[Federal Register Volume 65, Number 235 (Wednesday, December 6, 2000)]
[Notices]
[Pages 76241-76244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30918]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-978; FRL-6748-9]


Notice of Filing Pesticide Petitions to Establish Tolerances for 
Certain Pesticide Chemicals in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES:  Comments, identified by docket control number PF-978, must be 
received on or before January 5, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-978 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Carol E. Frazer, 
Biopesticides and Pollution Prevention Division (7511C),

[[Page 76242]]

Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
308-8810; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register-Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-978. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-978 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-978. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency

[[Page 76243]]

of the submitted data at this time or whether the data support granting 
of these petitions. Additional data may be needed before EPA rules on 
the petitions.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: November 17, 2000.
  Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by section 408(d)(3) of the FFDCA. The summaries of 
the petitions were prepared by the petitioner and represent the view of 
the petitioner. EPA is publishing the petitioner's summaries verbatim 
without editing it in any way. The petitioner's summaries announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemicals 
residues or an explanation of why no such method is needed.

1. Auxein Corporation

PP 7F4842 and PP 7F4843

    EPA has received pesticide petitions PP 7F4842 and PP 7F4843 from 
Auxein Corporation, 3125 Sovereign Drive, Suite B, Lansing, MI 48911-
4240, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 
346a(d), to amend 40 CFR part 180 to establish amendments of existing 
tolerance exemptions for the biochemical pesticides L-glutamic acid and 
gamma aminobutyric acid (GABA) pursuant to section 408(d)(2)(A)(i) of 
the FFDCA, as amended. Auxein Corporation has submitted the following 
summaries of information, data, and arguments in support of their 
pesticide petitions. These summaries were prepared by Auxein 
Corporation and EPA has not fully evaluated the merits of the pesticide 
petitions. The summaries may have been edited by EPA if the terminology 
used was unclear, the summaries contained extraneous material, or the 
summaries unintentionally made the reader conclude that the findings 
reflected EPA's position and not the position of the petitioner.

PP 7F4842

    In the Federal Register of October 29, 1997 (62 FR 56268, FRL-5751-
3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a(e) announcing the filing of a pesticide tolerance petition (PF-
772) by Auxein Corporation. This notice included a summary of the 
petition prepared by the petitioner and this summary contained 
conclusions and arguments to support its conclusion that the petition 
complied with the Food Quality Protection Act (FQPA) of 1996. This 
petition requested that 40 CFR part 180 be amended by establishing an 
exemption from the requirement of a tolerance for residues of the 
biological pest control agent glutamic acid in or on all raw 
agricultural commodities. The final rule exempted the biochemical 
glutamic acid from the requirement of a tolerance on all raw 
agricultural commodities when used as a plant growth enhancer in 
accordance with good agricultural practices. EPA published a final rule 
establishing a tolerance exemption in the Federal Register on January 
7, 1998 (63 FR 679-682) (FRL-5764-4) amending 40 CFR 1180.1187. An 
amendment to this petition and thus the final rule establishing a 
tolerance exemption, was requested by Auxein Corporation to change the 
name of the active ingredient from the above to L-glutamic acid. In the 
Federal Register of September 25, 1998 (63 FR 51302) Auxein Corporation 
requested a correction to the name. Throughout the preamble to the 
final rule and in the codified text (40 CFR 180.1187), reference was 
made to ``glutamic acid.'' Auxein Corporation brought to the Agency's 
attention that the requested tolerance was for residues of ``L-glutamic 
acid'' rather than ``glutamic acid.'' This technical amendment 
corrected the preamble and the codified text in the January 7, 1998 
final rule. Therefore, in the preamble to FR Doc. 98-359, published at 
63 FR 679, FRL-6029-1, January 7, 1998, reference to ``glutamic acid'' 
was changed to refer to ``L-glutamic acid.'' Recent research performed 
on this active ingredient indicates the method of protection is not 
restricted to growth enhancement, and Auxein wishes to delete the 
wording ``when used as a plant growth enhancer'' from the present 
exemption as well as correct the term ``raw agricultural commodities'' 
to ``food commodities.''

A. Product Name and Proposed Use Practices

     AuxiGro WP Plant Metabolic Primer. When used as directed, AuxiGro 
has been shown to increase yields and/or quality of treated 
commodities, early ripening in certain vegetables, increased root 
growth, early flowering and fruit set, faster seed germination and 
rooting.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Supporting 
data for this section were submitted with PP 7F4842. Supporting product 
chemistry data for the end-use product, AuxiGro WP (EPA Reg. No. 70810-
1 was submitted on June 12, 1997 (MRID 44296801) and February 16, 1998 
(MRID 44538701).
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Supporting data for this section was submitted 
with PP 7F4842.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. 
Supporting data for this section was submitted with PP 7F4842.

C. Mammalian Toxicological Profile

    Supporting data for this section was submitted with PP 7F4842.

D. Aggregate Exposure

    1. Dietary exposure-- i. Food. No differences in exposure are 
expected compared to those described in PP 7F4842.
    ii. Drinking water. No differences in exposure are expected 
compared to those described in PP 7F4842.
    2. Non-dietary exposure. No differences in exposure are expected 
compared to those described in PP 7F4842.

E. Cumulative Exposure

    No differences in exposure are expected compared to those described 
in PP 7F4842.

F. Safety Determination

    1. U.S. population. Based on its abundance in nature and long 
history of use by humans without deleterious effects, there is 
reasonable certainty that no harm will result from aggregate exposure 
to the U.S. population, including infants and children, to residues of 
L-glutamic acid. This includes all dietary exposure and all other 
exposure for which there is reliable information. This is a reasonable 
conclusion because of the preponderance of data from open literature 
supporting the safe use of L-glutamic acid in foods, the supporting 
acute toxicity data on AuxiGro, and inconsequential exposure resulting 
from its application to crops.
    2. Infants and children. No differences in exposure are expected

[[Page 76244]]

compared to those described in PP 7F4842.

G. Existing Tolerances

    Existing tolerances have been established for L-glutamic acid, 40 
CFR part 180.1187.

H. International Tolerances

    No Codex maximum residue levels have been established for L-
glutamic acid.

PP 7F4843

    In the Federal Register of October 29, 1997 (62 FR 57170, FRL-5751-
3) EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a(e) announcing the filing of a pesticide tolerance petition (PF-
772) by Auxein Corporation. This notice included a summary of the 
petition prepared by the petitioner and this summary contained 
conclusions and arguments to support its conclusion that the petition 
complied with the FQPA of 1996. This petition requested that 40 CFR 180 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of the biological pest control agent gamma 
aminobutyric acid in or on all food commodities. The final rule 
exempted the biochemical gamma aminobutyric acid from the requirement 
of a tolerance on all food commodities when used as a plant growth 
enhancer in accordance with good agricultural practices. EPA published 
a final rule establishing a tolerance exemption in the Federal Register 
on January 7, 1998 (63 FR 676-679) (FRL-5764-5) amending 40 CFR 
1180.1188. Recent research performed on this active ingredient 
indicates the method of protection is not restricted to growth 
enhancement, and Auxein Corporation wishes to delete the wording ``when 
used as a plant growth enhancer'' from the present exemption.

A. Product Name and Proposed Use Practices

     AuxiGro WP Plant Metabolic Primer. When used as directed, AuxiGro 
has been shown to increase yields and/or quality of treated 
commodities, early ripening in certain vegetables, increased root 
growth, early flowering and fruit set, faster seed germination and 
rooting.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Supporting 
data for this section were submitted with PP 7F4843. Supporting product 
chemistry data for the end-use product, AuxiGro WP (EPA Reg. No. 70810-
1) were submitted on June 12, 1997 (MRID 44296801) and February 16, 
1998 (MRID 44538701).
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Supporting data for this section were submitted 
with PP 7F4843.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. 
Supporting data for this section were submitted with PP 7F4843.

C. Mammalian Toxicological Profile

    Supporting data for this section were submitted with PP 7F4843.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. No differences in exposure are 
expected compared to those described in PP 7F4843.
    ii. Drinking water. No differences in exposure are expected 
compared to those described in PP 7F4843.
    2. Non-dietary exposure. No differences in exposure are expected 
compared to those described in PP 7F4843.

E. Cumulative Exposure

    No differences in exposure are expected compared to those described 
in PP 7F4843.

F. Safety Determination

    1. U.S. population. Based on its abundance in nature and long 
history of use by humans without deleterious effects, there is 
reasonable certainty that no harm will result from aggregate exposure 
to the U.S. population, including infants and children, to residues of 
GABA. This includes all anticipated dietary exposure and all other 
exposures for which there is reliable information. This is a reasonable 
conclusion because exposure to GABA resulting from label directed use 
is inconsequential, does not cross the blood-brain barrier, and is 
consumed daily by the human population from naturally occurring 
sources.
    2. Infants and children. No differences in exposure are expected 
compared to those described in PP 7F4843.

G. Existing Tolerances

    Existing tolerances have been extablished for gamma aminobutyric 
acid (GABA), 40 CFR part 180.1188.

H. International Tolerances

    No Codex maximum residue levels have been established for gamma 
aminobutyric acid (GABA)
[FR Doc. 00-30918 Filed 12-5-00; 8:45a.m.]
BILLING CODE 6560-50-S