[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Rules and Regulations]
[Pages 28444-28448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11204]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0863; FRL-9909-17]
Amine Salts of Alkyl (C8-C24)
Benzenesulfonic Acid (Dimethylaminopropylamine, Isopropylamine, Mono-,
Di-, and Triethanolamine); Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends two exemptions from the requirement of
a tolerance for residues of diethanolamine salts of alkyl
(C8-C24) benzenesulfonic acid (not to exceed 7%
of pesticidal formulations) and two exemptions from the requirement of
a tolerance for residues of dimethylaminopropylamine, isopropylamine,
ethanolamine, and triethanolamine salts of alkyl (C8-
C24) benzenesulfonic acid (without limitation), herein
referred to collectively as amine salts of alkyl (C8-
C24) benzenesulfonic acid (dimethylaminopropylamine,
isopropylamine, mono-, di-, and triethanolamine), or ASABSA, when used
as inert ingredients applied to growing crops and to animals. The Joint
Inerts Task Force Cluster Support Team 8 (JITF CST 8) c/o Huntsman
Corp., submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting amendment of two existing exemptions
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of ASABSA.
DATES: This regulation is effective May 16, 2014. Objections and
requests for hearings must be received on or before July 15, 2014, 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-2012-0863, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0863 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 15, 2014. 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-2012-0863, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of August 5, 2009 (74 FR 38924) (FRL-8430-
2), EPA issued a final rule announcing the establishment of a tolerance
exemption pursuant to a pesticide petition (PP 8E7472) by the Joint
Inerts Task Force Cluster Support Team 8 (JITF CST 8) c/o CropLife
America, 1156 15th St. NW., Suite 400, Washington, DC 20005. The
petition requested that 40 CFR 180.920 and 180.930 be amended by
establishing exemptions from the requirement of a tolerance for
residues of diethanolamine salts of alkyl (C8-
C24) benzenesulfonic acid and dimethylaminopropylamine,
isopropylamine, ethanolamine, and triethanolamine salts of alkyl
(C8-C24) benzenesulfonic acid when used as inert
ingredients (surfactants) in pesticide formulations applied to growing
crops and animals. The current petition seeks to expand the exemptions
for ASABSA
[[Page 28445]]
by adding additional chemicals identified by Chemical Abstract Service
Registry Numbers (CAS Reg. Nos.).
In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2),
EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 2E8087) by the Joint
Inerts Task Force, Cluster Support Team 8, (JITF CST 8), c/o Huntsman
Corp., 8600 Gosling Rd., The Woodlands, TX 77381. The petition
requested that 40 CFR 180.920 and 180.930 be amended by modifying two
exemptions from the requirement of a tolerance for residues of
diethanolamine salts of alkyl (C8-C24)
benzenesulfonic acid (not to exceed 7% of pesticide formulation) to
include CAS Reg. Nos. 67815-95-6, 67889-94-5, 67889-95-6, 68259-34-7,
68478-47-7, 68567-68-0, 68815-34-9, 68815-37-2, 68891-02-1, 84989-15-1,
85338-09-6, 90194-39-1, 90194-40-4, and 90218-08-9 and two exemptions
from the requirement of a tolerance for residues of
dimethylaminopropylamine, isopropylamine, ethanolamine, and
triethanolamine salts of alkyl (C8-C24)
benzenesulfonic acid (without limitation) to include CAS Reg. Nos.
3088-30-0, 12068-12-1, 26836-07-7, 58089-99-9, 61886-59-7, 61931-76-8,
67924-05-4, 68110-32-7, 68259-35-8, 68442-72-8, 68567-69-1, 68815-30-5,
68815-35-0, 68953-98-0, 70528-84-6, 72391-21-0, 84961-74-0, 85480-55-3,
85480-56-4, 85995-82-0, 90194-54-0, 90194-55-1, 90218-09-0, 90218-11-4,
96687-54-6, 99924-49-9, 121617-08-1, and 193562-36-6. That document
referenced a summary of the petition prepared by JITF CST 8, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
In this petition, the JITF CST 8 claims that the requested chemical
CAS Reg. Nos. listed in Unit II. should be covered by the published
tolerance exemptions for ASABSA and that no further data or review is
required to amend the existing tolerance exemption to include the
additional CAS Reg. Nos.
Based upon review of the data supporting the petition, EPA has
confirmed that the requested CAS Reg. Nos. are appropriately added to
the currently approved respective descriptors for ASABSA.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
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(b)(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. Section 408(b)(2)(C) of FFDCA 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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for ASABSA including exposure
resulting from the exemption amended by this action. EPA's assessment
of exposures and risks associated with ASABSA follows.
The Agency agrees with the petitioner that CAS Reg. Nos. 67815-95-
6, 67889-94-5, 67889-95-6, 68259-34-7, 68478-47-7, 68567-68-0, 68815-
34-9, 68815-37-2, 68891-02-1, 84989-15-1, 85338-09-6, 90194-39-1,
90194-40-4, and 90218-08-9 are diethanolamine salts of alkyl
(C8-C24) benzenesulfonic acid similar to those
present in the existing exemption.
The Agency agrees with the petitioner that CAS Reg. Nos. 3088-30-0,
12068-12-1, 26836-07-7, 58089-99-9, 61886-59-7, 61931-76-8, 67924-05-4,
68110-32-7, 68259-35-8, 68442-72-8, 68567-69-1, 68815-30-5, 68815-35-0,
68953-98-0, 70528-84-6, 72391-21-0, 84961-74-0, 85480-55-3, 85480-56-4,
85995-82-0, 90194-54-0, 90194-55-1, 90218-09-0, 90218-11-4, 96687-54-6,
99924-49-9, 121617-08-1, and 193562-36-6 are dimethylaminopropylamine,
isopropylamine, ethanolamine, and triethanolamine salts of alkyl
(C8-C24) benzenesulfonic acid similar to those
present in the existing exemption.
In 2009, in establishing the exemptions for ASABSA, EPA assessed
the safety generally using worst case exposure assumptions (74 FR
38924) (FRL-8430-2). Based upon the review of the data supporting this
petition, EPA has confirmed that the requested CAS Reg. Nos. are
appropriately added to the currently approved descriptors. The
requested CAS Reg. Nos. consist of compounds that are amine salts of
alkyl (C8-C24) benzenesulfonic acid
(dimethylaminopropylamine, isopropylamine, mono-, di-, and
triethanolamine). As such, the requested CAS Reg. Nos. fall within the
existing tolerance exemption descriptors for diethanolamine salts of
alkyl (C8-C24) benzenesulfonic acid and
dimethylaminopropylamine, isopropylamine, ethanolamine, and
triethanolamine salts of alkyl (C8-C24)
benzenesulfonic acid given in 40 CFR 180.920 and 180.930.
The Agency has determined that the proposed addition of the
requested CAS Reg. Nos. is adequately supported by the existing data
and assessment and that
[[Page 28446]]
no additional data or review is required. Inclusion of the additional
chemicals described in Unit IV. in the risk assessments for the ASABSA
would in no way alter the prior risk assessments given the generic
findings on toxicity and the worst case exposure assumptions used in
those risk assessments. Accordingly, based on the findings in that
earlier rule, EPA has determined that there is a reasonable certainty
that no harm to any population subgroup, including infants and
children, will result from aggregate exposure to ASABSA by including
the additional chemicals described in Unit IV., under reasonably
foreseeable circumstances. Therefore, the amendment to an existing
requirement of a tolerance under 40 CFR 180.920, and 180.930 for
residues of ASABSA to include the chemicals described in Unit IV. is
safe under FFDCA section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical level of residues of
diethanolamine salts of alkyl (C8-C24)
benzenesulfonic acid that cannot be exceeded in or on any food
commodities. EPA is establishing a limitation on the amount of the
diethanolamine salts of alkyl (C8-C24)
benzenesulfonic acid that may be used in pesticide formulations. That
limitation will be enforced through the pesticide registration process
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or
distribution that contains greater than 7% of the diethanolamine salts
of alkyl (C8-C24) benzenesulfonic acid by weight
in the pesticide formulation.
VI. Conclusions
Therefore, the exemptions from the requirement of a tolerance under
40 CFR 180.920 and 180.930 for diethanolamine salts of alkyl
(C8-C24) benzenesulfonic acid (not to exceed 7%
of pesticide formulations) and dimethylaminopropylamine,
isopropylamine, ethanolamine, and triethanolamine salts of alkyl
(C8-C24) benzenesulfonic acid are amended to
include the requested CAS Reg. Nos. when used as inert ingredients
(surfactants) in pesticide formulations applied to growing crops and to
animals.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement for a
tolerance in response to a petition submitted to the Agency under FFDCA
section 408(d). The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4,
1993). Because this final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VIII. 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 7, 2014.
G. Jeffrey Herndon,
Acting 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. 180.920, revise the following inert ingredients in the
table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
[[Page 28447]]
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Inert ingredients Limits Uses
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* * * * * * *
Diethanolamine salts of alkyl Not to exceed 7% Surfactants, related adjuvants of surfactants.
(C8-C24) benzenesulfonic acid of pesticide
(CAS Reg. Nos. 26545-53-9, formulation.
67815-95-6, 67889-94-5, 67889-
95-6, 68259-34-7, 68478-47-7,
68567-68-0, 68815-34-9, 68815-
37-2, 68891-02-1, 68953-97-9,
84989-15-1, 85338-09-6, 90194-
39-1, 90194-40-4, 90218-08-9).
* * * * * * *
Dimethylaminopropylamine, ................. Surfactants, related adjuvants of surfactants.
isopropylamine, ethanolamine,
and triethanolamine salts of
alkyl (C8-C24)
benzenesulfonic acid (CAS
Reg. Nos. 3088-30-0, 12068-12-
1, 26264-05-1, 26836-07-7,
27323-41-7, 55470-69-4, 58089-
99-9, 61886-59-7, 61931-76-8,
67924-05-4, 68110-32-7, 68259-
35-8, 68411-31-4, 68442-72-8,
68567-69-1, 68584-24-7, 68584-
25-8, 68648-81-7, 68648-96-4,
68649-00-3, 68815-30-5, 68815-
35-0, 68910-32-7, 68953-93-5,
68953-98-0, 70528-84-6, 72391-
21-0, 84961-74-0, 85480-55-3,
85480-56-4, 85995-82-0, 90194-
42-6, 90194-53-9, 90194-54-0,
90194-55-1, 90218-09-0, 90218-
11-4, 90218-35-2, 96687-54-6,
99924-49-9, 121617-08-1,
157966-96-6, 193562-36-6,
319926-68-6, 877677-48-0,
1093628-27-3).
* * * * * * *
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0
3. In Sec. 180.930, revise the following inert ingredients in the
table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Diethanolamine salts of alkyl Not to exceed 7% Surfactants, related adjuvants of surfactants.
(C8-C24) benzenesulfonic acid of pesticide
(CAS Reg. Nos. 26545-53-9, formulation.
67815-95-6, 67889-94-5, 67889-
95-6, 68259-34-7, 68478-47-7,
68567-68-0, 68815-34-9, 68815-
37-2, 68891-02-1, 68953-97-9,
84989-15-1, 85338-09-6, 90194-
39-1, 90194-40-4, 90218-08-9).
* * * * * * *
Dimethylaminopropylamine, ................. Surfactants, related adjuvants of surfactants.
isopropylamine, ethanolamine,
and triethanolamine salts of
alkyl (C8-C24)
benzenesulfonic acid (CAS
Reg. Nos. 3088-30-0, 12068-12-
1, 26264-05-1, 26836-07-7,
27323-41-7, 55470-69-4, 58089-
99-9, 61886-59-7, 61931-76-8,
67924-05-4, 68110-32-7, 68259-
35-8, 68411-31-4, 68442-72-8,
68567-69-1, 68584-24-7, 68584-
25-8, 68648-81-7, 68648-96-4,
68649-00-3, 68815-30-5, 68815-
35-0, 68910-32-7
68953-93-5, 68953-98-0, 70528-
84-6, 72391-21-0, 84961-74-0,
85480-55-3, 85480-56-4, 85995-
82-0, 90194-42-6, 90194-53-9,
90194-54-0, 90194-55-1, 90218-
09-0, 90218-11-4, 90218-35-2,
96687-54-6, 99924-49-9,
121617-08-1, 157966-96-6,
193562-36-6, 319926-68-6,
877677-48-0, 1093628-27-3)..
* * * * * * *
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[FR Doc. 2014-11204 Filed 5-15-14; 8:45 am]
BILLING CODE 6560-50-P