Document ID: EPA-HQ-OPP-2015-0524-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Propanamide, 2-hydroxy-N, N-dimethyl-
Posted Date: 2016-05-02T04:00Z

[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Rules and Regulations]
[Pages 26141-26146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10227]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0524; FRL-9944-10]

Propanamide, 2-hydroxy-N, N-dimethyl- ; 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 propanamide, 2-hydroxy-N, N-dimethyl- 
(CAS Reg. No. 35123-06-9) when used as an inert ingredient (solvent/co-
solvent) in pesticides applied to growing crops and raw agricultural 
commodities after harvest under 40 CFR 180.910 or in pesticides applied 
to animals under 40 CFR 180.930 limited to maximum concentration of 20% 
by weight in the pesticide formulation. Spring Trading Company, LLC on 
behalf of BASF Corporation submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment 
of an exemption from the

[[Page 26142]]

requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of propanamide, 2-
hydroxy-N, N-dimethyl-.

DATES: This regulation is effective May 2, 2016. Objections and 
requests for hearings must be received on or before July 1, 2016, 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-2015-0524, is available at http://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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://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-2015-0524 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 
July 1, 2016. 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-2015-0524, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 9, 2015 (80 FR 54257) (FRL-
9933-26), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10782) by Spring Trading Company, LLC (10805 W. Timberwagon Circle 
Spring, TX 77380) on behalf of BASF Corporation (100 Campus Drive, 
Florham Park, NJ 07932). The petition requested that 40 CFR 180.910 and 
40 CFR 180.930 be amended by establishing 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) in pesticide formulations applied to growing crops 
and raw agricultural commodities after harvest or in pesticides applied 
to animals, respectively. That document referenced a summary of the 
petition prepared by Spring Trading Company, LLC on behalf of BASF 
Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
limited the maximum concentration of propanamide, 2-hydroxy-N, N-
dimethyl to 20% by weight in pesticide formulations. The reasons for 
this change are explained in Unit V.B. below.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

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

[[Page 26143]]

result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 lethal dose (LD)50s 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 
milligrams/kilogram/day (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 Deductive 
Estimation of Risk from Existing Knowledge (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.

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 http://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 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 Food Quality Protection

[[Page 26144]]

Act Safety Factor (FQPA SF) was reduced to 1x. Default values of 100% 
absorption were used in dermal and inhalation toxicity endpoint 
selection.

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 (PCT) was assumed, default processing 
factors, and tolerance-level residues for all foods and use limitations 
of not more than 20% 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 http://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 parts per billion (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).
    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 Web site 
at http://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 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 (1mg/kg/day) will be protective of effects seen at 500 
mg/kg/day. In addition, the Agency used conservative exposure 
estimates, with 100 PCT, 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 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

[[Page 26145]]

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 
28.4% 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).
    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 115 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. 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 
154 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, these 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).
    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 591 for adult 
males and females. Adult residential exposure combines indoor hard 
surface, wiping with a high-end post-application dermal exposure from 
contact with treated lawns. As the level of concern is for MOEs that 
are lower than 100, this MOE is not of concern. EPA has concluded the 
combined intermediate-term aggregated food, water, and residential 
exposures result in an aggregate MOE of 214 for children. Children's 
residential exposure includes total exposures associated with contact 
with treated surfaces (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 20% by weight of propanamide, 2-
hydroxy-N, N- dimethyl-.

B. Revisions to Petitioned-For Tolerance Exemptions

    Based upon an evaluation of the data included in the petition, EPA 
is establishing an exemption from the requirement of a tolerance for 
residues of propanamide, 2-hydroxy-N, N-dimethyl when used in pesticide 
formulations as an inert ingredient (solvent/co-solvent), not to exceed 
20% by weight of the formulation, instead of the unlimited use 
requested. When considering unlimited use resulted in aggregate risks 
of concern, the petitioner revised their request to seek a 20% 
limitation by weight of formulation. The basis for this revision can be 
found at http://www.regulations.gov in document ``Propanamide, 2-
hydroxy-N, N-dimethyl-; Human Health Risk Assessment and Ecological 
Effects Assessment to Support Proposed Exemption From the Requirement 
of a Tolerance When Used as an Inert Ingredient in Pesticide 
Formulations'' in docket ID number EPA-HQ-OPP-2015-0524.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for residues of propanamide, 2-
hydroxy-N, N-dimethyl- (Reg. No. 35123-06-9) when used as an inert 
ingredient (solvent/co-solvent) at a maximum concentration of 20% by 
weight in pesticide formulations applied to growing crops or raw 
agricultural commodities after harvest and under 40 CFR 180.930 when 
used in pesticide formulations applied to animals.

VII. Statutory and Executive Order Reviews

    This action establishes 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). 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

[[Page 26146]]

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: April 21, 2016.
Daniel J. Rosenblatt,
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, add alphabetically the inert ingredient to the 
table to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Propanamide, 2-hydroxy-N, N-      Not to exceed 20%   Solvent/co-
 dimethyl- (CAS Reg. No. 35123-    by weight in        solvent.
 06-9).                            pesticide
                                   formulation.
 
                              * * * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.930, add alphabetically the inert ingredient to 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-      Not to exceed 20%   Solvent/co-solvent
 dimethyl- (CAS Reg. No. 35123-    by weight in
 06-9).                            pesticide
                                   formulation.
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-10227 Filed 4-29-16; 8:45 am]
 BILLING CODE 6560-50-P