[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Rules and Regulations]
[Pages 11583-11589]
[FR Doc No: 2015-04277]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0110; FRL-9921-85]

Metaldehyde; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
metaldehyde 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). This regulation additionally removes the
established tolerances in or on fruit, citrus group 10 and tomato as
the tolerances will be superseded by tolerances established by this
action.

DATES: This regulation is effective March 4, 2015. Objections and
requests for hearings must be received on or before May 4, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0110 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an

objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0110 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
May 4, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0110, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 25, 2014 (79 FR 10459) (FRL-
9906-77), 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
3E8223) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.523 be amended by
establishing tolerances for residues of the molluscicide metaldehyde,
2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on clover, forage at 0.5
parts per million (ppm); clover, hay at 0.5 ppm; ginseng at 0.05 ppm;
vegetable legume, edible podded, subgroup 6A at 0.8 ppm; pea and bean,
succulent shelled, subgroup 6B at 0.2 ppm; vegetable, foliage of
legume, except soybean, subgroup 7A at 1.5 ppm; tomato subgroup 8-10A
at 0.24 ppm; and fruit, citrus, group 10-10 at 0.26 ppm. Clover, forage
and clover, hay were proposed as tolerances with regional
registrations. Additionally, the petition requested removing the
established tolerances in or on fruit, citrus, group 10 at 0.26 ppm;
and tomato at 0.24 ppm, upon establishment of the proposed tolerances.
That document referenced a summary of the petition prepared by Lonza,
Inc., the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the proposed tolerances for clover, forage and clover, hay
from 0.5 ppm to 0.60 ppm. The reason for these changes are explained in
Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue* *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for metaldehyde including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with metaldehyde 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 principal toxic effects for metaldehyde are clinical
signs of neurotoxicity, as well as changes in the liver and testes/
prostate following repeated oral dosing. The dog is the most sensitive
species for neurotoxic effects. Nervous system effects observed in the
subchronic and chronic oral toxicity studies include: Ataxia and
tremors; twitching; salivation; emesis; rapid respiration in dogs and
maternal rats; and limb paralysis, spinal cord necrosis, and hemorrhage
in maternal rats. Liver effects include increased liver weight,
increased incidence of liver lesions (hepatocellular necrosis,
hepatocellular hypertrophy and inflammation), and an increased
incidence of hepatocellular adenomas in female rats and in both sexes
of mice. In dogs, atrophy of the testes and prostate was observed
following subchronic and chronic exposure.
    In the rat developmental toxicity study, maternal toxicity was
observed as evidenced by clinical signs including ataxia, tremors, and
twitching at the highest dose tested (HDT) in the absence of
developmental toxicity. There was no observed developmental or maternal
toxicity in the rabbit developmental toxicity study. In the 2-
generation rat reproductive toxicity study, mortality and clinical
signs including limb paralysis, spinal cord necrosis and hemorrhage
were observed in the maternal animals. Effects on the offspring in the
rat reproductive toxicity study consisted of decreased pup body weight
and body weight gains; reproductive toxicity was not observed.
    In the rat, clinical signs of neurotoxicity occurred at high dose
levels following repeated oral exposures. In the 90-day neurotoxicity
study, bilateral hindlimb paralysis was observed in one female rat at
the HDT.
    Chronic feeding studies in rats and mice indicated that metaldehyde
produced liver effects characterized by liver hypertrophy and liver
tumors. The chronic mouse toxicity study showed that metaldehyde was
associated with a common tumor in both sexes (liver tumors, adenomas),
and the rat chronic

toxicity study showed that metaldehyde was associated with liver
adenomas in the female. EPA has determined that quantification of risk
using a nonlinear Reference Dose (RfD) approach, using the chronic RfD/
Population-Adjusted Dose (PAD), will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
metaldehyde. That conclusion is based on the following considerations:
    1. Tumors found are commonly seen in the mouse;
    2. Liver tumors (adenomas) in both species were benign;
    3. Metaldehyde is not mutagenic;
    4. No carcinogenic response was seen in the male rat;
    5. Incidence of adenomas at the high dose in the female rat was
within the historical control range of the testing lab; and
    6. Both the No Observed Adverse Effect Level (NOAEL) and Lowest
Observed Adverse Effect Level (LOAEL) from the chronic rat study on
which the chronic RfD/PAD was based are well below the dose at which
adenomas were seen.
    Specific information on the studies received and the nature of the
adverse effects caused by metaldehyde as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Metaldehyde; Human Health Risk
Assessment for Proposed New Uses on Vegetable, Legume, Edible Podded
[Subgroup 6A], Pea and Bean, Succulent Shelled [Subgroup 6B],
Vegetable, Foliage of Legume, Except Soybean [Subgroup 7A], Clover
Forage and Hay, and Ginseng; and for Amendments to Existing Tolerances
[Tomato and Crop Group 10]'' in docket ID number EPA-HQ-OPP-2014-0110.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for metaldehyde used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of November 27, 2013 (78 FR 70864)
(FRL-9399-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metaldehyde, EPA considered exposure under the petitioned-
for tolerances as well as all existing metaldehyde tolerances in 40 CFR
180.523. EPA assessed dietary exposures from metaldehyde 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 metaldehyde. In estimating acute
dietary exposure, EPA used the Dietary Exposure Evaluation Model with
the Food Commodity Intake Database (DEEM-FCID). This software
incorporates 2003-2008 food consumption data from the U.S. Department
of Agriculture's National Health and Nutrition Examination Survey, What
We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA
used tolerance-level residues for all commodities and 100 percent crop
treated (PCT) estimates. The Agency also assumed processing factors to
be 1.0 for all commodities except for dried tomato, tomato juice,
cranberry juice, and high fructose corn syrup; for these commodities,
DEEM default processing factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level
residues for all commodities and assumed 100 PCT. The Agency also
assumed processing factors to be 1.0 for all commodities except for
dried tomato, tomato juice, cranberry juice, and high fructose corn
syrup; for these commodities, DEEM default processing factors were
used.
    iii. Cancer. As discussed in Unit III.A., EPA has concluded that a
nonlinear RfD approach is appropriate for assessing cancer risk to
metaldehyde. Cancer risk was assessed using the same exposure estimates
as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for metaldehyde. Tolerance-level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metaldehyde in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metaldehyde. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of metaldehyde
for acute exposures are estimated to be 205 parts per billion (ppb) for
surface water and 1,880 ppb for ground water and for chronic exposures
for non-cancer assessments are estimated to be 136 ppb for surface
water and 915 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
1,880 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 915 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).
    Metaldehyde is currently registered for the following uses that
could result in residential exposures: Residential ornamentals and
lawn/turf applications.

EPA assessed residential exposure using the following assumptions:
    i. Adult handler short-term inhalation exposures from loading/
applying metaldehyde products including liquid ready-to-use products
(with manually-pressurized hand wands, hose-end sprayers, and sprinkler
cans) and applying granules (via push-type rotary spreaders, belly
grinders, spoons, cups, hands, and shaker cans); and
    ii. Metaldehyde incidental post-application exposures assessed for
children, including short-term exposure from hand-to-mouth and object-
to-mouth contact with treated turf, and short- and intermediate-term
exposures from treated soil ingestion. While EPA did calculate an acute
incidental ingestion scenario for toddlers accidentally ingesting
granules of metaldehyde, it is not appropriate to aggregate this
scenario because it represents poisoning incident which is not likely
to overlap with the typical post-application exposure scenario. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found metaldehyde to share a common mechanism of
toxicity with any other substances, and metaldehyde does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
metaldehyde does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Developmental toxicity was
not observed in the rat or rabbit developmental toxicity studies, and
maternal toxicity was not observed in the rabbit. In the rat, maternal
toxicity was observed, as evidenced by clinical signs (ataxia, tremors,
and twitching) at the HDT. In the rat reproductive toxicity study,
mortality and clinical signs (limb paralysis, spinal cord necrosis and
hemorrhage) were observed in the maternal animals, and the effects on
the offspring consisted of decreased pup body weight and body weight
gains. Reproductive toxicity was not observed.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for metaldehyde is complete.
    ii. The toxicity database contains indications of neurotoxicity
resulting from exposure to metaldehyde, including:
    a. Clinical signs [ataxia, twitching, tremors, prostration, paresis
of hind legs] in female rats in the developmental toxicity study;
    b. Hindlimb paralysis, necrosis and hemorrhage in the spinal cord
and vertebra luxation in F0 dams during lactation period in the 2-
generation reproduction study;
    c. Bilateral hindlimb paralysis observed initially on day 10 in one
high-dose female sacrificed on day 22 due to poor condition in the 90-
day subchronic neurotoxicity study in rats; no neuropathology was
evident;
    d. Clinical signs [ataxia, tremors, twitching, salivation] in the
chronic dog study, which occurred within the first week of exposure and
persisted through week 19; other signs observed in the chronic dog
study included lateral position, reduced mobility, convulsions, and
vocalization in one female, and agitation in another.
    EPA has determined that the acute and developmental neurotoxicity
studies are not needed, nor are additional uncertainty factors (UFs)
necessary to account for neurotoxicity. There were no indications of
neurotoxic effects in developing rats or rabbits in either the
developmental or reproductive studies. Although there were some effects
in adult rats, those effects occurred at doses much higher than in the
dog study. The dog is the more sensitive species for neurotoxic effects
and points of departure (30 mg/kg/day and 10 mg/kg/day) are based on
the chronic dog oral toxicity study, which EPA considers to be
protective of any neurotoxicity at higher dose levels.
    iii. There is no evidence that metaldehyde results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to metaldehyde in drinking water. EPA used similarly
conservative assumptions to assess post application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
metaldehyde.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to metaldehyde will occupy 55% of the aPAD for all infants (less than 1
year old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metaldehyde from food and water will utilize 51% of the cPAD for all
infants less than 1 year old the population group receiving the
greatest exposure. Chronic exposures to metaldehyde are expected for
food and water only.

    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). Metaldehyde
is 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 metaldehyde. Using the exposure
assumptions described in this unit for short-term exposures, EPA has
concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 1,400 for adults and 590 for
children. Because EPA's level of concern for metaldehyde is a MOE of
100 or below, these MOEs 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). Metaldehyde is currently registered for uses that could result
in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with intermediate-term residential exposures to
metaldehyde.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 280 for children, only. Because EPA's level of concern
for metaldehyde is a MOE of 100 or below, this MOE is not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., EPA has concluded that a nonlinear RfD
approach is appropriate for assessing cancer risk to metaldehyde.
Cancer risk was assessed using the same cPAD and exposure estimates as
discussed in Unit III.A. and Unit III.C.1.ii. for the chronic risk
assessment. Based on the results discussed in Unit III.E.2., EPA
concludes that aggregate exposure to metaldehyde will not pose a 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 metaldehyde residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with mass
spectrometry (GC/MS) method (EN-CAS Method No. ENC-3/99, Revision 1) is
available to enforce the tolerance expression.

B. International Residue Limits

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

C. Response to Comments

    Six comments were posted in the docket for this action. However,
the comments received were regarding bee concerns for a different
chemical, sulfoxaflor. These comments were addressed at the time the
Agency assessed sulfoxaflor. As a result, the only comments received
were determined to be irrelevant to the Agency's tolerance action on
metaldehyde.

D. Revisions to Petitioned-For Tolerances

    The Agency has determined that tolerances of 0.60 ppm for clover
hay and forage are appropriate based on available residue data and use
of the OECD tolerance calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of metaldehyde
in or on the following commodities: Vegetable, legume, edible podded,
subgroup 6A at 0.80 ppm; pea and bean, succulent shelled, subgroup 6B
at 0.20 ppm; vegetable, foliage of legume, except soybean, subgroup 7A
at 1.5 ppm; tomato subgroup 8-10A at 0.24 ppm; fruit, citrus, group 10-
10 at 0.26; and ginseng at 0.05 ppm; and tolerances with regional
registrations for clover, forage at 0.60 ppm and clover, hay at 0.60
ppm. The regulation additionally removes the tolerances in or on fruit,
citrus group 10 and tomato.

VI. Statutory and Executive Order Reviews

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

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 23, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.523:
0
a. Revise the entry for ``Fruit, citrus, group 10'' in the table in
paragraph (a).
0
b. Add alphabetically the entries for ``Ginseng''; ``Pea and bean,
succulent shelled, subgroup 6B''; ``Tomato subgroup 8-10A'';
``Vegetable, foliage of legume, except soybean, subgroup 7A''; and
``Vegetable, legume, edible podded subgroup 6A'' to the table in
paragraph (a).
0
c. Remove the entry for ``Tomato'' in the table in paragraph (a).
0
d. Add alphabetically the entries for ``Clover, forage'' and ``Clover,
hay'' to the table in paragraph (c).
    The amendments read as follows:

Sec.  180.523  Metaldehyde; tolerances for residues.

    (a) * * *

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

                              * * * * * * *
------------------------------------------------------------------------
Fruit, citrus, group 10-10..............................            0.26
Ginseng.................................................            0.05
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Pea and bean, succulent shelled, subgroup 6B............            0.20
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Tomato subgroup 8-10A...................................            0.24
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Vegetable, foliage of legume, except soybean, subgroup               1.5
 7A.....................................................
Vegetable, legume, edible podded subgroup 6A............            0.80
------------------------------------------------------------------------

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

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Clover, forage..........................................            0.60
Clover, hay.............................................            0.60
------------------------------------------------------------------------

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

* * * * *
[FR Doc. 2015-04277 Filed 3-3-15; 8:45 am]
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