[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Rules and Regulations]
[Pages 17563-17569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07130]
[[Page 17563]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0697; FRL-9949-11]
Monoethanolamine; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of monoethanolamine (CAS Reg. No. 141-43-5)
when used as an inert ingredient (solvent) in pesticides applied to
growing crops and raw agricultural commodities after harvest limited to
a maximum concentration of 3.35% by weight in the pesticide
formulation. Technology Sciences Group Inc., on behalf of Doosan
Corporation, submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting establishment of an exemption from
the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of monoethanolamine
when used in accordance with the approved concentrations.
DATES: This regulation is effective April 12, 2017. Objections and
requests for hearings must be received on or before June 12, 2017, 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-2015-0697, 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, 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 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-2015-0697 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
June 12, 2017. 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-2015-0697, 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. Petition for Exemption
In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10839) by Technology Sciences Group Inc. (1150 18th Street NW., Suite
1000, Washington, DC 20036) on behalf of Doosan Corporation (864 B/5F,
Aict, 864-1, lui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-284,
Republic of Korea). The petition requested that 40 CFR 180.910 be
amended by establishing an exemption from the requirement of a
tolerance for residues of monoethanolamine (CAS Reg. No. 141-43-5) when
used as an inert ingredient (solvent) in pesticide formulations applied
to growing crops and raw agricultural commodities after harvest. That
document referenced a summary of the petition prepared by Technology
Sciences Group Inc. on behalf of Doosan Corporation, the petitioner,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
limited the maximum concentration of monoethanolamine to 3.35% by
weight in pesticide formulations. The reason for this change is
explained in Unit V.B. below.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
[[Page 17564]]
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 monoethanolamine including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with monoethanolamine
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by monoethanolamine 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.
The acute oral and dermal toxicities are low in rats and rabbits
for monoethanolamine. The lethal dose (LD50s) are >1,000
milligram/kilogram (mg/kg) in acute oral and dermal studies in the rat
and rabbit, respectively. Monoethanolamine is irritating to the skin at
1%, very irritating at >1% and corrosive at 10% in the rabbit. It is
corrosive to the eyes in rabbits. Acute inhalation toxicity is low; the
LD50 is >1.3 milligram/liter. It is not a dermal sensitizer
in the guinea pig maximization test or in the mouse local lymph node
assay.
Subchronic exposure to rats administered monoethanolamine via the
diet causes increases liver and kidney weights at 640 mg/kg/day. The
NOAEL is 320 mg/kg/day.
Monoethanolamine did not cause developmental nor maternal effects
up to 450 mg/kg/day, the highest dose tested, in a developmental
toxicity study via gavage in rats.
In developmental studies via dermal exposure, maternal toxicity
(irritation, necrosis, scabbing and scar formation) is observed in rats
at 225 mg/kg/day. Developmental toxicity in rats is not observed at 225
mg/kg/day, the highest dose tested. In rabbits, maternal toxicity (skin
irritation, necrosis, scabbing and scar formation) and developmental
toxicity (reduced body weight) are observed at 75 mg/kg/day. The NOAEL
is 25 mg/kg/day.
Parental, reproduction and offspring toxicities are observed at the
limit dose, 1,000 mg/kg/day. Toxicity is manifested as decreased sperm
head count in the cauda epididymidis; decreased absolute and relative
weight of epididymides, cauda epididymidis and prostate; fewer
implantation sites; higher post-implantation loss; and smaller litters
in F0 and/or F1 animals. The parental, reproduction and offspring
NOAELs are 300 mg/kg/day.
A chronic study conducted with a mixture containing 22%
monoethanolamine is available in the dog. Monoethanolamine administered
via the diet did not cause adverse effects up to 97.5 mg/kg/day
(adjusted dose, 21.45 mg/kg/day, the highest dose tested.
Carcinogenicity studies with monoethanolamine are not available.
However, a Derek Nexus structural alert analysis was conducted with
monoethanolamine and indicated no structural alerts for carcinogenicity
or mutagenicity. Therefore, monoethanolamine is not expected to be
carcinogenic.
Monoethanolamine is negative in an Ames test, chromosomal
aberrations, sister chromosome exchange and micronucleus assay and
chromosomal aberration test. It is weakly positive in the micronucleus
assay. However, based on the overall weight of evidence,
monoethanolamine is not considered mutagenic.
Monoethanolamine administered as a vapor or liquid aerosol for 28
days causes severe lesions in the larynx, minimal to mild lesions in
the nasal cavity, and minimal to mild signs of irritation in the
trachea and bronchiolar epithelia at 50 mg/cubic meter (m3)
(15.5 mg/kg/day). The NOAEL is 10 mg/m\3\ (3.1 mg/kg/day).
Clinical signs of neurotoxicity were observed in dogs and rats via
oral and inhalation routes exposure. In an inhalation toxicity study
conducted in 1960, initial excitation followed by central nervous
system depression was observed in dogs exposed to continuous vapors at
12-26 parts per million (ppm) for 24 hours/day, 7 days/week for 90
days. However, these observations in dogs are considered due to the
exposure regime rather than neurotoxic effects. In the same study, rats
continuously exposed to 5 ppm of monoethanolamine displayed lethargy
after 2 to 3 weeks of exposure. However, a more recent guideline study
showed that rats exposed to monoethanolamine via
[[Page 17565]]
inhalation for 28-days did not show central nervous system excitation,
depression or lethargy. In this study, salivation was the only effect
observed that suggested potential neurotoxicity but was not considered
a neurotoxic effect because it is likely due to the severely irritating
properties of monoethanolamine as it enters the nasal pharynx region.
In a developmental toxicity study in rats, lethargy, decreased response
to light cage ``tap'', increased activity and agitation were observed
at 500 mg/kg/day. Conversely, these effects were not reproduced in an
OECD guideline 2-generation reproductive toxicity study at doses up to
1,000 mg/kg/day. In another study, rats administered a single dose
monoethanolamine via intraperitoneal injection experienced a reduction
in brain (16.5%) and red blood cell (24.8%) cholinesterase levels when
compared to controls. In the same study, acetylcholinesterase activity
was inhibited in isolated rat brain homogenate following exposure to
3665 microgram/milliliter (ug/ml) 2-aminoethanolamine. However, the
effects in both studies are seen at doses (3320 mg/kg) well
above the limit dose, 1,000 mg/kg/day. Based on the overall weight of
evidence from the available studies, EPA concluded that
monoethanolamine is not neurotoxic.
Immunotoxicity studies are not available for review. However,
evidence of immunotoxicity is not observed in the submitted studies.
Monoethanolamine is rapidly absorbed and metabolized. Following
dermal or oral exposure, it is metabolized to acetaldehyde and ammonia.
The reaction is catalyzed by ethanolamine deaminase and further degrade
to CO2 via the formation of ethanolamine-O-phosphate. In
rats, the liver was the most active site of metabolism.
Monoethanolamine in the liver is methylated to choline and converted to
serine which in turn is made into hepatic proteins. In mice, urinary
metabolites are urea and glycine, along with smaller concentrations of
serine, monoethanolamine, choline and uric acid. Similarly, in rats,
urinary metabolites include urea, hippuric acid and uric acid. Dermal
absorption is estimated to be 60%.
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 monoethanolamine used
for human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Monoethanolamine for Use in Human Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-50 An acute effect was not found in the database therefore an acute dietary
years of age and General assessment is not necessary.
population including infants and
children).
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Chronic dietary (All populations) NOAEL = 300 mg/kg/ Chronic RfD = 3.00 Two-generation Reproduction
day. mg/kg/day. Toxicity Study-Rat
UFA = 10x........... cPAD = 3.00 mg/kg/ LOAEL = 1,000 mg/kg/day based on
day. decreased sperm head count in the
cauda epididymidis; decreased
absolute and relative weight of
epididymides, cauda epididymidis
and prostate; fewer implantation
sites; higher post-implantation
loss; and smaller litters in F1
and F2
UFH = 10x...........
FQPA SF = 1x........
Incidental oral short-term (1 to NOAEL = 300 mg/kg/ LOC for MOE = 100.. Two-generation Reproduction
30 days). day. Toxicity Study-Rat
UFA = 10x........... LOAEL = 1,000 mg/kg/day based on
decreased sperm head count in the
cauda epididymidis; decreased
absolute and relative weight of
epididymides, cauda epididymidis
and prostate; fewer implantation
sites; higher post-implantation
loss; and smaller litters in F1
and F2
UFH = 10x...........
FQPA SF = 1x........
Incidental oral intermediate-term NOAEL = 300 mg/kg/ LOC for MOE = 100.. Two-generation Reproduction
(1 to 6 months). day. Toxicity Study-Rat
[[Page 17566]]
UFA = 10x........... LOAEL = 1,000 mg/kg/day based on
decreased sperm head count in the
cauda epididymidis; decreased
absolute and relative weight of
epididymides, cauda epididymidis
and prostate; fewer implantation
sites; higher post-implantation
loss; and smaller litters in F1
and F2
UFH = 10x...........
FQPA SF = 1x........
Dermal short-term (1 to 30 days). NOAEL = 25 mg/kg/day LOC for MOE = 100.. Developmental Toxicity Study-
Dermal-Rabbit
UFA = 10x........... LOAEL = 75 mg/kg/day based on skin
irritation, progressing from
erythema to necrosis, scabbing
and scar formation.
UFH = 10x...........
FQPA SF = 1x........
Dermal intermediate-term (1 to 6 NOAEL = 25 mg/kg/day LOC for MOE = 100.. Developmental Toxicity Study-
months). Dermal-Rabbit
UFA = 10x........... LOAEL = 75 mg/kg/day based on skin
irritation, progressing from
erythema to necrosis, scabbing
and scar formation.
UFH = 10x...........
FQPA SF = 1x........
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100.. 28 Day Inhalation Toxicity Study-
days). study NOAEL= 10 mg/ Rat
m\3\ (equivalent to
3.1 mg/kg/day
(inhalation
absorption rate =
100%).
UFA = 10x........... LOAEL = 50 mg/m\3\ (equivalent to
15.5 mg/kg/day) based on local
effects in the larynx, trachea
and lungs.
UFH = 10x...........
FQPA SF = 1x........
Inhalation intermediate-(1 to 6 Inhalation (or oral) LOC for MOE = 100.. 28 Day Inhalation Toxicity Study-
months). study NOAEL= 10 mg/ Rat
m\3\ (equivalent to
3.1 mg/kg/day
(inhalation
absorption rate =
100%).
UFA = 10x........... LOAEL = 50 mg/m\3\ (equivalent to
15.5 mg/kg/day) based on local
effects in the larynx, trachea
and lungs.
UFH = 10x...........
FQPA SF = 1x........
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Cancer (Oral, dermal, inhalation) Based on a Derek structural alert analysis and the lack of mutagenicity,
monoethanolamine is considered not likely to be carcinogenic.
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C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to monoethanolamine, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from monoethanolamine in food as follows:
Dietary exposure (food and drinking water) to monoethanolamine can
occur following ingestion of foods with residues from treated crops.
Because no adverse effects attributable to a single exposure of
monoethanolamine are seen in the toxicity databases, an acute dietary
risk assessment is not necessary. For the chronic dietary risk
assessment, EPA used the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID TM,
Version 3.16, and food consumption information from the U.S. Department
of Agriculture's (USDA's) 2003-2008 National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, no residue data were submitted for
monoethanolamine. In the absence of specific residue data, EPA has
developed an approach which uses surrogate information to derive upper
bound exposure estimates for the subject inert ingredient. Upper bound
exposure estimates are based on the highest tolerance for a given
commodity from a list of high use insecticides, herbicides, and
fungicides. One hundred percent crop treated was assumed, default
processing factors, and tolerance-level residues for all foods and use
limitations of not more than 3.35% by weight in pesticide formulations.
A complete description of the general approach taken to assess inert
ingredient risks in the absence of residue data is contained in the
memorandum entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): Acute
and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and
Risk Assessments for the Inerts,'' (D361707, S. Piper, 2/25/09) and can
be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2008-0738.
2. Dietary exposure from drinking water. For the purpose of the
screening-level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for monoethanolamine, a
conservative drinking water concentration value of
[[Page 17567]]
100 parts per billion (ppb) based on screening level modeling was used
to assess the contribution to drinking water for the chronic dietary
risk assessments for 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., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Monoethanolamine may be used as an inert ingredient in pesticide
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
For residential handlers, the Agency assumed handlers may receive
short-term dermal and inhalation exposure to monoethanolamine from
formulations containing the inert ingredient in outdoor and indoor
scenarios. Intermediate-term or long-term exposure is not expected
because applications are not expected to occur daily or for more than
30 days. For post-application exposures to monoethanolamine in
pesticide formulations, the Agency assumed short-term dermal exposures
to adults from use on treated lawns and indoor surfaces and short-term
and intermediate-term dermal and oral exposures to children from
treated lawns, soils, and indoor surfaces. Since monoethanolamine is
not expected to be used as an inert ingredient in pesticide aerosol
products such as total release insecticide foggers, and given the fact
that monoethanolamine has a low vapor pressure (<1 mm Hg), it is not
expected to volatilize in indoor environments; therefore, post-
application inhalation exposure is not expected. A conservative
residential exposure and risk assessment was completed for pesticide
products containing monoethanolamine as inert ingredients.
Monoethanolamine is also present in cosmetics. Although the Agency
does not have data with which to quantitatively assess exposures that
result from these non-pesticidal (i.e., cosmetic) uses of
monoethanolamine, the Agency expects that the exposures to amounts of
monoethanolamine that might result from these uses are markedly less
than the conservative estimates of residential exposures resulting from
pesticide use and will not add any meaningful exposure to the Agency's
assessments of residential exposure from pesticide use. This is based
on the typical reported concentration ranges for monoethanolamine in
cosmetics, pesticidal products and the specific use patterns and
anticipated likely exposure levels, including the fact that cosmetics
products with monoethanolamine are designed for discontinuous, brief
use followed by thorough rinsing from the surface of the skin.
Therefore, the Agency believes that any contribution to aggregate
exposure from these non-pesticidal uses is likely to be negligible and
therefore, the assessments of exposures due to pesticide uses are
protective of non-pesticidal 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 monoethanolamine to share a common mechanism of
toxicity with any other substances, and monoethanolamine does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
monoethanolamine 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
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
The toxicity database for monoethanolamine contains a subchronic,
developmental, two-generation reproduction, chronic and mutagenicity
studies. There is no indication of immunotoxicity in the available
studies; therefore, there is no need to require an immunotoxicity
study. Fetal susceptibility is not observed in the developmental or
reproduction toxicity studies in rats. Reproduction toxicity (decreased
sperm head count in the cauda epididymidis; decreased absolute and
relative weight of epididymides, cauda epididymidis and prostate; fewer
implantation sites; higher post-implantation loss) is observed at the
limit dose (1,000 mg/kg/day) only. Fetal toxicity (reduced body weight)
is observed in the developmental toxicity study via the dermal route of
exposure in the rabbits. However, the effect occurs in the presence of
maternal toxicity (skin irritation, necrosis, scabbing and scar
formation). As described in detail above, signs of potential
neurotoxicity are observed in dogs and rats when exposed to
monoethanolamine via inhalation and intraperitoneally. However, based
on the overall weight of evidence from the available studies, EPA
concluded that monoethanolamine is not neurotoxic. In addition, the
Agency used conservative exposure estimates, with 100 percent crop
treated, tolerance-level residues, conservative drinking water modeling
numbers, and a conservative assessment of potential residential
exposure for infants and children. Based on the adequacy of the
toxicity, the conservative nature of the exposure assessment and the
lack of concern for prenatal and postnatal sensitivity, the Agency has
concluded that there is reliable data to determine that infants and
children will be safe if the FQPA SF of 10x is reduced to 1x.
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.
2. Chronic risk. Using the exposure assumptions described in this
unit for
[[Page 17568]]
chronic exposure, EPA has concluded that chronic exposure to
monoethanolamine from food and water will utilize 1.7% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
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).
Monoethanolamine may be used as an inert ingredient in pesticide
products that could result in short-term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to monoethanolamine. Using the exposure assumptions described above,
EPA has concluded that the combined short-term aggregated food, water,
and residential exposures result in MOEs of 182 for both adult males
and females. Adult residential exposure combines high-end dermal and
inhalation handler exposure from liquids/trigger sprayer/home garden
with a high-end post-application dermal exposure from contact with
treated lawns. EPA has concluded the combined short-term aggregated
food, water, and residential exposures result in an aggregate MOE of
400 for children. Children's residential exposure includes total
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). As the level of concern is for MOEs that are lower
than 100, these MOEs are not of concern.
Monoethanolamine is also present in some cosmetics, intended for
discontinuous, brief use, followed by thorough rinsing from the surface
of the skin. In the absence of actual residential exposure data
resulting from such uses, the Agency considered information on the
typical concentrations of monoethanolamine in cosmetics as well as
typical use and likely exposures. Based on that review, the Agency
believes the contribution from non-pesticidal (i.e., cosmetic) sources
of monoethanolamine is likely to be insignificant compared to the
exposures conservatively estimated to occur as a result of the use of
monoethanolamine as an inert ingredient in pesticide formulations and
that the assessments of aggregate exposures due to pesticide uses more
than adequately protect for exposure from non-pesticidal uses.
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).
Monoethanolamine may be used as an inert ingredient in pesticide
products that could result in intermediate-term residential exposure
and the Agency has determined that it is appropriate to aggregate
chronic exposure through food and water with intermediate-term
residential exposures to monoethanolamine. Using the exposure
assumptions described above, EPA has concluded that the combined
intermediate-term aggregated food, water, and residential exposures
result in aggregate MOEs of 1310 for adult males and females. Adult
residential exposure combines liquids/trigger sprayer/home garden with
a high-end post-application dermal exposure from contact with treated
lawns. EPA has concluded the combined intermediate-term aggregated
food, water, and residential exposures result in an aggregate MOE of
742 for children. Children's residential exposure includes total
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). As the level of concern is for MOEs that are lower
than 100, this MOE is not of concern.
Monoethanolamine is also present cosmetics. In the absence of
actual residential exposure data resulting from such uses, the Agency
considered information on the typical concentrations of
monoethanolamine in cosmetics as well as typical use and likely
exposures. Based on that review, the Agency believes the contribution
from non-pesticidal sources of monoethanolamine is likely to be
negligible and that the assessments of aggregate exposures due to
pesticide uses more than adequately protect for exposure from non-
pesticidal uses.
5. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis, the lack of mutagenicity and the lack of
specific organ toxicity in the chronic toxicity study, monoethanolamine
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 monoethanolamine.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
monoethanolamine in or on any food commodities. EPA is establishing a
limitation on the amount of monoethanolamine that may be used in
pesticide formulations applied to growing crops. That limitation will
be enforced through the pesticide registration process under the
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7
U.S.C. 136 et seq. EPA will not register any pesticide formulation for
use on growing crops for sale or distribution that exceeds 3.35% by
weight of monoethanolamine.
B. Revisions to Petitioned-For Tolerances
Based upon an evaluation of the data included in the petition, EPA
is establishing an exemption from the requirement of a tolerance for
residues of monoethanolamine when used in pesticide formulations as an
inert ingredient (solvent/co-solvent), not to exceed 3.35% by weight of
the formulation, instead of the unlimited use requested. Because
unlimited use of monoethanolamine resulted in aggregate risks of
concern, the EPA is establishing a 3.35% limitation by weight of
formulation to support the safety finding of this tolerance exemption.
The concern for unlimited use of this inert ingredient is documented on
page 5 of the Agency's risk assessment document ``Monoethanolamine;
Human Health Risk Assessment and Ecological Effects Assessment to
Support Proposed Exemption from the Requirement of a Tolerance When
Used as an Inert Ingredient in Pesticide Formulations,'' which can be
found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2015-0697.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for residues of monoethanolamine (CAS
Reg. No. 141-43-5) when used as an inert ingredient (solvent/co-
solvent) at a maximum concentration of 3.35% by weight in pesticide
formulations applied to growing crops or raw agricultural commodities
after harvest.
VII. Statutory and Executive Order Reviews
This action establishes an exemption to the requirement for 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
[[Page 17569]]
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 exemption 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).
VIII. 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: March 7, 2017.
Michael Goodis,
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. 180.910, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Monoethanolamine (CAS Reg. No. Not to exceed 3.35% by Solvent.
141-43-5). weight in pesticide
formulation.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2017-07130 Filed 4-11-17; 8:45 am]
BILLING CODE 6560-50-P