[Federal Register: October 20, 2004 (Volume 69, Number 202)]
[Rules and Regulations]
[Page 61599-61605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc04-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0327; FRL-7682-1]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on
almond, hulls; bean, dry; bean, succulent; and leafy greens subgroup
4A, except spinach. Interregional Research Project Number 4 (IR-4)
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective October 20, 2004. Objections and
requests for hearings must be received on or before December 20, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0327. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Maria I. Rodriguez, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6710; e-mail address:
rodriguez.maria@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:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of April 21, 2003 (68 FR 19528) (FRL-7301-
6), 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
3E6530; note that this PP was inadvertently reported as PP 2E6530 in
the unit entitled Summary of Petition of that notice) by IR-4, 681 U.S.
Highway 1 South, New Brunswick, NJ 08902-3390. The petition
requested that 40 CFR 180.532 be amended by establishing tolerances for
residues of the fungicide cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-
2-pyrimidinamine, in or on almond, hulls at 8.0 parts per million
(ppm). That notice included a summary of the petition prepared by IR-4,
the registrant. There were no comments received in response to the
notice of filing.
In the Federal Register of September 1, 2004 (69 FR 53436) (FRL-
7676-4), 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 petitions (PP
3E6638 and PP 3E6700) by IR-4, 681 U.S. Highway 1 South, New
Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.532 be
amended by establishing a tolerance for residues of the fungicide
cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on
leafy greens subgroup 4A, except spinach at 30 ppm (PP 3E6638); bean,
dry and bean, succulent at 0.6 ppm each (PP 3E6700). That notice
included a summary of the petition prepared by IR-4, the registrant.
Comments were received from one individual in New Jersey opposing and
objecting the establishment of tolerances for residues of cyprodinil.
The individual criticized IR-4's involvement in the pesticide
registration as well as EPA's way of conducting pesticide registration.
EPA's response to the public comments received is in Unit V. of this
document.
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
[[Page 61600]]
aggregate exposure to the pesticide chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section
408(b)(2) of FFDCA, for tolerances for residues of cyprodinil in or on
almond, hulls at 8.0 ppm; bean, dry and bean, succulent at 0.6 ppm
each; and leafy greens subgroup 4A, except spinach at 30 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by cyprodinil as well
as the no observed adverse effect level (NOAEL) and the lowest observed
adverse effect level (LOAEL) from the toxicity studies reviewed are
discussed in the Federal Register of September 19, 2003 (68 FR 54808)
(FRL-7326-4).
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for cyprodinil used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 19, 2003 (68 FR Page
54808) (FRL-7326-4).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.532) for the residues of cyprodinil, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from cyprodinil in food as
follows:
i. Acute exposure. Acute dietary 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 one-day
or single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), which incorporates food consumption
data as reported by respondents in the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII), and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: An unrefined, Tier 1 acute dietary
exposure assessment (using tolerance-level residues, DEEM default
processing factors and assuming 100% crop treated for all proposed
commodities) was conducted for the females 13-49 years old population
subgroup.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: An unrefined, Tier 1 chronic dietary
[[Page 61601]]
exposure assessment (using tolerance-level residues, DEEM default
processing factors, and assuming 100% crop treated for all proposed
commodities) was conducted for the general U.S. population and various
population subgroups.
iii. Cancer. A quantitative cancer aggregate-exposure assessment
was not performed because cyprodinil is not carcinogenic.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for cyprodinil in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of cyprodinil.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The SCI-GROW model is used to predict pesticide
concentrations in shallow ground water. For a screening-level
assessment for surface water EPA will use FIRST (a tier 1 model) before
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the
PRZM/EXAMS model that uses a specific high-end runoff scenario for
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and both models include a percent crop area factor as an
adjustment to account for the maximum percent crop coverage within a
watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to cyprodinil they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of cyprodinil
for acute exposures are estimated to be 73 parts per billion (ppb) for
surface water and 0.062 ppb for ground water. The EECs for chronic
exposures are estimated to be 61 ppb for surface water and 0.062 ppb
for ground 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).
Cyprodinil is not registered for use on any sites 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to cyprodinil and any other
substances and cyprodinil does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that cyprodinil has 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
the policy statements released by EPA's OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There are no concerns or
uncertainties for pre- and/or post-natal exposure.
3. Conclusion. There is a complete toxicity data base for
cyprodinil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The 10X default
safety factor (SF) to protect infants and children has been reduced to
1X. The basis for the recommendation has been discussed in Unit III.D.
of the final rule published in the Federal Register of September 19,
2003 (68 FR 54808) (FRL-7326-4).
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult
[[Page 61602]]
female), and 1L/10 kg (child). Default body weights and drinking water
consumption values vary on an individual basis. This variation will be
taken into account in more refined screening-level and quantitative
drinking water exposure assessments. Different populations will have
different DWLOCs. Generally, a DWLOC is calculated for each type of
risk assessment used: Acute, short-term, intermediate-term, chronic,
and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
cyprodinil will occupy, 4% of the aPAD of 1.5 mg/kg/day for females 13
to 49 years. For the general population, no toxic effects of concern
that could be attributed to a single exposure were observed in the oral
toxicity studies, including the developmental toxicity studies in rats
and rabbits. Therefore, cyprodinil is not expected to pose an acute
risk to this population subgroup. In addition, there is potential for
acute dietary exposure to cyprodinil in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the aPAD, as shown in Table 1. of this unit:
Table 1.--Aggregate Risk Assessment for Acute Exposure to Cyprodinil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 1.5 4 73 0.062 43,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
cyprodinil from food will utilize 38% of the cPAD of 0.03 mg/kg/day for
the U.S. population, and 67% of the cPAD for the most highly exposed
population subgroup, children 1-2 years old. There are no residential
uses for cyprodinil that result in chronic residential exposure to
cyprodinil. In addition, there is potential for chronic dietary
exposure to cyprodinil in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
Table 2. of this unit:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyprodinil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.03 38 61 0.062 650
------------------------------------------------
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Cyprodinil is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Cyprodinil is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, cyprodinil was
classified as ``not likely to be carcinogenic to humans.'' Therefore,
cyprodinil 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, and to infants and children from aggregate
exposure to cyprodinil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. Head and leaf lettuce, lima bean, dry bean, and
snap bean were analyzed using Novartis working method AG-631B. The
method uses High Performance Liquid Chromatography (HPLC) with Column
Switching. Almonds were analyzed using Syngenta tolerance enforcement
method AG-631A. The method uses HPLC with Column Switching, with
modifications. The confirmatory method uses HPLC with Ultraviolet
detection (HPLC/UV). 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; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
Canada, Codex, and Mexico do not have maximum residue limits (MRLs)
[[Page 61603]]
for residues of cyprodinil in/on the proposed crops. Therefore,
harmonization is not an issue.
V. EPA's Response to Public Comments Received Regarding the Notice of
Filing
Comments were received from one individual in New Jersey opposing
and objecting the establishment of tolerances for residues of
cyprodinil. The individual criticized IR-4's involvement in the
pesticide registration as well as EPA's way of conducting pesticide
registration. The comments were in response to the notice of filing
published in the Federal Register of September 1, 2004 (69 FR 53436)
(FRL-7676-4).
One comment indicated that IR-4 and Rutgers University are
profiteering by registering pesticides for Syngenta. The IR-4 program
was created by Congress in 1963 in order to assist minor crop growers
in the process of obtaining pesticide registrations. IR-4 National
Coordinating Headquarters is located at Rutgers University in New
Jersey and receives the majority (90%) of its funding from the USDA. It
is the only publicly funded program that conducts research and submits
petitions for tolerances. IR-4 operates in collaboration with USDA, the
Land Grant University System, the agrochemical industry, commodity
associations, and EPA. IR-4 identifies needs, prioritizes accordingly,
and conducts research. The majority (over 80%) of IR-4's research is
conducted on reduced-risk chemicals. Under the Pesticide Registration
Improvement Act (PRIA), IR-4 works in cooperation with the registrant
to request a waiver for the registration services. The waiver may be
granted if the application is solely associated by simultaneous
submission with a tolerance petition in connection with IR-4 and if it
is in the public interest. This fee waiver serves as an incentive to
pursue registration of minor uses supported by the IR-4 program. In
addition to the work done in pesticide registration, IR-4 develops risk
mitigation measures for existing registered products. Therefore, IR-4
and Rutgers University are not profiteering from registering
pesticides.
Another comment alleged that according to information on the fifth
page of the notice of filing, there is no data at EPA to support the
pesticide registration. The comment applies to the use of ``available
data'' concerning the cumulative effects of the pesticide's residues
and ``other substances that have a common mechanism of toxicity.'' In
this case, EPA did not assume that this chemical has a common mechanism
of toxicity with other substances as the chemical does not generate
metabolites produced also by other chemicals. For specific information
regarding EPA's approach to the use of common mechanism of toxicity to
evaluate the cumulative effects of chemicals, please refer to EPA's
website at http://www.epa.gov/pesticides/cumulative/ to see policy
statements.
An additional comment indicated that during animal testing, rabbits
are abused, tortured, and fed toxic chemicals. EPA test guidelines
recommend rabbits as test animals in acute eye irritation studies as
well as in longer term studies such as developmental toxicity and
reproduction studies. Results obtained from studies conducted with
animals (in general) are relevant to humans because cells and molecules
of humans can be very similar to those of animals. Therefore, if a
pesticide causes toxicity in animals, it is likely to do so in humans
as well. EPA supports the use of the least possible number of animals
in the pertinent studies. In addition, it should be noted that
currently there are no in vitro studies that can address the concerns
these studies satisfy. EPA is working with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM) to
investigate in vitro methods to determine the toxicological concerns
associated with the use of pesticides.
VI. Conclusion
Therefore, the tolerances are established for residues of
cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on
almond, hulls at 8.0 ppm; bean, dry and bean, succulent at 0.6 ppm
each; and leafy greens subgroup 4A, except spinach at 30 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0327 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before December
20, 2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0327, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,
[[Page 61604]]
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: October 6, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR part 180 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 180.532 is amended as follows:
0
a. By revising the commodity ``Almond, hulls'' in the table in
paragraph (a).
0
b. By alphabetically adding commodities to the table in paragraph (a).
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
[[Page 61605]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 8.0
* * * * *
Bean, dry.................................................. 0.6
Bean, succulent............................................ 0.6
* * * * *
Leafy greens subgroup 4A, except spinach................... 30
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-23261 Filed 10-19-04; 8:45 am]
BILLING CODE 6560-50-S