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New research reveals challenges in genetically engineered cropregulatory process by he ni





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New research reveals challenges in genetically engineered cropregulatory process by
Article Posted: 02/02/2013
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New research reveals challenges in genetically engineered cropregulatory process


 
Business,Business News,Business Opportunities
A new innovation can completely reshape an industry - inspiringboth optimism and debate. The development of genetically engineered(GE) crops in the 1980's ignited a buzz in the agriculturalcommunity with the potential for higher crop yields and betternutritional content, along with the reduction of herbicide andpesticide use. GE crops grew to play a significant role in theU.S., with more than 160 million acres of farmland used to produceGE crops in 2011. However, the development of new GE crops has recently slowed to atrickle due to litigation over field testing and deregulation.University of Minnesota researchers Esther McGinnis, Alan Smith,and Mary Meyer set out to determine the cause of these litigationlulls responsible for slowing GE progress in the U.S. Three federal agencies are responsible for regulating plantbiotechnology in the United States.

The Food and DrugAdministration (FDA) oversees food and animal feed safety aspectsof GE crops. The Environmental Protection Agency (EPA) is responsible for cropsengineered to produce pesticidal substances. Lastly, the U.S.Department of Agriculture's Animal and Plant Health InspectionService (APHIS) regulates the planting of GE crops under the PlantProtection Act, introduced in 2000, to consolidate relatedresponsibilities previously spread across various legislativestatutes. APHIS regulates GE crops if the donor organism, recipient organism,or vector or vector agent meets the plant pest definition or theAPHIS administrator believes the organism to be a plant pest.

The agency's regulatory decisions have met much criticism in thelast decade, inspiring the U of M research team to determine if andwhere APHIS may have gone wrong. The team used past lawsuits ascase studies to determine whether APHIS failed to recognize theenvironmental impacts of GE crops and made legal errors in failingto comply with the sometimes strict procedures of U.S.environmental law. After rising exponentially in the mid-1980s, the first commerciallygrown GE crop, the Flavr Savr tomato, was approved for sale in theU.S. in 1994.

Many farmers since then, adopted GE crops as theirown, excited by the prospects of scientific advancement andfinancial reward. GE crop testing declined rapidly in 2003 in response to the firstlawsuit. "Before that time, APHIS was dealing with a pretty heavycase load," says McGinnis. "Their compliance with NEPA may haveslipped and left them vulnerable to lawsuits." NEPA, the National Environmental Policy Act, is a U.S.

nationalpolicy that was established in 1969 to promote environmentalprotection. NEPA requires environmental agencies to keep anin-depth administrative record of their actions that validates theagency's rationale in reaching regulatory decisions. The lack oftransparency in creating these administrative records has been apoint of criticism APHIS has faced in recent years. McGinnis and her fellow researchers also pointed out that many ofthe lawsuits used in their study demonstrate that APHIS failed todifferentiate between traditional GE crops, such as corn, soybeans,and cotton, and new GE crops presenting considerable regulatorychallenges. Take the genetic engineering of creeping bentgrass, for example.This weedy, wind-pollinated perennial raises unique gene flowconcerns that aren't seen in more traditional herbicide-tolerantcrops.

APHIS has failed to distinguish novel GE crops like this oneand hold them to the rigorous evaluation standards required byenvironmental law, which has led to lawsuits that have grounded theGE crop regulatory process to a halt. "APHIS needs to prioritize its resources. It needs to be spendingmore time regulating novel crops," says McGinnis. "I'm certainlynot advocating more regulation of traditional agronomic crops.Really, it's about focusing on these novel crops that raise moreissues." APHIS has recently announced plans to streamline their regulatoryreview process of GE crops, and plans on implementing severalefficiency improvements.

These include executing more defineddeadlines, better resource management, and earlier opportunity forpublic involvement. "If APHIS can solicit public comment earlier in the regulatoryprocess, it can more efficiently incorporate stakeholder concernsinto either the environmental assessment or the environmentalimpact statement that it prepares in conjunction with itsregulatory decision," says McGinnis. While APHIS says it has already begun to apply new, more efficientprocess steps and more defined deadlines, changes to publicengagement have yet to be implemented. The agency's complete set ofrevised procedures go into effect after the plans are published inthe Federal Register.

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