80_FR_26037 80 FR 25950 - 1-Octanol; Exemption From the Requirement of a Tolerance

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

ENVIRONMENTAL PROTECTION AGENCY

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

Page Range25950-25953
FR Document2015-10364

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 Issue 87 (Wednesday, May 6, 2015)
[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]


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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.

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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



                                            25950              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                              Dated: April 22, 2015.                                available at http://www.regulations.gov               and may also request a hearing on those
                                            Jack Housenger,                                         or at the Office of Pesticide Programs                objections. You must file your objection
                                            Director, Office of Pesticide Programs.                 Regulatory Public Docket (OPP Docket)                 or request a hearing on this regulation
                                              Therefore, 40 CFR chapter I is                        in the Environmental Protection Agency                in accordance with the instructions
                                            amended as follows:                                     Docket Center (EPA/DC), West William                  provided in 40 CFR part 178. To ensure
                                                                                                    Jefferson Clinton Bldg., Rm. 3334, 1301               proper receipt by EPA, you must
                                            PART 174—[AMENDED]                                      Constitution Ave. NW., Washington, DC                 identify docket ID number EPA–HQ–
                                                                                                    20460–0001. The Public Reading Room                   OPP–2014–0353 in the subject line on
                                            ■ 1. The authority citation for part 174                is open from 8:30 a.m. to 4:30 p.m.,                  the first page of your submission. All
                                            continues to read as follows:                           Monday through Friday, excluding legal                objections and requests for a hearing
                                              Authority: 7 U.S.C. 136–136y; 21 U.S.C.               holidays. The telephone number for the                must be in writing, and must be
                                            346a and 371.                                           Public Reading Room is (202) 566–1744,                received by the Hearing Clerk on or
                                                                                                    and the telephone number for the OPP                  before July 6, 2015. Addresses for mail
                                            ■ 2. In § 174.502, revise paragraph (b) to              Docket is (703) 305–5805. Please review               and hand delivery of objections and
                                            read as follows:                                        the visitor instructions and additional               hearing requests are provided in 40 CFR
                                            § 174.502 Bacillus thuringiensis Cry1A.105              information about the docket available                178.25(b).
                                            protein; exemption from the requirement of              at http://www.epa.gov/dockets.                          In addition to filing an objection or
                                            a tolerance.                                            FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                          hearing request with the Hearing Clerk
                                            *     *    *     *    *                                 Robert McNally, Biopesticides and                     as described in 40 CFR part 178, please
                                              (b) Residues of Bacillus thuringiensis                Pollution Prevention Division (7511P),                submit a copy of the filing (excluding
                                            Cry1A.105 protein in or on soybean are                  Office of Pesticide Programs,                         any Confidential Business Information
                                            exempt from the requirement of a                        Environmental Protection Agency, 1200                 (CBI)) for inclusion in the public docket.
                                            tolerance when used as a plant-                         Pennsylvania Ave. NW., Washington,                    Information not marked confidential
                                            incorporated protectant in the food and                 DC 20460–0001; main telephone                         pursuant to 40 CFR part 2 may be
                                            feed commodities of soybean.                            number: (703) 305–7090; email address:                disclosed publicly by EPA without prior
                                                                                                    BPPDFRNotices@epa.gov.                                notice. Submit the non-CBI copy of your
                                            [FR Doc. 2015–10624 Filed 5–5–15; 8:45 am]
                                                                                                                                                          objection or hearing request, identified
                                            BILLING CODE 6560–50–P                                  SUPPLEMENTARY INFORMATION:
                                                                                                                                                          by docket ID number EPA–HQ–OPP–
                                                                                                    I. General Information                                2014–0353, by one of the following
                                                                                                                                                          methods:
                                            ENVIRONMENTAL PROTECTION                                A. Does this action apply to me?                        • Federal eRulemaking Portal: http://
                                            AGENCY                                                     You may be potentially affected by                 www.regulations.gov. Follow the online
                                            40 CFR Part 180                                         this action if you are an agricultural                instructions for submitting comments.
                                                                                                    producer, food manufacturer, or                       Do not submit electronically any
                                            [EPA–HQ–OPP–2014–0353; FRL–9924–81]                     pesticide manufacturer. The following                 information you consider to be CBI or
                                                                                                    list of North American Industrial                     other information whose disclosure is
                                            1-Octanol; Exemption From the                           Classification System (NAICS) codes is                restricted by statute.
                                            Requirement of a Tolerance                              not intended to be exhaustive, but rather               • Mail: OPP Docket, Environmental
                                            AGENCY:  Environmental Protection                       provides a guide to help readers                      Protection Agency Docket Center (EPA/
                                            Agency (EPA).                                           determine whether this document                       DC), (28221T), 1200 Pennsylvania Ave.
                                            ACTION: Final rule.                                     applies to them. Potentially affected                 NW., Washington, DC 20460–0001.
                                                                                                    entities may include:                                   • Hand Delivery: To make special
                                            SUMMARY:   This regulation establishes an                  • Crop production (NAICS code 111).                arrangements for hand delivery or
                                            exemption from the requirement of a                        • Animal production (NAICS code                    delivery of boxed information, please
                                            tolerance for residues of the biochemical               112).                                                 follow the instructions at http://
                                            pesticide 1-octanol in or on root and                      • Food manufacturing (NAICS code                   www.epa.gov/dockets/contacts.html.
                                            tuber vegetables. D–I–1–4, Inc., a                      311).                                                   Additional instructions on
                                            division of 1,4-Group, Inc., submitted a                   • Pesticide manufacturing (NAICS                   commenting or visiting the docket,
                                            petition to EPA under the Federal Food,                 code 32532).                                          along with more information about
                                            Drug, and Cosmetic Act (FFDCA),                                                                               dockets generally, is available at http://
                                                                                                    B. How can I get electronic access to                 www.epa.gov/dockets.
                                            requesting an amendment to the                          other related information?
                                            exemption from the requirement of a                                                                           II. Background and Statutory Findings
                                            tolerance. This regulation eliminates the                 You may access a frequently updated
                                            need to establish a maximum                             electronic version of 40 CFR part 180                    In the Federal Register of August 1,
                                            permissible level for residues of 1-                    through the Government Publishing                     2014 (79 FR 44729) (FRL–9911–67),
                                            octanol in or on root and tuber                         Office’s e-CFR site at http://                        EPA issued a document pursuant to
                                            vegetables.                                             www.ecfr.gov/cgi-bin/text-                            FFDCA section 408(d)(3), 21 U.S.C.
                                                                                                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  346a(d)(3), announcing the filing of a
                                            DATES: This regulation is effective May                                                                       pesticide tolerance petition (PP 3F8195)
                                                                                                    40tab_02.tpl. To access the OCSPP test
                                            6, 2015. Objections and requests for                                                                          by D–I–1–4, Inc., a division of 1,4-
                                                                                                    guidelines referenced in this document
                                            hearings must be received on or before                                                                        Group, Inc. (the Petitioner), P.O. Box
                                                                                                    electronically, please go to http://
                                            July 6, 2015, and must be filed in                                                                            860, Meridian, ID 83360. The petition
                                                                                                    www.epa.gov/ocspp and select ‘‘Test
                                            accordance with the instructions                                                                              requested that 40 CFR part 180 be
                                                                                                    Methods and Guidelines.’’
tkelley on DSK3SPTVN1PROD with RULES




                                            provided in 40 CFR part 178 (see also                                                                         amended by establishing an exemption
                                            Unit I.C. of the SUPPLEMENTARY                          C. How can I file an objection or hearing             from the requirement of a tolerance for
                                            INFORMATION).                                           request?                                              residues of 1-octanol, applied post-
                                            ADDRESSES: The docket for this action,                    Under FFDCA section 408(g), 21                      harvest to stored potatoes and other
                                            identified by docket identification (ID)                U.S.C. 346a, any person may file an                   sprouting root and tuber crops. That
                                            number EPA–HQ–OPP–2014–0353, is                         objection to any aspect of this regulation            document referenced a summary of the


                                       VerDate Sep<11>2014   19:32 May 05, 2015   Jkt 235001   PO 00000   Frm 00054   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                          25951

                                            petition prepared by the Petitioner,                    inhibiting sprout growth on stored                    1-octanol per kilogram body weight
                                            which is available in the docket, http://               potatoes and other sprouting root and                 (mg/kg); however, the Agency does not
                                            www.regulations.gov. There were no                      tuber crops when applied after                        consider this to be an adverse effect
                                            comments received in response to the                    harvesting.                                           because the effect occurs at a very high
                                            notice of filing.                                          There is a significant history of                  dose, much higher dose than the level
                                               Section 408(c)(2)(A)(i) of FFDCA                     human dietary exposure to 1-octanol. 1-               at which humans are likely to be
                                            allows EPA to establish an exemption                    Octanol occurs naturally in the essential             exposed, given the half-life of this
                                            from the requirement for a tolerance (the               oils of green tea, grapefruit, California             substance and the classification of the
                                            legal limit for a pesticide chemical                    orange, bitter orange, Turkish rose and               pesticide: A plant growth regulator
                                            residue in or on a food) only if EPA                    Bulgarian rose. 1-Octanol has also been               intended for use before long-term
                                            determines that the exemption is ‘‘safe.’’              identified as a component of fried                    storage. EPA concludes that 1-octanol
                                            Section 408(c)(2)(A)(ii) of FFDCA                       bacon, roasted filberts, raw and roasted              has no subchronic toxic effects and is
                                            defines ‘‘safe’’ to mean that ‘‘there is a              earth almonds, mutton, chicken, pork,                 not a developmental toxicant. There are
                                            reasonable certainty that no harm will                  raw beef, frankfurters, nectarines, apple             no known effects of 1-octanol on
                                            result from aggregate exposure to the                   juice, common guava, Gruyere cheese                   endocrine systems via oral, dermal, or
                                            pesticide chemical residue, including                   and in foods processed from cassava                   inhalation routes of exposure.
                                            all anticipated dietary exposures and all               root. The amount of 1-octanol has been
                                            other exposures for which there is                      quantified in some foods: Fermented                   IV. Aggregate Exposures
                                            reliable information.’’ This includes                   soybean curds were found to contain                     In examining aggregate exposure,
                                            exposure through drinking water and in                  164.8 to 337.1 micrograms per kilogram                FFDCA section 408 directs EPA to
                                            residential settings, but does not include              (ug/kg) of 1-octanol, and duck meat and               consider available information
                                            occupational exposure. Pursuant to                      duck fat were found to contain 1-octanol              concerning exposures from the pesticide
                                            FFDCA section 408(c)(2)(B), in                          as a volatile component at 8.88 parts per             residue in food and all other non-
                                            establishing or maintaining in effect an                billion (ppb) and 12.69 ppb,                          occupational exposures, including
                                            exemption from the requirement of a                     respectively. 1-Octanol is approved by                drinking water from ground water or
                                            tolerance, EPA must take into account                   the FDA for use as a direct food additive             surface water and exposure through
                                            the factors set forth in FFDCA section                  under 21 CFR 172.230 in microcapsules                 pesticide use in gardens, lawns, or
                                            408(b)(2)(C), which require EPA to give                 for flavoring substances and under 21                 buildings (residential and other indoor
                                            special consideration to exposure of                    CFR 172.515 as a synthetic flavoring                  uses).
                                            infants and children to the pesticide                   substance and adjuvant.
                                                                                                       EPA has already determined under                   A. Dietary Exposure
                                            chemical residue in establishing a
                                            tolerance and to ‘‘ensure that there is a               the FFDCA that there is a reasonable                     The proposed use patterns may result
                                            reasonable certainty that no harm will                  certainty that no harm will result from               in dietary exposure to 1-octanol,
                                            result to infants and children from                     aggregate exposures to 1-octanol, when                however, dietary exposure as a result of
                                            aggregate exposure to the pesticide                     1-octanol is used as an inert ingredient              the application of 1-octanol to post-
                                            chemical residue. . . . ’’ Additionally,                (specifically as a solvent or co-solvent)             harvest potatoes and other root tubers is
                                            EPA is required to take into account the                in pesticide products applied to food. In             expected to be insignificant. 1-Octanol
                                            factors set forth in FFDCA section                      addition, 1-octanol has been registered               is volatile and is expected to degrade in
                                            408(b)(2)(D).                                           for use as an active ingredient to control            the atmosphere by reaction with
                                               EPA performs a number of analyses to                 tobacco sucker and as an inert                        photochemically-produced hydroxyl
                                            determine the risks from aggregate                      ingredient for nonfood and fragrance                  radicals; its half-life is estimated to be
                                            exposure to pesticide residues. First,                  uses.                                                 from 3.5 minutes to 1.3 days. The
                                            EPA determines the toxicity of                             For a summary of the data upon                     typical length of time between
                                            pesticides. Second, EPA examines                        which EPA relied, and its human health                application of the pesticide and
                                            exposure to the pesticide through food,                 risk assessment based on that data,                   consumption of the potatoes will exceed
                                            drinking water, and through other                       please refer to the March 13, 2015                    this half-life. Therefore, residues of 1-
                                            exposures that occur as a result of                     document entitled: ‘‘Federal Food, Drug,              octanol are unlikely to occur at the time
                                            pesticide use in residential settings.                  and Cosmetic Act (FFDCA)                              of consumption. No significant exposure
                                                                                                    Considerations for 1-Octanol’’ available              via drinking water is expected from its
                                            III. Toxicological Profile                              in the docket for this action.                        use as an active ingredient in this
                                               Consistent with FFDCA section                                                                              pesticide as 1-octanol is applied indoors
                                                                                                    B. Biochemical Pesticide Toxicology
                                            408(b)(2)(D), EPA has reviewed the                                                                            only. Some dietary exposure is expected
                                                                                                    Data Requirements
                                            available scientific data and other                                                                           from the use of 1-octanol as an inert
                                            relevant information in support of this                   All applicable mammalian toxicology                 ingredient in pesticide formulations.
                                            action and considered its validity,                     data requirements supporting the                         Some dietary exposure to 1-octanol
                                            completeness and reliability, and the                   petition to establish an exemption from               might occur through other nonpesticidal
                                            relationship of this information to                     the requirement of a tolerance for the                sources as a result of its natural
                                            human risk. EPA has also considered                     use of 1-octanol as an active ingredient,             presence in other foods or from its use
                                            available information concerning the                    post-harvest, on root and tuber                       as a food additive and flavoring
                                            variability of the sensitivities of major               vegetables have been fulfilled. No                    substance. Should exposure occur,
                                            identifiable subgroups of consumers,                    significant toxicological effects were                however, minimal to no risk is expected
                                            including infants and children.                         observed in any of the acute toxicity                 for the general population, including
                                                                                                    studies and no toxic endpoints were                   infants and children, due to the low
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                                            A. Overview of 1-Octanol                                established as a result of these studies.             toxicity of 1-octanol.
                                              1-Octanol, or octyl alcohol, is a linear              In addition, data and information
                                            saturated aliphatic alcohol containing                  submitted indicate that 1-octanol is not              B. Other Non-Occupational Exposure
                                            eight carbons. It is classified as a                    genotoxic. A developmental toxicity                     Other non-occupational exposure to
                                            biochemical pesticide and functions as                  study (subchronic) revealed increased                 1-octanol from pesticidal use may occur
                                            a plant growth regulator (PGR) by                       salivation (maternal) at 1,000 milligrams             in tobacco products from its use on


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                                            25952              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            tobacco or in or on other food and non-                 (FQPA)(SF). In applying this provision,               Concerning Regulations That
                                            food commodities, as a result of its use                EPA either retains the default value of               Significantly Affect Energy Supply,
                                            as a pesticide inert ingredient. However,               10X, or uses a different additional or no             Distribution, or Use’’ (66 FR 28355, May
                                            minimal to no risk is expected for the                  safety factor when reliable data are                  22, 2001) or Executive Order 13045,
                                            general population, including infants                   available to support a different                      entitled ‘‘Protection of Children from
                                            and children, due to the low toxicity of                additional or no safety factor.                       Environmental Health Risks and Safety
                                            this chemical as demonstrated in the                      As part of its qualitative assessment,              Risks’’ (62 FR 19885, April 23, 1997).
                                            data submitted and evaluated by the                     EPA evaluated the available toxicity and              This final rule does not contain any
                                            Agency, as fully explained in the March                 exposure data on 1-octanol and                        information collections subject to OMB
                                            13, 2015 document entitled: ‘‘Federal                   considered its validity, completeness,                approval under the Paperwork
                                            Food, Drug, and Cosmetic Act (FFDCA)                    and reliability, as well as the                       Reduction Act (PRA), 44 U.S.C. 3501 et
                                            Considerations for 1-Octanol’’ available                relationship of this information to                   seq., nor does it require any special
                                            in the docket for this action.                          human risk. EPA considers the toxicity                considerations under Executive Order
                                                                                                    database to be complete and has                       12898, entitled ‘‘Federal Actions to
                                            V. Cumulative Effects From Substances
                                                                                                    identified no residual uncertainty with               Address Environmental Justice in
                                            With a Common Mechanism of Toxicity
                                                                                                    regard to prenatal and postnatal toxicity             Minority Populations and Low-Income
                                               Section 408(b)(2)(D)(v) of FFDCA                     or exposure. No hazard was identified                 Populations’’ (59 FR 7629, February 16,
                                            requires that, when considering whether                 based on the available studies; therefore,            1994).
                                            to establish, modify, or revoke a                       EPA concludes that there are no                          Since tolerances and exemptions that
                                            tolerance, the Agency consider                          threshold effects of concern to infants,              are established on the basis of a petition
                                            ‘‘available information’’ concerning the                children, or adults from 1-octanol. As a              under FFDCA section 408(d), such as
                                            cumulative effects of a particular                      result, EPA concludes that no additional              the exemption in this final rule, do not
                                            pesticide’s residues and ‘‘other                        margin of exposure (safety) is necessary.             require the issuance of a proposed rule,
                                            substances that have a common                                                                                 the requirements of the Regulatory
                                            mechanism of toxicity.’’                                VII. Analytical Enforcement                           Flexibility Act (RFA) (5 U.S.C. 601 et
                                               EPA has not found 1-octanol to share                 Methodology                                           seq.), do not apply.
                                            a common mechanism of toxicity with                       An analytical method is not required                   This final rule directly regulates
                                            any other substances, and 1-octanol                     for enforcement purposes since the                    growers, food processors, food handlers,
                                            does not appear to produce a toxic                      Agency is establishing an exemption                   and food retailers, not States or tribes,
                                            metabolite produced by other                            from the requirement of a tolerance                   nor does this action alter the
                                            substances. For the purposes of this                    without any numerical limitation.                     relationships or distribution of power
                                            tolerance action, therefore, EPA has                                                                          and responsibilities established by
                                            assumed that 1-octanol does not have a                  VIII. Conclusion                                      Congress in the preemption provisions
                                            common mechanism of toxicity with                         Based on its assessment of 1-octanol,               of FFDCA section 408(n)(4). As such,
                                            other substances. For information                       EPA concludes that there is a reasonable              the Agency has determined that this
                                            regarding EPA’s efforts to determine                    certainty that no harm will result to the             action will not have a substantial direct
                                            which chemicals have a common                           general population, or to infants and                 effect on States or tribal governments,
                                            mechanism of toxicity and to evaluate                   children, from aggregate exposure to 1-               on the relationship between the national
                                            the cumulative effects of such                          octanol. Therefore, an amendment to the               government and the States or tribal
                                            chemicals, see EPA’s Web site at http://                exemption of a tolerance is established               governments, or on the distribution of
                                            www.epa.gov/pesticides/cumulative.                      for residues of 1-octanol in or on root               power and responsibilities among the
                                            VI. Determination of Safety for U.S.                    and tuber vegetables.                                 various levels of government or between
                                                                                                      The Agency is issuing the exemption                 the Federal Government and Indian
                                            Population, Infants and Children
                                                                                                    for residues on root and tuber vegetables             Tribes. Thus, the Agency has
                                               FFDCA section 408(b)(2)(C) provides                  instead of limiting this exemption to                 determined that Executive Order 13132,
                                            that, in considering the establishment of               post-harvest indoor applications to root              entitled ‘‘Federalism’’ (64 FR 43255,
                                            a tolerance or tolerance exemption for a                and tuber vegetables because these                    August 10, 1999) and Executive Order
                                            pesticide chemical residue, EPA shall                   restrictions are not relevant to the                  13175, entitled ‘‘Consultation and
                                            assess the available information about                  FFDCA safety finding for 1-octanol.                   Coordination with Indian Tribal
                                            consumption patterns among infants                      Those limitations are related to the use              Governments’’ (65 FR 67249, November
                                            and children, special susceptibility of                 of the pesticide and regulated under                  9, 2000) do not apply to this final rule.
                                            infants and children to pesticide                       FIFRA.                                                In addition, this final rule does not
                                            chemical residues, and the cumulative                                                                         impose any enforceable duty or contain
                                            effects on infants and children of the                  IX. Statutory and Executive Order
                                                                                                    Reviews                                               any unfunded mandate as described
                                            residues and other substances with a                                                                          under Title II of the Unfunded Mandates
                                            common mechanism of toxicity. In                           This final rule establishes an                     Reform Act of 1995 (UMRA) (2 U.S.C.
                                            addition, FFDCA section 408(b)(2)(C)                    exemption from the requirement of a                   1501 et seq.).
                                            provides that EPA shall apply an                        tolerance under FFDCA section 408(d)                     This action does not involve any
                                            additional tenfold (10X) margin of safety               in response to a petition submitted to                technical standards that would require
                                            for infants and children in the case of                 the Agency. The Office of Management                  Agency consideration of voluntary
                                            threshold effects to account for prenatal               and Budget (OMB) has exempted these                   consensus standards pursuant to section
                                            and postnatal toxicity and the                          types of actions from review under                    12(d) of the National Technology
                                            completeness of the database on toxicity                Executive Order 12866, entitled                       Transfer and Advancement Act of 1995
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                                            and exposure, unless EPA determines                     ‘‘Regulatory Planning and Review’’ (58                (NTTAA) (15 U.S.C. 272 note).
                                            that a different margin of safety will be               FR 51735, October 4, 1993). Because
                                            safe for infants and children. This                     this final rule has been exempted from                X. Congressional Review Act
                                            additional margin of safety is commonly                 review under Executive Order 12866,                     Pursuant to the Congressional Review
                                            referred to as the Food Quality                         this final rule is not subject to Executive           Act (5 U.S.C. 801 et seq.), EPA will
                                            Protection Act Safety Factor                            Order 13211, entitled ‘‘Actions                       submit a report containing this rule and


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                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                          25953

                                            other required information to the U.S.                  ADDRESSES:    The docket for this action,             or request a hearing on this regulation
                                            Senate, the U.S. House of                               identified by docket identification (ID)              in accordance with the instructions
                                            Representatives, and the Comptroller                    number EPA–HQ–OPP–2006–0075, is                       provided in 40 CFR part 178. To ensure
                                            General of the United States prior to                   available at http://www.regulations.gov               proper receipt by EPA, you must
                                            publication of the rule in the Federal                  or at the Office of Pesticide Programs                identify docket ID number EPA–HQ–
                                            Register. This action is not a ‘‘major                  Regulatory Public Docket (OPP Docket)                 OPP–2006–0075 in the subject line on
                                            rule’’ as defined by 5 U.S.C. 804(2).                   in the Environmental Protection Agency                the first page of your submission. All
                                                                                                    Docket Center (EPA/DC), West William                  objections and requests for a hearing
                                            List of Subjects in 40 CFR Part 180
                                                                                                    Jefferson Clinton Bldg., Rm. 3334, 1301               must be in writing, and must be
                                              Environmental protection,                             Constitution Ave. NW., Washington, DC                 received by the Hearing Clerk on or
                                            Administrative practice and procedure,                  20460–0001. The Public Reading Room                   before July 6, 2015. Addresses for mail
                                            Agricultural commodities, Pesticides                    is open from 8:30 a.m. to 4:30 p.m.,                  and hand delivery of objections and
                                            and pests, Reporting and recordkeeping                  Monday through Friday, excluding legal                hearing requests are provided in 40 CFR
                                            requirements.                                           holidays. The telephone number for the                178.25(b).
                                              Dated: April 10, 2015.                                Public Reading Room is (202) 566–1744,                  In addition to filing an objection or
                                            Robert McNally,                                         and the telephone number for the OPP                  hearing request with the Hearing Clerk
                                            Director, Biopesticides and Pollution                   Docket is (703) 305–5805. Please review               as described in 40 CFR part 178, please
                                            Prevention Division, Office of Pesticide                the visitor instructions and additional               submit a copy of the filing (excluding
                                            Programs.                                               information about the docket available                any Confidential Business Information
                                                                                                    at http://www.epa.gov/dockets.                        (CBI)) for inclusion in the public docket.
                                              Therefore, 40 CFR chapter I is
                                                                                                    FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                          Information not marked confidential
                                            amended as follows:
                                                                                                    Susan Lewis, Registration Division                    pursuant to 40 CFR part 2 may be
                                            PART 180—[AMENDED]                                      (7505P), Office of Pesticide Programs,                disclosed publicly by EPA without prior
                                                                                                    Environmental Protection Agency, 1200                 notice. Submit the non-CBI copy of your
                                            ■ 1. The authority citation for part 180                Pennsylvania Ave. NW., Washington,                    objection or hearing request, identified
                                            continues to read as follows:                           DC 20460–0001; main telephone                         by docket ID number EPA–HQ–OPP–
                                                Authority: 21 U.S.C. 321(q), 346a and 371.          number: (703) 305–7090; email address:                2006–0075, by one of the following
                                                                                                    RDFRNotices@epa.gov.                                  methods:
                                            ■ 2. Add § 180.1330 to subpart D to read                                                                        • Federal eRulemaking Portal: http://
                                            as follows:                                             SUPPLEMENTARY INFORMATION:                            www.regulations.gov. Follow the online
                                            § 180.1330 1-Octanol; exemption from the                I. General Information                                instructions for submitting comments.
                                            requirement of a tolerance.                                                                                   Do not submit electronically any
                                                                                                    A. Does this action apply to me?                      information you consider to be CBI or
                                              An exemption from the requirement
                                            of a tolerance is established for residues                 You may be potentially affected by                 other information whose disclosure is
                                            of 1-octanol in or on root and tuber                    this action if you are an agricultural                restricted by statute.
                                            vegetables when applied as a plant                      producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                            growth regulator in accordance with                     pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                            label directions and good agricultural                  list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                            practices.                                              Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                                                                                    not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                            [FR Doc. 2015–10364 Filed 5–5–15; 8:45 am]
                                                                                                    provides a guide to help readers                      arrangements for hand delivery or
                                            BILLING CODE 6560–50–P
                                                                                                    determine whether this document                       delivery of boxed information, please
                                                                                                    applies to them. Potentially affected                 follow the instructions at http://
                                                                                                    entities may include:                                 www.epa.gov/dockets/contacts.html.
                                            ENVIRONMENTAL PROTECTION
                                            AGENCY                                                     • Crop production (NAICS code 111).                  Additional instructions on
                                                                                                       • Animal production (NAICS code                    commenting or visiting the docket,
                                            40 CFR Part 180                                         112).                                                 along with more information about
                                                                                                       • Food manufacturing (NAICS code                   dockets generally, is available at http://
                                            [EPA–HQ–OPP–2006–0075; FRL–9925–97]                     311).                                                 www.epa.gov/dockets.
                                            Fenazaquin; Pesticide Tolerances                           • Pesticide manufacturing (NAICS                   II. Summary of Petitioned-For
                                                                                                    code 32532).                                          Tolerance
                                            AGENCY:  Environmental Protection
                                            Agency (EPA).                                           B. How can I get electronic access to                    In the Federal Register of April 20,
                                                                                                    other related information?                            2011 (76 FR 22067) (FRL–8869–7), EPA
                                            ACTION: Final rule.
                                                                                                       You may access a frequently updated                issued a document pursuant to FFDCA
                                            SUMMARY:   This regulation establishes                  electronic version of EPA’s tolerance                 section 408(d)(3), 21 U.S.C. 346a(d)(3),
                                            tolerances for residues of fenazaquin in                regulations at 40 CFR part 180 through                announcing the filing of a pesticide
                                            or on almonds and cherries. Gowan                       the Government Printing Office’s e-CFR                petition (PP 1F7825) by Gowan
                                            Company requested these tolerances                      site at http://www.ecfr.gov/cgi-bin/text-             Company, P.O. Box 5569, Yuma, AZ
                                            under the Federal Food, Drug, and                       idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  85366. The petition requested that 40
                                            Cosmetic Act (FFDCA).                                   40tab_02.tpl.                                         CFR 180.632 be amended by
                                            DATES: This regulation is effective May                                                                       establishing tolerances for residues of
                                            6, 2015. Objections and requests for                    C. How can I file an objection or hearing             the insecticide fenazaquin, 4-[2-[4-(1,1-
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                                            hearings must be received on or before                  request?                                              dimethylethyl)phenyl]
                                            July 6, 2015, and must be filed in                        Under FFDCA section 408(g), 21                      ethoxy]quinazoline, in or on fruit, pome
                                            accordance with the instructions                        U.S.C. 346a, any person may file an                   group at 0.35 parts per million (ppm);
                                            provided in 40 CFR part 178 (see also                   objection to any aspect of this regulation            cucurbit group at 0.25 ppm; almond,
                                            Unit I.C. of the SUPPLEMENTARY                          and may also request a hearing on those               hulls at 4.5 ppm; apple, wet pomace at
                                            INFORMATION).                                           objections. You must file your objection              0.6 ppm; berry fruit group at 0.6 ppm;


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Document Created: 2015-12-16 07:41:56
Document Modified: 2015-12-16 07:41:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactRobert 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
FR Citation80 FR 25950 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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