82_FR_39006 82 FR 38849 - 1-Triacontanol; Exemption From the Requirement of a Tolerance

82 FR 38849 - 1-Triacontanol; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 157 (August 16, 2017)

Page Range38849-38852
FR Document2017-17338

This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide 1-triacontanol (TA) in or on all food commodities when used in accordance with label directions and good agricultural practices. CH Biotech R&D, Co., LTD submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of TA in or on all food commodities when used in accordance with label directions and good agricultural practices.

Federal Register, Volume 82 Issue 157 (Wednesday, August 16, 2017)
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Rules and Regulations]
[Pages 38849-38852]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17338]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0259; FRL-9964-94]


1-Triacontanol; 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-triacontanol 
(TA) in or on all food commodities when used in accordance with label 
directions and good agricultural practices. CH Biotech R&D, Co., LTD 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of TA in or on all food commodities when 
used in accordance with label directions and good agricultural 
practices.

DATES: This regulation is effective August 16, 2017. Objections and 
requests for hearings must be received on or before October 16, 2017, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0259, 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 (BPPD) (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:

[[Page 38850]]

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0259 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 
October 16, 2017. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0259, 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 29, 2016 (81 FR 59165) (FRL-9950-
22), 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 6F8459) by CH Biotech R&D Co., LTD C/O Spring Trading 
Company, 203 Dogwood Trail, Magnolia, TX 77354. The petition requested 
that 40 CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of 1-triacontanol. That 
document referenced a summary of the petition prepared by the 
petitioner James Yowell of Spring Trading Company, 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, FFDCA section 408(b)(2)(D) requires that 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 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-Triacontanol

    1-Triacontanol (TA), a long chain fatty alcohol (LCOH- C30), 
naturally occurs in plant, and insect waxes and constitutes a regular 
part of the human diet. As a pesticide, TA functions as a plant growth 
regulator. It promotes germination, root, stem and leaf growth, and 
flowering, as well as improving the seed, thus increasing plant 
production and quality. In terms of the mechanism of action, TA can be 
absorbed through the plant's stem and leaf, and may promote plant 
growth, increase accumulation of dry matter, improve the permeability 
of cell membrane, increase chlorophyll content, improve photosynthetic 
intensity, and increase activity of amylase, oxidase and peroxidase. 
With regard to its presence in insect wax, TA constitutes the majority 
of long chain fatty alcohols found in beeswax, naturally secreted 
through the bee's abdomen. In addition to the dietary consumption of TA 
from foods, humans are already exposed to 1-triacontanol because of its 
use in cosmetics, toiletries, surface lubricants, and pharmaceutical 
preparations; products that are broadly used across the consumer 
products industry with highest per person consumer exposures resulting 
from use in personal care products. For the pharmaceutical industry, 
there are overall health benefits such as anti-inflammatory and

[[Page 38851]]

cholesterol lowering properties from the use of TA (Federal Food, Drug, 
and Cosmetic Act (FFDCA) Considerations for 1-Triacontanol EPA-HQ-OPP-
2016-0259).
    An aggregate risk assessment for TA for dietary (food and drinking 
water) exposures was not conducted as no toxicological endpoints have 
been identified in the toxicity database. EPA has determined under the 
FFDCA that there is reasonable certainty that no harm will result to 
the general population or to infants and children from aggregate 
exposure to TA.
    There are no human health or environmental risks of concern 
associated with this assessment. Therefore, EPA has no objection to the 
registration of the proposed manufacturing use product, associated end 
use product, and an exemption from a food tolerance.
    For a summary of the data upon which EPA relied, please refer to 
the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for 1-Triacontanol'' (June 13, 2017), available in the 
docket for this action.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable toxicology data requirements supporting the petition 
to establish an exemption from the requirement of a tolerance for the 
use of TA as an active ingredient in or on food commodities, when used 
in accordance with label direction and good agricultural practices, 
have been fulfilled. Based on the submitted data and the results of 
studies using comparable long chain fatty alcohols, there are no human 
health risks of concern associated with TA and there is sufficient 
information to justify an exemption from the requirement of a tolerance 
for this compound on all food commodities. Acute studies on TA show 
that this long chain fatty alcohol is Toxicology Category IV for: Acute 
oral toxicity, Acute dermal toxicity, Acute eye irritation, and Primary 
dermal irritation. TA is not a dermal sensitizer. Waivers were granted 
for subchronic toxicology studies including the 90-day Oral study, 
Developmental toxicity study, and Genetic toxicity testing based on 
existing scientific literature for structurally similar long chain 
fatty alcohols that demonstrate that fatty alcohols rapidly and readily 
become degradable and pose no risks to human health or to the 
environment.

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

    An aggregate risk assessment for TA for dietary (food and drinking 
water) exposures was not conducted as no toxicological endpoints have 
been identified in the toxicity database.

B. Other Non-Occupational Exposure

    Other non-occupational exposure to 1-triacontanol from pesticidal 
use is not expected to occur as the TA biodegrades rapidly and the 
product is applied at low application rates of 500 part per millions 
(ppm) three to four times per season. There are no residential uses for 
TA that would result in non-occupational exposure.

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 TA to share a common mechanism of toxicity with 
any other substances, and TA does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that TA 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. 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 TA 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 
TA. As a result, EPA concludes that no additional margin of exposure 
(safety) is necessary.

VII. Other Considerations

A. 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.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that

[[Page 38852]]

EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for 1-triacontanol.

VIII. Conclusions

    Based on its assessment of 1-triacontanol, 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-
triacontanol. Therefore, an exemption is established for residues of 1-
triacontanol on all food commodities when used in accordance with label 
directions and good agricultural practices.

IX. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

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 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: July 31, 2017.
Richard P. Keigwin, Jr.,
Director, 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.  180.1345 to subpart D to read as follows:


Sec.  180.1345  1-Triacontanol; exemption from the requirement of a 
tolerance.

    Residues of the biochemical pesticide 1-Triacontanol are exempt 
from the requirement of a tolerance in or on all food commodities.

[FR Doc. 2017-17338 Filed 8-15-17; 8:45 am]
BILLING CODE 6560-50-P



                                                                  Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations                                                                                                38849

                                             Regulations That Significantly Affect                                      has determined that this action will not                                   other required information to the U.S.
                                             Energy Supply, Distribution, or Use’’ (66                                  have a substantial direct effect on States                                 Senate, the U.S. House of
                                             FR 28355, May 22, 2001) or Executive                                       or tribal governments, on the                                              Representatives, and the Comptroller
                                             Order 13045, entitled ‘‘Protection of                                      relationship between the national                                          General of the United States prior to
                                             Children from Environmental Health                                         government and the States or tribal                                        publication of the rule in the Federal
                                             Risks and Safety Risks’’ (62 FR 19885,                                     governments, or on the distribution of                                     Register. This action is not a ‘‘major
                                             April 23, 1997). This action does not                                      power and responsibilities among the                                       rule’’ as defined by 5 U.S.C. 804(2).
                                             contain any information collections                                        various levels of government or between
                                             subject to OMB approval under the                                          the Federal Government and Indian                                          List of Subjects in 40 CFR Part 180
                                             Paperwork Reduction Act (PRA) (44                                          tribes. Thus, the Agency has determined                                      Environmental protection,
                                             U.S.C. 3501 et seq.), nor does it require                                  that Executive Order 13132, entitled                                       Administrative practice and procedure,
                                             any special considerations under                                           ‘‘Federalism’’ (64 FR 43255, August 10,                                    Agricultural commodities, Pesticides
                                             Executive Order 12898, entitled                                            1999) and Executive Order 13175,                                           and pests, Reporting and recordkeeping
                                             ‘‘Federal Actions to Address                                               entitled ‘‘Consultation and Coordination                                   requirements.
                                             Environmental Justice in Minority                                          with Indian Tribal Governments’’ (65 FR
                                                                                                                                                                                                      Dated: July 18, 2017.
                                             Populations and Low-Income                                                 67249, November 9, 2000) do not apply
                                             Populations’’ (59 FR 7629, February 16,                                    to this action. In addition, this action                                   Donna S. Davis,
                                             1994).                                                                     does not impose any enforceable duty or                                    Acting Director, Registration Division, Office
                                                Since tolerances and exemptions that                                    contain any unfunded mandate as                                            of Pesticide Programs.
                                             are established on the basis of a petition                                 described under Title II of the Unfunded                                     Therefore, 40 CFR chapter I is
                                             under FFDCA section 408(d), such as                                        Mandates Reform Act (UMRA) (2 U.S.C.                                       amended as follows:
                                             the tolerance in this final rule, do not                                   1501 et seq.).
                                             require the issuance of a proposed rule,                                      This action does not involve any                                        PART 180—[AMENDED]
                                             the requirements of the Regulatory                                         technical standards that would require
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                                     Agency consideration of voluntary                                          ■ 1. The authority citation for part 180
                                             seq.), do not apply.                                                       consensus standards pursuant to section                                    continues to read as follows:
                                                This action directly regulates growers,                                 12(d) of the National Technology
                                             food processors, food handlers, and food                                                                                                                  Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                                        Transfer and Advancement Act
                                             retailers, not States or tribes, nor does                                  (NTTAA) (15 U.S.C. 272 note).                                              ■ 2. In § 180.960, alphabetically add the
                                             this action alter the relationships or                                                                                                                polymers in the table to read as follows:
                                             distribution of power and                                                  X. Congressional Review Act
                                             responsibilities established by Congress                                     Pursuant to the Congressional Review                                     § 180.960 Polymers; exemptions from the
                                             in the preemption provisions of FFDCA                                      Act (5 U.S.C. 801 et seq.), EPA will                                       requirement of a tolerance.
                                             section 408(n)(4). As such, the Agency                                     submit a report containing this rule and                                   *         *         *        *         *

                                                                                                                                        Polymer                                                                                                      CAS No.


                                                       *                           *                                 *                                 *                                 *                                *                           *
                                             Fatty acids, rape-oil, triesters with polyethylene glycol ether with glycerol (3:1); minimum number average molecular weight (in
                                               amu), 1800 .......................................................................................................................................................................................   688045–21–8

                                                           *                               *                               *                               *                               *                               *                          *



                                             [FR Doc. 2017–17337 Filed 8–15–17; 8:45 am]                                EPA under the Federal Food, Drug, and                                      Docket Center (EPA/DC), West William
                                             BILLING CODE 6560–50–P                                                     Cosmetic Act (FFDCA), requesting an                                        Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                        exemption from the requirement of a                                        Constitution Ave. NW., Washington, DC
                                                                                                                        tolerance. This regulation eliminates the                                  20460–0001. The Public Reading Room
                                             ENVIRONMENTAL PROTECTION                                                   need to establish a maximum                                                is open from 8:30 a.m. to 4:30 p.m.,
                                             AGENCY                                                                     permissible level for residues of TA in                                    Monday through Friday, excluding legal
                                                                                                                        or on all food commodities when used                                       holidays. The telephone number for the
                                             40 CFR Part 180                                                            in accordance with label directions and                                    Public Reading Room is (202) 566–1744,
                                             [EPA–HQ–OPP–2016–0259; FRL–9964–94]                                        good agricultural practices.                                               and the telephone number for the OPP
                                                                                                                        DATES: This regulation is effective                                        Docket is (703) 305–5805. Please review
                                             1-Triacontanol; Exemption From the                                         August 16, 2017. Objections and                                            the visitor instructions and additional
                                             Requirement of a Tolerance                                                 requests for hearings must be received                                     information about the docket available
                                             AGENCY:  Environmental Protection                                          on or before October 16, 2017, and must                                    at http://www.epa.gov/dockets.
                                             Agency (EPA).                                                              be filed in accordance with the
                                                                                                                                                                                                   FOR FURTHER INFORMATION CONTACT:
                                                                                                                        instructions provided in 40 CFR part
                                             ACTION: Final rule.                                                                                                                                   Robert McNally, Biopesticides, and
                                                                                                                        178 (see also Unit I.C. of the
                                                                                                                                                                                                   Pollution Prevention Division (BPPD)
                                             SUMMARY:   This regulation establishes an                                  SUPPLEMENTARY INFORMATION).
pmangrum on DSK3GDR082PROD with RULES




                                                                                                                                                                                                   (7511P), Office of Pesticide Programs,
                                             exemption from the requirement of a                                        ADDRESSES: The docket for this action,
                                                                                                                                                                                                   Environmental Protection Agency, 1200
                                             tolerance for residues of the biochemical                                  identified by docket identification (ID)                                   Pennsylvania Ave. NW., Washington,
                                             pesticide 1-triacontanol (TA) in or on all                                 number EPA–HQ–OPP–2016–0259, is
                                                                                                                                                                                                   DC 20460–0001; main telephone
                                             food commodities when used in                                              available at http://www.regulations.gov
                                                                                                                                                                                                   number: (703) 305–7090; email address:
                                             accordance with label directions and                                       or at the Office of Pesticide Programs
                                                                                                                                                                                                   BPPDFRNotices@epa.gov.
                                             good agricultural practices. CH Biotech                                    Regulatory Public Docket (OPP Docket)
                                             R&D, Co., LTD submitted a petition to                                      in the Environmental Protection Agency                                     SUPPLEMENTARY INFORMATION:



                                        VerDate Sep<11>2014         14:37 Aug 15, 2017         Jkt 241001       PO 00000       Frm 00029       Fmt 4700        Sfmt 4700      E:\FR\FM\16AUR1.SGM              16AUR1


                                             38850            Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations

                                             I. General Information                                  instructions for submitting comments.                 result to infants and children from
                                                                                                     Do not submit electronically any                      aggregate exposure to the pesticide
                                             A. Does this action apply to me?
                                                                                                     information you consider to be CBI or                 chemical residue. . . . ’’ Additionally,
                                                You may be potentially affected by                   other information whose disclosure is                 FFDCA section 408(b)(2)(D) requires
                                             this action if you are an agricultural                  restricted by statute.                                that the Agency consider ‘‘available
                                             producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   information concerning the cumulative
                                             pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 effects of a particular pesticide’s
                                             list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 residues’’ and ‘‘other substances that
                                             Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       have a common mechanism of toxicity.’’
                                             not intended to be exhaustive, but rather                 • Hand Delivery: To make special                       EPA performs a number of analyses to
                                             provides a guide to help readers                        arrangements for hand delivery or                     determine the risks from aggregate
                                             determine whether this document                         delivery of boxed information, please                 exposure to pesticide residues. First,
                                             applies to them. Potentially affected                   follow the instructions at http://                    EPA determines the toxicity of
                                             entities may include:                                   www.epa.gov/dockets/contacts.html.                    pesticides. Second, EPA examines
                                                • Crop production (NAICS code 111).                    Additional instructions on                          exposure to the pesticide through food,
                                                • Animal production (NAICS code                      commenting or visiting the docket,                    drinking water, and through other
                                             112).                                                   along with more information about                     exposures that occur as a result of
                                                • Food manufacturing (NAICS code                     dockets generally, is available at http://            pesticide use in residential settings.
                                             311).                                                   www.epa.gov/dockets.
                                                • Pesticide manufacturing (NAICS                                                                           III. Toxicological Profile
                                                                                                     II. Background and Statutory Findings
                                             code 32532).                                                                                                     Consistent with FFDCA section
                                                                                                        In the Federal Register of August 29,              408(b)(2)(D), EPA has reviewed the
                                             B. How can I get electronic access to                   2016 (81 FR 59165) (FRL–9950–22),                     available scientific data and other
                                             other related information?                              EPA issued a document pursuant to                     relevant information in support of this
                                               You may access a frequently updated                   FFDCA section 408(d)(3), 21 U.S.C.                    action and considered its validity,
                                             electronic version of 40 CFR part 180                   346a(d)(3), announcing the filing of a                completeness and reliability, and the
                                             through the Government Printing                         pesticide tolerance petition (PP 6F8459)              relationship of this information to
                                             Office’s e-CFR site at http://                          by CH Biotech R&D Co., LTD C/O                        human risk. EPA has also considered
                                             www.ecfr.gov/cgi-bin/text-                              Spring Trading Company, 203 Dogwood                   available information concerning the
                                             idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Trail, Magnolia, TX 77354. The petition               variability of the sensitivities of major
                                             40tab_02.tpl.                                           requested that 40 CFR part 180 be                     identifiable subgroups of consumers,
                                                                                                     amended by establishing an exemption                  including infants and children.
                                             C. How can I file an objection or hearing               from the requirement of a tolerance for
                                             request?                                                residues of 1-triacontanol. That                      A. Overview of 1-Triacontanol
                                               Under FFDCA section 408(g), 21                        document referenced a summary of the                     1-Triacontanol (TA), a long chain fatty
                                             U.S.C. 346a, any person may file an                     petition prepared by the petitioner                   alcohol (LCOH- C30), naturally occurs
                                             objection to any aspect of this regulation              James Yowell of Spring Trading                        in plant, and insect waxes and
                                             and may also request a hearing on those                 Company, which is available in the                    constitutes a regular part of the human
                                             objections. You must file your objection                docket, http://www.regulations.gov.                   diet. As a pesticide, TA functions as a
                                             or request a hearing on this regulation                 There were no comments received in                    plant growth regulator. It promotes
                                             in accordance with the instructions                     response to the notice of filing.                     germination, root, stem and leaf growth,
                                             provided in 40 CFR part 178. To ensure                     Section 408(c)(2)(A)(i) of FFDCA                   and flowering, as well as improving the
                                             proper receipt by EPA, you must                         allows EPA to establish an exemption                  seed, thus increasing plant production
                                             identify docket ID number EPA–HQ–                       from the requirement for a tolerance (the             and quality. In terms of the mechanism
                                             OPP–2016–0259 in the subject line on                    legal limit for a pesticide chemical                  of action, TA can be absorbed through
                                             the first page of your submission. All                  residue in or on a food) only if EPA                  the plant’s stem and leaf, and may
                                             objections and requests for a hearing                   determines that the exemption is ‘‘safe.’’            promote plant growth, increase
                                             must be in writing, and must be                         Section 408(c)(2)(A)(ii) of FFDCA                     accumulation of dry matter, improve the
                                             received by the Hearing Clerk on or                     defines ‘‘safe’’ to mean that ‘‘there is a            permeability of cell membrane, increase
                                             before October 16, 2017. Addresses for                  reasonable certainty that no harm will                chlorophyll content, improve
                                             mail and hand delivery of objections                    result from aggregate exposure to the                 photosynthetic intensity, and increase
                                             and hearing requests are provided in 40                 pesticide chemical residue, including                 activity of amylase, oxidase and
                                             CFR 178.25(b).                                          all anticipated dietary exposures and all             peroxidase. With regard to its presence
                                               In addition to filing an objection or                 other exposures for which there is                    in insect wax, TA constitutes the
                                             hearing request with the Hearing Clerk                  reliable information.’’ This includes                 majority of long chain fatty alcohols
                                             as described in 40 CFR part 178, please                 exposure through drinking water and in                found in beeswax, naturally secreted
                                             submit a copy of the filing (excluding                  residential settings, but does not include            through the bee’s abdomen. In addition
                                             any Confidential Business Information                   occupational exposure. Pursuant to                    to the dietary consumption of TA from
                                             (CBI)) for inclusion in the public docket.              FFDCA section 408(c)(2)(B), in                        foods, humans are already exposed to 1-
                                             Information not marked confidential                     establishing or maintaining in effect an              triacontanol because of its use in
                                             pursuant to 40 CFR part 2 may be                        exemption from the requirement of a                   cosmetics, toiletries, surface lubricants,
                                             disclosed publicly by EPA without prior                 tolerance, EPA must take into account                 and pharmaceutical preparations;
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                                             notice. Submit the non-CBI copy of your                 the factors set forth in FFDCA section                products that are broadly used across
                                             objection or hearing request, identified                408(b)(2)(C), which require EPA to give               the consumer products industry with
                                             by docket ID number EPA–HQ–OPP–                         special consideration to exposure of                  highest per person consumer exposures
                                             2016–0259, by one of the following                      infants and children to the pesticide                 resulting from use in personal care
                                             methods:                                                chemical residue in establishing a                    products. For the pharmaceutical
                                               • Federal eRulemaking Portal: http://                 tolerance and to ‘‘ensure that there is a             industry, there are overall health
                                             www.regulations.gov. Follow the online                  reasonable certainty that no harm will                benefits such as anti-inflammatory and


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                                                              Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations                                        38851

                                             cholesterol lowering properties from the                consider available information                        addition, FFDCA section 408(b)(2)(C)
                                             use of TA (Federal Food, Drug, and                      concerning exposures from the pesticide               provides that EPA shall apply an
                                             Cosmetic Act (FFDCA) Considerations                     residue in food and all other non-                    additional tenfold (10X) margin of safety
                                             for 1-Triacontanol EPA–HQ–OPP–2016–                     occupational exposures, including                     for infants and children in the case of
                                             0259).                                                  drinking water from ground water or                   threshold effects to account for prenatal
                                                An aggregate risk assessment for TA                  surface water and exposure through                    and postnatal toxicity and the
                                             for dietary (food and drinking water)                   pesticide use in gardens, lawns, or                   completeness of the database on toxicity
                                             exposures was not conducted as no                       buildings (residential and other indoor               and exposure, unless EPA determines
                                             toxicological endpoints have been                       uses).                                                that a different margin of safety will be
                                             identified in the toxicity database. EPA                                                                      safe for infants and children. This
                                             has determined under the FFDCA that                     A. Dietary Exposure
                                                                                                                                                           additional margin of safety is commonly
                                             there is reasonable certainty that no                     An aggregate risk assessment for TA                 referred to as the Food Quality
                                             harm will result to the general                         for dietary (food and drinking water)                 Protection Act Safety Factor. In
                                             population or to infants and children                   exposures was not conducted as no                     applying this provision, EPA either
                                             from aggregate exposure to TA.                          toxicological endpoints have been                     retains the default value of 10X, or uses
                                                There are no human health or                         identified in the toxicity database.                  a different additional or no safety factor
                                             environmental risks of concern                                                                                when reliable data are available to
                                             associated with this assessment.                        B. Other Non-Occupational Exposure
                                                                                                                                                           support a different additional or no
                                             Therefore, EPA has no objection to the                    Other non-occupational exposure to                  safety factor.
                                             registration of the proposed                            1-triacontanol from pesticidal use is not
                                             manufacturing use product, associated                   expected to occur as the TA biodegrades                  As part of its qualitative assessment,
                                             end use product, and an exemption                       rapidly and the product is applied at                 EPA evaluated the available toxicity and
                                             from a food tolerance.                                  low application rates of 500 part per                 exposure data on TA and considered its
                                                For a summary of the data upon                       millions (ppm) three to four times per                validity, completeness, and reliability,
                                             which EPA relied, please refer to the                   season. There are no residential uses for             as well as the relationship of this
                                             document entitled, ‘‘Federal Food, Drug,                TA that would result in non-                          information to human risk. EPA
                                             and Cosmetic Act (FFDCA)                                occupational exposure.                                considers the toxicity database to be
                                             Considerations for 1-Triacontanol’’                                                                           complete and has identified no residual
                                                                                                     V. Cumulative Effects From Substances                 uncertainty with regard to prenatal and
                                             (June 13, 2017), available in the docket
                                                                                                     With a Common Mechanism of Toxicity                   postnatal toxicity or exposure. No
                                             for this action.
                                                                                                        Section 408(b)(2)(D)(v) of FFDCA                   hazard was identified based on the
                                             B. Biochemical Pesticide Toxicology                     requires that, when considering whether               available studies; therefore, EPA
                                             Data Requirements                                       to establish, modify, or revoke a                     concludes that there are no threshold
                                                All applicable toxicology data                       tolerance, the Agency consider                        effects of concern to infants, children, or
                                             requirements supporting the petition to                 ‘‘available information’’ concerning the              adults from TA. As a result, EPA
                                             establish an exemption from the                         cumulative effects of a particular                    concludes that no additional margin of
                                             requirement of a tolerance for the use of               pesticide’s residues and ‘‘other                      exposure (safety) is necessary.
                                             TA as an active ingredient in or on food                substances that have a common                         VII. Other Considerations
                                             commodities, when used in accordance                    mechanism of toxicity.’’
                                             with label direction and good                              EPA has not found TA to share a                    A. Analytical Enforcement Methodology
                                             agricultural practices, have been                       common mechanism of toxicity with
                                             fulfilled. Based on the submitted data                  any other substances, and TA does not                    An analytical method is not required
                                             and the results of studies using                        appear to produce a toxic metabolite                  for enforcement purposes since the
                                             comparable long chain fatty alcohols,                   produced by other substances. For the                 Agency is establishing an exemption
                                             there are no human health risks of                      purposes of this tolerance action,                    from the requirement of a tolerance
                                             concern associated with TA and there is                 therefore, EPA has assumed that TA                    without any numerical limitation.
                                             sufficient information to justify an                    does not have a common mechanism of                   B. International Residue Limits
                                             exemption from the requirement of a                     toxicity with other substances. For
                                             tolerance for this compound on all food                 information regarding EPA’s efforts to                  In making its tolerance decisions, EPA
                                             commodities. Acute studies on TA show                   determine which chemicals have a                      seeks to harmonize U.S. tolerances with
                                             that this long chain fatty alcohol is                   common mechanism of toxicity and to                   international standards whenever
                                             Toxicology Category IV for: Acute oral                  evaluate the cumulative effects of such               possible, consistent with U.S. food
                                             toxicity, Acute dermal toxicity, Acute                  chemicals, see EPA’s Web site at http://              safety standards and agricultural
                                             eye irritation, and Primary dermal                      www.epa.gov/pesticides/cumulative.                    practices. EPA considers the
                                             irritation. TA is not a dermal sensitizer.                                                                    international maximum residue limits
                                                                                                     VI. Determination of Safety for U.S.                  (MRLs) established by the Codex
                                             Waivers were granted for subchronic
                                                                                                     Population, Infants and Children                      Alimentarius Commission (Codex), as
                                             toxicology studies including the 90-day
                                             Oral study, Developmental toxicity                         FFDCA section 408(b)(2)(C) provides                required by FFDCA section 408(b)(4).
                                             study, and Genetic toxicity testing based               that, in considering the establishment of             The Codex Alimentarius is a joint
                                             on existing scientific literature for                   a tolerance or tolerance exemption for a              United Nations Food and Agriculture
                                             structurally similar long chain fatty                   pesticide chemical residue, EPA shall                 Organization/World Health
                                             alcohols that demonstrate that fatty                    assess the available information about                Organization food standards program,
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                                             alcohols rapidly and readily become                     consumption patterns among infants                    and it is recognized as an international
                                             degradable and pose no risks to human                   and children, special susceptibility of               food safety standards-setting
                                             health or to the environment.                           infants and children to pesticide                     organization in trade agreements to
                                                                                                     chemical residues, and the cumulative                 which the United States is a party. EPA
                                             IV. Aggregate Exposures                                 effects on infants and children of the                may establish a tolerance that is
                                               In examining aggregate exposure,                      residues and other substances with a                  different from a Codex MRL; however,
                                             FFDCA section 408 directs EPA to                        common mechanism of toxicity. In                      FFDCA section 408(b)(4) requires that


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                                             38852            Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations

                                             EPA explain the reasons for departing                   or tribal governments, on the                         NATIONAL AERONAUTICS AND
                                             from the Codex level.                                   relationship between the national                     SPACE ADMINISTRATION
                                                The Codex has not established a MRL                  government and the States or tribal
                                             for 1-triacontanol.                                     governments, or on the distribution of                48 CFR Part 1852
                                             VIII. Conclusions                                       power and responsibilities among the                  RIN 2700–AE42
                                                                                                     various levels of government or between
                                                Based on its assessment of 1-                        the Federal Government and Indian                     NASA FAR Supplement: Preproposal/
                                             triacontanol, EPA concludes that there                  tribes. Thus, the Agency has determined               Pre-Bid Conference (2017–N023)
                                             is a reasonable certainty that no harm                  that Executive Order 13132, entitled
                                             will result to the general population, or               ‘‘Federalism’’ (64 FR 43255, August 10,               AGENCY:  National Aeronautics and
                                             to infants and children, from aggregate                 1999) and Executive Order 13175,                      Space Administration.
                                             exposure to 1-triacontanol. Therefore,                  entitled ‘‘Consultation and Coordination              ACTION: Final rule.
                                             an exemption is established for residues                with Indian Tribal Governments’’ (65 FR
                                             of 1-triacontanol on all food                           67249, November 9, 2000) do not apply                 SUMMARY:   NASA is issuing a direct final
                                             commodities when used in accordance                     to this action. In addition, this action              rule to amend the NASA FAR
                                             with label directions and good                          does not impose any enforceable duty or               Supplement (NFS) to remove reference
                                             agricultural practices.                                 contain any unfunded mandate as                       to the NASA Acquisition Information
                                                                                                     described under Title II of the Unfunded              System (NAIS) electronic posting
                                             IX. Statutory and Executive Order
                                                                                                     Mandates Reform Act (UMRA) (2 U.S.C.                  system and revise titles to agency
                                             Reviews
                                                                                                     1501 et seq.).                                        directives.
                                                This action establishes a tolerance
                                                                                                        This action does not involve any                   DATES:  This direct final rule is effective
                                             under FFDCA section 408(d) in
                                                                                                     technical standards that would require                October 16, 2017. Comments due on or
                                             response to a petition submitted to the
                                             Agency. The Office of Management and                    Agency consideration of voluntary                     before September 15, 2017. If adverse
                                             Budget (OMB) has exempted these types                   consensus standards pursuant to section               comments are received, NASA will
                                             of actions from review under Executive                  12(d) of the National Technology                      publish a timely withdrawal of the rule
                                             Order 12866, entitled ‘‘Regulatory                      Transfer and Advancement Act                          in the Federal Register.
                                             Planning and Review’’ (58 FR 51735,                     (NTTAA) (15 U.S.C. 272 note).                         FOR FURTHER INFORMATION CONTACT:
                                             October 4, 1993). Because this action                   X. Congressional Review Act                           Manuel Quinones, NASA, Office of
                                             has been exempted from review under                                                                           Procurement, telephone 202.358.2143.
                                                                                                       Pursuant to the Congressional Review
                                             Executive Order 12866, this action is                   Act (5 U.S.C. 801 et seq.), EPA will                  SUPPLEMENTARY INFORMATION:
                                             not subject to Executive Order 13211,                   submit a report containing this rule and              I. Background
                                             entitled ‘‘Actions Concerning                           other required information to the U.S.
                                             Regulations That Significantly Affect                                                                            During a recent quality review of the
                                                                                                     Senate, the U.S. House of
                                             Energy Supply, Distribution, or Use’’ (66                                                                     NFS to validate the accuracy and
                                                                                                     Representatives, and the Comptroller
                                             FR 28355, May 22, 2001) or Executive                                                                          relevancy of its policy, guidance, and
                                                                                                     General of the United States prior to
                                             Order 13045, entitled ‘‘Protection of                                                                         procedures, we discovered (1) an
                                                                                                     publication of the rule in the Federal
                                             Children from Environmental Health                                                                            outdated reference to the NASA
                                                                                                     Register. This action is not a ‘‘major
                                             Risks and Safety Risks’’ (62 FR 19885,                                                                        Acquisition Information System (NAIS)
                                                                                                     rule’’ as defined by 5 U.S.C. 804(2).
                                             April 23, 1997). This action does not                                                                         for posting agency business
                                             contain any information collections                     List of Subjects in 40 CFR Part 180                   opportunities and (2) superseded titles
                                             subject to OMB approval under the                         Environmental protection,                           to NASA directives. NASA posts all
                                             Paperwork Reduction Act (PRA), 44                       Administrative practice and procedure,                business opportunities through the
                                             U.S.C. 3501 et seq., nor does it require                Agricultural commodities, Pesticides                  Governmentwide Point of Entry (GPE)
                                             any special considerations under                        and pests, Reporting and recordkeeping                via the Internet at http://
                                             Executive Order 12898, entitled                         requirements.                                         www.fedbizopps.gov and agency
                                             ‘‘Federal Actions to Address                                                                                  directives are periodically reviewed and
                                                                                                       Dated: July 31, 2017.
                                             Environmental Justice in Minority                                                                             updated. This rule amends NFS
                                                                                                     Richard P. Keigwin, Jr.,                              1852.215–77 and 1852.245–82 to
                                             Populations and Low-Income
                                             Populations’’ (59 FR 7629, February 16,                 Director, Office of Pesticide Programs.               remove the reference to the NAIS
                                             1994).                                                    Therefore, 40 CFR chapter I is                      electronic posting system and update
                                                Since tolerances and exemptions that                 amended as follows:                                   titles to NASA policy directives
                                             are established on the basis of a petition                                                                    respectively.
                                             under FFDCA section 408(d), such as                     PART 180—[AMENDED]                                       NASA has not published a proposed
                                             the tolerance in this final rule, do not                                                                      rule in the Federal Register to make
                                                                                                     ■ 1. The authority citation for part 180
                                             require the issuance of a proposed rule,                                                                      these nonsubstantive changes because
                                                                                                     continues to read as follows:
                                             the requirements of the Regulatory                                                                            they affect only the internal operating
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                      Authority: 21 U.S.C. 321(q), 346a and 371.        procedures of the Government and have
                                             seq.), do not apply.                                    ■ 2. Add § 180.1345 to subpart D to read              no significant cost or administrative or
                                                This action directly regulates growers,              as follows:                                           cost impact on contractors or offerors.
                                             food processors, food handlers, and food                                                                      NASA does not anticipate opposition to
                                             retailers, not States or tribes, nor does               § 180.1345 1-Triacontanol; exemption from             the changes or significant adverse
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                                                                                                     the requirement of a tolerance.
                                             this action alter the relationships or                                                                        comments. However, if the Agency
                                             distribution of power and                                 Residues of the biochemical pesticide               receives a significant adverse comment,
                                             responsibilities established by Congress                1-Triacontanol are exempt from the                    it will withdraw this direct final rule by
                                             in the preemption provisions of FFDCA                   requirement of a tolerance in or on all               publishing a notice in the Federal
                                             section 408(n)(4). As such, the Agency                  food commodities.                                     Register. A significant adverse comment
                                             has determined that this action will not                [FR Doc. 2017–17338 Filed 8–15–17; 8:45 am]           is one that explains: (1) Why the direct
                                             have a substantial direct effect on States              BILLING CODE 6560–50–P                                final rule is inappropriate, including


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Document Created: 2017-08-16 10:27:29
Document Modified: 2017-08-16 10:27:29
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 August 16, 2017. Objections and requests for hearings must be received on or before October 16, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactRobert McNally, Biopesticides, and Pollution Prevention Division (BPPD) (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
FR Citation82 FR 38849 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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