[Federal Register Volume 64, Number 129 (Wednesday, July 7, 1999)]
[Proposed Rules]
[Pages 36640-36642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16933]


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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-
[email protected]. 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, 
[email protected].
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:
    [email protected]


    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
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[FR Doc. 99-16933 Filed 7-6-99; 8:45 am]
BILLING CODE 6560-50-F