Propanamide, 2-hydroxy-N, N-dimethyl-; Exemption From the Requirement of a Tolerance, 8428-8433 [2020-02042]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8428-8433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02042]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0279; FRL-10003-07]


Propanamide, 2-hydroxy-N, N-dimethyl-; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation established exemptions from the requirement of 
a tolerance for residues of propanamide, 2-hydroxy-N, N-dimethyl-, when 
used as an inert ingredient (solvent/co-solvent) in pesticides applied 
to growing crops and raw agricultural commodities after harvest, or in 
pesticides applied to animals, limited to 50% by weight in the 
pesticide formulations. Spring Trading Company,

[[Page 8429]]

LLC on behalf of BASF Corporation submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment 
to an existing requirement of a tolerance. This regulation eliminates 
the need to establish a maximum permissible level for residues of 
propanamide, 2-hydroxy-N, N-dimethyl-, when used in accordance with the 
terms of these exemptions.

DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 2020, 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-2019-0279, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [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 Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0279 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 14, 2020. 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-2019-0279, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11271) by 
Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354-5201) on 
behalf of BASF Corporation (100 Campus Drive, Florham Park, NJ 07932). 
The petition requested that existing exemptions from the requirement of 
a tolerance for residues of propanamide, 2-hydroxy-N, N-dimethyl- (CAS 
Reg. No. 35123-06-9) when used as an inert ingredient (solvent/co-
solvent) applied to growing crops and raw agricultural commodities 
after harvest (40 CFR 180.910) or in pesticides applied to animals 
(Sec.  180.930) be amended by increasing the limitation in pesticide 
formulations from 20% to 50%. That document referenced a summary of the 
petition prepared by Spring Trading Company on behalf of BASF 
Corporation, the petitioner, which is available in the docket, https://www.regulations.gov. One relevant comment was received on the notice of 
filing. EPA's response to this comment is discussed in Unit V.B.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will

[[Page 8430]]

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. EPA is required to consider the factors of 
section 408(b)(2)(C) and (D) in making determinations of safety for 
exemptions. 21 U.S.C. 346a(c)(2)(B). Section 408(b)(2)(C) of FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for propanamide, 2-hydroxy-N, N-
dimethyl- including exposure resulting from the exemption established 
by this action. EPA's assessment of exposures and risks associated with 
propanamide, 2-hydroxy-N, N-dimethyl- 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 propanamide, 2-hydroxy-N, N-dimethyl- 
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.
    Propanamide, 2-hydroxy-N, N-dimethyl- is of low acute oral, dermal 
and inhalation toxicity in rats; all LD50s are greater than 
1,000 mg/kg. Dermal irritation is not observed in rabbits. It is mildly 
irritating to the eyes of rabbits. It is not a dermal sensitizer in 
mice in the lymph node assay.
    The toxicity studies summarized below were all conducted with 
propanamide, 2-hydroxy-N, N-dimethyl- except the chronic toxicity 
study. That study was conducted with N, N-dimethylacetamide, a 
structurally similar chemical. The only difference between the two 
chemicals is that N, N-dimethylacetamide is missing a hydroxyl group on 
a carbon atom. Both compounds are expected to undergo similar 
metabolism (in this case, N-oxidation) by cytochrome P450 enzymes and 
have similar toxicological profiles; therefore, the Agency has 
determined the data to be suitable for evaluating propanamide.
    In rats, 90 days of oral exposure to propanamide, 2-hydroxy-N, N-
dimethyl- results in increased cholesterol and triglyceride levels, 
increased liver weights and centrilobular hypertrophy at 1,000 mg/kg/
day, the limit dose. The NOAEL is 500 mg/kg/day. Reproduction 
parameters, estrus cyclicity and sperm parameters were also evaluated 
in this study and were found to be unaffected at 1,000 mg/kg/day.
    A developmental toxicity study in rats showed no maternal toxicity 
at 500 mg/kg/day, the highest dose tested. Quantitative fetal 
susceptibility was observed as reduced body weight in pups at 500 mg/
kg/day. The developmental NOAEL was 200 mg/kg/day.
    Propanamide, 2-hydroxy-N, N-dimethyl- was not mutagenic in the 
Chinese hamster ovary (CHO) cells HGPRT locus gene mutation assay or 
the micronucleus test.
    Propanamide, 2-hydroxy-N, N-dimethyl- is not expected to be 
carcinogenic based on the absence of structural alerts using Derek 
Nexus program and the lack of mutagenicity. It is not expected to be 
neurotoxic based on the functional observation battery or on motor 
activity in the 90-day oral toxicity study in rats.
    Immunotoxicity studies for propanamide, 2-hydroxy-N, N-dimethyl- 
were not available for review. However, evidence of immunotoxicity was 
not observed in the submitted studies.
    Chronic studies with propanamide, 2-hydroxy-N, N-dimethyl- are not 
available for review. However, a chronic study conducted for 12 months 
in rats treated with N, N-dimethylacetamide, a structurally similar 
chemical, was used as surrogate data. In this study toxicity manifested 
as reduced bodyweight was observed at 300 mg/kg/day. The NOAEL is 100 
mg/kg/day.
    A dermal penetration study in rats showed that 50% of 2-hydroxy-N, 
N-dimethyl- is absorbed following 8 hours of exposure on skin. 
Therefore, the dermal absorption factor of 50% was used for risk 
assessment purposes.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    An acute effect was not found in the database therefore an acute 
dietary assessment is not necessary. The chronic reference dose (cRfD) 
as well as the toxicity endpoint applicable to all exposure scenarios 
was based on the 12-month chronic toxicity study in rats. In this 
study, the NOAEL was 100 mg/kg/day based on reduced bodyweights at 300 
mg/kg/day, the LOAEL. This

[[Page 8431]]

represents the lowest NOAEL in the most sensitive species in the 
toxicity database. The standard uncertainty factors were applied to 
account for interspecies (10X) and intraspecies (10X) variations. The 
FQPA safety factor was reduced to 1x. The dermal absorption factor of 
50% was applied based on a dermal penetration study in rats. A default 
value of 100% was used for the inhalation absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to propanamide, 2-hydroxy-N, N-dimethyl-, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance. EPA assessed dietary exposures from propanamide, 2-hydroxy-
N, N-dimethyl- in food as follows:
    Dietary exposure (food and drinking water) to propanamide, 2-
hydroxy-N, N-dimethyl- can occur following ingestion of foods with 
residues from treated crops and animals. Because no adverse effects 
attributable to a single exposure of propanamide, 2-hydroxy-N, N-
dimethyl- are seen in the toxicity databases, an acute dietary risk 
assessment is not necessary. For the chronic dietary risk assessment, 
EPA used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCIDTM, Version 3.16, and 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) 2003-2008 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no 
residue data were submitted for propanamide, 2-hydroxy-N, N-dimethyl-. 
In the absence of specific residue data, EPA has developed an approach 
which uses surrogate information to derive upper bound exposure 
estimates for the subject inert ingredient. Upper bound exposure 
estimates are based on the highest tolerance for a given commodity from 
a list of high use insecticides, herbicides, and fungicides. One 
hundred percent crop treated was assumed, default processing factors, 
and tolerance-level residues for all foods and use limitations of not 
more than 50% by weight in pesticide formulations. A complete 
description of the general approach taken to assess inert ingredient 
risks in the absence of residue data is contained in the memorandum 
entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic 
Aggregate (Food and Drinking Water) Dietary Exposure and Risk 
Assessments for the Inerts,'' (D361707, S. Piper, 2/25/09) and can be 
found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-
2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the 
screening-level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for propanamide, 2-
hydroxy-N, N-dimethyl-, a conservative drinking water concentration 
value of 100 ppb based on screening level modeling was used to assess 
the contribution to drinking water for the chronic dietary risk 
assessments for parent compound. These values were directly entered 
into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Propanamide, 2-hydroxy-N, N-dimethyl- may be used in inert 
ingredients in products that are registered for specific uses that may 
result in residential exposure, such as pesticides used in and round 
the home. The Agency conducted an assessment to represent worst-case 
residential exposure by assessing propanamide, 2-hydroxy-N, N-dimethyl- 
in pesticide formulations (outdoor scenarios) and in disinfectant-type 
uses (indoor scenarios), limited to 5% by weight in pesticide 
formulations.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found propanamide, 2-hydroxy-N, N-dimethyl- to share a 
common mechanism of toxicity with any other substances, and 
propanamide, 2-hydroxy-N, N-dimethyl- does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that propanamide, 2-
hydroxy-N, N-dimethyl- does not have a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA Safety Factor (SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    The toxicity database for propanamide, 2-hydroxy-N, N-dimethyl- 
contains a subchronic, developmental, chronic, and mutagenicity 
studies. There is no indication of neurotoxicity or immunotoxicity in 
the available studies; therefore, there is no need to require 
neurotoxicity or immunotoxicity studies. Quantitative fetal 
susceptibility was observed in the developmental study in rats. Fetal 
toxicity (reduced bodyweight) was observed at 500 mg/kg/day, the 
highest dose tested, while toxicity was not observed in maternal 
animals. The developmental NOAEL was 200 mg/kg/day. However, fetal 
effects are not of concern since the cRfD (1 mg/kg/day) will be 
protective of effects seen at 500 mg/kg/day. In addition, the Agency 
used conservative exposure estimates, with 100 percent crop treated, 
tolerance-level residues, conservative drinking water modeling numbers, 
and a worst-case assessment of potential residential exposure for 
infants and children. Based on the adequacy of the toxicity and 
exposure databases 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

[[Page 8432]]

PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
propanamide, 2-hydroxy-N, N-dimethyl- from food and water will utilize 
70.6% of the cPAD for children 1 to 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).
    Propanamide, 2-hydroxy-N, N-dimethyl- may be used as an inert 
ingredient in pesticide products that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to propanamide, 2-hydroxy-N, N-
dimethyl-. Using the exposure assumptions described above, EPA has 
concluded that the combined short-term aggregated food, water, and 
residential exposures result in MOEs of 374 for both adult males and 
females. Adult residential exposure combines high-end dermal and 
inhalation handler exposure from liquids/trigger sprayer/home garden 
with a high-end post- application dermal exposure from contact with 
treated lawns. EPA has concluded the combined short-term aggregated 
food, water, and residential exposures result in an aggregate MOE of 
132 for children. Children's residential exposure includes total 
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). As the level of concern is for MOEs that are lower 
than 100, this MOEs is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Propanamide, 2-hydroxy-N, N-dimethyl- may be used as an inert 
ingredient in pesticide products that could result in intermediate-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
intermediate-term residential exposures to propanamide, 2-hydroxy-N, N-
dimethyl-. Using the exposure assumptions described above, EPA has 
concluded that the combined intermediate-term aggregated food, water, 
and residential exposures result in aggregate MOEs of 498 for adult 
males and females. Adult residential exposure combines liquids/trigger 
sprayer/home garden with a high-end post-application dermal exposure 
from contact with treated lawns. EPA has concluded the combined 
intermediate-term aggregated food, water, and residential exposures 
result in an aggregate MOE of 137 for children. Children's residential 
exposure includes total exposures associated with contact with treated 
lawns (dermal and hand-to-mouth exposures). As the level of concern is 
for MOEs that are lower than 100, this MOE is not of concern.
    5. Aggregate cancer risk for U.S. population. Based on a DEREK 
structural alert analysis, the lack of mutagenicity and the lack of 
specific organ toxicity in the chronic toxicity study, propanamide, 2-
hydroxy-N, N-dimethyl- is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to propanamide, 2-hydroxy-N, N-dimethyl-.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
propanamide, 2-hydroxy-N, N-dimethyl- in or on any food commodities. 
EPA is establishing a limitation on the amount of propanamide, 2-
hydroxy-N, N-dimethyl- that may be used in pesticide formulations 
applied to growing crops. That limitation will be enforced through the 
pesticide registration process under the Federal Insecticide, 
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA 
will not register any pesticide formulation for use on growing crops 
for sale or distribution that exceeds 50% by weight of propanamide, 2-
hydroxy-N, N-dimethyl-.

B. Response to Comments

    The Agency received one relevant comment opposing a tolerance 
exemption for an increased concentration of 2-hydroxy-N, N-dimethyl- in 
pesticide formulations. Under the existing legal framework provided by 
FFDCA section 408, EPA is authorized to establish pesticide chemical 
tolerances or exemptions where persons seeking such tolerances or 
exemptions have demonstrated that the pesticide chemical meets the 
safety standard imposed by the statute. EPA has sufficient data to 
evaluate the potential adverse effects from exposure to this pesticide 
chemical, including data on the potential for long-term effects. After 
evaluating that data and other information, EPA has determined that the 
tolerance exemptions for this chemical are safe. The commenter has not 
provided any information supporting a conclusion that the tolerance 
exemption is not safe.

VI. Conclusions

    Therefore, the exemptions from the requirement of a tolerance under 
40 CFR 180.910 and under 40 CFR 180.930 for residues of propanamide, 2-
hydroxy-N, N-dimethyl- (CAS Reg. No. 35123-06-9) when used as an inert 
ingredient (solvent/co-solvent) are modified to allow use at a maximum 
concentration of 50% by weight in pesticide formulations applied to 
growing crops or raw agricultural commodities after harvest when used 
in pesticide formulations applied to animals, respectively.

VII. Statutory and Executive Order Reviews

    This action amends exemptions to the requirement for a tolerance 
under FFDCA section 408(d) in response to a petition submitted to the 
Agency. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). 
Because this action has been exempted from review under Executive Order 
12866, this action is 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), nor is 
it considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). 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

[[Page 8433]]

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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 17, 2020.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.910, revise the inert ingredient ``Propanamide, 2-
hydroxy-N, N-dimethyl- (CAS Reg. No. 35123-06-9)'' in the table to read 
as follows:


Sec.  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
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Propanamide, 2-hydroxy-N, N-dimethyl-     Not to exceed 50% by weight in   Solvent/co-solvent.
 (CAS Reg. No. 35123-06-9).                pesticide formulation.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


0
3. In Sec.  180.930, revise the inert ingredient ``Propanamide, 2-
hydroxy-N, N-dimethyl- (CAS Reg. No. 35123-06-9)'' in the table to read 
as follows:


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

* * * * *

----------------------------------------------------------------------------------------------------------------
            Inert ingredients                          Limits                               Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Propanamide, 2-hydroxy-N, N-dimethyl-     Not to exceed 50% by weight in   Solvent/co-solvent.
 (CAS Reg. No. 35123-06-9).                pesticide formulation.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2020-02042 Filed 2-13-20; 8:45 am]
BILLING CODE 6560-50-P