Chlorate; Pesticide Exemptions From Tolerance, 66138-66143 [2018-27908]
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Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations
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pollution control, Incorporation by
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Dated: November 30, 2018.
Deborah Jordan,
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Part 52, chapter I, title 40 of the Code
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PROMULGATION OF
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1. The authority citation for part 52
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Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220 is amended by
adding paragraph (c)(509)(i)(B) to read
as follows:
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§ 52.220
Identification of plan-in part.
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(B) Feather River Air Quality
Management District.
(1) Rule 3.23, ‘‘Natural Gas-Fired
Water Heaters, Small Boilers, and
Process Heaters’’ adopted on October 3,
2016.
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[FR Doc. 2018–27756 Filed 12–21–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0063; FRL–9986–85]
Chlorate; Pesticide Exemptions From
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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).
This regulation establishes an
exemption from the requirement of a
tolerance for residues of chlorate in or
on cantaloupe and tomato under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
This regulation is effective
December 26, 2018. Objections and
requests for hearings must be received
on or before February 25, 2019 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0063, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Anita Pease, Antimicrobials Division
(7510P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
ADFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2017–0063 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 25, 2019. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0063, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
SUMMARY:
DATES:
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instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
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II. Summary of Petitioned-For
Exemptions
In the Federal Register of December
15, 2017 (82 FR 59604) (FRL–9970–50),
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 4F8325) by ICA
Trinova, Inc., 1 Beavers Street, Suite B,
Newnan, GA 30263. The petition
requested that EPA (1) establish a
tolerance for residues of chlorate in or
on cantaloupes at 1.5 parts per million
(ppm), and (2) establish an exemption
from the requirement of a tolerance for
residues of chlorate in or on tomatoes.
Chlorate is a by-product of chlorine
dioxide, which is generated from the
active ingredient, sodium chlorite, when
it is applied via fumigation to tomatoes
and cantaloupes post- harvest, during
storage and shipment. The Agency
reviewed submitted residue chemistry
data for chlorine dioxide and chlorate.
Given that residues for chlorine dioxide
were not detected and only residues of
chlorate were quantified, EPA has
determined that tolerance exemptions
are appropriate for chlorate on both
tomatoes and cantaloupes.
A summary of the petition prepared
by ICA Trinova Inc., the petitioner and
registrant is available in the docket,
https://www.regulations.gov. Comments
were received on the notice of filing; the
Agency’s response to these comments is
located in Unit IV.B. of this document.
For reasons explained in Unit IV.C.,
EPA is establishing an exemption from
the requirement of a tolerance for
residues of chlorate in or on cantaloupe
and tomato.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement of a tolerance (the
legal limit for a pesticide chemical
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residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(c)(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. In making this
safety determination, EPA must take
into consideration the factors laid out in
section 408(b)(2)(C) and (D).
Specifically, 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
therein, 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 chlorate
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with chlorate 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.
Sodium chlorite is the active
ingredient that is applied to the
tomatoes and cantaloupe. Once applied,
it is activated by a weak acid, creating
gaseous chlorine dioxide. As chlorine
dioxide is released, it also produces the
byproduct, chlorate. Based on submitted
residue data, the only residues of the
pesticide with the potential for being
present on food commodities are
chlorate ions; therefore, the Agency
assessed the safety of aggregate exposure
to chlorate in support of this tolerance
action.
Inorganic chlorates (also known as
chlorate salts) encompass all chlorates
including the most abundant salt,
sodium chlorate. Toxicology data
relevant to the human health risk
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assessment are summarized here and
more information about the toxicology
data and references can be found in the
Risk Assessment of Tomato and
Cantaloupe Fumigation with Sodium
Chlorite 3.2% (chlorine dioxide gas) and
Inorganic Chlorates Human Health
Assessment Scoping Document in
Support of Registration Review (Docket
ID No. EPA–HQ–OPP–2016–0080–0008)
both of which can be found in the
docket for this action at https://
www.regulations.gov.
The hazard database indicates that the
thyroid is the primary target organ of
chlorate. Effects observed in subchronic
and chronic toxicity studies show
increased thyroid gland weights, colloid
depletion, decreases in triiodothyronine
(T3) and thyroxine (T4) accompanied by
increases in thyroid stimulating
hormone (TSH), increased incidence of
thyroid follicular cell hypertrophy,
thyroid cell mineralization, follicular
cell hyperplasia, and adenomas or
carcinomas in rat studies. Other effects
include hematological changes
(hemoglobin concentration, hematocrit,
decreased red blood counts (RBC), and
increased reticulocyte counts in
females), methemoglobin concentration
changes, and pituitary vacuolization in
subchronic studies starting at doses 10fold higher than where thyroid effects
are observed.
In a 2-year drinking water study, there
was some evidence of thyroid gland
follicular cell tumors in male rats;
however, because chlorate is not
mutagenic and these tumors were only
seen at high doses, chlorate is not likely
to be carcinogenic since the chronic
reference dose is below the dose at
which alteration of thyroid hormone
homeostasis occurs. Moreover, although
there was equivocal and marginal
evidence of increased pancreatic islet
carcinoma in female mice, the Agency
has concluded that the selected chronic
reference dose is protective of these
potential cancer effects.
No increased qualitative or
quantitative susceptibility in rats or
rabbits was seen in reproduction and
developmental studies with chlorate.
Chlorate did not cause developmental
effects in rats at doses up to the limit
dose (1,000 mg/kg/day) or in rabbits up
to half the limit dose. Although chlorate
has not been evaluated for neurotoxic
effects, acute and subchronic toxicity
studies do not indicate any neurotoxic
potential. In a 2-generation reproduction
toxicity study, increased absolute and
relative thyroid weight and increased
incidence of slight to moderate
hyperactivity of the thyroid glands were
reported in parental and adult F1 males
and females at doses 14x higher than the
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thyroid effects identified in the adult rat
subchronic and chronic studies.
The chronic oral toxicity of chlorate
was examined in a study conducted by
the National Toxicology Program (NTP).
In this study, Fischer 344 rats (50/sex/
group) were exposed to drinking water
containing 0, 125, 1,000, or 2,000 mg/L
chlorate for 2 years (equivalent to 5/5,
35/45, and 75/95 mg/kg/day (males/
females)). T4 and T3 levels were
significantly reduced at 35 and 75 mg/
kg/day on day 4, and in 75 mg/kg/day
males and females at week 3. TSH was
significantly increased in 35 and 75 mg/
kg/day males on day 4 and at week 3,
in 35 and 75 mg/kg/day females on day
4, in 75 mg/kg/day females at week 3,
and in 75 mg/kg/day males and females
at week 13. At the high dose, increased
incidences of thyroid gland follicular
cell carcinoma were seen in male rats
(incidence: 4/47) compared to none in
controls, and of thyroid gland follicular
cell adenoma or carcinoma (combined)
in males (incidence: 6/47) and females
(incidence: 4/46) compared to one
animal in controls of both sexes. The
incidences of thyroid gland follicular
cell hypertrophy were significantly
increased in mid- and high-dose groups
of males (33/43 and 40/47 vs. 4/47 in
control) and females (3/47, 7/47, 27/43,
42/46 vs. 3/47 in control).
In the Agency’s 2006 risk assessment
for inorganic chlorates, Revised
Inorganic Chlorates. HED Chapter of the
Reregistration Eligibility Decision
Document (RED) (Docket ID No. EPA–
HQ–OPP–2005–0507–0004) a lower
95% confidence limit of the benchmark
dose (BMDL) of 0.9 mg/kg/day was
derived, based on thyroid gland
follicular cell hypertrophy at the 5 mg/
kg/day dose from the rat chronic cancer
study (NTP, 2005). EPA has reconsidered the data and determined that
the original benchmark dose derived
from the study was not sufficiently
supported as an effect level at 5 mg/kg/
day, and that the 5 mg/kg/day dose can
be supported as a NOAEL for the study.
The point of departure (POD) for
chronic dietary (all populations)
exposures is thus the 5 mg/kg/day dose,
based on changes in thyroid hormones
(decreased T3, decreased T4, and
increased TSH), and increased
incidence of thyroid follicular cell
hypertrophy in male and female rats at
the next highest dose of 35/45 mg/kg/
day (males and females respectively).
Mineralization of the thyroid at the 5
mg/kg/day dose level was not
considered to be adverse.
Specific information on the studies
received and the nature of the adverse
effects caused by chlorate as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
titled ‘‘Risk Assessment of Tomato and
Cantaloupe Fumigation with Sodium
Chlorite 3.2% (chlorine dioxide gas) in
docket ID number EPA–HQ–OPP–2017–
0063.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological 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 NOAEL and 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 nonthreshold risks, the Agency assumes
that any amount of exposure will lead
to some degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints from the documents
referenced in section III, A, for chlorate
used for human risk assessment is
shown in Table 1.
TABLE 1—TOXICOLOGY ENDPOINTS FOR USE IN CHLORATE HUMAN HEALTH RISK ASSESSMENTS
Exposure/scenario
Point of
departure
Uncertainty/
FQPA safety
factors
RfD, PAD,
level of
concern for risk
assessment
Acute dietary (All populations, including infants and children, and
females 13—49 years of age).
Chronic dietary (All populations) ....
N/A ...................
N/A ...................
N/A ....................
RfD = cPAD =
0.17 mg/kg/
day.
UF = 30x (10x
intraspecies,
3x interspecies) FQPA
SF = 1x.
NOAEL = 5 mg/
kg/day.
Cancer (Oral, dermal, inhalation) ..
Study and toxicological effects
None of the available studies provided an endpoint of toxicity attributable to a single exposure.
2 year NTP Study (2005)—rat.
MRID 49683134.
LOAEL = 35/45 mg/kg/day (male/female) based
on changes in thyroid hormones after 3 weeks
(decreased T4, T3, & increased TSH), increased incidence of thyroid gland follicular cell
hypertrophy in males and females (after 3
weeks and 2 years).
The chronic reference dose will be protective of potential carcinogenicity.
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UF = uncertainty factor, FQPA SF = Special 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, MOE = margin of exposure, LOC = level of
concern, N/A = not applicable
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to chlorate, EPA considered
exposure under the petitioned-for
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tolerance and exemption as well as
existing exposures to chlorate. EPA
assessed dietary exposures from
chlorate in food as follows:
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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
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occurring as a result of a 1-day or single
exposure.
No such effects were identified in the
toxicological studies for chlorate;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA separately assessed the
components of chronic dietary exposure
and then aggregated them for assessing
chronic risk. For existing food crop
uses, EPA relied on the assessment of
food crop exposures contained in the
2006 Inorganic Chlorates Reregistration
Eligibility Document. For the
petitioned-for use on cantaloupe, EPA
based its assessment on the current
version of Dietary Exposure Evaluation
Model—Food Consumption Intake
Database—DEEM–FCIDTM (version
3.16), the food consumption data from
the 2003–2008 U.S. Department of
Agriculture’s National Health and
Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA),
and assumed 100 percent of the
cantaloupe crop treated. For the dietary
exposure resulting from use in paper
mills, EPA based its exposure
assessment on standard operating
procedure screening-level analyses
reported in the registration review
human health scoping document,
Inorganic Chlorates Human Health
Assessment Scoping Document in
Support of Registration Review.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to chlorate. Cancer risk was
assessed using the same exposure
estimates as discussed in Unit III.C.1. ii.
iv. Anticipated residue and Percent
Crop Treated (PCT) information. EPA
used anticipated residue information
and PCT estimates in the dietary food
assessment.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
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Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only
under the following conditions:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area and the exposure
estimate does not understate exposure
for the population in such area. In
addition, the Agency must provide for
periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for
existing uses for the chronic dietary
exposure assessment as follows: corn:
<1%; cotton (seed treatment): 5%; dry
beans/peas: <1%; flaxseed: <1%;
peppers (chili peppers): <1%; potatoes;
<1%; rice: 1%; safflower (seed
treatment): 2%; sorghum: <1%;
soybeans: 5%; soybeans (seed
treatment): <1%; sunflower (seed
treatment): <1%; sweet corn: <1%;
wheat: 1%; and wheat seed (seed
treatment): <1%. For crops not
specified, 100% PCT was used.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and
California Department of Pesticide
Regulation (CalDPR) Pesticide Use
Reporting (PUR) for the chemical/crop
combination for the most recent 10
years. EPA uses an average PCT for
chronic dietary risk analysis and a
maximum PCT for acute dietary risk
analysis. The average PCT figures for
each existing use are derived by
combining available public and private
market survey data for that use,
averaging across all observations, and
rounding up to the nearest 5%, except
for those situations in which the average
PCT is less than 1% or less than 2.5%.
In those cases, the Agency would use
less than 1% or less than 2.5% as the
average PCT value, respectively. The
maximum PCT figure is the highest
observed maximum value reported
within the most recent 10 years of
available public and private market
survey data for the existing use and
rounded up to the nearest multiple of
5%, except where the maximum PCT is
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less than 2.5%, in which case, the
Agency uses less than 2.5% as the
maximum PCT.
2. Dietary exposure from drinking
water. The estimated drinking water
concentration (EDWC) was obtained
from monitoring data gathered between
2013–2015 and are contained in the SixYear Review Technical Report for
Chlorate. For purposes of this
assessment, EPA used the median
concentration of 120 micrograms/liter.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). At this
time, there are no longer any registered
uses of chlorate that result in nonoccupational, residential exposures.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found inorganic chlorates
to share a common mechanism of
toxicity with any other substances, and
chlorate does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that chlorate does not have a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general, section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10x, or uses a different
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additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
No increased qualitative or quantitative
susceptibility in rats or rabbits was seen
in reproduction and developmental
studies with chlorate. Chlorate did not
cause developmental effects in rats at
doses up to 1,000 mg/kg/day or in
rabbits at doses up to 500 mg/kg/day.
No pre- or postnatal susceptibility was
observed in a reproduction study in rats.
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 chlorate is
adequate to characterize the potential
for prenatal or postnatal risk for infants
and children.
ii. There is no indication in the
available database that chlorate is a
neurotoxicant.
iii. There was no pre- or postnatal
sensitivity or susceptibility observed in
the submitted developmental studies in
rats and rabbits and the 2-generation
reproduction study in rats.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary assessment is based on a
conservative estimate of dietary
exposures and drinking water
monitoring data. These assessments will
not underestimate the exposure and
risks posed by chlorate.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, chlorate is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to chlorate from
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16:56 Dec 21, 2018
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food and water will utilize 8.4% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. There are no residential
pesticide uses for chlorate.
3. Short- and Intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Short- and intermediate-term adverse
effects were identified; however,
chlorate is not registered for any use
patterns that would result in either
short- or intermediate-term residential
exposure. Short- and intermediate-term
risk is assessed based on short- and
intermediate-term residential exposure
plus chronic dietary exposure. Because
there is no short- or intermediate-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess short- and
intermediate-term risk), no further
assessment of short- or intermediateterm risk is necessary, and EPA relies on
the chronic dietary risk assessment for
evaluating short- and intermediate-term
risk for chlorate.
4. Aggregate cancer risk for U.S.
population. A cancer aggregate
assessment was not conducted
separately, as the chronic aggregate
assessment is protective of cancer for
the general U.S. population. Based on
the results of the assessment of chronic
risk, the Agency concludes that
exposure to chlorate will not result in a
cancer risk of concern.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to chlorate
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. Response to Comments
Two comments were received in
response to the Notice of Filing, neither
of which raised issues related to the
safety of the tolerances in this action.
Because they raise issues outside the
scope of this rulemaking, the Agency is
not addressing them here.
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C. Revisions to Petitioned-For
Tolerances
The residue data indicate that
following use of the pesticide, there
were detectable chlorate residues on the
cantaloupe rind, although none were
detected in the edible portions of the
cantaloupe, and that chlorate residues
on tomato were indistinguishable from
background levels of chlorate on tomato.
Because EPA does not anticipate use on
either commodity to contribute to
dietary exposure, EPA is issuing an
exemption from the requirement of
tolerance residues on cantaloupe and
tomato. This tolerance exemption covers
potential residues in or on these
commodities as a result of direct
application and allows for the shipment
of these commodities in interstate
commerce.
V. Conclusion
An exemption from the requirement
of a tolerance is established for residues
of chlorate in or on tomato and
cantaloupe.
VI. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
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under FFDCA section 408(d) 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
amozie on DSK3GDR082PROD with RULES
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 30, 2018.
Anita Pease,
Acting Director, Antimicrobial Division,
Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
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16:56 Dec 21, 2018
Jkt 247001
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1364 to subpart D to read
as follows:
■
§ 180.1364 Chlorate; exemption from the
requirement of a tolerance.
Residues of chlorate in or on tomato
and cantaloupe are exempt from the
requirement of a tolerance when
resulting from the application of
gaseous chlorine dioxide as a fungicide,
bactericide, and antimicrobial pesticide.
[FR Doc. 2018–27908 Filed 12–21–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[EPA–R06–RCRA–2018–0395; FRL–9987–
30–Region 6]
Louisiana: Final Authorization of State
Hazardous Waste Management
Program Revision
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
On September 5, 2018, the
Environmental Protection Agency (EPA)
published a notice of proposed
rulemaking to approve a revision to the
State of Louisiana hazardous waste
program under the Resource
Conservation and Recovery Act (RCRA)
and provided for a thirty-day public
comment period. The public comment
period closed on October 5, 2018, and
EPA received fifteen comments. The
EPA has reviewed and analyzed all
submitted comments, and now issues
this final rule. After consideration of all
comments, EPA confirms that the
program revisions to the State of
Louisiana hazardous waste program
satisfy all requirements needed to
qualify for final authorization.
DATES: This final authorization is
effective December 26, 2018.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–R06–RCRA–2018–0395. All
documents in the docket are listed in
www.regulation.gov index. Although
listed in the index, some of the
information is not publicly available.
e.g., Confidential Business Information
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
SUMMARY:
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66143
copy. Publicly available docket
materials are available either
electronically through
www.regulation.gov or in hard copy.
You can view and copy Louisiana’s
application and associated publicly
available materials from 8:30 a.m. to
4:00 p.m., Monday through Friday, at
the following locations: Louisiana
Department of Environmental Quality,
602 N Fifth Street, Baton Rouge,
Louisiana 70884–2178, phone number
(225) 219–3559 and EPA, Region 6, 1445
Ross Avenue, Suite 1200, Dallas, Texas
75202–2733, phone number (214) 665–
8533.
FOR FURTHER INFORMATION CONTACT:
Alima Patterson, Region 6, Regional
Authorization/Codification Coordinator,
Permit Section (6MM–RP), Multimedia
Division, (214) 665–8533, EPA Region 6,
1445 Ross Avenue, Suite 1200, Dallas,
Texas 75202–2733, and Email address
patterson.alima@epa.gov.
SUPPLEMENTARY INFORMATION:
A. What revisions is EPA authorizing
with this action?
On March 13, 2018, LDEQ submitted
a final complete program revision
application seeking authorization of its
program revision in accordance with 40
CFR 271.21. EPA now makes a final
decision that LDEQ’s hazardous waste
program revisions satisfy all the
requirements necessary to qualify for
final authorization. EPA will continue
to implement and enforce Hazardous
and Solid Waste Amendments of 1984
(HSWA) provisions for which the State
is not authorized. For a list of rules that
become effective with this Final Rule,
please see the Proposed Rulemaking
published in the September 5, 2018,
Federal Register at 83 FR 45061.
B. What were the comments and
responses to EPA’s proposal?
EPA received fifteen comments.
Twelve comments were supportive of
EPA to grant the State of Louisiana
portions of the Subtitle C Hazardous
Waste Management Program and two
were irrelevant to the proposed
rulemaking. EPA received a written
adverse comment from TD*X Associates
LP, Beaumont Texas, (TD*X) requesting
that EPA not authorize the State of
Louisiana to implement the regulatory
provisions commonly known as the
‘‘Verified Recycler Exemption,’’ or
‘‘VRE.’’ EPA received only one adverse
comment, from TD*X, opposing EPA’s
proposal to authorize revisions to
Louisiana’s hazardous waste
regulations. The full set of comments
can be found in the docket for this
action. The commenter asserts that the
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]]>Agencies
[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66138-66143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27908]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0063; FRL-9986-85]
Chlorate; Pesticide Exemptions From Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of chlorate in or on cantaloupe and tomato
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 26, 2018. Objections and
requests for hearings must be received on or before February 25, 2019
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0063, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: ADFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0063 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 25, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0063, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online
[[Page 66139]]
instructions for submitting comments. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Exemptions
In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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
4F8325) by ICA Trinova, Inc., 1 Beavers Street, Suite B, Newnan, GA
30263. The petition requested that EPA (1) establish a tolerance for
residues of chlorate in or on cantaloupes at 1.5 parts per million
(ppm), and (2) establish an exemption from the requirement of a
tolerance for residues of chlorate in or on tomatoes. Chlorate is a by-
product of chlorine dioxide, which is generated from the active
ingredient, sodium chlorite, when it is applied via fumigation to
tomatoes and cantaloupes post- harvest, during storage and shipment.
The Agency reviewed submitted residue chemistry data for chlorine
dioxide and chlorate. Given that residues for chlorine dioxide were not
detected and only residues of chlorate were quantified, EPA has
determined that tolerance exemptions are appropriate for chlorate on
both tomatoes and cantaloupes.
A summary of the petition prepared by ICA Trinova Inc., the
petitioner and registrant is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing;
the Agency's response to these comments is located in Unit IV.B. of
this document. For reasons explained in Unit IV.C., EPA is establishing
an exemption from the requirement of a tolerance for residues of
chlorate in or on cantaloupe and tomato.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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(c)(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. In making this safety determination, EPA must
take into consideration the factors laid out in section 408(b)(2)(C)
and (D). Specifically, 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 therein, 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 chlorate including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with chlorate 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.
Sodium chlorite is the active ingredient that is applied to the
tomatoes and cantaloupe. Once applied, it is activated by a weak acid,
creating gaseous chlorine dioxide. As chlorine dioxide is released, it
also produces the byproduct, chlorate. Based on submitted residue data,
the only residues of the pesticide with the potential for being present
on food commodities are chlorate ions; therefore, the Agency assessed
the safety of aggregate exposure to chlorate in support of this
tolerance action.
Inorganic chlorates (also known as chlorate salts) encompass all
chlorates including the most abundant salt, sodium chlorate. Toxicology
data relevant to the human health risk assessment are summarized here
and more information about the toxicology data and references can be
found in the Risk Assessment of Tomato and Cantaloupe Fumigation with
Sodium Chlorite 3.2% (chlorine dioxide gas) and Inorganic Chlorates
Human Health Assessment Scoping Document in Support of Registration
Review (Docket ID No. EPA-HQ-OPP-2016-0080-0008) both of which can be
found in the docket for this action at https://www.regulations.gov.
The hazard database indicates that the thyroid is the primary
target organ of chlorate. Effects observed in subchronic and chronic
toxicity studies show increased thyroid gland weights, colloid
depletion, decreases in triiodothyronine (T3) and thyroxine (T4)
accompanied by increases in thyroid stimulating hormone (TSH),
increased incidence of thyroid follicular cell hypertrophy, thyroid
cell mineralization, follicular cell hyperplasia, and adenomas or
carcinomas in rat studies. Other effects include hematological changes
(hemoglobin concentration, hematocrit, decreased red blood counts
(RBC), and increased reticulocyte counts in females), methemoglobin
concentration changes, and pituitary vacuolization in subchronic
studies starting at doses 10-fold higher than where thyroid effects are
observed.
In a 2-year drinking water study, there was some evidence of
thyroid gland follicular cell tumors in male rats; however, because
chlorate is not mutagenic and these tumors were only seen at high
doses, chlorate is not likely to be carcinogenic since the chronic
reference dose is below the dose at which alteration of thyroid hormone
homeostasis occurs. Moreover, although there was equivocal and marginal
evidence of increased pancreatic islet carcinoma in female mice, the
Agency has concluded that the selected chronic reference dose is
protective of these potential cancer effects.
No increased qualitative or quantitative susceptibility in rats or
rabbits was seen in reproduction and developmental studies with
chlorate. Chlorate did not cause developmental effects in rats at doses
up to the limit dose (1,000 mg/kg/day) or in rabbits up to half the
limit dose. Although chlorate has not been evaluated for neurotoxic
effects, acute and subchronic toxicity studies do not indicate any
neurotoxic potential. In a 2-generation reproduction toxicity study,
increased absolute and relative thyroid weight and increased incidence
of slight to moderate hyperactivity of the thyroid glands were reported
in parental and adult F1 males and females at doses 14x higher than the
[[Page 66140]]
thyroid effects identified in the adult rat subchronic and chronic
studies.
The chronic oral toxicity of chlorate was examined in a study
conducted by the National Toxicology Program (NTP). In this study,
Fischer 344 rats (50/sex/group) were exposed to drinking water
containing 0, 125, 1,000, or 2,000 mg/L chlorate for 2 years
(equivalent to 5/5, 35/45, and 75/95 mg/kg/day (males/females)). T4 and
T3 levels were significantly reduced at 35 and 75 mg/kg/day on day 4,
and in 75 mg/kg/day males and females at week 3. TSH was significantly
increased in 35 and 75 mg/kg/day males on day 4 and at week 3, in 35
and 75 mg/kg/day females on day 4, in 75 mg/kg/day females at week 3,
and in 75 mg/kg/day males and females at week 13. At the high dose,
increased incidences of thyroid gland follicular cell carcinoma were
seen in male rats (incidence: 4/47) compared to none in controls, and
of thyroid gland follicular cell adenoma or carcinoma (combined) in
males (incidence: 6/47) and females (incidence: 4/46) compared to one
animal in controls of both sexes. The incidences of thyroid gland
follicular cell hypertrophy were significantly increased in mid- and
high-dose groups of males (33/43 and 40/47 vs. 4/47 in control) and
females (3/47, 7/47, 27/43, 42/46 vs. 3/47 in control).
In the Agency's 2006 risk assessment for inorganic chlorates,
Revised Inorganic Chlorates. HED Chapter of the Reregistration
Eligibility Decision Document (RED) (Docket ID No. EPA-HQ-OPP-2005-
0507-0004) a lower 95% confidence limit of the benchmark dose (BMDL) of
0.9 mg/kg/day was derived, based on thyroid gland follicular cell
hypertrophy at the 5 mg/kg/day dose from the rat chronic cancer study
(NTP, 2005). EPA has re-considered the data and determined that the
original benchmark dose derived from the study was not sufficiently
supported as an effect level at 5 mg/kg/day, and that the 5 mg/kg/day
dose can be supported as a NOAEL for the study. The point of departure
(POD) for chronic dietary (all populations) exposures is thus the 5 mg/
kg/day dose, based on changes in thyroid hormones (decreased T3,
decreased T4, and increased TSH), and increased incidence of thyroid
follicular cell hypertrophy in male and female rats at the next highest
dose of 35/45 mg/kg/day (males and females respectively).
Mineralization of the thyroid at the 5 mg/kg/day dose level was not
considered to be adverse.
Specific information on the studies received and the nature of the
adverse effects caused by chlorate as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled ``Risk Assessment of Tomato
and Cantaloupe Fumigation with Sodium Chlorite 3.2% (chlorine dioxide
gas) in docket ID number EPA-HQ-OPP-2017-0063.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological 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
NOAEL and the LOAEL. Uncertainty/safety factors are used in conjunction
with the POD to calculate a safe exposure level--generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints from the documents
referenced in section III, A, for chlorate used for human risk
assessment is shown in Table 1.
Table 1--Toxicology Endpoints for Use in Chlorate Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
RfD, PAD,
Uncertainty/ level of
Exposure/scenario Point of FQPA safety concern for Study and toxicological
departure factors risk effects
assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All N/A............ N/A............ N/A............ None of the available studies
populations, including provided an endpoint of
infants and children, and toxicity attributable to a
females 13--49 years of age). single exposure.
Chronic dietary (All RfD = cPAD = UF = 30x (10x NOAEL = 5 mg/kg/ 2 year NTP Study (2005)--rat.
populations). 0.17 mg/kg/day. intraspecies, day. MRID 49683134.
3x LOAEL = 35/45 mg/kg/day (male/
interspecies) female) based on changes in
FQPA SF = 1x. thyroid hormones after 3
weeks (decreased T4, T3, &
increased TSH), increased
incidence of thyroid gland
follicular cell hypertrophy
in males and females (after 3
weeks and 2 years).
----------------------------------------------------------------------------------
Cancer (Oral, dermal, The chronic reference dose will be protective of potential carcinogenicity.
inhalation).
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special 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, MOE = margin of exposure, LOC = level of concern, N/A = not applicable
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorate, EPA considered exposure under the petitioned-for
tolerance and exemption as well as existing exposures to chlorate. EPA
assessed dietary exposures from chlorate 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
[[Page 66141]]
occurring as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
chlorate; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA separately assessed the components of chronic dietary
exposure and then aggregated them for assessing chronic risk. For
existing food crop uses, EPA relied on the assessment of food crop
exposures contained in the 2006 Inorganic Chlorates Reregistration
Eligibility Document. For the petitioned-for use on cantaloupe, EPA
based its assessment on the current version of Dietary Exposure
Evaluation Model--Food Consumption Intake Database--DEEM-
FCIDTM (version 3.16), the food consumption data from the
2003-2008 U.S. Department of Agriculture's National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA),
and assumed 100 percent of the cantaloupe crop treated. For the dietary
exposure resulting from use in paper mills, EPA based its exposure
assessment on standard operating procedure screening-level analyses
reported in the registration review human health scoping document,
Inorganic Chlorates Human Health Assessment Scoping Document in Support
of Registration Review.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to chlorate. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1. ii.
iv. Anticipated residue and Percent Crop Treated (PCT) information.
EPA used anticipated residue information and PCT estimates in the
dietary food assessment.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only under the following conditions:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area and the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for existing uses for the chronic
dietary exposure assessment as follows: corn: <1%; cotton (seed
treatment): 5%; dry beans/peas: <1%; flaxseed: <1%; peppers (chili
peppers): <1%; potatoes; <1%; rice: 1%; safflower (seed treatment): 2%;
sorghum: <1%; soybeans: 5%; soybeans (seed treatment): <1%; sunflower
(seed treatment): <1%; sweet corn: <1%; wheat: 1%; and wheat seed (seed
treatment): <1%. For crops not specified, 100% PCT was used.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use are derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
2. Dietary exposure from drinking water. The estimated drinking
water concentration (EDWC) was obtained from monitoring data gathered
between 2013-2015 and are contained in the Six-Year Review Technical
Report for Chlorate. For purposes of this assessment, EPA used the
median concentration of 120 micrograms/liter.
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). At this time, there
are no longer any registered uses of chlorate that result in non-
occupational, residential exposures.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found inorganic chlorates to share a common mechanism
of toxicity with any other substances, and chlorate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
chlorate does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general, section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different
[[Page 66142]]
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. No increased qualitative or
quantitative susceptibility in rats or rabbits was seen in reproduction
and developmental studies with chlorate. Chlorate did not cause
developmental effects in rats at doses up to 1,000 mg/kg/day or in
rabbits at doses up to 500 mg/kg/day. No pre- or postnatal
susceptibility was observed in a reproduction study in rats.
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 chlorate is adequate to characterize
the potential for prenatal or postnatal risk for infants and children.
ii. There is no indication in the available database that chlorate
is a neurotoxicant.
iii. There was no pre- or postnatal sensitivity or susceptibility
observed in the submitted developmental studies in rats and rabbits and
the 2-generation reproduction study in rats.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary assessment is based on a conservative estimate
of dietary exposures and drinking water monitoring data. These
assessments will not underestimate the exposure and risks posed by
chlorate.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
chlorate is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
chlorate from food and water will utilize 8.4% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential pesticide uses for chlorate.
3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Short- and intermediate-term adverse effects were identified;
however, chlorate is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short- and intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for chlorate.
4. Aggregate cancer risk for U.S. population. A cancer aggregate
assessment was not conducted separately, as the chronic aggregate
assessment is protective of cancer for the general U.S. population.
Based on the results of the assessment of chronic risk, the Agency
concludes that exposure to chlorate will not result in a cancer risk of
concern.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to chlorate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Response to Comments
Two comments were received in response to the Notice of Filing,
neither of which raised issues related to the safety of the tolerances
in this action. Because they raise issues outside the scope of this
rulemaking, the Agency is not addressing them here.
C. Revisions to Petitioned-For Tolerances
The residue data indicate that following use of the pesticide,
there were detectable chlorate residues on the cantaloupe rind,
although none were detected in the edible portions of the cantaloupe,
and that chlorate residues on tomato were indistinguishable from
background levels of chlorate on tomato. Because EPA does not
anticipate use on either commodity to contribute to dietary exposure,
EPA is issuing an exemption from the requirement of tolerance residues
on cantaloupe and tomato. This tolerance exemption covers potential
residues in or on these commodities as a result of direct application
and allows for the shipment of these commodities in interstate
commerce.
V. Conclusion
An exemption from the requirement of a tolerance is established for
residues of chlorate in or on tomato and cantaloupe.
VI. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition
[[Page 66143]]
under FFDCA section 408(d) 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: November 30, 2018.
Anita Pease,
Acting Director, Antimicrobial 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. Add Sec. 180.1364 to subpart D to read as follows:
Sec. 180.1364 Chlorate; exemption from the requirement of a
tolerance.
Residues of chlorate in or on tomato and cantaloupe are exempt from
the requirement of a tolerance when resulting from the application of
gaseous chlorine dioxide as a fungicide, bactericide, and antimicrobial
pesticide.
[FR Doc. 2018-27908 Filed 12-21-18; 8:45 am]
BILLING CODE 6560-50-P
