[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Rules and Regulations]
[Pages 67104-67108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30040]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0773; FRL-8801-8]


Prometryn; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the residues of 
prometryn in or on celeriac, roots; celeriac, tops; cilantro, leaves; 
coriander, dried leaves; leaf petioles subgroup 4B; okra; parsley, 
leaves; parsley, dried leaves; and increases the tolerance level for 
carrot, root. Additionally, the tolerance for celery is removed since 
it is included in the leafy petioles subgroup 4B and the regional 
tolerance for parsley leaves is removed since it is superseded by the 
tolerance established in this action. Interregional Research Project 
No. 4 (IR-4) requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and 
requests for hearings must be received on or before February 16, 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-2008-0773. 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: Barbara Madden, Registration Division 
(7505P), 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 
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. To access the OPPTS harmonized test 
guidelines referenced in this document electronically, please go to 
http://

[[Page 67105]]

www.epa.gov/oppts and select ``Test Methods & Guidelines'' on the left-
side navigation menu.

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-2008-0773 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 February 16, 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-2008-0773, 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 Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
8E7434 and 8E7436) by IR-4, 500 College Road East, Suite 201W, 
Princeton, New Jersey 08540. The petition requested that 40 CFR 180.222 
be amended by establishing tolerances for residues of the herbicide 
prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-triazine, in or on 
carrots at 0.7 parts per million (ppm); celeriac, roots at 0.05 ppm; 
celeriac, tops at 0.05 ppm; cilantro, fresh at 4.0 ppm, cilantro, dried 
at 15 ppm; okra at 0.05 ppm; parsley, leaves at 0.7 ppm, (all the 
preceding in PP 8E7434); and leaf petiole subgroup 4B at 0.5 ppm (PP 
8E7436). That notice referenced a summary of the petition prepared by 
Syngenta Crop Protection, Inc., the registrant, on behalf of IR-4, 
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 carrot, roots from 0.7 ppm to 0.45 ppm; celeriac, tops from 
0.05 ppm to 0.20 ppm; cilantro, leaves from 4.0 ppm to 3.5 ppm; 
coriander, dried leaves from 15.0 ppm to 9.0 ppm; parsley, leaves from 
0.7 ppm to 0.60 ppm. EPA also revised several commodity terms and 
determined that a tolerance is required for parsley, dried leaves at 
1.5 ppm.The reasons for these changes are 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 residues of prometryn on carrot, roots at 0.45 ppm; 
celeriac, roots at 0.05 ppm; celeriac, tops at 0.20 ppm; cilantro, 
leaves at 3.5 ppm; coriander, dried leaves at 9.0 ppm; leaf petioles 
subgroup 4B at 0.50 ppm; okra at 0.05 ppm; parsley, leaves at 0.60 ppm; 
and parsley, dried leaves at 1.5 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.
    Prometryn demonstrated minimal acute toxicity via the oral, dermal, 
and inhalation routes. Prometryn is mildly irritating to the eyes, 
slightly irritating to the skin, and is not a skin sensitizer.
    In a 28-day feeding study in mice, prometryn caused decreased body 
weight and/or mortality at doses that exceed the limit dose. No 
evidence of local or systemic toxicity was observed in a 21-day dermal 
toxicity study in rabbits. In a chronic oncogenicity study in mice, 
decreased body-weight gain at the highest dose tested was the only 
adverse effect observed. In a combined chronic toxicity/carcinogenicity 
study in rats, decreased body weight, body-weight gains, and renal 
toxicity (mineralized concretions) were observed at the highest dose 
only. There was no evidence of carcinogenicity in either study and 
prometryn was non-mutagenic when tested in a battery of genotoxicity 
assays. Following long-term exposure of dogs to prometryn, multi-organ 
toxicity (degenerative hepatic changes, renal tubule degeneration, bone 
marrow atrophy) was observed at the highest dose tested.
    Prometryn is neither a developmental nor a reproductive toxicant. 
Adverse effects were observed primarily at the highest doses tested; 
offspring toxicity was observed at the same doses as maternal/parental 
toxicity. In the developmental toxicity study in the rat, decreased 
body weight and food consumption, and clinical signs of toxicity were 
observed in dams; decreased fetal body weight, and incomplete 
ossification of sternebrae and metacarpals were observed at the same 
dose in offspring. In the developmental toxicity study in rabbits, 
decreased food consumption and increased incidence of resorptions, 
abortions, and post-implantation loss were observed in maternal animals 
that

[[Page 67106]]

led to a decreased number of viable litters and live fetuses at the 
highest dose tested. In the 2-generation rat production study, 
decreased food consumption, body weight, and body-weight gain were 
observed in parental animals, and decreased body weight was observed in 
offspring at the same dose. There was no evidence of toxicity to the 
reproductive organs in the study.
    Specific information on the studies received and the nature of the 
adverse effects caused by prometryn 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 ``Section 3 Registration Request to 
Add New Uses on Carrot, Celeriac, Cilantro, Okra, Parsley, and Leaf 
Petioles (Crop Subgroup 4B). Human-Health Risk Assessment,'' at page 36 
in docket ID number EPA-HQ-OPP-2008-0773.

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 prometryn used for 
human risk assessment can be found at http://www.regulations.gov in the 
document ``Section 3 Registration Request to Add New Uses on Carrot, 
Celeriac, Cilantro, Okra, Parsley, and Leaf Petioles (Crop Subgroup 
4B). Human-Health Risk Assessment,'' at page 19 in docket ID number 
EPA-HQ-OPP-2008-0773.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prometryn, EPA considered exposure under the petitioned-for 
tolerances as well as all existing prometryn tolerances in 40 CFR 
180.222. EPA assessed dietary exposures from prometryn 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. Such effects (increased 
incidence of resorptions, abortions, and post-implantation loss and 
decreased number of live fetuses) were identified in the toxicological 
studies for prometryn for the population subgroup females 13 to 49 
years old; no such effects were identified for the general population 
or other population subgroups.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As 
to residue levels in food, EPA assumed that all food commodities 
contain tolerance level residues and that 100% of all crops are treated 
with prometryn. EPA also used the default processing factors for all 
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 to residue levels in food, EPA assumed that all food 
commodities contain tolerance level residues and that 100% of all crops 
are treated with prometryn. EPA also used the default processing 
factors for all processed commodities.
    iii. Cancer. Prometryn was classified by the Agency in Group E 
(``Evidence of non-carcinogenicity for humans''), based on the lack of 
oncogenic effects at any dose in both rats and mice. Therefore an 
exposure assessment to evaluate cancer risks 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 prometryn. Tolerance level residues and 100% CT 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 prometryn in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of prometryn. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of prometryn for acute 
exposures are estimated to be 377.4 parts per billion (ppb) for surface 
water and 23.2 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 157.9 ppb for surface water and 
23.2 ppb for ground water.
    For acute dietary risk assessment, the water concentration value of 
377.4 ppb was used to assess the contribution to drinking water. For 
chronic dietary risk assessment, the water concentration value of 157.9 
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).
    Prometryn 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.''

[[Page 67107]]

    EPA has not found prometryn to share a common mechanism of toxicity 
with any other substances, and prometryn does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that prometryn 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 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. Developmental toxicity 
studies showed no increased sensitivity of fetuses when compared to 
maternal animals following in utero exposures of rats or rabbits. The 
multi-generation reproduction study in rats showed no increased 
sensitivity of offspring when compared to parental animals. No evidence 
of developmental anomalies of the fetal nervous system was observed in 
the prenatal developmental toxicity studies in either rats or rabbits 
up to maternally toxic dose levels.
    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 prometryn 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 toxicology 
database for prometryn does not show any evidence of treatment-related 
effects on the nervous or immune system. The overall weight-of-evidence 
suggests that this chemical does not directly target the nervous or the 
immune system. In addition, prometryn does not belong to a class of 
chemicals (e.g., the organotins, heavy metals, halogenated aromatic 
hydrocarbons) that would be expected to be immunotoxic. Although an 
immunotoxicity study and acute and subchronic neurotoxicity studies are 
required as a part of new data requirements in the 40 CFR part 158 for 
conventional pesticide registration, the Agency does not believe that 
conducting a functional immunotoxicity study or acute and subchronic 
neurotoxicity studies will result in a lower POD than that currently 
use for overall risk assessment, and therefore, a database uncertainty 
factor is not needed to account for lack of these studies.
    ii. There is no indication that prometryn 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 prometryn 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% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to prometryn in drinking water. These assessments 
will not underestimate the exposure and risks posed by prometryn.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to prometryn will occupy 16% of the aPAD for females 13 to 49 years 
old, the population group receiving the greatest exposure. No adverse 
effect resulting from a single-oral exposure was identified for the 
remaining population groups and no acute dietary endpoint was selected. 
Therefore, prometryn 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 
prometryn from food and water will utilize 30% of the cPAD for all 
infants < 1 year old, the population group receiving the greatest 
exposure. There are no residential uses for prometryn.
    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).
    Prometryn is not registered for any use patterns that would result 
in residential exposure. Therefore, the short- and intermediate-term 
aggregate risk is the sum of the risk from exposure to prometryn 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.C.1.iii., the Agency has concluded that prometryn is not likely to 
be carcinogenic to humans, therefore, a cancer risk is not of concern 
for this chemical.
    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 prometryn residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/flame 
photometric detection/sulfur (GC/FPD/S)) 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 currently no established Codex MRLs for prometryn.

C. Revisions to Petitioned-for Tolerances

    Based upon review of the data supporting the petition, EPA has

[[Page 67108]]

modified carrot, roots from 0.7 ppm to 0.45 ppm; celeriac, tops from 
0.05 ppm to 0.20 ppm; cilantro, leaves from 4.0 ppm to 3.5 ppm; 
coriander, dried leaves from 15.0 ppm to 9.0 ppm; parsley, leaves from 
0.7 ppm to 0.60 ppm. EPA revised these tolerance levels 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. EPA also revised the 
commodity term for cilantro dried to coriander, dried leaves, to be in 
compliance with correct commodity definition. Additionally, EPA 
determined that a tolerance is required for parsley, dried leaves at 
1.5 ppm. Additionally, the tolerance for celery is removed since it is 
included in the leaf petioles subgroup 4B and the regional tolerance 
for parsley leaves is removed since it is superseded by the tolerance 
established in this action.

V. Conclusion

    Therefore, tolerances are established for residues of prometryn, 
2,4-bis(isopropylamino)-6-methylthio-s-triazine, in or on celeriac, 
roots at 0.05 ppm; celeriac, tops at 0.20 ppm; cilantro, leaves at 3.5 
ppm; coriander, dried leaves at 9.0 ppm; leaf petioles subgroup 4B at 
0.50 ppm; okra at 0.05 ppm; parsley, leaves at 0.60 ppm; parsley, dried 
leaves at 1.5 ppm and increases the tolerance level for carrot, root to 
0.45 ppm. Additionally, the tolerance for celery is removed since it is 
included in the leafy petioles subgroup 4B and the regional tolerance 
for parsley leaves is removed since it is superseded by the tolerance 
established in this action.

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: December 8, 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. In Sec.  180.222, in the table to paragraph (a) by revising the 
entry for ``carrot, roots''; by removing footnote 1, and the entry for 
``celery,'' and by adding alphabetically entries for ``celeriac, 
roots''; ``celeriac, tops''; ``cilantro, leaves''; ``coriander, dried 
leaves''; ``leaf petioles subgroup 4B''; ``okra''; ``parsley, leaves''; 
and ``parsley, dried leaves'' to read as follows, and in the table to 
paragraph (c) by removing the entry for ``parsley, leaves.''


Sec.  180.222  Prometryn; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Carrot, roots........................................               0.45
Celeriac, roots......................................               0.05
Celeriac, tops.......................................               0.20
Cilantro, leaves.....................................                3.5
Coriander, dried leaves..............................                9.0
                                * * * * *
Leaf petioles subgroup 4B............................               0.50
Okra.................................................               0.05
Parsley, dried leaves................................                1.5
Parsley, leaves......................................               0.60
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-30040 Filed 12-17-09; 8:45 am]
BILLING CODE 6560-50-S