Apr. 29, 2016
Feedstuffs magazine reports:
Several agricultural groups have submitted comments voicing concerns to the U.S. Department of Agriculture regarding the Animal & Plant Health Inspection Service's (APHIS) proposed revisions to biotechnology crop regulations.
In February, APHIS announced its intent to conduct a programmatic economic impact study as part of a comprehensive study of its Part 340 regulations of biotech crops. Under these regulations, APHIS makes science-based determinations of whether biotech-enhanced traits pose a plant pest risk or noxious weed risk.
Five national grain-based organizations cautioned APHIS not to make premature and ill-advised changes to its biotech regulations that could result in increased domestic and international market disruptions for grain and grain products.
The statement - authored by the National Grain & Feed Assn. and joined by North American Export Grain Assn., Corn Refiners Assn., North American Millers Assn. and National Oilseed Processors Assn. - said the outcome of any revision to APHIS's biotech regulations should be either acceptable to - or comparable and compatible with regulatory approaches used by - competent government authorities in important U.S. markets so as to minimize or prevent the risk of market and trade disruptions.
The comments state, "We believe that any changes to U.S. biotech regulatory processes, including Part 340, should be considered only after advance, robust and thorough discussions with competent government authorities in countries that represent important U.S. export markets, during which alignment in regulatory approaches is achieved to the maximum extent possible. ... This is even more important currently, given ongoing and potentially productive discussions occurring between the private sector and various foreign governments on whether and how to address the regulatory treatment of important new breeding technologies," such as gene editing techniques.
The groups said there is no indication that adequate consultations or buy-in from foreign governments have occurred to date.
The American Soybean Assn. (ASA) said it is particularly concerned by the potential for changes in the regulatory system to disrupt international trade. It said the U.S. government and soybean industry are actively encouraging foreign trading partners to adopt product-based regulatory review systems for biotech traits that are similar to U.S. systems.
"This issue is critically important to U.S. soybean producers, since we export over half of our annual production, and biotech traits are expressed in over 90% of the varieties we plant," ASA stated. "A sudden or unexpected change in our regulatory policy could prevent the introduction of new biotech products in the U.S., since nearly all countries have a zero tolerance for the presence of traits they haven't approved. This would effectively shut down the process for developing and introducing new products."
ASA commended APHIS for undertaking this initiative and said it supports the goal of updating regulations to reflect changes in the environment for the development and commercialization of the products of biotechnology.
"Any changes to the regulations should be tailored to address specific problems in a clear and transparent manner," ASA said in its comments. "In addition, APHIS must consider the potential impact of changes in its policies on the international as well as the domestic regulatory and commercial environment for biotech products."
ASA expressed support for the proposed regulatory approach that is product based, regulates only products that pose a documented risk and is consistent with APHIS's authority and intent to modernize its regulations and called for oversight that is transparent, predictable and proportionate to the actual risk posed.
The grain groups' statement also cited the need for APHIS to develop a clearly defined, specific regulatory process for biotech-enhanced agricultural products that have unique functional characteristics (e.g., output traits) that may adversely affect the functionality and/or compositional and nutritional integrity of the product and downstream users if the trait becomes present in the commingled, fungible supply chain at levels exceeding certain thresholds.
The organizations faulted APHIS for seemingly divorcing the review of its regulations that determine whether a biotech trait poses a plant pest or noxious weed risk from the Obama Administration's ongoing comprehensive review of the so-called Coordinated Framework for biotechnology that involves other federal agencies like the Food & Drug Administration and Environmental Protection Agency, which have oversight of other aspects of pre-market reviews of biotech-enhanced products.
In comments, the National Sorghum Producers said it is concerned that APHIS's proposed changes to the seed technology regulatory framework ultimately will have the effect of regulating non-transgenic or non-genetically modified crops in the same fashion they do transgenic ones currently. It also is concerned that this expansion of APHIS's regulatory powers will slow down the delivery of new technologies and varieties to farmers' fields and significantly increase costs.
Further, consistent with previous statements the grain groups have made to APHIS, the joint statement also urged APHIS to consider the concept of "conditional deregulation" in instances where scientific risk assessment has found that a given biotech-enhanced trait does not present a plant pest or noxious weed risk but the trait has not been approved in important U.S. export markets or has a functionally different output trait.
Under this concept, APHIS would continue to provide permit-controlled oversight of prudent stewardship and risk responsibility plans put in place by biotech owners/providers to minimize the potential for traits that could pose market disruptions from becoming commingled in the fungible commodity supply stream.
The groups noted that the "conditional deregulation" concept is consistent with USDA's obligation to consider the potential economic impacts on U.S. agriculture of commercialization of biotech-enhanced traits.
It also would contribute to preserving the efficiencies and cost-competitiveness of the fungible, commingled U.S. and global grain and oilseed supply in which commodities from various regions of the world can be sourced in a timely and efficient manner in response to customer demand without concern over regulatory status, thereby enhancing food security.