Dichlormid; Pesticide Tolerances, 69401-69407 [2016-24214]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Rules and Regulations]
[Pages 69401-69407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24214]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0121; FRL-9951-90]


Dichlormid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
dichlormid in or on all commodities for which there is a tolerance for 
metolachlor and S-metolachlor. Drexel Chemical Company requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 6, 2016. Objections and 
requests for hearings must be received on or before December 5, 2016, 
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-2016-0121, 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), 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Acting Director, 
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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance

[[Page 69402]]

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-2016-0121 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 
December 5, 2016. 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-2016-0121, 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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), 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 
IN-10858) by Drexel Chemical Company, P.O. Box 13327, Memphis, TN 
38113-03227. Although the notice announced the petition requested that 
40 CFR 180.469 be amended by establishing tolerances for residues of 
the inert ingredient (safener) dichlormid, in or on all commodities for 
which there is a tolerance for metolachlor and S-metolachlor at 0.05 
parts per million (ppm), the notice of filing submitted simply listed 
numerous commodities that were intended to correspond to the 
commodities for which metolachlor and s-metolachlor tolerances were 
established. That document referenced a summary of the petition 
prepared by Drexel Chemical Company, the registrant, which is available 
in the docket, https://www.regulations.gov. There were no comments 
received in response to the notice of filing.
    To ensure consistency between the notice of filing and the petition 
filed and to avoid any confusion, EPA requested that Drexel revise and 
resubmit their notice of filing to clarify that the request is to 
establish tolerances for residues of the inert ingredient (safener) 
dichlormid, in or on all commodities for which there is a tolerance for 
metolachlor and S-metolachlor at 0.05 ppm. Upon receiving that revised 
petition, EPA issued a notice of filing of that petition pursuant to 
FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3) in the Federal Register 
of July 20, 2016 (81 FR 47150) (FRL-9948-45). The petition requested 
that 40 CFR 180.469 be amended by establishing tolerances for residues 
of the inert ingredient (safener) dichlormid, in or on all commodities 
for which there is a tolerance for metolachlor and S-metolachlor at 
0.05 ppm. That revised petition prepared by Drexel Chemical Company, 
the registrant, is available in the docket, https://www.regulations.gov. 
There was one comment received in response to this notice of filing; 
however, the comment was not related to this chemical or petition and 
is therefore, not relevant to this action.

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 dichlormid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with dichlormid 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 database for dichlormid has been previously reviewed by 
the Agency, most recently March 23, 2011 when the permanent tolerance 
for dichlormid was issued (76 FR 16308) (FRL-8866-2). No new data was 
reviewed as part of this petition for tolerance.
    Specific information on the studies received and the nature of the 
adverse effects caused by dichlormid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
    In acute toxicity studies, dichlormid exhibits low to moderate 
toxicity, depending on the route of exposure. The oral lethal dose 
(LD)50 for dichlormid in rats is 2,816 milligram/kilogram 
(mg/kg) in males and 2,146 mg/kg for females (Category III). The dermal 
LD50 of dichlormid in rats is greater than 2,000 mg/kg 
(Category III). The acute inhalation lethal concentration 
(LC)50 in rats is greater than 5.5 mg/(L) (Category IV). 
Dichlormid is mildly irritating to the skin of rabbits (Category IV) 
and severely irritating to the eyes of rabbits

[[Page 69403]]

(Category II). Dichlormid is a mild dermal sensitizer.
    The liver is the target organ in subchronic and chronic toxicity 
studies in rats and dogs. There are two 90-day rat toxicity studies are 
available. One older study (1972), was determined to be an unacceptable 
study. In the other study, toxicity was manifested as minor decreased 
in body weight gains and food efficiency in females and on increased 
liver weight and a slightly increased (not statistically significant) 
incidence of liver lipidosis in males. Similarly two 90-day toxicity 
studies in dogs are available. In the newer study, via capsules, 
decreased body weight gains, hematological and clinical chemistry 
alternations, liver toxicity and voluntary muscle pathological changes 
were observed. In a 1-year toxicity study in the dogs, voluntary muscle 
fiber degeneration and slight to moderate vacuolation of the adrenal 
cortex was observed at 20 mg/kg/day. There was also increased in 
alkaline phosphatase activity in both sexes and decreased in aspartate 
aminotransferase activity in females. Liver weights (absolute and 
relative to body) were increased in both sexes.
    In a developmental toxicity study in rats, decreased mean absolute 
body weights, body weight gains, and food consumption was observed in 
maternal animals. Developmental toxicity in rats was manifested as 
marginal increased in skeletal anomalies in the presence of maternal 
toxicity. In the developmental toxicity study in rabbits, increased 
incidence of alopecia and decreased mean maternal body weight gains and 
food consumption was observed in maternal animals. The fetal effects in 
rabbits, exhibited in the presence of maternal toxicity, were 
manifested as increases in post-implantation loss accompanied by an 
increase number of resorptions/doe (both early and late resorptions), 
decreased number of live/fetuses/litter, and slightly decreased mean 
fetal body weights. In a 2-generation reproduction study in rats, no 
treatment related effects on reproductive parameters were observed. 
Minimal increased liver weight, minimal decreased weight gain and 
minimal decreased in food consumption was observed in parental animals. 
Increased liver weights were observed in the offspring.
    No increased incidences of treatment related tumors were observed 
in mice and rats. In the carcinogenicity study in mice, kidney changes 
and changes in reproductive organs were observed, while rats exhibited 
decreased body weights and liver toxicity. Mutagenic potential for 
dichlormid was evaluated in an adequate battery of in vivo and in vitro 
assays. A negative response was observed in these assays except in one 
in vitro assay (mouse lymphoma assay). However, the in vivo mouse 
micronucleus assay was negative.
    In an acute neurotoxicity study in rats, decreased body weight 
gains with lower food consumption was observed in both sexes. 
Functional observational battery (FOB) measurements at the time of peak 
effect (4 hrs post dose) showed decreased activity, hunching, increased 
touch response, lachrimation, piloerection, reduced splay reflex, and 
signs of salivation. These effects were deemed slight with a greater 
incidence in females. No treatment-related changes in bodyweight, food 
consumption, FOB, motor activity, brain weight, or neuropathology were 
identified in the 90-day neurotoxicity study in rats; however, the high 
dose of 750 ppm (equal to 55.4 mg/kg/day) was not considered as 
adequate for testing. No evidence of immunotoxicity was observed in a 
dietary immunotoxicity study in rats. There were no treatment related 
effects on spleen and thymus weights at any of the doses of dichlormid 
tested.
    Approximately 90% of the orally administered dose was absorbed in 
rats. Urinary excretion was the major route of elimination of orally 
administered dichlormid, consistently accounting for 60-78% of the 
administered dose over 48-168 hours following a single oral dose. Fecal 
excretion accounted for ~8-20% of a single oral dose. Approximately 70-
77% of urinary excretion (representing 52-54% of the administered dose) 
occurred within 24 hours. No gender-related difference in rate or 
amount of urinary excretion was observed. No significant accumulation 
in the body was observed. Dichlormid was metabolized via two pathways:
    1. Initial dechlorination followed by formation of various 
chlorinated, water-soluble metabolites, and;
    2. Formation of various chlorinated metabolites.
    In a subchronic inhalation toxicity study in rats via whole body 
exposure for 6 hours a day, 5 days/week for 14 weeks, decreased body 
weights and increased liver weights were observed at the highest dose 
tested. The increased liver weights was considered as an adaptive 
response. Chromorhinorrhea, a respiratory system clinical observation 
based on the discharge of colored secretion from the nostrils, was 
exhibited consistently in the two top dose exposure groups. Microscopic 
pathology identified in the two top dose exposure groups, dose-
dependent respiratory tract tissue alterations involving the olfactory 
epithelium for both genders.

B. Toxicological Points of Departure/Levels of Concern

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

[[Page 69404]]



      Table 1--Summary of Toxicological Dose and Endpoints for Dichlormid Use in Human Risk Assessment \1\
----------------------------------------------------------------------------------------------------------------
                                                             FQPA SF and
        Exposure scenario            Dose and factors     endpoint for risk     Study and toxicological effects
                                                              assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary, all populations     NOAEL = 10 mg/kg....  FQPA SF = 1........  Developmental Toxicity Study--Rat
 including infants and children.   UF = 100............  aPAD = acute RfD/    Maternal LOAEL = 40 mg/kg/day
                                   Acute RfD = 0.10 mg/   FQPA SF = 0.10 mg/   based on decreased body weight
                                    kg/day.               kg/day.              gain and food consumption (most
                                                                               significant on days 7-10 of
                                                                               dosing).
Chronic Dietary, all populations.  NOAEL = 5 mg/kg/day.  FQPA SF = 1........  1-year Study--Dog
                                   UF = 100............  cPAD = chr RfD/FQPA  LOAEL = 20 mg/kg/day (male,
                                   Chronic RfD = 0.05     SF = 0.05 mg/kg/     female), based on increased liver
                                    mg/kg/day..           day..                weights, increased in alkaline
                                                                               phosphatase activity, minimal
                                                                               muscle fiber degeneration in,
                                                                               slight to moderate vacuolation of
                                                                               the inner cortex of the adrenal
                                                                               gland, and increased kidney
                                                                               weights (females).
----------------------------------------------------------------------------------------------------------------
Dermal Absorption................   100% default; neither a dermal absorption study nor a dermal toxicity study
                                                  (for extrapolation) is available in the database.
----------------------------------------------------------------------------------------------------------------
Short-term Dermal................  Oral NOAEL = 10.0 mg/ MOE = 100..........  Developmental toxicity Study--Rats
                                    kg/day.                                   Maternal LOAEL = 40 mg/kg/day
                                                                               based on decreased body weight
                                                                               gain and food consumption (most
                                                                               significant on days 7-10 of
                                                                               dosing). This dose/endpoint/study
                                                                               was used for deriving the aRfD.
                                                                               Dermal toxicity study is not
                                                                               available. 100% dermal absorption
                                                                               factor should be used for this
                                                                               risk assessment.
Intermediate- and Long-Term        Oral NOAEL = 5 mg/kg/ MOE = 100..........  1-year study--Dog
 (Dermal).                          day.                                      LOAEL = 20 mg/kg/day (male,
                                                                               female), based on increased liver
                                                                               weights, increased in alkaline
                                                                               phosphatase activity, minimal
                                                                               muscle fiber degeneration in,
                                                                               slight to moderate vacuolation of
                                                                               the inner cortex of the adrenal
                                                                               gland, and increased kidney
                                                                               weights (females).
Inhalation (All Durations).......  2 [mu]g/L...........  MOE = 100..........  14-week inhalation study
                                                                              LOAEL = 20 [mu]g/L based on
                                                                               clinical signs, increased liver
                                                                               and kidney weights, gross
                                                                               pathology and non-neoplastic
                                                                               histopathology. The route of
                                                                               exposure in this study is
                                                                               appropriate for this risk
                                                                               assessment.
Cancer...........................  ....................  ...................  No evidence of carcinogenicity in
                                                                               rats and mice.
----------------------------------------------------------------------------------------------------------------
\1\ UF = uncertainty factor; FQPA SF = FQPA Safety Factor; NOAEL = no observed adverse effect level; LOAEL =
  lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference
  dose; LOC = level of concern; MOE = margin of exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dichlormid, EPA considered exposure under the petitioned-
for tolerances as well as all existing dichlormid tolerances in 40 CFR 
180.469. The assessment was conducted using the proposed tolerance of 
0.05 ppm for those commodities for which there is a current tolerance 
for metolachlor and S-metolachlor as well as for all commodities to 
account for the potential dietary exposure that could result from 
dichlormid should additional tolerances be established for metolachlor 
and S-metolachlor. EPA assessed dietary exposures from dichlormid 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 dichlormid. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII). As to residue levels in food, EPA used 
tolerance level residues (i.e., 0.05 ppm) and 100% crop treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
CSFII. As to residue levels in food, EPA used tolerance level residues 
(i.e., 0.05 ppm) and 100% crop treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that dichlormid 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for dichlormid. Tolerance level residues (i.e., 0.05 
ppm) and 100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. For the current screening 
level dietary risk assessment, to support the request for expanded 
tolerances for dichlormid, a conservative drinking water concentration 
value of 100 parts per billions (ppb), based on screening level 
modeling, was used to account for the contribution of the additional 
commodities to drinking water for the chronic dietary risk assessments 
for the parent compound. These values were directly entered into the 
dietary exposure model.
    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). Dichlormid is not 
contained in any pesticide formulation 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

[[Page 69405]]

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 dichlormid to share a common mechanism of 
toxicity with any other substances, and dichlormid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
dichlormid 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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of infants and children from in utero exposure 
to dichlormid based on developmental toxicity study in rats. In this 
study the developmental toxicity was manifested as marginal increased 
in skeletal anomalies (developmental toxicity NOAEL 40 mg/kg/day) at a 
one dose higher than the NOAEL for maternal toxicity (NOAEL 10 mg/kg/
day). There is qualitative evidence of increased susceptibility 
demonstrated following in utero exposure in the prenatal developmental 
toxicity study in rabbits, since fetal effects observed (resorptions, 
decreased live fetuses per litter, and decreased fetal body weight) are 
considered to be more severe than those observed in maternal animals 
(increased alopecia, decreased body weight gain and food consumption). 
In this study the NOAEL for maternal and developmental toxicity is 30 
mg/kg/day. There is no evidence increased susceptibility of infants and 
children from pre-and post-natal exposure to dichlormid in the two 
generation reproduction study. In this study, increased liver, weights, 
decreased body weight gain and decreased food consumption was observed 
in parental animals and increased liver weights in the offspring.
    There is no/low concern for increased qualitative susceptibility 
seen in the developmental toxicity study in rabbits because there is 
well characterized NOAEL for the developmental toxicity.
    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 dichlormid is complete. All part 158 
data requirements are fulfilled. The dichlormid toxicity database 
included subchronic studies in rats and dogs, mutagenicity battery, 
carcinogenicity studies in mice and rats, developmental toxicity study 
in rats and rabbits, 2-generation reproduction study, acute and 
subchronic neurotoxicity study, immunotoxicity study, metabolism and 
repeat dose inhalation toxicity study.
    ii. There is no indication that dichlormid is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity based on acute and 
subchronic neurotoxicity study.
    iii. There is no evidence that dichlormid 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. There was some evidence of increased qualitative susceptibility 
seen in the developmental toxicity study in rabbits, however, there is 
no residual uncertainty or concern because there is well characterized 
NOAEL for the developmental toxicity and regulatory end points are 
below the NOAEL for the developmental effects thus providing additional 
margin of safety.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to dichlromid in drinking water. These assessments 
will not underestimate the exposure and risks posed by dichlromid.

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 dichlormid will occupy 26.2% of the aPAD for all infants (<1 year 
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 
dichlormid from food and water will utilize 15.3% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for dichlormid.
    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). A short-term 
adverse effect was identified; however, dichlormid is not contained in 
any pesticide product registered for any use patterns that would result 
in short-term residential exposure. Short-term risk is assessed based 
on short-term residential exposure plus chronic dietary exposure. 
Because there is no short-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-term risk is necessary, and 
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for dichlormid.
    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). An intermediate-term adverse effect was identified; however, 
dichlormid is not contained in any pesticide product registered for any 
use patterns that would result in intermediate-term

[[Page 69406]]

residential exposure. Intermediate-term risk is assessed based on 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no 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 intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for dichlormid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity, dichlormid is not expected to pose a 
cancer risk to humans.
    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 dichlormid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen 
selective thermionic detection) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for dichlormid.

V. Conclusion

    Therefore, tolerances are established for residues of dichlormid, 
in or on all commodities for which there is a tolerance for metolachlor 
and S-metolachlor at 0.05 ppm as listed in 40 CFR 180.368.

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). 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 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: September 27, 2016.
Michael Goodis,
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.  180.469, redesignate the existing paragraph (a) as (a)(1), 
and add paragraph (a)(2) to read as follows:


Sec.  180.469   Dichlormid; Tolerances for residues.

    (a) General. (1) * * *
    (2) Tolerances are established for residues of dichlormid, 
including its metabolites and degradates, at 0.05 parts per million 
(ppm) when used as an inert ingredient (herbicide safener) in pesticide 
formulations containing metolachlor or S-metolachlor in or on raw 
agricultural commodities for which tolerances have been established for 
metolachlor or S-metolachlor. Compliance with the tolerances is to be 
determined by measuring only

[[Page 69407]]

dichlormid (2,2-dichloro-N,N-di-2-propenylacetamide).
* * * * *
[FR Doc. 2016-24214 Filed 10-5-16; 8:45 am]
 BILLING CODE 6560-50-P