[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: 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.
[[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:
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 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