Prometryn; Pesticide Tolerances, 55635-55641 [2013-22107]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Rules and Regulations]
[Pages 55635-55641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22107]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0590; FRL-9395-4]


Prometryn; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
prometryn in or on succulent snap bean, dill oil, fresh dillweed 
leaves, and dried dillweed leaves. This regulation additionally removes 
the established tolerance with regional restrictions on dill, since it 
is superseded by the tolerance on fresh dillweed leaves. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 11, 2013. Objections and 
requests for hearings must be received on or before November 12, 2013, 
and

[[Page 55636]]

must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0590, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

 B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2012-0590 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 12, 2013. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0590, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2E8053) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 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 bean, snap, 
succulent at 0.05 parts per million (ppm); bean, forage at 0.09 ppm; 
dill, leaves at 0.3 ppm; dill, dried leaves at 1.1 ppm; and dill, oil 
at 1.3 ppm. That document referenced a summary of the petition prepared 
on behalf of IR-4 by Syngenta Crop Protection, the registrant, which is 
available in the docket, https://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 
corrected the commodity terminology for certain proposed tolerances and 
has revised the tolerance expression for all commodities. 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 prometryn including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with prometryn 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

[[Page 55637]]

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.
    In the subchronic oral feeding study in mice, prometryn caused 
decreased body weight (bwt) and/or mortality at doses that exceeded the 
limit dose. In chronic oral toxicity studies, effects primarily 
occurred only at the highest doses tested for dogs, rats, and mice, 
though the dog is considered the most sensitive species. Effects in the 
dog included degenerative hepatic changes, renal tubule degeneration, 
and bone marrow atrophy. In developmental studies with prometryn, fetal 
effects were observed primarily at the highest doses tested and in the 
presence of maternal toxicity. In rats, decreased bwt, decreased food 
consumption, and clinical signs of toxicity were observed in dams. 
Decreased fetal bwt and incomplete ossification of sternebrae and 
metacarpals were observed at the same dose in offspring. In rabbits, 
maternal effects included decreased food consumption and an increased 
incidence of resorptions, abortions, and post-implantation loss; these 
effects corresponded with a decreased number of viable litters and live 
fetuses at the same dose. In the 2-generation rat reproductive study, 
decreased food consumption, bwt, and bwt gain were observed in parental 
animals, and decreased bwts were observed in offspring at the same 
dose.
    Preliminary review of the rat acute and subchronic neurotoxicity 
studies reveals lower mean total and/or ambulatory locomotor activity 
counts noted for both sexes on the first day of treatment in the acute 
study, and no signs of neurotoxicity in the subchronic study. In the 
immunotoxicity study, there was a decreased humoral response in the 
sheep red blood cell assay. No evidence of local or systemic toxicity 
was observed in a 21-day dermal toxicity study in rabbits.
    In a combined chronic toxicity and carcinogenicity study in rats, 
effects included decreased bwt, bwt gains, and renal toxicity, 
exhibited as mineralized concretions. In a carcinogenicity study in 
mice, the only effect was decreased bwt gain. Prometryn has been 
classified with ``evidence of non-carcinogenicity for humans'' based on 
the lack of oncogenic effects at any dose in both rats and mice. 
Prometryn was determined to be non-mutagenic and non-clastogenic in in 
vitro and in vivo genotoxicity assays.
    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 https://www.regulations.gov in document: ``Prometryn: Human-Health Risk 
Assessment for the Proposed Uses on Snap Bean and Dill.'' pp. 32-34 in 
docket ID number EPA-HQ-OPP-2012-0590.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD), and a safe 
margin of exposure (MOE). 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 expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for prometryn used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Prometryn for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (Females 13-49 years of  NOAEL = 12 mg/kg/day     Acute RfD = 0.12 mg/kg/  Developmental toxicity
 age).                                  UFA = 10x UFH = 10x      day, aPAD = 0.12 mg/kg/  (rabbit) LOAEL = 72 mg/
                                        FQPA SF = 1x.            day.                     kg/day based on
                                                                                          increased incidence of
                                                                                          resorptions,
                                                                                          abortions, and post-
                                                                                          implantation loss
                                                                                          leading to decreased
                                                                                          number of viable
                                                                                          litters and live
                                                                                          fetuses.
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Acute dietary (General population         No effects attributable to a single exposure were identified for the
 including infants and children).         general population, including infants and children. Therefore, a dose
                                               and endpoint were not selected for this exposure scenario.
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Chronic dietary (All populations)....  NOAEL = 3.75 mg/kg/day   Chronic RfD = 0.04 mg/   Chronic toxicity (dog;
                                        UFA = 10x UFH = 10x      kg/day, cPAD = 0.04 mg/  dietary) LOAEL = 37.5
                                        FQPA SF = 1x.            kg/day.                  mg/kg/day based on
                                                                                          degenerative hepatic
                                                                                          changes, renal tubule
                                                                                          degeneration, and bone
                                                                                          marrow atrophy.
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[[Page 55638]]

 
Cancer (Oral, dermal, inhalation)....        Classified as ``evidence of non-carcinogenicity for humans.''
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

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 were identified 
for prometryn for females 13-49 years old, the only acute population 
subgroup of concern for this assessment. In estimating acute dietary 
exposure, EPA used Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses 
food consumption data from the U.S. Department of Agriculture's 
(USDA's) National Health and Nutrition Examination Survey, ``What We 
Eat in America'' (NHANES/WWEIA) from 2003 through 2008. As to residue 
levels in food, EPA used tolerance-level residues for all commodities, 
100 percent crop treated (PCT) estimates, and utilized DEEM version 
7.81 default processing factors when appropriate.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level 
residues for all commodities, assumed 100 PCT, and utilized DEEM 
default processing factors when appropriate.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that prometryn does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
prometryn. 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 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 https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of prometryn for 
surface waters are expected to be 377.4 parts per billion (ppb) for 
acute exposures and 157.9 ppb for chronic exposures. For ground water, 
the EDWC is expected to be 23.2 ppb for acute and chronic exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration values 
of 377.4 ppb and 157.9 ppb were used to assess the contribution of 
drinking water for the acute and chronic dietary risk assessments, 
respectively.
    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.''
    Prometryn is a triazine, and certain triazine pesticides were 
identified as a common mechanism group (CMG) by EPA in a 2002 paper 
entitled, ``The Grouping of a Series of Triazine Pesticides Based on a 
Common Mechanism of Toxicity.'' However, prometryn was excluded from 
the triazine CMG because it does not share the toxicity profile of the 
CMG triazines. Therefore, for the purposes of this action, EPA is 
assuming that prometryn does not have a common mechanism of toxicity 
with other substances, and prometryn does not produce a toxic 
metabolite known to be produced by other substances. For information 
regarding EPA's efforts to determine which substances have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
substances, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (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 in rats and rabbits and a 2-generation reproduction study in 
rats are available to assess potential fetal and offspring sensitivity 
to prometryn, and there is no evidence of increased quantitative 
prenatal susceptibility following prometryn exposure in these studies. 
In the 2-generation rat reproductive study, no evidence of toxicity to 
the

[[Page 55639]]

reproductive organs was observed and the effects that were observed in 
the offspring (decreased bwt) occurred at the same dose as those 
observed in parental animals (decreased food consumption, bwt, and bwt 
gain). In both rats and rabbit developmental toxicity studies, fetal 
and offspring effects occurred at maternal/parental doses. Fetal 
effects in rats included decreased fetal bwt, incomplete ossification 
of sternebrae and metacarpals observed at the same dose as maternal 
toxicity, including decreased bwt, decreased food consumption, and 
clinical signs of toxicity. In rabbits, fetal effects included a 
decreased number of viable litters and live fetuses noted in the 
presence of decreased food consumption and an increased incidence of 
resorptions, abortions, and post-implantation loss in maternal rabbits.
    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. In the last 
final rule for prometryn, published in the Federal Register of December 
18, 2009 (74 FR 67104) (FRL-8801-8), immunotoxicity (OCSPP Guideline 
870.7800) and acute and subchronic neurotoxicity (OCSPP Guideline 
870.6200) studies were reported as data gaps required in 40 CFR part 
158 for pesticide registration. These studies were recently submitted 
to the Agency and are pending formal review. Preliminary review 
suggests that these studies will not affect the endpoints selected for 
assessing the dietary risks of concern. In the immunotoxicity study, 
although there was a decreased humoral response in the sheep red blood 
cell assay, this effect is not expected to impact the risk assessment. 
This effect was observed at the limit dose (1,044 milligrams/kilogram/
day (mg/kg/day) and is at least one order of magnitude higher than the 
effects used for the acute and chronic dietary endpoints causing a very 
low level of concern. The preliminary review of the acute neurotoxicity 
study shows some indication of neurotoxicity; however, since the POD 
chosen for risk assessment is lower than the dose that caused the 
observed effects in this study, it is thus considered protective of 
these effects. Additionally, there were no signs of neurotoxicity 
observed in the subchronic neurotoxicity study. Therefore, there is no 
need for a developmental neurotoxicity study or additional UFs to 
account for neurotoxicity.
    ii. There is no evidence that prometryn results in increased 
susceptibility in young rats in the 2-generation reproduction study. 
The effects noted in in utero rats and rabbits in the prenatal 
developmental studies do not indicate increased susceptibility because:
    a. The effects are well characterized.
    b. Clear NOAELs were established.
    c. The developmental rabbit study is being used in endpoint 
selection.
    iii. 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 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-term, intermediate-term, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    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 17% of the aPAD for females 13-49 years old, 
the population subgroup identified as having a potential acute 
exposure.
    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 23% of the cPAD for all 
infants less than 1-year old, the population group receiving the 
greatest exposure. There are no residential uses for prometryn.
    3. Short-term and Intermediate-term risks. Short-term and 
intermediate-term aggregate exposures take into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Short-term 
and intermediate-term adverse effects were identified; however, 
prometryn is not registered for any use patterns that would result in 
short-term or intermediate-term residential exposures. Short-term and 
intermediate-term risk is assessed based on short-term and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there are no short-term or intermediate-term residential 
exposures and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess short-term risk), no further assessment of 
short-term or intermediate-term risks are necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term and 
intermediate-term risks for prometryn.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, prometryn is not expected to pose a cancer risk to humans.
    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

    An enforcement methodology (gas chromatography/flame photometric 
detection/sulfur (GC/FPD/S)), Method AG-559, 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; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that

[[Page 55640]]

EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for prometryn.

C. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA has determined 
that the proposed tolerance in or on bean, forage at 0.09 ppm is not 
necessary. The Agency determined that this tolerance level is not 
necessary because bean, forage is not a significant livestock feed 
item. Additionally, the Agency revised the proposed commodity 
terminology for dill, leaves to dillweed, fresh leaves and dill, dried 
leaves to dillweed, dry leaves in order to reflect the correct 
commodity terminology. Finally, the Agency has revised the tolerance 
expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of prometryn not specifically 
mentioned.
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of prometryn, 
2,4-bis(isopropylamino)-6-methylthio-s-triazine, in or on bean, snap, 
succulent at 0.05 ppm; dill, oil at 1.3 ppm; dillweed, fresh leaves at 
0.30 ppm; and dillweed, dried leaves at 1.1 ppm. This regulation 
additionally removes the established tolerance with regional 
restrictions in or on dill at 0.3 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: August 29, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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:
0
a. Revise the introductory text of paragraph (a).
0
b. Add alphabetically ``bean, snap, succulent,'' ``dill, oil,'' 
``dillweed, dried leaves,'' and ``dillweed, fresh leaves'' to the table 
in paragraph (a).
0
c. Remove and reserve paragraph (c).
0
d. Revise the introductory text of paragraph (d).
    The amendments read as follows:


Sec.  180.222  Prometryn; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide prometryn, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-
triazine, in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Bean, snap, succulent...................................            0.05
 
                                * * * * *
Dill, oil...............................................            1.3
Dillweed, dried leaves..................................            1.1
Dillweed, fresh leaves..................................            0.30
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional exemptions. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of the herbicide prometryn, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only prometryn, 
2,4-bis(isopropylamino)-6-

[[Page 55641]]

methylthio-s-triazine, in or on the following raw agricultural 
commodities.
* * * * *
[FR Doc. 2013-22107 Filed 9-10-13; 8:45 am]
BILLING CODE 6560-50-P