[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Rules and Regulations]
[Pages 36063-36068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12878]


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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-Tetramethyl- and 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.

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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 post-harvest, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the 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

[[Page 36064]]

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-observed-adverse-
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

[[Page 36065]]

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.
    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 long-term exposures are not 
expected

[[Page 36066]]

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-to-mouth 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 
intermediate-term 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

[[Page 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

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, 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:


Sec.  180.910   Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

                        Table 1 to Sec.   180.910
------------------------------------------------------------------------
        Inert ingredients             Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
5-decyne-4,7-diol, 2,4,7,9-        ...........  surfactant, related
 tetramethyl- (CAS Reg. No. 126-                 adjuvant of surfactants
 86-3).                                          and carriers.
6-dodecyne-5,8-diol, 2,5,8,11-     ...........  surfactant, related
 tetramethyl- (CAS Reg. No. 68227-               adjuvant of surfactants
 33-8).                                          and carriers.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  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:

[[Page 36068]]

Sec.  180.930   Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

                        Table 1 to Sec.   180.930
------------------------------------------------------------------------
        Inert ingredients             Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
5-decyne-4,7-diol, 2,4,7,9-        ...........  surfactant, related
 tetramethyl- (CAS Reg. No. 126-                 adjuvant of surfactants
 86-3).                                          and carriers.
6-dodecyne-5,8-diol, 2,5,8,11-     ...........  surfactant, related
 tetramethyl- (CAS Reg. No. 68227-               adjuvant of surfactants
 33-8).                                          and carriers.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2022-12878 Filed 6-14-22; 8:45 am]
BILLING CODE 6560-50-P