[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Rules and Regulations]
[Pages 27130-27134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10950]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0261; FRL-9339-6]
Ametoctradin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
ametoctradin in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 9, 2012. Objections and
requests for hearings must be received on or before July 9, 2012, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0261. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Shaunta Hill, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 347-8961; 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
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://ecfr.gpoaccess.gov/cgi/t/text/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
[[Page 27131]]
identify docket ID number EPA-HQ-OPP-2010-0261 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 July 9, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0261, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-for Tolerance
In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7695)
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC. The
petition requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the fungicide ametoctradin, including its
metabolites and degradates, in or on brassica, head and stem, subgroup
5A at 12 parts per million (ppm); brassica, leafy greens, subgroup 5B
at 50 ppm; grape at 5.0 ppm; grape, raisin at 8 ppm; hop, dried cones
at 9 ppm; onion, bulb, subgroup 3-07A at 1.2 ppm; onion, green,
subgroup 3-07B at 16 ppm; vegetable, cucurbit, group 9 at 4.5 ppm;
vegetable, fruiting, group 8-10 at 2 ppm; vegetable, leafy, except
brassica, group 4, at 70 ppm, and vegetable, tuberous and corm,
subgroup 1C at 0.05 ppm. That notice referenced a summary of the
petition prepared by BASF Corporation, 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
proposed different tolerance levels under a cooperative global review
process. The reason for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 ametoctradin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with ametoctradin
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.
In toxicity testing with ametoctradin, no single dose or repeated
dose study performed by any route of exposure produced a significant
toxic effect up to or within 75-80% of the limit dose (1000 mg/kg/day).
This includes the studies performed with the ametoctradin metabolites.
There was also no evidence of carcinogenicity or mutagenicity and
therefore ametoctradin is considered ``Not Likely to Be Carcinogenic to
Humans''.
Specific information on the studies received and the nature of the
adverse effects caused by ametoctradin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``BAS 650 F (Ametoctradin): Human
Health Risk Assessment for the Proposed New Fungicide Active
Ingredient,'' at p. 10 in docket ID number EPA-HQ-OPP-2010-0261.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. Based on the available data,
there were no adverse acute or chronic effects identified as to any
population groups (including infants and children).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
[[Page 27132]]
exposure to ametoctradin, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from ametoctradin 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. No such effects were
identified in the toxicological studies for ametoctradin; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. No chronic dietary exposure assessment was
conducted because no chronic effect of concern was identified in the
available data.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that ametoctradin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
2. Dietary exposure from drinking water. Exposure to ametoctradin
via drinking water from the proposed uses is expected to be minimal
based on its short half life in soil. Ametoctradin degradates (F01,
F02, F03, F04) are likely to contribute much greater drinking water
exposure because they are more persistent and more mobile than the
parent. However, no adverse effects were observed in the submitted
toxicological studies for ametoctradin regardless of the route of
exposure. Thus, no drinking water exposure assessments are needed.
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). Ametoctradin is not
registered for homeowner uses; however, some of the proposed uses could
be used by commercial applicators in areas that residential
postapplication exposure could occur (i.e., ornamentals on golf courses
or in residential landscapes). No adverse effects were observed in the
submitted toxicological studies for ametoctradin regardless of the
route of exposure. Thus, no residential handler or postapplication
exposure assessments are needed.
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 ametoctradin to share a common mechanism of
toxicity with any other substances, and ametoctradin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
ametoctradin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Based on the complete
database, there were no adverse effects noted in the developmental
toxicity or reproductive toxicity studies.
3. Conclusion. Based on review of the available ametoctradin
toxicological studies, no toxicological points of departure where
selected for ametoctradin and thus, an additional safety factor to
protect children is not needed. That decision is based on the following
findings:
i. The toxicity database for ametoctradin is complete.
ii. There is no indication that ametoctradin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that ametoctradin 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 concerns identified with regard to exposure to
ametoctradin and thus there are no uncertainties identified in the
exposure databases.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
ametoctradin is not expected to pose an acute risk.
2. Chronic risk. No adverse effect resulting from a chronic
exposure was identified and no chronic endpoint was selected.
Therefore, ametoctradin is not expected to pose a chronic risk.
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). Because no
short-term adverse effect was identified, ametoctradin is not expected
to pose a short-term risk.
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). Because no intermediate-term adverse effect was identified,
ametoctradin is not expected to pose a intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, ametoctradin is not expected to pose a cancer risk to humans.
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 ametoctradin residues.
[[Page 27133]]
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology using liquid chromatography tandem
mass spectrometry (LC/MS/MS) 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:
[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 U.N. 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 ametoctradin.
C. Revisions to Petitioned-for Tolerances
Ametoctradin is a candidate for global registration in the USA,
Australia, and Canada and import tolerance establishment in the
European Union (EU) for varying uses. Under a cooperative joint review
process, harmonized MRLs were proposed by the Agency, the Pesticide
Management Regulatory Agency of Canada (PMRA), and the EU.
Although much effort was made to harmonize with the EU proposed
import-MRLs, there remained a few crops (celery, broccoli, cucumber and
hops) where the proposed global registration recommended MRLs differed.
This is primarily because EU's practice for setting MRLs is to lower
the MRL as much as possible hence they try to assign MRLs to selected
individual crops within a crop group as opposed to assigning a crop
group MRL which is normally higher than all the estimated MRLs for
individual crops. This approach is impractical for North American Free
Trade Agreement (NAFTA) regions as there are other crops within a crop
group petitioned for registration.
The Organization for Economic Co-operation and Development's (OECD)
MRL calculation procedures used to estimate the proposed MRLs. The MRLs
were derived using the average of individual residue data points from
each field trial conducted at maximum applications rates and the lowest
PHI, and assuming the presence of adjuvants (as indicated on the
proposed labels). In estimating MRLs for crop groups, the highest
estimated MRL for individual representative crops were selected.
For some crops, field trials were conducted at concentrated and
diluted solutions. In these cases, MRLs were chosen using only the
residue data for applications with concentrated solution if the
concentrated solution residue data showed significant differences from
the whole residue dataset (concentrated and diluted solution
applications).
V. Conclusion
Therefore, tolerances are established for residues of ametoctradin,
including its metabolites and degradates, in or on brassica, head and
stem, subgroup 5A at 9.0 ppm; brassica, leafy greens, subgroup 5B at 50
ppm; grape at 4.0 ppm; grape, raisin at 8.0 ppm; hop, dried cones at 10
ppm; onion, bulb, subgroup 3-07A at 1.5 ppm; onion, green, subgroup 3-
07B at 20 ppm; spinach at 50 ppm; vegetable, cucurbit, group 9 at 3.0
ppm; vegetable, fruiting, group 8-10 at 1.5 ppm; vegetable, leafy,
except brassica, group 4, except spinach at 40 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not
[[Page 27134]]
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: April 27, 2012.
Steven Bradbury,
Director, 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. Add Sec. 180.663 to read as follows:
Sec. 180.663 Ametoctradin; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide ametoctradin, including its metabolites and degradates, in or
on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only ametoctradin (5-ethyl-6-octyl[1,2,4]triazolo[1,5-
a]pyrimidin-7-amine).
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................ 9.0
Brassica, leafy greens, subgroup 5B......................... 50
Grape....................................................... 4.0
Grape, raisin............................................... 8.0
Hop, dried cones............................................ 10.0
Onion, bulb, subgroup 3-07A................................. 1.5
Onion, green, subgroup 3-07B................................ 20.0
Spinach..................................................... 50.0
Vegetable, cucurbit, group 9................................ 3.0
Vegetable, fruiting, group 8-10............................. 1.5
Vegetable, leafy, except Brassica, group 4, except spinach.. 40.0
Vegetable, tuberous and corm, subgroup 1C................... 0.05
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2012-10950 Filed 5-8-12; 8:45 am]
BILLING CODE 6560-50-P