[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Rules and Regulations]
[Pages 71633-71638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25166]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0558; FRL-9951-78]


Metaldehyde; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances with regional 
registration 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).

DATES: This regulation is effective October 18, 2016. Objections and 
requests for hearings must be received on or before December 19, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0558, 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: Michael Goodis, Acting Director, 
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: [email protected].

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.

[[Page 71634]]

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-2015-0558 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 
December 19, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0558, 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 Wednesday, September 9, 2015 (80 FR 
54257) (FRL-9933-26), 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 5E8377) by Interregional Research Project Number 4 (IR-4), 
IR-4 Headquarters, 500 College Road 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, 
2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on beet, garden, roots 
at 0.05 parts per million (ppm); beet, garden, tops at 0.08 ppm; hop, 
dried cones at 0.05 ppm; rutabaga, roots at 0.05 ppm; turnip, greens 
(tops) at 0.08 ppm; turnip, roots at 0.05 ppm; wheat, forage at 0.05 
ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.05 ppm and wheat, straw 
at 0.05 ppm. That document referenced a summary of the petition 
prepared 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 made 
certain modifications to the petitioned-for crop tolerances. The reason 
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 database 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 shows that the principal toxic 
effects are clinical signs of neurotoxicity. The dog is the most 
sensitive species for the neurotoxic effects. The nervous system 
effects observed in subchronic and chronic oral toxicity studies 
include: (1) Neurotoxic signs, i.e., ataxia; tremor; twitching; 
salivation; emesis; and rapid respiration in dogs and maternal rats; 
and (2) neuropathology, i.e., limb paralysis, spinal cord necrosis, and 
hemorrhage in maternal rats.
    The liver is a target organ following subchronic and chronic oral 
exposure to metaldehyde as evidenced by increased liver weight, 
increased incidence of liver lesions, i.e., hepatocellular necrosis, 
hepatocellular hypertrophy, inflammation, and an increased incidence of 
hepatocellular adenomas/carcinomas in female rats and hepatocellular 
adenomas in both sexes of mice. The testes and prostate are also target 
organs following subchronic and chronic exposure as evidenced by 
atrophy of both organs in dogs.
    Developmental toxicity was not observed in the rat or rabbit 
developmental toxicity studies. Maternal toxicity was not observed in 
the rabbit, although maternal toxicity was observed in the rat, as 
evidenced by clinical signs including ataxia, tremors, and twitching at 
the highest dose tested (HDT). In the rat reproductive toxicity study, 
mortality and clinical signs, i.e., 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.
    In chronic feeding studies in mice and rats, benign liver tumors 
were seen in both sexes of mice and in female rats. The Agency has 
determined that quantification of risk using a non-linear Reference 
Dose (RfD) approach for metaldehyde 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) The tumors found are commonly seen in the mouse; 
(2) the 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

[[Page 71635]]

female rat was within the historical control range of the testing lab; 
and (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/population-adjusted dose (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 New Uses on Garden Beets, Hops, Rutabaga, 
Turnips and Wheat with Regional Registration in the Pacific 
Northwest,'' in docket ID number EPA- HQ-OPP-2015-0558.

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 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 PAD or a 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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-9388-8).

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 
software with the Food Commodity Intake Database (DEEM-FCID), Version 
3.16, which incorporates 2003-2008 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). As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities and 100 percent crop treated (PCT). In addition, the Agency 
assumed processing factors to be 1.0 for all commodities except for 
tomato, dried; 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 DEEM-FCID, Version 3.16, which incorporates 
2003-2008 food consumption data from the USDA's, NHANES/WWEIA. As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities and 100 PCT. Processing factors were assumed to be 1.0 for 
all commodities except for tomato, dried; tomato, juice; cranberry, 
juice; and high fructose corn syrup; for these commodities, DEEM 
default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA 
concluded that quantification of risk using a non-linear RfD approach 
will adequately account for all chronic toxicity, including 
carcinogenicity. Therefore, a dietary exposure assessment for the 
purpose of assessing cancer risk was not conducted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
metaldehyde. Tolerance-level residues and 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    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 1880 ppb for ground water. Chronic exposures for non-
cancer assessments are estimated to be 136 ppb for surface water and 
915 ppb for ground water.
    For acute dietary risk assessment, the full distribution of ground 
water concentrations from the PRZM-GW model was used to assess the 
contribution from drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 915 ppb was used to assess the contribution from 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 and exposure factors: For adult residential 
handlers, EPA conducted a short-term exposure assessment of metaldehyde 
for adults based on the inhalation route, incorporating the maximum 
labeled application rate, and unit exposure values and estimates for 
area treated/amount handled taken from the 2012 Residential Standard 
Operating Procedures (SOPs). The scenario resulting in the highest 
adult exposure in a residential setting was hand dispersal of granules, 
which was used in the short-term aggregate assessment. Additional 
scenarios assessed included; loading and applying distinct metaldehyde 
product types, i.e., liquid ready-to-use products applied manually via 
pressurized hand wands, hose-end sprayers, and sprinkler cans, as well 
as

[[Page 71636]]

applying granular products via push-type rotary spreaders, belly 
grinders, spoons, cups, hands, and shaker cans.
    For children, the highest estimated metaldehyde exposure resulted 
from post-application incidental oral exposures of short-term duration 
from hand-to-mouth and object-to-mouth contact with treated turf, and 
short- and intermediate-term exposures from treated soil. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 no 
maternal toxicity observed in the rabbit. Maternal toxicity was 
observed in the rat, as evidenced by clinical signs, i.e., ataxia, 
tremors, and twitching, however these effects were observed only at the 
highest dose tested. In the rat reproductive toxicity study, mortality 
and clinical signs, i.e., 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. Although there are indications of neurotoxicity from exposure 
to metaldehyde, there are clear NOAELs/LOAELS for these effects, and 
Points of Departure selected for risk assessment are protective for 
these effects. 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 following in utero exposure to metaldehyde in either the 
rat or rabbit developmental toxicity study, and there is no evidence of 
increased susceptibility following in utero and/or pre-/post-natal 
exposure in the 2-generation reproduction study in rats.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on established and proposed tolerance-level residues, 100 PCT, default 
processing factors, and EDWCs from chronic ground water (worst case) 
models to assess exposure to metaldehyde in drinking water. EPA used 
similarly conservative assumptions to assess exposure to adult 
handlers, and post application exposure of children (including 
incidental oral exposure of toddlers). These assessments will not 
underestimate the exposure and risks posed by metaldehyde based on the 
current and proposed use patterns.

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 18% of the aPAD for the general population, 
and 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 22% of the cPAD for the 
general population, and 52% of the cPAD for all infants less than 1 
year old, the population group receiving the greatest exposure. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of metaldehyde is 
not expected.
    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 1400 for adults and 580 for 
children. Because EPA's level of concern for metaldehyde

[[Page 71637]]

is an 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 270 (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, EPA believes that quantification of metaldehyde 
risk using a non-linear RfD approach will adequately account for all 
related chronic toxicity, including carcinogenicity. Based on the 
chronic risk assessment, 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\TM\ Method No. ENC-3/99, Revision 
1) is available to enforce the tolerance expression. The limit of 
quantitation (LOQ) for this method is 0.05 ppm for all plant 
commodities except hops, for which it is 0.10 ppm.
    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: 
[email protected].

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. Revisions to Petitioned-for Tolerances

    For hop, dried cones, the analytical method was not successfully 
validated at the proposed tolerance level of 0.05 ppm. Therefore, EPA 
is establishing the tolerance level for this commodity at the lowest 
validated LOQ for hops of 0.10 ppm. In addition, the commodity 
definition proposed as ``beet, garden, tops'' is corrected to read: 
``beet, garden, leaves''.

V. Conclusion

    Therefore, tolerances are established for residues of metaldehyde, 
2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on beet, garden, leaves 
at 0.08 ppm; beet, garden, roots at 0.05 ppm; hop, dried cones at 0.10 
ppm; rutabaga, roots at 0.05 ppm; turnip, greens at 0.08 ppm; turnip, 
roots at 0.05 ppm; wheat, forage at 0.05 ppm; wheat, grain at 0.05 ppm; 
wheat, hay at 0.05 ppm and wheat, straw at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

[[Page 71638]]

List of Subjects in 40 CFR Part 180

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

    Dated: September 30, 2016.
Michael L. Goodis,
Acting 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, add alphabetically the commodities ``beet, garden, 
leaves''; ``beet, garden, roots''; ``hop, dried cones''; ``rutabaga, 
roots''; ``turnip greens''; ``turnip, roots''; ``wheat, forage''; 
``wheat, grain''; ``wheat, hay''; and ``wheat, straw'' to the table in 
paragraph (c) to read as follows:


Sec.  180.523  Metaldehyde; tolerances for residues.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beet, garden, leaves.......................................         0.08
Beet, garden, roots........................................         0.05
 
                                * * * * *
Hop, dried cones...........................................         0.10
Rutabaga, roots............................................         0.05
 
                                * * * * *
Turnip greens..............................................         0.08
Turnip, roots..............................................         0.05
Wheat, forage..............................................         0.05
Wheat, grain...............................................         0.05
Wheat, hay.................................................         0.05
Wheat, straw...............................................         0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-25166 Filed 10-17-16; 8:45 am]
BILLING CODE 6560-50-P