[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Rules and Regulations]
[Pages 69401-69407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24214]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0121; FRL-9951-90]
Dichlormid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
dichlormid in or on all commodities for which there is a tolerance for
metolachlor and S-metolachlor. Drexel Chemical Company requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 6, 2016. Objections and
requests for hearings must be received on or before December 5, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0121, is available at 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\
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FQPA SF and
Exposure scenario Dose and factors endpoint for risk Study and toxicological effects
assessment
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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).
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Dermal Absorption................ 100% default; neither a dermal absorption study nor a dermal toxicity study
(for extrapolation) is available in the database.
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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.
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\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