[Federal Register Volume 65, Number 42 (Thursday, March 2, 2000)]
[Notices]
[Pages 11311-11313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5050]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-921; FRL-6494-3]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals in or on Food; Cry1F Plant-Pesticide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket control number PF-921, must be 
received on or before April 3, 2000.

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-921 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Mike Mendelsohn, 
Biopesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 308-8375; 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'' 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-921. 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-921 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

[[Page 11312]]

Resources and Services Division (7502C), Office of Pesticide Programs 
(OPP), Environmental Protection Agency, Ariel Rios Bldg., 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-921. 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 a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemical 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 this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: February 23, 2000.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA has not fully evaluated the merits of the pesticide 
petition. The summary may have been edited by EPA if the terminology 
used was unclear, the summary contained extraneous material, or the 
summary unintentionally made the reader conclude that the findings 
reflected EPA's position and not the position of the petitioner. The 
petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Mycogen Seeds c/o Dow AgroSciences LLC

0F6078

    EPA has received a pesticide petition (0F6078) from Mycogen Seeds 
c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-
1054 proposing, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 
to establish an exemption from the requirement of a tolerance for the 
plant-pesticide Bacillus thuringiensis Cry1F protein and the genetic 
material necessary for its production in plants in or on all food 
commodities.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Mycogen Seeds c/o Dow AgroSciences LLC has submitted the following 
summary of information, data, and arguments in support of their 
pesticide petition.
    Bacillus thuringiensis subspecies aizawai Cry1F insect control 
protein is expressed in corn plants to provide protection from key 
lepidopteran insect pests such as the European corn borer. Cry1F-
protected field corn provides growers with a highly efficacious tool 
for controlling important insect pests in corn in a manner that is 
fully compatible with integrated pest management practices.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The Cry1F 
gene was isolated from Bacillus thuringiensis subspecies aizawai 
modified before it was inserted into corn plants. The Cry1F 
insecticidal protein has been adequately characterized. Several safety 
studies were conducted using a microbially produced test substance that 
contained 11.4% Cry1F protein. Studies conducted to establish the 
equivalence of the Cry1F protein obtained from corn or from a microbial 
source demonstrate that the materials are similar with respect to 
molecular weight, immunoreactivity, lack of post-translational 
modification (glycosylation) N-terminal amino acid sequence, and 
spectrum of bioactivity.
    2. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. No 
analytical method is included because this petition requests an 
exemption from the requirement for a tolerance.

[[Page 11313]]

C. Mammalian Toxicological Profile

    Cry proteins have been deployed as safe and effective pest control 
agents in microbial Bacillus thuringiensis formulations for almost 40 
years. There are currently 180 registered microbial Bacillus 
thuringiensis products in the United States for use in agriculture, 
forestry, and vector control. The numerous toxicology studies conducted 
with these microbial products show no significant adverse effects, and 
demonstrate that the products are practically non-toxic to mammals. An 
exemption from the requirement of a tolerance has been in place for 
these products since at least 1971 (40 CFR 180.1011).
    Toxicology studies conducted to determine the toxicity of Cry1F 
insect control protein demonstrated that the protein has very low 
toxicity. In an acute oral toxicity study in the mouse, the estimated 
acute LD50 by gavage was determined to be > 5,050 
milligrams/kilograms of the microbially produced test substance. This 
dose is 12,190  x  greater than the estimated 95th percentile for human 
dietary exposure to Cry1F protein resulting from consumption of foods 
derived from Cry1F protected corn. This estimate assumes that 100% of 
the corn crop produces Cry1F protein and that the protein is not 
degraded or otherwise eliminated in food processing. This extremely 
conservative estimate of the margin of exposure further supports the 
safety of Cry1F proteins to humans.
    In an in vitro study, Cry1F protein was rapidly and extensively 
degraded in simulated gastric conditions in the presence of pepsin. 
Cry1F was completely proteolyzed to amino acids and small peptide 
fragments within 5 minutes at molar ratios approximating 1:100 
(Cry1F:pepsin). This indicates that the protein is highly susceptible 
to digestion in the human digestive tract and that the potential for 
adverse health effects from chronic exposure is virtually nonexistent. 
Moreover, proteins in general are not known to be carcinogenic. A 
search of relevant data bases indicated that the amino acid sequence of 
the Cry1F protein exhibits no significant homology to the sequences of 
known allergens or protein toxins. Thus, Cry1F is highly unlikely to 
exhibit an allergic response.
    The genetic material necessary for the production of the Cry1F 
insect control protein are nucleic acids unscheduled DNA synthesis 
which are common to all forms of plant and animal life. There are no 
known instances of where nucleic acids have caused toxic effects as a 
result of dietary exposure.
    Collectively, the available data on Cry1F protein along with the 
safe use history of microbial Bacillus thuringiensis products 
establishes the safety of the plant pesticide Bacillus thuringiensis 
subspecies aizawai Cry1F insect control protein and the genetic 
material necessary for its production in all raw agricultural 
commodities.

D. Aggregate Exposure

    In summary the potential for significant aggregate exposure to 
Cry1F protein is highly unlikely.
    1. Dietary exposure--i. Food. Significant dietary exposure to Cry1F 
protein is unlikely to occur. Dietary exposures at very low levels, via 
ingestion of processed commodities, although they may occur, are 
unlikely to be problematic because of the low toxicity and the high 
degree of digestibility of the protein.
    ii. Drinking water. In addition, the protein is not likely to be 
present in drinking water because the protein is deployed in minute 
quantities within the plant, and studies demonstrate that Cry1F protein 
is rapidly degraded in soil.
    2. Non-dietary exposure. Because Bacillus thuringiensis subspecies 
aizawai Cry1F insect control protein is expressed in minute quantities 
and is retained within the plant, there is virtually no potential for 
dermal or inhalation exposure to the protein.

E. Cumulative Exposure

    Common modes of toxicity are not relevant to consideration of the 
cumulative exposure to Bacillus thuringiensis Cry1F insect control 
protein. The product has demonstrated low toxicity and these effects do 
not appear to be cumulative with any other known compounds.

F. Safety Determination

    1. U.S. population. The deployment of the product in minute 
quantities within the plant, the very low toxicity of the product, the 
lack of allergenic potential, and the high degree of digestibility of 
the protein, are all factors in support of Mycogen's assertion that no 
significant risk is posed by exposure of the U.S. population to 
Bacillus thuringiensis subspecies aizawai Cry1F insect control protein.
    2. Infants and children. Non-dietary exposure to infants and 
children is not anticipated, due to the proposed use pattern of the 
product. Due to the very low toxicity of the product, the lack of 
allergenic potential, and the high degree of digestibility of the 
protein, dietary exposure is anticipated to be at very low levels and 
is not anticipated to pose any harm to infants and children.

G. Effects on the Immune and Endocrine Systems

    Given the rapid digestibility of Cry1F delta endotoxin, no chronic 
effects are expected. Cry1F delta endotoxin, or metabolites of the 
endotoxin are not known to, or are expected to have any effect on the 
immune or endocrine systems. Proteins in general are not carcinogenic, 
therefore, no carcinogenic risk is associated with the Cry1F protein.

H. Existing Tolerances

    There are no existing tolerances or exemptions from tolerance for 
Bacillus thuringiensis subspecies aizawai Cry1F.

I. International Tolerances

    There are no existing tolerances or exemptions from tolerance for 
Bacillus thuringiensis subspecies aizawai Cry1F.
[FR Doc. 00-5050 Filed 3-1-00; 8:45 am]
BILLING CODE 6560-50-F