ENVIRONMENTAL RISK ASSESSMENT

History of the Act◦ The primary purpose of TSCA is to regulate

chemical substances and mixtures It does so by regulating both the distribution of

existing chemicals and the manufacture of new chemicals based on their risks to health and the environment

The scope of the term “new chemical substances and mixtures” is defined in the statute and in EPA’s regulations

TSCA seeks to control hazardous inputs into commerce and industry rather than regulating by-products from manufacturing processes

◦ The TSCA Inventory Under TSCA any person who manufactures,

processes or imports a new chemical substance or mixture for commercial purposes must submit a “notice of intent” (known as a Premanufacture Notice or PMN) to the EPA at least 90 days before they begin manufacturing or processing

The person must submit test data for the substance

The EPA subsequently determines if the new chemical or mixture presents an unreasonable risk to health and environment or if testing on the new chemical must be performed

The EPA’s initial inventory was compiled from information submitted by chemical manufacturers

◦ The original inventory is periodically updated to add new chemicals for which PMNs are filed

◦ There are currently over 75,000 chemicals on the database

Premanufacture Notices (PMNs)◦ If a company plans to import, manufacture or

process a new chemical substance, it must give the EPA at least 90 days’ notice Before a company can give notice, it must decide

whether its proposed substance is in fact “new”

◦ The EPA takes action to control potential risks to health or the environment on approximately 10% of the PMNs submitted

◦ Only 2-3% of these currently undergo a more stringent standard review

◦ TSCA regulations exempt from PMN requirements “substances manufactured or imported only in small quantities solely for research and development” The regulations also exempt substances

manufactured or imported for test-marketing and for export

Also exempt are certain by-products, impurities formed ancillary to a chemical reaction or production process and certain polymers

EPA Review of Premanufacture Notices◦ Once the EPA receives a PMN, the Agency

publishes a notice in the Federal Register◦ When the PMN is complete the EPA has 90 days

(in some circumstances, 180 days) to decide whether to prohibit or regulate manufacture of the new chemical

◦ The EPA reviews PMNs in six stages. These stages include: prenotice communication, process start-up, initial

review, detailed review, regulatory response, and closeout.

◦ If the EPA takes no action on the notice within 90 days, the manufacturer may begin production -- the manufacturer must supply the EPA with further notice that manufacture will commence

◦ At that point the EPA adds the chemical to the TSCA Inventory

TSCA Testing Provisions◦ The EPA can require a manufacturer to test its

chemical if the substance may pose an unreasonable risk or if potential exposure to humans and the environment is substantial

◦ If the EPA requires testing, it must devise a test rule

Significant New Use Rules (SNURs)◦ Under TSCA EPA has authority to issue a

Significant New Use Rule or SNUR if the EPA determines that a use of a chemical substance is a significant new use Once a SNUR is issued, a PMN is required for the

specified new uses of the existing chemical

Regulation of Unreasonable Risk◦ If the EPA decides that a chemical presents an

unreasonable risk, it can do a variety of things including:

Completely prohibit manufacture Prohibit or limit certain use Prescribe quantity and concentration limits in

manufacture Specify quality control measures that must be used by

the manufacturer or processor Require tests that are reasonable and necessary to

assure compliance with regulations issued under § 6 Establish recordkeeping requirements Control disposal Impose labeling and other public disclosure

requirements

Qualitative and quantitative valuation of environmental status

ERA is is comprised of: 1. human health risk assessment; 2. ecological risk assessment.

to learn about the risks to reduce the risk

Probability of frequency of events causing one or more immediate fatalities.

Chance of death for an individual within a specified population in each year.

Number of deaths from lifetime exposure. Loss of life expectancy considers the age

at which death occurs. Deaths per tone of product, or per facility.

Risk analysis and assessment: identification of hazards to people and the environment, the determination of the probability of occurrence of these hazards, and the magnitude of the events.

Risk limits - entails defining the acceptability of the risk, which can be classified as acceptable or in need of reduction.

Risk reduction: design and implementation of risk-reducing measures and controls.

hazard identification; dose-response assessment; exposure assessment; risk characterization.

Involves:

Determines the likelihood of the occurrence/non-occurrence of adverse ecological effects as a result of exposure to hazard

chemicals toxic to humans, animals, and plants; materials that are highly flammable or explosive; mechanical equipment, the failure of which would

endanger persons and property; structural failure (e.g., dam or containment vessel); natural disasters that exacerbate technological

hazards; ecosystem damage (e.g., soil erosion).

Regulation of PCBs under TSCA◦ Polychlorinated Biphenyls (PCBs) are a group of

highly stable chemicals that achieved widespread industrial use by the time of TSCA’s enactment

◦ PCBs are synthetic chemicals that fall within the group known as chlorinated hydrocarbons

◦ PCBs were specifically included in the TSCA legislation due to growing concern about their environmental effects and due to evidence that PCBs are highly toxic in animals

◦ Tests on laboratory animals showed that PCBs could cause cancers, tumors, birth defects and reproductive failures

◦ The EPA issued regulations on use and retirement of PCB-containing transformers in or near commercial buildings

◦ The Agency also regulates the unintended by-product manufacture of PCBs

◦ The PCB regulations also include certain recordkeeping requirements

Regulation of Asbestos under TSCA◦ In 1989 the EPA issued a final rule under TSCA to

phase out the use of asbestos in commercial products

◦ The asbestos rule was designed to ban the use of asbestos in new products by 1997

Section 8(e) requires manufacturers, importers, processors and distributors who obtain information “which reasonably supports the conclusion that [a] substance or mixture presents a substantial risk of injury to health or the environment” to inform the EPA immediately

Section 8(c) requires the manufacturer and processors of chemical substances to “maintain records of significant adverse reactions to health or the environment … alleged to have been caused by the substance or mixture”

Enforcement and Penalties under TSCA◦ TSCA allows EPA to inspect any facility where

chemical substances are manufactured, processed, or stored

◦ TSCA allows the EPA to pursue civil penalties of up to $25,000 per day for each violation of the statute

◦ The Agency can also seek criminal fines of up to $25,000 per day and imprisonment of up to one year