Cyromazine; Pesticide Tolerances, 22252-22256 [2010-9741]
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Commodity
imidacloprid, in or on the following
commodities, when present therein as a
0.75 result of the application of the pesticide
0.05 to growing crops listed in this section
3.0 and other non-food crops as follows:
Parts per million
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Peanut, meal ..................
Pecan ..............................
Persimmon ......................
Pistachio .........................
Pomegranate ..................
Potato, chip .....................
Potato, processed potato
waste ...........................
Poultry, fat ......................
Poultry, meat ..................
Poultry, meat byproducts
Pulasan ...........................
Rambutan .......................
Rapeseed, seed .............
Raspberry, wild ...............
Safflower, seed ...............
Salal ................................
Sapodilla .........................
Sapote, black ..................
Sapote, mamey ..............
Sheep, fat .......................
Sheep, meat ...................
Sheep, meat byproducts
Soursop ..........................
Soybean, forage .............
Soybean, hay ..................
Soybean, meal ................
Soybean, seed ................
Spanish lime ...................
Star apple .......................
Starfruit ...........................
Strawberry ......................
Sugar apple ....................
Sunflower, seed ..............
Tomato, paste .................
Tomato, puree ................
Vegetable, brassica
leafy, group 5 ..............
Vegetable, cucurbit,
group 9 ........................
Vegetable, fruiting, group
8 ..................................
Vegetable, leaves of root
and tuber, group 2 ......
Vegetable, legume,
group 6, except soybean ............................
Vegetable, root and
tuber, group 1, except
sugar beet ...................
Watercress ......................
Watercress, upland .........
Wax jambu ......................
0.05
0.90
0.40
0.90
0.05
0.05
0.05
3.0
3.0
0.05
2.5
0.05
3.5
1.0
1.0
1.0
0.30
0.30
0.30
0.30
8.0
35
4.0
3.5
3.0
1.0
1.0
0.50
0.30
0.05
6.0
3.0
3.5
0.5
1.0
4.0
4.0
16:00 Apr 27, 2010
Rice, grain ......................
Vegetable, foliage of legume, group 7 ...............
Vegetable, legume,
group 6 ........................
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division,
Office of Pesticide Programs,
Parts per million
Environmental Protection Agency, 1200
0.05 Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
2.5 (703) 305–6463; e-mail address:
madden.barbara@epa.gov.
0.40
3.5
3.5
1.0
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0.3
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–9761 Filed 4–27–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0866; FRL–8801–6]
Cyromazine; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of cyromazine in
or on succulent beans at 2.0 parts per
million (ppm). Interregional Research
Project Number 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
28, 2010. Objections and requests for
hearings must be received on or before
June 28, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0866. All documents in the
docket are listed in the docket index
available at https://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
https://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,
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I. General Information
A. Does this Action Apply to Me?
ADDRESSES:
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
Tolerances are established for indirect
or inadvertent residues of the
insecticide imidacloprid, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only the sum of imidacloprid
(1-[6-chloro-3-pyridinyl) methyl]-Nnitro-2-imidazolidinimine) and its
metabolites containing the 6chloropyridinyl moiety, calculated as
the stoichiometric equivalent of
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Commodity
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
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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 Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods & Guidelines’’ on the left-side
navigation menu.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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–2009–0866 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
as required by 40 CFR part 178 on or
before June 28, 2010.
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 that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0866, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
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.
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II. Petition for Tolerance
In the Federal Register of April 13,
2009 (74 FR 16866) (FRL–8396–6), 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 8E7470) by
Interregional Research Project Number 4
(IR-4), 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.414 be
amended by establishing tolerances for
residues of the insecticide cyromazine,
(N-cyclopropyl-1,3,5-triazine-2,4,6triamine) in or on bean, succulent at 2.0
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parts per million (ppm). That notice
referenced a summary of the petition
prepared by Syngenta, the registrant, on
behalf of IR-4 which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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 the petitioned-for
tolerances for residues of cyromazine on
bean, succulent at 2.0 ppm. EPA’s
assessment of exposures and risks
associated with establishing tolerances
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. Cyromazine is not
an eye irritant or a dermal sensitizer but
is a mild skin irritant. The liver and
bone marrow (hematological system) are
the primary targets for oral toxicity for
cyromazine based on a chronic dog
study. Decrease in body weight and food
consumption are also common effects of
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cyromazine as observed in chronic dog,
rat, mouse, and rabbit studies. No
dermal or systemic toxicity was seen at
the highest dose tested in two 21–day
dermal toxicity studies in rabbits. No
neurotoxicity studies with cyromazine
are available. However, the cyromazine
chemical class (triazine) does not
generally target the central or peripheral
nervous system and available data show
no evidence of neurotoxic potential for
cyromazine. There is no evidence that
cyromazine is teratogenic or that
offspring are more susceptible than
adults based on developmental toxicity
studies in rats and rabbits. In the 2–
generation reproduction study in rats no
reproductive effects were observed.
Cyromazine was shown not to be
carcinogenic in mice or rats following
long-term dietary administration and is
classified as ‘‘not likely to be
carcinogenic to humans.’’ The available
mutagenicity data suggest that
cyromazine does not have genotoxic
activity. Specific information on the
studies received and the nature of the
adverse effects caused by cyromazine as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in docket ID
number EPA–HQ–OPP–2009–0866,
pages 25–27 of the document titled
‘‘Cyromazine Human Health Risk
Assessment for Proposed New Use of
Cyromazine on Succulent Beans.’’
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
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. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
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aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
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 greater than that 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for cyromazine used for
human risk assessment can be found at
https://www.regulations.gov in docket ID
number EPA–HQ–OPP–2009–0866,
page 15 of the document titled
‘‘Cyromazine. Human Health Risk
Assessment for Proposed New Use of
Cyromazine on Succulent Beans.’’
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to cyromazine, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing cyromazine tolerances in 40
CFR 180.414. EPA assessed dietary
exposures from cyromazine 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 cyromazine;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. A chronic
dietary risk assessments was conducted
for cyromazine using the Dietary
Exposure Evaluation Model (DEEMFCID, Version 2.03), which uses food
consumption data from the USDA’s
Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994–1996 and
1998. As to residue levels in food,
tolerance level residues and 100% crop
treated assumptions were used. DEEM
default and empirical processing factors
were used to modify the tolerance
values.
iii. Cancer. Based on the absence of
evidence of carcinogenicity in two
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adequate rodent carcinogenicity studies,
EPA has classified cyromazine as ‘‘not
likely to be carcinogenic to humans.’’
Therefore, a quantitative exposure
assessment to evaluate cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for cyromazine. Tolerance level residues
and/or 100% crop treated 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 cyromazine in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of cyromazine.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://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 cyromazine for chronic
exposures for non-cancer assessments
are estimated to be 15.8 parts per billion
(ppb) for surface water and 1.1 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 15.8 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Cyromazine 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.’’
Cyromazine contains a symmetrical
triazine substructure like the herbicides
simazine and atrazine, but atrazine and
simazine are chlorotriazines, and the
toxicity of these chemicals is associated
with the presence of a chlorine
substituent on the triazine ring.
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Cyromazine is not a chlorotriazine. The
chlorotriazines have a much different
toxicological profile than does
cyromazine which does not have a
chlorine substituent on the triazine ring.
EPA has not found cyromazine to share
a common mechanism of toxicity with
any other substances, and cyromazine
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that cyromazine 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 website at https://
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 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 available data, there is no
quantitative and qualitative evidence of
increased susceptibility observed
following in utero cyromazine exposure
to rats and rabbits or following prenatal/
postnatal exposure in the 2–generation
reproduction study. The database is
considered adequate for selection of
study endpoints and determination of a
dose/response to characterize the
potential prenatal or postnatal toxicity
of cyromazine to infants and children.
No increase in susceptibility was seen
in developmental toxicity studies in rat
and rabbit or reproductive toxicity
studies in the rat. Toxicity to offspring
was observed at dose levels the same or
greater than those causing maternal or
parental toxicity. Based on the results of
developmental and reproductive
toxicity studies, there is not a concern
for increased qualitative and/or
quantitative susceptibility following in
utero exposure to cyromazine.
3. Conclusion. EPA has determined
that reliable data show the safety of
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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
cyromazine is complete except for acute
and subchronic neurotoxicity studies
and immunotoxicity testing. Recent
changes to 40 CFR part 158 make these
studies (OPPTS Guideline 870.7800)
required for pesticide registration;
however, the available data for
cyromazine do not show potential for
neurotoxicity or immunotoxicity.
Although specific neurotoxicity studies
have not yet been submitted, there is no
evidence of neurotoxicity in any study
in the toxicity database for cyromazine.
In the absence of specific
immunotoxicity studies, EPA has
evaluated the available cyromazine
toxicity database to determine whether
an additional database uncertainty
factor is needed to account for potential
immunotoxicity. No evidence of
immunotoxicity was found. Due to the
lack of evidence of immunotoxicity for
cyromazine, EPA does not believe that
conducting immunotoxicity testing will
result in a NOAEL less than the cRfD
NOAEL of 1.5 mg/kg bw/day already
established for cyromazine.
Consequently, the EPA believes the
existing data are sufficient for endpoint
selection for exposure/risk assessment
scenarios and for evaluation of the
requirements under the FQPA, and an
additional database uncertainty factor
does not need to be applied.
ii. There is no indication that
cyromazine 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
cyromazine 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 dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to cyromazine
in drinking water.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
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appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases 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 POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute 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, cyromazine 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 cyromazine
from food and water will utilize 85% of
the cPAD for children 1 to 2 years old,
the population group receiving the
greatest exposure. There are no
residential uses for cyromazine.
3. Short- and intermediate term risk.
Short- and intermediate-term aggregate
exposure takes into account short-term
and intermediate-term residential
exposure plus chronic exposure to food
and water (considered to be a
background exposure level).
Cyromazine is not registered for any use
patterns that would result in residential
exposure. Therefore, the short-term and
intermediate-term aggregate risk is the
sum of the risk from exposure to
cyromazine through food and water and
will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S.
population. Cyromazine is classified as
a ‘‘Group E’’ chemical (negative for
carcinogenicity in humans). This
classification is based on the lack of
evidence of carcinogenicity in mice and
rats. EPA does not expect cyromazine to
pose a cancer risk.
5. 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 cyromazine
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Methods AG-408 [high-performance
liquid chromatography/ultraviolet
(HPLC/UV)] and AG-417A [gas-liquid
chromatography/nitrogen-phosphorus
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22255
detector (GLC/NPD)] are the tolerance
enforcement methods for cyromazine as
published in the Pesticide Analytical
Manual (PAM), Vol. II. These methods
combined and with minor modifications
comprise Method AG-621. The residue
data submitted in support of this
petition were generated using Methods
AG-408 and AG-621. Method AG-621
has been adequately validated for use
for the determination of residues of
cyromazine in/on bulb vegetables, leafy
Brassica vegetables, and turnip greens.
Method AG-408 is adequate for
enforcement of the proposed tolerance
for residues of cyromazine.
B. International Residue Limits
There are currently no established
Codex maximum residue limits (MRLs)
for residues of cyromazine on succulent
beans.
V. Conclusion
Therefore, tolerances are established
for residues of cyromazine, Ncyclopropyl-1,3,5-triazine-2,4,6triamine, in or on bean, succulent at 2.0
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
E:\FR\FM\28APR1.SGM
28APR1
22256
Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations
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) (Public Law 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
sroberts on DSKD5P82C1PROD with RULES
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.
VerDate Mar<15>2010
16:00 Apr 27, 2010
Jkt 220001
Dated: March 26, 2010.
Lois Rossi,
Director, Registration DivisionOffice of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
Crop Protection, Inc. requested the new
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
28, 2010. Objections and requests for
hearings must be received on or before
June 28, 2010, 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–
■ 2. Section 180.414 is amended by
OPP–2009–0162. All documents in the
alphabetically adding the following
docket are listed in the docket index
commodity to the table in paragraph
available at https://www.regulations.gov.
(a)(1) to read as follows:
Although listed in the index, some
information is not publicly available,
§180.414 Cyromazine; tolerances for
e.g., Confidential Business Information
residues
(CBI) or other information whose
(a)* * * (1)* * *
disclosure is restricted by statute.
Certain other material, such as
Commodity
Parts per million
copyrighted material, is not placed on
*
*
*
*
* the Internet and will be publicly
available only in hard copy form.
Bean, succulent ....
2.0 Publicly available docket materials are
*
*
*
*
*
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
*
*
*
*
*
Regulatory Public Docket in Rm. S–
[FR Doc. 2010–9741 Filed 4–27–10; 8:45 am]
4400, One Potomac Yard (South Bldg.),
BILLING CODE 6560–50–S
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
ENVIRONMENTAL PROTECTION
excluding legal holidays. The Docket
AGENCY
Facility telephone number is (703) 305–
40 CFR Part 180
5805.
FOR FURTHER INFORMATION CONTACT:
[EPA–HQ–OPP–2009–0162; FRL–8817–3]
Rosemary Kearns, Registration Division
(7505P), Office of Pesticide Programs,
Difenoconazole Pesticide Tolerances
Environmental Protection Agency, 1200
AGENCY: Environmental Protection
Pennsylvania Ave., NW., Washington,
Agency (EPA).
DC 20460–0001; telephone number:
ACTION: Final rule.
(703) 305–5611; e-mail address:
kearns.rosemary@epa.gov.
SUMMARY: This regulation establishes
SUPPLEMENTARY INFORMATION:
tolerances for residues of the fungicide
difenoconazole in or on: Almond, hulls; I. General Information
brassica, head and stem, subgroup 5A;
A. Does this Action Apply to Me?
brassica, leafy green, subgroup 5B;
citrus, dried pulp; citrus, oil; fruit,
You may be potentially affected by
citrus, group 10; grape; grape, raisin;
this action if you are an agricultural
nut, tree, group 14; onion, bulb,
producer, food manufacturer, or
subgroup 3-07A; onion, green, subgroup pesticide manufacturer. Potentially
3-07B; pistachio; and vegetable,
affected entities may include, but are
cucurbit, group 9. EPA is also revising
not limited to those engaged in the
the difenoconazole crop and animal
following activities:
tolerance expressions; deleting all
• Crop production (NAICS code 111).
section 18 difenoconazole tolerances
• Animal production (NAICS code
that are no longer needed as a result of
112).
this action; reinstating tolerances for
• Food manufacturing (NAICS code
wheat forage, wheat grain, and wheat
311).
straw, which were inadvertently
• Pesticide manufacturing (NAICS
removed when previous tolerances were code 32532).
established; correcting the existing
This listing is not intended to be
tolerance for beet, sugar; and deleting
exhaustive, but rather to provide a guide
the grape import superscript. Syngenta
for readers regarding entities likely to be
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
E:\FR\FM\28APR1.SGM
28APR1
Agencies
[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22252-22256]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9741]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0866; FRL-8801-6]
Cyromazine; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cyromazine in or on succulent beans at 2.0 parts per million (ppm).
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 28, 2010. Objections and
requests for hearings must be received on or before June 28, 2010, 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-2008-0866. All documents in the
docket are listed in the docket index available at https://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 https://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: Barbara Madden, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-6463; e-mail address: madden.barbara@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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test guidelines referenced in this
document electronically please go to https://www.epa.gov/oppts and
select ``Test Methods & Guidelines'' on the left-side navigation menu.
[[Page 22253]]
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2009-0866 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 as required by 40 CFR part 178
on or before June 28, 2010.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0866, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line 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. Petition for Tolerance
In the Federal Register of April 13, 2009 (74 FR 16866) (FRL-8396-
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
8E7470) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.414 be amended by establishing tolerances for residues
of the insecticide cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-
triamine) in or on bean, succulent at 2.0 parts per million (ppm). That
notice referenced a summary of the petition prepared by Syngenta, the
registrant, on behalf of IR-4 which is available to the public in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
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 the petitioned-for
tolerances for residues of cyromazine on bean, succulent at 2.0 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances 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. Cyromazine is not an eye irritant or a dermal sensitizer but
is a mild skin irritant. The liver and bone marrow (hematological
system) are the primary targets for oral toxicity for cyromazine based
on a chronic dog study. Decrease in body weight and food consumption
are also common effects of cyromazine as observed in chronic dog, rat,
mouse, and rabbit studies. No dermal or systemic toxicity was seen at
the highest dose tested in two 21-day dermal toxicity studies in
rabbits. No neurotoxicity studies with cyromazine are available.
However, the cyromazine chemical class (triazine) does not generally
target the central or peripheral nervous system and available data show
no evidence of neurotoxic potential for cyromazine. There is no
evidence that cyromazine is teratogenic or that offspring are more
susceptible than adults based on developmental toxicity studies in rats
and rabbits. In the 2-generation reproduction study in rats no
reproductive effects were observed. Cyromazine was shown not to be
carcinogenic in mice or rats following long-term dietary administration
and is classified as ``not likely to be carcinogenic to humans.'' The
available mutagenicity data suggest that cyromazine does not have
genotoxic activity. Specific information on the studies received and
the nature of the adverse effects caused by cyromazine 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
https://www.regulations.gov in docket ID number EPA-HQ-OPP-2009-0866,
pages 25-27 of the document titled ``Cyromazine Human Health Risk
Assessment for Proposed New Use of Cyromazine on Succulent Beans.''
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
[[Page 22254]]
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and chronic-term risks are evaluated
by comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
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
greater than that 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for cyromazine used for
human risk assessment can be found at https://www.regulations.gov in
docket ID number EPA-HQ-OPP-2009-0866, page 15 of the document titled
``Cyromazine. Human Health Risk Assessment for Proposed New Use of
Cyromazine on Succulent Beans.''
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyromazine, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyromazine tolerances in 40 CFR
180.414. EPA assessed dietary exposures from cyromazine 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
cyromazine; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. A chronic dietary risk assessments was
conducted for cyromazine using the Dietary Exposure Evaluation Model
(DEEM-FCID, Version 2.03), which uses food consumption data from the
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998. As to residue levels in food, tolerance level
residues and 100% crop treated assumptions were used. DEEM default and
empirical processing factors were used to modify the tolerance values.
iii. Cancer. Based on the absence of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, EPA has classified
cyromazine as ``not likely to be carcinogenic to humans.'' Therefore, a
quantitative exposure assessment to evaluate cancer risk is
unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for cyromazine. Tolerance level residues and/or 100%
crop treated 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 cyromazine in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyromazine. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://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 cyromazine for chronic exposures for
non-cancer assessments are estimated to be 15.8 parts per billion (ppb)
for surface water and 1.1 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 15.8 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). Cyromazine 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.''
Cyromazine contains a symmetrical triazine substructure like the
herbicides simazine and atrazine, but atrazine and simazine are
chlorotriazines, and the toxicity of these chemicals is associated with
the presence of a chlorine substituent on the triazine ring. Cyromazine
is not a chlorotriazine. The chlorotriazines have a much different
toxicological profile than does cyromazine which does not have a
chlorine substituent on the triazine ring. EPA has not found cyromazine
to share a common mechanism of toxicity with any other substances, and
cyromazine does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that cyromazine 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 website at
https://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 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 available data,
there is no quantitative and qualitative evidence of increased
susceptibility observed following in utero cyromazine exposure to rats
and rabbits or following prenatal/postnatal exposure in the 2-
generation reproduction study. The database is considered adequate for
selection of study endpoints and determination of a dose/response to
characterize the potential prenatal or postnatal toxicity of cyromazine
to infants and children. No increase in susceptibility was seen in
developmental toxicity studies in rat and rabbit or reproductive
toxicity studies in the rat. Toxicity to offspring was observed at dose
levels the same or greater than those causing maternal or parental
toxicity. Based on the results of developmental and reproductive
toxicity studies, there is not a concern for increased qualitative and/
or quantitative susceptibility following in utero exposure to
cyromazine.
3. Conclusion. EPA has determined that reliable data show the
safety of
[[Page 22255]]
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 cyromazine is complete except for
acute and subchronic neurotoxicity studies and immunotoxicity testing.
Recent changes to 40 CFR part 158 make these studies (OPPTS Guideline
870.7800) required for pesticide registration; however, the available
data for cyromazine do not show potential for neurotoxicity or
immunotoxicity. Although specific neurotoxicity studies have not yet
been submitted, there is no evidence of neurotoxicity in any study in
the toxicity database for cyromazine. In the absence of specific
immunotoxicity studies, EPA has evaluated the available cyromazine
toxicity database to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity.
No evidence of immunotoxicity was found. Due to the lack of evidence of
immunotoxicity for cyromazine, EPA does not believe that conducting
immunotoxicity testing will result in a NOAEL less than the cRfD NOAEL
of 1.5 mg/kg bw/day already established for cyromazine. Consequently,
the EPA believes the existing data are sufficient for endpoint
selection for exposure/risk assessment scenarios and for evaluation of
the requirements under the FQPA, and an additional database uncertainty
factor does not need to be applied.
ii. There is no indication that cyromazine 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 cyromazine 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 dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to cyromazine in drinking water.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute 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,
cyromazine 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
cyromazine from food and water will utilize 85% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for cyromazine.
3. Short- and intermediate term risk. Short- and intermediate-term
aggregate exposure takes into account short-term and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Cyromazine is not
registered for any use patterns that would result in residential
exposure. Therefore, the short-term and intermediate-term aggregate
risk is the sum of the risk from exposure to cyromazine through food
and water and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. Cyromazine is
classified as a ``Group E'' chemical (negative for carcinogenicity in
humans). This classification is based on the lack of evidence of
carcinogenicity in mice and rats. EPA does not expect cyromazine to
pose a cancer risk.
5. 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 cyromazine residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Methods AG-408 [high-performance liquid chromatography/ultraviolet
(HPLC/UV)] and AG-417A [gas-liquid chromatography/nitrogen-phosphorus
detector (GLC/NPD)] are the tolerance enforcement methods for
cyromazine as published in the Pesticide Analytical Manual (PAM), Vol.
II. These methods combined and with minor modifications comprise Method
AG-621. The residue data submitted in support of this petition were
generated using Methods AG-408 and AG-621. Method AG-621 has been
adequately validated for use for the determination of residues of
cyromazine in/on bulb vegetables, leafy Brassica vegetables, and turnip
greens. Method AG-408 is adequate for enforcement of the proposed
tolerance for residues of cyromazine.
B. International Residue Limits
There are currently no established Codex maximum residue limits
(MRLs) for residues of cyromazine on succulent beans.
V. Conclusion
Therefore, tolerances are established for residues of cyromazine,
N-cyclopropyl-1,3,5-triazine-2,4,6-triamine, in or on bean, succulent
at 2.0 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
[[Page 22256]]
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) (Public Law 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: March 26, 2010.
Lois Rossi,
Director, Registration DivisionOffice of Pesticide Programs.
0
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 180.414 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows:
Sec. 180.414 Cyromazine; tolerances for residues
(a)* * * (1)* * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Bean, succulent................................ 2.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-9741 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S