Document ID: EPA-HQ-OPP-2002-0201-0002
Agency: epa
Document Type: Rule
Title: Inert ingredients: Denial of Pesticide Petitions 2E6491 (N-Acyl Sarcosines and Sodium N-Acyl Sarcosinates), 7E4810 (Crezasin), and 7E4811 (Mival)
Posted Date: 2008-02-08T05:00Z

[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Rules and Regulations]               
[Page 7472-7475]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe08-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2002-0201; FRL-8342-4]

 
Inert ingredients: Denial of Pesticide Petitions 2E6491 (N-Acyl 
Sarcosines and Sodium N-Acyl Sarcosinates), 7E4810 (Crezasin), and 
7E4811 (Mival)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is denying three petitions to amend or establish 
exemptions from pesticide tolerances because insufficient data were 
available to the Agency to make the safety finding of FFDCA section 
408(c)(2): PP 2E6491 submitted by Hampshire Chemical Corporation to 
amend the inert ingredient tolerance exemption under 40 CFR 180.1207 
for certain N-acyl sarcosines and sodium N-acyl sarcosinates, and PP 
7E4810 (Crezasin) and PP 7E4811 (Mival) submitted by Globe Tech 
Industries Corporation to establish an inert ingredient tolerance 
exemption under Sec.  180.920.

DATES: This regulation is effective February 8, 2008. Objections and 
requests for hearings must be received on or before April 8, 2008, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2002-0201. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-2857; e-mail address: martin.kathleen@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. 
Potentially affected entities may include, but are not limited to, 
those engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be

[[Page 7473]]

affected by this action. Other types of entities not listed in this 
unit could also be affected. The North American Industrial 
Classification System (NAICS) codes have been provided to assist you 
and others in determining whether this action might apply to certain 
entities. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2002-0201 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before April 8, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2002-0201, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background

A. What Action is the Agency Taking?

    1. Denial of Pesticide Petition 2E6491 (N-Acyl Sarcosines and 
Sodium N-Acyl Sarcosinates).
    In December 1999, EPA established exemptions from the requirement 
of a tolerance at 40 CFR 180.1207 for residues of certain N-acyl 
sarcosines and sodium N-acyl sarcosinates when used as inert 
ingredients (surfactants) at levels not to exceed 10% in pesticide 
formulations containing glyphosate (64 FR 68044; December 6, 1999). The 
specific N-acyl sarcosines and sodium N-acyl sarcosinates were: N-
oleoyl sarcosine (CAS 110-25-8); N-stearoyl sarcosine (CAS 142-48-3); 
N-lauroyl sarcosine (CAS 97-78-9); N-myristoyl sarcosine (CAS 52558-73-
3); N-cocoyl sarcosine mixture (CAS 68411-97-2); N-methyl-N-(1-oxo-9-
octodecenyl) glycine (CAS 3624-77-9); N-methyl-N-(1-oxooctadecyl) 
glycine (CAS 5136-55-0); N-methyl-N-(1-oxododecyl) glycine (CAS 137-16-
6); N-methyl-N-(1-oxotetradecyl glycine (CAS 30364-51-3); and N-cocoyl 
sarcosine sodium salt mixture (CAS 61791-59-1).
    In the Federal Register of September 18, 2002 (67 FR 58799) (FRL-
7194-5), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 2E6491) by Hampshire Chemical 
Corporation. The petition requested that 40 CFR 180.1207, which 
pertains to the N-acyl sarcosines and sodium N-acyl sarcosinates listed 
in the previous paragraph, be amended to add pesticide formulations 
containing the active ingredients 2,4-D, atrazine, dicamba, and 
glufosinate ammonium; the existing tolerance exemption is limited to 
formulations containing glyphosate. No comments were received in 
response to the notice of filing.
    In evaluating the petitioner's request (PP 2E6491), EPA determined 
that significant and important data were missing from the petitioner's 
submission. First, certain data submitted by the petitioner (e.g., 
acute, subchronic, and chronic toxicity) are inadequate and not 
acceptable. The data are unpublished, and no basic quality information 
(in compliance with Good Laboratory Practices) is provided, including 
when the studies were conducted. Second, the submitter did not provide 
adequate developmental and reproductive toxicity data. In making the 
FFDCA safety determination, EPA considers the validity, completeness, 
and reliability of the data that are available to the Agency (FFDCA 
sections 408(b)(2)(D) and 408(c)(2)(B)), and the available information 
concerning the special susceptibility of infants and children. If 
reproductive and developmental toxicity data are not available, or if 
such information is not available in the open literature, screening 
level reproductive and developmental toxicity data may be acceptable 
for assessing the special susceptibility of infants and children. For 
the sarcosines, EPA communicated with the petitioner regarding the 
developmental/reproductive toxicity data gap; no further information or 
data were received.
    Because the safety finding, as required under FFDCA section 
408(c)(2), could not be made due to insufficient data, EPA is denying 
the petitioner's request to amend the existing tolerance exemption for 
the N-acyl sarcosines and sodium N-acyl sarcosinates.
    2. Denial of Pesticide Petitions 7E4810 (Crezasin) and 7E4811 
(Mival).
    In the Federal Register of December 2, 1997 (62 FR 63940) (FRL-
5751-9), EPA issued two notices pursuant to section 408 of FFDCA, 21 
U.S.C. 346a announcing the filing of pesticide petitions (PP 7E4810 and 
PP 7E4811) by Globe Tech Industries Corporation. The petitions 
requested that EPA establish inert ingredient tolerance exemptions 
under 40 CFR 180.920 for the use of Crezasin (PP 7E4810) and Mival (PP 
7E4811) in pesticide formulations used on growing crops only.
    In evaluating the petitioner's requests, EPA determined that 
significant and important data in the petitioner's submission were 
inadequate and not acceptable, including the residue chemistry and the 
description of the chemicals' product chemistry data. EPA has been 
unable to contact or locate the petitioner, Globe Tech Corporation, 
about the data deficiencies. In making the FFDCA safety determination, 
EPA considers the validity, completeness, and reliability of the data 
that are available to the Agency (FFDCA section 408(b)(2)(D) and 
408(c)(2)(B)). Because the safety finding required under FFDCA section 
408(b)(2) could not be

[[Page 7474]]

made due to insufficient data, EPA is denying the petitioner's request 
to establish inert ingredient tolerance exemptions under 40 CFR 180.920 
for the use of Crezasin (PP 7E4810) and Mival (PP 7E4811).

B. What is the Agency's Authority for Taking this Action?

    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.''

III. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
provides essentially the same process for persons to ``object'' to a 
regulation for an exemption from the requirement of a tolerance issued 
by EPA under new section 408(d), as was provided in the old FFDCA 
sections 408 and 409. However, the period for filing objections is now 
60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2002-0201 in the subject line on 
the first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before April 8, 
2008.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request 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 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice. Mail your written 
request to: Office of the Hearing Clerk (1900L), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. You may also deliver your request to the Office of the Hearing 
Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III.A., you 
should also send a copy of your request to Public Information and 
Records Integrity Branch (PIRIB) for its inclusion in the official 
record that is described in ADDRESSES. Mail your copies, identified by 
docket ID number EPA-HQ-OPP-2002-0201, to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by 
courier, bring a copy to the location of PIRIB described in ADDRESSES. 
You may also send an electronic copy of your request via e-mail to: 
opp-docket@epa.gov. Please use an ASCII file format and avoid the use 

of special characters and any form of encryption. Copies of electronic 
objections and hearing requests will also be accepted on disks in 
WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in 
your electronic copy. You may also submit an electronic copy of your 
request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IV. Statutory and Executive Order Reviews

    This final rule denies a request to amend an exemption from 
tolerance 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 rule has been exempted from 
review under Executive Order 12866 due to its lack of significance, 
this rule is not subject to Executive Order 13211, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). 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., 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 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); 
or 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 
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), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various

[[Page 7475]]

levels of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).
    Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by state and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (59 FR 22951, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: January 28, 2008.
Marty Monell,
Acting Director, Office of Pesticide Programs.
[FR Doc. E8-2175 Filed 2-7-08; 8:45 am]

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