Research Results

Evaluation of the U.S. Regulatory Process for Crops Developed through Biotechnology

Council for Agricultural Science and Technology, (CAST),
www.cast-science.org

Regulators need adequate resources to make more information available to the public about how decisions on biotechnology are made, according to a new Council for Agricultural Science and Technology (CAST) issue paper. The "Evaluation of the U.S. Regulatory Process for Crops Developed through Biotechnology" paper includes recommendations for policy and research in agricultural biotechnology. It is particularly timely as the Environmental Protection Agency is making decisions regarding the registration fate of biotechnology-derived crops, such as Bt corn.

A group of nine science and policy experts prepared the issue paper for CAST, which represents 36 food and agricultural scientific organizations. "Having accepted the unenviable task of evaluating how U.S. regulatory agencies determine the safety of biotech crops, we decided to describe the process, then comment on how the process can be improved" explained food safety expert Bruce Chassy of the University of Illinois.

The paper's authors found that the U.S. regulatory process for evaluating biotechnology-derived crops is comprehensive and meets its charge of ensuring that biotechnology-derived foods are at least as safe as foods derived using traditional breeding techniques. "The greatest challenge is not having access to the documentation on how regulators come to their decisions", said Chassy. "We believe the public would have more confidence in the process if they knew the rationale for regulatory decisions to accept or reject new biotech crops. Safety testing data are available to the public. Now we need to provide adequate resources so the regulators can explain their decision-making rationale."

Four Key Questions Evaluated
The authors address (1) How are safety assessment and regulatory reviews conducted? (2) Can obvious strengths and weaknesses of that process be identified? (3) Can improvements be made in conduct and direction of independent research, in performance of safety assessments, in opportunities for consumer participation, or in any other aspects of the regulatory process that will both enhance the quality of the assessments and further ensure the ultimate safety of biotechnology-derived crop products? and (4) Are there improvements to the regulatory review process for biotechnology-derived plants that will enhance public confidence in the process?

Policy Recommendations

• Retain the current case-by-case safety assessment approach and continue to emphasize regulatory conditions carefully tailored to address risks identified for individual biotechnology-derived plant products.
  
• Finalize the Food and Drug Administration's (FDA) current proposal for a mandatory, premarket notification in lieu of the present policy of voluntary consultation for all food products of agricultural biotechnology.
  
• Provide the public with rapid, comprehensive accessibility to applications and supporting health and safety data submitted to regulatory agencies for biotechnology-derived products.
  
• Issue approvals for both food and feed use for crops intended to enter commodity streams.
  
• Provide the additional resources sorely needed for key regulatory review functions.

Research Recommendations

• Conduct additional research on selected topics to ensure that present-day questions can be answered and that future developments will be assessed adequately.
  
• Develop rapid screening methods for biotechnology-derived crop proteins in raw agricultural commodities, such as grain and vegetables.
  
• Conduct additional research to support regulatory oversight and product stewardship of biotechnology-derived crops currently on the market.
  
• Carry out additional research on the potential health, safety, and environmental effects of biotechnology-derived products that are not designed to be substantially equivalent to their conventional counterparts (sometimes referred to as next generation biotechnology-derived crops).
  
• Conduct additional research on food allergies and identification and characterization of allergenic food proteins.

CAST is an international consortium of 36 scientific and professional societies. It assembles, interprets, and communicates science-based information regionally, nationally, and internationally on food, fiber, agricultural, natural resource, and related societal and
environmental issues to its stakeholders - legislators, regulators, policy makers, the media, the private sector, and the public. For more information contact: Dr. Bruce M, Chassy, 217-244-7291, b-chassy@uiuc.edu

Illinois Livestock Industry Faces Crossroads
Peter Goldsmith, Assist. Prof., Agribusiness and Farm Management, 217-333-5131, pgoldsmi@uiuc.edu, Author: Bob Sampson, Extension Communications Specialist, (217) 244-0225, rsampson@uiuc.edu

Illinois's livestock industry, no longer as vibrant as it once was, stands today at a crossroads, according to a University of Illinois study that examined the economic impact, challenges, and potential futures of the industry. However, livestock production retains a significant economic impact on certain regions of the state.

"In 1979, livestock accounted for 1.68 percent of the gross state product," said Peter Goldsmith, assistant professor in the Department of Agricultural and Consumer Economics and coauthor of "The Economic Impact of Illinois's Livestock Industry" with Hedi Idris, a research assistant in the department.

"By 1999, that figure had fallen to .37 percent, a decline of four per cent per year. This dramatic shift has been due to the combined effects of the decline of the livestock sector and the expansion of the state's economy over the 22-year span. In terms of the nominal value of livestock marketings, the volume of business has decreased 36 percent or 1.8 percent per year. This is an annual contraction of $42 million per year. Most of the decline has occurred in the past 10 years."

Commercial enterprises in Illinois are broken down as follows: 45 percent are swine units, 21 percent are dairy farms, 22 percent are cow-calf operations, and 12 percent are a fed cattle enterprise. Goldsmith said livestock is a $3.4 billion industry in Illinois that directly employs 28,610 people with a total employment impact of 43,198. The industry annually contributes more than $330 million in taxes.

"While swine enterprises make up 45 percent of the commercial livestock business, they account for 53 percent of livestock's total cash receipts," he said. "More than 18,000 jobs are associated with the state's swine industry. Beef is second, generating over $800 million in output and directly employing more than 14,000 full time equivalents of labor. Dairy produces half as much economic activity ($486 million) as beef." The state's poultry industry accounts for 765 jobs in direct employment and slightly over $81 million in direct output. Sheep account for 169 direct jobs and nearly $6 million in direct output.

"One question of interest to the livestock industry is the question of new livestock investment scenarios and their impact on the rest of the economy," said Goldsmith. "To address this, we looked at three scenarios: a 2,400-sow farrow-to-finish operation, a 400-cow dairy, and a 2,400-head cattle-feeding operation." The analysis indicated that siting the 2,400 sow operation in Illinois would directly generate over $5 million in sales and have significant impacts on wholesale trade, real estate, feed grains, and support enterprises. The figure for a 400-cow dairy is $1.4 million. For siting a 2,400-head feeder operation the figure is about $2.5 million.

Examining the state's livestock industry from a supply-demand perspective revealed some interesting facts. "Livestock producers outside the state and outside the country are mostly meeting the demands of the state," said Goldsmith. "While at first glance, this portends great opportunities for local producers, that would not be entirely correct. This is because the supply-demand matrix in the modern food industry is not dominated, as it once was, by location. "Competitiveness now is much more a function of intangible assets such as human, organizational, and social capital. Therefore, while opportunities abound in the meat industry, location and land are only two of many criteria for competitiveness in the new agricultural economy."

The study also identifies the economic impact of livestock production on Illinois counties. The leading counties in this category are Henry, Stephenson, DeKalb, and Clinton. Each contributes over $100 million to the economy. Counties most dependent upon livestock agriculture are Carroll, Jasper, Greene, and Pike each comprising over 22 percent of their respective county's economy.

"The evidence is clear that based on economic data alone Illinois's livestock industry is not as vibrant as it once was," said Goldsmith. "However, livestock still has significant impact on certain regions within the state." Two possible strategies face the Illinois livestock industry as it stands at a crossroads. One path would be to continue operating as in the past. The result would be a continuation of the current trends. The other path values livestock agriculture as an economic engine and seeks to reinvigorate the industry. Pursuing this strategy involves complex decisions, new tactics and business practices." Goldsmith recommends that the industry address two complementary issues-Illinois's livestock business environment and the livestock industry's legitimacy.

"The business environment issue involves policy development to create an environment hospitable to livestock enterprises as is done with other industries in the economy, i.e., tax incentives, infrastructure improvements, and access to State contracts," said Goldsmith. "Complementary to this, the industry needs to engage in a legitimizing process. This process recognizes that stakeholders outside the industry are impacted directly and indirectly by the industry. Their needs, such as the environment, animal welfare, and food safety have to be addressed. Unless their needs are addressed probusiness policies will be difficult to formulate and, if formulated, difficult to implement."

Keeping Nutrients in Manure
Lupe Chavez, ARS News Service, 301-504-1627, ljchavez@ars.usda.gov

Manure-treating practices that reduce ammonia emissions and preserve nitrogen in the manure for plant use have been developed by Agricultural Research Service scientists. The treatments reduced ammonia release by more than 55 percent overall. Nitrogen is lost from manure when ammonia, a nitrogen-containing compound in the manure, escapes to the atmosphere through a process called volatilization. The loss of nitrogen makes the manure less useful as a fertilizer.

Alan Lefcourt and John Meisinger, colleagues at the ARS Animal and Natural Resources Institute in Beltsville, Md. (http://www.anri.barc.usda.gov/), conducted tests to improve the retention of manure nitrogen for organic use. They found that adding 2.5 percent alum or 6.25 percent zeolite to manure slurry by wet weight reduced ammonia loss by 60 and 55 percent, respectively.

Alum and zeolite, acidifying and sequestering agents, helped reduce the formation of ammonia gas and its volatilization, or release, into the air. Alum lowered the pH level of the tested dairy slurry below 5, a level that limits the amount of ammonia released from the manure. Zeolite, commonly used in kitty litter, acted as a cation-exchange medium, binding with the chemicals that would form ammonia and preventing volatilization. To measure ammonia loss, the researchers utilized a canopy and wind-tunnel system. A variable-speed fan pulled air over the manure samples and ammonia gases were trapped in acid bottles as they passed through the system. Ammonia losses were measured over a period of 96 hours.

Lefcourt and Meisinger initiated their research in response to problems created by increased animal production on farms and dwindling land available for spreading manure as fertilizer. Crop plants can take up and use the nitrogen and phosphorus in the manure. However, when too much nitrogen escapes into the air, excess phosphorus is left in the manure and soil. By limiting ammonia losses from manure, the team of scientists can create better ratios of nitrogen to phosphorus for farm crops. Moreover, zeolite-treated slurries are also a nitrogen-rich, slow-release, fertilizer. Treating dairy slurry with either alum or zeolite is cost-effective and safe. Slurries treated with alum would cost less than 50 cents a day per lactating cow. Zeolite costs should be similar, although volume pricing is not currently available.

At the ARS Animal and Natural Resources Institute, Lefcourt works in the Instrumentation and Sensing Laboratory (http://www.barc.usda.gov/anri/isl/). Meisinger works in the Institute's Environmental Quality Laboratory (http://www.barc.usda.gov/anri/eql/).