Guide TSCAs Impact on Society and Chemical Industry

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The EPA review process by statute takes no less than 90 days but can take considerably longer. Once the chemical is commercialized subject to a consent order, the notifier is legally required to observe the terms and conditions in the consent order. Whether a biobased chemical is new or existing is a question that needs to be known well in advance of any plans for commercial activities. If an Inventory listing for the chemical s can be established, the PMN hurdle as a new chemical can be avoided. If one or more of the chemicals is subject to TSCA new chemical notification, this point needs to be recognized and addressed early.

When EPA targets a chemical for regulation, this will result in unplanned delays, potentially lasting for months to years, resulting in a barrier to commercialization. Given the origins of the Inventory with its prevalence of petroleum-based substances, a number of anomalous situations arise. This can lead to a disproportionate amount of regulatory scrutiny at the point of commercial introduction when these new, presumptively greener chemicals are attempting to break into the market and compete with established nonrenewable chemicals that, as Inventory-listed substances, escape such regulatory scrutiny under TSCA.

Emphasizing the benefits of a biobased new chemical is important. Know the TSCA requirements, understand the regulatory responsibilities, and be prepared to meet both the requirements and the responsibilities as a part of a business development plan for the biobased chemical. Recognize and understand the importance of how a chemical is named and identified and how that can affect new chemical responsibilities. It is important to understand the relevance of chemical nomenclature and naming conventions to the manufacturing process.

If EPA is likely to impose testing requirements on a biobased new chemical, consider the benefits of either doing the testing in advance of the notification or, if future commercialization plans involve additional structurally similar new chemicals, whether it might make sense to develop a testing strategy that would encompass and account for the range of new chemicals likely to be introduced.

TSCA and the regulation of renewable chemicals

If other firms are known to be active in this area of new chemical development, there might be significant cost saving and advocacy opportunities for organizing consortia to share the costs and responsibility of testing. Work with EPA. Advocate, Advocate, Advocate. As a final thought, advocate the benefits of a biobased new chemical. This should involve careful preparation of the points that can be made on the optional Pollution Prevention section of the PMN notice.

Beyond that, there may be value in recognizing and advocating the bigger-picture policy benefits of biobased chemicals to ensure that the EPA new chemical reviewers are aware of and appropriately consider and value those aspects. While EPA at the higher management levels is likely aware of US government policy drivers such as the recently announced National Bioeconomy Blueprint [6] , this awareness may or may not have reached the scientists and other career EPA staff levels actually reviewing PMN notifications.

Lynn L. Charles M. Over his 32 year career at EPA, he gained broad and deep experience in chemical notification, assessment, and management issues as a senior executive, mid-level manager, and technical assessor. For instance, the European parliament implemented a successful comprehensive reform of REACH by applying the "No data, no market" rule to pressure chemical manufacturers to submit safety data for both new and existing chemicals produced in or exported to Europe. The group is calling for greater oversight and reporting of health hazards of chemicals contained in everyday products.

TSCA can promote environmental justice in communities where minorities and low-income residents disproportionately bear great exposure to toxic chemicals increasing their risk to suffer from "chronic diseases and conditions such as prostate cancer, learning disabilities, asthma, infertility, and obesity. Communities from minority groups are disproportionately affected by "environmental threats from toxic contamination, locally unwanted land use LULUs to unsafe and substandard housing and natural-resource extractions" cannot wait for years until bureaucratic processes demonstrate their health has been at risk from living under these conditions.

Environmental disparities is a prevalent issue for low income-people as they become trapped in "housing discrimination" [58] living in polluted neighborhoods unable to relocate to a nicer area. Environmental justice groups can engage the community to impact local state and federal policy. TSCA regulation can protect public health by "limiting the market for hazardous chemicals and promote safe chemical production.

The elderly are vulnerable from exposure to chemicals that may impair their weak immune system, and cause heart disease among other health issues from interactions with medication. Children are vulnerable to the health impacts of environmental injustice because their immune system is immature and they cannot handle the amount of chemicals in relation to the size of their body. To protect vulnerable groups the federal, state and local government could implement better policy to protect them from the increasing number of chemical exposure happening in daily basis.

Children are more susceptible to develop patterns of illness with longtime effect in their health for which chemical exposure can be contributing pediatric disease. The main health problems associated with environmental chemical pollutants are asthma, lead poisoning and obesity. Therefore, "information on potential toxicity" can help parents to make better decisions about the products they purchase for the use of the children.

The Chemical Industry and Pollution

Information about the toxicity is only available for about "two-thirds of the high production volume HPV chemicals. For instance, in , the state of Maine implemented the Kid-Safe Act to protect children from exposure to lead in toys "and bisphenol A better known as BPA in baby bottles" [50] [65] In January , the Center for Science in the Public Interest released a report entitled Seeing Red - Time for Action on Food Dyes which criticized the continued use of artificial food coloring in the United States.

The report urges the Food and Drug Administration to take action to ban or curtail the use of such dyes. Pregnant women exposure to toxic chemicals in daily basis "can impact the reproductive and developmental health" during critical windows of development, this may lead to a higher risk for birth defects and childhood illnesses and "disability across the entire span of human life. Eating healthy food can reduce the impact of toxic chemicals, for instance consuming organic food. Mothers who are breastfeeding can expose their child to toxic chemicals in their milk.

When the diet of children is modified from "conventional to organic food, the levels of pesticides in their bodies decline," but low-income families have to prioritize their needs and buying organic food may not be possible because of a budget constraint [69] [70]. Occupational exposure to chemicals can happen through direct skin contact, inhalation, ingestion or eye contact.

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People working under certain occupations are more exposed to toxic chemicals that can have a negative longtime effect in their health. If the rate of exposure exceeds the capacity of the body to detoxify and eliminate them, it can accumulate in the body and potentially harm it. Male and female fertility can be compromised from exposure to toxic chemicals. Communities near agricultural farms may be at higher risk for exposure to pesticides. Farm workers are exposed to pesticide-related illness from the use of chemicals that can have delayed health effect such as cancer and reproductive dysfunction.

Among the chemicals farmers get exposed, Dibromochloropropane DBCP , a soil fumigant used to control nematodes can lead to "testicular toxicity and human reproductive dysfunction. Corporations can show social responsibility by removing products from the market and introducing similar alternatives that can benefit vulnerable groups. It included new requirements on early detection technology and plans that protect against drinking water contamination. Lautenberg Chemical Safety for the 21st Century Act". In June the House passed H. Congress passed a reconciled version of the reform bill, the Frank R.

On Wednesday, June 22, , President Barack Obama signed the bill into law, remarking that "even in the current polarized political process here in Washington, things can work. Developing a sufficient information is important for risk management and for prevention from potential hazardous substances. Under REACH and European Chemicals Agency regulations, chemical companies are required to provide quantity of chemicals and depending on the quantity, the companies need to further develop data on human health and environment for both existing and new chemicals. Under the TSCA, the EPA needs to collect data to assess the potential risks of chemicals and requires developing substantial evidence in order to withstand judicial review and policy making.


REACH requires chemical manufacturers, importers, and downstream users to ensure that the chemicals do not negatively affect human health or the environment and they should request authorization to produce or import hazardous chemicals and the companies to search for safer alternatives. In order to restrict, REACH must demonstrate the chemical's risk to human health or the environment that needs to be addressed at the community wide level and identify the most appropriate set of risk reduction measures and safer substitutes. Information disclosure gives an opportunity to the public to immediately react and avoid exposure to potential chemical hazards and risks for example by changing consumer behavior or applying pressure on the chemical firms etc.

"Performance Matters" by Emery Berger

In the other hand, information disclosure also can motivate firms to search for safer alternatives. However, the EPA can only disclose confidential business information when it determines such disclosure is necessary to protect human health or the environment from an unreasonable risk. Similar to TSCA, REACH mandates chemical companies to disclosure of health and safety information that allows public to have an access to the basic chemical information, including brief profiles of hazardous properties, authorized uses, and risk management measures. TSCA does not require chemical companies to perform risk assessments on new chemicals.

However, it allows companies to perform voluntary risk assessments on their new chemicals. For existing chemicals, companies are required to notify the EPA immediately of new unpublished information on chemicals that have potential risks but are not required to conduct risk assessments.

REACH requires chemical companies to submit their registration yearly with the information on the overall quantity of production or importing of a chemical in metric tons per year in a technical dossier and immediately report if any significant changes occur in the quantity. TSCA: Chemical companies must provide the EPA a reasonable third year estimate for their new chemicals in total production volume at the time a Premanufacture Notices is submitted. For every 5 years, the existing chemicals on the TSCA inventory and produced at quantities of 25, pounds or more must be reported.

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