[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Rules and Regulations]
[Pages 11583-11589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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the tolerances will be superseded by tolerances established by this 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 (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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="135d7c677a707660537663723d747c65">[email protected]</a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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

[[Page 11584]]

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:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
    <bullet> 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

[[Page 11585]]

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.

[[Page 11586]]

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.

[[Page 11587]]

    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,

[[Page 11588]]

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


[[Page 11589]]

* * * * *
[FR Doc. 2015-04277 Filed 3-3-15; 8:45 am]
BILLING CODE 6560-50-P


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