81 FR 26141 - Propanamide, 2-hydroxy-N, N-dimethyl- ; Exemption from the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 84 (May 2, 2016)

Page Range		26141-26146
FR Document		2016-10227

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

Federal Register, Volume 81 Issue 84 (Monday, May 2, 2016)

[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Rules and Regulations]
[Pages 26141-26146]
From the Federal Register Online  [www.thefederalregister.org]
[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: [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 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-FCID^TM, 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

26142 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations

requirement of a tolerance. This through the Government Printing petition (PP IN–10782) by Spring
regulation eliminates the need to Office’s e-CFR site at http:// Trading Company, LLC (10805 W.
establish a maximum permissible level www.ecfr.gov/cgi-bin/text- Timberwagon Circle Spring, TX 77380)
for residues of propanamide, 2-hydroxy- idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ on behalf of BASF Corporation (100
N, N-dimethyl-. 40tab_02.tpl. Campus Drive, Florham Park, NJ 07932).
DATES: This regulation is effective May The petition requested that 40 CFR
C. How can I file an objection or hearing
2, 2016. Objections and requests for 180.910 and 40 CFR 180.930 be
request? amended by establishing exemptions
hearings must be received on or before
July 1, 2016, and must be filed in Under FFDCA section 408(g), 21 from the requirement of a tolerance for
accordance with the instructions U.S.C. 346a, any person may file an residues of propanamide, 2-hydroxy-N,
provided in 40 CFR part 178 (see also objection to any aspect of this regulation N-dimethyl- (CAS Reg. No. 35123–06–9)
Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those when used as an inert ingredient
INFORMATION). objections. You must file your objection (solvent/co-solvent) in pesticide
or request a hearing on this regulation formulations applied to growing crops
ADDRESSES: The docket for this action,
in accordance with the instructions and raw agricultural commodities after
identified by docket identification (ID)
provided in 40 CFR part 178. To ensure harvest or in pesticides applied to
number EPA–HQ–OPP–2015–0524, is
proper receipt by EPA, you must animals, respectively. That document
available at http://www.regulations.gov
identify docket ID number EPA–HQ– referenced a summary of the petition
or at the Office of Pesticide Programs
OPP–2015–0524 in the subject line on prepared by Spring Trading Company,
Regulatory Public Docket (OPP Docket)
the first page of your submission. All LLC on behalf of BASF Corporation, the
in the Environmental Protection Agency
objections and requests for a hearing petitioner, which is available in the
Docket Center (EPA/DC), West William
must be in writing, and must be docket, http://www.regulations.gov.
Jefferson Clinton Bldg., Rm. 3334, 1301
received by the Hearing Clerk on or There were no comments received in
Constitution Ave. NW., Washington, DC
before July 1, 2016. Addresses for mail response to the notice of filing.
20460–0001. The Public Reading Room Based upon review of the data
is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and
hearing requests are provided in 40 CFR supporting the petition, EPA has limited
Monday through Friday, excluding legal the maximum concentration of
holidays. The telephone number for the 178.25(b).
In addition to filing an objection or propanamide, 2-hydroxy-N, N-dimethyl
Public Reading Room is (202) 566–1744, to 20% by weight in pesticide
hearing request with the Hearing Clerk
and the telephone number for the OPP formulations. The reasons for this
as described in 40 CFR part 178, please
Docket is (703) 305–5805. Please review change are explained in Unit V.B.
submit a copy of the filing (excluding
the visitor instructions and additional below.
any Confidential Business Information
information about the docket available
(CBI)) for inclusion in the public docket. III. Inert Ingredient Definition
at http://www.epa.gov/dockets.
Information not marked confidential
FOR FURTHER INFORMATION CONTACT: Inert ingredients are all ingredients
pursuant to 40 CFR part 2 may be
Susan Lewis, Registration Division disclosed publicly by EPA without prior that are not active ingredients as defined
(7505P), Office of Pesticide Programs, notice. Submit the non-CBI copy of your in 40 CFR 153.125 and include, but are
Environmental Protection Agency, 1200 objection or hearing request, identified not limited to, the following types of
Pennsylvania Ave. NW., Washington, by docket ID number EPA–HQ–OPP– ingredients (except when they have a
DC 20460–0001; main telephone 2015–0524, by one of the following pesticidal efficacy of their own):
number: (703) 305–7090; email address: methods: Solvents such as alcohols and
RDFRNotices@epa.gov. • Federal eRulemaking Portal: http:// hydrocarbons; surfactants such as
SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online polyoxyethylene polymers and fatty
instructions for submitting comments. acids; carriers such as clay and
I. General Information
Do not submit electronically any diatomaceous earth; thickeners such as
A. Does this action apply to me? information you consider to be CBI or carrageenan and modified cellulose;
You may be potentially affected by other information whose disclosure is wetting, spreading, and dispersing
this action if you are an agricultural restricted by statute. agents; propellants in aerosol
producer, food manufacturer, or • Mail: OPP Docket, Environmental dispensers; microencapsulating agents;
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ and emulsifiers. The term ‘‘inert’’ is not
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. intended to imply nontoxicity; the
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. ingredient may or may not be
not intended to be exhaustive, but rather • Hand Delivery: To make special chemically active. Generally, EPA has
provides a guide to help readers arrangements for hand delivery or exempted inert ingredients from the
determine whether this document delivery of boxed information, please requirement of a tolerance based on the
applies to them. Potentially affected follow the instructions at http:// low toxicity of the individual inert
entities may include: www.epa.gov/dockets/contacts.html. ingredients.
• Crop production (NAICS code 111). Additional instructions on
IV. Aggregate Risk Assessment and
• Animal production (NAICS code commenting or visiting the docket,
Determination of Safety
112). along with more information about
• Food manufacturing (NAICS code dockets generally, is available at Section 408(c)(2)(A)(i) of FFDCA
311). http://www.epa.gov/dockets. allows EPA to establish an exemption
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• Pesticide manufacturing (NAICS from the requirement for a tolerance (the
II. Petition for Exemption legal limit for a pesticide chemical
code 32532).
In the Federal Register of September residue in or on a food) only if EPA
B. How can I get electronic access to 9, 2015 (80 FR 54257) (FRL–9933–26), determines that the tolerance is ‘‘safe.’’
other related information? EPA issued a document pursuant to Section 408(b)(2)(A)(ii) of FFDCA
You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a, defines ‘‘safe’’ to mean that ‘‘there is a
electronic version of 40 CFR part 180 announcing the filing of a pesticide reasonable certainty that no harm will

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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 26145

and no acute dietary endpoint was 2-hydroxy-N, N-dimethyl-. Using the requirement of a tolerance for residues
selected. exposure assumptions described above, of propanamide, 2-hydroxy-N, N-
2. Chronic risk. Using the exposure EPA has concluded that the combined dimethyl when used in pesticide
assumptions described in this unit for intermediate-term aggregated food, formulations as an inert ingredient
chronic exposure, EPA has concluded water, and residential exposures result (solvent/co-solvent), not to exceed 20%
that chronic exposure to propanamide, in aggregate MOEs of 591 for adult by weight of the formulation, instead of
2-hydroxy-N, N-dimethyl- from food males and females. Adult residential the unlimited use requested. When
and water will utilize 28.4% of the exposure combines indoor hard surface, considering unlimited use resulted in
cPAD for children 1–2 years old, the wiping with a high-end post-application aggregate risks of concern, the petitioner
population group receiving the greatest dermal exposure from contact with revised their request to seek a 20%
exposure. treated lawns. As the level of concern is limitation by weight of formulation. The
3. Short-term risk. Short-term for MOEs that are lower than 100, this basis for this revision can be found at
aggregate exposure takes into account MOE is not of concern. EPA has http://www.regulations.gov in document
short-term residential exposure plus concluded the combined intermediate- ‘‘Propanamide, 2-hydroxy-N, N-
chronic exposure to food and water term aggregated food, water, and dimethyl-; Human Health Risk
(considered to be a background residential exposures result in an Assessment and Ecological Effects
exposure level). aggregate MOE of 214 for children. Assessment to Support Proposed
Propanamide, 2-hydroxy-N, N- Children’s residential exposure includes Exemption From the Requirement of a
dimethyl- may be used as an inert total exposures associated with contact Tolerance When Used as an Inert
ingredient in pesticide products that with treated surfaces (dermal and hand- Ingredient in Pesticide Formulations’’ in
could result in short-term residential to-mouth exposures). As the level of docket ID number EPA–HQ–OPP–2015–
exposure and the Agency has concern is for MOEs that are lower than 0524.
determined that it is appropriate to 100, this MOE is not of concern.
aggregate chronic exposure through food VI. Conclusions
5. Aggregate cancer risk for U.S.
and water with short-term residential population. Based on a DEREK Therefore, an exemption from the
exposures to propanamide, 2-hydroxy- structural alert analysis, the lack of requirement of a tolerance is established
N, N-dimethyl-. Using the exposure mutagenicity and the lack of specific under 40 CFR 180.910 for residues of
assumptions described above, EPA has organ toxicity in the chronic toxicity propanamide, 2-hydroxy-N, N-dimethyl-
concluded that the combined short-term (Reg. No. 35123–06–9) when used as an
study, propanamide, 2-hydroxy-N, N-
aggregated food, water, and residential inert ingredient (solvent/co-solvent) at a
dimethyl- is not expected to pose a
exposures result in MOEs of 115 for maximum concentration of 20% by
cancer risk to humans.
both adult males and females. Adult weight in pesticide formulations
6. Determination of safety. Based on
residential exposure combines high-end applied to growing crops or raw
these risk assessments, EPA concludes
dermal and inhalation handler exposure agricultural commodities after harvest
that there is a reasonable certainty that
from liquids/trigger sprayer/home and under 40 CFR 180.930 when used
no harm will result to the general
garden with a high-end post- in pesticide formulations applied to
population, or to infants and children
application dermal exposure from animals.
from aggregate exposure to
contact with treated lawns. Adult
propanamide, 2-hydroxy-N, N- VII. Statutory and Executive Order
residential exposure combines high-end
dimethyl-. Reviews
dermal and inhalation handler exposure
from liquids/trigger sprayer/home V. Other Considerations This action establishes exemptions to
garden with a high-end post- the requirement for a tolerance under
application dermal exposure from A. Analytical Enforcement Methodology FFDCA section 408(d) in response to a
contact with treated lawns. EPA has An analytical method is not required petition submitted to the Agency. The
concluded the combined short-term for enforcement purposes since the Office of Management and Budget
aggregated food, water, and residential Agency is not establishing a numerical (OMB) has exempted these types of
exposures result in an aggregate MOE of tolerance for residues of propanamide, actions from review under Executive
154 for children. Children’s residential 2-hydroxy-N, N-dimethyl- in or on any Order 12866, entitled ‘‘Regulatory
exposure includes total exposures food commodities. EPA is establishing a Planning and Review’’ (58 FR 51735,
associated with contact with treated limitation on the amount of October 4, 1993). Because this action
lawns (dermal and hand-to-mouth propanamide, 2-hydroxy-N, N-dimethyl- has been exempted from review under
exposures). As the level of concern is for that may be used in pesticide Executive Order 12866, this action is
MOEs that are lower than 100, these formulations applied to growing crops. not subject to Executive Order 13211,
MOEs are not of concern. That limitation will be enforced through entitled ‘‘Actions Concerning
4. Intermediate-term risk. the pesticide registration process under Regulations That Significantly Affect
Intermediate-term aggregate exposure the Federal Insecticide, Fungicide, and Energy Supply, Distribution, or Use’’ (66
takes into account intermediate-term Rodenticide Act (‘‘FIFRA’’), 7 U.S.C. FR 28355, May 22, 2001) or Executive
residential exposure plus chronic 136 et seq. EPA will not register any Order 13045, entitled ‘‘Protection of
exposure to food and water (considered pesticide formulation for use on Children from Environmental Health
to be a background exposure level). growing crops for sale or distribution Risks and Safety Risks’’ (62 FR 19885,
Propanamide, 2-hydroxy-N, N- that exceeds 20% by weight of April 23, 1997). This action does not
dimethyl- may be used as an inert propanamide, 2-hydroxy-N, N- contain any information collections
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ingredient in pesticide products that dimethyl-. subject to OMB approval under the
could result in intermediate-term Paperwork Reduction Act (PRA) (44
residential exposure and the Agency has B. Revisions to Petitioned-For Tolerance U.S.C. 3501 et seq.), nor does it require
determined that it is appropriate to Exemptions any special considerations under
aggregate chronic exposure through food Based upon an evaluation of the data Executive Order 12898, entitled
and water with intermediate-term included in the petition, EPA is ‘‘Federal Actions to Address
residential exposures to propanamide, establishing an exemption from the Environmental Justice in Minority

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$26146 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations Populations and Low-Income that Executive Order 13132, entitled Register. This action is not a ‘‘major Populations’’ (59 FR 7629, February 16, ‘‘Federalism’’ (64 FR 43255, August 10, rule’’ as defined by 5 U.S.C. 804(2). 1994). 1999) and Executive Order 13175, List of Subjects in 40 CFR Part 180 Since tolerances and exemptions that entitled ‘‘Consultation and Coordination are established on the basis of a petition with Indian Tribal Governments’’ (65 FR Environmental protection, under FFDCA section 408(d), such as 67249, November 9, 2000) do not apply Administrative practice and procedure, the exemptions in this final rule, do not to this action. In addition, this action Agricultural commodities, Pesticides require the issuance of a proposed rule, does not impose any enforceable duty or and pests, Reporting and recordkeeping the requirements of the Regulatory contain any unfunded mandate as requirements. Flexibility Act (RFA) (5 U.S.C. 601 et described under Title II of the Unfunded Dated: April 21, 2016. seq.), do not apply. Mandates Reform Act (UMRA) (2 U.S.C. Daniel J. Rosenblatt, 1501 et seq.). Acting Director, Registration Division, Office This action directly regulates growers, food processors, food handlers, and food This action does not involve any of Pesticide Programs. retailers, not States or tribes, nor does technical standards that would require Therefore, 40 CFR chapter I is this action alter the relationships or Agency consideration of voluntary amended as follows: distribution of power and consensus standards pursuant to section responsibilities established by Congress 12(d) of the National Technology PART 180—[AMENDED] in the preemption provisions of FFDCA Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). ■ 1. The authority citation for part 180 section 408(n)(4). As such, the Agency continues to read as follows: has determined that this action will not VIII. Congressional Review Act have a substantial direct effect on States Authority: 21 U.S.C. 321(q), 346a and 371. or tribal governments, on the Pursuant to the Congressional Review ■ 2. In § 180.910, add alphabetically the relationship between the national Act (5 U.S.C. 801 et seq.), EPA will inert ingredient to the table to read as government and the States or tribal submit a report containing this rule and follows: governments, or on the distribution of other required information to the U.S. power and responsibilities among the Senate, the U.S. House of § 180.910 Inert ingredients used pre- and various levels of government or between Representatives, and the Comptroller post-harvest; exemptions from the the Federal Government and Indian General of the United States prior to requirement of a tolerance. tribes. Thus, the Agency has determined publication of the rule in the Federal * * * * * Inert ingredients Limits Uses * * * * * * * Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123–06–9) Not to exceed 20% by weight in Solvent/co-solvent. pesticide formulation. * * * * * * * ■ 3. In § 180.930, add alphabetically the § 180.930 Inert ingredients applied to inert ingredient to the table to read as animals; exemptions from the requirement of a tolerance. follows: * * * * * Inert ingredients Limits Uses * * * * * * * Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123–06–9) Not to exceed 20% by weight in Solvent/co-solvent pesticide formulation. * * * * * * * [FR Doc. 2016–10227 Filed 4–29–16; 8:45 am] BILLING CODE 6560–50–P mstockstill on DSK3G9T082PROD with RULES VerDate Sep<11>2014 17:39 Apr 29, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4700 Sfmt 9990 E:\FR\FM\02MYR1.SGM 02MYR1$

Document Created: 2016-04-30 13:35:20
Document Modified: 2016-04-30 13:35:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		81 FR 26141
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements