[Federal Register Volume 84, Number 56 (Friday, March 22, 2019)]
[Rules and Regulations]
[Pages 10695-10700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05406]



[[Page 10695]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0671; FRL-9987-25]


Mandipropamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mandipropamid in or on multiple commodities 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 March 22, 2019. Objections and 
requests for hearings must be received on or before May 21, 2019, 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-2017-0671, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton 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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 http://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-2017-0671 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 
May 21, 2019. 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-2017-0671, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
7E8629) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of mandipropamid, 4-chloro-N-[2-
(3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-[alpha]-(2-propynyloxy)-
benzeneacetamide], in or on the raw agricultural commodities: Asparagus 
bean, edible podded at 0.90 parts per million (ppm); Bean (Phaseolus 
spp.), edible podded at 0.90 ppm; Bean (Vigna spp.), edible podded at 
0.90 ppm; Brassica, leafy greens, subgroup 4-16B at 25 ppm; Catjang 
bean, edible podded at 0.90 ppm; Celtuce at 20 ppm; Chinese longbean, 
edible podded at 0.90 ppm; Citrus, dried pulp at 0.14 ppm; Citrus, oil 
at 2.2 ppm; Cowpea, edible podded at 0.90 ppm; Florence fennel at 20 
ppm; French bean, edible podded at 0.90 ppm; Fruit, citrus, group 10-10 
at 0.5 ppm; Garden bean, edible podded at 0.90 ppm; Goa bean, edible 
podded at 0.90 ppm; Green bean, edible podded at 0.90 ppm; Guar bean, 
edible podded at 0.90 ppm; Jackbean, edible podded at 0.90 ppm; Kidney 
bean, edible podded at 0.90 ppm; Kohlrabi at 3 ppm; Lablab bean, edible 
podded at 0.90 ppm; Leaf petiole vegetable subgroup 22B at 20 ppm; 
Leafy greens subgroup 4-16A at 25 ppm; Moth bean, edible podded at 0.90 
ppm; Mung bean, edible podded at 0.90 ppm; Navy bean, edible podded at 
0.90 ppm; Rice bean, edible podded at 0.90 ppm; Scarlet runner bean, 
edible podded at 0.90 ppm; Snap bean, edible podded at 0.90 ppm; Sword 
bean, edible podded at 0.90 ppm; Urd bean, edible podded at 0.90 ppm; 
Vegetable soybean, edible podded at 0.90 ppm; Vegetable, Brassica, head 
and stem, group 5-16 at

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3 ppm; Velvet bean, edible podded at 0.90 ppm; Wax bean, edible podded 
at 0.90 ppm; Winged pea, edible podded at 0.90 ppm; and Yardlong bean, 
edible podded at 0.90 ppm.
    Additionally, the petition requested to amend 40 CFR 180.637 by 
removing the tolerances for residues of mandipropamid in or on the raw 
agricultural commodities Bean, snap at 0.90 ppm; Brassica, head and 
stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 
ppm; and Vegetable, leafy except Brassica, group 4 at 20 ppm.
    That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some tolerances are being established as 
well as some of the commodities in which tolerances are being 
established. The reason 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.
    Subchronic and chronic studies indicate that the liver and kidney 
are the primary target organs for mandipropamid. Liver effects observed 
in subchronic studies with rats, mice and dogs included periportal 
hypertrophy (rats), increased eosinophilia (rats and mice), increased 
plasma albumin, total protein, cholesterol, and gamma-glutamyl 
transferase (rats), increased liver weights (rats, mice and dogs), 
increased liver enzymes (dogs), increased pigment in hepatocytes and 
Kupffer cells (dogs), and centrilobular hepatocyte vacuolation (dogs). 
In the chronic dog study, increases in microscopic pigment in the 
liver, and increased liver enzymes were observed. In the chronic rat 
and mouse studies, liver toxicity was not observed. Nephrotoxicity was 
observed in the chronic rat study; however, in the chronic mouse study, 
only decreased body weight and food utilization were observed. The 
findings of liver toxicity and nephrotoxicity are consistent with the 
results from metabolism studies, in which radioactivity levels in liver 
and kidney were typically higher than other tissues. There were no 
consistent sex-related differences in target organ toxicity, although 
male rats appeared to be more sensitive to body weight effects.
    No evidence of neurotoxicity was observed in the database, 
including rat acute or subchronic neurotoxicity studies. No systemic or 
dermal toxicity was observed in the rat following dermal exposure for 
28 days up to the limit dose.
    No evidence of increased pre- or postnatal quantitative or 
qualitative susceptibility was observed. No fetal or maternal toxicity 
was observed in developmental toxicity studies in the rat and rabbit. 
Decreased pup weights were observed in the rat two-generation 
reproduction study in the presence of decreased parental body weight 
and food utilization.
    There was no evidence of a treatment-related increase in tumor 
incidence in the mouse carcinogenicity study or the rat chronic/
carcinogenicity study. There was no evidence of genotoxicity in 
bacterial reverse gene mutation, mammalian in vitro forward gene 
mutation, mammalian in vivo clastogenicity, or unscheduled DNA 
synthesis assays. 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 http://www.regulations.gov in the document titled ``Mandipropamid. Aggregate 
Human Health Risk Assessment Supporting Section 3 Registration of 
Proposed New Uses on Citrus Fruits Group 10-10 and Succulent Beans, 
Along with Various Crop Group and Subgroup Conversions'' on pages 35-39 
in docket ID number EPA-HQ-OPP-2017-0671.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for mandipropamid used for 
human risk assessment is shown in Table 1 of this unit.

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 Table 1--Summary of Toxicological Doses and Endpoints for Mandipropamid 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(All populations,            No appropriate endpoint for a single exposure was identified in the
 including infants and children, and                                    database.
 females 13-49).
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL= 5 mg/kg/day.....  Chronic RfD = 0.05 mg/   Chronic toxicity study--
                                       UFA = 10x..............   kg/day.                  dog.
                                       UFH = 10x..............  cPAD = 0.05 mg/kg/day..  LOAEL = 40 mg/kg/day,
                                       FQPA SF = 1x...........                            based on increased
                                                                                          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.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. 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 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 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, the chronic dietary risk 
assessment assumed tolerance-level residues in all commodities with 
existing tolerances except tuberous and corm vegetable subgroup 1C. For 
the chronic dietary risk assessment, this subgroup was assessed at 
0.115 ppm, which assumes tolerance-level residues of parent 
mandipropamid (0.09 ppm), and includes metabolite SYN 500003 in parent-
equivalents (at 0.025 ppm). Tolerance-level residues associated with 
the proposed new uses and crop group conversions were also used in the 
assessment. The Agency's 2018 Default Processing Factors were used for 
all processed commodities for which they were available. The empirical 
processing factor from the grape processing study was used for grape 
wine/sherry (1.5X). A processing factor was not used for grape raisin 
because a tolerance is currently established in raisin. Similarly, 
processing factors were not used for citrus oil and dried pulp because 
the Agency is establishing separate tolerances in these commodities.
    iii. Cancer. Based on the lack of evidence of carcinogenicity or 
genotoxicity, the Agency has classified mandipropamid as ``not likely 
to be a human carcinogen'' and therefore, there is no concern for 
cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for mandipropamid. Tolerance level residues and 100 PCT were 
assumed for all food commodities except as noted in section III.C.ii.
    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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the FQPA 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 are estimated to be 9.0 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 the chronic dietary risk 
assessment, the water concentration value of 79 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).
    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

[[Page 10698]]

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 website at 
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
pre- or postnatal quantitative or qualitative susceptibility was 
observed. No fetal or maternal toxicity was observed in developmental 
toxicity studies in the rat and rabbit. Decreased pup weights were 
observed in the rat two-generation reproduction study in the presence 
of decreased parental body weight and food utilization.
    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 assessments were performed based 
on 100 PCT and tolerance-level residues except as noted in section 
III.C.ii. 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 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 49% 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 either short- or intermediate-term residential exposure. 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- or 
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

    There is an adequate enforcement method available for the 
quantitation of mandipropamid in plant commodities. Method RAM 415/01, 
using high performance liquid chromatography with tandem mass 
spectrometric detection (LC/MS/MS), has been adequately validated by an 
independent laboratory. It has a validated limit of quantitation (LOQ) 
of 0.01 ppm. An acceptable confirmatory method is also available.
    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: 
[email protected].

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 EPA explain 
the reasons for departing from the Codex level.
    There are no harmonization issues with Codex regarding the new use 
on citrus fruits because Codex has not established MRLs for 
mandipropamid in citrus commodities. Additionally, Codex has not 
established an MRL in

[[Page 10699]]

snap beans, so this is not a harmonization issue. Regarding the updated 
crop group/subgroup conversions, the tolerance in leafy vegetable group 
4-16 is harmonized with the corresponding Codex MRLs. The tolerance in 
Brassica head and stem vegetable group 5-16, and the individual 
tolerance in kohlrabi, is harmonized with the Codex MRLs in cabbage and 
Chinese napa cabbage, but not the Codex MRL in broccoli. There are no 
Codex MRLs in Brussels sprouts, cauliflower or kohlrabi. The EPA is not 
harmonizing with the Codex MRL in broccoli because it is lower than the 
U.S. tolerance in Brassica head and stem vegetable group 5-16; setting 
a lower tolerance in broccoli could result in violative residues for 
U.S. growers. The tolerance in leaf petiole subgroup 22B, with 
individual tolerances in celtuce and Florence fennel, is harmonized 
with the Codex MRL in celery.

C. Revisions to Petitioned-For Tolerances

    EPA's tolerance levels are expressed to provide sufficient 
precision for enforcement purposes, and this may include the addition 
of trailing zeros (0.50 ppm rather than the proposed 0.5 ppm). The 
Agency does this in order to avoid the situation where rounding of an 
observed violative residue to the level of precision of the tolerance 
expression would result in a residue being considered non-violative 
(such as 0.54 ppm being rounded to 0.5 ppm). EPA made this revision for 
Fruit, citrus, group 10-10, Kohlrabi, and Vegetable, Brassica, head and 
stem, group 5-16.
    Because the petitioner proposed separate tolerances in both 
subgroups 4-16A and 4-16B at 25 ppm, the Agency is establishing a 
single tolerance in leafy vegetable group 4-16 at 25 ppm rather than 
separate tolerances in the two subgroups. In addition, the Agency 
revised the commodity terminology to use the correct commodity 
definition for Florence fennel, which is Fennel, Florence, fresh leaves 
and stalk.
    The proposed tolerance in citrus dried pulp (0.14 ppm) was 
incorrectly based on the dried pulp processing factor (2.9X) multiplied 
by the lowest average field trial value (LAFT) of 0.049 ppm from the 
orange field trials. However, per Office of Chemical Safety and 
Pollution Prevention (OCSPP) Residue Chemistry Test Guideline 860.1520, 
EPA based the tolerance on the processing factor (2.9X) multiplied by 
the highest average field trial value (HAFT) of 0.231 ppm from the 
lemon field trials (which had the highest HAFT of the three 
representative commodities), yielding a result of 0.67 ppm. Per the 
rounding protocol in the Organization for Economic Cooperation and 
Development (OECD) MRL Calculator User Guide, this result was increased 
to 0.70 ppm.
    Similarly, the proposed tolerance in citrus oil (2.2 ppm) was 
incorrectly based on the oil processing factor (45X) multiplied by the 
LAFT of 0.049 ppm from the orange field trials. As for dried pulp, EPA 
based the tolerance in citrus oil on the processing factor (45X) 
multiplied by the HAFT of 0.231 ppm from the lemon field trials, 
yielding a result of 10.4 ppm. Per the rounding protocol in the OECD's 
MRL Calculator User Guide this result was increased to 15 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of mandipropamid 
in or on Asparagus bean, edible podded at 0.90 ppm; Bean (Phaseolus 
spp.), edible podded at 0.90 ppm; Bean (Vigna spp.), edible podded at 
0.90 ppm; Catjang bean, edible podded at 0.90 ppm; Celtuce at 20 ppm; 
Chinese longbean, edible podded at 0.90 ppm; Citrus, dried pulp at 0.70 
ppm; Citrus, oil at 15 ppm; Cowpea, edible podded at 0.90 ppm; Fennel, 
Florence, fresh leaves and stalk at 20 ppm; French bean, edible podded 
at 0.90 ppm; Fruit, citrus, group 10-10 at 0.50 ppm; Garden bean, 
edible podded at 0.90 ppm; Goa bean, edible podded at 0.90 ppm; Green 
bean, edible podded at 0.90 ppm; Guar bean, edible podded at 0.90 ppm; 
Jackbean, edible podded at 0.90 ppm; Kidney bean, edible podded at 0.90 
ppm; Kohlrabi at 3.0 ppm; Lablab bean, edible podded at 0.90 ppm; Leaf 
petiole vegetable subgroup 22B at 20 ppm; Moth bean, edible podded at 
0.90 ppm; Mung bean, edible podded at 0.90 ppm; Navy bean, edible 
podded at 0.90 ppm; Rice bean, edible podded at 0.90 ppm; Scarlet 
runner bean, edible podded at 0.90 ppm; Snap bean, edible podded at 
0.90 ppm; Sword bean, edible podded at 0.90 ppm; Urd bean, edible 
podded at 0.90 ppm; Vegetable, Brassica, head and stem, group 5-16 at 
3.0 ppm; Vegetable, leafy, group 4-16 at 25 ppm; Vegetable soybean, 
edible podded at 0.90 ppm; Velvet bean, edible podded at 0.90 ppm; Wax 
bean, edible podded at 0.90 ppm; Winged pea, edible podded at 0.90 ppm; 
and Yardlong bean, edible podded at 0.90 ppm.
    Additionally, the existing tolerances in/on Bean, snap at 0.90 ppm; 
Brassica, head and stem, subgroup 5A at 3 ppm; Brassica, leafy greens, 
subgroup 5B at 25 ppm; and Vegetable, leafy except Brassica, group 4 at 
20 ppm are removed as unnecessary since they are covered by the new 
tolerances.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action 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 action 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,

[[Page 10700]]

entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000) do not apply to this 
action. In addition, this action does not impose any enforceable duty 
or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act (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 (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: March 14, 2019.
Michael Goodis,
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, in the table to paragraph (a):
0
a. Add alphabetically the entry ``Asparagus bean, edible podded'';
0
b. Remove the entry for ``Bean, snap'';
0
c. Add alphabetically the entries ``Bean (Phaseolus spp.), edible 
podded'' and ``Bean (Vigna spp.), edible podded'';
0
d. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and 
``Brassica, leafy greens, subgroup 5B''; and
0
e. Add alphabetically the entries ``Catjang bean, edible podded''; 
``Celtuce''; ``Chinese longbean, edible podded''; ``Citrus, dried 
pulp''; ``Citrus, oil''; ``Cowpea, edible podded''; ``Fennel, Florence, 
fresh leaves and stalk''; ``French bean, edible podded''; ``Fruit, 
citrus, group 10-10''; ``Garden bean, edible podded''; ``Goa bean, 
edible podded''; ``Green bean, edible podded''; ``Guar bean, edible 
podded''; ``Jackbean, edible podded''; ``Kidney bean, edible podded''; 
``Kohlrabi''; ``Lablab bean, edible podded''; ``Leaf petiole vegetable 
subgroup 22B''; ``Moth bean, edible podded''; ``Mung bean, edible 
podded''; ``Navy bean, edible podded''; ``Rice bean, edible podded''; 
``Scarlet runner bean, edible podded''; ``Snap bean, edible podded''; 
``Sword bean, edible podded''; ``Urd bean, edible podded''; 
``Vegetable, Brassica, head and stem, group 5-16''; and ``Vegetable, 
leafy, group 4-16'';
0
f. Remove the entry for ``Vegetable, leafy except Brassica, group 4''; 
and
0
g. Add alphabetically the entries ``Vegetable soybean, edible podded''; 
``Velvet bean, edible podded''; ``Wax bean, edible podded''; ``Winged 
pea, edible podded''; and ``Yardlong bean, edible podded''.
    The additions read as follows:


Sec.  180.637  Mandipropamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus bean, edible podded...............................        0.90
 
                                * * * * *
Bean (Phaseolus spp.), edible podded........................        0.90
Bean (Vigna spp.), edible podded............................        0.90
Catjang bean, edible podded.................................        0.90
Celtuce.....................................................          20
Chinese longbean, edible podded.............................        0.90
Citrus, dried pulp..........................................        0.70
Citrus, oil.................................................          15
Cowpea, edible podded.......................................        0.90
Fennel, Florence, fresh leaves and stalk....................          20
French bean, edible podded..................................        0.90
Fruit, citrus, group 10-10..................................        0.50
 
                                * * * * *
Garden bean, edible podded..................................        0.90
 
                                * * * * *
Goa bean, edible podded.....................................        0.90
 
                                * * * * *
Green bean, edible podded...................................        0.90
Guar bean, edible podded....................................        0.90
 
                                * * * * *
Jackbean, edible podded.....................................        0.90
Kidney bean, edible podded..................................        0.90
Kohlrabi....................................................         3.0
Lablab bean, edible podded..................................        0.90
Leaf petiole vegetable subgroup 22B.........................          20
Moth bean, edible podded....................................        0.90
Mung bean, edible podded....................................        0.90
Navy bean, edible podded....................................        0.90
 
                                * * * * *
Rice bean, edible podded....................................        0.90
Scarlet runner bean, edible podded..........................        0.90
Snap bean, edible podded....................................        0.90
Sword bean, edible podded...................................        0.90
Urd bean, edible podded.....................................        0.90
Vegetable, Brassica, head and stem, group 5-16..............         3.0
 
                                * * * * *
Vegetable, leafy, group 4-16................................          25
Vegetable soybean, edible podded............................        0.90
 
                                * * * * *
Velvet bean, edible podded..................................        0.90
Wax bean, edible podded.....................................        0.90
Winged pea, edible podded...................................        0.90
Yardlong bean, edible podded................................        0.90
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-05406 Filed 3-21-19; 8:45 am]
 BILLING CODE 6560-50-P