1-Triacontanol; Exemption From the Requirement of a Tolerance, 38849-38852 [2017-17338]
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38849
Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations
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 18, 2017.
Donna S. Davis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, alphabetically add the
polymers in the table to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Polymer
CAS No.
*
*
*
*
*
*
Fatty acids, rape-oil, triesters with polyethylene glycol ether with glycerol (3:1); minimum number average molecular weight (in
amu), 1800 .......................................................................................................................................................................................
*
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[FR Doc. 2017–17337 Filed 8–15–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0259; FRL–9964–94]
1-Triacontanol; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
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
SUMMARY:
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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 https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
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688045–21–8
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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 https://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:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations
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).
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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 https://
www.ecfr.gov/cgi-bin/textidx?&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: https://
www.regulations.gov. Follow the online
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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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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, https://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
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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 1triacontanol 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
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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
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consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational 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 nonoccupational 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 https://
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
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38851
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
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Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for 1-triacontanol.
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VIII. Conclusions
Based on its assessment of 1triacontanol, 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
VerDate Sep<11>2014
14:37 Aug 15, 2017
Jkt 241001
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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1345 to subpart D to read
as follows:
■
§ 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
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NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Part 1852
RIN 2700–AE42
NASA FAR Supplement: Preproposal/
Pre-Bid Conference (2017–N023)
National Aeronautics and
Space Administration.
ACTION: Final rule.
AGENCY:
NASA is issuing a direct final
rule to amend the NASA FAR
Supplement (NFS) to remove reference
to the NASA Acquisition Information
System (NAIS) electronic posting
system and revise titles to agency
directives.
SUMMARY:
This direct final rule is effective
October 16, 2017. Comments due on or
before September 15, 2017. If adverse
comments are received, NASA will
publish a timely withdrawal of the rule
in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Manuel Quinones, NASA, Office of
Procurement, telephone 202.358.2143.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
During a recent quality review of the
NFS to validate the accuracy and
relevancy of its policy, guidance, and
procedures, we discovered (1) an
outdated reference to the NASA
Acquisition Information System (NAIS)
for posting agency business
opportunities and (2) superseded titles
to NASA directives. NASA posts all
business opportunities through the
Governmentwide Point of Entry (GPE)
via the Internet at https://
www.fedbizopps.gov and agency
directives are periodically reviewed and
updated. This rule amends NFS
1852.215–77 and 1852.245–82 to
remove the reference to the NAIS
electronic posting system and update
titles to NASA policy directives
respectively.
NASA has not published a proposed
rule in the Federal Register to make
these nonsubstantive changes because
they affect only the internal operating
procedures of the Government and have
no significant cost or administrative or
cost impact on contractors or offerors.
NASA does not anticipate opposition to
the changes or significant adverse
comments. However, if the Agency
receives a significant adverse comment,
it will withdraw this direct final rule by
publishing a notice in the Federal
Register. A significant adverse comment
is one that explains: (1) Why the direct
final rule is inappropriate, including
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Agencies
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Rules and Regulations]
[Pages 38849-38852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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 https://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: BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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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 https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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
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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 https://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
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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.
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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