Rule2022-12878
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 15, 2022
Effective
June 15, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 115 (Wednesday, June 15, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12878]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#37657371657958435e5452447752475619505841"><span class="__cf_email__" data-cfemail="73213735213d1c071a101600331603125d141c05">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 (LD<INF>50</INF>) being greater than 500 mg/kg. TMDDD exhibits low
acute oral toxicity with the rat acute oral LD<INF>50</INF> being
greater than 5,000 mg/kg. Dermal toxicity is moderate in rabbits for
both chemicals, as the LD<INF>50</INF> is greater than 1,000 mg/kg, the
highest dose tested. Acute toxicity via inhalation is low. Both have a
lethal concentration (LC<INF>50</INF>) > 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 <a href="https://www.epa.gov/pesticides/factsheets/riskassess.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 15, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.