Regulatory Affairs—Agriculturaland Environmental

Monsanto Asks for Nonregulated Statusof Drought-Tolerant Corn

WASHINGTON, DC 5/4/11—The Animal andPlant Health Inspection Service of the US Departmentof Agriculture said today that Monsanto Co has peti-tioned the agency to grant nonregulated status to itsMON 87460 corn, which has been genetically engi-neered to require less water. Drought tolerance is oneof the traits environmentalists have been saying compa-nies should be adding to their genetically engineeredplants rather than the insecticidal and herbicide-tolerance traits that have been the focus of commercialefforts.

The USDA’s request for comments on whether thecorn poses a plant pest risk was published in theMay 11 edition of the Federal Register (76 FR27303–27304).

The new strain was created by introducing coldshock protein B from Bacillus subtilis. The APHIShas prepared a draft environmental assessment

� � �

Syngenta Wants Its Boll-Weevil-ResistantCotton to Be Unregulated

—Environmentalist Opposition Likely

WASHINGTON, DC 5/11/11—Syngenta Biotech-nology has filed a petition for deregulated status ofits Lepidopteran-resistant cotton with the Animaland Plant Health Inspection Service of the US Depart-ment of Agriculture (event COT67B). The insectsagainst which the cotton is protected include the cot-ton bollworm, the cabbage looper, and the tobaccobudworm. The APHIS is soliciting comments onwhether the cotton poses a plant pest risk (76 FR27301–27303) and has published a draft environmen-tal assessment of the plants. The cotton has been fieldtested under APHIS monitoring.

The plants express the Cry1Ab protein derived fromBacillus thuringiensis subsp. kurstaki HD-1.

To the general public, ‘‘Lepidopteran’’ is synony-mous with ‘‘butterfly,’’ so strong environmentalist op-position to deregulation of the cotton seems likely.

� � �

Risk Assessment of Oral RabiesVaccine Released

WASHINGTON, DC 8/4/11—The Animal andPlant Health Inspection Service of the US Departmentof Agriculture is releasing its risk and environmentalassessment of a field test of an oral rabies vaccine inWest Virginia. The vaccine is intended to immunizeraccoons and striped skunks against rabies, a viral dis-ease that is uniformly fatal. Rabid wildlife poses a riskto domestic animals and to humans that enter the areawhere the infected animals live.

The initial vaccine contained a glycoprotein createdfrom genes of the vaccinia and rabies viruses. In fieldtests, the vaccine was protective in some species, but itdid not produce widespread immunity in skunks.These animals thus are considered to pose a continu-ing threat to humans, domestic animals, and wildlife.

The vaccine also is being used to immunize coyotes(Texas) and gray foxes (Texas, New Mexico, and Ari-zona).

The Announcement is available at 76 FR 48119–48120.

The agency is now planning to test the efficacy andsafety of another recombinant vaccine, produced by Arte-mis, in which human adenovirus-5 delivers the gene for arabies glycoprotein (AdRG1.3) with the hope it will pro-duce greater population immunity in skunks. The test willtake place in a 560-square mile area including land ownedby the US Forest Service but not Wilderness Areas.

APHIS’ review and analysis of the proposed actionare documented in detail in an environmental assess-ment, Field Trial of an Experimental Rabies Vaccine,Human Adenovirus Type 5 Vector in West Virginia,published in July.

� � �

30 Biotechnology Law Report 689Number 6, 2011# Mary Ann Liebert, Inc.DOI: 10.1089/blr.2011.9763

689