Document ID: EPA-HQ-OPP-2015-0697-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Monoethanolamine
Posted Date: 2017-04-12T04:00Z

[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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 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
----------------------------------------------------------------------------------------------------------------
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).
                                  ------------------------------------------------------------------------------
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........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Based on a Derek structural alert analysis and the lack of mutagenicity,
                                            monoethanolamine is considered not likely to be carcinogenic.
----------------------------------------------------------------------------------------------------------------

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