Mandipropamid; Pesticide Tolerances, 76987-76992 [2013-30348]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 245 (Friday, December 20, 2013)]
[Rules and Regulations]
[Pages 76987-76992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30348]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0980; FRL-9903-57]


Mandipropamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances in or on multiple 
commodities and removes several established tolerances for residues of 
mandipropamid, which are identified and discussed later in this 
document. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 20, 2013. Objections and 
requests for hearings must be received on or before February 18, 2014, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0980, 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.

[[Page 76988]]


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.

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-2012-0980 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 
February 18, 2014. 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-2012-0980, 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 February 27, 2013 (78 FR 13295) (FRL-
9380-2), 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 
2E8126) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.637 be amended by 
establishing tolerances for residues of the fungicide mandipropamid, 4-
chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-
propynyloxy)-benzeneacetamide, in or on basil, dried at 200 parts per 
million (ppm); basil, fresh at 30 ppm; bean, succulent at 0.90 ppm; 
cowpea, forage at 15 ppm; fruit, small, vine climbing, subgroup 13-07F, 
except fuzzy kiwifruit at 2.0 ppm; ginseng at 0.3 ppm; onion, bulb, 
subgroup 3-07A at 0.1 ppm; onion, green, subgroup 3-07B at 7.0 ppm; and 
vegetable, fruiting, group 8-10 at 1.0 ppm. The petition additionally 
requested to remove the established tolerances in or on grape at 1.4 
ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; okra at 1.0 
ppm; and vegetable, fruiting, group 8 at 1.0 ppm, upon establishment of 
the associated proposed tolerances. 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 
determined that the proposed tolerances should not be established on 
succulent bean or cowpea forage, and that a tolerance should be 
established on snap bean. The Agency has also determined that the 
proposed tolerances in or on small vine climbing fruit subgroup 13-07F, 
bulb onion subgroup 3-07A and green onion subgroup 3-07B should be 
revised. EPA has also revised the commodity terminology for fresh and 
dried basil and determined that the tolerance expression should be 
revised for all commodities. Finally, EPA determined that the time-
limited tolerance on fresh basil should be removed. 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 mandipropamid including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with mandipropamid 
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.

[[Page 76989]]

    Subchronic and chronic studies indicate that the liver is the 
primary target organ for mandipropamid. Liver effects were identified 
in subchronic studies with rats, mice, and dogs. Liver effects included 
increased plasma albumin, total protein, cholesterol, and gamma-
glutamyl transferase, as well as periportal hypertrophy in rats; 
increased liver enzymes, increased pigment in hepatocytes and Kupffer 
cells, and centrilobular hepatocyte vacuolation in dogs; increased 
eosinophilia in rats and mice; and increased liver weights in rats, 
mice and dogs. In the chronic dog study, increases in microscopic 
pigment in the liver and increased liver enzymes were observed. No 
liver effects were observed in chronic rat and mouse studies up to the 
highest doses tested. Instead, nephrotoxicity was observed in the 
chronic rat study and decreased body weight and food utilization was 
observed in the chronic mouse study. The findings of liver toxicity and 
nephrotoxicity are consistent with the results from metabolism studies 
where the tissues with the highest levels of radioactivity were the 
liver followed by the kidney.
    No evidence of neurotoxicity was observed in the acute or 
subchronic neurotoxicity screening battery. No systemic or dermal 
toxicity was observed following dermal exposure for 28 days, up to the 
limit dose. No immunotoxicity was observed up to the highest dose 
tested in the mouse immunotoxicity study.
    No evidence of increased quantitative or qualitative susceptibility 
was seen in developmental toxicity studies in rats and rabbits or in a 
2-generation reproduction study in rats. The only effects observed in 
fetuses or pups were in the 2-generation reproduction study, where 
decreased pup body weight was observed in the presence of maternal 
toxicity (decreased body weight, body weight gain, and food 
utilization). In addition, there was a delay in preputial separation in 
F1 males which was considered to be the result of lower body weights.
    There was no evidence of tumors in the carcinogenicity study in 
mice or in the chronic/carcinogenicity study in rats and there was no 
evidence that mandipropamid was mutagenic or clastogenic. Therefore, 
mandipropamid is classified as ``not likely to be carcinogenic to 
humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by mandipropamid 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, ``Mandipropamid: Human Health Risk 
Assessment For New Uses On Basil, Ginseng and Snap Beans, as Well as 
Crop Group Expansions for Fruiting Vegetable; Small Fruit, Vine 
Climbing, Except Fuzzy Kiwifruit; and Bulb Onion and Green Onion 
Subgroups.'' at pages 33-38 in docket ID number EPA-HQ-OPP-2012-0980.

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 the NOAEL and the LOAEL are identified. 
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 mandipropamid used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Mandipropamid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population    No endpoint attributable to a single exposure was identified.
 including infants and children and
 females 13-49 years old).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL=5 mg/kg/day.....  Chronic RfD = 0.05 mg/  Chronic Toxicity Study,
                                     UFA = 10x.............   kg/day.                 Dogs LOAEL = 40 mg/kg/day
                                     UFH = 10x.............  cPAD = 0.05 mg/kg/day.   based on increased
                                     FQPA SF = 1x..........                           incidence and severity of
                                                                                      microscopic pigment in the
                                                                                      liver and increased
                                                                                      alkaline phosphatase
                                                                                      activity in both sexes as
                                                                                      well as increased alanine
                                                                                      aminotransferase activity
                                                                                      in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  Classified as not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. Mg/kg/day = milligrams/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 mandipropamid, EPA considered exposure under the 
petitioned-for tolerances as well as all existing mandipropamid 
tolerances in 40 CFR 180.637. EPA assessed dietary exposures from 
mandipropamid 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

[[Page 76990]]

occurring as a result of a 1-day or single exposure. No such effects 
were identified in the toxicological studies for mandipropamid; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment 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 with the exception of 
subgroups 13-07F, 3-07A, and 3-07B, for which EPA used residue levels 
higher than the tolerance levels being established here; and tuberous 
and corm vegetable subgroup 1C, which was assessed at 0.026 ppm, in 
order to account for the SYN 500003 metabolite for this commodity. EPA 
assessed tolerances for subgroups 13-07F, 3-07A, and 3-07B using levels 
that were proposed by the petitioner and that were harmonized with 
Codex maximum residue levels. However, for reasons discussed in Unit 
IV.B., EPA is harmonizing these tolerance levels with the lower 
Canadian maximum residue levels (MRLs). The Agency also assumed 100 
percent crop treated (PCT) estimates for all commodities and utilized 
default DEEM-FCID TM (ver. 7.81) processing factors, with 
the exception of chemical-specific processing factors for grape wine 
and sherry.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that mandipropamid 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 and/or PCT information in the dietary assessment 
for mandipropamid. Tolerance level residues and/or 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 mandipropamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of mandipropamid. 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 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of mandipropamid for chronic 
exposures for non-cancer assessments are estimated to be 9.0 parts per 
billion (ppb) for surface water and 79 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 79 ppb was used to assess 
the contribution from 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). Mandipropamid 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 
mandipropamid to share a common mechanism of toxicity with any other 
substances, and mandipropamid does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that mandipropamid 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 Web site 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 Food Quality 
Protection Act (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. There were no treatment-
related effects observed in dams or fetuses in the developmental 
toxicity studies in rats or rabbits up to the limit dose of 1,000 
milligrams/kilogram/day (mg/kg/day). In the rat 2-generation 
reproductive study, decreased pup weight occurred only in the presence 
of comparable maternal toxicity (decreased body weight, body weight 
gain, and food utilization). Therefore, there is no increased 
quantitative or qualitative susceptibility to rat or rabbit offspring 
exposed in utero and/or postnatally to mandipropamid, and there are no 
residual uncertainties with respect to prenatal or postnatal exposure.
    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 mandipropamid is complete.
    ii. There is no indication that mandipropamid 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 mandipropamid 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 assessment was performed based on 
100 PCT and tolerance-level residues for all commodities, with the 
exception of tuberous and corm vegetable subgroup 1C, which was 
assessed for the tolerance level plus the metabolite. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to mandipropamid in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by mandipropamid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure

[[Page 76991]]

estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear 
cancer risks, EPA calculates the lifetime probability of acquiring 
cancer 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 appropriate PODs 
to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from 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, 
mandipropamid 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 
mandipropamid from food and water will utilize 46% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for mandipropamid.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified; 
however, mandipropamid is not registered for any use patterns that 
would result in short- or intermediate-term residential exposures. 
Short- and intermediate-term risk is assessed based on short- and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or intermediate-term residential exposure 
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- 
and intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for mandipropamid.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, mandipropamid 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 mandipropamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high performance liquid 
chromatography with tandem mass spectrometric detection (LC/MS/MS), 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 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 EPA explain the reasons 
for departing from the Codex level.
    The Codex has established MRLs for mandipropamid in or on bell and 
nonbell pepper at 1 ppm, bulb onion at 0.1 ppm, grape at 2 ppm, and 
spring onions at 7.0 ppm. The tolerances are harmonized with the U.S. 
tolerances established in or on fruiting vegetable group 8-10 
(including pepper) at 1.0 ppm. However, the tolerances in or on small 
vine climbing fruit except fuzzy kiwifruit subgroup 13-07F (including 
grape) at 1.4 ppm, bulb onion subgroup 3-07A at 0.05 ppm, and green 
onion subgroup 3-07B at 4 ppm are not harmonized with associated Codex 
MRLs on these commodities because it has been determined that the major 
export market for these commodities is Canada. Therefore, in order to 
maintain harmonization of U.S. tolerances and Canadian MRLs for these 
commodities, EPA is establishing these subgroup tolerances at the 
levels that align with the Canadian MRLs. There are no Codex MRLs on 
the other commodities associated with this action.

C. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petition, EPA has revised basil, 
fresh to basil, fresh leaves and basil, dried to basil, dried leaves in 
order to correct the commodity terminology. EPA also determined that 
the following proposed tolerances should be amended in order to 
harmonize with Canadian MRLs on associated commodities: Small vine 
climbing fruit except fuzzy kiwifruit subgroup 13-07F from 2.0 ppm to 
1.4 ppm; bulb onion subgroup 3-07A from 0.1 ppm to 0.05 ppm; and green 
onion subgroup 3-07B from 7.0 ppm to 4.0 ppm. Additionally, while EPA 
was petitioned for a tolerance on succulent bean, no field trial data 
were conducted on a succulent shelled bean cultivar in order to support 
the tolerance. Instead, the petitioner submitted snap bean data, which 
EPA determined is sufficient to support a tolerance of mandipropamid in 
or on bean, snap at 0.90 ppm. Snap beans are a subset of the larger 
succulent shelled bean definition, as defined in 40 CFR 180.1(g). 
Additionally, the Agency determined that the proposed tolerance in or 
on cowpea, forage cannot be established at this time because the use 
lacks a validated livestock analytical enforcement method for residues 
of mandipropamid. EPA also determined that the time-limited tolerance 
in or on fresh basil at 20 ppm should be removed, as it will be 
superseded by a permanent tolerance on fresh basil leaves at 30 ppm. 
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 mandipropamid not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only mandipropamid.

V. Conclusion

    Therefore, tolerances are established for residues of 
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)benzeneacetamide, in or on basil, dried leaves 
at 200 ppm; basil, fresh leaves at 30 ppm; bean, snap at 0.90 ppm; 
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
1.4 ppm; ginseng at 0.30 ppm; onion, bulb, subgroup 3-07A at 0.05 ppm; 
onion, green, subgroup 3-07B at 4.0 ppm; and vegetable, fruiting, group 
8-10 at 1.0 ppm. This regulation additionally removes the established 
tolerances in or on grape at 1.4 ppm; onion, dry bulb at 0.05 ppm; 
onion, green at 4 ppm; okra

[[Page 76992]]

at 1.0 ppm; and vegetable, fruiting, group 8 at 1.0 ppm. Finally, this 
regulation removes the time-limited tolerance in or on basil, fresh at 
20 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 tolerances 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: December 16, 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.  180.637:
0
a. Revise the introductory text in paragraph (a).
0
b. Remove ``Grape'', ``Okra'', ``Onion, dry bulb'', ``Onion green'', 
and ``Vegetable, fruiting, group 8'' from the table in paragraph (a).
0
c. Add ``Basil, dried leaves'', ``Basil, fresh leaves'', ``Bean, 
snap'', ``Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 
13-07F'', ``Ginseng'', ``Onion, bulb, subgroup 3-07A'', ``Onion, green, 
subgroup 3-07B'', and ``Vegetable, fruiting, group 8-10'' to the table 
in paragraph (a).
0
d. Revise the introductory text in paragraph (b).
0
e. Remove ``Basil, fresh'' from the table in paragraph (b).
    The amendments read as follows:


Sec.  180.637  Mandipropamid; tolerances for residues.

    (a) General. Tolerances are established for residues of 
mandipropamid, including its metabolites and degradates, in or on the 
commodities listed in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
mandipropamid (4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)benzeneacetamide) in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Basil, dried leaves.....................................             200
Basil, fresh leaves.....................................              30
Bean, snap..............................................            0.90
 
                                * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit,                  1.4
 subgroup 13-07F........................................
Ginseng.................................................            0.30
 
                                * * * * *
Onion, bulb, subgroup 3-07A.............................            0.05
Onion, green, subgroup 3-07B............................             4.0
 
                                * * * * *
Vegetable, fruiting, group 8-10.........................             1.0
 
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of mandipropamid, including its metabolites 
and degradates, in or on the commodities listed in the table below 
resulting from use of the pesticide pursuant to FFIFRA section 18 
emergency exemptions. Compliance with the tolerance levels specified 
below is to be determined by measuring only mandipropamid (4-chloro-N-
[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-[alpha]-(2-
propynyloxy)benzeneacetamide) in or on the commodity. The tolerances 
expire on the date specified in the table.
* * * * *
[FR Doc. 2013-30348 Filed 12-19-13; 8:45 am]
BILLING CODE 6560-50-P