80 FR 25950 - 1-Octanol; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 87 (May 6, 2015)

This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide 1-octanol in or on root and tuber vegetables. D-I-1-4, Inc., a division of 1,4- Group, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to the exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1-octanol in or on root and tuber vegetables.

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25950-25953]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10364]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0353; FRL-9924-81]


1-Octanol; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the biochemical pesticide 1-octanol in 
or on root and tuber vegetables. D-I-1-4, Inc., a division of 1,4-
Group, Inc., submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), requesting an amendment to the exemption from 
the requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of 1-octanol in or 
on root and tuber vegetables.

DATES: This regulation is effective May 6, 2015. Objections and 
requests for hearings must be received on or before July 6, 2015, 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-2014-0353, 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: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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-2014-0353 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 6, 2015. 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-2014-0353, 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. Background and Statutory Findings

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 3F8195) by D-I-1-4, Inc., a division of 1,4-Group, Inc. 
(the Petitioner), P.O. Box 860, Meridian, ID 83360. The petition 
requested that 40 CFR part 180 be amended by establishing an exemption 
from the requirement of a tolerance for residues of 1-octanol, applied 
post-harvest to stored potatoes and other sprouting root and tuber 
crops. That document referenced a summary of the

[[Page 25951]]

petition prepared by the Petitioner, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    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 exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require 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. . . 
. '' Additionally, EPA is required to take into account the factors set 
forth in FFDCA section 408(b)(2)(D).
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability, 
and the relationship of this information 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.

A. Overview of 1-Octanol

    1-Octanol, or octyl alcohol, is a linear saturated aliphatic 
alcohol containing eight carbons. It is classified as a biochemical 
pesticide and functions as a plant growth regulator (PGR) by inhibiting 
sprout growth on stored potatoes and other sprouting root and tuber 
crops when applied after harvesting.
    There is a significant history of human dietary exposure to 1-
octanol. 1-Octanol occurs naturally in the essential oils of green tea, 
grapefruit, California orange, bitter orange, Turkish rose and 
Bulgarian rose. 1-Octanol has also been identified as a component of 
fried bacon, roasted filberts, raw and roasted earth almonds, mutton, 
chicken, pork, raw beef, frankfurters, nectarines, apple juice, common 
guava, Gruyere cheese and in foods processed from cassava root. The 
amount of 1-octanol has been quantified in some foods: Fermented 
soybean curds were found to contain 164.8 to 337.1 micrograms per 
kilogram (ug/kg) of 1-octanol, and duck meat and duck fat were found to 
contain 1-octanol as a volatile component at 8.88 parts per billion 
(ppb) and 12.69 ppb, respectively. 1-Octanol is approved by the FDA for 
use as a direct food additive under 21 CFR 172.230 in microcapsules for 
flavoring substances and under 21 CFR 172.515 as a synthetic flavoring 
substance and adjuvant.
    EPA has already determined under the FFDCA that there is a 
reasonable certainty that no harm will result from aggregate exposures 
to 1-octanol, when 1-octanol is used as an inert ingredient 
(specifically as a solvent or co-solvent) in pesticide products applied 
to food. In addition, 1-octanol has been registered for use as an 
active ingredient to control tobacco sucker and as an inert ingredient 
for nonfood and fragrance uses.
    For a summary of the data upon which EPA relied, and its human 
health risk assessment based on that data, please refer to the March 
13, 2015 document entitled: ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Considerations for 1-Octanol'' available in the docket for this 
action.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the petition to establish an exemption from the requirement of a 
tolerance for the use of 1-octanol as an active ingredient, post-
harvest, on root and tuber vegetables have been fulfilled. No 
significant toxicological effects were observed in any of the acute 
toxicity studies and no toxic endpoints were established as a result of 
these studies. In addition, data and information submitted indicate 
that 1-octanol is not genotoxic. A developmental toxicity study 
(subchronic) revealed increased salivation (maternal) at 1,000 
milligrams 1-octanol per kilogram body weight (mg/kg); however, the 
Agency does not consider this to be an adverse effect because the 
effect occurs at a very high dose, much higher dose than the level at 
which humans are likely to be exposed, given the half-life of this 
substance and the classification of the pesticide: A plant growth 
regulator intended for use before long-term storage. EPA concludes that 
1-octanol has no subchronic toxic effects and is not a developmental 
toxicant. There are no known effects of 1-octanol on endocrine systems 
via oral, dermal, or inhalation routes of exposure.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    The proposed use patterns may result in dietary exposure to 1-
octanol, however, dietary exposure as a result of the application of 1-
octanol to post-harvest potatoes and other root tubers is expected to 
be insignificant. 1-Octanol is volatile and is expected to degrade in 
the atmosphere by reaction with photochemically-produced hydroxyl 
radicals; its half-life is estimated to be from 3.5 minutes to 1.3 
days. The typical length of time between application of the pesticide 
and consumption of the potatoes will exceed this half-life. Therefore, 
residues of 1-octanol are unlikely to occur at the time of consumption. 
No significant exposure via drinking water is expected from its use as 
an active ingredient in this pesticide as 1-octanol is applied indoors 
only. Some dietary exposure is expected from the use of 1-octanol as an 
inert ingredient in pesticide formulations.
    Some dietary exposure to 1-octanol might occur through other 
nonpesticidal sources as a result of its natural presence in other 
foods or from its use as a food additive and flavoring substance. 
Should exposure occur, however, minimal to no risk is expected for the 
general population, including infants and children, due to the low 
toxicity of 1-octanol.

B. Other Non-Occupational Exposure

    Other non-occupational exposure to 1-octanol from pesticidal use 
may occur in tobacco products from its use on

[[Page 25952]]

tobacco or in or on other food and non-food commodities, as a result of 
its use as a pesticide inert ingredient. However, minimal to no risk is 
expected for the general population, including infants and children, 
due to the low toxicity of this chemical as demonstrated in the data 
submitted and evaluated by the Agency, as fully explained in the March 
13, 2015 document entitled: ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Considerations for 1-Octanol'' available in the docket for this 
action.

V. 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 1-octanol to share a common mechanism of toxicity 
with any other substances, and 1-octanol does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that 1-octanol 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.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, FFDCA 
section 408(b)(2)(C) 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 that a different margin of safety will be safe for infants 
and children. This additional margin of safety is commonly referred to 
as the Food Quality Protection Act Safety Factor (FQPA)(SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional or no safety factor when reliable data 
are available to support a different additional or no safety factor.
    As part of its qualitative assessment, EPA evaluated the available 
toxicity and exposure data on 1-octanol and considered its validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. EPA considers the toxicity database to be 
complete and has identified no residual uncertainty with regard to 
prenatal and postnatal toxicity or exposure. No hazard was identified 
based on the available studies; therefore, EPA concludes that there are 
no threshold effects of concern to infants, children, or adults from 1-
octanol. As a result, EPA concludes that no additional margin of 
exposure (safety) is necessary.

 VII. 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.

VIII. Conclusion

    Based on its assessment of 1-octanol, 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 1-
octanol. Therefore, an amendment to the exemption of a tolerance is 
established for residues of 1-octanol in or on root and tuber 
vegetables.
    The Agency is issuing the exemption for residues on root and tuber 
vegetables instead of limiting this exemption to post-harvest indoor 
applications to root and tuber vegetables because these restrictions 
are not relevant to the FFDCA safety finding for 1-octanol. Those 
limitations are related to the use of the pesticide and regulated under 
FIFRA.

IX. Statutory and Executive Order Reviews

    This final rule 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 final rule has been exempted from review 
under Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

X. 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

[[Page 25953]]

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 10, 2015.
Robert McNally,
Director, Biopesticides and Pollution Prevention 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. Add Sec.  180.1330 to subpart D to read as follows:


Sec.  180.1330  1-Octanol; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of 1-octanol in or on root and tuber vegetables when applied 
as a plant growth regulator in accordance with label directions and 
good agricultural practices.

[FR Doc. 2015-10364 Filed 5-5-15; 8:45 am]
 BILLING CODE 6560-50-P