RITE is a demand for Integrity, transparency and accountability.
The central role of regulatory risk assessment is to protect public and environment health. In order to retain relevance and public trust, regulatory risk management authorities and agencies have an obligation to adapt and incorporate 21st century scientific understanding in order to protect the population from adverse harm from environmental chemicals. This is as much a demand for economic accountability as it is a demand to take action to prevent harm to humanity and the environment.
Risk assessment that does not respond to new complexities, and fails to acknowledge the economic cost of degraded health or contaminated drinking-water, now or in the future, is failing its' duty. Pollution is borderless. Chemical pollution can affect multiple human systems, as it can leach through an aquifer system. Responsible governments must take all precaution to prevent downstream adverse events, from hormonally induced cancer to contaminated drinking water.
The role of risk assessment agencies who assess hazardous substances, is not to facilitate trade, nor to vigorously defend existing guidelines. It is to ensure public safety. Government employees have duties (fiduciary obligation) which arise from the purpose and intent of the Act under which they operate. For example:
'The purpose of this Act is to protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms.'
Regulators have a duty to move away from single active ingredient 'silo' thinking, and address the complexity of multiple environmental chemical exposures; new advances in formulation toxicity and understanding of human vulnerability to hormonally and environmentally relevant chemical exposures. Regulators have an obligation to ensure that risk assessment is dynamic and complex, because, after all, this is the twenty-first century.
A. What should risk assessments’ bottom-line be?
It’s simple. Protect the rights of the most vulnerable.:
1. The foetus and developing baby, paying particular attention to first trimester of pregnancy.
2. Babies, toddlers, children and teenagers have accepted ‘windows of vulnerability’ that result in greater risk of harm in an adult if exposed to the same level of exposure.
3. Assure safety by adoption of the precautionary principle where there is uncertainty.
B. Should safety assessment look at the active ingredient, or the full formulation?
Full formulation is acknowledged as having greater efficacy (greater toxicity). Scientific studies demonstrate the mixture is more toxic than the single active ingredient. In the 21st century we have the technical capability to understand complete formulation (mixture) toxicity.
C. How should we select the studies to understand true toxicity and protect the most vulnerable?
Conduct a full literature review of the published literature. Good science should be replicable, and the ‘peer review process’ ensures that these published studies must be transparent enough to ensure that a scientist expert in that field, looking at the study, could replicate it. Published research is akin to a form of insurance that ensures the science is sound while restricting unscientific results that may include judgements and assumptions. Wide ranging review enables greater understanding of the complex, subtle and dynamic factors that can lead to disease.
Optimum transparency - Never hide secret studies. All industry studies must be published, and other data used to influence decision-making on must be published. All ‘reviews’ must only contain studies and data that are also published. Today most of the studies used by governments for decision-making (eg. Arriving at our daily exposure levels for chemicals) are hidden behind commercial confidentiality agreements. The data is narrowly focused, frequently old, locked away, and scientists are unable to research other results from the same laboratory that help unravel the historical background to why certain claims are made.
Go low and understand low dose epigenetic impacts. Traditionally governments evaluate toxicity in terms of daily exposure at milligrams per kilogram of bodyweight a day. This may seem a low level, but in the 21st century, it's actually high. New advancements unravelling how our genes work, how human biology functions at the intracellular (or biologically relevant) level; and how the chemistry of our body functions – has resulted in the knowledge that chemicals can adversely harm the human body at levels at parts per billion and parts per trillion. Critically, it is time to sweep aside dose-response dogma and understand that hormones, (the endocrine system) can respond to chemical influences in a non-linear fashion. Extremely delicate – environmentally relevant – levels of exposure can be now demonstrated to harm us while exposure at intermediate levels may cause no harm.
Redefine Lifetime. Good science must understand low dose exposure from pre-conception through to the equivalent of an 80 or 90 year old. Today’s protocols consider a lifetime as equivalent to a 60 year old, and developmental studies do not dose in the critically important first trimester.
Who chooses? Remove industry responsibility for selecting studies for assessment. Only risk assessment agencies should have responsibility for conducting a literature review and selecting studies.
Restrict bias and conflicts of interest. The role of government agencies when undertaking risk assessment of hazardous substances, including pesticides, is not to 'work with industry.' Close relationships with industry have placed regulatory agencies in positions where decisions have not been made in the public interest. The role of risk assessment agencies is to assess available published scientific studies for safety in order to prevent adverse harm to public and environment from the same chemical mixtures they are approving or re-registering.
Over the last 30 years pesticide corporations have developed successful 'extension strategies' to maintain and increase sales. Build business. This is how corporations should work. The result of this, is that today, pesticides like Roundup can be sprayed ON our food. Not just on our soil. Not just on our weeds. On our food.
The rights of corporate entities to hide data in the form of a confidentiality agreement, appears to take precedence over the infant and childs' right to safe risk assessment.
When pesticides are sprayed on our staple foods, wheat, oats, rye, corn, animal feed, soy, canola and other oilseed crops, the amount of pesticides in the body cumulatively increases.
The international pesticide toxicity assessment agencies - US Environmental Protection Agency, the World Health Organisation and the European Commission - declare permitted pesticide exposure levels (for example glyphosate) - how much the population can tolerate every day for the rest of our lives. These agencies are gatekeepers. Governments confer with these agencies to approve of new pesticides or to raise residue levels.
These agencies have enormous influence over government policy. Yet data used to arrive at permitted exposure levels is directly selected by the 'registrant' or 'sponsor'. The same industry that directly depends on a favourable result to ensure the product can be marketed.
RITE : Requirement for Independent Toxicity Evaluations.
10 demands for change in the processes and methods used to assess pesticides for toxicity.
These 10 demands, or principles have been developed to remove the opacity, the inconsistencies, outdated 20th century scientific dogma and conflicts of interest within the existing assessment institutions - the European Commission (and within the EC, the RMS & EFSA), World Health Organisation and the US Environmental Protection Agency.
Current controversy and indecision in risk assessment for glyphosate is a symptom of a greater problem that is degrading trust in government and it's ability to make decisions in the public interest. The public and environment has lot more to be concerned about than just the revolving door.
The public are witnessing profound institutional failure.
Where is the endocrine research concerning the full formulation? The thyroid research?
There are massive data gaps.
Regard the examples of the original research - direct quotes from the source, the original studies held with the EPA, WHO and European Commission.
These are the studies that declare the safe levels of pesticides. And look at how much they dismiss, excuse or downplay, the toxic effects of pesticides.
The corporations that supply these studies are the same corporations that market the chemical formulations - a profound conflict of interest.