Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Rules and Regulations 36063 

for First-Class Mail International will 

increase to $5.05. 

D Customs Clearance and Delivery 

Fee: The Customs Clearance and 

Delivery Fee per dutiable item for 

Inbound Letter Post letters and flats will 

increase to $7.50. 

D International Business ReplyTM

service (IBRS): The price for IBRS cards 

will increase to $1.90, and the price for 

IBRS envelopes (up to 2 ounces) will 

increase to $2.40. 

New prices will be listed in the 

updated Notice 123, Price List. 

Joshua J. Hofer, 

Attorney, Ethics & Legal Compliance. 

[FR Doc. 2022–12845 Filed 6–14–22; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0663; FRL–9875–01– 

OCSPP] 

5-Decyne-4,7-Diol, 2,4,7,9-Tetramethyland 6-Dodecyne-5,8-Diol, 2,5,8,11- 

Tetramethyl-; 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 5-decyne-4,7- 

diol, 2,4,7,9-tetramethyl- (CAS Reg. No. 

126–86–3), herein referred to as TMDD, 

and 6-dodecyne-5,8-diol, 2,5,8,11- 

tetramethyl- (CAS Reg. No. 68227–33– 

8), herein referred to as TMDDD, when 

used as inert ingredients (surfactants, 

related adjuvant of surfactants and 

carriers) in pesticide formulations 

applied to growing crops pre- and postharvest, and applied in/on animals. 

Spring Trading Company (new name 

Spring Regulatory Sciences) on behalf of 

Evonik Corp., submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting the 

establishment of exemptions from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of TMDD and TMDDD. 

DATES: This regulation is effectiveJune 

15, 2022. Objections and requests for 

hearings must be received on or before 

August 15, 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–2017–0663, 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 and the OPP 

Docket is (202) 566–1744. For the latest 

status information on EPA/DC services, 

docket access, visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echevarria, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (202) 566–1030; 

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–2017–0663 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 

August 15, 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– 

2017–0663, 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 March 12, 

2018 (83 FR 12311) (FRL–9974–76), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–11077) by Spring 

Regulatory Sciences, 6620 Cypresswood 

Dr, Suite 250, Spring, TX 77379 on 

behalf of Evonik Corp., P.O. Box 34628, 

Richmond, VA 23234. The petition 

requested that 40 CFR 180.910 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of TMDD (CAS Reg. No. 126– 

86–3) and TMDDD (CAS Reg. No. 

68227–33–8) when used as inert 

ingredients (surfactants, related 

adjuvant of surfactants and carriers) in 

pesticide formulations applied to 

growing crops pre- and post-harvest and 

applied in/on animals under 40 CFR 


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36064 Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Rules and Regulations 

180.930. That document referenced a 

summary of the petition prepared by 

Spring Regulatory Sciences on behalf of 

Evonik Corp., the petitioner, which is 

available in the docket via https://

www.regulations.gov. There were no 

relevant comments received in response 

to the notice of filing. 

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 the 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 the 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 TMDD and 

TMDDD including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with TMDD and 

TMDDD 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 TMDD and TMDDD as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

TMDD and TMDDD are being 

assessed together because there is only 

a difference in carbon chain length 

between the two surfactants. Therefore, 

based on structure similarity, the 

toxicity profile is expected to be similar 

for TMDD and TMDDD. 

Acute toxicity studies were available 

for both chemicals. TMDD exhibits 

moderate acute oral toxicity with the rat 

acute oral lethal dose (LD50) being 

greater than 500 mg/kg. TMDDD 

exhibits low acute oral toxicity with the 

rat acute oral LD50 being greater than 

5,000 mg/kg. Dermal toxicity is 

moderate in rabbits for both chemicals, 

as the LD50 is greater than 1,000 mg/kg, 

the highest dose tested. Acute toxicity 

via inhalation is low. Both have a lethal 

concentration (LC50) > 20 mg/L. The 

chemicals are both highly irritating to 

the eyes and slightly irritating to the 

skin of rabbits. TMDD is not a skin 

sensitizer. The results for skin 

sensitization are equivocal for TMDDD. 

Based on the available repeated-dose 

data on TMDD and TMDDD, the central 

nervous system is a major target organ, 

with convulsions, tremors, paralysis 

and/or incoordination seen in dogs at 

250 mg/kg/day following treatment for 

91 days via capsule. The liver is also a 

target organ, with hepatocellular 

swelling observed in the one-generation 

reproduction toxicity study in rats but 

these effects were observed only at the 

limit dose (1,000 mg/kg/day). 

Additionally, non-specific effects 

(decreased body weights) were observed 

in offspring in the one-generation 

reproduction toxicity study, but these 

occurred at the same doses in which 

maternal toxicity was observed. 

No mutagenicity, genotoxicity or 

chromosomal aberrations are seen in a 

battery of mutagenicity tests with TMDD 

and TMDDD. Both chemicals were 

negative in the Ames test, chromosome 

aberration test and mouse lymphoma 

assay. 

Neurotoxicity studies are not 

available for review. Convulsions, 

tremors, paralysis and/or incoordination 

were observed at 250 mg/kg/day in dogs 

in a 91-day oral toxicity study via 

gavage. However, a clear NOAEL was 

established for these effects and the 

chronic population adjusted dose 

(cPAD) of 2 mg/kg/day is based on this 

study. Therefore, there is no concern for 

neurotoxicity. 

Immunotoxicity toxicity studies are 

not available for review. However, no 

evidence of immunotoxicity is seen in 

the available 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 (LOCs) 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 NOAEL and the LOAEL 

Uncertainty/safety factors are used in 

conjunction with the POD to calculate a 

safe exposure level generally referred to 

as a population-adjusted dose (PAD) or 

a reference dose (RfD)—and a safe 


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margin of exposure (MOE). For nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see https://

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

No acute endpoint was identified; 

therefore, an acute assessment is not 

necessary. The 91-day oral study in dogs 

was selected for chronic dietary 

exposure as well as incidental oral, 

dermal and inhalation exposure 

scenarios. In this study, convulsions, 

tremors, paralysis and/or incoordination 

were observed at 250 mg/kg/day. This 

represents the lowest NOAEL in the 

database in the most sensitive species. 

The standard uncertainty factors (UFs) 

were applied to account for interspecies 

(10x) and intraspecies (10x) variations. 

The default value of 100% was used for 

the dermal and inhalation absorption 

factors. 

C. Exposure Assessment 

1. Dietary exposure. In evaluating 

dietary exposure to TMDD and TMDDD, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from TMDD 

and TMDDD in food as follows: 

An acute dietary assessment was not 

performed due to the lack of adverse 

effects attributed to a single dietary 

exposure seen in the toxicity databases. 

In conducting the chronic dietary 

exposure assessment using the Dietary 

Exposure Evaluation Model DEEM– 

FCIDTM, Version 4.02, EPA used food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

2005–2010 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 TMDD and TMDDD. 

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 ‘‘Update to 

D361707: Dietary Exposure and Risk 

Assessments for the Inerts.’’ (12/21/ 

2021) and can be found at https://

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2018–0090. 

In the dietary exposure assessment, 

the Agency assumed 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. 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, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for TMDD 

and TMDDD, a conservative drinking 

water concentration value of 100 parts 

per billion (ppb) based on screening 

level modeling was used to assess the 

contribution to drinking water for 

chronic dietary risk assessments for 

TMDD and TMDDD. The exposure for 

food and water utilized 14.2% and 

51.5% of the cPAD (2.00 mg/kg/day) for 

the U.S. population and children 1 to 2 

years old, respectively. 

2. Residential exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., for lawn and 

garden pest control, indoor pest control, 

termiticides, and flea and tick control 

on pets). TMDD and TMDDD may be 

used as inert ingredients in pesticide 

products that are registered for specific 

uses that may result in residential 

exposure. A conservative residential 

exposure and risk assessments were 

completed for pesticide products 

containing TMDD and TMDDD as inert 

ingredients. The Agency assessed 

pesticide products containing TMDD 

and TMDDD using exposure scenarios 

used by OPP to represent conservative 

residential handler exposure. Further 

details of this residential exposure and 

risk analysis can be found at https://

www.regulations.gov in the 

memorandum entitled: ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations,’’ (D364751, 5/7/09, 

Lloyd/LaMay in docket ID number 

EPA–HQ–OPP–2008–0710). 

For residential handler short-term 

exposure scenarios, MOEs ranged from 

230 to 33,000 and are not of concern 

(i.e., MOEs are >100). Residential 

handler intermediate-term and longterm exposures are not expected 


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because applications are not expected to 

occur daily or for more than 30 days. 

For residential post-application 

exposure scenarios (short- and 

intermediate-term), MOEs ranged from 

510 to 13,000,000 and are not of concern 

(i.e., MOEs are >100). 

3. 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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

TMDD and TMDDD and any other 

substances because TMDD and TMDDD 

do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance exemption, therefore, EPA has 

assumed that TMDD and TMDDD 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 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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 all exposure 

scenarios for the following reasons. The 

toxicity database for TMDD and TMDDD 

contain a combined repeated dose 

toxicity study with the reproduction/ 

developmental toxicity screening test, a 

one-generation reproduction toxicity 

and mutagenicity studies. No fetal 

susceptibility is observed in either the 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test or in the 1- 

generation reproduction toxicity study 

in rats. Offspring toxicity (decreased 

body weights at weaning and lactation) 

is seen in the one-generation 

reproduction toxicity study only at the 

same dose as maternal toxicity 

(hepatocellular swelling), 1,000 mg/kg/ 

day. No reproduction toxicity is seen in 

the available studies. Convulsions, 

tremors, paralysis and/or incoordination 

were observed at 250 mg/kg/day in dogs 

in a 91-day oral toxicity study. 

However, a clear NOAEL was 

established for these effects and the 

selected POD is based on this study. 

Therefore, there is no concern for 

neurotoxicity. 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, TMDD and TMDDD 

are 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 TMDD and 

TMDDD from food and water will 

utilize 51.5% 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). 

TMDD and TMDDD are currently 

used as inert ingredients in pesticide 

products that are registered for uses 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 TMDD and TMDDD. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 149 for adults. 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. For children, the 

aggregate MOE is 141. Children’s 

residential exposure includes total 

exposures associated with contact with 

treated lawns (dermal and hand-tomouth exposures). Because EPA’s level 

of concern for TMDD and TMDDD are 

MOEs below 100, the calculated MOEs 

are 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). 

TMDD and TMDDD are currently 

used as inert ingredients in pesticide 

products that are registered for uses 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 TMDD and 

TMDDD. 

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 aggregate MOEs of 592 for adults. 

Adult residential exposure includes 

high end post application dermal 

exposure from contact with treated 

lawns. For children the aggregate MOE 

is 170. Children’s residential exposure 

includes total exposures associated with 

contact with treated lawns (dermal and 

hand-to-mouth exposures). Because 

EPA’s level of concern for TMDD and 

TMDDD are MOEs below 100, the 

calculated MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. EPA has not identified any 

concerns for carcinogenicity relating to 

TMDD and TMDDD. TMDD and 


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Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Rules and Regulations 36067 

TMDDD are not expected to pose a 

cancer risk to humans; therefore, a 

cancer aggregate assessment was not 

conducted. 

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 TMDD and 

TMDDD 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 TMDD and 

TMDDD in or on any food commodities. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for residues of 

TMDD and TMDDD when used as inert 

ingredients (surfactants, related 

adjuvant of surfactants and carriers) in 

pesticide formulations applied in/on 

growing crops pre- and post-harvest and 

applied in/on animals under 40 CFR 

180.930. 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). 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 exemptions 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). 

Dated: June 9, 2022. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I 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 entries for ‘‘5-decyne-4,7-diol, 

2,4,7,9-tetramethyl- (CAS Reg. No. 126– 

86–3)’’ and ‘‘6-dodecyne-5,8-diol, 

2,5,8,11-tetramethyl- (CAS Reg. No. 

68227–33–8)’’ to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

TABLE 1 TO § 180.910 

Inert ingredients Limits Uses 

*******

5-decyne-4,7-diol, 2,4,7,9-tetramethyl- (CAS Reg. No. 126–86–3) .......... .................... surfactant, related adjuvant of surfactants and carriers. 

6-dodecyne-5,8-diol, 2,5,8,11-tetramethyl- (CAS Reg. No. 68227–33–8) .................... surfactant, related adjuvant of surfactants and carriers. 

*******

■ 3. In § 180.930, amend Table 1 to 

180.930, by adding in alphabetical 

order, the entries for ‘‘5-decyne-4,7-diol, 

2,4,7,9-tetramethyl- (CAS Reg. No. 126– 

86–3)’’ and ‘‘6-dodecyne-5,8-diol, 

2,5,8,11-tetramethyl- (CAS Reg. No. 

68227–33–8)’’ to read as follows: 


jspears on DSK121TN23PROD with RULES1
36068 Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Rules and Regulations 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

TABLE 1 TO § 180.930 

Inert ingredients Limits Uses 

*******

5-decyne-4,7-diol, 2,4,7,9-tetramethyl- (CAS Reg. No. 126–86–3) .......... .................... surfactant, related adjuvant of surfactants and carriers. 

6-dodecyne-5,8-diol, 2,5,8,11-tetramethyl- (CAS Reg. No. 68227–33–8) .................... surfactant, related adjuvant of surfactants and carriers. 

*******

[FR Doc. 2022–12878 Filed 6–14–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0188; FRL–9858–01– 

OCSPP] 

IN–11669: Cellulose, Ethyl 2- 

Hydroxyethyl Ether; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of cellulose, ethyl 

2-hydroxyethyl ether (CAS Reg. No. 

9004–58–4), when used as an inert 

ingredient in a pesticide chemical 

formulation. Spring Regulatory 

Sciences, on behalf of Nouryon 

Chemicals LLC USA, submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of cellulose, ethyl 2- 

hydroxyethyl ether, on food or feed 

commodities. 

DATES: This regulation is effective June 

15, 2022. Objections and requests for 

hearings must be received on or before 

August 15, 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–2022–0188, 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 and the OPP 

Docket is (202) 566–1744. For the latest 

status information on EPA/DC services, 

docket access, visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (202) 566–1030; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to ae? 

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. 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–2022–0188 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 

August 15, 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– 

2022–0188, 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. 


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