[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Rules and Regulations]
[Pages 26462-26467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10709]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0388; FRL-9346-6]
Dimethomorph; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the tolerances for residues of
dimethomorph, (E,Z)-4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl]morpholine in or certain commodities as discussed in
this document. BASF Corporartion requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 4, 2012. Objections and
requests for hearings must be received on or before July 3, 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-2011-0388. 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: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-9096; email address: gibson.tamue@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.
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 identify
docket ID number EPA-HQ-OPP-2011-0388 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 3, 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-2011-0388, 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 July 20, 2011 (76 FR 43231) (FRL-8880-
1), 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
0F7800) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC
27709. The petition requested that EPA amend 40 CFR part 180 by raising
tolerances for residues of the fungicide dimethomorph, in or on
brassica, head and stem, subgroup 5A from 2.0 ppm to 5.0 ppm; brassica,
leafy greens, subgroup 5B from 20.0 ppm to 30.0 ppm; green onion,
subgroup 3B from 2.0 ppm to 11.0 ppm. The petition also requested that
40 CFR part 180 be amended by establishing a tolerance for the residues
of the fungicide dimethomorph, in or on vegetable, leafy at 16 ppm (PP
0F7816). The notice
[[Page 26463]]
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.
In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-
8848-3), 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
0F7751) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC
27709. The petition requested that EPA establish a tolerance for
residues of the fungicide dimethomorph, in or on grape at 3.5 ppm. The
notice referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petitions, EPA has
revised the proposed tolerance level and commodity definition for
vegetable, bulb, group 3 and removed the established tolerance for the
regional registration for grape. Tolerances for the national
registration for grape and onion, bulb subgroup 3-07A were lowered.
Tolerances for brassica, head and stem, subgroup 5A; brassica, leafy
greens, subgroup 5B; vegetable, leafy except brassica, group 4; onion,
green, subgroup 3-07B were raised. Tolerances for grape, raisin were
established for domestic registrations and were also raised. EPA is
also establishing rotational crop tolerances for wheat, forage; wheat,
hay; and wheat, straw. EPA has made various changes to the commodity
definitions and tolerance levels sought in the petition and also is
establishing rotational crop tolerances. The reason for these changes
are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for dimethomorph including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with dimethomorph 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.
Dimethomorph has low acute toxicity via the oral and dermal routes
of exposure. Chronic risk is regulated based on effects seen in body
weight decrements and liver effects in the female rat. There was no
evidence of increased incidence of any neoplasms at the limit dose
tested in carcinogenicity studies tested in rats and mice. Dimethomorph
is classified as ``not likely'' to be a human carcinogen based on the
lack of evidence of carcinogenicity in carcinogenicity studies in rats
and mice. The available data for dimethomorph does not show evidence of
neurotoxicity. There is a subchronic neurotoxicity study available
which demonstrated no neurotoxic effects in the study. In addition,
neither the subchronic nor chronic toxicity studies in rats or dogs,
nor the developmental toxicity studies indicated that the nervous
system was affected by treatment with dimethomorph.
Specific information on the studies received and the nature of the
adverse effects caused by dimethomorph 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 ``Dimethomorph: Human Health Risk
Assessment to Support Amended Use on Grapes, Bulb Vegetables, Leafy
Brassica Vegetables, and Leafy Vegetables,'' pp. 35-38 in docket ID
number EPA-HQ-OPP-2011-0388.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for dimethomorph used for
human risk assessment is shown in the Table this unit.
[[Page 26464]]
Table--Summary of Toxicological Doses and Endpoints for Dimethomorph for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 No endpoint Not applicable..... No study selected.
years of age). attributable to a
single dose was
identified.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population No endpoint Not applicable..... No study selected.
including infants and children). attributable to a
single dose was
identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 11 mg/kg/day Chronic RfD = 0.1 Carcinogenicity study in rats.
UFA = 10x........... mg/kg/day. LOAEL = 46.3 mg/kg/day based on
UFH = 10x........... cPAD = 0.1 mg/kg/ decreased body weight and
FQPA SF = 1x........ day. increases in liver lesions in
female rats.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
concern. mg/kg/day = milligram/kilogram/day.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dimethomorph, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethomorph tolerances in 40
CFR 180.493. EPA assessed dietary exposures from dimethomorph 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 toxic effects
attributable to a single dose were observed in the toxicological
studies for dimethomorph; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues and 100 percent crop treated (PCT). Dietary Evaluation
Exposure Model (DEEM) default processing factors were used.
iii. Cancer. Based on the data summarized in Unit III.A.,
dimethomorph has been classified as ``not likely'' to be a human
carcinogen. EPA has concluded that dimethomorph does not pose a cancer
risk to humans. Therefore, a dietary exposure assessment for the
purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for dimethomorph. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for dimethomorph in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of dimethomorph. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of dimethomorph for
acute exposures are estimated to be 81.1 parts per billion (ppb) for
surface water and 0.264 ppb for ground water.
For chronic exposures for non-cancer assessments are estimated to
be 24.7 ppb for surface water and 0.264 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For chronic dietary risk assessment, the water concentration of
value 24.7 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Dimethomorph is not
registered for any specific use patterns that would result in
residential exposure.
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 dimethomorph to share a common mechanism of
toxicity with any other substances, and dimethomorph does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
dimethomorph does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this
[[Page 26465]]
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. The available data did not
provide evidence of any increased susceptibility in the offspring in
either of the two developmental toxicity studies or in the 2-generation
reproduction study. In either of these two studies toxicity was not
seen in the offspring occurring at doses lower than in the parent in
any of the studies. Additionally, the effects seen in the young were
qualitatively similar to those in the parents.
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 dimethomorph is complete.
ii. There is no indication that dimethomorph 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 dimethomorph results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The unrefined chronic dietary risk assessment used tolerance
level residues, included modeled drinking water estimates, assumed 100
PCT, and incorporated DEEM default processing factors. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to dimethomorph in drinking water.
These assessments will not underestimate the exposure and risks posed
by dimethomorph.
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. 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,
dimethomorph is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
dimethomorph from food and water will utilize 27% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. There are no residential uses for dimethomorph and thus
residential exposure to residues of dimethomorph 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). Dimethomorph
is not registered for any use patterns that would result in residential
exposure. Therefore, the short-term aggregate risk is the sum of the
risk from exposure to dimethomorph through food and water and will not
be greater than the chronic aggregate 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). Dimethomorph is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to dimethomorph through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, dimethomorph 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 dimethomorph residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
FAMS-002-04 which utilizes high pressure liquid chromatography with
ultraviolet detection (HPLC/UV) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health 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 established MRLs for dimethomorph in or on grape at 2
ppm; and grape, raisin at 5 ppm. These MRLs are different than the
tolerances being established for dimethomorph in this action because
the MRLs are based on residue data derived from Europe.
C. Response to Comments
One comment was received from a private citizen (in reference to
tolerance petition 0F7751) who encouraged the Agency to continue to
reduce the risk to human health and the environment from pesticide
usage. The Agency recognizes that some individuals believe that
pesticide use should not be permitted. However, under the existing
legal framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA), EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by the statute.
D. Revisions to Petitioned-For Tolerances
The crop group regulations (40 CFR 180.41) were recently amended
pertaining to Crop Group 3--Bulb Vegetables, and the revised Crop group
is designated Crop group 3-07 Bulb Vegetable. The revised crop group
now contains two subgroups: Bulb, subgroup
[[Page 26466]]
3-07A and onion, green, subgroup 3-07B. Because BASF proposed to modify
its existing Crop Group 3 tolerance by adding a revised green onion
tolerance, EPA has determined it is appropriate to establish both
onion, bulb subgroup 3-07A and onion, green, subgroup 3-07B tolerances
rather than a Crop Group 3 tolerance and a green onion tolerance. Based
on analysis of residue levels from crop field trail data and tolerance
calculation procedures, EPA is setting the onion, bulb subgroup 3-07A
tolerance at 0.6 ppm and the onion, green, subgroup 3-07B tolerance at
15 ppm. EPA is removing the existing Crop Group 3 tolerance.
Additionally, based on analysis of residue levels from crop field
trail data and tolerance calculation procedures, EPA is raising
tolerance levels for grape, raisin; brassica, head and stem, subgroup
5A; brassica, leafy greens, subgroup 5B; and vegetable, leafy, except
brassica, group 4. For the same reason, EPA is lowering the tolerance
for grape. Additionally, because the Agency is amending the BASF
registration to allow use on grapes in the U.S., EPA is removing the
footnote in the tolerance stating that such a registration does not
exist.
Subsequent to the filing of the petition, the petitioner requested
that the Agency establish tolerances in cereal grain commodities
(forage, hay and straw) that are rotated to fields following use
dimethomorph on commodities covered by the tolerances established in
this action. The Agency determined that rotated crop tolerances would
be appropriate for wheat, forage; wheat, hay; and wheat, straw.
V. Conclusion
Therefore, amended tolerances are established for residues of
dimethomorph, in or on brassica, head and stem, subgroup 5A at 6.0 ppm;
brassica, leafy greens, subgroup 5B at 30.0 ppm; onion, bulb subgroup
3-07A at 0.6 ppm; onion, green, subgroup 3-07B at 15.0 ppm; grape at
3.0 ppm; and grape, raisin at 7.0 ppm. A tolerance is established for
residues of dimethomorph, in or on vegetable, leafy except brassica,
group 4 at 30.0 ppm. This regulation also establishes tolerances for
the indirect or inadvertent residues of dimethomorph, in or on wheat,
forage at 0.15 ppm; wheat hay at 0.15 ppm and wheat, straw at 0.4 ppm.
Furthermore, this regulation removes established tolerances on
vegetable, bulb, group 3 and footnote pertaining the lack of a
registration for use on grapes.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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 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 25, 2012.
Daniel J. Rosenblatt,
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. Section 180.493 is amended as follows:
0
i. Remove the entry for ``Vegetable, bulb, group 3''; and footnote 1
from the table in paragraph (a);
0
ii. By revising the entries for ``Brassica, head and stem, subgroup
5A,'' ``Brassica, leafy greens, subgroup 5B'' and ``Grape, raisin'' and
alphabetically adding new entries to the table in paragraph (a);
0
iii. Remove ``Grape'' from the table in paragraph (c);
0
iv. Revise paragraph (d) .
The amendments read as follows:
Sec. 180.493 Dimethomorph; tolerances for residues.
(a) * * *
[[Page 26467]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................... 6.0
Brassica, leafy greens, subgroup 5B..................... 30.0
* * * * *
Grape................................................... 3.0
Grape, raisin........................................... 7.0
* * * * *
Onion, bulb, subgroup 3-07A............................. 0.6
Onion, green, subgroup 3-07B............................ 15.0
* * * * *
Vegetable, leafy (except Brassica) group 4.............. 30.0
------------------------------------------------------------------------
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of the fungicide dimethomorph,
in or on the commodities in the following table. Compliance with the
following tolerance levels specified in the following table is to be
determined by measuring only dimethomorph (E,Z)-4-[3-(4-chlorophenyl)-
3-(3,4-dimethoxyphenyl)acryloyl]morpholine calculated in or on the
following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Wheat, forage........................................... 0.15
Wheat, hay.............................................. 0.15
Wheat, straw............................................ 0.4
------------------------------------------------------------------------
[FR Doc. 2012-10709 Filed 5-3-12; 8:45 am]
BILLING CODE 6560-50-P