Regulatory Oversight of Genetically Engineered Microorganisms: Has Regulation Inhibited Innovation?

/ Using detailed interviews with company representatives and researchers in the field, this paper examines the factors that might account for the slow pace of development of genetically engineered microorganisms (GEMs) intended for environmental release. We specifically analyzed the role of the regulatory system in shaping innovation. We identified at least two cases where industry decided to discontinue the development of a genetically engineered microbial product because of concerns over regulatory oversight. However, most often industry decisions to continue or halt development of GEMs were based on an evaluation of the particular product's efficacy and potential for profitability. Thus the inability of GEMs to perform up to expectations in the field, rather than the regulatory constraints, appears to be the factor responsible for the slow pace of development. KEY WORDS: Genetically engineered microorganisms; Biotechnology; Regulation of biotechnology; Innovation; Environmental release     

TRENDS IN PRECIPITATION AND STREAM CHEMISTRY IN A PRISTINE OLD-GROWTH FOREST WATERSHED,OLYMPIC NATIONAL PARK,WASHINGTON1

ABSTRACT: Human induced long-term changes in precipitation and stream chemistry have been observed in eastern North America and Europe, but few long-term studies have been conducted in coastal western North America. The objectives of this research were to determine: (1) time trends in precipitation and stream chemistry in a pristine old-growth forest watershed, and (2) seasonal patterns in precipitation and stream chemistry. It was conducted in 58 ha West Twin Creek Watershed, Hoh River Valley, Olympic National Park, Washington from 1984 to 1993. Vegetation consists of old-growth forest, with western hemlock, Douglas-fir, western redcedar, Pacific silver fir, and Sitka spruce being the dominant tree species. Annual precipitation varied from 2336 to 4518 mm during the study period with the majority of the rain falling between October and May. Chemistry of precipitation was strongly dominated by oceanic influences with Na and Cl being the dominant ions. The chemistry of the stream was influenced by bedrock weathering and was dominated by Ca, HCO₃, and SO₄ and was not strongly related to precipitation chemistry. The pH of precipitation averaged 5.3 over time and ranged from 4.3 to 7.1, while the stream pH averaged 7.5 and ranged from 5.5 to 9.0. There were few long-term trends in the chemical constituents of bulk precipitation or stream water with the exception of a slight decrease in NO₃ in precipitation and an increase of SO₄ in stream water. A trend of decreasing concentrations of Ca, Mg and Na in precipitation also occurred. There were no significant seasonal patterns in precipitation although the highest SO₄ concentrations usually occurred in late spring and summer perhaps due marine algal activity. Strong seasonal trends occurred in concentrations of HCO₃, SO₄, Ca, Mg, and Na in stream water resulting from weathering and stream flow patterns, with highest ion concentrations occurring just before the onset of the rainy season. Pulses of NO₃ in the stream were observed during fall and early winter resulting from the release of NO₃ which had accumulated in soils or sediments.     

Euro Chlor Risk Assessment for the Marine Environment Osparcom Region: North Sea - 1,1,2-Trichloroethane

This risk assessment on 1,1,2-trichloroethane (T112) was carried out specifically for the marine environment, according to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programs in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the "predicted environmental concentrations" (PEC) and the "predicted no effect concentrations" (PNEC) for the marine aquatic environment. In total, 22 studies for fish, 45 studies for invertebrates and 9 studies for algae have been evaluated. Both acute and chronic toxicity studies have been taken into account and the appropriate assessment factors have been used to define a PNEC value of 300 µg/l. Most of the available monitoring data apply to rivers and estuaries and were used to calculate PECs. The most recent data (1991-1995) support a typical PEC of 0.01 µg T112/l water and a worst case PEC of 5 µg T112/l water. The calculated PEC/PNEC ratios give a safety margin of 60 to 30,000 between the predicted no effect concentration and the exposure concentration. Additional evaluation of environmental fate and bioaccumulation characteristics showed that no concern is expected for food chain accumulation.     

Migration of Birds as an Indicator of Broad-Scale Environmental Condition

The general profile of the pollution of drinking water, originating from groundwater, by nitrates, chloride and arsenic, in the Prefecture of Thessaloniki, was studied in this project. Samples (tap water) were collected from 52 areas-villages of the Prefecture, during a period of 6 months. The analytical results were related to certain points on the map of the area, thus producing coloured representations of the Prefecture, according to the concentration of the corresponding pollutant. The statistical analysis of the data led to some conclusions concerning the causes of pollution and the relation of the concentrations to certain physico-chemical parameters. Nitrate concentration of samples collected from two specific regions were especially high, sometimes above the highest permitted level. A limited number of samples (13.5%) contained arsenic concentrations above the imminent EC drinking water limit (10 ppb). The majority of the tap water samples, collected from areas along the seashore contained increased concentrations of chloride ions, which is a clear indication of seawater intrusion into the related aquifers.     

Holling's Figure-Eight Model: A Technical Reevaluation in Relation to Climate Change and Biodiversity

Holling proposed a four-phase conceptual model of ecosystem dynamics that includes exploitation, conservation, and destructive and renewal components to explain the failure of many natural resource management schemes. The model is drawn as a sideways figure-eight i.e. . There are two dimensions in this model, connectivity (abscissa) and the amount of capital stored in the system (ordinate). This conceptual model has been suggested as a guide to thinking about the impact of climate change on biodiversity, but the two dimensions are insufficient and the alignment of the figure-eight model is problematic when compared with actual data. Kay has adjusted the dimensions of the figure-eight model and renamed the abscissa as exergy stored and the ordinate as exergy consumed. We realign the original figure-eight model, labeling the abscissa as carbon stored and the ordinate as nutrients, such that the relative values of both axes are in qualitative agreement with data from four different studies. This new alignment is then shown to fit relatively well with Holling's original labels. This revision of the figure-eight model brings Holling's model into agreement with observations and provides insight into the linkages between biodiversity and climate change.     

Euro Chlor Risk Assessment for the Marine Environment Osparcom Region: North Sea - 1,2-Dichloroethane

This risk assessment on 1,2-dichloroethane (EDC) was carried out specifically for the marine environment, according to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programs in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the "predicted environmental concentrations" (PEC) and the "predicted no effect concentrations" (PNEC) for the marine aquatic environment. In total, 21 studies for fish, 17 studies for invertebrates and 7 studies for algae have been evaluated. Both acute and chronic toxicity studies have been taken into account and the appropriate assessment factors have been used to define a PNEC value of 1100 µg/l. Most of the available monitoring data apply to rivers and estuaries and were used to calculate PECs. The most recent data (1991-1995) support a typical PEC of 0.5 µg EDC/l and a worst case PEC of 6.4 µg EDC/l. The calculated PEC/PNEC ratios give a safety margin of 170 to 2200 between the predicted no effect concentration and the exposure concentration. Additional evaluation of environmental fate and bioaccumulation characteristics showed that no concern is expected for food chain accumulation.     

Euro Chlor Risk Assessment for the Marine Environment Osparcom Region: North Sea - Chloroform

This risk assessment on chloroform was carried out specifically for the marine environment, according to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programs in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the "predicted environmental concentrations" (PEC) and the "predicted no effect concentrations" (PNEC) for the marine aquatic environment. In total, 23 studies for fish, 17 studies for invertebrates and 10 studies for algae have been evaluated. Both acute and chronic toxicity studies have been taken into account and the appropriate assessment factors have been used to define a typical PNEC value of 72 µg/l. Due to limitations of the studies evaluated, a worst PNEC of 1 µg/l could also be used. Most of the available monitoring data apply to rivers and estuaries and were used to calculate PECs. The most recent data (1991-1995) support a typical PEC of 0.2 µg chloroform per litre of water and a worst case PEC of 5 to 11.5 µg chloroform per litre of water. The calculated PEC/PNEC ratios give a safety margin of 6 to 360 between the predicted no effect concentration and the exposure concentrations. A worst case ratio, however, points to a potential risk for sensitive species. Refinement of the assessment is necessary by looking for more data. Additional evaluation of environmental fate and bioaccumulation characteristics showed that no concern is expected for food chain accumulation.     

Euro Chlor Risk Assessment for the Marine Environment Osparcom Region: North Sea - Tetrachloroethylene

This risk assessment on tetrachloroethylene (PER) was carried out specifically for the marine environment, according to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programs in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the "predicted environmental concentrations" (PEC) and the "predicted no effect concentrations" (PNEC) for the marine aquatic environment. In total, 18 studies for fish, 13 studies for invertebrates and 8 studies for algae have been evaluated. Both acute and chronic toxicity studies have been taken into account and the appropriate assessment factors have been used to define a PNEC value of 51 µg/l. Most of the available monitoring data apply to rivers and estuary waters and were used to calculate PECs. The most recent data (1991-1995) support a typical PEC of 0.2 µg PER/l water and a worst case PEC of 2.5 µg PER/l water. The calculated PEC/PNEC ratios give a safety margin of 20 to 250 between the predicted no effect concentration and the exposure concentration. Additional evaluation of environmental fate and bioaccumulation characteristics showed that no concern is expected for food chain accumulation.     

Bioremediation of Stranded Oil on an Arctic Shoreline

The application of slow-release and soluble fertilizers proved to be an effective and environmentally benign way of stimulating oil biodegradation on an Arctic shoreline. Fertilizer application to the surface of the beach delivered nutrients to the oiled sediment beneath the beach surface. There was no significant run-off of this fertilizer to either the nearshore water or to unfertilized plots, and there were no adverse toxicological effects of the fertilizer application. The fertilizer application was followed by an increase in oxygen consumption and carbon dioxide evolution from the beach, increased microbial biomass, and significantly greater biodegradation of oil on the plots that had received fertilizer. The rate of oil biodegradation was approximately doubled over the course of a year by fertilizer applications in the first two months after the spill.Simple test kits proved adequate to monitor the fertilizer-application process in the field in a time frame that would allow the application process to be fine-tuned during treatment on a real spill. Simple test kits and portable instrumentation were useful in demonstrating the initial success of the bioremediation strategy.