US industry-friendly regulation

November 2014


Aerial crop spraying. CC photo by US Fish and Wildlife Service HQ on Flickr
“As man proceeds toward his announced goal of the conquest of nature, he has written a depressing record of destruction, directed not only against the Earth he inhabits but against the life that shares it with him.” (Rachel Carson 1962)
The US Environmental Protection Agency (EPA) was established, in part, to stem the tide of this destruction.
 
Man-made agri-materials are applied locally but become distributed widely by weather, water-systems, food webs, and living and mechanical vectors. The potential for environmental and human health effects is huge and, in America, is subject to the EPA doing its job responsibly.
 
Over half-a-century after Rachel Carson's chilling warning, a damning critique of the US approach to pesticide risk assessment has been published. The paper uses atrazine, a herbicide used in America but now banned in Europe, as an example, but the points made apply equally to GM crops and their associated chemicals.
 
Four key fundamental concerns are raised:

1. Inherent conflicts of interest
 
The EPA requires companies which manufacture agri-materials to supply the data for their risk assessment. Furthermore, the Agency works with industry to establish the methodology and experimental design for safety studies. This system not only lets industry set its own risk assessment agenda but the complexity and logistics of protocols make testing prohibitively expensive for independent replication. (COMMENT And in the case of patented materials such as GM crops, test materials are not made available.)

Many studies have shown that funding source is a major predictor of the outcome of a safety test. Industry is perfectly positioned to distort the science it its favour.
 
On top of the danger of unrecognised harmful materials in our environment, real adverse impacts obscured by industry make the regulatory process sluggish to respond. This adds to the risk.
 
The authors point out that conflicts of interest may compromise professional judgement, and lead to a serious loss of confidence in all associated industry products and in their regulation.
 
COMMENT It's worth noting that the fifteen authors of the critique “declare they have no actual or potential competing financial interests”. They also have an appropriate range of expertise in the their subject, something which may be missing from industry science. Eleven of them are professors and the team expertise spans environmental science, forestry, river ecology, biology, human health and occupational medicine.
 
2. Failure to use all available relevant data.
 
The EPA sets rigid criteria for the inclusion of studies in its risk assessments. For example, it will use only data which supply quantitative information so that they can be used to set allowable exposures. Failure to meet ideal experimental criteria is therefore used to reject results which could demonstrate important cause-effect relationships.
 
Effectively the EPA sacrifices independent replication for a long list of test criteria.
 
In the case of atrazine, the EPA restrictions eliminated 74 our of 75 safety studies from its risk assessment, and the chemical was approved on the basis of a single study.
 
3. Over-reliance on laboratory studies
 
The EPA operates on the assumption that field studies will yield weaker evidence due to the interacting complexities in the real world. Since harmful effects may exist within this natural complexity, they will never be revealed in the simplified scenario of a laboratory. 
 
COMMENT The authors also describe an underlying unrealistic expectation on the part of the EPA that experimental results using living materials will be uniform. In fact even small genetic differences between inbred laboratory animals result in wide differences in responses to stressors. This evident lack of understanding of biology is even more important when dealing with GMOs: industry has successfully fed regulators the use of irrelevant historical controls to obscure the inevitable novel features of GMOs, and their possible implications for safety. For example see Bt SOYA FEEDS PESTS – November 2014.
 
4. Failure to act on recommendations of Science Advisory Panels
 
Science Advisory Panels are the only 'watchdog' over EPA policy, but the Agency is not obliged to act on their advice nor to justify its actions.
 
In conclusion , the critique offers four measures to “improve the reliability of (the EPA) process”: 
  • Eliminate the use of studies with conflicts of interests, and separate industry influence from safety research
  • Include all available research in risk assessments and apply a weight of evidence approach
  • Include both laboratory and field studies in regulatory decisions
  • Explicitly address Science Advisory Panel recommendations.
 

OUR COMMENT 

 
Until the US get its chemical- and GM-safety regulations in order, Europe must not accept its GMOs nor use of its agri-chemicals, nor should it allow any trade agreements to override safety considerations. Check out HERE'S A TTIP – November 2014 
 
SOURCE
 
Michelle D. Boone, et al., 2014, Pesticide Regulation amid the Influence of Industry, BioScience 3.09.14

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