Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10983 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0364; FRL–9534–01– 

OCSPP] 

Fatty Acids, Esters With Ethoxylated 

Triethanolamine; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of fatty acids, talloil, esters with triethanolamine, 

ethoxylated (CAS Reg No. 68605–38–9) 

and fatty acids, C8–18 and C18-unsatd., 

esters with polyethylene glycol ether 

with triethanolamine (3:1) (CAS Reg No. 

2464873–19–4) (herein referred to 

20ETO and 10ETO, respectively) when 

used as inert ingredients (surfactant) in 

pesticide formulations applied to 

growing crops pre- and post-harvest, not 

to exceed 10% in the final pesticide 

formulation. Exponent, Inc. on behalf of 

Lamberti USA, Incorporated 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 20ETO 

and 10ETO. 

DATES: This regulation is effective 

February 28, 2022. Objections and 

requests for hearings must be received 

on or before April 29, 2022, 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–2021–0364, 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. Due to the 

public health concerns related to 

COVID–19, the EPA Docket Center 

(EPA/DC) and Reading Room is open to 

visitors by appointment only. For the 

latest status information on EPA/DC 

services and access, visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, 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 Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

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–2021–0364 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 April 

29, 2022. 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– 

2021–0364, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://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 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. Petition for Exemption 

In the Federal Register of August 3, 

2021 (86 FR 41809) (FRL–8792–01), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–11506) by Exponent, 

Inc. (1150 Connecticut Ave., Suite 1100, 

Washington, DC 20036) on behalf of 

Lamberti USA, Incorporated (P.O. Box 

1000, Hungerford, TX 77448). The 

petition requested that the 40 CFR be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of 20ETO (CAS Reg No. 68605– 

38–9) and 10ETO (CAS Reg No. 

2464873–19–4) when used as inert 

ingredients (surfactant) in pesticide 

formulations applied to growing crops 

pre- and post-harvest under 40 CFR 

180.910. That document referenced a 

summary of the petition prepared by 

Exponent, Inc. on behalf of Lamberti 

USA, Incorporated, the petitioner, 

which is available in the docket, https:// 

www.regulations.gov. No comments 

were received on the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has limited 

the maximum concentration of 20ETO 

or 10ETO to not more than 10% in 

pesticide formulations for use under 40 

CFR 180.910. This limitation is based on 

the Agency’s risk assessment which can 

be found at https://www.regulations.gov 

in the document titled ‘‘Fatty acids, 

Tall-Oil, Esters with Triethanolamine, 

Ethoxylated (20ETO) and Fatty Acids, 

C8–18 or C18-Unsatd., Esters with 


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Polyethylene Glycol Ether with 

Triethanolamine (3:1) (10ETO); Human 

Health Risk Assessment and Ecological 

Effects Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations’’ 

in docket ID number EPA–HQ–OPP– 

2021–0364. 

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 

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 20ETO and 

10ETO including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with 20ETO and 

10ETO 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 20ETO and 10ETO as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

EPA considered studies on either 

substance to evaluate the toxicity of 

both substances. Based on the available 

data, the acute oral toxicity is expected 

to be low for 20ETO and 10ETO because 

the oral LD50 (lethal dose) for 20ETO is 

greater than 2,000 milligrams/kilogram 

(mg/kg). Both substances are also not 

expected to be acutely toxic via dermal 

exposure, as the LD50 for 20ETO is 

greater than 2,000 mg/kg in rats. The 

substances are also not expected to be 

irritating to the skin in the rat and rabbit 

nor sensitizing to the guinea pig. 

However, the substances are expected to 

be minimally irritating to the rabbit eye. 

No repeated-dose toxicity studies are 

available for 10ETO or 20ETO. 

Therefore, data for triethanolamine 

(TEA) and fatty acids, tall oil were used, 

based on the predicted degradation 

pathways of 20ETO and 10ETO. 

Subchronic oral toxicity studies in 

guinea pigs via gavage (TEA) and rats 

(fatty acids, tall oil) via the diet resulted 

in hepatocellular cloudy swelling and 

fatty change in the liver and cloudy 

swelling of the convoluted tubules and 

Henle’s loop in the kidney at 400 and 

450 mg/kg/day, respectively, following 

60- and 120-day exposures. The no 

observed adverse effect level (NOAEL) 

in these studies is 200 and 225 mg/kg/ 

day for the guinea pig and rat, 

respectively. Increased liver and kidney 

weights and histological lesions are 

observed at 730 mg/kg/day in a 90-day 

oral toxicity study in rats. The NOAEL 

in this study is 170 mg/kg/day. Chronic 

exposure via drinking water (TEA) 

resulted in an increased incidence and 

severity of chronic nephropathy at 455 

mg/kg/day in rats. No LOAEL was 

established in this study. In mice, 

decreased body weight was observed at 

1,688 mg/kg/day following chronic 

exposure via drinking water (TEA). 

In subchronic dermal toxicity studies, 

no systemic toxicity was observed up to 

1,000 mg/kg/day, the limit dose, in rats. 

However, in the same study, an 

increased incidence of hypertrophy of 

the pituitary gland pars intermedia was 

observed at 2,000 mg/kg/day and dermal 

effects manifested as increased 

incidence and severity of acanthosis and 

inflammation at 500 mg/kg/day. In 

mice, no systemic toxicity was observed 

up to 4,000 mg/kg/day following 13 

weeks of exposure. Mild dermal 

hyperplasia was observed at 140 mg/kg/ 

day and an increased incidence and 

severity of acanthosis was seen at 250 

mg/kg/day. 

Following chronic dermal exposure in 

rats, an increased incidence of 

acanthosis and inflammation along with 

ulcers and dermal erosion was observed 

at 63 mg/kg/day. 

A developmental toxicity study 

showed no maternal or developmental 

toxicity up to 1,125 mg/kg/day in mice. 

Another developmental toxicity study 

via the dermal exposure showed no 

toxicity up to 30 mg/kg/day, which was 

the highest dose tested in rats. Further, 

no parental, offspring, or reproduction 

toxicity was observed in a 2-generation 

reproduction toxicity study in rats (fatty 

acid, tall oil) up to 5,000 mg/kg/day. In 

a combined reproduction/ 

developmental toxicity test, a decrease 

in the number of implantation sites and 

litter size, and an increase in the 

number of post-implantation loss were 

observed at 1,000 mg/kg/day. The 

NOAEL is 300 mg/kg/day. However, 


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there is no concern for fetal 

susceptibility or reproduction toxicity 

since the cRfD (0.455 mg/kg/day) is 

protective of effects seen at 1,000 mg/ 

kg/day. 

Several mutagenicity studies with 

TEA and fatty acids, tall oil (e.g., Ames, 

chromosome aberration, micronucleus 

assay, sister chromatid exchange, and 

cell dominant lethal assay) were 

reviewed and the results for these 

studies are negative. 

Two chronic/carcinogenicity studies 

in which the test substance was 

administered via drinking water were 

also reviewed. In mice, decreased 

bodyweight was observed at 1,688 mg/ 

kg/day. The NOAEL is 673 mg/kg/day. 

No evidence of an increased incidence 

of tumors was seen in this study. In rats, 

chronic nephropathy is observed in 

female rats at 455 mg/kg/day. A NOAEL 

was not established in this study. An 

increased incidence of hepatocellular 

adenomas was observed at doses greater 

than 1,000 mg/kg/day. The chronic 

reference dose (cRfD) is based on this 

study. 

Neurotoxicity and immunotoxicity 

studies are not available for review. 

However, evidence of neurotoxicity and 

immunotoxicity was not observed in the 

submitted studies. 

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 https://

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for 20ETO and 10ETO used 

for human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 20ETO AND 10ETO FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/safety 

factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13 to 50 

years of age, General population 

including infants and children).

An acute effect was not found in the database therefore an acute dietary assessment is not necessary. 

Chronic dietary (All populations) ........ LOAEL= 455 mg/kg/day 

UFA = 10x 

UFH = 10x 

UFL = 10x 

FQPA SF = 1x 

Chronic RfD = 0.455 

mg/kg/day.

cPAD = 0.455 mg/kg/ 

day. 

Chronic/Carcinogenicity Study (TEA). 

LOAEL = 455 mg/kg/day based on chronic nephropathy in female rats. 

Incidental oral intermediate-term (1 to 

6 months).

NOAEL= 300 mg/kg/day 

UFA = 10x UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..... Combined Reproduction/Developmental (TEA). LOAEL = 1,000 mg/kg/ 

day based on decreased number of implantation sites and litter size, 

and an increased number of post-implantation loss. 

Inhalation short-term (1 to 30 days) .. Inhalation study NOAEL 

= 43.39 mg/kg/day 

(inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..... 16-Day Inhalation Toxicity Study (TEA). LOAEL = 86.77 mg/kg/day 

based on laryngeal inflammation. 

Inhalation intermediate-term (1 to 6 

months).

Inhalation study NOAEL 

= 43.39 mg/kg/day 

(inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

UFs = 10x 

FQPA SF = 1x 

LOC for MOE = 1000 ... 16-Day Inhalation Toxicity Study (TEA) LOAEL = 86.77 mg/kg/day 

based on laryngeal inflammation. 

Cancer (Oral, dermal, inhalation) ...... There is no evidence of carcinogenicity in the available database. The RfD approach is protective of any potential carcinogenic effects. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. 

MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk 

assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 20ETO and 10ETO, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 20ETO 

and 10ETO in food as follows: 

In conducting the chronic dietary 

exposure assessment using the Dietary 


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Exposure Evaluation Model DEEM– 

FCIDTM, Version 3.16, EPA used 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 10ETO and 20ETO. 

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. 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 https://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0738. 

Generally, in the dietary exposure 

assessments for inert ingredients, the 

Agency assumes that the residue level of 

the inert ingredient would be no higher 

than the highest tolerance for a given 

commodity. Implicit in this assumption 

is that there would be similar rates of 

degradation (if any) between the active 

and inert ingredient and that the 

concentration of inert ingredient in the 

scenarios leading to these highest levels 

of tolerances would be no higher than 

the concentration of the active 

ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. However, in assessing this 

petition request, the Agency assumed 

that a product consisted of 10% percent 

10ETO and 20ETO. Further, pesticide 

products rarely have a single inert 

ingredient; rather there is generally a 

combination of different inert 

ingredients used which additionally 

reduces the concentration of any single 

inert ingredient in the pesticide product 

in relation to that of the active 

ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, this 

conservative assumption will lead to a 

significant exaggeration of actual 

exposures. EPA does not believe that 

this approach underestimates exposure 

in the absence of residue data. 

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 10ETO 

and 20ETO, a conservative drinking 

water concentration value of 100 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 nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, for lawn and 

garden pest control, indoor pest control, 

termiticides, flea and tick control on 

pets, and hard surface disinfection on 

walls, floors, tables). 

20ETO and 10ETO 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 20ETO and 10ETO from 

formulations containing the inert 

ingredient in outdoor and indoor 

scenarios. Short- and intermediate-term 

dermal exposures were not quantitated 

since no systemic toxicity is observed in 

dermal toxicity studies. Also, 

intermediate- and long-term inhalation 

exposures are not expected because 

applications are not expected to occur 

daily or for more than 30 days. 

Therefore, only short-term inhalation 

exposures were estimated and were 

based on the NOAEL of 43.39 mg/kg/ 

day and a LOC for an MOE of 100. The 

short-term residential handler MOE is 

36000, which is not a risk of concern 

because EPA considers MOEs of 100 or 

less to be of concern. The Agency also 

considered intermediate-term incidental 

oral exposures to children due to 

residential exposure associated with 

contact with treated surfaces (dermal 

and hand-to-mouth exposures). The 

MOE is 1964 for children, which is not 

a risk of concern because EPA considers 

MOEs of 100 or less to be of concern. 

As introduced above, 10ETO and 

20ETO are expected to biodegrade into 

TEA and fatty acids, tall oil. Residential 

exposure to TEA may occur from 

existing pesticide uses as well as from 

non-pesticide products that may be used 

in and around the home, such as 

cosmetics. Dermal contact is the 

primary route of exposure to TEA in 

cosmetics. However, a dermal endpoint 

of concern was not identified, and 

therefore a quantitative dermal exposure 

assessment is not necessary. TEA can be 

used in products that may be sprayed, 

however, so there is the potential for 

inhalation exposure. The Cosmetic 

Ingredient Review (CIR) Expert Panel 

has noted that 95% to 99% of TEA 

particles produced in cosmetic aerosols 

are not respirable. This assumption, 

coupled with the small actual exposure 

in the breathing zone and the 

concentrations at which TEA is used, 

suggests that inhalation would not be a 

significant route of exposure that might 

lead to local respiratory or systemic 

toxic effects (Fiume et. al., 2013). Small 

amounts of TEA may also be ingested 

(oral exposure) from lipsticks as they are 

reported to potentially contain up to 1% 

TEA. However, any contribution to the 

estimated oral pesticide exposure 

resulting from cosmetic uses is likely to 


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be insignificant in comparison to the 

estimates for exposure from the 

pesticide use. 

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 20ETO and 10ETO 

to share a common mechanism of 

toxicity with any other substances, and 

20ETO and 10ETO do not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that 20ETO and 10ETO do 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:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

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 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 for the chronic 

dietary assessment for the following 

reasons. The toxicity database for 

20ETO and 10ETO contains 

developmental, 2-generation 

reproduction, combined reproduction/ 

developmental toxicity and 

mutagenicity studies. There is no 

indication of immunotoxicity or 

neurotoxicity in the available studies; 

therefore, there is no need to require an 

immunotoxicity or neurotoxicity study. 

Additionally, no fetal susceptibility or 

reproduction toxicity was observed in 

the available studies. Based on the 

adequacy of the toxicity database, 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. Therefore, 20ETO and 10ETO 

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 20ETO and 

10ETO from food and water will utilize 

32.6% of the cPAD for children 1–2 

years old, the population group 

receiving the greatest exposure. 

3. Short-term risk. Short-term 

aggregate exposure generally takes into 

account short-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

20ETO and 10ETO may be used as 

inert ingredients in pesticide products 

that could result in short-term 

residential exposure. The Agency has 

determined that it is not appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to 20ETO and 10ETO since 

toxicological effects were different 

depending on the route of exposure. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term residential 

exposures result in aggregate MOEs of 

36000 for adult males and females. 

Because EPA’s level of concern for 

20ETO and 10ETO is an MOE of 100 or 

below, this MOE is not of concern. 

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). 

20ETO and 10ETO may be used as 

inert ingredients in pesticide products 

that could result in intermediate-term 

residential exposure, and the Agency 

has determined that it is not appropriate 

to aggregate chronic exposure through 

food and water with intermediate-term 

residential exposures to 20ETO and 

10ETO since toxicological effects were 

different depending on the route of 

exposure. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 1964 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

surfaces (dermal and hand-to-mouth 

exposures). Because EPA’s level of 

concern for children’s residential 

exposure (incidental oral exposure) to 

20ETO and 10ETO is an MOE of 100 or 

below, this MOE is not of concern. 

5. Long-term risk. Long-term aggregate 

exposure takes into account long-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Long-term residential exposures are 

not expected from the use of 20ETO and 

10ETO in pesticides used in and around 

the home. Therefore, long-term 

aggregate exposure considers chronic 

food and water. The MOE is 10833 

based on the cPAD of 0.455 mg/kg/day. 

As the level of concern is for an MOE 

that is lower than 1000, this MOE is not 

of concern. 

TEA, a metabolite of 10ETO and 

20ETO, may be used as inert ingredients 

in non-pesticide products that could 

result in long-term residential exposure. 

Based on the exposure assumptions 

described in unit IV. C. 3, the Agency 

anticipates that the contribution to the 

estimated oral non-pesticide exposure 

due to its use in cosmetics is likely to 

be insignificant in comparison to the 

estimates for exposure from the 

pesticide use. Therefore, the Agency 

believes the assessments of aggregate 

exposures due to pesticide uses more 

than adequately protect for exposure 

from uses in cosmetics products. 

6. Aggregate cancer risk for U.S. 

population. Based on the lack of tumors 

in the carcinogenicity studies in rats 

and mice and the lack of mutagenicity, 

20ETO and 10ETO are not expected to 

pose a cancer risk to humans. 

7. Determination of safety. Taking 

into consideration all available 


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10988 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

information on 20ETO and 10ETO, EPA 

concludes that there is a reasonable 

certainty that no harm will result to the 

general population, including infants 

and children, from aggregate exposure 

to 20ETO and 10ETO residues. 

V. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of 20ETO and 

10ETO in or on any food commodities. 

EPA is establishing a limitation on the 

amount of 20ETO and 10ETO that may 

be used in pesticide formulations. This 

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 food use that 

exceeds 10% in the final pesticide 

formulations for indoor and outdoor 

residential use. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of 20ETO (CAS Reg No. 

68605–38–9) and 10ETO (CAS Reg No. 

2464873–19–4) when used as inert 

ingredients (surfactant) in pesticide 

formulations applied to growing crops 

pre- and post-harvest under 40 CFR 

180.910. 

VII. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

the Agency. The Office of Management 

and Budget (OMB) has exempted these 

types of actions from review under 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993). Because 

this action has been exempted from 

review under Executive Order 12866, 

this action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997). 

This action does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.), nor does it require any special 

considerations under Executive Order 

12898, entitled ‘‘Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994), EPA seeks to achieve 

environmental justice, the fair treatment 

and meaningful involvement of any 

group, including minority and/or lowincome populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

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: February 22, 2022. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR part 

180 as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.910, amend Table 1 to 

180.910 by adding in alphabetical order 

the inert ingredients ‘‘Fatty acids, talloil, esters with triethanolamine, 

ethoxylated’’ and ‘‘Fatty acids, C8–18 and 

C18-unsatd., esters with polyethylene 

glycol ether with triethanolamine (3:1)’’ 

to reads as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10989 

TABLE 1 TO 180.910 

Inert ingredients Limits 

(%) Uses 

*******

Fatty acids, tall-oil, esters with triethanolamine, ethoxylated (CAS Reg. No. 68605–38–9) .................................. 10 Surfactant. 

Fatty acids, C8–18 and C18-unsatd., esters with polyethylene glycol ether with triethanolamine (3:1) (CAS Reg. 

No. 2464873–19–4).

10 Surfactant. 

*******

[FR Doc. 2022–04123 Filed 2–25–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 206 

[Docket DARS–2019–0051] 

RIN 0750–AK67 

Defense Federal Acquisition 

Regulation Supplement: Exception to 

Competition for Certain Follow-On 

Production Contracts (DFARS Case 

2019–D031) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is issuing a final rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement a section of the 

National Defense Authorization Act for 

Fiscal Year 2016 that modifies the 

criteria required to exempt from 

competition certain follow-on 

production contracts. 

DATES: Effective February 28, 2022. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Kimberly R. Ziegler, telephone 571– 

372–6095. 

SUPPLEMENTARY INFORMATION: 

I. Background 

DoD published a proposed rule in the 

Federal Register at 84 FR 50811 on 

September 26, 2019, to amend DFARS 

206.001 to implement section 815 of the 

National Defense Authorization Act 

(NDAA) for Fiscal Year (FY) 2016 (Pub. 

L. 114–92). Section 815 repeals and 

replaces section 845 of the NDAA for FY 

1994 (Pub. L. 103–160; 10 U.S.C. 2371 

note) with 10 U.S.C. 2371b, which 

modifies the authority of DoD to carry 

out other transaction (OT) agreements 

for prototype projects, as well as the 

criteria required to award an associated 

follow-on production contract to the 

participants in the other transaction 

agreement without the use of 

competitive procedures. One 

respondent submitted comments on the 

proposed rule. 

II. Discussion and Analysis 

A. Summary of Significant Changes 

The purpose of this rule is to provide 

contracting officers with updated 

internal guidance when awarding a 

follow-on production contract that is 

exempt from the competitive procedures 

of Federal Acquisition Regulation part 

6, as set forth in 10 U.S.C. 2371b. The 

rule is not intended to implement 

policy, regulation, or guidance on DoD’s 

authority to enter into OT prototype 

agreements at 10 U.S.C. 2371b. As such, 

this final rule changes the rule text to 

specify that the agreements officer for 

the OT agreement for the prototype 

project is responsible for providing to 

the contracting officer information that 

confirms the requirements to award a 

noncompetitive follow-on production 

contract, as specified in 10 U.S.C. 2371b 

and DoD OT agreement policy, have 

been met. 

B. Analysis of Public Comments 

DoD reviewed the public comments in 

the development of the final rule. A 

discussion of the comments and the 

changes made to the rule as a result of 

those comments is provided, as follows: 

Comment: The respondent advised 

that DoD should provide clear guidance 

on what constitutes ‘‘successful 

completion’’ of a prototype transaction; 

the rule text should be clarified to 

explain what it means to award a 

follow-on production contract to ‘‘the 

participants in the transaction,’’ as 

contracts are usually made between the 

Government and a single entity; the rule 

should clarify what a ‘‘participant’’ is, 

given that not all parties to a transaction 

necessarily participate in the project. 

The respondent also advised that the 

rule should be revised to clarify the 

prerequisites for awarding the OT for 

the prototype project and the 

prerequisites for awarding a follow-on 

production contract. Specifically, one of 

the criteria for awarding a follow-on 

production contract is that the OT for 

the prototype project is based on 

specific determinations made by certain 

acquisition officials according to 

different threshold values. The 

proposed rule, however, applies these 

determination requirements only to the 

follow-on production contract, when 

they should instead apply only to the 

initial OT agreement. Response: This rule is not intended to 

implement policy, regulation, or 

guidance on DoD’s authority to enter 

into OT prototype agreements at 10 

U.S.C. 2371b. Instead, the Office of the 

Under Secretary of Defense for 

Acquisition and Sustainment 

(OUSD(A&S)) is the organization 

responsible for promulgation of policy 

for OT agreements, which can be 

viewed at https://aaf.dau.edu/aaf/otguide/. As a result, this rule is modified 

to clarify that the contracting officer 

does not make the determination that 

the prototype project was successfully 

completed and, instead, should receive 

that information from the agreements 

officer for the OT agreement. Comment: The respondent advised 

that 32 CFR part 3 should be updated 

to reflect the current authority at 10 

U.S.C. 2371b. 

Response: This comment is outside 

the scope of this rule, which amends 48 

CFR chapter 2. 

C. Other Changes 

The proposed numbering of the 

DFARS text is redesignated as DFARS 

206.001–70 from 206.001(S–70) to align 

with FAR system drafting conventions. 

III. Applicability to Contracts at or 

Below the Simplified Acquisition 

Threshold, for Commercial Products 

Including Commercially Available Offthe-Shelf Items, and for Commercial 

Services 

This rule only impacts the internal 

operating procedures of the agency. The 

rule does not impose any new 

requirements on contracts at or below 


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