Document ID: EPA-HQ-OPP-2008-0361-0003
Agency: epa
Document Type: Rule
Title: Cyhalofop-butyl; Pesticide Tolerances
Posted Date: 2009-04-08T04:00Z

[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Rules and Regulations]               
[Page 15876-15880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap09-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0361; FRL-8406-8]

 
Cyhalofop-butyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of cyhalofop-butyl, cyhalofop acid and the di-acid metabolite in or on 
rice, grain and rice, wild, grain. Interregional Research Project 
Number 4 (IR-4) and Dow AgroSciences, LLC, requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation 
also removes the expired, time-limited tolerances for residues of 
cyhalofop-butyl, cyhalofop acid and the di-acid metabolite in or on on 
rice, grain and rice, straw.

DATES: This regulation is effective April 8, 2009. Objections and 
requests for hearings must be received on or before June 8, 2009, 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-2008-0361. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: 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: stanton.susan@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 
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 e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

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-2008-0361 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 8, 2009.
    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-2008-0361, 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 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 Registers of June 4, 2008 (73 FR 31862) (FRL-8365-3) 
and August 29, 2008 (73 FR 50963) (FRL-8379-2), EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP 8E7341) by 
Interregional Research Project Number 4 (IR-4), 500 College Road East, 
Suite 201W, Princeton, NJ, 08540; and a pesticide petition (PP 8F7403) 
by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268, 
respectively. The petitions requested that 40 CFR 180.576 be amended by 
establishing tolerances for combined residues of the herbicide 
cyhalofop-butyl, R-(+)-n-butyl-2-(4(4-cyano-2-fluorophenoxy)-
phenoxy)propionate, plus cyhalofop acid, R-(+)-2-(4(4-cyano-2-
fluorophenoxy)-phenoxy)propionic acid) and the di-acid metabolite, 
(2R)-4-[4-(1-carboxyethoxy)phenoxy]-3-fluorobenzoic acid, in or on 
rice, grain (PP 8F7403) and rice, wild, grain (PP 8E7341) at 0.03 parts 
per million (ppm);

[[Page 15877]]

and in or on rice, straw at 8.0 ppm (8F7403). The notices referenced 
summaries of the petitions prepared by Dow AgroSciences, LLC, the 
registrant, which are available to the public in the dockets 
established for each action (PP 8E7341: Docket ID number EPA-HQ-OPP-
2008-0361; and PP 8F7403: Docket ID number EPA-HQ-OPP-2008-0600) at 
http://www.regulations.gov. Comments were received on the notice of 
filing of PP 8F7403 (rice, grain). EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting these petitions and 
current Agency policy, EPA has determined that the proposed tolerance 
on rice, straw is unnecessary and should not be established. The reason 
for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of cyhalofop-butyl, cyhalofop acid and 
the di-acid metabolite on rice, grain and rice, wild, grain at 0.03 
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.
    Cyhalofop-butyl has low or minimal acute toxicity via the oral, 
dermal and inhalation routes of exposure. It is minimally irritating to 
the eye, non-irritating to the skin and is not a dermal sensitizer.
    Kidney effects were observed after subchronic and chronic dosing of 
the rat and mouse as well as in the rabbit developmental and rat 
reproduction studies. In the 90-day rat study, lipofuscin pigment 
deposition in proximal tubule kidney cells was noted in both sexes in 
addition to hepatocyte eosinophilic granules (males only); and in the 
90-day mouse study (females only), there was an increase in absolute 
and relative kidney weights as well as swelling of the proximal tubule 
cells. In the rabbit developmental study, 1/18 dams in the mid-dose 
group and 9/18 dams in the high-dose group died or were sacrificed in 
extremis after exhibiting hematuria (gross pathological examinations 
revealed cloudy or dark colored kidneys). Slight kidney tubular cell 
swelling was observed only in adult males in the rat reproductive 
toxicity study. In the 18-month mouse carcinogenicity study, kidney 
findings included tubular dilatation, chronic glomurulonephritis and 
hyaline casts in females (not males). In both sexes in the chronic/
carcinogenicity rat study increased deposition of kidney changes (early 
and increased deposition of the pigments lipofuscin and hemosiderin in 
the renal proximal tubular cells) was observed. In addition, in females 
only, renal mineralization was observed.
    Non-kidney effects observed following subchronic or chronic 
exposure to cyhalofop-butyl included hyperplasia of the stomach mucosal 
epithelium (male mice only) in the 18-month mouse carcinogenicity study 
and brown and/or atrophied thymuses and decreased thymus weight in the 
90-day dog study. The thymus effects, which could be an indication of 
potential immunotoxicity, were not observed in the 1-year dog study or 
in other species (rats, mice or rabbits) and were not seen in any 
tested species following chronic exposure to cyhalofop-butyl.
    There was no evidence of developmental, reproductive or endocrine 
toxicity in the toxicology studies for cyhalofop-butyl. In the rat 
developmental toxicity study, there were no maternal or fetal effects 
observed up to the limit dose. In the rabbit developmental toxicity 
study, no fetal effects were observed up to the limit dose; whereas 
kidney effects (deaths related to hematuria and the occurrence of 
cloudy or dark colored kidneys on gross pathological examination) were 
seen in maternal animals. Slight kidney tubular cell swelling was 
observed in adult males in the rat reproductive toxicity study with no 
evidence of treatment-related effects observed in females or offspring.
    There were no systemic or neurotoxic effects noted at the limit 
dose in the gavage acute neurotoxicity study or in the 90-day feeding 
neurotoxicity study.
    In a previous 2002 risk assessment for cyhalofop-butyl, it was not 
possible to assess the carcinogenic potential of cyhalofop-butyl due to 
insufficient dosing in the rat and mouse carcinogenicity studies. In 
the absence of acceptable data, EPA assumed that cyhalofop-butyl had 
the same carcinogenic potential as the structural analog, diclofop-
methyl, and conducted an exposure asssessment to evaluate cancer risk 
using quantitative linear low-dose extrapolation and the Q1* for 
diclofop-methyl of 2.3 x 10-1 (mg/kg/day)-1. 
Subsequently, two specific mechanistic studies (Peroxisome Proliferator 
Receptor-Alpha Reporter Assays (PPAR[alpha])) in the mouse were 
submitted to EPA. Review of the mechanistic data indicated that 
cyhalofop-butyl is not a liver toxicant/carcinogen for humans, since 
the PPAR[alpha] rodent liver mode of action is not likely to occur in 
humans; and that the doses in the original long-term studies were 
approaching a maximum tolerated dose. In addition, there were no 
positive effects in the battery of mutagenic studies. Based on these 
findings, EPA has classified cyhalofop-butyl as ``Not Likely to be 
Carcinogenic to Humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by cyhalofop-butyl 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 the document Cyhalofop-butyl: Human Health Risk 
Assessment for Proposed Uses on Wild Rice and A Proposed Amended 
Labeling for Clincher[reg] SF Herbicide, page 30 in docket ID number 
EPA-HQ-OPP-2008-0361.

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

[[Page 15878]]

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 cyhalofop-butyl used 
for human risk assessment can be found at http://www.regulations.gov in 
the document Cyhalofop-butyl: Human Health Risk Assessment for Proposed 
Uses on Wild Rice and A Proposed Amended Labeling for Clincher[reg] SF 
Herbicide, page 16 in docket ID number EPA-HQ-OPP-2008-0361.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyhalofop-butyl, EPA considered exposure under the 
petitioned-for tolerances. There are no other tolerances in effect for 
cyhalofop-butyl. EPA assessed dietary exposures from cyhalofop-butyl 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 cyhalofop-butyl; therefore, 
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture 1994-1996 and 1998 Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA 
assumed that all rice and wild rice commodities would be treated with 
cyhalofop-butyl and contain tolerance-level residues.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, and mechanistic studies in mice, EPA classified 
cyhalofop-butyl as ``Not Likely to be Carcinogenic To Humans;'' 
therefore, an exposure assessment for evaluating cancer risk is not 
needed for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for cyhalofop-butyl. 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 cyhalofop-butyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of cyhalofop-butyl. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    Based on the Tier I Rice model and Screening Concentration in 
Ground Water (SCI-GROW) model, the estimated drinking water 
concentrations (EDWCs) of cyhalofop-butyl for chronic exposures for 
non-cancer assessments (the only dietary exposure scenario for which a 
toxicological endpoint of concern was identified) are estimated to be 
21 parts per billion (ppb) for surface water and 0.152 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 value of 21 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).
    Cyhalofop-butyl is not registered for any specific use patterns 
that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found cyhalofop-butyl to share a common mechanism of 
toxicity with any other substances, and cyhalofop-butyl does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyhalofop-butyl 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 prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for cyhalofop-butyl includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. There were no treatment-related effects observed in 
fetuses or offspring in any of these studies.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF

[[Page 15879]]

were reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for cyhalofop-butyl is complete, except 
for immunotoxicity data, and EPA has determined that an additional 
uncertainty factor is not required to account for potential 
immunotoxicity. EPA began requiring functional immunotoxicity testing 
of all food and non-food use pesticides on December 26, 2007. Since 
this requirement is relatively new, these data are not yet available 
for cyhalofop-butyl. In the absence of specific immunotoxicity studies, 
EPA has evaluated the available cyhalofop-butyl toxicity data to 
determine whether an additional database uncertainty factor is needed 
to account for potential immunotoxicity.
    Brown and/or atrophied thymuses and decreased thymus weight were 
observed in the 90-day dog study. However, these effects, which could 
be an indication of potential immunotoxicity, were not observed in the 
1-year dog study or in other species (rats, mice or rabbits) and were 
not seen in any tested species following chronic exposure to cyhalofop-
butyl. Based on these considerations, EPA has concluded that the doses 
and endpoints selected for risk assessment (along with traditional 
uncertainty factors) are protective of potential immunotoxicity and an 
additional uncertainty factor is not needed.
    ii. There is no indication that cyhalofop-butyl 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 cyhalofop-butyl results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in offspring in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed 
assuming 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to cyhalofop-butyl in drinking water. Residential 
exposure of infants and children is not expected. These assessments 
will not underestimate the exposure and risks posed by cyhalofop-butyl.

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, 
cyhalofop-butyl 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 
cyhalofop-butyl from food and water will utilize 15% of the cPAD for 
infants, less than 1-year old, the population group receiving the 
greatest exposure. There are no residential uses for cyhalofop-butyl.
    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). Cyhalofop-
butyl is not registered for any use patterns that would result in 
residential exposure. Therefore, the short-term aggregate risk is the 
sum of the risk from exposure to cyhalofop-butyl through food and water 
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Cyhalofop-butyl is not registered for any use patterns that 
would result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to cyhalofop-butyl through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Cyhalofop-butyl is 
classified as ``not likely to be carcinogenic to humans'' and is, 
therefore, 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 cyhalofop-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography/Mass 
Spectrometry (GC/MS) Method GRM 99.06) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX, Canadian or Mexican maximum residue limits 
(MRLS) established for cyhalofop-butyl on the commodities associated 
with these petitions.

C. Response to Comments

    An anonymous citizen objected to the presence of any pesticide 
residues on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned completely. However, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
contemplates that tolerances greater than zero may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Dow AgroSciences proposed a tolerance for residues of cyhalofop-
butyl on rice, straw. EPA recently concluded that rice straw is not a 
significant livestock feed item. Insignificant livestock feed items are 
considered covered by the tolerance for the raw agricultural commodity 
with which they are associated (62 FR 66020; December 17, 1997). 
Therefore, the proposed tolerance on rice, straw is unnecessary and is 
not being established.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
cyhalofop-

[[Page 15880]]

butyl, R-(+)-n-butyl-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionate, 
plus cyhalopfop acid, R-(+)-2-(4(4-cyano-2-fluorophenoxy)-
phenoxy)propionic acid) and the di-acid metabolite, (2R)-4-[4-(1-
carboxyethoxy)phenoxy]-3-fluorobenzoic acid, in or on rice, grain and 
rice, wild, grain at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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 27, 2009.
Lois Rossi,
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 180.576 is amended by revising the table in paragraph (a) to 
read as follows:

Sec.  180.576  Cyhalofop-butyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Rice, grain..........................................               0.03
Rice, wild, grain....................................               0.03
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-7990 Filed 4-7-09; 8:45 am]

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