[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Rules and Regulations]
[Pages 57854-57860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25713]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0536; FRL-9970-38]


Ziram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of ziram 
in or on hazelnut. United Phosphorus, Inc. requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 8, 2017. Objections and 
requests for hearings must be received on or before February 6, 2018, 
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-2016-0536, 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 L. 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-2016-0536 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 6, 2018. 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-2016-0536, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online

[[Page 57855]]

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 November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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 
6F8493) by United Phosphorus, Inc., 630 Freedom Business Center, Suite 
402, King of Prussia, PA 19406. The petition requested that 40 CFR 180 
be amended by establishing a tolerance for residues of the fungicide 
ziram, zinc dimethyldithiocarbamate, in or on filbert (hazelnut) at 0.1 
parts per million (ppm). That document referenced a summary of the 
petition prepared by United Phosphorus, Inc., 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 
revised the tolerance value to add an additional significant figure and 
also revised the commodity term from filbert (hazelnut) to hazelnut. 
The reason for this change is 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 ziram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with ziram 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.
    The primary target organs of ziram are the nervous system, liver, 
and thyroid. A single oral dose causes neurological impairments (ataxia 
and slight impaired gait) while repeated short-term exposure results in 
inhibition of brain cholinesterase and brain neurotoxic esterase in 
rats. Developmental neurotoxic effects were not observed in offspring 
of the most recent DNT study. Liver histopathology was identified 
throughout the database at various doses in the rat subchronic and 
chronic studies and the mouse carcinogenicity study, and at times is 
accompanied by increases in hepatic serum enzyme levels. Chronic 
studies also included thyroid effects, specifically follicular cell 
hypertrophy and c-cell carcinoma. When ziram was administered orally in 
rats, it was rapidly absorbed, distributed, and excreted via urine, 
expired air, and excreted feces within 72 hours. Small amounts were 
widely distributed in the body with the highest tissue concentrations 
in the liver, fat, kidney, spleen, lung, thyroid, and adrenals. 
Metabolites were not identified.
    There is no quantitative or qualitative evidence of increased 
susceptibility following in utero exposure to rats and rabbits and 
following pre-/postnatal exposure to rats in the developmental, 
reproduction, and developmental neurotoxicity studies with ziram. There 
was an apparent quantitative evidence of increased susceptibility 
identified in an older unacceptable developmental neurotoxicity study 
in rats. Increased motor activity was observed in the offspring at the 
lowest dose tested, while the maternal rats exhibited reduced body 
weights and/or body weight gains, and decreased food consumption during 
gestation and lactation at the highest dose tested. However, this study 
was classified as unacceptable since brain morphometric analysis--a key 
evaluation in DNTs--was not conducted. A second DNT study was submitted 
and does not demonstrate quantitative susceptibility. This second DNT 
identifies a clear NOAEL and includes brain morphometric data on post-
natal day 21 and 72 rats with no treatment-related effects.
    Based on the occurrence of benign tumors (hemangiomas) in male CD 
(SD) BR male rats, supported by an increasing trend in preputial gland 
adenomas in male F344 rats. However, since no hemangiosarcomas or 
preputial gland carcinomas were observed, no treatment-related increase 
in tumors was identified in the female CD(SD) BR or female F344/N rat, 
and because ziram was not carcinogenic to CD-1 mice (both genders), and 
there is no concern regarding mutagenicity, the EPA has determined that 
quantification of risk using a non-linear approach (i.e., RfD) will 
adequately account for all chronic toxicity, including carcinogenicity, 
that could result from exposure to ziram.
    Ziram has low acute toxicity via the dermal and oral routes. 
However, ziram is classified as Toxicity Category I for eye irritation 
and a Category II for the acute inhalation study. Ziram is also a 
moderate dermal sensitizer. Specific information on the studies 
received and the nature of the adverse effects caused by ziram 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 document ``Ziram. Human Health 
Risk Assessment for Proposed New Use on Hazelnuts (Filberts) in Tree 
Nuts Crop Group 14-12'', pages 12-17, in docket ID number EPA-HQ-OPP-
2016-0536.

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

[[Page 57856]]

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 ziram used for human 
risk assessment is shown in the Table of this unit.

      Table--Summary of Toxicological Doses and Endpoints for Ziram for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations)..  LOAEL = 15 mg/kg/day  Acute RfD = 0.05 mg/ Acute Neurotoxicity in rat (MRID
                                    UFA = 10x.            kg/day.              43362801.
                                   UFH = 10x...........  aPAD = 0.05 mg/kg/   LOAEL = 15 mg/kg/day based on
                                   FQPA SF (UFL) = 3x..   day.                 ataxia and slight impairment of
                                                                               gait.
                                                                              NOAEL not established.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.6 mg/kg/    Chronic RfD = 0.016  52-Week Oral Toxicity in dog (MRID
                                    day.                  mg/kg/day.           42823901).
                                   UFA = 10x...........  cPAD = 0.016 mg/kg/  LOAEL = 6.6 mg/kg/day based on
                                   UFH = 10x...........   day..                liver histopathology (aggregates
                                   FQPA SF = 1x........                        of Kupffer cells and macrophages,
                                                                               increased foci of degenerate
                                                                               hepatocytes, infiltration of
                                                                               inflammatory cells around central
                                                                               veins, and increased
                                                                               centrilobular fibrocytes) in
                                                                               males.
----------------------------------------------------------------------------------------------------------------
Short term oral (Adult only).....  NOAEL= 7.5 mg/kg/     Residential LOC for  Prenatal Oral Developmental in
                                    day.                  MOE = 100.           rabbit (MRID 00161316).
                                   UFA = 10x...........                       LOAEL = 15 mg/kg/day based on
                                   UFH = 10x...........                        increased incidence of
                                   FQPA SF = 1x........                        resorptions and post implantation
                                                                               loss.
----------------------------------------------------------------------------------------------------------------
Dermal Short and Intermediate      Oral study..........  Residential and      Prenatal Oral Developmental in
 term (Adult only).                NOAEL= 7.5 mg/kg/day   Occupational LOC     rabbit (MRID 00161316).
                                    (dermal absorption    for MOE = 100.      LOAEL = 15 mg/kg/day based on
                                    rate = 1.0% *).                            increased incidence of
                                   UFA = 10x...........                        resorptions and post implantation
                                   UFH = 10x...........                        loss.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation Short and Intermediate  Oral study..........  Residential and      Prenatal Oral Developmental in
 term.                             NOAEL= 7.5 mg/kg/      Occupational LOC     rabbit (MRID 00161316)
                                    day..                 for MOE = 100.      LOAEL = 15 mg/kg/day based on
                                   UFA = 10x...........                        increased incidence of
                                   UFH = 10x...........                        resorptions and post implantation
                                   FQPA SF = 1x........                        loss.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  EPA has determined that a nonlinear approach is appropriate and that the cRfD
                                    will be protective of cancer effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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). UFL = use of a LOAEL to extrapolate a NOAEL.
* The dermal absorption rate of 1.0% was derived from the ratio of LOAELs in the rabbit oral developmental study
  and the 21-day dermal rabbit study (RED, 2003).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ziram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing ziram tolerances in 40 CFR 180.116. 
EPA assessed dietary exposures from ziram 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 ziram. In estimating acute dietary 
exposure, EPA used food consumption information from the United States 
Department of Agriculture (USDA) Nationwide Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA) conducted 
from 2003-2008. As to residue levels in food, the acute dietary 
analysis was obtained from the Dietary Exposure

[[Page 57857]]

Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; 
version 3.16). The assessment is based on the maximum percent crop 
treated estimates for some commodities and assumed 100% crop treated 
for all others. The analyses also assumed a distribution of residues 
based on field trial data or the Food and Drug Administration (FDA) 
monitoring data.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA Nationwide 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, 
the chronic dietary analysis was obtained from the Dietary Exposure 
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; 
version 3.16). The assessment is based on the average percent crop 
treated estimates for some commodities and assumed 100% crop treated 
for all others. The analyses also assumed a distribution of residues 
based on field trial data or the FDA monitoring data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to ziram. Cancer risk was assessed using the same exposure 
estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the maximum PCT for existing uses as follows 
in the acute dietary risk assessment: Almonds: 35%; apples: 20%; 
apricots: 70%; blueberries: 40%; cherries: 15%; grapes: 10%; 
nectarines: 65%; peaches: 40%; pears: 35%; pecans: 2.5%; and tomatoes: 
6%.
    The following average percent crop treated estimates were used in 
the chronic dietary risk assessments for the following crops that are 
currently registered for ziram: almonds: 15%; apples: 15%; apricots: 
35%; blueberries: 30%; cherries: 5%; grapes: 5%; nectarines: 45%; 
peaches: 25%; pears: 15%; pecans: 2.5%; and tomatoes: 6%.
    For strawberries, the Agency calculated percent detectable residue 
values from the FDA samples and used that number (4.5%) in the acute 
and chronic evaluations.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than 5%. In those 
cases, EPA rounds to either 2.5% or 1%, whichever is appropriate. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%, except when 
the maximum PCT is less than 5%; then EPA uses 2.5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1. iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which ziram may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for ziram in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of ziram. 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 Pesticide Water Calculator (PWC 1.52) and Pesticide 
Root Zone Model Ground Water (PRZM GW), the estimated drinking water 
concentrations (EDWCs) of ziram for acute exposures are estimated to be 
103.7 parts per billion (ppb) for surface water and <0.001 ppb for 
ground water. For chronic exposures for non-cancer assessments are 
estimated to be 2.74 ppb for surface water and <0.001 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 103.7 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 2.74 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,

[[Page 57858]]

indoor pest control, termiticides, and flea and tick control on pets).
    There are no conventional residential uses of ziram. However, there 
is a registered use of exterior latex paint, an antimicrobial use, for 
ziram which could result in residential exposures. The registered 
antimicrobial use in exterior latex paint (in-can-preservative) may be 
used by a homeowner and applied either by airless sprayer or by brush. 
Short-term aggregate risk assessments were previously conducted for 
adults only; the sole registered scenario resulting in residential 
exposures. Residential handler risks are not of concern for the 
loading/application of exterior latex paints either by airless spray or 
brush (i.e., the combined dermal and inhalation MOE is >100). 
Residential post-application inhalation exposures are expected to be 
negligible due to the low vapor pressure of ziram (1.4E-7 mmHg at 25 
[deg]C) and low dermal contact potential to treated surfaces.
    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.''
    The Agency reevaluated the existing data suggesting that the 
dithiocarbamates can be grouped based on a common mechanism of 
toxicity. The dithiocarbamates included were mancozeb, maneb, metiram, 
Na-dimethyldithiocarbamate, ziram, thiram, ferbam, and metam sodium. 
EPA concluded that the available evidence shows that the neuropathology 
induced by treatment of rats with the dithiocarbamates cannot be linked 
with the formation of carbon disulfide because: (a) The neuropathology 
induced by the dithiocarbamates is not consistent with the 
neuropathology induced by exposure to carbon disulfide, (b) there is a 
lack of concordance between doses of the dithiocarbamates that induce 
neuropathology and the amounts of carbon disulfide formed during 
metabolism and (c) there is evidence that more than one mechanism of 
toxicity could be operative that accounts for dithiocarbamate induced 
neuropathology because there is no consistent pattern of neuropathology 
reported in studies with this subgroup of carbamates. Accordingly, the 
available evidence does not support grouping the dithiocarbamates based 
on a common mechanism for neuropathology. For the purposes of this 
tolerance action, therefore, EPA has assumed that ziram 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://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. There is no quantitative or 
qualitative evidence of increase in susceptibility following in utero 
exposure to rats and rabbits and following pre-/postnatal exposure to 
rats in the developmental, the reproduction, and the acceptable DNT 
studies with ziram.
    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 for all scenarios except acute dietary, for 
which the FQPA SF is being reduced to 3X. That decision is based on the 
following findings:
    i. The toxicity database for ziram is adequate for evaluating and 
characterizing its toxicity, except for where a NOAEL is extrapolated 
from a LOAEL in the acute neurotoxicity study used as the endpoint for 
assessing acute dietary exposure. EPA has determined that a 3x FQPA SF 
to account for the extrapolation is sufficient to protect infants and 
children because of the impacts observed at the LOAEL were minimal and 
other studies did not show effects occurring at similar doses.
    ii. There is indication that ziram is a neurotoxic chemical and an 
acceptable developmental neurotoxicity study has been submitted. A 
single oral dose resulted in ataxia in both sexes and slight impaired 
gait in males. Repeated short term oral exposure resulted in inhibition 
of brain cholinesterase in both sexes and brain neurotoxic esterase 
activity in male rats. Developmental neurotoxic effects were not 
observed in offspring of the most recent DNT study. Chronic dietary 
exposure in adult rats resulted in atrophy and reductions in crural 
muscle weights. Crural muscles function in the motion of the rodent's 
grasping foot claw.
    iii. There is no evidence that ziram results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies, in young rats in the 2-generation reproduction 
study, or in the most recent DNT study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary and non-dietary exposure estimates were based on 
several conservative assumptions and will not underestimate the 
exposure and risk. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to ziram 
in drinking water. EPA used similarly conservative assumptions to 
assess post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by ziram.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to ziram will occupy 26% of the aPAD for children 1-2 years old, the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
ziram from food and water will utilize 1.4% of the cPAD for Children 1-
2, the population group receiving the greatest exposure. Based on the 
explanation in Unit III.C.3., regarding residential use

[[Page 57859]]

patterns, chronic residential exposure to residues of ziram is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Ziram is currently registered for uses that could result in short-
term residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to ziram.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 170 for adults. 
Because EPA's level of concern for ziram is a MOE of 100 or below, 
these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
ziram is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., the Agency has determined that quantification of risk using a 
non-linear approach (i.e., RfD) will adequately account for all chronic 
toxicity, including carcinogenicity, that could result from exposure to 
ziram. Because the Agency's assessment indicates that aggregate 
exposure will be below the Agency's level of concern for chronic risk, 
the Agency concludes such exposure will not pose an aggregate cancer 
risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to ziram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (colorimetric method, Method I) is 
available to enforce the tolerance expression.

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. The Codex has not 
established a MRL for ziram.

C. Revisions to Petitioned-For Tolerances

    EPA revised the 0.1 ppm value to 0.10 ppm based on the practice to 
add the additional significant figure to provide clarity about 
permissible residues. In addition, the commodity term for the tolerance 
was revised from filbert (hazelnut) to hazelnut to be consistent with 
the general food and feed commodity vocabulary EPA uses for tolerances 
and exemptions.

V. Conclusion

    Therefore, tolerance is established for residues of ziram, zinc 
dimethyldithiocarbamate, in or on hazelnut at 0.10 ppm.
    In addition, EPA is making a number of housekeeping adjustments to 
this rule. First, consistent with the Agency's policy for drafting the 
tolerance expression, EPA is revising the tolerance expression to 
clarify that the tolerance covers residues of the parent as well as 
metabolites and degradates of the pesticide chemical in accordance with 
section 408(a)(3) of the FFDCA, and to clarify how residues of the 
chemical are to be measured to determine compliance with the tolerance 
levels. Second, because the tolerance for blackberries has expired by 
its terms, EPA is removing that tolerance from section 180.116. 
Finally, because no current tolerances have an expiration date, the 
third column is not necessary, so EPA is removing that column.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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). 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 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 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, 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

[[Page 57860]]

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: November 9, 2017.
Daniel J. Rosenblatt,
Acting 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.  180.116, revise paragraph (a) to read as follows:


Sec.  180.116   Ziram; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide ziram (zinc dimethyldithiocarbamate), including its 
metabolites and degradates, in or on the commodities in the table below 
as a result of the application of ziram. Compliance with the tolerance 
levels specified below is to be determined by measuring total 
dithiocarbamates, determined as CS2, evolved during acid digestion and 
expressed as zinc ethylenebisdithiocarbamate.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................    \1\ 0.10
Apple.......................................................     \1\ 7.0
Apricot.....................................................     \1\ 7.0
Blueberry...................................................     \1\ 7.0
Cherry, sweet...............................................     \1\ 7.0
Cherry, tart................................................     \1\ 7.0
Grape.......................................................         7.0
Hazelnut....................................................        0.10
Huckleberry.................................................         7.0
Peach.......................................................         7.0
Pear........................................................     \1\ 7.0
Pecan.......................................................        0.10
Quince......................................................     \1\ 7.0
Strawberry..................................................         7.0
Tomato......................................................     \1\ 7.0
------------------------------------------------------------------------
\1\ Some of these tolerances were established on the basis of data
  acquired at the public hearings held in 1950 (formerly Sec.   180.101)
  and the remainder were established on the basis of pesticide petitions
  presented under the procedure specified in the amendment to the
  Federal Food, Drug, and Cosmetic Act by Public Law 518, 83d Congress
  (68 Stat. 511).

* * * * *
[FR Doc. 2017-25713 Filed 12-7-17; 8:45 am]
 BILLING CODE 6560-50-P