Risks unreasonable

In choosing among these regulatory measures. Section 6(a) directs EPA to restrict the chemical only to the extent necessary to protect adequately against [the] risk it poses and to impose the least burdensome requirements. This emphasis on minimizing the burdens of regulation is also reflected in Section 2(b)(3) of TSCA, under which EPA must exercise its authority in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation.  

Even where EPA seeks to impose labeling requirements, moreover, the Agency has the burden of demonstrating that the chemical or chemical class it seeks to regulate is capable of adverse human health or environmental effects. Under Section 6(a), before EPA can invoke any of the Section s regulatory mechanisms, including labeling requirements, it must determine that there is a reasonable basis to conclude that the chemical presents or will present an unreasonable risk of injury to health or the environment. 

While TSCA does not specifically define the term unreasonahle risk, some guidance on its meaning is provided by Section 6(c). Under this provision, EPA must consider, and publish a statement with respect to, four factors before promulgating a rule under Section 6(a)  

EPA s findings on these issues must, under Section 19(c) of TSCA, be supported by substantial evidence in the rulemaking record. .. taken as a whole.  

The balancing process required by Section 6(c) suggests that the unreasonableness of a risk is to be judged in terms of the regulatory action by which EPA proposes to control that risk. If the rule s adverse economic consequences will be substantial but the chemical s potential for health or environment harm will be small, EPA could properly conclude that the risk associated with the chemical is reasonable. On the other hand, where the proposed rule would not materially reduce the chemical s benefits but would prevent serious 

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As part of TSCA, EPA can require the testing of any chemical if there is the possibiUty of an unreasonable risk to health or environment or if there is significant human or environmental exposure. If the substance poses an unreasonable risk, EPA can prohibit the manufacture, processing, or distribution of the substance limit the amount of the substance that can be manufactured, processed, or distributed prohibit a particular use for the substance limit the concentration of the substance during manufacture, processing, or distribution regulate disposal methods for the substance and require manufacturers to maintain records of process and to conduct tests to assure compliance with EPA rules. 

CIBA, Mtra fne Concerns Poses No Unreasonable Risk, OGA-560-00180-A, 1994. 

Regulation. Dental implants are regulated by the Food and Dmg Administration. AH dental implants faH iato the FDA class III which covers devices that are life sustaioiag, life supportiag, or are implanted iato the body and have the potential to cause unreasonable risk, illness, or iajury. Devices ia class III are requited to have appHcatioas for premarket approval (315). There are 15 to 20 companies that have FDA marketing clearance for specific dental implants, based on substantial equivalency to implants marketed prior to 1976, and approximately one third of these companies are foreign. Marketing clearance is not the same as premarket approval. 

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

Any substance or material in a quantity or form which pxjses an unreasonable risk to health, safety and property when transported in commerce. 

CPSA is a significant consumer safety law. It is part of U.S. legislative law and augments the common law and case of product liability. Purpose of the law is (1) to protect the public against unreasonable risks of injury... 

Most of the provisions of the Toxic Substances Control Act (TSCA) of 1976 (PL 94-469) rely in some way on risk assessment of chemicals. Under the reporting requirements of the statute, any manufacturer, processor, or distributor of a chemical for commercial purposes must inform the EPA immediately after discovering any information which "reasonably supports the conclusion" that a chemical substance or mixture "presents a substantial risk of injury to health or to the environment" unless the EPA Administrator has been adequately informed already. EPA is mandated to establish regulations for testing new or existing substances when it is determined that there is not enough health or environmental information, that testing is necessary to develop such information and that the chemical or mixture "may present an unreasonable risk of injury to health or the environment."... 

Products containing ephedra were used extensively by the American public for weight loss and to enhance athletic performance. Ephedra, a stimulant similar to amphetamine, increases blood pressure and heart rate after only one dose, significantly increasing a person s risk of heart attack, stroke, and death. Because ephedra is a dietary supplement, the FDA did not review its safety or efficacy before it became available to the American public. According to law, the FDA could only prohibit the sale of the dietary supplement if it was proven to present a significant or unreasonable risk of injury. 

In February 2004, the FDA withdrew ephedra, one of the most popular dietary supplements, from the market because it finally had enough information to prove that ephedra presented an unreasonable risk of illness or injury under the conditions of use recommended on the product labeling. This withdrawal did not happen until many people suffered from the terrible potential side effects of this supplement (see Chapter 4). 

Coming to grips with death was a turning point for me. During my first year of having MCS, when my fear of death was so intense, I made peace with the idea that I might not live. It has given me more freedom to take risks when necessary, but not unreasonable risks. 

The Office of Toxic Substances is devoting substantial resources to issuing exemptions to PMN requirements which should still further reduce the regulatory burden. Naturally, these exemptions will cover only those new chemicals which are expected to pose no unreasonable risk to health or the environment. As you heard this morning from David Zoll of CMA, we are approaching this... 

Mr. Don Clay, Director of the Office of Toxic Substances, discussed the premanufacture review procedures and experience with PMNs to date at a meeting of the Organization for Economic Cooperation on Development (OECD) Chemicals Forum in December, (10). He noted that EPA s chemistry, toxicology, and exposure assessment teams normally complete their preliminary evaluation within a week of receipt of a PMN, and, that preliminary assessment eliminates about 50 percent of the substances as chemicals of low concern. They then proceed to structure activity analysis and reasonable worst case assumptions to assess unreasonable risk or the need for more data. 

The Chemical Manufacturers Association (CMA) had reached similar conclusions about a year ago and filed a petition with EPA suggesting that there was a strong case to be made for exemptive relief under Section 5 (h)(4) of TSCA for many polymers, site-limited intermediates, and chemicals produced in volumes of less than 25,000 pounds per year. (An examination of the effect of PMN costs at various prices and levels of production reveals that the PMN cost, as a percentage of total cost per pound of product, generally rises most rapidly as output falls below 25,000 pounds. See the Appendix for a more detailed discussion.) It is CMA s firm belief that exemption could be granted in terms that would operate to assure "no unreasonable risk" to the public in terms of either health or the environment. 

Most polymers are inherently non-toxic and can be sufficiently defined to present no unreasonable risk. Site-limited intermediates have limited exposure potential by definition which together with chronic hazard control language will present no unreasonable risk but will result in real economic savings. 

A 25,000-pound annual production volume exemption is also a rational point at which to establish an exemption economically. Such an exemption would sharply reduce the economic impact of PMN requirements while protecting the public from unreasonable risk. 

TSCA "Unreasonable Risk" Regulations, and Other Restrictions. During the three years that companies have been submitting PMN s to EPA, the Agency has developed a number of means for informally regulating the production and use of certain new chemicals. In addition, 5(f) authorizes EPA to initiate more formal regulatory actions, primarily involving lawsuits. 

In addition to these informal means for regulating, 5(f) authorizes EPA to seek restrictions upon the production, distribution, use, and disposal of new substances that "present or will present an unreasonable risk of injury to health or the environment. To ban a new chemical outright, the Agency must obtain an injunction from a U.S. district court. Any other restrictions... 

Second, EPA could issue rules under S 8(a) to require periodic reports concerning the commercial development of certain new substances once they enter production. Unlike SNUR s, S 8(a) requirements would not prevent companies from continuing their production and marketing activities. Rather, EPA would review information contained in the 8(a) reports, and then could pursue control actions under its other TSCA authorities for regulating existing chemicals (i.e. 4 test rules, or 6(a) "unreasonable risk" regulat ions). 

The goal of the Toxic Substances Control Act (TSCA) is to provide authority to regulate chemical substances which present an unreasonable risk of injury to health or the environment. An important feature of TSCA requires the administrator of the Environmental Protection Agency (EPA) to examine such data on existing chemicals and, when it is insufficient, to direct industry to conduct tests. 

So, after 6 years of debate, TSCA was born. This was an important six years. Many of the environmental laws of our country were enacted during the 1960 s and early 70 s. TSCA was to be the "cap" on all of the laws - filling all the gaps that existed between the previous laws. It was also designed to put in place, a law to regulate all chemicals in commerce which may present an unreasonable risk in any part of the chemical s life cycle. Any part of the life cycle can be regulated from R D through production, distribution and disposal. 

So in TSCA, we have a "balancing-type law" wherein the Administrator is required to consider not just the risks associated with a chemical, but also whether it is an unreasonable risk in light of the benefits associated with the chemical. For the Administrator to regulate a chemical substance or mixture under Section 6 of TSCA, the law requires that "the Administrator shall consider... 

The basic thrust of TSCA is to control unreasonable risks, not all risks — but unreasonable risks. 

Section 6 - authorizes the EPA upon determination of an unreasonable risk to, by rule, ban the chemical, prohibit or limit certain uses or require labeling. 

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