Assignment #1: Toxicity and Exposure
Critical Data Analysis in Regulation
Mohammad Monwar Hossain
October 5, 2018
The purpose of this article by Lyndon (2016) is to explore how laws effect the production and dissemination of information related to chemical exposer and toxicity and increases data quality for the goal reducing chemical harm and increasing chemical safety. This article covers seven parts: uses of toxicity and exposure data; market's failure to produce toxicity and exposure data; the effect the law has on information production; right-to-know laws; expand and improve data production with funding and planning on specific model and national contingency plan; toxicity data collection and management using accessibility principles; and toxics control and the confusion in the existing statutory scheme (Lyndon, 2016).
The Uses of Toxicity and Exposure Data
Toxicity and exposure data are use in health risk assessments because scientist use statistical estimates to determine the likelihood between a chemical and a disease. This data can also be used to diagnoses and treat patients, in research, in planning and government regulation, industrial hygiene, and chemical product development and production (Lyndon, 2016). Toxicity and exposure data can also be used to predict adverse health effect in humanins by performing hazard assessments (Lyndon, 2016). It is difficult to plan or defend against toxicity and limit and exposure to chemical agents if there is no system in place to collect this data, link databases and record incidences to analyze it. Another use for this type of data is to be able to identify the nature of chemical exposure, which can be categorized into attributes and provide clarity and clearer linkages between chemicals and the effects on humans and the environment. Thus, there are scientific, medical, and economic uses of this data.
Lack of Data and the Effects on the Market for Chemicals
There is a lack of toxicity and exposure data due to it being a “public good” nature of the information because a public good is shared by everyone (Lyndon, 2016). Since only a few people have a vested interest in developing this “public good”, they will carry the bulk of the risk in investing in this effort and the rest of the people will benefit from this development without putting in the same level of effort. An example of this is research because lot of funds go into research and development with a very low success rate. The one success is shared by everyone. For example, research in asbestos showed that it was carcinogenic, and the knowledge spread and was no longer used to construct buildings. Due to lack of interest, there is lack of research and there for lack of data. Other reasons for lack of data are the expensive cost to do the research, laboratory tests are inexact, and confounding variables affect the research when studying industrial work place settings (Lyndon, 2016). Also, “toxicity and exposure are negative features of chemical products… [and no company wants to] reveal the negative characteristics of their products” (Lyndon, 2016, p. 1813).
This effects the market for chemicals because toxicity levels will affect product quality, which will cause the consumers to be wary of the products and not trust it (Lyndon, 2016). Potential customers do not have the knowledge or expertise to determine high quality products with low toxicity levels from other products that may have high toxicity levels that are numerous, which effects the overall quality of all products (Lyndon, 2016). Without accurate information and research, the public remains ignorant of the true harms of toxicity levels and cannot ask for help to make the right choices (Lyndon, 2016). This is where government regulations come into play to assist the public in making choices that do not harm them be preventing these harms from appearing in the market in the first place. Companies must spend more money to comply with these regulations and the public benefits from this move.
Effect of Law on Information Production
Law discourages information production and distribution of toxicity data because the manufacture has to put on more money to perform the research to prove a closer connection and they don't want to do that because they may be potentially liable (Lyndon, 2016). In the case of court of law, the manufactures do not want information to spread about how to identify causal relationship with respect to chemicals because the negative effects would be protection (Lyndon, 2016). If a chemical is a suspect as a cause, then research has to prove or disprove its role in the crime and get the company to test the product (Lyndon, 2016). The law has helped set standards for human exposure to chemicals through two methods: ex ante regulation, which requires a product burden of proof for safety; ex post regulation, which collects the initial toxicity and exposure information (Lyndon, 2016). There are incentives to do research to reveal increasing uncertainty on suspected toxic chemicals under review (Lyndon, 2016).
Right-to-Know Laws and Polycentric Decision Making in Toxics Control
Right-to-know laws “articulate minimum standards of warning and informed consent
for hazardous chemicals” (Lyndon, 2016, p. 1829). It changed how information on chemicals are presented through disclosing the identity of chemicals and information about chemicals' effects (Lyndon, 2016). This law requires identification of the chemical and to warn worker of the known chemical hazard and the adverse health effect must be communicated (Lyndon, 2016). There are rules for labelling requirements for chemical products and safety in the work place (Lyndon, 2016). For example, Material Data Sheet (MSDS) “contains information about the chemical substance, including its chemical identity, the name used on the container label, its physical and chemical characteristics, health hazards, primary routes of entry or exposure, the regulatory provisions applicable to it, safety precautions, emergency first aid procedures, the date of preparation of the MSDS, and the name, address, and telephone number of the person responsible for preparing it” (Lyndon, 2016, p. 1827). Polycentric decision making can be done by workers because they have access to chemical data through the market, medical, and liability system to make informed choices about their exposure and take preventative measures to reduce toxicity in their work place (Lyndon, 2016).
The Toxicity Data Collection and Management System Proposed
National superfund program came out to clean up hazardous waste and this program is a combination of three elements: plan for action by the government; source of funding to link the costs of cleanup; and open participation with financial support (Lyndon, 2016). Superfund program is instructive as a model program to do research against a specific action plan or goal, standardizing research, reimbursement to those that are affected by the research study's outcome, national study plan and toxicology research agenda and grant programs, etc. “investment would come at the beginning of the production process, when information can be useful in many environmental and health dimensions” (Lyndon, 2016, p. 1838 )
Main benefit is “providing a better basis for product screening in the marketplace and by removing the pall cast over safe products by uncertainty about toxicity” (Lyndon, 2016, p. 1838).
By providing a basis product screening and removing the pall cast over safe product research super study would be more beneficial and easier to administer than the superfund program (Lyndon, 2016). “A super study program could be designed to produce less uncertainty as to liability for study costs” (Lyndon, 2016, p. 1840). This study program could support the research efforts and manufacturing framework (Lyndon, 2016). Improve research interest outside of government regulation and company's interests to encourage more research and more accurately, and substitute toxic chemicals with known lesser or alternative chemicals that do little to no harm to humans or the environment.
Functions of Information in Toxics Control and Confusion in the Existing Statutory Scheme
To serve environmental, occupational, and public health needs toxicity data information should be available in public, knowledge of toxicity is a public good that everyone should benefit from because it affects human health (Lyndon, 2016). Toxicology is a resource where knowledge is power and benefits from collaborative efforts and open communication so that it's accessible to all. Development of a uniform chemical coding system, directory of chemical information, compatibility with other systems and formats, surveillance system to collect information and incident reports will help to data access in the local public. Also, dissemination of knowledge in different formats (e.g., posters, presentations, symbols) will make it easier.
There are lots of problems of trade secrecy of information because companies don't want to disclose certain information to their competitors because of cconfidentiality agreements which make hard to get around. The databases being developed under right-to-know laws, which will make it easier for non-business people to disclose information for public safety (Lyndon, 2016). “Laws may require five types of actions with respect to chemicals: (1) mere disclosure of the identity of the chemical agent to which humans are exposed; (2) warning of its known hazards; (3) testing to determine hazards; (4) curtailing the exposure by reducing the discharge of the chemical; and (5) compensation for any injuries proved to be caused by chemical exposure” (Lyndon, 2016, p. 1856). For public safety each entails will affect differently and different costs for individual exposure (Lyndon, 2016).
o How to deal with warning and testing standards, what is the legal significance of these chemical research findings, how to get exposure data if you need to prove toxicity of the substance before doing research on exposures?
o It may be difficult to determine which chemicals should be studied to determine toxicity levels and may miss other chemicals that have not been linked to current exposure incidences.
Some chemical substances are harmful for human and animals, if these hazardous chemicals are present in the environment human body can accumulate this chemical substance, which rise to problems such as allergies. This chemical substance will affect the environment which is a “public good”. The uncertainty of chemical toxicity due to lack of information had decreased interest in research into chemical safety and decreased private production of toxicity information when marketing chemicals so it affects the safety of the public. The lack of quality toxicity and exposure data has led to regulations and science policies that limit innovation in this area of research due to the way these laws have developed.
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