Regulatory Affairs—Agriculturaland Environmental

APHIS Considering Non-browning Apple

—Apple Growers Oppose Genetically

Engineered Fruit

WASHINGTON, D.C. 7/12/12—The Animal andPlant Health Inspection Service of the U.S. Depart-ment of Agriculture said today it has received an ap-plication from Okanagan Specialty Fruits, Inc. ofBritish Columbia for deregulation of apples geneti-cally engineered to resist browning through inser-tion of a polyphenol oxidase suppression sequence.The Canadian company hopes to introduce GoldenDelicious and Granny Smith versions of its Arctic�

Apples.The plants are not transgenic, as the inserted se-

quence was derived from apples. Introducing extracopies of the gene activates RNA interference, reduc-ing the concentration of the browning-causing en-zyme. Field tests have already been conducted.

Comments on the petition will be accepted for 60days. APHIS said it is ‘‘encourage[ing] the submis-sion of scientific data, studies, or research to supportyour comments,’’ a no doubt futile attempt to discour-age the sending of dozens of copies of letters expressingopposition to genetic engineering with no supportingdata.

Producers of other apples are opposed to allowinggeneral planting of the apples because they fearharm to the image of apples as a natural, healthyfood.

‘‘We don’t think it’s in the best interest of theapple industry of the United States to have thatproduct in the marketplace at this time,’’ said Chris-tian Schlect, President of the Northwest Horticul-tural Council.

At present, apple slices often are treated withcalcium and ascorbic acid to preserve their fresh-sliced appearance, but this treatment can affect thetaste.

Organized opposition to genetically modifiedfoods has convinced some consumers that theyare dangerous to eat. One opponent said the modi-fied apples might make it possible to sell rotten ap-ples that would still look fresh. The company saysthat this is not possible: rotten apples would lookrotten.

An Environmental Assessment, as required by theNational Environmental Policy Act, is being prepared.

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Drought Helps Evaluationof New Strains of Corn

—Early Results Indicate Utility

of Genetically Modified Plants

MIDWESTERN U.S. 8/12/12—The severe droughtthat has hit the Midwest this year has had a benefit forsome seed producers. Corn that has been geneticallyengineered to be drought tolerant is growing well,boosting its prospects for clearance for widespreadplanting and ensuring that the entire U.S. corn cropwill not be lost.

Pioneer Hi-Bred’s AQUAmax corn is being fieldtested in South Dakota, and Monsanto also is seeinggood results in a field trial of its DroughtGard product.

The companies pointed out that planting corn thatallows use of herbicides, as the drought-tolerantstrains do, also is important under the present condi-tions because weeds ‘‘rob’’ the soil of water.

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Does EPA Know What Prions Are?

—Federal Register Notice Says ‘‘Prion’’

Is Being Classified as a Pest

WASHINGTON, D.C. 8/2/12—Martha Morell,Acting Director, Office of Pesticide Programs at theEnvironmental Protection Agency today said in theFederal Register that she has forwarded to the Secreta-ries of the U.S. Department of Agriculture and theDepartment of Health and Human Services ‘‘a draftregulatory document concerning Declaration ofPrion as a Pest Under FIFRA; Related Amendments;and Availability of Final Test Guidelines (77 FR46373–46374 [August 3, 2012]). The draft regulatorydocument itself is not yet available to the public.

The full text of this somewhat puzzling document isavailable in the documents section of this issue.

Prions are self-replicating proteins associated withseveral transmissible spongiform encephalopathies suchas Creutzfeld-Jakob disease and kuru. One type ofprion is responsible for bovine spongiform encephalopa-thy (mad cow disease), which is transmissible to humanswho consume infected beef. The infection of British cat-tle with the disease is believed to have been the result offeeding them brains from sheep infected with scrapie.

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31 Biotechnology Law Report 478Number 5, 2012# Mary Ann Liebert, Inc.DOI: 10.1089/blr.2012.9745

478

Drought Should Not AffectRenewable Fuel Standard

—BIO and Other Organizations Fight

to Keep Production of Corn-Based

Ethanol High Despite Poor Crop

WASHINGTON, D.C. 8/3/12—The BiotechnologyIndustry Organization has sent a letter trying to coun-ter a plea by 156 members of the U.S. House of Rep-resentatives to the Environmental Protection Agencyto modify its Renewable Fuel Standard because thedrought in the Midwest has drastically reduced thecorn harvest. According to BIO, reducing the require-ment for biofuels for this year would have adverseconsequences for several years.

Eight biofuel groups (the Advanced Biofuels Associ-ation, Advanced Ethanol Council, Algal Biomass Organ-ization, American Coalition for Ethanol, BiotechnologyIndustry Organization, Growth Energy, National Biodie-sel Board, and Renewable Fuels Association) are sup-porting BIO’s action and have formed the BiofuelsProducers Coordinating Council. They say less corn isbeing used this year for ethanol production because ofshortages of supply.

The BIO letter maintains that the ‘‘long-term changesto federal energy policy’’ advocated by the Members ofCongress might sacrifice ‘‘future energy security and jobgrowth.’’

‘‘The solution to the drought that they propose is un-likely to provide relief to livestock producers, farmers,or consumers; it could, however, produce unintendedconsequences for biotech companies developing ad-vanced biofuels and, thus, have a long-term negativeimpact on consumers and our nation’s ability to de-velop critical sources of alternative energy.’’

An Iowa State University professor has claimedthat ending the Renewable Fuel Standard would reducecorn prices by 5% at most. Livestock feeders responded

that this is not trivial; according to their calculations,a 5% drop in corn prices would save their industry $1billion.

The rise in the price of corn has led farmers to sendlarge numbers of cattle, pigs, and chickens to market.This has produced a short-term decline in meat prices,but those prices are already starting to rise on supplyshortages and are expected to be significantly higherwithin a few months.

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FONSI for Oral Rabies Vaccine

—Field Test Just Completed

WASHINGTON, D.C. 8/16/12—The WildlifeServices division of the Animal and Plant HealthInspection Service of the U.S. Department of Agricul-ture today released its finding of no significant impact(FONSI) for the AdRG1.3 oral rabies vaccine in a fieldtrial on USDA and Forest Service lands in New Hamp-shire, New York, Ohio, Vermont, and West Virginia (77FR 49409–49410 [August 16, 2012]). No wildlife pre-serves were treated.

Oral rabies vaccine is being incorporated into foodpellets that are spread in areas where rabies is preva-lent in wildlife. Animals that consume the pellets be-come immunized against infection with the 100%fatal virus. Wildlife is the deepest reservoir of rabiesin the United States.

APHIS had solicited comments on the proposedtrial and received nine, five of them from the same in-dividual. One commenter said APHIS should preparean Environmental Impact Statement but gave no rea-son this more difficult endeavor would be appropriate.

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Biotechnology Law Report � Volume 31, Number 5 479