
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Rules and Regulations]
[Pages 3723-3726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01154]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0373; FRL-9941-17]


Propanoic acid, 2-methyl-, monoester With 2,2,4-trimethyl-1,3-
pentanediol; 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 propanoic acid, 2-methyl-, monoester 
with 2,2,4-trimethyl-1,3-pentanediol when used as an inert ingredient 
(solvent, co-solvent) in pesticide formulations applied to growing 
crops or raw agricultural commodities under the EPA's regulations. Dow 
AgroSciences 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 propanoic acid, 
2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol.

DATES: This regulation is effective January 22, 2016. Objections and 
requests for hearings must be received on or before March 22, 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-2015-0373, 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-

[[Page 3724]]

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-2015-0373 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 
March 22, 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-2015-0373, 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 August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10786) by 
Dow AgroSciences, 9330 Zionville Rd., Indianapolis, IN 46268. The 
petition requested that 40 CFR 180.910 be amended by establishing an 
exemption from the requirement of a tolerance for residues of propanoic 
acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol (CAS 
Reg. No. 25265-77-4) when used as an inert ingredient as a solvent or 
co-solvent in pesticide formulations applied to growing crops or raw 
agricultural commodities after harvest. That document referenced a 
summary of the petition prepared by Dow AgroSciences, the petitioner, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of 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 propanoic acid, 2-methyl-, 
monoester with 2,2,4-trimethyl-1,3-pentanediol including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with propanoic acid, 2-
methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol 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 propanoic acid, 2-methyl-, monoester 
with 2,2,4-trimethyl-1,3-pentanediol 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.
    Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol has low acute toxicity with oral lethal dose 
(LD)50 values >3,200 milligram/kilogram (mg/kg), dermal 
LD50 values >14,000

[[Page 3725]]

mg/kg, and inhalation lethal concentration (LC)50 values 
>3.55 mg/liter (L) in rats, rabbits, and guinea pigs. In a 15-day oral 
gavage study in rats, the NOAEL was >1,000 mg/kg/day. In a combined 
repeat dose toxicity and developmental and reproductive toxicity 
screening test in rats, no reproductive or developmental toxicity was 
observed at doses up to 1,000 mg/kg body weight (bw)/day, the highest 
dose tested.
    No chronic toxicity studies were available; however, the lack of 
systemic toxicity in two shorter repeat dose studies at the limit dose 
of 1,000 mg/kg bw/day indicates that chronic toxicity is not a concern.
    Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol was negative genotoxicity in the Ames assay and in vivo 
micronucleus assay.
    No cancer study is available for propanoic acid, 2-methyl-, 
monoester with 2,2,4-trimethyl-1,3-pentanediol, however based on the 
lack of genotoxicity, no adverse effects seen in subchronic toxicity 
studies, and structure-activity relationship models (QSAR) modeling 
that did not indicate any triggers for carcinogenicity, propanoic acid, 
2-methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is not 
expected to be carcinogenic.
    Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol is a mixture of the 1-substituted (-65%) and the 3-
substituted (-35%) monoisobutyrate isomers of 2,2,4-trimethyl-l,3-
pentanediol. The half-life of the 1-substituted isomer in human and rat 
blood is between 15 to 22 minutes. No specific information is available 
on toxicity of propanoic acid, 2-methyl-, monoester with 2,2,4-
trimethyl-1,3-pentanediol metabolites. However, propanoic acid, 2-
methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol is rapidly 
metabolized in rat blood, and toxicity of parent propanoic acid, 2-
methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol in rats was not 
observed at doses up to 1,000 mg/kg/day, so metabolite toxicity is 
anticipated to be low.

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.
    Since there is no indication of toxicity at the limit dose, a 
toxicological endpoint of concern for risk assessment purposes was not 
identified. Since no endpoint of concern was identified for the acute 
and chronic dietary exposure assessment and short and intermediate 
dermal and inhalation exposure, a quantitative risk assessment for 
propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-
1,3-pentanediol, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol in food as follows:
    Dietary exposure can occur from eating foods containing residues of 
propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol. Because no hazard endpoint of concern was identified for 
the acute and chronic dietary assessment (food and drinking water), a 
quantitative dietary exposure risk assessment was not conducted.
    2. Dietary exposure from drinking water. Propanoic acid, 2-methyl-, 
monoester with 2,2,4-trimethyl-1,3-pentanediol residues may be found in 
drinking water. However, since an endpoint of concern was not 
identified for the dietary assessment (food and drinking water), a 
quantitative dietary exposure risk assessment was not conducted.
    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).
    Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol is used as an inert ingredient in pesticide products that 
could result in short- and intermediate-term residential exposure. 
However, based on the lack of toxicity, a quantitative exposure 
assessment from residential exposures was not performed.
    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 propanoic acid, 2-methyl-, monoester with 2,2,4-
trimethyl-1,3-pentanediol to share a common mechanism of toxicity with 
any other substances, and propanoic acid, 2-methyl-, monoester with 
2,2,4-trimethyl-1,3-pentanediol does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that propanoic acid, 2-
methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol 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

    Based on an assessment of propanoic acid, 2-methyl-, monoester with 
2,2,4-trimethyl-1,3-pentanediol, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children, and has determined that a qualitative assessment 
is appropriate. As part of its qualitative assessment, the Agency did 
not use safety factors for assessing risk, and no additional safety 
factor is needed for assessing risk to infants and children.

[[Page 3726]]

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.
    Based on the lack of any toxicological endpoints of concern, 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 propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-
1,3-pentanediol residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for propanoic acid, 2-methyl-, 
monoester with 2,2,4-trimethyl-1,3-pentanediol (CAS Reg. No. 25265-77-
4) when used as an inert ingredient (solvent or co-solvent) in 
pesticide formulations applied to growing crops or raw agricultural 
commodities after harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption 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 12, 2016.
Susan Lewis,
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 entry ``Propanoic acid, 2-
methyl-, monoester with 2,2,4-trimethyl-1,3-pentanediol'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
Propanoic acid, 2-methyl-,         ..............  Solvent, co-solvent.
 monoester with 2,2,4-trimethyl-
 1,3-pentanediol (CAS Reg. No.
 25265-77-4).....................
 
                              * * * * * * *
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[FR Doc. 2016-01154 Filed 1-21-16; 8:45 am]
 BILLING CODE 6560-50-P


