EPA Seeks to Exempt Certain Plant Incorporated Protectants

The EPA is laying the groundwork to exempt certain genetically engineered plants from regulation under federal pesticide laws, according to a draft policy document.  While use of the genetically engineered (GE) materials known as viral coat protein plant incorporated protectants (VCP-PIPs) would still be overseen by the U.S. Department of Agriculture (USDA), industry hopes that removing EPA will allow companies to develop the virus-protecting PIPs for major crops. 

The Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) requires EPA to register all PIPs as a pesticide, though there has been controversy over how the regulatory language applies to GE crops.  Previous policy on broader PIP regulation prompted opposition by several EPA regions.  Now, EPA's new draft GE policy begins the process for exempting VCP-PIPs from all requirements under FIFRA, which could allow industry to move forward in applying them to some of the most widely grown crops in the United States, such as corn and soybeans.  VCP-PIPs are currently limited to two crops, squash and papaya.  In early December, EPA's FIFRA Scientific Advisory Panel reviewed the agency's technical backing for the draft policy.  EPA officials at the meeting said they could grant exemptions under FIFRA in one of two ways.  EPA could acknowledge that VCP-PIP crops are adequately regulated by another agency, such as USDA, or it could examine data to conclude that the VCP-PIP plants present a low-risk for ecological damage.  One agency official speaking at the meeting said that both EPA and USDA agreed that EPA needed to pursue its own basis for exempting VCP-PIPs, due to the complexity of regulating GE crops.  Thus, the agency is pursuing the second type of exemption option for the genetic material.  The draft document notes that individual VCP-PIPs must meet a set of criteria - meant to establish that PIPs pose low environmental risks - in order to be considered for the EPA exemption.  If a VCP-PIP fails any of the criteria, it would become subject to EPA's FIFRA regulation, according to the document.  "Products that fail to meet one or more of the exemption criteria would need to obtain a registration," the document says.  The registration process is the first step of EPA's pesticide regulatory oversight. 

The draft policy for exempting VCP-PIPs also states that the key consideration is whether incorporating such genes could spread to other plants, potentially causing ecological disruption by giving plants that were contaminated with GEs in the wild a selective advantage over other wild plants in an ecosystem.  In light of that, the draft policy states that any plants EPA is considering granting exemptions for have no "wild or weedy" relatives in the United States.  If EPA finalizes the draft policy, USDA would continue to monitor crops grown with VCP-PIPs. 

Panelists at the December meeting generally supported the agency's assertion that PIPs present low ecological risk, though they urged the agency to develop a flexible regulatory approach to handle unforeseen issues.  For example, one panelist noted that global climate change could cause plants to migrate to new areas, thus presenting new potential for anti-viral genes to spread.  A scientist at Friends of the Earth (FOE) says the potential for gene recombination with other viruses could create other unforeseen hazards, a criticism also noted by several panelists. "One of the main risks associated with viral coat proteins is recombination of the viral gene with native viruses to create new strains, whose properties cannot be predicted and could be hazardous," the FOE scientist says.  An industry official at the SAP meeting said biotech research on PIPs has grown stagnant in the face of poor market acceptance and what one official referred to as "excessive and burdensome regulations" by EPA and USDA.  The officials added that industry is using outreach measures to generate better market acceptance, and hopes federal agencies will soften regulation on VCP-PIPs to allow research to continue and expand to other crops.  EPA has identified 37 agricultural plants potentially eligible for the exemption, including staples such as soybean, corn, potato, barley and several fruits.  (Risk Policy Report, 12/14/05). 

Next