N-Acyl sarcosines and Sodium N-acyl sarcosinates; Tolerance
Exemption
[Federal Register: July 7, 1999 (Volume 64, Number 129)]
[Proposed Rules]
[Page 36640-36642]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy99-39]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300885; FRL-6088-4]
RIN 2070-AB18
N-Acyl sarcosines and Sodium N-acyl sarcosinates; Tolerance
Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish an exemption from the requirement of
a tolerance for residues of 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 as inert ingredients (surfactants) in pesticide
formulations containing glyphosate. EPA is proposing this regulation on
its own initiative.
DATES: Written comments should be submitted to EPA on or before
September 7, 1999.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA.
Comments and data may also be submitted electronically to: opp-
docket@epa.gov. Follow the instructions under Unit V. of this document.
No Confidential Business Information (CBI) should be submitted through
e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
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. 119 at the Virginia address
given in this unit, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Amelia M. Acierto, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-8377,
acierto.amelia@epa.gov.
SUPPLEMENTARY INFORMATION: Prior to the enactment of the Food Quality
Protection Act of 1996 (FQPA), EPA proposed that exemptions from the
requirement of a tolerance be established for 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-oxotetracdecyl)glycine; and N-cocoyl sodium salt
mixture], in response to a pesticide petition (PP 4E4417) submitted by
Hampshire Chemical Company, 55 Hayden Avenue, Lexington, MA 02173
pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e). EPA published the proposed rule in the
Federal Register of July 24, 1996 (61 FR 38423). There were no comments
received in response to the proposed rule.
This document represents an EPA-initiated proposal to establish
tolerance exemptions for the above noted substances to include the
Agency's determination of safety for the tolerance exemptions in view
of the FQPA amendments to section 408 of FFDCA. EPA is proposing this
regulation on its own initiative pursuant to section 408(e)(1)(B) of
FFDCA.
I. Risk Assessment and Statutory Authority
New section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food commodity) only if EPA
determines that the tolerance is ``safe.'' Section 408(c)(2)(A)(ii)
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.'' These include
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(B) requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption 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.''
II. Risk Assessment and Statutory Findings
N-acyl sarcosines and sodium N-acyl sarcosinates form a large class
of chemical compounds where the acyl group is derived from fatty acids
such as lauric, oleic and stearic acid and/or derived from the combined
fatty acids of coconut oil. N-acyl sarcosine and sodium N-acyl
sarcosinates are metabolized by humans to sarcosine and the
corresponding fatty acids. Sarcosine is ubiquitous in biological
materials and is present in such foods as egg yolks, turkey, ham,
vegetables, legumes, etc.
Sarcosine is reported to be formed from dietary intake of choline
and from the metabolism of methionine and is rapidly degraded to
glycine, which, in addition to its importance as a constituent of
protein, plays a
[[Page 36641]]
significant role in various physiological processes as a prime
metabolic source of components of living cells such as glutathione,
creatine, purines and serine. The concentration of sarcosine in blood
serum of normal human subjects is reported to be 1.59 + 1.08 micromoles
per liter.
Based upon the proposed use as an inert ingredient in glyphosate
formulations, dietary (food) exposure to N-acyl sarcosines and/or
sodium N-acyl sarcosinates would not be expected to exceed the
theoretical maximum residue concentration (TMRC) of glyphosate to the
U.S. population of 0.03 mg/kg/day. Dietary exposure to N-acyl
sarcosines and/or sodium N-acyl sarcosinates at or below these levels
would not result in any increases in the normal sarcosine blood serum
concentrations found in humans.
Taking into account the proposed use in glyphosate formulations,
the Agency has concluded with reasonable certainty that residues of N-
acyl sacosines and/or the sodium N-acyl sarcosinates in drinking water
would be negligible, and that no harm will result from aggregate
exposure to N-acyl sacosines and/or the sodium N-acyl sarcosinates.
III. Cumulative Exposure to Substances with Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether N-acyl sarcosines and sodium N-acyl sarcosinates have a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, N-acyl sarcosines and sodium N-acyl sarcosinates
do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that N-acyl sarcosines and sodium N-acyl sarcosinates
have a common mechanism of toxicity with other substances.
A. Aggregate Risks and Determination of Safety
Based upon the ubiquitous presence of sarcosine in human tissue and
the fact that N-acyl sarcosines are readily metabolized to the N-acyl
sarcosines and their salts, the Agency believes that exposure to this
chemical will not pose a dietary risk under any forseable circumstances
to the U.S. population, including infants and children. The Agency has
arrived at this conclusion because of the inconsequential increases in
dietary exposure resulting from its use as an inert ingredient in
glyphosate formulations. EPA concludes that there is a reasonable
certainty of no harm from the establishment of this tolerance
exemption.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects in calculating a dose level that accounts for pre-and
post-natal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of safety are incorporated into EPA risk
assessments either directly through the use of margin of exposure
analysis or through using uncertainty factors (safety) in calculating a
dose level that poses no appreciable risk to humans.
Due to the ubiquitous nature of sarcosine in human tissue and food,
EPA has not used a safety factor analysis in assessing the risk of N-
acyl sarcosines and sodium N-acyl sarcosinates. For the same reason,
application of the additional safety factor for infants and children
would not be appropriate.
B. Other Considerations
1. Endocrine disruptors. There are no reports of any estrogenic and
other adverse effects to human population as a result of the use of N-
acyl sarcosines and/or sodium N-acyl sarcosinates.
2. Analytical enforcement methodology. The Agency is establishing
an exemption from the requirement of a tolerance without any numerical
limitation; therefore, the Agency has concluded that an analytical
method is not required for enforcement purposes for N-acyl sarcosines
and sodium N-acyl sarcosinates.
C. Existing Tolerances
No existing tolerances or exemptions from the requirement of a
tolerance have been issued for N-acyl sarcosines and/or sodium N-acyl
sarcosinates as pesticide chemicals in the United States.
D. International Residue Limits
No CODEX maximum residue levels have been established for N-acyl
sarcosines and/or sodium N-acyl sarcosinates.
E. Conclusion
Therefore, based on the information and data considered, EPA is
proposing an exemption from the requirement of a tolerance be
established for residues of N-acyl sarcosines and sodium N-acyl
sarcosinates when used as inert ingredients (surfactants) in pesticide
formulations containing glyphosate at a concentration not to exceed 10%
weight of the formulation.
IV. Comments
Under FFDCA section 408(e)(2), EPA must provide for a public
comment period before issuing a final tolerance or tolerance exemption
under section 408(e)(1). The public comment period is to be for 60 days
unless the Administrator for good cause finds that it is in the public
interest to reduce that comment period.
V. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number [OPP-300885] (including comments and data submitted
electronically as described in this unit). 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 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The official rulemaking record is located at the
Virginia address in ADDRESSES at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [OPP-300885]. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
VI. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This action proposes an exemption from the tolerance requirement
under FFDCA section 408(e). 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).
[[Page 36642]]
In addition, this proposed rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require special OMB
review in accordance with Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997).
In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions was published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's proposed rule does not create an unfunded Federal mandate
on State, local, or tribal governments. The proposed rule does not
impose any enforceable duties on these entities. Accordingly, the
requirements of section 1(a) of Executive Order 12875 do not apply to
this proposed rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998), EPA may not issue a regulation that is not required by statute,
that significantly or uniquely affects the communities of Indian tribal
governments, and that imposes substantial direct compliance costs on
those communities, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by the tribal
governments. If the mandate is unfunded, EPA must provide OMB, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies on matters
that significantly or uniquely affect their communities.''
Today's proposed rule does not significantly or uniquely affect
the communities of Indian tribal governments. This action does not
involve or impose any requirements that affect Indian tribes.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 22, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 would continue to read as
follows:
Authority: 15 U.S.C. 321(q), 346(a) and 371.
2. By adding new Sec. 180.1207 to read as follows:
Sec. 180.1207 N-acyl sarconsines and sodium N-acyl sarcosinates;
exemption from requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the following substances when used as inert ingredients
(surfactants) at levels not to exceed 10% in pesticide formulations
containing glyphosate:
------------------------------------------------------------------------
Name CAS Reg. No.
------------------------------------------------------------------------
N-acyl sarcosines.......................................
N-oleoyl sarcosine.................................... 110-25-8
N-stearoyl sarcosine.................................. 142-48-3
N-lauroyl sarcosine................................... 97-78-9)
N-myristoyl sarcosine................................. 52558-73-3
N-cocoyl sarcosine mixture............................ 68411-97-2
Sodium N-acyl sarcosinates..............................
N-methyl-N-(1-oxo-9-octodecenyl) glycine.............. 3624-77-9
N-methyl -N-(1-oxooctadecyl) glycine.................. 5136-55-0
N-methyl-N- (1-oxododecyl) glycine.................... 137-16-6
N-methyl-N-(1-oxotetradecyl glycine................... 30364-51-3
N-cocoyl sarcosine sodium salt mixture................ 61791-59-1
------------------------------------------------------------------------
[FR Doc. 99-16933 Filed 7-6-99; 8:45 am]
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