Document ID: EPA-HQ-OPP-2012-0706-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Metaldehyde
Posted Date: 2013-11-27T05:00Z

[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Rules and Regulations]
[Pages 70864-70870]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28370]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0706; FRL-9399-8]

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. This regulation additionally removes 
the established tolerances in or on berry group 13 and strawberry, as 
the tolerances will be superseded by tolerances established by this 
action. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 27, 2013. Objections and 
requests for hearings must be received on or before January 27, 2014, 
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-2012-0706, 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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-2012-0706 in the subject line on

[[Page 70865]]

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 January 27, 2014. 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-2012-0706, 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 September 28, 2012 (77 FR 59578) (FRL-
9364-6), 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 
2E8070) by IR-4, 500 College Rd. East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.523 be amended by 
establishing tolerances for residues of the molluscicide metaldehyde in 
or on berry, low growing, subgroup 13-07G at 6.25 parts per million 
(ppm); bushberry subgroup 13-07B at 0.15 ppm; caneberry subgroup 13-07A 
at 0.15 ppm; corn, field, forage at 0.25 ppm; corn, field, grain at 
0.05 ppm; corn, field, stover at 0.15 ppm; corn, sweet, kernel plus cob 
with husks removed at 0.05 ppm; grass, forage at 1.5 ppm; grass, hay at 
1.8 ppm; leaf petioles subgroup 4B at 0.80 ppm; peppermint, oil at 14 
ppm; peppermint, tops at 3.5 ppm; soybean, seed at 0.05 ppm; spearmint, 
oil at 14 ppm; spearmint, tops at 3.5 ppm; taro, corm at 0.25 ppm; and 
taro, leaves at 0.60 ppm. That document referenced a summary of the 
petition prepared on behalf of IR-4 by Lonza, Inc., 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 petition, EPA has 
revised the proposed tolerances for several commodities and has 
determined that tolerances on sweet corn forage and stover are 
necessary. The Agency has also determined that the tolerance expression 
should be revised for all commodities. The reasons for these changes 
are explained in Unit IV.C.

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 toxicity profile of metaldehyde demonstrates that the principal 
toxic effects 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; emesis; rapid respiration in dogs 
and maternal rats; limb paralysis, spinal cord necrosis, and hemorrhage 
in maternal rats; salivation; and twitching. 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 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 highest dose tested.
    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 classified 
metaldehyde as having ``suggestive evidence of carcinogenicity'' and 
has determined that quantification of risk using a nonlinear reference 
dose (RfD)

[[Page 70866]]

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.
    6. Both the no-observed-adverse-effect-level (NOAEL) and the 
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 NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document: ``Metaldehyde; Human Health Risk 
Assessment for Proposed Uses on Grass Grown for Seed, Leaf Petioles 
[Crop Subgroup 4B], Wetland Taro, Field & Sweet Corn, Mint, and 
Soybeans, and for Amendments to Existing Tolerances [Crop Subgroups 13-
07A, B, & G]'' in pp. 37-43 in docket ID number EPA-HQ-OPP-2012-0706.

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 the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a PAD or 
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 shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Metaldehyde for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       Risk assessment
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Acute dietary (General population  NOAEL = 30 mg/kg/day  Acute RfD = 0.30 mg/ Chronic dog oral toxicity study.
 including infants and children    UFA = 10x...........   kg/day.             LOAEL = 90 mg/kg/day, based on
 and females 13-49).               UFH = 10x...........  aPAD = 0.30 mg/kg/    clinical signs (ataxia, tremor,
                                   FQPA SF = 1x........   day.                 salivation, twitching) seen on
                                                                               day 1 of dosing (both sexes).
Chronic dietary (All populations)  NOAEL = 10 mg/kg/day  Chronic RfD = 0.10   Chronic dog oral toxicity study.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 30 mg/kg/day, based on
                                   UFH = 10x...........  cPAD = 0.10 mg/kg/    death and atrophy of the testes
                                   FQPA SF = 1x........   day.                 and prostate.
Incidental oral short-term (1 to   NOAEL = 30 mg/kg/day  LOC for MOE = 100..  Chronic dog oral toxicity study.
 30 days).                         UFA = 10x...........                       LOAEL = 90 mg/kg/day, based on
                                   UFH = 10x...........                        clinical signs (ataxia, tremor,
                                   FQPA SF = 1x........                        salivation, twitching) seen on
                                                                               day 1 of dosing (both sexes).
Incidental oral intermediate-term  NOAEL = 10 mg/kg/day  LOC for MOE = 100..  Chronic dog oral toxicity study.
 (1 to 6 months).                  UFA = 10x...........                       LOAEL = 30 mg/kg/day, based on
                                   UFH = 10x...........                        death and atrophy of the testes
                                   FQPA SF = 1x........                        and prostate.
Inhalation short-term (1 to 30     NOAEL = 30 mg/kg/day  LOC for MOE = 100..  Chronic dog oral toxicity study.
 days).                            UFA = 10x...........                       LOAEL = 90 mg/kg/day, based on
                                   UFH = 10x...........                        clinical signs (ataxia, tremor,
                                   FQPA SF = 1x........                        salivation, twitching) seen on
                                                                               day 1 of dosing (both sexes).
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Suggestive Evidence of Carcinogenicity; EPA has determined
                                    that quantification of risk using the chronic RfD/PAD will adequately
                                    account for all chronic toxicity, including carcinogenicity.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to metaldehyde, EPA considered exposure under the petitioned-
for tolerances as well as all existing metaldehyde tolerances in 40 CFR 
180.523. EPA assessed dietary

[[Page 70867]]

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 software with the Food Commodity 
Intake Database (DEEM-FCID) Version 3.16, which uses food consumption 
data from the U.S. Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, ``What We Eat in America'' (NHANES/
WWEIA) from 2003 through 2008. As to residue levels in food, EPA used 
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 version 7.81 default processing factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 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 version 7.81 default processing 
factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that chronic RfD/PAD is protective 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 1,740 ppb for ground water. Chronic exposures are 
estimated to be 136 ppb for surface water and 635 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration values 
of 1,740 ppb and 635 ppb were used to assess the contribution to 
drinking water for the acute and chronic dietary risk assessments, 
respectively.
    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 the following residential exposures:
    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.)
    ii. Metaldehyde incidental postapplication 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/EPA-OPP HED_Residential%20SOPS_Feb2012.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.'' 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 Food Quality 
and Protection Act Safety Factor (FQPA SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. Developmental toxicity 
studies in rats and rabbits and a 2-generation reproduction study in 
rats are available to assess potential fetal and offspring sensitivity 
to metaldehyde. There is no evidence of increased qualitative or 
quantitative susceptibility in any of these studies.
    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. EPA has 
determined that the immunotoxicity study required for pesticide 
registration is not needed, nor are addition UFs necessary to account 
for immunotoxicity concerns. The toxicology database reveals no 
evidence of treatment-related effects on the

[[Page 70868]]

immune system suggesting that the immune system is not the primary 
target organ. EPA considers the NOAELs selected for risk assessment to 
be protective of any potential immunotoxic effects for infants and 
children. Given the information regarding the retrospective analysis 
for immunotoxicity studies and the existing data on metaldehyde 
toxicity, EPA considers the NOAELs selected for risk assessment to be 
protective of potential immunotoxic effects for infants and children.
    ii. There is a concern for neurotoxicity resulting from exposure to 
metaldehyde; however, most neurotoxic signs were seen in rats at doses 
above 100 mg/kg. These neurotoxic signs included:
    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 the 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, with no evident 
neuropathology.
    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 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. Neurotoxicity effects observed 
in the rat occur only at high dose levels. The dog is the more 
sensitive species for neurotoxic effects and points of departure are 
based on the chronic dog oral toxicity study, which EPA considers to be 
protective of any neurotoxicity at higher dose levels. Finally, there 
is a subchronic neurotoxicity study available for metaldehyde with a 
clearly defined NOAEL/LOAEL.
    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 postapplication incidental oral 
exposures of children. 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 
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 metaldehyde will occupy 99% 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 36% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure.
    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 1,900 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. Because EPA's level of concern for 
metaldehyde is a MOE of 100 or below, this MOEs 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. See Unit III.E.2.
    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, a gas chromatography with mass 
spectrometry (GC/MS) method (EN-CAS Method No. ENC-3/99, Revision 1) is 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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

[[Page 70869]]

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. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA revised the 
proposed tolerances for several commodities, as follows: Corn, field, 
forage from 0.25 ppm to 0.30 ppm; corn, field, stover from 0.15 ppm to 
0.10 ppm; grass, forage from 1.5 ppm to 2.0 ppm; grass, hay from 1.8 
ppm to 2.0 ppm; leaf petioles subgroup 4B from 0.80 ppm to 0.50 ppm; 
peppermint, oil from 14 ppm to 12 ppm; peppermint, tops from 3.5 ppm to 
4.0 ppm; spearmint, oil from 14 ppm to 12 ppm; spearmint, tops from 3.5 
ppm to 4.0 ppm; taro, corm from 0.25 ppm to 0.15 ppm; and taro, leaves 
from 0.60 ppm to 1.0 ppm. The Agency revised these tolerance levels 
based on analysis of the residue field trial data using the 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculation procedures. Additionally, the Agency has determined that 
tolerances in or on corn, sweet, forage at 0.30 ppm and corn, sweet, 
stover at 0.10 ppm are necessary. Because sweet corn forage and stover 
may bear detectable metaldehyde residues and be used as a livestock 
feedstuff, it was determined that these tolerances should be 
established in order to support the use of metaldehyde in or on sweet 
corn.
    Finally, the Agency has revised the tolerance expression to 
clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of metaldehyde not specifically 
mentioned.
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only metaldehyde.

V. Conclusion

    Therefore, tolerances are established for residues of metaldehyde, 
2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on berry, low growing, 
subgroup 13-07G at 6.25 ppm; bushberry subgroup 13-07B at 0.15 ppm; 
caneberry subgroup 13-07A at 0.15 ppm; corn, field, forage at 0.30 ppm; 
corn, field, grain at 0.05 ppm; corn, field, stover at 0.10 ppm; corn, 
sweet, forage at 0.30; corn, sweet, kernel plus cob with husks removed 
at 0.05 ppm; corn, sweet, stover at 0.10 ppm; grass, forage at 2.0 ppm; 
grass, hay at 2.0 ppm; leaf petioles subgroup 4B at 0.50 ppm; 
peppermint, oil at 12 ppm; peppermint, tops at 4.0 ppm; soybean, seed 
at 0.05 ppm; spearmint, oil at 12 ppm; spearmint, tops at 4.0 ppm; 
taro, corm at 0.15 ppm; and taro, leaves at 1.0 ppm;. The regulation 
additionally removes the tolerances in or on berry group 13 at 0.15 ppm 
and strawberry at 6.25 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: October 25, 2013.
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.  180.523, revise paragraphs (a) and (c) to read as follows:

Sec.  180.523  Metaldehyde; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
molluscicide metaldehyde, including its metabolites and degradates, in 
or on the commodities listed in the following table. Compliance with 
the specified tolerance levels is to be determined by measuring only 
metaldehyde, 2,4,6,8-

[[Page 70870]]

tetramethyl-1,3,5,7-tetroxocane, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Artichoke, globe...........................................         0.07
Berry, low growing, subgroup 13-07G........................         6.25
Bushberry subgroup 13-07B..................................         0.15
Cactus.....................................................         0.07
Caneberry subgroup 13-07A..................................         0.15
Corn, field, forage........................................         0.30
Corn, field, grain.........................................         0.05
Corn, field, stover........................................         0.10
Corn, sweet, forage........................................         0.30
Corn, sweet, kernel plus cob with husks removed............         0.05
Corn, sweet, stover........................................         0.10
Fruit, citrus, group 10....................................         0.26
Grass, forage..............................................          2.0
Grass, hay.................................................          2.0
Leaf petioles subgroup 4B..................................         0.50
Lettuce....................................................         1.73
Peppermint, oil............................................           12
Peppermint, tops...........................................          4.0
Spearmint, oil.............................................           12
Spearmint, tops............................................          4.0
Taro, corm.................................................         0.15
Taro, leaves...............................................          1.0
Tomato.....................................................         0.24
Vegetable, brassica, leafy, group 5........................          2.5
Watercress.................................................          3.2
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with a 
regional registration as defined in Sec.  180.1(l) are established for 
residues of the molluscicide metaldehyde, including its metabolites and 
degradates, in or on the following commodities. Compliance with the 
specified tolerance level is to be determined by measuring only 
metaldehyde, 2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on the 
commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Soybean, seed..............................................         0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-28370 Filed 11-26-13; 8:45 am]
BILLING CODE 6560-50-P