Fragrance Components; Exemption From the Requirement of a Tolerance, 28839-28843 [2015-11959]
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Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations
This document notifies the
public as required by the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) that the EPA Administrator
has forwarded to the Secretary of the
United States Department of Agriculture
(USDA) a draft regulatory document
concerning Pesticides; Agricultural
Worker Protection Standard Revisions.
The draft regulatory document is not
available to the public until after it has
been signed and made available by EPA.
DATES: See Unit I. under SUPPLEMENTARY
INFORMATION.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–0184, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory 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:
Kathy Davis, Field and External Affairs
Division (7506P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington DC 20460–0001; telephone
number: (703) 308–7002; email address:
davis.kathy@epa.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. What action is EPA taking?
Section 25(a)(2)(B) of FIFRA requires
the EPA Administrator to provide the
Secretary of USDA with a copy of any
draft final rule at least 30 days before
signing it in final form for publication
in the Federal Register. The draft final
rule is not available to the public until
after it has been signed by EPA. If the
Secretary of USDA comments in writing
regarding the draft final rule within 15
days after receiving it, the EPA
Administrator shall include the
comments of the Secretary of USDA, if
requested by the Secretary of USDA,
and the EPA Administrator’s response
to those comments with the final rule
that publishes in the Federal Register.
If the Secretary of USDA does not
comment in writing within 15 days after
receiving the draft final rule, the EPA
Administrator may sign the final rule for
publication in the Federal Register any
time after the 15-day period.
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II. Do any statutory and Executive
Order reviews apply to this
notification?
No. This document is merely a
notification of submission to the
Secretary of USDA. As such, none of the
regulatory assessment requirements
apply to this document.
List of Subjects in 40 CFR Part 170
Agricultural worker safety,
Environmental protection, Farmworker,
Handler, Pesticide handler, Pesticide
safety training, Pesticide worker safety,
Worker, Worker Protection Standard
regulations, WPS.
Dated: May 12, 2015.
Jack Housenger,
Director, Office of Pesticide Programs.
[FR Doc. 2015–11962 Filed 5–19–15; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0821; FRL–9927–38]
Fragrance Components; Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of various
fragrance component substances when
used as inert ingredients in
antimicrobial pesticide formulations for
use on food contact surfaces in public
eating places, dairy-processing
equipment, and food-processing
equipment and utensils. This regulation
eliminates the need to establish a
maximum permissible level for residues
of these various fragrance component
substances
SUMMARY:
This regulation is effective May
20, 2015. Objections and requests for
hearings must be received on or before
July 20, 2015, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0821, 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
ADDRESSES:
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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:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
BILLING CODE 6560–50–P
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A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Publishing
Office’s e-CFR site at 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 the Federal Food, Drug, and
Cosmetic Act (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–2013–0821 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
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received by the Hearing Clerk on or
before July 20, 2015. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2013–0821, 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. Today’s Action
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A. What is the authority for this action?
EPA is taking this action under
section 408(e) the FFDCA, 21 U.S.C.
346a(e), which allows EPA to establish
a tolerance exemption under FFDCA
section 408, 21 U.S.C. 346a et se.
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
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tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which requires EPA to give
special consideration to exposure of
infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . . ’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of FFDCA section 408 and
a complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/regulating/
tolerances.htm.
B. What action is the Agency taking?
EPA, on its own initiative under
FFDCA section 408(e), is establishing
exemptions from the requirement of a
tolerance for residues of various
fragrance component substances
identified at the end of this document.
III. EPA’s Proposal
In the Federal Register of July 25,
2014 (79 FR 43350) (FRL–9910–53),
EPA proposed, on its own initiative
under FFDCA section 408(e), 21 U.S.C.
346a(e), to establish exemptions from
the requirement of a tolerance for
residues of acetaldehyde (CAS Reg. No.
75–07–0), acetic acid (CAS Reg. No. 64–
19–7), allyl cyclohexyl propionate (CAS
Reg. No. 2705–87–5), butryic acid (CAS
Reg. No. 107–92–6), butyl alcohol (CAS
Reg. No. 71–36–3), citral (CAS Reg. No.
5392–40–5), citronellol (CAS Reg. No.
106–22–9), citronellyl acetate (CAS Reg.
No. 150–84–5), b-damascone, (Z)-(CAS
Reg. No. 23726–92–3), decanal (CAS
Reg. No. 112–31–2), (E)-4-decenal (CAS
Reg. No. 65405–70–1), decanoic acid
(CAS Reg. No. 334–48–5), 1-decanol
(CAS Reg. No. 112–30–1), 2,6-dimethyl5-heptanal (CAS Reg. No. 106–72–9), 2dodecanol, (2E)- (CAS Reg. No. 20407–
84–5), d-limonene (CAS Reg. No. 5989–
27–5), ethyl 2-methylbutyrate (CAS Reg.
No. 452–79–1), (E)-geraniol (CAS Reg.
No. 106–24–1), (E)-geraniol acetate (CAS
Reg. No. 105–87–3), heptanal (CAS Reg.
No. 111–71–7), heptanoic acid (CAS
Reg. No. 111–14–8), heptyl alcohol
(CAS Reg. No. 111–70–6), hexanal (CAS
Reg. No. 66–25–1), hexanoic acid (CAS
Reg. No. 142–62–1), (Z)-3-hexenol (CAS
Reg. No. 928–96–1), (Z)-3-hexenol
acetate (CAS Reg. No. 3681–71–8), hexyl
acetate (CAS Reg. No. 142–92–7), hexyl
alcohol (CAS Reg. No. 111–27–3), lauric
acid (CAS Reg. No.143–07–7), lauric
aldehyde (CAS Reg. No. 112–54–9),
lauryl alcohol (CAS Reg. No. 112–53–8),
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methyl-a-ionone (CAS Reg. No. 127–42–
4), 3-methyl-2-butenyl acetate (CAS Reg.
No. 1191–16–8), 2-methylundecanal
(CAS Reg. No. 110–41–8),
myristaldehyde (CAS Reg. No. 124–25–
4), myristic acid (CAS Reg. No. 544–63–
8), neryl acetate (CAS Reg. No. 141–12–
8), n-hexanol (CAS Reg. No. 111–27–3),
nonanal (CAS Reg. No. 124–19–6),
nonanoic acid (CAS Reg. No. 112–05–0),
nonyl alcohol (CAS Reg. No. 143–08–8),
octanal (CAS Reg. No. 124–13–0),
octanoic acid (CAS Reg. No. 124–07–2),
1-octanol (CAS Reg. No. 111–87–5),
palmitic acid (CAS Reg. No. 57–10–3),
propionic acid (CAS Reg. No. 79–09–4),
stearic acid (CAS Reg. No. 57–11–4), 2tridecanal (CAS Reg. No. 7774–82–5),
3,5,5-trimethylhexanal (CAS Reg. No.
5435–64–3), undecanal (CAS Reg. No.
112–44–7), undecyl alcohol (CAS Reg.
No. 112–42–5), valeraldehyde (CAS Reg.
No. 110–62–3), and valeric acid (CAS
Reg. No. 109–52–4) when used as
fragrance components (i.e., inert
ingredients) in antimicrobial pesticide
formulations for use on food-contact
surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils at
end-use concentrations not to exceed
100 parts per million (ppm).
As discussed in that document, EPA
has reviewed the available scientific
data and other relevant information in
support of this action, consistent with
FFDCA section 408(c)(2), and the factors
specified in FFDCA section 408(b)(2)(C
and D). EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure for
these various fragrance components
including exposure resulting from the
exemptions from the requirement of a
tolerance established by this action. For
a detailed discussion of the aggregate
risk assessments and determination of
safety that support the establishment of
these exemptions from the requirement
of a tolerance, please refer to the July 25,
2014 Federal Register final rule and its
supporting documents, available at
https://regulations.gov.
IV. Public Comments
EPA received nine comments to the
proposed rule. Six of the comments
were fully supportive of the proposed
rule. One comment made specific
reference to the fragrance component
acetaldehyde and stated that the risk
assessment of acetaldehyde should
reconsider the compound’s cancer risk.
The comment noted that part of the
safety finding for the fragrance
components was based on no structural
alerts for genotoxicity or carcinogenicity
but in the case of acetaldehyde EPA had
previously considered acetaldehyde to
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be a probable human carcinogen based
on inadequate human cancer studies
and animal studies that have shown
increased incidence of nasal tumors in
rats and laryngeal tumors in hamsters
after inhalation exposure. The Agency
agrees with the commenter that the
safety analysis provided in the proposed
rule, which relies on human exposure
threshold values for non-cancer risks, is
not applicable to acetaldehyde and
therefore, cannot be used to support an
exemption for acetaldehyde. As such,
EPA is not establishing in this final rule
an exemption from the requirement of a
tolerance for acetaldehyde as a fragrance
component for use in antimicrobial
pesticide formulations for use on foodcontact surfaces in public eating places,
dairy-processing equipment, and foodprocessing equipment and utensils at
end-use concentrations not to exceed
100 ppm.
Two comments made reference to
fragrance sensitivity among certain
individuals. The Agency understands
the commenter’s concerns, however the
legal framework provided by FFDCA
section 408 states that tolerances may be
set when the pesticide chemical meets
the safety standard imposed by that
statute. The Agency is required by
FFDCA section 408 to estimate the risk
of the potential exposure to these
residues. Neither the supporting
information cited by the commenters or
other reliable data demonstrate the
occurrence of specific adverse effects
directly attributable to exposures to the
substances listed in Unit III and EPA
has concluded that there is a reasonable
certainty that no harm will result to the
general population and to infants and
children from aggregate exposure to the
fragrance components listed in Unit III
when used as inert ingredients in
antimicrobial formulations for use on
food contact surfaces in public eating
places, dairy processing equipment, and
food processing equipment and utensils
at end-use concentrations not to exceed
100 ppm.
V. Final Rule and Determination of
Safety
Except for the exclusion of
acetaldehyde, EPA is not making any
changes to the risk assessment or final
rule text that was proposed in July 25,
2014 Federal Register. Therefore, EPA
concludes that there is a reasonable
certainty that no harm will result to the
general population and to infants and
children from aggregate exposure to
acetic acid; allyl cylcohexylpropionate;
butryic acid; butyl alcohol; citral;
citronellol; citronellyl acetate; bdamascone, (Z)-; decanal; (E)-4-decenal;
decanoic acid; 1-decanol; 2,6-dimethyl-
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5-heptanal; 2-dodecanol, (2E)-; dlimonene; ethyl 2-methylbutyrate; (E)geraniol; (E)-geraniol acetate; heptanal;
heptanoic acid; heptyl alcohol; hexanal;
hexanoic acid; (Z)-3-hexenol; (Z)-3hexenol acetate; hexyl acetate; hexyl
alcohol; lauric acid; lauric aldehyde;
lauryl alcohol; methyl-a-ionone; 3methyl-2-butenyl acetate; 2methylundecanal; myristaldehyde;
myristic acid; neryl acetate; n-hexanol;
nonanal; nonanoic acid; nonyl alcohol;
octanal; octanoic acid; 1-octanol;
palmitic acid; propionic acid; stearic
acid; 2-tridecanal; 3,5,5trimethylhexanal; undecanal; undecyl
alcohol; valeraldehyde; and valeric acid
residues when used as when used as
fragrance components (i.e., inert
ingredients) in antimicrobial pesticide
formulations for use on food-contact
surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils at
end-use concentrations not to exceed
100 ppm.
VI. 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
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for the fragrance components listed in
Unit II above.
VII. Conclusion
Therefore, exemptions from the
requirement of a tolerance are
established for residues of acetic acid
(CAS Reg. No. 64–19–7), allyl
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cyclohexyl propionate (CAS Reg. No.
2705–87–5), butryic acid (CAS Reg. No.
107–92–6), butyl alcohol (CAS Reg. No.
71–36–3), citral (CAS Reg. No. 5392–40–
5), citronellol (CAS Reg. No. 106–22–9),
citronellyl acetate (CAS Reg. No. 150–
84–5), b-damascone, (Z)- (CAS Reg. No.
23726–92–3), decanal (CAS Reg. No.
112–31–2), (E)-4-decenal (CAS Reg. No.
65405–70–1), decanoic acid (CAS Reg.
No. 334–48–5), 1-decanol (CAS Reg. No.
112–30–1), 2,6-dimethyl-5-heptanal
(CAS Reg. No. 106–72–9), 2-dodecanol,
(2E)- (CAS Reg. No. 20407–84–5), dlimonene (CAS Reg. No. 5989–27–5),
ethyl 2-methylbutyrate (CAS Reg. No.
452–79–1), (E)-geraniol (CAS Reg. No.
106–24–1), (E)-geraniol acetate (CAS
Reg. No. 105–87–3), heptanal (CAS Reg.
No. 111–71–7), heptanoic acid (CAS
Reg. No. 111–14–8), heptyl alcohol
(CAS Reg. No. 111–70–6), hexanal (CAS
Reg. No. 66–25–1), hexanoic acid (CAS
Reg. No. 142–62–1), (Z)-3-hexenol (CAS
Reg. No. 928–96–1), (Z)-3-hexenol
acetate (CAS Reg. No. 3681–71–8), hexyl
acetate (CAS Reg. No. 142–92–7), hexyl
alcohol (CAS Reg. No. 111–27–3), lauric
acid (CAS Reg. No. 143–07–7), lauric
aldehyde (CAS Reg. No. 112–54–9),
lauryl alcohol (CAS Reg. No. 112–53–8),
methyl-a-ionone (CAS Reg. No. 127–42–
4), 3-methyl-2-butenyl acetate (CAS Reg.
No. 1191–16–8), 2-methylundecanal
(CAS Reg. No. 110–41–8),
myristaldehyde (CAS Reg. No. 124–25–
4), myristic acid (CAS Reg. No. 544–63–
8), neryl acetate (CAS Reg. No. 141–12–
8), n-hexanol (CAS Reg. No. 111–27–3),
nonanal (CAS Reg. No. 124–19–6),
nonanoic acid (CAS Reg. No. 112–05–0),
nonyl alcohol (CAS Reg. No. 143–08–8),
octanal (CAS Reg. No. 124–13–0),
octanoic acid (CAS Reg. No. 124–07–2),
1-octanol (CAS Reg. No. 111–87–5),
palmitic acid (CAS Reg. No. 57–10–3),
propionic acid (CAS Reg. No. 79–09–4),
stearic acid (CAS Reg. No. 57–11–4), 2tridecanal (CAS Reg. No. 7774–82–5),
3,5,5-trimethylhexanal (CAS Reg. No.
5435–64–3), undecanal (CAS Reg. No.
112–44–7), undecyl alcohol (CAS Reg.
No. 112–42–5), valeraldehyde (CAS Reg.
No. 110–62–3), and valeric acid (CAS
Reg. No. 109–52–4) when used as
fragrance components (i.e., inert
ingredients) in antimicrobial pesticide
formulations for use on food-contact
surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils at
end-use concentrations not to exceed
100 ppm.
VIII. Statutory and Executive Order
Reviews
This action establishes exemptions
from the requirement of a tolerance
under FFDCA section 408(e). The Office
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of Management and Budget (OMB) has
exempted tolerance actions from review
under Executive Orders 12866, entitled
Regulatory Planning and Review (58 FR
51735, October 4, 1993) and 13563,
entitled Improving Regulation and
Regulatory Review (76 FR 3821, January
21, 2011). As a result, 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). Nor does it require OMB
review or any Agency action under
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.); does not 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); and 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).
This action directly regulates growers,
food processors, food handlers, and food
Pesticide chemical
retailers, but it does not regulate State
or tribal governments. 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). Therefore, the Agency
has determined that Executive Orders
13132, entitled Federalism (64 FR
43255, August 10, 1999) and 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,
contain any unfunded mandate, or
otherwise significantly or uniquely
affect small governments as described in
the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
Under the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that this action will not
have significant negative economic
impact on a substantial number of small
entities. Establishing an exemption from
the requirement of a pesticide tolerance
is, in effect, the removal of a regulatory
restriction on pesticide residues in food
and thus such an action will not have
any negative economic impact on any
entities, including small entities.
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.
CAS Reg. No.
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: May 8, 2015.
G. Jeffrey Herndon,
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 § 180.940, revise the entry for
‘‘Acetic acid’’ and alphabetically add
the following inert ingredients to the
table in paragraph (a) to read as follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
*
*
Limits
64–19–7
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Allyl cylcohexylpropionate .........................
*
2705–87–5
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Butryic acid ................................................
Butyl alcohol ..............................................
Citral ..........................................................
Citronellol ..................................................
Citronellyl acetate ......................................
b-Damascone, (Z)- ....................................
Decanal .....................................................
(E)-4-Decenal ............................................
Decanoic acid ............................................
1-Decanol ..................................................
*
107–92–6
71–36–3
5392–40–5
106–22–9
150–84–5
23726–92–3
112–31–2
65405–70–1
334–48–5
112–30–1
When
When
When
When
When
When
When
When
When
When
*
*
2,6-Dimethyl-5-heptanal ............................
2-Dodecanol, (2E)- ....................................
mstockstill on DSK4VPTVN1PROD with RULES
Acetic acid .................................................
*
106–72–9
20407–84–5
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Ethyl 2-methylbutyrate ..............................
*
452–79–1
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
(E)-Geraniol ...............................................
(E)-Geraniol acetate ..................................
Heptanal ....................................................
Heptanoic acid ..........................................
*
106–24–1
105–87–3
111–71–7
111–14–8
When
When
When
When
VerDate Sep<11>2014
17:09 May 19, 2015
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E:\FR\FM\20MYR1.SGM
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28843
Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations
Pesticide chemical
CAS Reg. No.
Limits
Heptyl alcohol ............................................
Hexanal .....................................................
Hexanoic acid ............................................
n-Hexanol ..................................................
(Z)-3-Hexenol ............................................
(Z)-3-Hexenol acetate ...............................
Hexyl acetate ............................................
111–70–6
66–25–1
142–62–1
111–27–3
928–96–1
3681–71–8
142–92–7
When
When
When
When
When
When
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ready
ready
ready
ready
ready
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100
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100
100
100
100
ppm.
ppm.
ppm.
ppm.
ppm.
ppm.
ppm.
*
*
Lauric acid .................................................
Lauric aldehyde .........................................
Lauryl alcohol ............................................
d-Limonene ...............................................
*
143–07–7
112–54–9
112–53–8
5989–27–5
When
When
When
When
*
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ready
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is
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100
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*
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ppm.
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*
*
Methyl-a-ionone ........................................
3-Methyl-2-butenyl acetate ........................
2-Methylundecanal ....................................
*
127–42–4
1191–16–8
110–41–8
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Myristaldehyde ..........................................
Myristic acid ..............................................
Neryl acetate .............................................
*
124–25–4
544–63–8
141–12–8
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Nonanal .....................................................
Nonanoic acid ...........................................
Nonyl alcohol .............................................
*
124–19–6
112–05–0
143–08–8
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Octanal ......................................................
*
124–13–0
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Octanoic acid ............................................
1-Octanol ...................................................
*
124–07–2
111–87–5
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Palmitic acid ..............................................
*
57–10–3
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Propionic acid ............................................
*
79–09–4
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
Stearic acid. ..............................................
*
57–11–4
*
*
*
*
When ready for use, the end-use concentration is not to exceed 100 ppm.
*
*
2-Tridecanal ..............................................
3,5,5-Trimethylhexanal ..............................
Undecanal .................................................
Undecyl alcohol .........................................
Valeraldehyde ...........................................
Valeric acid ................................................
*
7774–82–5
5435–64–3
112–44–7
112–42–5
110–62–3
109–52–4
*
*
*
*
*
*
When
When
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*
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*
*
[FR Doc. 2015–11959 Filed 5–19–15; 8:45 am]
for
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
mstockstill on DSK4VPTVN1PROD with RULES
[EPA–HQ–OPP–2014–0340; FRL–9926–62]
Trinexapac-ethyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of trinexapac-
SUMMARY:
17:09 May 19, 2015
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100
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100
100
100
*
ppm.
ppm.
ppm.
ppm.
ppm.
ppm.
*
ethyl in or on multiple commodities
which are identified and discussed later
in this document. Syngenta Crop
protection LLC requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
This regulation is effective May
20, 2015. Objections and requests for
hearings must be received on or before
July 20, 2015, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
DATES:
E:\FR\FM\20MYR1.SGM
20MYR1
]]>Agencies
[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Rules and Regulations]
[Pages 28839-28843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11959]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0821; FRL-9927-38]
Fragrance Components; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of various fragrance component substances
when used as inert ingredients in antimicrobial pesticide formulations
for use on food contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils. This
regulation eliminates the need to establish a maximum permissible level
for residues of these various fragrance component substances
DATES: This regulation is effective May 20, 2015. Objections and
requests for hearings must be received on or before July 20, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0821, 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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing 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 the Federal Food, Drug, and Cosmetic Act (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-
2013-0821 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
[[Page 28840]]
received by the Hearing Clerk on or before July 20, 2015. Addresses for
mail and hand delivery of objections and hearing requests are provided
in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0821, 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. Today's Action
A. What is the authority for this action?
EPA is taking this action under section 408(e) the FFDCA, 21 U.S.C.
346a(e), which allows EPA to establish a tolerance exemption under
FFDCA section 408, 21 U.S.C. 346a et se. 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 requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . . ''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of FFDCA section 408 and a complete description
of the risk assessment process, see https://www.epa.gov/pesticides/regulating/tolerances.htm.
B. What action is the Agency taking?
EPA, on its own initiative under FFDCA section 408(e), is
establishing exemptions from the requirement of a tolerance for
residues of various fragrance component substances identified at the
end of this document.
III. EPA's Proposal
In the Federal Register of July 25, 2014 (79 FR 43350) (FRL-9910-
53), EPA proposed, on its own initiative under FFDCA section 408(e), 21
U.S.C. 346a(e), to establish exemptions from the requirement of a
tolerance for residues of acetaldehyde (CAS Reg. No. 75-07-0), acetic
acid (CAS Reg. No. 64-19-7), allyl cyclohexyl propionate (CAS Reg. No.
2705-87-5), butryic acid (CAS Reg. No. 107-92-6), butyl alcohol (CAS
Reg. No. 71-36-3), citral (CAS Reg. No. 5392-40-5), citronellol (CAS
Reg. No. 106-22-9), citronellyl acetate (CAS Reg. No. 150-84-5),
[beta]-damascone, (Z)-(CAS Reg. No. 23726-92-3), decanal (CAS Reg. No.
112-31-2), (E)-4-decenal (CAS Reg. No. 65405-70-1), decanoic acid (CAS
Reg. No. 334-48-5), 1-decanol (CAS Reg. No. 112-30-1), 2,6-dimethyl-5-
heptanal (CAS Reg. No. 106-72-9), 2-dodecanol, (2E)- (CAS Reg. No.
20407-84-5), d-limonene (CAS Reg. No. 5989-27-5), ethyl 2-
methylbutyrate (CAS Reg. No. 452-79-1), (E)-geraniol (CAS Reg. No. 106-
24-1), (E)-geraniol acetate (CAS Reg. No. 105-87-3), heptanal (CAS Reg.
No. 111-71-7), heptanoic acid (CAS Reg. No. 111-14-8), heptyl alcohol
(CAS Reg. No. 111-70-6), hexanal (CAS Reg. No. 66-25-1), hexanoic acid
(CAS Reg. No. 142-62-1), (Z)-3-hexenol (CAS Reg. No. 928-96-1), (Z)-3-
hexenol acetate (CAS Reg. No. 3681-71-8), hexyl acetate (CAS Reg. No.
142-92-7), hexyl alcohol (CAS Reg. No. 111-27-3), lauric acid (CAS Reg.
No.143-07-7), lauric aldehyde (CAS Reg. No. 112-54-9), lauryl alcohol
(CAS Reg. No. 112-53-8), methyl-[alpha]-ionone (CAS Reg. No. 127-42-4),
3-methyl-2-butenyl acetate (CAS Reg. No. 1191-16-8), 2-methylundecanal
(CAS Reg. No. 110-41-8), myristaldehyde (CAS Reg. No. 124-25-4),
myristic acid (CAS Reg. No. 544-63-8), neryl acetate (CAS Reg. No. 141-
12-8), n-hexanol (CAS Reg. No. 111-27-3), nonanal (CAS Reg. No. 124-19-
6), nonanoic acid (CAS Reg. No. 112-05-0), nonyl alcohol (CAS Reg. No.
143-08-8), octanal (CAS Reg. No. 124-13-0), octanoic acid (CAS Reg. No.
124-07-2), 1-octanol (CAS Reg. No. 111-87-5), palmitic acid (CAS Reg.
No. 57-10-3), propionic acid (CAS Reg. No. 79-09-4), stearic acid (CAS
Reg. No. 57-11-4), 2-tridecanal (CAS Reg. No. 7774-82-5), 3,5,5-
trimethylhexanal (CAS Reg. No. 5435-64-3), undecanal (CAS Reg. No. 112-
44-7), undecyl alcohol (CAS Reg. No. 112-42-5), valeraldehyde (CAS Reg.
No. 110-62-3), and valeric acid (CAS Reg. No. 109-52-4) when used as
fragrance components (i.e., inert ingredients) in antimicrobial
pesticide formulations for use on food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils at end-use concentrations not to exceed 100
parts per million (ppm).
As discussed in that document, EPA has reviewed the available
scientific data and other relevant information in support of this
action, consistent with FFDCA section 408(c)(2), and the factors
specified in FFDCA section 408(b)(2)(C and D). EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure for these various fragrance components including exposure
resulting from the exemptions from the requirement of a tolerance
established by this action. For a detailed discussion of the aggregate
risk assessments and determination of safety that support the
establishment of these exemptions from the requirement of a tolerance,
please refer to the July 25, 2014 Federal Register final rule and its
supporting documents, available at https://regulations.gov.
IV. Public Comments
EPA received nine comments to the proposed rule. Six of the
comments were fully supportive of the proposed rule. One comment made
specific reference to the fragrance component acetaldehyde and stated
that the risk assessment of acetaldehyde should reconsider the
compound's cancer risk. The comment noted that part of the safety
finding for the fragrance components was based on no structural alerts
for genotoxicity or carcinogenicity but in the case of acetaldehyde EPA
had previously considered acetaldehyde to
[[Page 28841]]
be a probable human carcinogen based on inadequate human cancer studies
and animal studies that have shown increased incidence of nasal tumors
in rats and laryngeal tumors in hamsters after inhalation exposure. The
Agency agrees with the commenter that the safety analysis provided in
the proposed rule, which relies on human exposure threshold values for
non-cancer risks, is not applicable to acetaldehyde and therefore,
cannot be used to support an exemption for acetaldehyde. As such, EPA
is not establishing in this final rule an exemption from the
requirement of a tolerance for acetaldehyde as a fragrance component
for use in antimicrobial pesticide formulations for use on food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils at end-use concentrations not to
exceed 100 ppm.
Two comments made reference to fragrance sensitivity among certain
individuals. The Agency understands the commenter's concerns, however
the legal framework provided by FFDCA section 408 states that
tolerances may be set when the pesticide chemical meets the safety
standard imposed by that statute. The Agency is required by FFDCA
section 408 to estimate the risk of the potential exposure to these
residues. Neither the supporting information cited by the commenters or
other reliable data demonstrate the occurrence of specific adverse
effects directly attributable to exposures to the substances listed in
Unit III and EPA has concluded that there is a reasonable certainty
that no harm will result to the general population and to infants and
children from aggregate exposure to the fragrance components listed in
Unit III when used as inert ingredients in antimicrobial formulations
for use on food contact surfaces in public eating places, dairy
processing equipment, and food processing equipment and utensils at
end-use concentrations not to exceed 100 ppm.
V. Final Rule and Determination of Safety
Except for the exclusion of acetaldehyde, EPA is not making any
changes to the risk assessment or final rule text that was proposed in
July 25, 2014 Federal Register. Therefore, EPA concludes that there is
a reasonable certainty that no harm will result to the general
population and to infants and children from aggregate exposure to
acetic acid; allyl cylcohexylpropionate; butryic acid; butyl alcohol;
citral; citronellol; citronellyl acetate; [beta]-damascone, (Z)-;
decanal; (E)-4-decenal; decanoic acid; 1-decanol; 2,6-dimethyl-5-
heptanal; 2-dodecanol, (2E)-; d-limonene; ethyl 2-methylbutyrate; (E)-
geraniol; (E)-geraniol acetate; heptanal; heptanoic acid; heptyl
alcohol; hexanal; hexanoic acid; (Z)-3-hexenol; (Z)-3-hexenol acetate;
hexyl acetate; hexyl alcohol; lauric acid; lauric aldehyde; lauryl
alcohol; methyl-[alpha]-ionone; 3-methyl-2-butenyl acetate; 2-
methylundecanal; myristaldehyde; myristic acid; neryl acetate; n-
hexanol; nonanal; nonanoic acid; nonyl alcohol; octanal; octanoic acid;
1-octanol; palmitic acid; propionic acid; stearic acid; 2-tridecanal;
3,5,5-trimethylhexanal; undecanal; undecyl alcohol; valeraldehyde; and
valeric acid residues when used as when used as fragrance components
(i.e., inert ingredients) in antimicrobial pesticide formulations for
use on food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils at end-use
concentrations not to exceed 100 ppm.
VI. 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 EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for the fragrance components
listed in Unit II above.
VII. Conclusion
Therefore, exemptions from the requirement of a tolerance are
established for residues of acetic acid (CAS Reg. No. 64-19-7), allyl
cyclohexyl propionate (CAS Reg. No. 2705-87-5), butryic acid (CAS Reg.
No. 107-92-6), butyl alcohol (CAS Reg. No. 71-36-3), citral (CAS Reg.
No. 5392-40-5), citronellol (CAS Reg. No. 106-22-9), citronellyl
acetate (CAS Reg. No. 150-84-5), [beta]-damascone, (Z)- (CAS Reg. No.
23726-92-3), decanal (CAS Reg. No. 112-31-2), (E)-4-decenal (CAS Reg.
No. 65405-70-1), decanoic acid (CAS Reg. No. 334-48-5), 1-decanol (CAS
Reg. No. 112-30-1), 2,6-dimethyl-5-heptanal (CAS Reg. No. 106-72-9), 2-
dodecanol, (2E)- (CAS Reg. No. 20407-84-5), d-limonene (CAS Reg. No.
5989-27-5), ethyl 2-methylbutyrate (CAS Reg. No. 452-79-1), (E)-
geraniol (CAS Reg. No. 106-24-1), (E)-geraniol acetate (CAS Reg. No.
105-87-3), heptanal (CAS Reg. No. 111-71-7), heptanoic acid (CAS Reg.
No. 111-14-8), heptyl alcohol (CAS Reg. No. 111-70-6), hexanal (CAS
Reg. No. 66-25-1), hexanoic acid (CAS Reg. No. 142-62-1), (Z)-3-hexenol
(CAS Reg. No. 928-96-1), (Z)-3-hexenol acetate (CAS Reg. No. 3681-71-
8), hexyl acetate (CAS Reg. No. 142-92-7), hexyl alcohol (CAS Reg. No.
111-27-3), lauric acid (CAS Reg. No. 143-07-7), lauric aldehyde (CAS
Reg. No. 112-54-9), lauryl alcohol (CAS Reg. No. 112-53-8), methyl-
[alpha]-ionone (CAS Reg. No. 127-42-4), 3-methyl-2-butenyl acetate (CAS
Reg. No. 1191-16-8), 2-methylundecanal (CAS Reg. No. 110-41-8),
myristaldehyde (CAS Reg. No. 124-25-4), myristic acid (CAS Reg. No.
544-63-8), neryl acetate (CAS Reg. No. 141-12-8), n-hexanol (CAS Reg.
No. 111-27-3), nonanal (CAS Reg. No. 124-19-6), nonanoic acid (CAS Reg.
No. 112-05-0), nonyl alcohol (CAS Reg. No. 143-08-8), octanal (CAS Reg.
No. 124-13-0), octanoic acid (CAS Reg. No. 124-07-2), 1-octanol (CAS
Reg. No. 111-87-5), palmitic acid (CAS Reg. No. 57-10-3), propionic
acid (CAS Reg. No. 79-09-4), stearic acid (CAS Reg. No. 57-11-4), 2-
tridecanal (CAS Reg. No. 7774-82-5), 3,5,5-trimethylhexanal (CAS Reg.
No. 5435-64-3), undecanal (CAS Reg. No. 112-44-7), undecyl alcohol (CAS
Reg. No. 112-42-5), valeraldehyde (CAS Reg. No. 110-62-3), and valeric
acid (CAS Reg. No. 109-52-4) when used as fragrance components (i.e.,
inert ingredients) in antimicrobial pesticide formulations for use on
food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils at end-use
concentrations not to exceed 100 ppm.
VIII. Statutory and Executive Order Reviews
This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(e). The Office
[[Page 28842]]
of Management and Budget (OMB) has exempted tolerance actions from
review under Executive Orders 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993) and 13563, entitled Improving
Regulation and Regulatory Review (76 FR 3821, January 21, 2011). As a
result, 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). Nor does it require
OMB review or any Agency action under 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.); does not 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); and 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).
This action directly regulates growers, food processors, food
handlers, and food retailers, but it does not regulate State or tribal
governments. 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). Therefore, the
Agency has determined that Executive Orders 13132, entitled Federalism
(64 FR 43255, August 10, 1999) and 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, contain any unfunded mandate, or otherwise
significantly or uniquely affect small governments as described in the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.),
the Agency hereby certifies that this action will not have significant
negative economic impact on a substantial number of small entities.
Establishing an exemption from the requirement of a pesticide tolerance
is, in effect, the removal of a regulatory restriction on pesticide
residues in food and thus such an action will not have any negative
economic impact on any entities, including small entities.
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: May 8, 2015.
G. Jeffrey Herndon,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.940, revise the entry for ``Acetic acid'' and
alphabetically add the following inert ingredients to the table in
paragraph (a) to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
----------------------------------------------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
Acetic acid................................... 64-19-7 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Allyl cylcohexylpropionate.................... 2705-87-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Butryic acid.................................. 107-92-6 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Butyl alcohol................................. 71-36-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Citral........................................ 5392-40-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Citronellol................................... 106-22-9 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Citronellyl acetate........................... 150-84-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
[beta]-Damascone, (Z)-........................ 23726-92-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Decanal....................................... 112-31-2 When ready for use, the end-use concentration is
not to exceed 100 ppm.
(E)-4-Decenal................................. 65405-70-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Decanoic acid................................. 334-48-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
1-Decanol..................................... 112-30-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
2,6-Dimethyl-5-heptanal....................... 106-72-9 When ready for use, the end-use concentration is
not to exceed 100 ppm.
2-Dodecanol, (2E)-............................ 20407-84-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Ethyl 2-methylbutyrate........................ 452-79-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
(E)-Geraniol.................................. 106-24-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
(E)-Geraniol acetate.......................... 105-87-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Heptanal...................................... 111-71-7 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Heptanoic acid................................ 111-14-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
[[Page 28843]]
Heptyl alcohol................................ 111-70-6 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Hexanal....................................... 66-25-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Hexanoic acid................................. 142-62-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
n-Hexanol..................................... 111-27-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
(Z)-3-Hexenol................................. 928-96-1 When ready for use, the end-use concentration is
not to exceed 100 ppm.
(Z)-3-Hexenol acetate......................... 3681-71-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Hexyl acetate................................. 142-92-7 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Lauric acid................................... 143-07-7 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Lauric aldehyde............................... 112-54-9 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Lauryl alcohol................................ 112-53-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
d-Limonene.................................... 5989-27-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Methyl-[alpha]-ionone......................... 127-42-4 When ready for use, the end-use concentration is
not to exceed 100 ppm.
3-Methyl-2-butenyl acetate.................... 1191-16-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
2-Methylundecanal............................. 110-41-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Myristaldehyde................................ 124-25-4 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Myristic acid................................. 544-63-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Neryl acetate................................. 141-12-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Nonanal....................................... 124-19-6 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Nonanoic acid................................. 112-05-0 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Nonyl alcohol................................. 143-08-8 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Octanal....................................... 124-13-0 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Octanoic acid................................. 124-07-2 When ready for use, the end-use concentration is
not to exceed 100 ppm.
1-Octanol..................................... 111-87-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Palmitic acid................................. 57-10-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Propionic acid................................ 79-09-4 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
Stearic acid.................................. 57-11-4 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
2-Tridecanal.................................. 7774-82-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
3,5,5-Trimethylhexanal........................ 5435-64-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Undecanal..................................... 112-44-7 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Undecyl alcohol............................... 112-42-5 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Valeraldehyde................................. 110-62-3 When ready for use, the end-use concentration is
not to exceed 100 ppm.
Valeric acid.................................. 109-52-4 When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 2015-11959 Filed 5-19-15; 8:45 am]
BILLING CODE 6560-50-P
