[Federal Register Volume 61, Number 143 (Wednesday, July 24, 1996)]
[Proposed Rules]
[Pages 38423-38426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18388]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4417/P671; FRL-5382-8]
RIN 2070-AC18
N-Acyl Sarcosines and Sodium N-Acyl Sarcosinates; Proposed
Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of N-acyl sarcosines [N-
oleoyl sarcosine, N-stearoyl sarcosine, N-lauroyl sarcosine, N-
myristoyl sarcosine, N-cocoyl sarcosine mixture] and sodium N-acyl
sarcosinates [N-methyl-N-(1-oxo-9-octodecenyl) glycine, N-methyl-N-(1-
oxooctadecyl) glycine, N-methyl-N-(1-oxododecyl) glycine, N-methyl-N-
(1-oxotetradecyl) glycine, and N-cocoyl sarcosine sodium salt mixture
be exempted from the requirement of a tolerance when used at levels not
to exceed 10% as inert ingredients (surfactants) in pesticide
formulations applied to growing crops, crops after harvest, and on
animals. This proposed regulation was requested by Hampshire
[[Page 38424]]
Chemical Company, pursuant to the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: Comments, identified by the docket control number [PP 4E4417/
P671], must be received on or before August 23, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person deliver comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the address given above, from 8 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [PP 4E4417/P671]. No CBI should be submitted through
e-mail. Electronic comments on this proposed rule may be filed online
at many Federal Depository Libraries. Additional information on
electronic submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703) 308-
8375, e-mail: acierto.amelia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Hampshire Chemical Company, 55 Hayden
Avenue, Lexington, MA 02173, has submitted pesticide petition (PP)
4E4417 to EPA requesting that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e),
propose to amend 40 CFR 180.1001(c) and (e) by establishing an
exemption from the requirement of a tolerance for N-acyl sarcosines [N-
oleoyl sarcosine (CAS Reg. No. 110-25-8); N-stearoyl sarcosine (CAS
Reg. No. 142-48-3); N-lauroyl sarcosine (CAS Reg. No. 97-78-9); N-
myristoyl sarcosine (CAS Reg. No. 52558-73-3); N-cocoyl sarcosine
mixture (CAS Reg. No. 68411-97-2); and sodium N-acyl sarcosinates [N-
methyl-N-(1-oxo-9-octodecenyl) glycine (CAS Reg. No. 3624-77-9); N-
methyl-N-(1-oxooctadecyl) glycine (CAS Reg. No. 5136-55-0); N-methyl-N-
(1-oxododecyl) glycine (CAS Reg. No. 137-16-6); N-methyl-N-(1-
oxotetradecyl glycine (CAS Reg. No. 30364-51-3); and N-cocoyl sarcosine
sodium salt mixture (CAS Reg. No. 61791-59-1)] when used at levels not
to exceed 10% as inert ingredients (surfactants) in pesticide
formulations applied to growing crops, crops after harvest and animals
under 40 CFR 180.1001(c) and (e).
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.
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an inert ingredient. The Agency has decided that no
data, in addition to that described below, for N-acyl sarcosines and
their corresponding sodium salts will need to be submitted. The
rationale for this decision is described below:
1. N-Acyl sarcosines form a large class of chemical compounds that
have been used for years in soaps, toiletries, toothpastes, medicated
skin cleaners and shampoos and other consumer products.
2. N-Acyl sarcosines have approved uses under the Federal Food,
Drug, and Cosmetic Act (FFDCA):
(a) Lauroyl and stearoyl sarcosines are approved for use as release
agents in coatings at levels up to 0.3% by weight of the finished food
packaging cellophane (21 CFR 177.1200).
(b) Lauroyl sarcosine, sodium salt is approved for use in food
packaging made of vinylidine chloride copolymer up to 0.35% by weight
(21 CFR 177.1200) and for use in holding food (21 CFR 175.105).
(c) Oleoyl sarcosine [listed as N-methyl-N-(1-oxo-9-octadecenyl)
glycine] is approved for use as a corrosion inhibitor at levels of up
to 0.5% of the lubricants used on machinery used for processing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting or holding food (21 CFR 178.3570).
3. N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or
derived from the combined fatty acids of coconut oil (i.e., cocoyl) are
approved for use as anti-static and/or antifogging agents at levels up
to a total of 0.15% by weight of polyolefin film used for packaging
meat, fresh fruits, and fresh vegetables (21 CFR 178.3130).
4. The structurally similar compounds, N-methyl-N-oleoyltaurine,
sodium salt and N-methyl-N-palmitoyltaurine, sodium salt are approved
for use as surfactants in pesticide formulations applied to growing
crops or to raw agricultural commodities under 40 CFR 180.1001(c) and
are included in the EPA's list of inert ingredients accepted for non-
food use.
5. N-Methyl-N-oleoyl glycine and N-methyl-N-oleoyltaurine, sodium
salt, two other structurally similar compounds, are included in the EPA
list of inert ingredients approved for non-food use pesticides.
6. N-Acyl sarcosines were negative in dermal irritation, dermal
sensitization and mutagenicity studies.
7. Hazard to aquatic organisms is not expected at the proposed use
rates based on ecotoxicology studies of N-acyl sarcosines with fish and
aquatic invertebrates.
8. Based on the worst case assumption regarding the dietary risks
resulting
[[Page 38425]]
from exposure to N-acyl sarcosines and its salts when used at levels
not to exceed 10% of pesticide formulations, residues of N-acyl
sarcosines and their sodium salts would not be considered to be
toxicologically significant.
Based on the extensive use of N-acyl sarcosines and their sodium
salts in various consumer products such as toothpastes, soaps,
medicated skin cleaners and medicated shampoos; its physico-chemical
properties; the fact that some of these chemicals have been approved
for food use applications, and the review of its use, the Agency does
not believe that a potential for hazard exists when N-acyl sarcosines
and their sodium salts are used in accordance with good agricultural
practice. The Agency believes that these ingredients are useful and a
tolerance is not necessary to protect the public health. Therefore, EPA
proposes that the exemption from the requirement of a tolerance be
established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this proposal be referred
to an Advisory Committee in accordance with section 408(e) of FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket control number, [PP 4E4417/P671].
A record has been established for this rulemaking under docket
number [PP 4E4417/P671] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the Virginia address in ADDRESSES at the
beginning of this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 of Executive Order 12866.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1955 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement explaining the factual basis for this
determination was published in the Federal Register of May 4, 1981 (46
FR 24950).
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 10, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.1001 the table in paragraph (c) and (e) is amended
by adding alphabetically the following inert ingredients:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(c) * * *
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Inert ingredients Limits Uses
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* * * * * * *
N-Cocoyl sarcosine mixture (CAS Not to exceed 10% Surfactant.
Reg. No. 68411-97-2) [composed by weight of
of N-methyl-N-(1-oxooctyl) pesticide
glycine, N-methyl-N-(1-oxodecyl) formulation.
glycine, N-methyl-N-(1-
oxododecyl) glycine, N-methyl-N-
(1-oxotetradecyl) glycine, (N-
methyl-N-(1-oxohexadecyl)
glycine and N-methyl-N-(1-
oxooctadecyl)glycine.
N-Cocoyl sarcosine, sodium salt Not to exceed 10% Surfactant.
mixture (CAS Reg. No. 61791-59- by weight of
1). pesticide
formulation.
* * * * * * *
N-Lauroyl sarcosine (CAS Reg. No. Not to exceed 10% Surfactant.
97-78-9). by weight of
pesticide
formulation.
* * * * * * *
N-Methyl-N-(1-oxododecyl) Not to exceed 10% Surfactant.
glycine, sodium salt (CAS Reg. by weight of
No. 137-16-6). pesticide
formulation.
N-Methyl-N-(1-oxo-9-octadecenyl) Not to exceed 10% Surfactant.
glycine, sodium salt CAS Reg. by weight of
No. 3624-77-9). pesticide
formulation.
N-Methyl-N-(1-oxooctadecyl) Not to exceed 10% Surfactant.
glycine, sodium salt (CAS Reg. by weight of
No. 5136-55-0). pesticide
formulation.
[[Page 38426]]
N-Methyl-N-(1-oxotetradecyl) Not to exceed 10% Surfactant.
glycine, sodium salt (CAS Reg. by weight of
No. 30364-51-3). pesticide
formulation.
* * * * * * *
N-Myristoyl sarcosine (CAS Reg. Not to exceed 10% Surfactant.
No. 52558-73-3). by weight of
pesticide
formulation.
* * * * * * *
N-Oleoyl sarcosine (CAS Reg. No. Not to exceed 10% Surfactant.
110-25-8). by weight of
pesticide
formulation.
* * * * * * *
N-Stearoyl sarcosine (CAS Reg. Not to exceed 10% Surfactant.
No. 142-48-3). by weight of
pesticide
formulation.
* * * * * * *
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* * * * *
(e) * * *
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Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
N-Cocoyl sarcosine mixture (CAS Not to exceed 10% Surfactant.
Reg. No. 68411-97-2) [composed by weight of
of N-methyl-N-(1-oxooctyl) pesticide
glycine, N-methyl-N-(1-oxodecyl) formulation.
glycine, N-methyl-N-(1-
oxododecyl) glycine, N-methyl-N-
(1-oxotetradecyl) glycine, (N-
methyl-N-(1-oxohexadecyl)
glycine and N-methyl-N-(1-
oxooctadecyl)glycine.
N-Cocoyl sarcosine, sodium salt Not to exceed 10% Surfactant.
mixture (CAS Reg. No. 61791-59- by weight of
1). pesticide
formulation.
* * * * * * *
N-Lauroyl sarcosine (CAS Reg. No. Not to exceed 10% Surfactant.
97-78-9). by weight of
pesticide
formulation.
* * * * * * *
N-Methyl-N-(1-oxododecyl) Not to exceed 10% Surfactant.
glycine, sodium salt (CAS Reg. by weight of
No. 137-16-6). pesticide
formulation.
N-Methyl-N-(1-oxo-9-octadecenyl) Not to exceed 10% Surfactant.
glycine, sodium salt CAS Reg. by weight of
No. 3624-77-9). pesticide
formulation.
N-Methyl-N-(1-oxooctadecyl) Not to exceed 10%
glycine, sodium salt (CAS Reg. by weight of
No. 5136-55-0). pesticide
formulation.
N-Methyl-N-(1-oxotetradecyl) Not to exceed 10% Surfactant.
glycine, sodium salt (CAS Reg. by weight of
No. 30364-51-3). pesticide
formulation.
* * * * * * *
N-Myristoyl sarcosine (CAS Reg. Not to exceed 10% Surfactant.
No. 52558-73-3). by weight of
pesticide
formulation.
* * * * * * *
N-Oleoyl sarcosine (CAS Reg. No. Not to exceed 10% Surfactant.
110-25-8). by weight of
pesticide
formulation.
* * * * * * *
N-Stearoyl sarcosine (CAS Reg. Not to exceed 10% Surfactant.
No. 142-48-3). by weight of
pesticide
formulation.
* * * * * * *
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[FR Doc. 96-18388 Filed 7-23-96; 8:45 am]
BILLING CODE 6560-50-F
