81_FR_69595 81 FR 69401 - Dichlormid; Pesticide Tolerances

81 FR 69401 - Dichlormid; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 194 (October 6, 2016)

Page Range69401-69407
FR Document2016-24214

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).

Federal Register, Volume 81 Issue 194 (Thursday, October 6, 2016)
[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Rules and Regulations]
[Pages 69401-69407]
From the Federal Register Online  [www.thefederalregister.org]
[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 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, 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: [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

[[Page 69402]]

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-2016-0121 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: 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 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, http://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, http://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 http://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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act 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: 
[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. 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



                                                               Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations                                         69401

                                              Accordingly, no additional costs to                     J. Executive Order 12898: Federal                     requested these tolerances under the
                                              State, local, or tribal governments, or to              Actions To Address Environmental                      Federal Food, Drug, and Cosmetic Act
                                              the private sector, will result from this               Justice in Minority Populations and                   (FFDCA).
                                              action.                                                 Low-Income Population                                 DATES:  This regulation is effective
                                              E. Executive Order 13132: Federalism                      The EPA lacks the discretionary                     October 6, 2016. Objections and
                                                                                                      authority to address environmental                    requests for hearings must be received
                                                This action does not have federalism                  justice in this rulemaking.                           on or before December 5, 2016, and
                                              implications. It will not have substantial                                                                    must be filed in accordance with the
                                              direct effects on the states, on the                    K. Congressional Review Act (CRA)
                                                                                                                                                            instructions provided in 40 CFR part
                                              relationship between the national                         This action is subject to the CRA, and              178 (see also Unit I.C. of the
                                              government and the states, or on the                    the EPA will submit a rule report to                  SUPPLEMENTARY INFORMATION).
                                              distribution of power and                               each House of the Congress and to the                 ADDRESSES: The docket for this action,
                                              responsibilities among the various                      Comptroller General of the United                     identified by docket identification (ID)
                                              levels of government.                                   States. This action is not a ‘‘major rule’’           number EPA–HQ–OPP–2016–0121, is
                                                                                                      as defined by 5 U.S.C. 804(2).                        available at http://www.regulations.gov
                                              F. Executive Order 13175: Coordination
                                              With Indian Tribal Governments                          L. Petitions for Judicial Review                      or at the Office of Pesticide Programs
                                                                                                                                                            Regulatory Public Docket (OPP Docket)
                                                This action does not have tribal                        Under section 307(b)(1) of the Clean                in the Environmental Protection Agency
                                              implications, as specified in Executive                 Air Act, petitions for judicial review of             Docket Center (EPA/DC), West William
                                              Order 13175, because the SIP is not                     this action must be filed in the United               Jefferson Clinton Bldg., Rm. 3334, 1301
                                              approved to apply on any Indian                         States Court of Appeals for the                       Constitution Ave. NW., Washington, DC
                                              reservation land or in any other area                   appropriate circuit by December 5,                    20460–0001. The Public Reading Room
                                              where the EPA or an Indian tribe has                    2016. Filing a petition for                           is open from 8:30 a.m. to 4:30 p.m.,
                                              demonstrated that a tribe has                           reconsideration by the Administrator of               Monday through Friday, excluding legal
                                              jurisdiction, and will not impose                       this final rule does not affect the finality          holidays. The telephone number for the
                                              substantial direct costs on tribal                      of this rule for the purposes of judicial             Public Reading Room is (202) 566–1744,
                                              governments or preempt tribal law.                      review nor does it extend the time                    and the telephone number for the OPP
                                              Thus, Executive Order 13175 does not                    within which a petition for judicial                  Docket is (703) 305–5805. Please review
                                              apply to this action.                                   review may be filed, and shall not                    the visitor instructions and additional
                                                                                                      postpone the effectiveness of such rule               information about the docket available
                                              G. Executive Order 13045: Protection of                 or action. This action may not be                     at http://www.epa.gov/dockets.
                                              Children From Environmental Health                      challenged later in proceedings to
                                              Risks and Safety Risks                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                                                                      enforce its requirements (see section
                                                                                                                                                            Michael Goodis, Acting Director,
                                                                                                      307(b)(2)).
                                                The EPA interprets Executive Order                                                                          Registration Division (7505P), Office of
                                              13045 as applying only to those                         List of Subjects in 40 CFR Part 52                    Pesticide Programs, Environmental
                                              regulatory actions that concern                           Environmental protection, Air                       Protection Agency, 1200 Pennsylvania
                                              environmental health or safety risks that               pollution control, Ammonia,                           Ave. NW., Washington, DC 20460–0001;
                                              the EPA has reason to believe may                       Incorporation by reference,                           main telephone number: (703) 305–
                                              disproportionately affect children, per                 Intergovernmental relations, Nitrogen                 7090; email address: RDFRNotices@
                                              the definition of ‘‘covered regulatory                  dioxide, Particulate matter, Reporting                epa.gov.
                                              action’’ in section 2–202 of the                        and recordkeeping requirements, Sulfur                SUPPLEMENTARY INFORMATION:
                                              Executive Order. This action is not                     dioxide.
                                              subject to Executive Order 13045                                                                              I. General Information
                                              because it does not impose additional                      Dated: September 23, 2016.
                                                                                                      Alexis Strauss,
                                                                                                                                                            A. Does this action apply to me?
                                              requirements beyond those imposed by
                                              state law.                                              Acting Regional Administrator, EPA Region                You may be potentially affected by
                                                                                                      9.                                                    this action if you are an agricultural
                                              H. Executive Order 13211: Actions That                  [FR Doc. 2016–24082 Filed 10–5–16; 8:45 am]           producer, food manufacturer, or
                                              Significantly Affect Energy Supply,                                                                           pesticide manufacturer. The following
                                                                                                      BILLING CODE 6560–50–P
                                              Distribution, or Use                                                                                          list of North American Industrial
                                                                                                                                                            Classification System (NAICS) codes is
                                                This action is not subject to Executive
                                                                                                      ENVIRONMENTAL PROTECTION                              not intended to be exhaustive, but rather
                                              Order 13211, because it is not a
                                                                                                      AGENCY                                                provides a guide to help readers
                                              significant regulatory action under
                                                                                                                                                            determine whether this document
                                              Executive Order 12866.                                  40 CFR Part 180                                       applies to them. Potentially affected
                                              I. National Technology Transfer and                     [EPA–HQ–OPP–2016–0121; FRL–9951–90]
                                                                                                                                                            entities may include:
                                              Advancement Act (NTTAA)                                                                                          • Crop production (NAICS code 111).
                                                                                                      Dichlormid; Pesticide Tolerances                         • Animal production (NAICS code
                                                Section 12(d) of the NTTAA directs                                                                          112).
                                              the EPA to use voluntary consensus                      AGENCY:  Environmental Protection                        • Food manufacturing (NAICS code
                                              standards in its regulatory activities                  Agency (EPA).                                         311).
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                                              unless to do so would be inconsistent                   ACTION: Final rule.                                      • Pesticide manufacturing (NAICS
                                              with applicable law or otherwise                                                                              code 32532).
                                              impractical. The EPA believes that this                 SUMMARY:   This regulation establishes
                                              action is not subject to the requirements               tolerances for residues of dichlormid in              B. How can I get electronic access to
                                              of section 12(d) of the NTTAA because                   or on all commodities for which there                 other related information?
                                              application of those requirements would                 is a tolerance for metolachlor and S-                   You may access a frequently updated
                                              be inconsistent with the CAA.                           metolachlor. Drexel Chemical Company                  electronic version of EPA’s tolerance


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                                              69402            Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations

                                              regulations at 40 CFR part 180 through                  pesticide petition (PP IN–10858) by                   other exposures for which there is
                                              the Government Printing Office’s e-CFR                  Drexel Chemical Company, P.O. Box                     reliable information.’’ This includes
                                              site at http://www.ecfr.gov/cgi-bin/text-               13327, Memphis, TN 38113–03227.                       exposure through drinking water and in
                                              idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Although the notice announced the                     residential settings, but does not include
                                              40tab_02.tpl.                                           petition requested that 40 CFR 180.469                occupational exposure. Section
                                                                                                      be amended by establishing tolerances                 408(b)(2)(C) of FFDCA requires EPA to
                                              C. How can I file an objection or hearing
                                                                                                      for residues of the inert ingredient                  give special consideration to exposure
                                              request?
                                                                                                      (safener) dichlormid, in or on all                    of infants and children to the pesticide
                                                Under FFDCA section 408(g), 21                        commodities for which there is a                      chemical residue in establishing a
                                              U.S.C. 346a, any person may file an                     tolerance for metolachlor and S-                      tolerance and to ‘‘ensure that there is a
                                              objection to any aspect of this regulation              metolachlor at 0.05 parts per million                 reasonable certainty that no harm will
                                              and may also request a hearing on those                 (ppm), the notice of filing submitted                 result to infants and children from
                                              objections. You must file your objection                simply listed numerous commodities                    aggregate exposure to the pesticide
                                              or request a hearing on this regulation                 that were intended to correspond to the               chemical residue . . . .’’
                                              in accordance with the instructions                     commodities for which metolachlor and                   Consistent with FFDCA section
                                              provided in 40 CFR part 178. To ensure                  s-metolachlor tolerances were                         408(b)(2)(D), and the factors specified in
                                              proper receipt by EPA, you must                         established. That document referenced a               FFDCA section 408(b)(2)(D), EPA has
                                              identify docket ID number EPA–HQ–                       summary of the petition prepared by                   reviewed the available scientific data
                                              OPP–2016–0121 in the subject line on                    Drexel Chemical Company, the                          and other relevant information in
                                              the first page of your submission. All                  registrant, which is available in the                 support of this action. EPA has
                                              objections and requests for a hearing                   docket, http://www.regulations.gov.                   sufficient data to assess the hazards of
                                              must be in writing, and must be                         There were no comments received in                    and to make a determination on
                                              received by the Hearing Clerk on or                     response to the notice of filing.                     aggregate exposure for dichlormid
                                              before December 5, 2016. Addresses for                     To ensure consistency between the                  including exposure resulting from the
                                              mail and hand delivery of objections                    notice of filing and the petition filed               tolerances established by this action.
                                              and hearing requests are provided in 40                 and to avoid any confusion, EPA                       EPA’s assessment of exposures and risks
                                              CFR 178.25(b).                                          requested that Drexel revise and
                                                In addition to filing an objection or                                                                       associated with dichlormid follows.
                                                                                                      resubmit their notice of filing to clarify
                                              hearing request with the Hearing Clerk                  that the request is to establish tolerances           A. Toxicological Profile
                                              as described in 40 CFR part 178, please                 for residues of the inert ingredient                     EPA has evaluated the available
                                              submit a copy of the filing (excluding                  (safener) dichlormid, in or on all                    toxicity data and considered its validity,
                                              any Confidential Business Information                   commodities for which there is a                      completeness, and reliability as well as
                                              (CBI)) for inclusion in the public docket.              tolerance for metolachlor and S-                      the relationship of the results of the
                                              Information not marked confidential                     metolachlor at 0.05 ppm. Upon
                                                                                                                                                            studies to human risk. EPA has also
                                              pursuant to 40 CFR part 2 may be                        receiving that revised petition, EPA
                                                                                                                                                            considered available information
                                              disclosed publicly by EPA without prior                 issued a notice of filing of that petition
                                                                                                                                                            concerning the variability of the
                                              notice. Submit the non-CBI copy of your                 pursuant to FFDCA section 408(d)(3), 21
                                                                                                                                                            sensitivities of major identifiable
                                              objection or hearing request, identified                U.S.C. 346a(d)(3) in the Federal Register
                                                                                                                                                            subgroups of consumers, including
                                              by docket ID number EPA–HQ–OPP–                         of July 20, 2016 (81 FR 47150) (FRL–
                                                                                                                                                            infants and children. The database for
                                              2016–0121, by one of the following                      9948–45). The petition requested that 40
                                                                                                                                                            dichlormid has been previously
                                              methods:                                                CFR 180.469 be amended by
                                                • Federal eRulemaking Portal: http://                                                                       reviewed by the Agency, most recently
                                                                                                      establishing tolerances for residues of
                                              www.regulations.gov. Follow the online                                                                        March 23, 2011 when the permanent
                                                                                                      the inert ingredient (safener)
                                              instructions for submitting comments.                   dichlormid, in or on all commodities for              tolerance for dichlormid was issued (76
                                              Do not submit electronically any                        which there is a tolerance for                        FR 16308) (FRL–8866–2). No new data
                                              information you consider to be CBI or                   metolachlor and S-metolachlor at 0.05                 was reviewed as part of this petition for
                                              other information whose disclosure is                   ppm. That revised petition prepared by                tolerance.
                                              restricted by statute.                                  Drexel Chemical Company, the                             Specific information on the studies
                                                • Mail: OPP Docket, Environmental                     registrant, is available in the docket,               received and the nature of the adverse
                                              Protection Agency Docket Center (EPA/                   http://www.regulations.gov. There was                 effects caused by dichlormid as well as
                                              DC), (28221T), 1200 Pennsylvania Ave.                   one comment received in response to                   the no-observed-adverse-effect-level
                                              NW., Washington, DC 20460–0001.                         this notice of filing; however, the                   (NOAEL) and the lowest-observed-
                                                • Hand Delivery: To make special                      comment was not related to this                       adverse-effect-level (LOAEL) from the
                                              arrangements for hand delivery or                       chemical or petition and is therefore,                toxicity studies are discussed in this
                                              delivery of boxed information, please                   not relevant to this action.                          unit.
                                              follow the instructions at http://                                                                               In acute toxicity studies, dichlormid
                                              www.epa.gov/dockets/contacts.html.                      III. Aggregate Risk Assessment and                    exhibits low to moderate toxicity,
                                                                                                      Determination of Safety                               depending on the route of exposure. The
                                                Additional instructions on
                                              commenting or visiting the docket,                         Section 408(b)(2)(A)(i) of FFDCA                   oral lethal dose (LD)50 for dichlormid in
                                              along with more information about                       allows EPA to establish a tolerance (the              rats is 2,816 milligram/kilogram (mg/kg)
                                              dockets generally, is available at http://              legal limit for a pesticide chemical                  in males and 2,146 mg/kg for females
                                              www.epa.gov/dockets.                                    residue in or on a food) only if EPA                  (Category III). The dermal LD50 of
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                                                                                                      determines that the tolerance is ‘‘safe.’’            dichlormid in rats is greater than 2,000
                                              II. Summary of Petitioned-for Tolerance                 Section 408(b)(2)(A)(ii) of FFDCA                     mg/kg (Category III). The acute
                                                 In the Federal Register of April 25,                 defines ‘‘safe’’ to mean that ‘‘there is a            inhalation lethal concentration (LC)50 in
                                              2016 (81 FR 24044) (FRL–9944–86),                       reasonable certainty that no harm will                rats is greater than 5.5 mg/(L) (Category
                                              EPA issued a document pursuant to                       result from aggregate exposure to the                 IV). Dichlormid is mildly irritating to
                                              FFDCA section 408(d)(3), 21 U.S.C.                      pesticide chemical residue, including                 the skin of rabbits (Category IV) and
                                              346a(d)(3), announcing the filing of a                  all anticipated dietary exposures and all             severely irritating to the eyes of rabbits


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                                                               Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations                                        69403

                                              (Category II). Dichlormid is a mild                        No increased incidences of treatment                  In a subchronic inhalation toxicity
                                              dermal sensitizer.                                      related tumors were observed in mice                  study in rats via whole body exposure
                                                 The liver is the target organ in                     and rats. In the carcinogenicity study in             for 6 hours a day, 5 days/week for 14
                                              subchronic and chronic toxicity studies                 mice, kidney changes and changes in                   weeks, decreased body weights and
                                              in rats and dogs. There are two 90-day                  reproductive organs were observed,                    increased liver weights were observed at
                                              rat toxicity studies are available. One                 while rats exhibited decreased body                   the highest dose tested. The increased
                                              older study (1972), was determined to                   weights and liver toxicity. Mutagenic                 liver weights was considered as an
                                              be an unacceptable study. In the other                  potential for dichlormid was evaluated                adaptive response. Chromorhinorrhea, a
                                              study, toxicity was manifested as minor                 in an adequate battery of in vivo and in              respiratory system clinical observation
                                              decreased in body weight gains and                      vitro assays. A negative response was                 based on the discharge of colored
                                              food efficiency in females and on                       observed in these assays except in one                secretion from the nostrils, was
                                              increased liver weight and a slightly                   in vitro assay (mouse lymphoma assay).                exhibited consistently in the two top
                                              increased (not statistically significant)               However, the in vivo mouse                            dose exposure groups. Microscopic
                                              incidence of liver lipidosis in males.                  micronucleus assay was negative.                      pathology identified in the two top dose
                                              Similarly two 90-day toxicity studies in                   In an acute neurotoxicity study in                 exposure groups, dose-dependent
                                              dogs are available. In the newer study,                 rats, decreased body weight gains with                respiratory tract tissue alterations
                                              via capsules, decreased body weight                     lower food consumption was observed                   involving the olfactory epithelium for
                                              gains, hematological and clinical                       in both sexes. Functional observational               both genders.
                                              chemistry alternations, liver toxicity                  battery (FOB) measurements at the time
                                              and voluntary muscle pathological                       of peak effect (4 hrs post dose) showed               B. Toxicological Points of Departure/
                                              changes were observed. In a 1-year                      decreased activity, hunching, increased               Levels of Concern
                                              toxicity study in the dogs, voluntary                   touch response, lachrimation,
                                              muscle fiber degeneration and slight to                                                                          Once a pesticide’s toxicological
                                                                                                      piloerection, reduced splay reflex, and
                                              moderate vacuolation of the adrenal                                                                           profile is determined, EPA identifies
                                                                                                      signs of salivation. These effects were
                                              cortex was observed at 20 mg/kg/day.                                                                          toxicological points of departure (POD)
                                                                                                      deemed slight with a greater incidence
                                              There was also increased in alkaline                                                                          and levels of concern to use in
                                                                                                      in females. No treatment-related
                                              phosphatase activity in both sexes and                                                                        evaluating the risk posed by human
                                                                                                      changes in bodyweight, food
                                              decreased in aspartate aminotransferase                                                                       exposure to the pesticide. For hazards
                                                                                                      consumption, FOB, motor activity, brain
                                              activity in females. Liver weights                                                                            that have a threshold below which there
                                                                                                      weight, or neuropathology were
                                              (absolute and relative to body) were                                                                          is no appreciable risk, the toxicological
                                                                                                      identified in the 90-day neurotoxicity
                                              increased in both sexes.                                                                                      POD is used as the basis for derivation
                                                                                                      study in rats; however, the high dose of
                                                 In a developmental toxicity study in                                                                       of reference values for risk assessment.
                                                                                                      750 ppm (equal to 55.4 mg/kg/day) was
                                              rats, decreased mean absolute body                                                                            PODs are developed based on a careful
                                                                                                      not considered as adequate for testing.
                                              weights, body weight gains, and food                                                                          analysis of the doses in each
                                                                                                      No evidence of immunotoxicity was
                                              consumption was observed in maternal                                                                          toxicological study to determine the
                                                                                                      observed in a dietary immunotoxicity
                                              animals. Developmental toxicity in rats                                                                       dose at which no adverse effects are
                                                                                                      study in rats. There were no treatment
                                              was manifested as marginal increased in                                                                       observed (the NOAEL) and the lowest
                                                                                                      related effects on spleen and thymus
                                              skeletal anomalies in the presence of                                                                         dose at which adverse effects of concern
                                                                                                      weights at any of the doses of
                                              maternal toxicity. In the developmental                                                                       are identified (the LOAEL). Uncertainty/
                                                                                                      dichlormid tested.
                                              toxicity study in rabbits, increased                       Approximately 90% of the orally                    safety factors are used in conjunction
                                              incidence of alopecia and decreased                     administered dose was absorbed in rats.               with the POD to calculate a safe
                                              mean maternal body weight gains and                     Urinary excretion was the major route of              exposure level—generally referred to as
                                              food consumption was observed in                        elimination of orally administered                    a population-adjusted dose (PAD) or a
                                              maternal animals. The fetal effects in                  dichlormid, consistently accounting for               reference dose (RfD)—and a safe margin
                                              rabbits, exhibited in the presence of                   60–78% of the administered dose over                  of exposure (MOE). For non-threshold
                                              maternal toxicity, were manifested as                   48–168 hours following a single oral                  risks, the Agency assumes that any
                                              increases in post-implantation loss                     dose. Fecal excretion accounted for                   amount of exposure will lead to some
                                              accompanied by an increase number of                    ∼8–20% of a single oral dose.                         degree of risk. Thus, the Agency
                                              resorptions/doe (both early and late                    Approximately 70–77% of urinary                       estimates risk in terms of the probability
                                              resorptions), decreased number of live/                 excretion (representing 52–54% of the                 of an occurrence of the adverse effect
                                              fetuses/litter, and slightly decreased                  administered dose) occurred within 24                 expected in a lifetime. For more
                                              mean fetal body weights. In a 2-                        hours. No gender-related difference in                information on the general principles
                                              generation reproduction study in rats,                  rate or amount of urinary excretion was               EPA uses in risk characterization and a
                                              no treatment related effects on                         observed. No significant accumulation                 complete description of the risk
                                              reproductive parameters were observed.                  in the body was observed. Dichlormid                  assessment process, see http://
                                              Minimal increased liver weight,                         was metabolized via two pathways:                     www.epa.gov/pesticides/factsheets/
                                              minimal decreased weight gain and                          1. Initial dechlorination followed by              riskassess.htm.
                                              minimal decreased in food consumption                   formation of various chlorinated, water-                A summary of the toxicological
                                              was observed in parental animals.                       soluble metabolites, and;                             endpoints for dichlormid used for
                                              Increased liver weights were observed                      2. Formation of various chlorinated                human health risk assessment are
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                                              in the offspring.                                       metabolites.                                          shown in Table 1 of this unit.




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                                              69404                 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations

                                                 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                                    Study and toxicological effects
                                                                                                                                         risk 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 based on decreased body
                                                                                                Acute RfD = 0.10                        FQPA SF = 0.10                       weight gain and food consumption (most significant on days
                                                                                                  mg/kg/day                             mg/kg/day                            7–10 of dosing).
                                              Chronic Dietary, all populations                  NOAEL = 5 mg/kg/                      FQPA SF = 1 ...........              1-year Study—Dog
                                                                                                  day.                                cPAD = chr RfD/                      LOAEL = 20 mg/kg/day (male, female), based on increased
                                                                                                UF = 100                                FQPA SF = 0.05                       liver weights, increased in alkaline phosphatase activity, mini-
                                                                                                Chronic RfD = 0.05                      mg/kg/day.                           mal muscle fiber degeneration in, slight to moderate
                                                                                                  mg/kg/day.                                                                 vacuolation of the inner cortex of the adrenal gland, and in-
                                                                                                                                                                             creased 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                     MOE = 100 ..............             Developmental toxicity Study—Rats
                                                                                                  mg/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 de-
                                                                                                                                                                             riving the aRfD. Dermal toxicity study is not available. 100%
                                                                                                                                                                             dermal absorption factor should be used for this risk assess-
                                                                                                                                                                             ment.
                                              Intermediate- and Long-Term                       Oral NOAEL = 5 mg/                    MOE = 100 ..............             1-year study—Dog
                                                 (Dermal).                                        kg/day.                                                                  LOAEL = 20 mg/kg/day (male, female), based on increased
                                                                                                                                                                             liver weights, increased in alkaline phosphatase activity, mini-
                                                                                                                                                                             mal muscle fiber degeneration in, slight to moderate
                                                                                                                                                                             vacuolation of the inner cortex of the adrenal gland, and in-
                                                                                                                                                                             creased kidney weights (females).
                                              Inhalation (All Durations) ..........             2 μg/L ......................         MOE = 100 ..............             14-week inhalation study
                                                                                                                                                                           LOAEL = 20 μg/L based on clinical signs, increased liver and
                                                                                                                                                                             kidney weights, gross pathology and non-neoplastic
                                                                                                                                                                             histopathology. The route of exposure in this study is appro-
                                                                                                                                                                             priate 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 ef-
                                              fect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose; LOC = level of concern; MOE = margin of exposure.


                                              C. Exposure Assessment                                                    United States Department of Agriculture                                2. Dietary exposure from drinking
                                                 1. Dietary exposure from food and                                      (USDA) 2003–2008 Nationwide                                         water. For the current screening level
                                              feed uses. In evaluating dietary                                          Continuing Surveys of Food Intake by                                dietary risk assessment, to support the
                                              exposure to dichlormid, EPA considered                                    Individuals (CSFII). As to residue levels                           request for expanded tolerances for
                                              exposure under the petitioned-for                                         in food, EPA used tolerance level                                   dichlormid, a conservative drinking
                                              tolerances as well as all existing                                        residues (i.e., 0.05 ppm) and 100% crop                             water concentration value of 100 parts
                                              dichlormid tolerances in 40 CFR                                           treated.                                                            per billions (ppb), based on screening
                                              180.469. The assessment was conducted                                        ii. Chronic exposure. In conducting                              level modeling, was used to account for
                                              using the proposed tolerance of 0.05                                      the chronic dietary exposure assessment                             the contribution of the additional
                                              ppm for those commodities for which                                       EPA used the food consumption data                                  commodities to drinking water for the
                                              there is a current tolerance for                                          from the USDA 2003–2008 CSFII. As to                                chronic dietary risk assessments for the
                                              metolachlor and S-metolachlor as well                                     residue levels in food, EPA used                                    parent compound. These values were
                                              as for all commodities to account for the                                 tolerance level residues (i.e., 0.05 ppm)                           directly entered into the dietary
                                              potential dietary exposure that could                                     and 100% crop treated.                                              exposure model.
                                              result from dichlormid should                                                                                                                    3. From non-dietary exposure. The
                                                                                                                           iii. Cancer. Based on the data                                   term ‘‘residential exposure’’ is used in
                                              additional tolerances be established for
                                                                                                                        summarized in Unit III.A., EPA has                                  this document to refer to non-
                                              metolachlor and S-metolachlor. EPA
                                                                                                                        concluded that dichlormid does not                                  occupational, non-dietary exposure
                                              assessed dietary exposures from
                                                                                                                        pose a cancer risk to humans. Therefore,                            (e.g., for lawn and garden pest control,
                                              dichlormid in food as follows:
                                                 i. Acute exposure. Quantitative acute                                  a dietary exposure assessment for the                               indoor pest control, termiticides, and
                                              dietary exposure and risk assessments                                     purpose of assessing cancer risk is                                 flea and tick control on pets).
                                              are performed for a food-use pesticide,                                   unnecessary.                                                        Dichlormid is not contained in any
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                                              if a toxicological study has indicated the                                   iv. Anticipated residue and percent                              pesticide formulation registered for any
                                              possibility of an effect of concern                                       crop treated (PCT) information. EPA did                             specific use patterns that would result
                                              occurring as a result of a 1-day or single                                not use anticipated residue and/or PCT                              in residential exposure.
                                              exposure. Such effects were identified                                    information in the dietary assessment                                  4. Cumulative effects from substances
                                              for dichlormid. In estimating acute                                       for dichlormid. Tolerance level residues                            with a common mechanism of toxicity.
                                              dietary exposure, EPA used food                                           (i.e., 0.05 ppm) and 100% CT were                                   Section 408(b)(2)(D)(v) of FFDCA
                                              consumption information from the                                          assumed for all food commodities.                                   requires that, when considering whether


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                                                               Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations                                       69405

                                              to establish, modify, or revoke a                       is 30 mg/kg/day. There is no evidence                 E. Aggregate Risks and Determination of
                                              tolerance, the Agency consider                          increased susceptibility of infants and               Safety
                                              ‘‘available information’’ concerning the                children from pre-and post-natal                         EPA determines whether acute and
                                              cumulative effects of a particular                      exposure to dichlormid in the two                     chronic dietary pesticide exposures are
                                              pesticide’s residues and ‘‘other                        generation reproduction study. In this                safe by comparing aggregate exposure
                                              substances that have a common                           study, increased liver, weights,                      estimates to the acute PAD (aPAD) and
                                              mechanism of toxicity.’’                                decreased body weight gain and                        chronic PAD (cPAD). For linear cancer
                                                 EPA has not found dichlormid to                      decreased food consumption was                        risks, EPA calculates the lifetime
                                              share a common mechanism of toxicity                    observed in parental animals and                      probability of acquiring cancer given the
                                              with any other substances, and                          increased liver weights in the offspring.             estimated aggregate exposure. Short-,
                                              dichlormid does not appear to produce
                                                                                                         There is no/low concern for increased              intermediate-, and chronic-term risks
                                              a toxic metabolite produced by other
                                                                                                      qualitative susceptibility seen in the                are evaluated by comparing the
                                              substances. For the purposes of this
                                                                                                      developmental toxicity study in rabbits               estimated aggregate food, water, and
                                              tolerance action, therefore, EPA has
                                              assumed that dichlormid does not have                   because there is well characterized                   residential exposure to the appropriate
                                              a common mechanism of toxicity with                     NOAEL for the developmental toxicity.                 PODs to ensure that an adequate MOE
                                              other substances. For information                          3. Conclusion. EPA has determined                  exists.
                                                                                                                                                               1. Acute risk. Using the exposure
                                              regarding EPA’s efforts to determine                    that reliable data show the safety of
                                              which chemicals have a common                                                                                 assumptions discussed in this unit for
                                                                                                      infants and children would be
                                              mechanism of toxicity and to evaluate                                                                         acute exposure, the acute dietary
                                                                                                      adequately protected if the FQPA SF
                                              the cumulative effects of such                                                                                exposure from food and water to
                                                                                                      were reduced to 1X. That decision is
                                              chemicals, see EPA’s Web site at http://                                                                      dichlormid will occupy 26.2% of the
                                                                                                      based on the following findings:
                                              www.epa.gov/pesticides/cumulative.                                                                            aPAD for all infants (<1 year old), the
                                                                                                         i. The toxicity database for dichlormid            population group receiving the greatest
                                              D. Safety Factor for Infants and                        is complete. All part 158 data                        exposure.
                                              Children                                                requirements are fulfilled. The                          2. Chronic risk. Using the exposure
                                                 1. In general. Section 408(b)(2)(C) of               dichlormid toxicity database included                 assumptions described in this unit for
                                              FFDCA provides that EPA shall apply                     subchronic studies in rats and dogs,                  chronic exposure, EPA has concluded
                                              an additional tenfold (10X) margin of                   mutagenicity battery, carcinogenicity                 that chronic exposure to dichlormid
                                              safety for infants and children in the                  studies in mice and rats, developmental               from food and water will utilize 15.3%
                                              case of threshold effects to account for                toxicity study in rats and rabbits, 2-                of the cPAD for children 1–2 years old,
                                              prenatal and postnatal toxicity and the                 generation reproduction study, acute                  the population group receiving the
                                              completeness of the database on toxicity                and subchronic neurotoxicity study,                   greatest exposure. There are no
                                              and exposure unless EPA determines                      immunotoxicity study, metabolism and                  residential uses for dichlormid.
                                              based on reliable data that a different                 repeat dose inhalation toxicity study.                   3. Short-term risk. Short-term
                                              margin of safety will be safe for infants                  ii. There is no indication that                    aggregate exposure takes into account
                                              and children. This additional margin of                 dichlormid is a neurotoxic chemical and               short-term residential exposure plus
                                              safety is commonly referred to as the                   there is no need for a developmental                  chronic exposure to food and water
                                              Food Quality Protection Act Safety                      neurotoxicity study or additional UFs to              (considered to be a background
                                              Factor (FQPA SF). In applying this                      account for neurotoxicity based on acute              exposure level). A short-term adverse
                                              provision, EPA either retains the default               and subchronic neurotoxicity study.                   effect was identified; however,
                                              value of 10X, or uses a different                                                                             dichlormid is not contained in any
                                                                                                         iii. There is no evidence that                     pesticide product registered for any use
                                              additional safety factor when reliable
                                                                                                      dichlormid results in increased                       patterns that would result in short-term
                                              data available to EPA support the choice
                                              of a different factor.                                  susceptibility in in utero rats or rabbits            residential exposure. Short-term risk is
                                                 2. Prenatal and postnatal sensitivity.               in the prenatal developmental studies or              assessed based on short-term residential
                                              There is no evidence of increased                       in young rats in the 2-generation                     exposure plus chronic dietary exposure.
                                              susceptibility of infants and children                  reproduction study. There was some                    Because there is no short-term
                                              from in utero exposure to dichlormid                    evidence of increased qualitative                     residential exposure and chronic dietary
                                              based on developmental toxicity study                   susceptibility seen in the developmental              exposure has already been assessed
                                              in rats. In this study the developmental                toxicity study in rabbits, however, there             under the appropriately protective
                                              toxicity was manifested as marginal                     is no residual uncertainty or concern                 cPAD (which is at least as protective as
                                              increased in skeletal anomalies                         because there is well characterized                   the POD used to assess short-term risk),
                                              (developmental toxicity NOAEL 40 mg/                    NOAEL for the developmental toxicity                  no further assessment of short-term risk
                                              kg/day) at a one dose higher than the                   and regulatory end points are below the               is necessary, and EPA relies on the
                                              NOAEL for maternal toxicity (NOAEL                      NOAEL for the developmental effects                   chronic dietary risk assessment for
                                              10 mg/kg/day). There is qualitative                     thus providing additional margin of                   evaluating short-term risk for
                                              evidence of increased susceptibility                    safety.                                               dichlormid.
                                              demonstrated following in utero                            iv. There are no residual uncertainties               4. Intermediate-term risk.
                                              exposure in the prenatal developmental                  identified in the exposure databases.                 Intermediate-term aggregate exposure
                                              toxicity study in rabbits, since fetal                  The dietary food exposure assessments                 takes into account intermediate-term
                                              effects observed (resorptions, decreased                were performed based on 100% CT and                   residential exposure plus chronic
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                                              live fetuses per litter, and decreased                  tolerance-level residues. EPA made                    exposure to food and water (considered
                                              fetal body weight) are considered to be                 conservative (protective) assumptions in              to be a background exposure level). An
                                              more severe than those observed in                      the ground and surface water modeling                 intermediate-term adverse effect was
                                              maternal animals (increased alopecia,                   used to assess exposure to dichlromid in              identified; however, dichlormid is not
                                              decreased body weight gain and food                     drinking water. These assessments will                contained in any pesticide product
                                              consumption). In this study the NOAEL                   not underestimate the exposure and                    registered for any use patterns that
                                              for maternal and developmental toxicity                 risks posed by dichlromid.                            would result in intermediate-term


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                                              69406            Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations

                                              residential exposure. Intermediate-term                 V. Conclusion                                         ‘‘Federalism’’ (64 FR 43255, August 10,
                                              risk is assessed based on intermediate-                   Therefore, tolerances are established               1999) and Executive Order 13175,
                                              term residential exposure plus chronic                  for residues of dichlormid, in or on all              entitled ‘‘Consultation and Coordination
                                              dietary exposure. Because there is no                   commodities for which there is a                      with Indian Tribal Governments’’ (65 FR
                                              intermediate-term residential exposure                  tolerance for metolachlor and S-                      67249, November 9, 2000) do not apply
                                              and chronic dietary exposure has                        metolachlor at 0.05 ppm as listed in 40               to this action. In addition, this action
                                              already been assessed under the                         CFR 180.368.                                          does not impose any enforceable duty or
                                              appropriately protective cPAD (which is                                                                       contain any unfunded mandate as
                                              at least as protective as the POD used to               VI. Statutory and Executive Order                     described under Title II of the Unfunded
                                              assess intermediate-term risk), no                      Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                              further assessment of intermediate-term                    This action establishes tolerances                 1501 et seq.).
                                              risk is necessary, and EPA relies on the                under FFDCA section 408(d) in                            This action does not involve any
                                              chronic dietary risk assessment for                     response to a petition submitted to the               technical standards that would require
                                              evaluating intermediate-term risk for                   Agency. The Office of Management and                  Agency consideration of voluntary
                                              dichlormid.                                             Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                                 5. Aggregate cancer risk for U.S.                    of actions from review under Executive                12(d) of the National Technology
                                              population. Based on the lack of                        Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                              evidence of carcinogenicity, dichlormid                 Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                              is not expected to pose a cancer risk to                October 4, 1993). Because this action                 VII. Congressional Review Act
                                              humans.                                                 has been exempted from review under
                                                                                                      Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                                 6. Determination of safety. Based on                                                                       Act (5 U.S.C. 801 et seq.), EPA will
                                              these risk assessments, EPA concludes                   not subject to Executive Order 13211,
                                                                                                      entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                              that there is a reasonable certainty that                                                                     other required information to the U.S.
                                              no harm will result to the general                      Regulations That Significantly Affect
                                                                                                      Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                              population, or to infants and children,                                                                       Representatives, and the Comptroller
                                              from aggregate exposure to dichlormid                   FR 28355, May 22, 2001) or Executive
                                                                                                      Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                              residues.                                                                                                     publication of the rule in the Federal
                                                                                                      Children from Environmental Health
                                              IV. Other Considerations                                Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                                                                                      April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
                                              A. Analytical Enforcement Methodology
                                                                                                      contain any information collections                   List of Subjects in 40 CFR Part 180
                                                Adequate enforcement methodology                      subject to OMB approval under the
                                              (gas chromatography with nitrogen                                                                               Environmental protection,
                                                                                                      Paperwork Reduction Act (PRA) (44                     Administrative practice and procedure,
                                              selective thermionic detection) is                      U.S.C. 3501 et seq.), nor does it require
                                              available to enforce the tolerance                                                                            Agricultural commodities, Pesticides
                                                                                                      any special considerations under                      and pests, Reporting and recordkeeping
                                              expression. The method may be                           Executive Order 12898, entitled
                                              requested from: Chief, Analytical                                                                             requirements.
                                                                                                      ‘‘Federal Actions to Address
                                              Chemistry Branch, Environmental                         Environmental Justice in Minority                        Dated: September 27, 2016.
                                              Science Center, 701 Mapes Rd., Ft.                      Populations and Low-Income                            Michael Goodis,
                                              Meade, MD 20755–5350; telephone                         Populations’’ (59 FR 7629, February 16,               Acting Director, Registration Division, Office
                                              number: (410) 305–2905; email address:                  1994).                                                of Pesticide Programs.
                                              residuemethods@epa.gov.                                    Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                              B. International Residue Limits                         are established on the basis of a petition            amended as follows:
                                                                                                      under FFDCA section 408(d), such as
                                                 In making its tolerance decisions, EPA               the tolerance in this final rule, do not              PART 180—[AMENDED]
                                              seeks to harmonize U.S. tolerances with                 require the issuance of a proposed rule,
                                              international standards whenever                        the requirements of the Regulatory                    ■ 1. The authority citation for part 180
                                              possible, consistent with U.S. food                     Flexibility Act (RFA) (5 U.S.C. 601 et                continues to read as follows:
                                              safety standards and agricultural                       seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                              practices. EPA considers the                               This action directly regulates growers,            ■ 2. In § 180.469, redesignate the
                                              international maximum residue limits                    food processors, food handlers, and food              existing paragraph (a) as (a)(1), and add
                                              (MRLs) established by the Codex                         retailers, not States or tribes, nor does             paragraph (a)(2) to read as follows:
                                              Alimentarius Commission (Codex), as                     this action alter the relationships or
                                              required by FFDCA section 408(b)(4).                    distribution of power and                             § 180.469 Dichlormid; Tolerances for
                                              The Codex Alimentarius is a joint                       responsibilities established by Congress              residues.
                                              United Nations Food and Agriculture                     in the preemption provisions of FFDCA                   (a) General. (1) * * *
                                              Organization/World Health                               section 408(n)(4). As such, the Agency                  (2) Tolerances are established for
                                              Organization food standards program,                    has determined that this action will not              residues of dichlormid, including its
                                              and it is recognized as an international                have a substantial direct effect on States            metabolites and degradates, at 0.05 parts
                                              food safety standards-setting                           or tribal governments, on the                         per million (ppm) when used as an inert
                                              organization in trade agreements to                     relationship between the national                     ingredient (herbicide safener) in
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                                              which the United States is a party. EPA                 government and the States or tribal                   pesticide formulations containing
                                              may establish a tolerance that is                       governments, or on the distribution of                metolachlor or S-metolachlor in or on
                                              different from a Codex MRL; however,                    power and responsibilities among the                  raw agricultural commodities for which
                                              FFDCA section 408(b)(4) requires that                   various levels of government or between               tolerances have been established for
                                              EPA explain the reasons for departing                   the Federal Government and Indian                     metolachlor or S-metolachlor.
                                              from the Codex level. The Codex has not                 tribes. Thus, the Agency has determined               Compliance with the tolerances is to be
                                              established a MRL for dichlormid.                       that Executive Order 13132, entitled                  determined by measuring only


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                                                               Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Rules and Regulations                                         69407

                                              dichlormid (2,2-dichloro-N,N-di-2-                      depending on the total number of pages                generally do not have authority over
                                              propenylacetamide).                                     copied.                                               Indian Country. For this reason, owners
                                              *    *    *     *    *                                  FOR FURTHER INFORMATION CONTACT:                      and operators of MSWLF units located
                                              [FR Doc. 2016–24214 Filed 10–5–16; 8:45 am]             Steve Wall, Land Division, Mail Code                  in Indian Country cannot take advantage
                                              BILLING CODE 6560–50–P                                  LND 2–3 U.S. Environmental Protection                 of the flexibilities available to those
                                                                                                      Agency, 75 Hawthorne Street, San                      facilities that are within the jurisdiction
                                                                                                      Francisco, CA 94105–3901; telephone                   of an EPA-approved state program.
                                              ENVIRONMENTAL PROTECTION                                number: (415) 972–3381; fax number:                   However, the EPA has the authority
                                              AGENCY                                                  (415) 947–3564; email address:                        under sections 2002, 4004, and 4010 of
                                                                                                      wall.steve@epa.gov.                                   RCRA to promulgate site-specific rules
                                              40 CFR Part 258                                                                                               to enable such owners and operators to
                                                                                                      SUPPLEMENTARY INFORMATION:
                                                                                                                                                            use the flexible standards. See Yankton
                                              [EPA–R09–RCRA–2015–0445; FRL–9953–                      I. What did EPA propose?                              Sioux Tribe v. EPA, 950 F. Supp. 1471
                                              45–Region 9]
                                                                                                         After completing a review of Imperial              (D.S.D. 1996); Backcountry Against
                                              Final Determination To Approve Site-                    County’s Picacho Landfill Final                       Dumps v. EPA, 100 F.3d 147 (D.C. Cir.
                                              Specific Flexibility for Closure and                    Closure/Post-Closure Maintenance Plan                 1996). EPA refers to such rules as ‘‘Site-
                                              Monitoring of the Picacho Landfill                      and the associated SSFRs, EPA                         Specific Flexibility Determinations.’’
                                                                                                      proposed this rulemaking in the Federal               EPA has developed guidance for owners
                                              AGENCY:  Environmental Protection                       Register. The proposed determination                  and operators on preparing a request for
                                              Agency (EPA).                                           was published at 81 FR 20274, April 7,                such a site-specific rule, entitled ‘‘Site-
                                              ACTION: Final rule.                                     2016. EPA proposed to approve an                      Specific Flexibility Requests for
                                                                                                      alternative final cover that varies from              Municipal Solid Waste Landfills in
                                              SUMMARY:   The Environmental Protection                                                                       Indian Country, Draft Guidance,’’
                                                                                                      the final closure requirements of 40 CFR
                                              Agency, Region IX, is making a final                                                                          EPA530–R–97–016 (August 1997) (Draft
                                                                                                      258.60(a) but meets the criteria at 40
                                              determination to approve two Site-                                                                            Guidance).
                                                                                                      CFR 258.60(b), and alternative
                                              Specific Flexibility Requests (SSFRs)
                                                                                                      groundwater detection monitoring                      III. Background
                                              from Imperial County (County or
                                                                                                      parameters for post-closure monitoring
                                              Imperial County) to close and monitor                                                                           The Picacho Landfill is located on
                                                                                                      in accordance with 40 CFR 258.54(a).
                                              the Picacho Solid Waste Landfill                                                                              Quechan tribal lands on the Fort Yuma
                                              (Picacho Landfill or Landfill). The                     II. Legal Authority for This Action                   Indian Reservation approximately four
                                              Picacho Landfill is a commercial                           Under sections 1008, 2002, 4004, and               miles north-northeast of the community
                                              municipal solid waste landfill (MSWLF)                  4010 of the Resource Conservation and                 of Winterhaven, in Imperial County,
                                              operated by Imperial County from 1977                   Recovery Act of 1976 (RCRA) as                        California. The Picacho Landfill is a
                                              to the present on the Quechan Indian                    amended by the Hazardous and Solid                    commercial MSWLF operated by
                                              Tribe of the Fort Yuma Indian                           Waste Amendments of 1984 (HSWA), 42                   Imperial County from 1977 to the
                                              Reservation in California.                              U.S.C. 6901 et seq., Congress required                present. The landfill site is
                                                 EPA is promulgating a site-specific                  EPA to establish revised minimum                      approximately 12.5 acres.
                                              rule proposed on April 7, 2016, that                    federal criteria for MSWLFs, including                  In January 2006, the Tribe requested
                                              approves an alternative final cover and                 landfill location restrictions, operating             that EPA provide comments on the
                                              a modification to the prescribed list of                standards, design standards, and                      County’s closure plan. Between 2006
                                              groundwater detection-monitoring                        requirements for ground water                         and 2011, EPA worked with the Tribe,
                                              parameters for ongoing monitoring for                   monitoring, corrective action, closure                the Bureau of Indian Affairs (BIA) and
                                              the Picacho Landfill.                                   and post-closure care, and financial                  the County to develop the closure plan.
                                              DATES: This final rule is effective on                  assurance. Under RCRA section 4005,                   During this time, EPA also reviewed the
                                              October 6, 2016.                                        states are to develop permit programs                 SSFRs to determine whether they met
                                              ADDRESSES: EPA has established a                        for facilities that may receive household             technical and regulatory requirements.
                                              docket for this action under Docket ID                  hazardous waste or waste from                         On October 27, 2010, Imperial County
                                              No. EPA–R09–RCRA–2015–0445. All                         conditionally exempt small quantity                   submitted its Picacho Final Closure/
                                              documents in the docket are listed in                   generators of hazardous waste, and EPA                Post-Closure Maintenance Plan. EPA
                                              the http://www.regulations.gov index.                   is to determine whether the state’s                   provided a final round of comments on
                                              Publicly available docket materials are                 program is adequate to ensure that such               February 10, 2011, which Imperial
                                              available electronically in http://                     facilities will comply with the revised               County incorporated as an addendum.
                                              www.regulations.gov and in hard copy                    federal criteria.                                     On April 30, 2012, the Tribe approved
                                              at the EPA Library, located at the                         The MSWLF criteria are set forth in                the Picacho Landfill Final Closure/Post-
                                              Environmental Protection Agency,                        the Code of Federal Regulations at 40                 Closure Maintenance Plan as amended,
                                              Region IX, 75 Hawthorne Street, San                     CFR part 258. These regulations are                   and, pursuant to EPA’s Draft Guidance,
                                              Francisco, California. The EPA Library                  prescriptive, self-implementing and                   the Tribe forwarded to EPA two SSFRs
                                              is open from 9:00 a.m. to 4:00 p.m.,                    apply directly to owners and operators                that had been submitted by Imperial
                                              Monday through Thursday, excluding                      of MSWLFs. Many of these criteria                     County to close and monitor the Picacho
                                              legal holidays, and is located in a                     include a flexible performance standard               Landfill. The requests sought EPA
                                              secured building. To review docket                      as an alternative to the prescriptive, self-          approval to use an alternative final
sradovich on DSK3GMQ082PROD with RULES




                                              materials at the EPA Library, it is                     implementing regulation. The flexible                 cover meeting the performance
                                              recommended that the public make an                     standard is not self-implementing, and                requirements of 40 CFR 258.60(a), and
                                              appointment by calling (415) 947–4406                   requires approval by the Director of an               to modify the prescribed list of
                                              during normal business hours. Copying                   EPA-approved state MSWLF permitting                   groundwater detection-monitoring
                                              arrangements will be made through the                   program. However, EPA’s approval of a                 parameters provided in 40 CFR
                                              EPA Library and billed directly to the                  state program generally does not extend               258.54(a)(1) and (2) for ongoing
                                              recipient. Copying costs may be waived                  to Indian Country because states                      monitoring.


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Document Created: 2016-10-06 02:37:19
Document Modified: 2016-10-06 02:37:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael 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
FR Citation81 FR 69401 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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