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17708
Federal Register
/Vol. 66, No. 64/Tuesday, April 3, 2001/Notices
risks to public health or theenvironment. Therefore, EPA issued aregistration for the Cry9C protein andthe genetic material necessary for itsproduction (called a plant-pesticide) in1998 to AgrEvo (now AventisCropScience). EPA limited theregistration by requiring that allStarLink corn only be used in domesticanimal feed and for industrial purposes.EPA did not approve the use of StarLinkcorn in foods destined for humanconsumption because of unansweredquestions about the potentialallergenicity of the Cry9C protein.Because of Aventis
’
continuinginterest in obtaining approval for use of StarLink in the production of humanfood and the novel scientific issuesraised concerning the assessment of potential allergenicity, EPA called ameeting of the FIFRA ScientificAdvisory Panel (SAP), on February 29,2000 regarding Cry9C protein. (The SAPprovides independent scientific adviceand recommendations to the Agency asto the impact on health and theenvironment of regulatory actionsconcerning pesticides and pesticide-related issues.) The February 29, 2000SAP report stated that it could not bedetermined whether or not Cry9C is apotential food allergen.In September 2000, Cry9C DNA wasdetected in a finished food product -taco shells. Subsequently, the DNA andprotein have been found in corn grainand other corn products in the foodsupply. These detections indicated that,despite the EPA restrictions, somequantities of StarLink corn had directlyentered the human food chain.On October 12, 2000, Aventisrequested that the registration for theirStarLink corn product be voluntarilycancelled. As a result, StarLink corn isnot authorized for planting in futureyears. On October 25, 2000, Aventisamended its petition for a food toleranceexemption under the Federal Food,Drug, and Cosmetic Act (FFDCA) to askfor a temporary tolerance of 4 years tocover any Cry9C protein and Cry9CDNA that may be present in human foodmade from StarLink corn planted in1998, 1999, and 2000. Aventissubmitted additional information withits petition to support its contention thatthe Cry9C protein posed no allergenicrisk to public health. EPA convenedanother SAP meeting on November 28,2000 to consider the question of thepotential of the Cry9C protein to be anallergen, whether there is an adequateamount of the protein in corn to causesensitization, what amount of Cry9Cmight be in the human food supply if this time limited tolerance exemptionwere to be approved, and reports of adverse incidents for alleged humanexposure. More information includingthe Aventis submission, EPA
’
s papersfor SAP review, backgroundinformation, and the SAP final reportscan be found on the following web sites:
http://www.epa.gov/pesticides/ biopesticides/cry9c/index.htmhttp://www.epa.gov/scipoly/sap/index.htm
The final report from the November28, 2000 SAP meeting, which wasissued on December 1, 2000, expressedthe consensus of the Panel that whileCry9C has a
‘‘
medium likelihood
’’
to bea food allergen, the combination of theexpression level of the protein and theamount of corn found to be commingledposes a
‘‘
low probability
’’
to sensitizeindividuals to Cry9C.The Panel report noted that thelikelihood of the protein being detectedin different corn products variedconsiderably, especially depending onthe method of processing and whetherthe product was from white or yellowcorn. The Cry9C DNA was onlyengineered into certain yellow cornvarieties. The SAP report called on EPAto only include in our dietaryassessment those ingredients from cornthat contain protein after processing.The SAP report states that items such ascorn syrup, corn oil, and starch containvirtually no protein.In follow-up to the SAP report, EPAcollected and evaluated information onthe impacts of the wet milling processon levels of protein in finished humanfood products. The assessmentconcludes that use of StarLink corn inwet-milling results in no (or essentiallyno) residues of Cry9C protein in humanfood fractions - corn oil, corn syrup,alcohol, corn starch. This informationwould support a conclusion that there isno human health risk from eating suchfood fractions. EPA is now solicitingpublic comments on its analysis of theimpact of wet milling on the Cry9Cprotein content in food.In addition to the general public, TheAgency will specifically contact andrequest comments from the followingexperts in the processing of corn forfood:1. Dr. R. Carl Hoseney of R and RResearch in Manhattan, KS.2. Dr. Barry Jacobsen of Montana StateUniversity in Bozeman, Montana.3. Dr. David Lineback of theUniversity of Maryland in College Park,Maryland.4. Dr. Llyod Rooney of Texas A&MUniversity in College Station, Texas.The Agency will take intoconsideration all comments receivedand publish the availability of its finalwet milling assessment in the
FederalRegister
. The final wet millingassessment will also be considered aspart of EPA
’
s overall review of Aventis
’
pending petition for an exemption forCry9C in human food, PP 9F05050.
B. What is the Agency 
’ 
s Authority for Taking this Action? 
The Federal Food, Drug, and CosmeticAct provides the legal authority for EPAto take this action.
List of Subjects
Environmental protection, plant-incorporated protectants.
Dated: March 7, 2001.
Janet L. Andersen,
Director, Biopesticides and PollutionPrevention Division.
[FR Doc. 01
–
8138 Filed 4
–
2
–
01; 8:45 a.m.]
BILLING CODE 6560
 –
50
 –
S
ENVIRONMENTAL PROTECTIONAGENCY
[FRL
 –
6961
 –
1]
Notice of Proposed ProspectivePurchaser Agreement Pursuant to theComprehensive EnvironmentalResponse, Compensation and LiabilityAct of 1980, as Amended by theSuperfund Amendments andReauthorization Act of 1986
AGENCY
:
Environmental ProtectionAgency.
ACTION
:
Notice; request for publiccomment.
SUMMARY
:
Notice is hereby given of aproposed Prospective PurchaserAgreement and Covenant Not To Sue,executed between the United States, on behalf of the U.S. EnvironmentalProtection Agency (
‘‘
EPA
’’
), and PulaskiIndustrial Corporation (
‘‘
Purchaser
’’
) inaccordance with the ComprehensiveEnvironmental Response,Compensation, and Liability Act of 1980, 42 U.S.C. 9601
–
9675, as amended(
‘‘
CERCLA
’’
). The proposed agreementwill allow reuse of an abandonedindustrial facility associated with theMetcoa Radiation Superfund Site(
‘‘
Site
’’
) in Pulaski, Lawrence County,Pennsylvania, and will resolve certainpotential EPA claims under section 107of CERCLA, 42 U.S.C. 9607, against thePurchaser. The proposed agreement isnow subject to public comment, afterwhich the United States may modify orwithdraw its consent if commentsreceived disclose facts or circumstancesindicating that the proposed agreementis inappropriate, improper orinadequate.The proposed agreement concerns a21.74 acre property (
‘‘
the Property
’’
)located within the approximately 22.5
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