
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Rules and Regulations]
[Pages 14617-14620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05701]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0378; FRL-9956-02]


Isoamyl Acetate; 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 isoamyl acetate (CAS Reg. No. 123-92-2) 
when used as an inert ingredient (buffering agent) in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest. The Technology Sciences Group on behalf of the Jeneil 
Biosurfactant Company 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.

DATES: This regulation is effective March 22, 2017. Objections and 
requests for hearings must be received on or before May 22, 2017, 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-2016-0378, 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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: 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-2016-0378 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 
May 22, 2017. 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-2016-0378, 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 29, 2016 (81 FR 59165) (FRL-9950-
22), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10851) by 
the Technology Sciences Group, 1150 18th Street NW., Suite 1000, 
Washington, DC 20036, on behalf of the Jeneil Biosurfactant Company, 
400 N. Dekora Woods Blvd., Saukville, WI 53080. The petition requested 
that 40 CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of isoamyl acetate (CAS Reg. 
No.123-92-2) when used as an inert ingredient (buffering agent) in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest. That document referenced a summary of the 
petition prepared by the Technology

[[Page 14618]]

Sciences Group on behalf of the Jeneil Biosurfactant Company the 
petitioner, which is available in the docket, http://www.regulations.gov. One comment was received and posted to this 
docket. The comment did not pertain to isoamyl acetate but to a totally 
unrelated compound.
    This regulation eliminates the need to establish a maximum 
permissible level for residues of isoamyl acetate when applied in 
accordance with the conditions under 40 CFR 180.910.

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 isoamyl acetate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with isoamyl acetate 
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 isoamyl acetate 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.
    Isoamyl acetate exhibits low levels of acute toxicity with oral 
lethal dose (LD)50s for rats and rabbits being 16.6 grams/
kilogram (g/kg) and 7.4 g/kg respectively. The dermal LD50 
for rabbits is >5g/kg. It is not irritating to rabbit skin.
    The National Toxicology Program reported dogs exposed to 5,000 
parts per million (ppm) isoamyl acetate via inhalation for one hour 
showed drowsiness and nasal irritation. Cats exposed to 4,000 ppm 
isoamyl acetate for 20 minutes experienced eye and nose irritation.
    The potential for eye irritation in rabbits was evaluated with a 
mixture of n-pentyl acetate and 2-methylbutyl acetate, two structural 
isomers of isoamyl acetate. Moderate conjunctival irritation, with no 
effects to the cornea or iris, resulted from ocular exposure and minor, 
transient conjunctival irritation was also observed. Conjunctival 
effects cleared up in 7 days.
    There are no repeat-dose toxicity studies with isoamyl acetate. 
However, there are studies available regarding isoamyl alcohol. Isoamyl 
acetate readily metabolizes to isoamyl alcohol and toxicity data on 
isoamyl alcohol may be used as a surrogate for isoamyl acetate.
    In a 4-week range-finding drinking water study, SPF-Wistar rats 
received isoamyl alcohol doses of 360 milligrams/kilogram/day (mg/kg/
day) for two weeks and 1160 mg/kg/day for the next two weeks (20,000 
and 16,000 ppm respectively). The higher concentration was unpalatable 
to the rats. Exposure to isoamyl alcohol did not affect body weight 
gain or food consumption and no effects were observed upon gross post-
mortem examination. The NOAEL for this study is 1,160 mg/kg/day.
    In a subsequent 90-day study, rats were given daily drinking water 
concentrations of 0, 1,000, 4,000 and 16,000 ppm isoamyl alcohol (males 
0, 73, 295, 1,068 mg/kg/day and females 91, 385, 1,657 mg/kg/day, 
respectively). Treatment did not induce any effect on mortality, body 
weight, various clinical chemistry parameters, or organ weights or any 
abnormality at gross and microscopic examination. There were marginal 
increases in red blood cell counts in the male animals of the mid- and 
high-dose groups and slight decreases in mean corpuscular volume and 
mean corpuscular hemoglobin content in the male animals of the high-
dose group. The highest dose levels tested were the no observed-
adverse-effect levels (NOAEL) in the drinking water study in rats 
(1,068 and 1,657 mg/kg/day in males and females respectively.
    In a 17-week oral gavage study, Ash/CSE rats were administered 
daily doses of 0, 150, 500 or 1,000 mg/kg/day isoamyl alcohol. 
Parameters and endpoints evaluated included clinical observations, body 
weight, food and water consumption, hematology, clinical chemistry, 
urinalysis, organ weights (brain, liver, heart, spleen, stomach, small 
intestine, caecum, adrenals, gonads, pituitary and thyroid) and 
macroscopic and microscopic evaluations. Two high-dose rats died from 
lung congestion which was

[[Page 14619]]

attributed to gavage error. No deaths or abnormalities in behavior 
occurred during the study in any of the test groups. After 17 weeks 
treatment, there were slight decreases in body weight gain in the high-
dose males. That was ascribed to 5-10% lower food consumption compared 
to controls. No other consistent test-related effects were seen in any 
of the test groups. The NOAEL under the conditions of this study was 
1,000 mg/kg/day.
    Isoamyl acetate was negative in bacteria cell and in vitro 
genotoxicity assays as well as one in vivo study. It did not induce 
reverse gene mutations in Salmonella typhimurium in the absence and 
presence of metabolic activation.
    Prenatal toxicity to isoamyl alcohol was studied using Wistar rats 
and Himalayan rabbits exposed 6 hours/day on gestational days 6-15 and 
7-19 respectively. Dose concentrations were 0, 500, 2,500 and 10,000 
mg/m\3\ (0, 135, 675, 2,700 ppm). All rats and rabbits were sacrificed 
on days 20 and 29 respectively. In both species, maternal toxicity was 
manifested by slight retardation of body weight gain during the first 
days of the exposure period in animals of the high-dose group. The 
rabbits of this group had eye irritation (reddish, lid closure, or 
slight discharge) during exposure. There were no compound-related signs 
of embryo/fetotoxicity or teratogenicity in any of the treated rat 
groups. In rabbits, there was a statistically significant increase 
incidence of total fetal soft tissue variations mainly caused by a 
significant increase in the incidence of `separated origin of 
carotids'. However, the incidences of variations were within the range 
of biological variation and unexpectedly low in control animals. The 
NOAEL for maternal toxicity in both rats and rabbits was 2,500 mg/m\3\ 
(675 ppm; 1,013 mg/kg/day) and the NOAEL for developmental toxicity was 
10,000 mg/m\3\ (2,700 ppm; 4,054 mg/kg/day).
    An in vitro Hydra attenuata developmental toxicity assay was 
conducted with isoamyl acetate. It was equally toxic to adults and 
embryos indicating low concern for developmental toxicity.
    The Joint FAO/WHO Expert Committee on Food Additives summarized a 
chronic study where male and female rats received 2% isoamyl alcohol in 
their drinking water. No adverse effects or tumors were observed up to 
2,000 mg/kg/day in rats given isoamyl alcohol in their drinking water 
for 53-56 weeks.
    A DEREK analysis conducted on the isoamyl acetate structure did not 
reveal any structural alerts for possible carcinogenicity with regard 
to systemic and organ toxicity or mutagenicity. Therefore, based on the 
results of the DEREK analysis, the lack of toxicity in the submitted 
studies, and the lack of mutagenicity, isoamyl acetate is not expected 
to be carcinogenic to humans.

B. Toxicological Points of Departure/Levels of Concern

    Due to the lack of adverse effects in the available data, no 
toxicological endpoint of concern has been identified. Therefore, a 
quantitative assessment of human exposure and risk is not necessary and 
have not been conducted.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isoamyl acetate, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from isoamyl acetate in food as follows:
    Under this exemption from the requirement of a tolerance, residues 
of isoamyl acetate may be found on foods from crops that were treated 
with pesticide formulations containing isoamyl acetate. However, a 
quantitative dietary exposure assessment was not conducted since an 
endpoint for risk assessment was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of 
concern was not identified for the acute and chronic dietary 
assessment, a quantitative dietary exposure risk assessment for 
drinking water was not conducted, although exposures may be expected 
from use on food crops.
    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).
    Isoamyl acetate may be used in pesticide products and non-pesticide 
products that may be used around the home. Based on the discussion in 
Unit IV.B., a quantitative residential exposure assessment for isoamyl 
acetate was not conducted.
    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 isoamyl acetate to share a common mechanism of 
toxicity with any other substances, and isoamyl acetate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
isoamyl acetate 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

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    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. Based on an 
assessment of isoamyl acetate, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of isoamyl acetate will 
not pose a risk to the U.S. population, including infants and children, 
and that there is a reasonable certainty that no harm will result to 
the general population, or to infants and children from aggregate 
exposure to isoamyl acetate 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.

[[Page 14620]]

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for isoamyl acetate (CAS Reg. No. 123-
92-2) when used as an inert ingredient (buffering agent) in pesticide 
formulations applied to growing crops and 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: February 13, 2017.
Michael Goodis,
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.

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            Inert ingredients                          Limits                              Uses
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                                                  * * * * * * *
Isoamyl acetate (CAS Reg. No. 123-92-2)..  .............................  Buffering Agent.
 
                                                  * * * * * * *
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[FR Doc. 2017-05701 Filed 3-21-17; 8:45 am]
BILLING CODE 6560-50-P


