[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33078-33081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15294]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1029; FRL-6787-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

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-1029, must be 
received on or before July 20, 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-1029 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Mike Mendelsohn, 
Biopesticides and Pollution Prevention Division, Registration Division 
(7511C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 308-8715; 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'' ``Regulation

[[Page 33079]]

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-1029. 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-1029 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-1029. 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 a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic 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 support 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: June 7, 2001.
Kathleen D. Knox,
Director, Biopesticides and Pollution Prevention Division.

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. 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.

Aventis CropSciences

PP 1F6308

    EPA has received a pesticide petition [1F6308] from Aventis 
CropSciences, 2 TW Alexander Drive, Research Triangle Park, NC 27709, 
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 by establishing a tolerance for residues of 
the plant-pesticide Cry9C and the genetic material necessary for its 
production in or on the raw commodity corn at 20 parts per billion 
(ppb).
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Aventis CropSciences has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Aventis CropSciences and

[[Page 33080]]

EPA has not fully evaluated the merits of the pesticide petition. The 
following summary is directly from the Aventis submission, and does not 
necessarily reflect the findings of the EPA.

A. Product Name and Proposed Use Practices

    StarLink corn contained the insect control protein named Cry9C, 
which is derived from the common soil bacterium, Bacillus thuringiensis 
subsp. tolworthi. Aventis voluntarily canceled the registration for 
StarLink corn. However, StarLink corn grain grown in previous growing 
seasons and other corn containing Cry9C protein may continue to be used 
for animal feed or non-food industrial uses in accordance with the 
existing exemption from the requirement for a tolerance for these uses.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The Cry9C 
gene was isolated from the B.t. tolworthi strain, truncated, and 
modified before it was stably inserted into corn plants. The tryptic 
core of the microbially produced Cry9C delta-endotoxin is similar to 
the Cry9C protein found in event CBH-351. The Cry9C protein was 
produced and purified from a bacterial host, for the purposes of 
mammalian toxicity studies.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. The proposed enforcement method for use on raw 
corn destined for dry milling is the EnviroLogix or Strategic 
Diagnostics Inc. Lateral Flow Strip Test, both of which have been 
validated by USDA GIPSA and Aventis. The limit of detection for these 
two test is 20 ppb Cry9C protein. The method must be used in accordance 
with the recommended sampling methods (FDA Recommendations for Sampling 
and Testing Yellow Corn and Dry-milled Yellow Corn Shipments Intended 
for Human Food Use for Cry9C Protein Residues, FDA-CFSAN, January 19, 
2001).

C. Mammalian Toxicological Profile

    Aventis has conducted an extensive array of toxicological testing 
including oral and intravenous administration, as well as acute and 
short-term exposure. EPA has reviewed these data and concluded that 
there is no toxicological endpoint of concern, with the possible 
exception of allergenicity.
    The gene for the Cry9C protein comes from a non-allergenic common 
soil bacterium, Bacillus thuringiensis. The corn plant, into which the 
gene for the Cry9C protein was inserted, is rarely allergenic to 
humans. Expression of the gene for the Cry9C protein did not enhance 
the potential of corn to be allergenic, as demonstrated by the absence 
of any difference in reactivity to StarLink corn than to wild type non-
transgenic corn in radioallergosorbent tests (RAST) performed with 
human sera from corn allergic patients (MRID Number 443844-05).
    The Cry9C protein was not toxic upon single oral or repeated 
dietary administration to rats and has no linear amino acid sequence 
homology to any known human allergen or toxin (Oral LD50 > 
3,760 mg/kg/day, MRID Number 442581-07; Acute intravenous 
LD50 > 0.3 mg/kg/day (MRID Numbers 447343-02); 30-day 
repeated dose toxicity test in rats: up to 328 mg/kg/day produced no 
adverse effects, no binding to villi or enterocytes lining 
gastrointestinal tract (GI) crypts of both large and small intestines, 
MRID Numbers 447343-03, 443844-04, and 442581-09). RAST tests performed 
with sera from individuals allergic to the well-known human food 
allergens, wheat; rice; buckwheat; soy; peanut; milk; eggs; and shrimp 
confirmed that even individuals with pre-existing food allergies 
demonstrated no cross-reactivity to Cry9C (MRID Number 452464-01). The 
level of the Cry9C protein in whole corn grain, 0.0129%, is a very low 
level of total protein expression in the plant compared to most 
allergens which are present at 1-40% of the total plant protein (MRID 
Number 450257-01).
    The Cry9C protein is somewhat more stable than the other Bt Cry 
proteins already approved for food use. Cry9C does digest in simulated 
stomach fluids at pH of 1.2-1.5 within 30-60 minutes (within normal 
stomach emptying time) and does denature at temperatures likely to be 
encountered during cooking and processing (MRID Numbers 447343-05, 
442581-08, 451144-01, 4451144-02). Although Aventis interprets these 
data to mean that Cry9C protein is not an allergen, regulatory 
officials have not been able to confirm this assessment.

D. Aggregate Exposure

    Aventis developed an analytical method to determine Cry9C protein 
levels in intermediate and finished food products. Studies were 
conducted to assess the level of Cry9C protein typically found in 12 
representative food products made from 100% StarLink corn. These 
studies demonstrate that there is significant reduction (80-99.9%) of 
Cry9C protein levels, relative to levels found in raw corn, during the 
manufacture of food products. Three processing factors are responsible 
for destruction of Cry9C protein: heat, shear or pressure, and alkali 
treatment.
    1. Dietary exposure. Aventis has performed a new dietary risk 
assessment. Worst case estimates of potential dietary intake of Cry9C 
protein were calculated using Novigen Sciences, Inc., Food and Residue 
Evaluation Program (FARE) software, food consumption data in the 1994-
1996 USDA's Continuing Survey of Food Intakes by Individuals (CSFII), 
and the new Aventis study on reduction in Cry9C protein levels 
resulting from food processing. In essence, dietary intake of Cry9C 
protein was calculated as the product of consumption of corn protein-
containing foods and the expected concentration of Cry9C protein in 
such foods. Intakes were estimated on a ``per consumer'' basis for the 
overall U.S. population, children 1-6 years of age, children 7-12 years 
of age, the Hispanic population in the U.S., Hispanic children 1-6 
years of age, and Hispanic children 7-12 years of age.
    2. Non-dietary exposure. Since the Cy9C protein is expressed in 
plant tissues at very low levels, and since the StarLink product will 
no longer be used, exposure will be negligible to non-existent via all 
non-food routes.

E. Cumulative Exposure

    Common modes of toxicity are not relevant to the consideration of 
the cumulative exposure to Cry9C protein.

F. Safety Determination

    1. U.S. population. Dietary exposure will be the major route of 
exposure to the U.S. population. Estimated potential daily exposures 
for all subpopulations at the 99th percentile are below 0.37 
microgram per day, the exposure for the general population. The U.S. 
population in general had the highest estimated daily intake of all 
subpopulations examined. This newly refined dietary intake estimate of 
the Cry9C protein is 67 times lower than the EPA's November 2000 upper 
bound estimate for the U.S. population (25 micrograms per day, 
99th percentile), and 10 times below the highest estimate 
from the Aventis November 2000 estimate (3.9 micrograms per day for the 
Hispanic population, 99th percentile). Such exceedingly low 
levels of exposure, coupled with insufficient information to conclude 
whether or not Cry9C protein is actually a human food allergen, further 
support the SAP finding that the levels of Cry9C protein present in the 
human diet are insufficient to either sensitize or cause an allergic 
reaction. Therefore, the data support a finding of reasonable certainty 
of no harm and justify a tolerance at 20 ppb.

[[Page 33081]]

    2. Infants and children. As with the rest of the population, the 
primary route of exposure is dietary. The dietary exposure assessment 
indicates that children have less exposure than the general U.S. 
population. Accordingly, there is no need to apply an additional safety 
factor for infants and children.

G. Effects on the Immune and Endocrine Systems

    EPA's review of the submitted data concluded that there is no 
toxicological endpoint of concern, with the possible exception of 
allergenicity.

H. Existing Tolerances

    On May 22, 1998, EPA established an exemption from the requirement 
of a tolerance for residues of Cry9C protein and the genetic material 
necessary for its production in corn for feed use only; as well as in 
meat, poultry, milk or eggs resulting from animals fed such feed. This 
exemption remains in effect.

I. International Tolerances

    To date, no Codex, Canadian or Mexican tolerances exist for Bt 
subsp. tolworthi Cry9C protein in corn.

J. Conclusions

    Aventis CropScience believes that this petition provides adequate 
grounds for the establishment of a tolerance of 20 ppb for residues of 
the insecticide, Bt subsp. tolworthi Cry9C protein in or on the raw 
agricultural commodity, corn.
[FR Doc. 01-15294 Filed 6-19-01; 8:45 am]
BILLING CODE 6560-50-S