[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Rules and Regulations]
[Pages 72975-72984]
[FR Doc No: 2012-29683]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0472; FRL-9371-7]

Zeta Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of zeta-
cypermethrin 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 December 7, 2012. Objections and
requests for hearings must be received on or before February 5, 2013,
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-2010-0472, 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), EPA West 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 (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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-2010-0472 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
February 5, 2013. 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-2010-0472, 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.htm.
    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 issue of August 4, 2010 (75 FR 46924) (FRL-
8834-9), 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
0E7717) by the IR-4 Project, Rutgers, The State University of New
Jersey, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.418 be amended by establishing
tolerances for residues of the insecticide zeta-cypermethrin, in or on
pistachio at 0.05 parts per million (ppm), artichoke, globe at 0.80
ppm; barley, grain at 1.7 ppm; barley, hay at 5.0 ppm; barley, straw at
19.0 ppm; buckwheat, grain at 1.7 ppm; buckwheat, hay at 5.0 ppm;
buckwheat, straw at 19.0 ppm; oat, grain at 1.7 ppm; oat, hay at 5.0
ppm; oat, straw at 19.0 ppm; rye, grain at 1.7 ppm; rye, hay at 5.0
ppm; and rye, straw at 19.0 ppm. That document referenced a summary of
the petition prepared by FMC, the registrant, which is available in the
docket, http://www.regulations.gov. A comment was received on the
notice of filing. EPA's response to this comment is discussed in Unit
IV.C.
    In the Federal Register issue of February 25, 2011 (76 FR 10584)
(FRL-8863-3), 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 0E7804) by the IR-4 Project, Rutgers, The State University
of New Jersey, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.418 be amended by establishing
tolerances for residues of the insecticide zeta-cypermethrin, (S-
cyano(3-phenoxyphenyl) methyl ())(cis-trans 3-(2,2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and

its inactive R-isomers, in or on avocado, black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple at 0.45 ppm. That
document referenced a summary of the petition prepared by FMC, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petitions, EPA has
modified the levels for which tolerances are being established for some
commodities. The reason for these changes is 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 zeta-cypermethrin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with zeta-
cypermethrin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The petitions for registration of these new uses of zeta-
cypermethrin rely on zeta-cypermethrin data, as well as previously
submitted data for the related registered insecticide cypermethrin, and
the pending new active ingredient alpha-cypermethrin. Alpha-
cypermethrin, cypermethrin, and zeta-cypermethrin are all pyrethroid
insecticides and are isomer mixtures of the same chemical. Cypermethrin
consists of a mixture of eight isomers (four diastereoisomeric pairs).
Zeta-cypermethrin is composed of four of the eight isomers of
cypermethrin, and also contains one of the isomers in alpha-
cypermethrin. Alpha-cypermethrin consists of two of the four cis-
isomers of cypermethrin.
    Alpha-cypermethrin, cypermethrin, and zeta-cypermethrin have been
evaluated for a variety of toxic effects in experimental toxicity
studies. Behavioral changes commonly seen with type II pyrethroids were
consistently noted in the toxicology database. These included tremors,
gait abnormalities, limb conditions, ataxia, and hypersensitivity.
Additionally, body weight changes were routinely observed and mortality
was seen in a few studies in rats and dogs. Clinical signs were also
noted in all acute neurotoxicity studies. Decreased activity, gait
abnormalities, tremors, limb conditions, and hypersensitivity were
observed at the mid and high doses. Additionally, slight nerve
degeneration was seen in the acute neurotoxicity study with alpha-
cypermethrin at the high dose. In the subchronic neurotoxicity studies
with cypermethrin and zeta-cypermethrin, similar behavioral effects
were seen along with decreased food consumption, body weight, and body
weight gain.
    Dermal toxicity studies are available for zeta-cypermethrin (rat)
and cypermethrin (rabbit), in which local irritation was observed in
rats and rabbits at the highest doses tested. No systemic effects were
observed in the 21-day dermal study in the rat conducted with zeta-
cypermethrin at dose levels up to 1,000 milligram/kilogram/day (mg/kg/
day). In the dermal toxicity study in rabbits with cypermethrin,
systemic effects were observed (focal necrosis of the liver, decreased
testicular weights, and decreased body weight in females). However,
these observations in the rabbit were not used for risk assessment
because the testing method (i.e., abraded skin) does not simulate
actual exposure and results in compromised test conditions.
Additionally, there would be physiological differences between abraded
and non-abraded animals, further undermining the relevance of these
results for risk assessment.
    Developmental toxicity and reproduction studies are available for
the cypermethrins. In the developmental toxicity studies in rats with
cypermethrin and zeta-cypermethrin, there was no evidence of
developmental toxicity up to the highest doses tested. Maternal
toxicity included decreased body weight gain and food consumption in
both chemicals. Splayed limbs, spasms, and hypersensitivity to noise
and convulsions were seen with cypermethrin, and ataxia, urine-stained
abdominal fur, and fecal-stained fur were seen with zeta-cypermethrin.
In the developmental toxicity study in rats with alpha-cypermethrin,
offspring effects were limited to decreased fetal body weight. Maternal
effects observed in the study were unsteady gait, piloerection, limb
splay, and hypersensitivity to sound and touch at the same dose. In the
developmental toxicity studies in rabbits with alpha-cypermethrin,
cypermethrin, and zeta-cypermethrin, there was no evidence of
developmental toxicity up to the highest dose tested. Maternal effects
seen with cypermethrin included decreased body weight gain, anorexia,
abdomino-genital staining, decreased feces, and red or pink material in
the pan. With alpha-cypermethrin, maternal effects were body weight
loss and decreased food consumption. Multi-generation reproduction
studies in rats are available for cypermethrin and zeta-cypermethrin.
In the reproduction study with cypermethrin, decreased body weight gain
was observed in adult animals and decreased body weight was seen in
offspring animals at the highest dose tested. In the reproduction study
with zeta-cypermethrin, decreased body weight gain and mortality were
observed in offspring animals in the presence of mortality, increased
brain weights, decreased body weights, and neurotoxicity in maternal
animals.
    No effects were observed in an immunotoxicity study in rats with
alpha-cypermethrin up to the limit dose.
    Cypermethrin is classified as a Group C ``Possible human
carcinogen,'' based on an increased incidence of lung adenomas and
adenomas plus carcinomas combined in females in a mouse carcinogenicity
study. The presence of common benign tumors (lung adenomas), in one
species (mice) and one sex (female), with no increase in the proportion
of malignant tumors or decrease in the time-to-tumor occurrence,
together with the lack of

mutagenic activity, was not considered strong enough to warrant a
linear or no-threshold approach to quantitation of human cancer risk.
Quantification of risk using a non-linear approach (i.e., acute
population adjusted dose (aPAD), acute reference dose (aRfD)) will
adequately account for all chronic toxicity, including carcinogenicity
that could result from exposure to cypermethrin. While the Agency would
typically use a chronic population adjusted dose (cPAD) to protect for
cancer concerns, use of the aPAD is protective because increasing
toxicity with increasing duration of exposure is not demonstrated for
the cypermethrins. The no-observed-adverse-effect-level (NOAEL)
observed in the mouse cancer study in which tumors were observed is 14
mg/kg/day, 2-fold higher than the point of departure (POD) used for
acute risk assessment. The lowest-observed-adverse-effect-level (LOAEL)
in the mouse cancer study is 57 mg/kg/day based on liver effects, not
tumor formation. The tumors were seen at 229 mg/kg/day. The acute POD
of 7.16 mg/kg/day selected for risk assessment is 32-fold lower than
the dose that induced lung tumors in mice. Only the mouse study with
cypermethrin resulted in tumor formation, no evidence of
carcinogenicity was observed in cancer studies in rats with
cypermethrin or mice with alpha-cypermethrin.
    Acute lethality studies conducted with alpha-cypermethrin,
cypermethrin, and zeta-cypermethrin indicate moderate acute toxicity
via the oral route and low toxicity via the acute dermal or inhalation
routes. Additionally, mild irritation was seen in primary eye and skin
irritation studies but no dermal sensitization was observed.
    Specific information on the studies received and the nature of the
adverse effects caused by zeta-cypermethrin as well as the NOAEL and
the LOAEL from the toxicity studies can be found at http://www.regulations.gov on pp. 60-67 of the document entitled ``Zeta-
Cypermethrin--Human Health Risk Assessment for New Poultry House Use
and Agricultural Uses on Tropical Fruit, Artichoke, Barley, Oat, Rye,
Buckwheat, and Pistachio'' in docket ID number EPA-HQ-OPP-2010-0472.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological PODs and levels of concern (LOCs) 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. The 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 zeta-cypermethrin used
for human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Zeta-Cypermethrin for Use in Human Health Risk
                                                   Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety    RfD, PAD, LOC for  risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (children >= 6 years     Wolansky BMDL1SD = 7.16  Acute RfD = 0.07 mg/kg/  Wolansky BMD = 11.20 mg/
 old and adults).                       mg/kg.                   day.                     kg based on motor
                                       UFA = 10x..............  aPAD = 0.07 mg/kg/day..   activity.
                                       UFH =10x...............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Acute dietary (children <6 years old)  Wolansky BMDL1SD = 7.16  Acute RfD = 0.07 mg/kg/  Wolansky BMD = 11.20 mg/
                                        mg/kg.                   day.                     kg based on motor
                                       UFA = 10x..............  aPAD = 0.023 mg/kg/day.   activity.
                                       UFH =10x...............
                                       FQPA SF = 3x...........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  Because of the rapid reversibility of the most sensitive neurotoxicity
                                        endpoint used for quantifying risks, there is no increase in hazard with
                                        increasing dosing duration, and therefore the acute dietary endpoint is
                                        protective for chronic exposure
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30    Wolansky BMDL1SD = 7.16  LOC for MOE = 300......  Wolansky BMD = 11.20 mg/
 days).                                 mg/kg.                                            kg based on motor
                                       UFA = 10x..............                            activity.
                                       UFH =10x...............
                                       FQPA SF = 3x...........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 days)   NOAEL = 0.01 mg/L......  LOC for MOE = 100......  21-Day inhalation study
 (children <6 years old).              HEC = 0.008 mg/L.......                            in the rat. LOAEL =
                                       HED = 1.15 mg/kg/day...                            0.05 mg/L based on
                                       UFA = 3x...............                            increased salivation.
                                       UFH = 10x..............
                                       FQPA SF = 3x...........
----------------------------------------------------------------------------------------------------------------

Inhalation short-term (1 to 30 days)   NOAEL = 0.01 mg/L......  LOC for MOE = 30.......  21-Day inhalation study
 (children >= 6 years old and adults). HEC = 0.008 mg/L.......                            in the rat. LOAEL =
                                       HED = 1.15 mg/kg/day...                            0.05 mg/L based on
                                       UFA = 3x...............                            increased salivation.
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)....  Zeta-cypermethrin has been classified as a possible human carcinogen.
                                        Because of the rapid reversibility of the most sensitive neurotoxicity
                                        endpoint used for quantifying risks, there is no increase in hazard with
                                        increasing dosing duration. Therefore, the acute dietary endpoint is
                                        protective of the endpoints from repeat dosing studies, including cancer
                                        dietary exposures.
----------------------------------------------------------------------------------------------------------------
1SD = 1 standard deviation. BMD = benchmark dose. BMDL = benchmark dose (lower limit of a 95% confidence
  interval). FQPA SF = Food Quality Protection Act Safety Factor. HEC = human equivalent concentration. HED =
  human equivalent dose. L = Liter. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/
  day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD =
  population adjusted dose (a = acute). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from
  animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to zeta-cypermethrin, EPA considered exposure under the
petitioned-for tolerances as well as all existing zeta-cypermethrin
tolerances in 40 CFR 180.418. EPA assessed dietary exposures from zeta-
cypermethrin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for zeta-cypermethrin. In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA) 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As
to residue levels in food, EPA conducted a partially refined
(probabilistic) dietary exposure assessment to determine the exposure
and risk estimates which result from all the existing uses of
cypermethrin and zeta-cypermethrin, as well as proposed new uses of
alpha-cypermethrin and zeta-cypermethrin. Anticipated residues from
USDA Pesticide Data Program (PDP) monitoring data, field trial data,
and empirical processing factors were used where appropriate. Percent
crop treated (PCT) estimates were used for some commodities.
    ii. Chronic exposure. Based on the data summarized in Unit III.A.,
there is no increase in hazard from repeated exposures to zeta-
cypermethrin; the acute dietary exposure assessment is protective for
chronic dietary exposures because acute exposure levels are higher than
chronic exposure levels. Accordingly, a dietary exposure assessment for
the purpose of assessing chronic dietary risk was not conducted.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or non-linear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier non-cancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. As noted in Unit III.A., the Agency has
determined that quantification of risk using a non-linear approach
(i.e., aPAD) will adequately account for all chronic toxicity,
including carcinogenicity that could result from exposure to zeta-
cypermethrin. Additionally, because an assessment of cancer risk would
estimate exposure based on average residue levels and the acute
assessment used high-end residue levels, the acute dietary assessment
will be protective of any cancer effects resulting from consumption of
zeta-cypermethrin residues in foods.
    iv. Anticipated residue and percent crop treated (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.
    The following maximum PCT estimates were used in the acute dietary
risk assessment for the following crops that are currently registered
for zeta-cypermethrin/cypermethrin: Almonds, 2.5%; apples, 2.5%;
broccoli, 30%; cabbage, 30%; carrot, 10%; cauliflower, 25%; celery,
60%; cherries, 5%; grapefruit, 50%; green beans, 20%; green peas, 15%;
lemon, 2.5%; lettuce, 65%; orange, 45%; peach, 5%; peppers,

30%; potato, 5%; spinach, 45%; sweet corn, 20%; tomato, 10%; and
watermelon, 10%.
    The following average PCT estimates were used to calculate average
dietary exposures in order to assess short-term aggregate risk to the
cypermethrins for the following crops that are currently registered for
cypermethrin/zeta-cypermethrin: Almonds, 1%; apples, 1%; broccoli, 20%;
cabbage, 15%; carrot, 2.5%; cauliflower, 15%; celery, 35%; cherries,
5%; grapefruit, 35%; green beans, 15%; green peas, 10%; lemon, 1%;
lettuce, 55%; orange, 35%; peach, 2.5%; peppers, 15%; potato, 1%;
spinach, 30%; sweet corn, 15%; tomato, 5%; and watermelon, 2.5%.
    In most cases, EPA uses available data from the 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 6-7
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 zeta-cypermethrin 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 zeta-cypermethrin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of zeta-cypermethrin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of zeta-cypermethrin
for acute exposures are estimated to be 3.77 parts per billion (ppb)
for surface water and 0.0036 ppb for ground water. The annual average
typically used for chronic exposures are estimated to be 0.066 ppb for
surface water and 0.0036 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 3.77 ppb was used to
assess the contribution to drinking water. For the purpose of assessing
short-term aggregate risk (i.e., food, drinking water, and residential
exposures) the chronic water concentration value of 0.066 ppb was used
to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Cypermethrin and
zeta-cypermethrin are registered for use on a variety of indoor and
outdoor residential environments including: Lawns, gardens, pets, and
indoor surfaces and spaces.
    EPA assessed residential exposure using the following assumptions:
The quantitative exposure/risk assessment developed for residential
handlers is based on the following scenarios:
     Mixer/loader/applicator using hose-end sprayer on turf.
     Mixer/loader/applicator using backpack on turf and
gardens.
     Mixer/loader/applicator using manually pressurized
handwand for indoor surfaces.
     Application via aerosol can for indoor surfaces and space.
    Since a dermal endpoint was not identified, only a quantitative
inhalation handler exposure assessment was performed. Residential
handler inhalation exposure estimates were calculated based on a human
equivalent concentration and human equivalent dose which reflect 24
hours of exposure. Since handler exposure is expected to be
significantly less than 24 hours, the inhalation exposure estimates are
sufficiently protective of all scenarios (turf, gardens, and indoor
surface space). Although there is potential inhalation exposure
resulting from the application of dog tags and spot-on products for
pets, inhalation exposure is considered negligible for these scenarios
and therefore a quantitative assessment was not performed for these
uses.
    There is the potential for post-application exposure for
individuals as a result of being in an environment that has been
previously treated with cypermethrin or zeta-cypermethrin. Post-
application inhalation exposure resulting from activities on or around
previously treated turf is generally not assessed; the combination of
low vapor pressure for chemicals typically used as active ingredients
in outdoor residential pesticide products and dilution in outdoor air
is likely to result in minimal inhalation exposure. Therefore, a
quantitative post-application inhalation exposure assessment for
cypermethrin turf uses was not conducted. Since a dermal endpoint was
not identified, and indoor post-application inhalation exposure
resulting from aerosol space sprays, foggers, and pet (i.e., dog tag,
spot-on) uses is negligible, the only potential post-application
exposure pathways of concern are incidental oral for children, and
post-application inhalation exposure for adults and children resulting
from indoor crack and crevice applications made with a manually
pressurized handwand. The quantitative exposure/risk assessment for
residential post-application exposures is based on the following
scenarios:
     Incidental oral (hand-to-mouth, object-to-mouth, and soil
ingestion) exposure from turf for children.
     Incidental oral (hand-to-mouth and object-to-mouth)
exposure from indoor foggers for children.
     Incidental oral (hand-to-mouth and object-to-mouth)
exposure from pets for children.

     Inhalation exposure for adults and children resulting from
crack and crevice application to an indoor surface.
     Incidental oral (hand-to-mouth and object-to-mouth)
exposure for children from indoor surface applications.
    Risk estimates resulting from different exposure routes may be
combined when it is likely that they can occur simultaneously based on
the use pattern and when the toxicological effects across different
routes of exposure are the same. Although, in the case of children,
inhalation and incidental oral exposure routes share a common
toxicological endpoint, risk estimates were not combined for those
routes for turf, indoor fogger, and pet since post-application
inhalation exposure is considered negligible. However, inhalation and
incidental oral exposures were combined for post-application risk
assessment associated with the indoor crack and crevice use. Inhalation
and incidental oral routes have different LOCs. Therefore, in order to
combine exposure from the various routes the aggregate risk index (ARI)
approach is used to estimate exposure and risk. When this approach is
used, aggregate risks are not of concern provided the calculated ARI is
greater than one.
    The incidental oral scenarios from indoor exposure following crack
and crevice applications and outdoor exposure from turf were not
combined, not only because they are not likely to co-occur, but also
because combining these scenarios would be overly conservative due to
the conservative nature of each of the individual assessments.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    The Agency is required to consider the cumulative risks of
chemicals sharing a common mechanism of toxicity. The Agency has
determined that the pyrethroids and pyrethrins, including zeta-
cypermethrin, share a common mechanism of toxicity. The members of this
group share the ability to interact with voltage-gated sodium channels,
ultimately leading to neurotoxicity. The cumulative risk assessment for
the pyrethroids/pyrethrins was published in the Federal Register issue
of November 9, 2011 (76 FR 69726) (FRL-8888-9), and is available at
http://www.regulations.gov in the docket, EPA-HQ-OPP-2011-0746. Further
information about the determination that pyrethroids and pyrethrins
share a common mechanism of toxicity may be found in document ID number
EPA-HQ-OPP-2008-0489-0006.
    The cypermethrins were included in a recent cumulative risk
assessment for pyrethrins and pyrethroids. The proposed new uses of
zeta-cypermethrin will not significantly impact the cumulative
assessment because, in the cumulative assessment, residential exposure
was the greatest contributor to the total exposure. As there are no new
residential uses for the cypermethrins, the proposed new uses will have
no impact on the residential component of the cumulative risk
estimates.
    Dietary exposures make a minor contribution to total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid cumulative was much more highly refined than that performed
for the single chemical. The dietary exposure assessment for the single
chemical included conservative assumptions, using field trial data for
many commodities, including the proposed new uses with the assumption
of 100 PCT, and the most sensitive apical endpoint in the cypermethrins
hazard database was selected to derive the POD. Additionally, the POD
selected for zeta-cypermethrin is specific to the cypermethrins,
whereas the POD selected for the cumulative assessment was based on
common mechanism of action data that are appropriate for all 20
pyrethroids included in the cumulative assessment.
    For information regarding EPA's efforts to evaluate the risk of
exposure to pyrethroids, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional 10-fold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. In guideline developmental
and reproduction studies with the cypermethrins, there was no evidence
of increased qualitative or quantitative susceptibility in rats or
rabbits.
    In a guideline Developmental Neurotoxicity (DNT) study with zeta-
cypermethrin, there was increased sensitivity in the offspring based on
body weight changes in pups (5-10%) in the absence of treatment-related
effects in maternal animals. Although, there was a 5-8% decrease in
maternal body weight in this study, a body weight decrease of <10% is
generally not considered adverse in adults, as this is considered to be
within the range of variability because the magnitude of body weight
per se is typically small (as an example, a 3 gram (g) decrease in body
weight from a 338 g rat), and adults are no longer in the growth/
development phase. In contrast, the offspring are at a stage of growth
and development and are therefore expected to be gaining rather than
losing weight. Thus, a smaller percent decrease in body weight is
considered adverse in the young relative to adults. In the case of
zeta-cypermethrin, the decrease in body weight of the young is
comparable to adults; however, it was considered adverse in the young
but not in the adults. This disparity in interpretation leads to an
apparent increase in sensitivity in the young; however, concern is
reduced since the magnitude of body weight decrements was similar in
adult and young animals. The results from the DNT study are very
similar to results observed in the reproduction studies where body
weight changes (decreased body weight gain) were seen in maternal and
offspring animals at doses similar to those in the DNT study, with no
indication of increased susceptibility. Therefore, there is no residual
concern for effects observed in the study. Additionally, there are well
characterized dose responses with clear NOAELs and LOAELs for effects
seen in the DNT and reproduction studies and the endpoints and PODs
selected for risk assessment are protective.
    High-dose LD50 studies (studies assessing what dose
results in lethality to 50% of the tested population) in the scientific
literature indicate that pyrethroids can result in increased
quantitative sensitivity in the young, specifically in the form of
neurotoxicity. Examination of pharmacokinetic and

pharmacodynamic data indicates that the sensitivity observed at high
doses is related to pyrethroid age-dependent pharmacokinetics--the
activity of enzymes associated with the metabolism of pyrethroids. With
otherwise equivalent administered doses for adults and juveniles,
predictive pharmacokinetic models indicate that the differential adult-
juvenile pharmacokinetics will result in a 3X greater dose at the
target organ in juveniles compared to adults. No evidence of increased
quantitative or qualitative susceptibility was seen in the pyrethroid
scientific literature related to pharmacodynamics (the effect of
pyrethroids at the target tissue) both with regard to inter-species
differences between rats and humans and to differences between
juveniles and adults. Specifically, there are in vitro pharmacodynamic
data and in vivo data indicating similar responses between adult and
juvenile rats at low doses and data indicating that the rat is a
conservative model compared to the human based on species-specific
pharmacodynamics of homologous sodium channel isoforms in rats and
humans.
    3. Conclusion. EPA is reducing the FQPA SF to 3X for infants and
children less than 6 years of age. For the general population,
including children greater than 6 years of age, EPA is reducing the
FQPA SF to 1X. The decisions regarding the FQPA SFs being used are
based on the following considerations:
    i. The toxicology database for the cypermethrins is not complete.
While the database is considered to be complete with respect to the
guideline toxicity studies for zeta-cypermethrin, EPA lacks additional
data to fully characterize the potential for juvenile sensitivity to
neurotoxic effects of pyrethroids. In light of the literature studies
indicating a possibility of increased sensitivity in juvenile rats at
high doses, EPA has requested proposals for study protocols which could
identify and quantify potential juvenile sensitivity. However, when
evaluated together, the toxicity studies for alpha-cypermethrin,
cypermethrin, and zeta-cypermethrin can be used to characterize toxic
effects including potential developmental and reproductive toxicity,
immunotoxicity, and neurotoxicity. Acceptable developmental toxicity
studies in rats and rabbits, reproduction studies in rats,
neurotoxicity studies (Acute Neurotoxicity (ACN), Subchronic
Neurotoxicity (SCN), and DNT) in rats, and immunotoxicity studies in
rats are available. In addition, route-specific dermal and inhalation
studies are available.
    ii. After reviewing the extensive body of data and peer-reviewed
literature on pyrethroids, the Agency has reached a number of
conclusions regarding fetal and juvenile sensitivity for pyrethroids,
including the following:
     Based on an evaluation of over 70 guideline toxicity
studies for 24 pyrethroids submitted to the Agency, including prenatal
developmental toxicity studies in rats and rabbits, and pre- and
postnatal multi-generation reproduction toxicity studies and DNTs in
rats in support of pyrethroid registrations, there is no evidence that
pyrethroids directly impact developing fetuses. None of the studies
show any indications of fetal toxicity at doses that do not cause
maternal toxicity.
     Increased susceptibility was seen in offspring animals in
the DNT study with zeta-cypermethrin (decreased pup body weights) and
DNT and reproduction studies with beta-cyfluthrin (decreased body
weights and tremors). However, the reductions in body weight and the
other non-specific effects occur at higher doses than neurotoxicity,
the effect of concern for pyrethroids. The available developmental and
reproduction guideline studies in rats with zeta-cypermethrin did not
show increased sensitivity in the young to neurotoxic effects. Overall,
findings of increased sensitivity in juvenile animals in pyrethroid
studies are rare. Therefore, the residual concern for the postnatal
effects is reduced.
     High-dose LD50 studies (studies assessing what
dose results in lethality to 50% of the tested population) in the
scientific literature indicate that pyrethroids can result in increased
quantitative sensitivity to juvenile animals. Examination of
pharmacokinetic and pharmacodynamic data indicates that the sensitivity
observed at high doses is related to pyrethroid age-dependent
pharmacokinetics--the activity of enzymes associated with the
metabolism of pyrethroids. Furthermore, a rat physiologically-based
pharmacokinetic (PBPK) model predicts a three-fold increase of
pyrethroid concentration in juvenile brain compared to adults at high
doses.
     In vitro pharmacodynamic data and in vivo data indicate
that adult and juvenile rats have similar responses to pyrethroids at
low doses and therefore juvenile sensitivity is not expected at
relevant environmental exposures. Further, data also show that the rat
is a conservative model compared to the human based on species-specific
pharmacodynamics of homologous sodium channel isoforms.
    iii. There are no residual uncertainties with regard to dietary and
residential exposure. The dietary exposure assessments are based on
high-end health protective residue levels (that account for parent and
metabolites of concern), processing factors, and PCT assumptions.
Furthermore, conservative, upper-bound assumptions were used to
determine exposure through drinking water and residential sources, such
that these exposures have not been underestimated.
    Taking all of this information into account, EPA has reduced the
FQPA SF for women of child-bearing age and children over 6 to 1X
because there is no evidence in the over 70 guideline toxicity studies
submitted to the Agency, including prenatal developmental toxicity
studies in rats and rabbits, and multi-generation reproduction toxicity
studies and DNTs in rats, that pyrethroids directly impact developing
fetuses. Additionally, none of the studies show any indications of
fetal toxicity at doses that do not cause maternal toxicity. Because
there remains some uncertainty as to juvenile sensitivity due to the
findings in the high-dose LD50 studies, EPA is retaining a
FQPA SF for infants and children less than 6 years of age. By age 6,
the metabolic system is expected to be at or near adult levels thus
reducing concerns for potential age-dependant sensitivity related to
pharmacokinetics. EPA is seeking additional data to further
characterize the potential neurotoxicity for pyrethroids. However, EPA
has reliable data that show that reducing the FQPA SF to 3X will
protect the safety of infants and children. These data include:
     Data from guideline studies with zeta-cypermethrin at
relatively high doses that show no sensitivity with regard to
neurotoxic effects (the most sensitive effect for the pyrethroids) and
no residual concern regarding overall juvenile sensitivity (i.e.,
sensitivity seen in body weight changes occurred at doses above the
level chosen for the POD).
     Data showing that the potential sensitivity at high doses
is likely due to pharmacokinetics.
     A rat PBPK model predicting a three-fold increase of
pyrethroid concentration in juvenile brain compared to adults at high
doses due to age-dependent pharmacokinetics.
     Data indicating that the rat is a conservative model
compared to the human based on species-specific pharmacodynamics of
homologous sodium channel isoforms.

    For several reasons, EPA concludes these data show that a 3X factor
is protective of the safety of infants and children. First, it is
likely that the extensive guideline studies with zeta-cypermethrin
showing no neurotoxicity sensitivity between adults and juveniles
better characterize the potential sensitivity of juvenile animals than
the LD50 studies. The high doses that produced juvenile
sensitivity in the literature studies are well above normal dietary or
residential exposure levels of pyrethroids to juveniles and lower
levels of exposure anticipated from dietary and residential uses are
not expected to overwhelm the juvenile's ability to metabolize
pyrethroids, as occurred with the high doses used in the literature
studies. The fact that a greater sensitivity to the neurotoxicity of
pyrethroids is not found in guideline studies following in utero
exposures (based on 76 studies for 24 pyrethroids) supports this
conclusion, despite the relatively high doses used in the studies.
Second, in vitro and in vivo data indicate similar pharmacodynamic
response to pyrethroids between juvenile and adult rats. Finally, as
indicated, pharmacokinetic modeling only predicts a 3X difference
between juveniles and adults. Therefore, the FQPA SF of 3X is
protective of potential juvenile sensitivity.
    The portion of the uncertainty factor that accounts for potential
pharmacodynamic differences between animals and rats (i.e., the inter-
species extrapolation factor) are likely to overstate the risk of zeta-
cypermethrin given the data showing similarities in pharmacodynamics
between animals and humans. For the inter-species factor, the
pharmacodynamic portion of the factor is generally considered to be 3X,
however for pyrethroids the actual difference is likely to be lower
than 3X. In addition, there are data that show that there are no
lifestage pharmacodynamic differences between young and adult rats.
Standard uncertainty factors, such as those used in the zeta-
cypermethrin risk assessment, assume that there will be such
differences. Finally, as indicated, pharmacokinetic modeling only
predicts a 3X difference between juveniles and adults. Thus, even if
there is increased juvenile neurotoxic sensitivity and even if the
existing inter-species factor does not provide extra protection due to
the conservative nature of their pharmacodynamic components for
pyrethroids, the 3X additional factor will protect the young.

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
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to alpha-cypermethrin, cypermethrin, and zeta-cypermethrin will occupy
87% of the aPAD for all infants less than 1 year old and children 1-2
years old, the population groups receiving the greatest exposure.
    2. Chronic risk. Based on the data summarized in Unit III.A., there
is no increase in hazard with increasing dosing duration. Furthermore,
chronic dietary exposures will be lower than acute exposures.
Therefore, the acute aggregate assessment is protective of potential
chronic aggregate exposures.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Cypermethrin and zeta-cypermethrin are currently registered for
uses that could result in short-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to cypermethrin and zeta-cypermethrin.
    For assessing short-term aggregate risk, the average dietary
exposure estimate was used since it represents a background exposure
level from food and drinking water that may co-occur with residential
exposures. Dietary, inhalation, and incidental oral (hand to mouth)
risks for children, and dietary and inhalation risks for adults were
combined in this assessment, since the toxicological endpoints were the
same. However, the LOC values for children younger than 6 years old
were different for oral and inhalation exposure, with an incidental
oral LOC of 300, and an inhalation LOC of 100. Likewise, the inhalation
and dietary LOCs for adults were different, with an inhalation LOC of
30 and a dietary LOC of 100. Therefore, the respective risk estimates
are combined using the ARI approach. When this approach is used,
aggregate risks are not of concern provided the calculated ARI is
greater than 1. The ARI for adults was calculated to be 56 and the ARI
for children was 2.3. Because these ARIs are greater than 1, the risk
estimates are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term aggregate risk assessment was not
conducted because zeta-cypermethrin is acutely toxic and does not
increase in potency with repeated dosing. Because the neurotoxicity POD
used for acute risk assessment is lower (more protective) than PODs for
longer durations of exposure and acute and short-term exposure levels
are higher than longer term exposure levels, the acute and short-term
aggregate assessments are protective for intermediate-term aggregate
risks anticipated from cypermethrin and zeta-cypermethrin exposure.
    5. Aggregate cancer risk for U.S. population. For the reasons
discussed in Unit III.A. (cancer effects are non-linear and appear at
higher doses than acute effects) and Unit III.E.2. (chronic exposures
are lower than acute exposures), the acute aggregate assessment is
protective of potential cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to alpha-cypermethrin, cypermethrin, and zeta-cypermethrin
residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in ``PAM
Volume II'' for determining residues of alpha-cypermethrin,
cypermethrin, and zeta-cypermethrin in plant (Method I) and livestock
(Method II) commodities. Both methods are gas chromatographic methods
with electron-capture detection (GC/ECD), and have undergone successful
Agency petition method validations (PMVs). Method I has a limit of
detection (LOD) of 0.01 ppm, and Method II has LODs of 0.005 ppm in
milk, and 0.01 ppm in livestock tissues. These methods are not
stereospecific; thus no distinction is made between residues of
cypermethrin (all 8 stereoisomers), zeta-cypermethrin

(enriched in 4 isomers) and alpha-cypermethrin (2 isomers).

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.
    There are multiple Codex MRLs for zeta-cypermethrin, but all are in
conjunction with MRLs for total cypermethrin isomers (no MRLs have been
established solely for zeta-cypermethrin). However, although the
definitions of the covered isomers in the Codex MRLs and U.S.
tolerances differ formally, they are effectively harmonized since the
tolerance enforcement methods are not stereo-specific, and thus do not
distinguish between residues of alpha-cypermethrin, cypermethrin, and
zeta-cypermethrin. For enforcement purposes, the same moiety is being
regulated. These tolerances will result in harmonized MRLs between EPA
and Codex for mango (at 0.7 ppm) and papaya (at 0.5 ppm). The
tolerances for artichoke, barley, buckwheat, oats, and rye will not be
harmonized with Codex for the following reasons. In the case of
artichoke, Codex has set a lower MRL of 0.1 ppm based on field trials
conducted with alpha-cypermethrin with a different use pattern,
including a lower use rate and longer pre-harvest interval (PHI). The
Agency's tolerance for artichoke of 0.6 ppm is supported by the
submitted residue data, with a higher use rate and shorter PHI. In
addition, for grains (barley, oats, buckwheat, and rye), the Codex MRLs
assume a post-harvest treatment whereas the proposed use pattern in the
United States is for pre-harvest treatment.

C. Response to Comments

    A comment was received that objected to the proposed tolerances
primarily because of the amounts of pesticides already consumed and
carried by the American population.
    The Agency understands the commenter's concerns and recognizes that
some individuals believe that pesticides should be banned completely.
However, under the existing legal framework provided by FFDCA section
408, EPA is authorized to establish pesticide tolerances or exemptions
where 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.

D. Revisions to Petitioned-for Tolerances

    The Agency has modified the levels for which tolerances are being
established for artichoke, globe (0.80 to 0.60 ppm); barley, grain (1.7
to 3.0 ppm); barley, hay (5.0 to 6.0 ppm); barley, straw (19.0 to 20
ppm); buckwheat, grain (1.7 to 3.0 ppm); buckwheat, hay (5.0 to 6.0
ppm); buckwheat, straw (19.0 to 20.0 ppm); oat, grain (1.7 to 3.0 ppm);
oat, hay (5.0 to 6.0 ppm); oat, straw (19.0 to 20.0 ppm); rye, grain
(1.7 to 3.0 ppm); rye, hay (5.0 to 6.0 ppm); rye, straw (19.0 to 20.0
ppm); mango (0.45 to 0.70 ppm); and avocado; canistel; papaya;
sapodilla; sapote, black; sapote, mamey; and star apple (0.45 to 0.50
ppm). These revisions are due to either EPA's use of the Organization
for Economic Cooperation and Development (OECD) tolerance calculation
procedures or to harmonize with Codex MRLs.
    Also, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of zeta-cypermethrin not specifically
mentioned.
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of the
insecticide, zeta-cypermethrin, (S-cyano(3-phenoxyphenyl) methyl
())(cis-trans 3-(2,2-dichloroethenyl)-2,2
dimethylcyclopropanecarboxylate), including its metabolites and
degradates in or on pistachio at 0.05 ppm; artichoke, globe at 0.60
ppm; barley, grain at 3.0 ppm; barley, hay at 6.0 ppm; barley, straw at
20 ppm; buckwheat, grain at 3.0 ppm; buckwheat, hay at 6.0 ppm;
buckwheat, straw at 20.0 ppm; oat, grain at 3.0 ppm; oat, hay at 6.0
ppm; oat, straw at 20.0 ppm; rye, grain at 3.0 ppm; rye, hay at 6.0
ppm; rye, straw at 20.0 ppm; mango at 0.70 ppm; and avocado; canistel;
papaya; sapodilla; sapote, black; sapote, mamey; and star apple at 0.50
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined

that Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999) and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000) do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: November 30, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.418, revise the introductory text of paragraph (a)(2)
and alphabetically add the following commodities to the table in
paragraph (a)(2) to read as follows:

Sec.  180.418  Cypermethrin and an isomer zeta-cypermethrin; tolerances
for residues.

    (a) * * *
    (2) Tolerances are established for residues of zeta-cypermethrin,
(S-cyano(3-phenoxyphenyl) methyl ())(cis-trans 3-(2,2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate), including its
metabolites and degradates, in or on the commodities in the following
table. Compliance with the tolerance levels specified in the following
table is to be determined by measuring only total cypermethrin,
cyano(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropane carboxylate, in or on the commodity.

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

                                * * * * *
Artichoke, globe..........................................          0.60
Avocado...................................................          0.50
Barley, grain.............................................          3.0
Barley, hay...............................................          6.0
Barley, straw.............................................         20.0

                                * * * * *
Buckwheat, grain..........................................          3.0
Buckwheat, hay............................................          6.0
Buckwheat, straw..........................................         20.0

                                * * * * *
Canistel..................................................          0.50

                                * * * * *
Mango.....................................................          0.70

                                * * * * *
Oat, grain................................................          3.0
Oat, hay..................................................          6.0
Oat, straw................................................         20.0

                                * * * * *
Papaya....................................................          0.50

                                * * * * *
Pistachio.................................................          0.05

                                * * * * *
Rye, grain................................................          3.0
Rye, hay..................................................          6.0
Rye, straw................................................         20.0

                                * * * * *
Sapodilla.................................................          0.50
Sapote, black.............................................          0.50
Sapote, mamey.............................................          0.50

                                * * * * *
Star apple................................................          0.50

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

* * * * *
[FR Doc. 2012-29683 Filed 12-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Rules and Regulations]
[Pages 19438-19439]
[FR Doc No: 2018-09314]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2015-0851; FRL-9977-02--Region 6]

Approval and Promulgation of Implementation Plans; Louisiana;
Interstate Transport Requirements for the 2012 PM2.5 NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving portions of
Louisiana's State Implementation Plan (SIP) submittal and a technical
supplement, that address a CAA requirement that SIPs account for
potential interstate transport of air pollution that significantly
contributes to nonattainment or interferes with maintenance of the 2012
fine particulate matter (PM2.5) National Ambient Air Quality
Standards (NAAQS) in other states. EPA finds that emissions from
Louisiana sources do not contribute significantly to nonattainment in,
or interfere with maintenance by, any other state with regard to the
2012 PM2.5 NAAQS.

DATES: This rule is effective on June 4, 2018.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2015-0851. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas,
Texas 75202-2733.

FOR FURTHER INFORMATION CONTACT: Sherry Fuerst,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our
February 1, 2018 proposal (83 FR 4617). In that document we proposed to
approve portions of Louisiana's State Implementation Plan (SIP)
submittal and a technical supplement, that address a CAA requirement
that SIPs account for potential interstate transport of air pollution
that significantly contributes to nonattainment or interferes with
maintenance of the 2012 PM2.5 NAAQS in other states. We
proposed to determine that emissions from Louisiana sources do not
contribute significantly to nonattainment in, or interfere with
maintenance by, any other state with regard to the 2012
PM2.5 NAAQS.
    On March 6, 2018, we received six anonymous public comments on the
proposed rulemaking action. The comments are posted to the docket (EPA-
R06-OAR-2015-0851). Several of the commenters provided the air quality
index for March 2, 2018 for various locations across the USA and
compared them to various locations across Asia. Other commenters
discussed the shortcomings of the tariffs and conflict minerals law.
Such comments are not relevant to the Clean Air requirements being
addressed here and are outside the scope of this specific rule making
action.

II. Final Action

    We are approving the portions of the December 11, 2015 Louisiana
SIP revision pertaining to emissions that significantly contribute to
nonattainment or interfere with maintenance of the 2012
PM2.5 NAAQS in other states and the supplemental information
provided to us on July 7, 2017. We find that emissions from Louisiana
sources do not contribute significantly to nonattainment in, or
interfere with maintenance by, any other state with regard to the 2012
PM2.5 NAAQS.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);

     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 2, 2018. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter.

    Dated: April 25, 2018.
Anne Idsal,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart E--Louisiana

0
2. In Sec.  52.970, in paragraph (e), the second table titled ``EPA
Approved Louisiana Nonregulatory Provisions and Quasi-Regulatory
Measures'' is amended by adding an entry at the end for ``Interstate
transport for the 2012 PM2.5 NAAQS (contribute to
nonattainment or interfere with maintenance)'' to read as follows:

Sec.  52.970  Identification of plan

* * * * *
    (e) * * *

                  EPA-Approved Louisiana Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                                               State
     Name of SIP provision        Applicable geographic     submittal/     EPA approval date      Explanation
                                  or nonattainment area   effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Interstate transport for the     Statewide..............      12/11/2015  5/3/2018, [Insert   Adequate
 2012 PM2.5 NAAQS (contribute                                   7/7/2017   Federal Register    provisions
 to nonattainment or interfere                                             citation].          prohibiting
 with maintenance).                                                                            emissions which
                                                                                will contribute
                                                                                significantly to
                                                                                nonattainment in,
                                                                                or interfere with
                                                                                maintenance of
                                                                                the 2012 PM2.5
                                                                                NAAQS in any
                                                                                other State.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-09314 Filed 5-2-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39767-39768]
[FR Doc No: 2018-17138]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0281]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0094

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0094,
Ships Carrying Bulk Hazardous Liquids; without change. Our ICR
describes the information we seek to collect from the public. Review
and comments by OIRA ensure we only impose paperwork burdens
commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
September 10, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0281] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email: [email protected].
    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), ATTN: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2018-0281], and must be received by September
10, 2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents

mentioned in this notice, and all public comments, are in our online
docket at http://www.regulations.gov and can be viewed by following
that website's instructions. Additionally, if you go to the online
docket and sign up for email alerts, you will be notified when comments
are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0094.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (83 FR 24133, May 24, 2018)
required by 44 U.S.C. 3506(c)(2). That Notice elicited one comment. The
comment was unrelated to this Information Collection request.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Ships Carrying Bulk Hazardous Liquids.
    OMB Control Number: 1625-0094.
    Summary: This information is needed to ensure the safe transport of
bulk hazardous liquids on chemical tank vessels and to protect the
environment from pollution.
    Need: Under 46 U.S.C. 3703, the Coast Guard is authorized to
prescribe regulations for protection against hazards to life, property,
and navigation and vessel safety, and protection of the marine
environment. The regulations for the safe transport by vessel of
certain bulk dangerous cargoes are contained in 46 CFR part 153.
    Forms: CG-4602B, Cargo Record Book; CG-5148, International
Certificate of Fitness for the Carriage of Liquefied Gases in Bulk; CG-
5148A, Certificate of Fitness for the Carriage of Dangerous Chemicals
in Bulk; CG-5148B Certificate of Fitness for the Carriage of Dangerous
Chemicals in Bulk; and CG-5461, International Pollution Prevention
Certificate for the Carriage of Noxious Liquid Substances in Bulk.
    Respondents: Owners and operators of chemical tank vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 5,539
hours to 7,611 hours a year due to an increase in the estimated annual
number of respondents.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 31, 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2018-17138 Filed 8-9-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15764-15765]
[FR Doc No: 2012-6391]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0747]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Waiver of In Vivo
Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
16, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0575.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form Products and Type A Medicated
Articles--21 CFR 514.1(b)(7) and (b)(8) (OMB Control Number 0910-
0575)--Extension

    The Center for Veterinary Medicine has written this guidance to
address a perceived need for Agency guidance in its work with the
animal health industry. This guidance describes the procedures that the
Agency recommends for the review of requests for waiver of in vivo
demonstration of bioequivalence for generic soluble powder oral dosage
form products and Type A medicated articles.
    The Generic Animal Drug and Patent Term Registration Act of 1988
(Pub. L. 100-670) permitted generic drug manufacturers to copy those
pioneer drug products that were no longer subject to patent or other
marketing exclusivity protection. The approval for marketing these
generic products is based, in part, upon a demonstration of
bioequivalence between the generic product and pioneer product. This
guidance clarifies circumstances under which FDA believes the
demonstration of bioequivalence required by the statute does not need
to be established on the basis of in vivo studies for soluble powder
oral dosage form products and Type A medicated articles. The data
submitted in support of the waiver request are necessary to validate
the waiver decision. The requirement to establish bioequivalence
through in vivo studies (blood level bioequivalence or clinical
endpoint bioequivalence) may be waived for soluble powder oral dosage
form products or Type A medicated articles in either of two alternative
ways. A biowaiver may be granted if it can be shown that the generic
soluble powder oral dosage form product or Type A medicated article
contains the same active and inactive

ingredient(s) and is produced using the same manufacturing processes as
the approved comparator product or article. Alternatively, a biowaiver
may be granted without direct comparison to the pioneer product's
formulation and manufacturing process if it can be shown that the
active pharmaceutical ingredient(s) (API) is the same as the pioneer
product, is soluble, and that there are no ingredients in the
formulation likely to cause adverse pharmacologic effects. For the
purpose of evaluating soluble powder oral dosage form products and Type
A medicated articles, solubility can be demonstrated in one of two
ways: ``USP definition'' approach or ``Dosage adjusted'' approach. The
respondents for this collection of information are pharmaceutical
companies manufacturing animal drugs. FDA estimates the burden for this
collection of information as follows in tables 1 and 2 of this
document. The source of the above data is records of generic drug
applications over the past 10 years.
    In the Federal Register of October 24, 2011 (76 FR 65733), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment, which, however,
did not address the questions posed in 60-day notice regarding the
collection of information. The comment supported the bioequivalence
program but suggested a revision to the determination of
bioequivalence, which relates to the substance of the scientific
recommendations in the guidance document. Under FDA's good guidance
practices regulations (21 CFR 10.115(f)(4)), the public may suggest at
anytime that FDA revise a guidance document and under 21 CFR
10.115(g)(5), FDA will revise guidance documents in response to
comments when appropriate.
    FDA estimates the burden of this collection of information as
follows:

                    Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing                 1               1               1               5               5
 process approach...............
Same API/solubility approach....               5               5               5              10              50
                                 -------------------------------------------------------------------------------
    Total burden hours..........  ..............  ..............  ..............  ..............              55
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                  Table 2--Estimated Annual Reporting Burden for Type A Medicated Articles \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Same formulation/manufacturing                 2               2               2               5              10
 process approach...............
Same API/solubility approach....              10              10              10              20             200
                                 -------------------------------------------------------------------------------
    Total burden hours..........  ..............  ..............  ..............  ..............             210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6391 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P