of population including altering the
character of existing residential areas.

Substantially the same as current Part 6, §§ 6.108(a) and 6.605(b);
consolidated to clarify applicability to all actions subject to NEPA.

	The final rule also includes minor, technical amendments to the
Agency’s procedures for implementing Executive Order 12114,
“Environmental Effects Abroad of Major Federal Actions,” entitled in
EPA’s proposed regulations, “Assessing the Environmental Effects
Abroad of EPA Actions.”  Executive Order 12114 does not impose NEPA
compliance requirements on Federal agencies, rather it “furthers the
purpose” of NEPA and identifies the documents, including EISs and EAs,
to be used when conducting assessments under Executive Order 12114.
The Executive Order is “... solely for the purpose of establishing
internal procedures for Federal agencies to consider the significant
effects of their actions on the environment outside the [U.S.], its
territories and possessions ...” [Executive 0rder 12114, Section 3-1])
 EPA actions subject to both Executive Order 12114 and NEPA are
generally documented using EPA’s NEPA implementing procedures.

	Responsible Official under the proposed rule is defined to mean the EPA
official responsible for compliance with NEPA for individual actions
(see final rule, §6.102(b)(9)).

	EPA’s current NEPA implementing regulations include a list of
projects which normally result in the preparation of an EA in Subpart G
– Environmental Review Procedures for Office of Research and
Development Projects, Section 6.705 – Environmental assessment and
finding of no significant impact.

	Certain EPA actions are exempt from the procedural requirements of NEPA
and the CEQ Regulations under EPA’s current NEPA implementing
regulations and remain exempt under EPA’s final regulations.  See
Attachment 1.

	Approximately 75% of EPA’s grants are under the STAG appropriations
account.  Certain line items in the STAG appropriations account are not
subject to NEPA (see Attachment 1).  Grantee actions subject to NEPA are
predominately under the STAG appropriations account (including
consideration of the Wastewater Treatment Construction Grants Program
and other actions subject to NEPA, including those under the Agency’s
Environmental Programs and Management (EPM) account).

	For grantees, there may be a financial difference in that a grantee
generally may use EPA financial assistance to prepare an EID but not to
prepare a draft EA and supporting documents; for grantees, certain
third-party contractor costs may also be eligible for cost
reimbursement.  It has been EPA’s experience that grantees contract
directly for preparation of environmental information or use in-house
engineering contractors to prepare CE and EA documentation, without
seeking cost reimbursement.  Permit applicants are not eligible for EPA
financial assistance.

	For example, a grantee action for renovation of an existing wastewater
treatment or drinking water supply system may be categorically excluded.
 An EA may be required for a grantee action to construct a new sewage
treatment system in a small governmental jurisdiction; or to assess a
new source NPDES permit for a discharge from a concentrated animal
feeding operation for chickens, cattle, hogs or pigs.  An EIS may be
required for a grantee action to construct a new sewage treatment plant
with potential for significant impacts to wetlands, or cultural or
archaeological features; or to assess a new source NPDES permit for
discharges from an oil and gas extraction facility, or mining operation,
or a concentrated animal feeding operation with potential for
significant impacts to wetlands, or cultural or archaeological features,
or threatened or endangered species.

	Assistance agreement under the proposed rule is defined to mean an
award of federal assistance in the form of money or property in lieu of
money from EPA to an eligible recipient including grants and cooperative
agreements (see final rule, § 6.102(b)(3)).

	“Modernizing NEPA Implementation, Chapter 5, Categorical
Exclusions,” The NEPA Task Force Report to the Council on
Environmental Quality, September 2003.

 As defined in EPA’s On Site Wastewater Treatment Systems Manual
(EPA/625/R-00/008, February 2002), an on site system is a system relying
on natural processes and/or mechanical components that is used to
collect, treat, and disperse/discharge wastewater from single dwellings
or buildings.

	“Modernizing NEPA Implementation, Chapter 5, Categorical
Exclusions,” The NEPA Task Force Report to the Council on
Environmental Quality, September 2003.

 PAGE   10

 PAGE   9

 PAGE   23


[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Page 62499]
[FR Doc No: 2016-21683]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC16-176-000.
    Applicants: Mankato Energy Center, LLC, Southern Power Company.
    Description: Joint Application of Mankato Energy Center, LLC, et
al. for Authorization Under Section 203 of the Federal Power Act for
Disposition of Jurisdictional Facilities and Requests for Waivers,
Expedited Action, and Confidential Treatment.
    Filed Date: 9/1/16.
    Accession Number: 20160901-5242.
    Comments Due: 5 p.m. ET 9/22/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-2539-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Revisions to OATT Schedule
12--Appdx A re: RTEP Approved by the Board in Aug 2016 to be effective
11/30/2016.
    Filed Date: 9/1/16.
    Accession Number: 20160901-5239.
    Comments Due: 5 p.m. ET 9/22/16.

    Docket Numbers: ER16-2540-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Service Agreement No. 1571,
Queue No. M23 of PJM Interconnection, L.L.C.
    Filed Date: 9/1/16.
    Accession Number: 20160901-5241.
    Comments Due: 5 p.m. ET 9/22/16.

    Docket Numbers: ER16-2541-000.
    Applicants: Pioneer Wind Park I, LLC.
    Description: Baseline eTariff Filing: Pioneer Wind Park I, LLC MBR
Tariff to be effective 9/3/2016.
    Filed Date: 9/2/16.
    Accession Number: 20160902-5076.
    Comments Due: 5 p.m. ET 9/23/16.

    Docket Numbers: ER16-2542-000.
    Applicants: Public Service Company of New Mexico.
    Description: Compliance filing: Order Nos. 827 and 828 Single
Combined Compliance Filing to be effective 9/21/2016.
    Filed Date: 9/2/16.
    Accession Number: 20160902-5111.
    Comments Due: 5 p.m. ET 9/23/16.

    Docket Numbers: ER16-2543-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2016-09-02_SA 2946
MidAmerican-MidAmerican E&P (J498) to be effective 9/2/2016.
    Filed Date: 9/2/16.
    Accession Number: 20160902-5147.
    Comments Due: 5 p.m. ET 9/23/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 2, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-21683 Filed 9-8-16; 8:45 am]
BILLING CODE 6717-01-P