[Federal Register Volume 73, Number 79 (Wednesday, April 23, 2008)]
[Rules and Regulations]
[Pages 21834-21839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8371]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0872; FRL-8360-4]


Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of cyazofamid and its metabloite CCIM in or on carrot, roots. 
Interregional Research Project Number 4 (IR-4) requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 23, 2008. Objections and 
requests for hearings must be received on or before June 23, 2008, 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-2007-0872. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP

[[Page 21835]]

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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://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 pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0872 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 23, 2008.
    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-2007-0872, by one of the following methods:
     Federal eRulemaking Portal: http://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'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 September 28, 2007 (72 FR 55204) (FRL-
8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E7244) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 
40 CFR 180.601 be amended by establishing a tolerance for combined 
residues of the fungicide cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-
(4-methylphenyl)-1H-imidazole-1-sulfonamide, and its metabolite CCIM, 
4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, expressed as 
cyazofamid, in or on carrot, roots at 0.06 parts per million (ppm). 
That notice referenced a summary of the petition prepared by ISK 
Biosciences Corporation, the registrant, which is available to the 
public in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerance level for carrot roots. The reason for this 
change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.''
    Consistent with 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 combined residues of cyazofamid and its metabolite CCIM 
on carrot, roots at 0.09 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

[[Page 21836]]

concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    Cyazofamid has a low order of acute toxicity via the oral, dermal 
and inhalation routes of exposure. Cyazofamid produces minimal but 
reversible eye irritation, is a slight dermal irritant and is a weak 
dermal sensitizer. In subchronic toxicity studies in rats cyazofamid 
exhibited mild or low toxicity with the kidney being the primary target 
organ. Kidney effects included an increased number of ``basophilic 
kidney tubules'' and mild increases in urinary volume, pH, and protein. 
No adverse kidney effects or any other toxicity findings were noted in 
chronic toxicity studies in rats. Similarly, cyazofamid's overall 
toxicity profile in dogs seems to be limited. In both the 13 week and 
one year dog studies, there were no major toxicity findings up to a 
dose of 1,000 milligrams/kilogram body weight/day (mg/kg/bwt day). The 
only possible effect was increased cysts in parathyroids of both sexes 
and the pituitary in females observed in the high dose groups of the 
one year study.
    Skin lesions, which may be due to systemic allergy, were observed 
in the males of the 18 month mouse carcinogenicity study. At the high 
dose, approaching 1,000 mg/kg/day, male mice suffered hair loss due to 
scratching, which was confirmed at necropsy by increased incidence of 
body sores (head, neck, trunk, limb, and/or tail) and was correlated 
histologically with an increased incidence of acanthosis (hyperplasia), 
chronic active dermatitis, ulceration, and premature death. The 
sulfonamide moiety in the cyanoimidazole ring might have rendered 
cyazofamid an allergen, albeit a weak one. This is supported by the 
findings that cyazofamid is a moderate irritant in the primary rabbit 
skin test and is a positive weak sensitizer in the guinea pig skin 
maximization test. There were no skin allergies in the rat feeding 
study, which may be due to possible species variation.
    There were no maternal or developmental effects observed in the 
prenatal developmental toxicity study in rabbits and no maternal, 
reproductive or offspring effects in the 2-generation reproduction 
study in rats. There was some evidence of increased susceptibility 
following in utero exposure of rats in the prenatal developmental 
toxicity study. At the highest dose tested (HDT) (1,000 mg/kg/day), 
developmental effects (increased incidence of bent ribs) were observed 
in the absence of maternal toxicity.
    There were no indications of treatment-related adverse 
neurotoxicity findings including clinical signs, qualitative or 
quantitative neurobehavioral effects, brain weight, or gross/
microscopic pathology in the acute neurotoxicity study and no evidence 
of neurotoxicity in other available studies for cyazofamid.
    There was no evidence of carcinogenicity in the rat and mouse 
carcinogenicity studies and no evidence that cyazofamid is mutagenic in 
several in vivo and in vitro studies. Based on the results of these 
studies, EPA has classified cyazofamid as ``not likely to be 
carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by cyazofamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Human Health Risk Assessment to Support 
the Registration of Cyazofamid for Use on Carrot at pages 10 to 17 in 
docket ID number EPA-HQ-OPP-2007-0872.

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 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for cyazofamid used for 
human risk assessment can be found at http://www.regulations.gov in 
document Human Health Risk Assessment to Support the Registration of 
Cyazofamid for Use on Carrot at pages 18 to 21 in docket ID number EPA-
HQ-OPP-2007-0872.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyazofamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyazofamid tolerances in 40 CFR 
180.601. EPA assessed dietary exposures from cyazofamid 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. EPA identified such an 
effect (increased incidence of bent ribs in the rat prenatal 
developmental toxicity study) for the population subgroup, females, 13 
to 50 years old; however, no such effect was identified for the general 
population, including infants and children.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT for all existing and new uses of cyazofamid. 
Default processing factors were set to 1x based on the results of 
processing studies indicating that residues of cyazofamid do not 
concentrate in processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As in the acute dietary exposure

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assessment, EPA assumed tolerance-level residues and 100 PCT for all 
existing and new uses of cyazofamid and processing factors of 1x for 
all processed commodities.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified cyazofamid as ``not likely to be 
carcinogenic to humans.'' Therefore, a cancer exposure assessment was 
not conducted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
cyazofamid. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyazofamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyazofamid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Available environmental fate studies suggest cyazofamid is not very 
mobile and quickly degrades into a number of degradation products under 
different environmental conditions. Among the three major degradates 
for cyazofamid (CCIM, CCIM-AM, and CTCA), the two terminal ones are 
CCIM and CTCA. The highest estimated drinking water concentrations 
resulted from modeling which assumed application of 100% molar 
conversion of the parent into the terminal degradate CTCA. EPA used 
these estimates of CTCA in its dietary exposure assessments, a 
conservative approach that likely overestimates the exposure 
contribution from drinking water. Based on the Pesticide Root Zone 
Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening 
Concentration in Ground Water (SCI-GROW) models, the estimated drinking 
water concentrations (EDWCs) of CTCA for acute exposures are estimated 
to be 136 parts per billion (ppb) for surface water and 2.18 ppb for 
ground water; the EDWCs of CTCA for chronic exposures for non-cancer 
assessments are estimated to be 133 ppb for surface water and 2.18 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 136 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 133 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).
    Cyazofamid is currently registered for the following uses that 
could result in residential exposures: Disease control on 
professionally managed turf areas, such as golf courses and college/
professional sports fields. EPA assessed residential exposure using the 
following assumptions: Application by homeowners to residential turf is 
prohibited. Therefore, non-occupational (i.e., residential) handler 
exposure is not expected and was not assessed. Short and intermediate 
term post-application dermal exposure is possible for recreational 
golfers or players of various sports who use college/professional 
athletic fields after cyazofamid has been applied. EPA assessed post-
application exposure of adult golfers as well as young golfers 
(children 6-12 and children 3-5 years old). Post-application exposures 
on college/professional sports fields were assessed only for adults, 
since children are not expected to play on these types of athletic 
fields. The post-application exposure assessment was conducted using 
conservative assumptions, and the resulting exposure estimates are 
considered to represent high-end exposures.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found cyazofamid to share a common mechanism of 
toxicity with any other substances, and cyazofamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyazofamid 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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for pre-natal 
and post-natal toxicity and the completeness of the database on 
toxicity and exposure unless EPA determines based on reliable data that 
a different margin of safety will be safe for infants and children. 
This additional margin of safety is commonly referred to as the FQPA 
safety factor (SF). In applying this provision, EPA either retains the 
default value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Pre-natal and post-natal sensitivity. The pre- and post-natal 
toxicology database for cyazofamid includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. In the prenatal developmental toxicity study in rabbits, 
there were no maternal or developmental effects at any dose up to the 
limit dose of 1,000 mg/kg/day. Similarly, in the 2-generation 
reproduction study, the HDT (>1,000 mg/kg/day) did not cause maternal 
systemic, reproductive or offspring toxicity. There was some evidence 
of increased susceptibility following in utero exposure of rats in the 
prenatal developmental toxicity study. At the HDT (1,000 mg/kg/day), 
developmental effects (increased incidence of bent ribs) were observed 
in the absence of maternal toxicity.
    EPA concluded that the concern is low for the quantitative 
susceptibility seen in the rat developmental toxicity study and that 
there are no residual uncertainties because:
    i. The developmental effect is well identified with clear NOAEL/
LOAEL;
    ii. The developmental effect (increased bent ribs) is a reversible 
variation rather than a malformation;
    iii. The developmental effect is seen only at the limit dose of 
1,000 mg/kg/day;
    iv. This endpoint is used to establish the acute RfD for Females 
13-49; and
    v. The overall toxicity profile indicates that cyazofamid is not a 
very toxic compound.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for cyazofamid is complete.

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    ii. There is no indication that cyazofamid 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 cyazofamid results in increased 
susceptibility in in utero rabbits in the prenatal developmental study 
or in young rats in the 2-generation reproduction study. Although there 
is quantitative evidence of increased susceptibility in the pre-natal 
developmental study in rats, the degree of concern for pre-natal 
toxicity is low and the Agency did not identify any residual 
uncertainties after establishing toxicity endpoints and traditional UFs 
to be used in the risk assessment of cyazofamid.
    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 cyazofamid in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children (young golfers). These assessments will not underestimate the 
exposure and risks posed by cyazofamid.

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. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
cyazofamid will occupy <1% of the aPAD for females 13-50 years old, the 
population group of concern for acute effects. Cyazofamid is not 
expected to pose an acute risk to the general population, including 
infants and children.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyazofamid from food and water will utilize 1.1% of the cPAD for 
infants less than 1 year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
cyazofamid is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Cyazofamid is 
currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to cyazofamid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 330 
for adults, 7,100 for children 3-5 years old and 9,100 for children 6-
12 years old. The aggregate MOE for adults includes post-application 
exposures on athletic fields treated with cyazofamid, the worst-case 
post-application exposure scenario. The aggregate MOEs for children 
include post-application exposure of young golfers on treated golf 
courses.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Cyazofamid is currently registered for uses that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure to cyazofamid 
through food and water with intermediate-term exposures for cyazofamid. 
Since the endpoints and points of departure (NOAELs) are identical for 
short and intermediate-term exposures, the aggregate MOEs for 
intermediate-term exposure are the same as those for short-term 
exposure (330 for adults, 7,100 for children 3-5 years old and 9,100 
for children 6-12 years old).
    5. Aggregate cancer risk for U.S. population. EPA has classified 
cyazofamid into the category ``Not likely to be carcinogenic to 
humans''. Cyazofamid is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methodology is available to enforce the 
tolerance on carrot roots. Cyazofamid and the metabolite CCIM are 
completely recovered (>80% recovery) using FDA's Multi-Residue Protocol 
D (without cleanup). In addition, the petitioner has submitted the 
results of an Independent Laboratory Validation (ILV) for an HPLC/UV 
method (high performance liquid chromatography method using an ultra 
violet detector) which can be used as a single analyte confirmatory 
method. The methods 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: 
[email protected].

B. International Residue Limits

    There are no maximum residue limits (MRLs) established by Codex, 
Canada or Mexico for cyazofamid.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerance on ``carrot, roots'' should be 
increased from 0.06 ppm to 0.09 ppm. EPA revised the tolerance level 
based on analysis of the residue field trial data using the Agency's 
Tolerance Spreadsheet in accordance with the Agency's Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data.

V. Conclusion

    Therefore, a tolerance is established for combined residues of 
cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in 
or on carrot, roots at 0.09 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

[[Page 21839]]

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, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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: April 10, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office 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 180.601 is amended by alphabetically adding the following 
commodity to the table in paragraph (a) to read as follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Carrot, roots........................................               0.09
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-8371 Filed 4-22-08; 8:45 am]
BILLING CODE 6560-50-S