experimental use. The Society recognizes the exemption in Section 5(k) given to chemical substances for test marketing purposes, upon a showing of no unreasonable risk, or otherwise as the Administrator considers appropriate. However, we would only emphasize the importance to innovation that research samples distributed for testing and development purposes be exempt. We suggest the following addition to Section 3 (12), ". . . in commercial amounts for commercial purposes." Since temporary or experimental use permits issued during data collection in the case of pesticides have been important because of the lengthy development time necessary to satisfy those criteria, consideration might be given to doing so here.

Sharing the Costs of Testing

The Society supports the principle that a manufacturer should be required to pre-test new materials for hazards to man and the environment before their introduction into the marketplace, if the requirements for testing utilize scientific resources effectively. However, despite the best application of limited resources, the time and expense involved in testing will still be considerable, and unless adequate provision is made to protect the "pioneer," there will be little or no testing of anything except patentable compounds or products. The Society believes that protection of the "pioneer" is essential. A number of potentially useful products have never been made available to commerce because of their lack of patent protection.

To ensure that compounds other than only patentable ones are tested, the Society has recommended previously that exclusive use certificates valid for a definite period of time be issued to the original applicant, or alternatively, that subsequent applicants be required to share the costs of testing. We are pleased to note that Section 4 (c) provides for the sharing of testing costs. However, we believe the provision is not clear with regard to new competitors entering the market after a cost-sharing arrangement has been made.

Independent Panels of Qualified Experts

To deal with inevitable differences of opinion between applicants and the Government, the American Chemical Society recommends provision be made in the law for the participation of panels of qualified scientific experts, independent of parties involved, in the appeal process. There should also be provision for eventual appeal to the courts. Independent experts could also be extremely useful in establishing scientific procedures for hazard evaluation. The Society would hope that participation of this type could provide a basis for sound scientific judgment, uninfluenced by either public or political pressure.

Availability of Chemical Information

The American Chemical Society believes that the quality of scientific and technical information that would be available to the Administrator of the Environmental Protection Agency is another important consideration. Access to data on the toxicological, carcinogenic, mutagenic, and teratogenic properties of such substances is crucial to the evaluation of the hazards posed by these substances. In addition, information which might provide insight into other properties of these materials-such as decomposition patterns, byproducts, possible reaction with other compounds prevalent in the environment, etc.-will necessarily be part of the evaluation of hazards posed. As a major publisher of primary literature and of secondary services-indexing and abstracting-in the discipline of chemistry, the Society is willing to cooperate with the Environmental Protection Agency and any other federal agencies concerned with informationhandling to ensure the comprehensive compilation, storage, and expeditious access to chemical information.

Confidentiality of Information

The Society believes that an essential safeguard to proprietary rights is the confidentiality of information supplied to the Administrator. Although Section 14 covers this necessity to some degree, additional requirements to ensure confidentiality might be added, particularly if qualified panels of experts are involved in administering the Act.

Relationship to Federal, State, and Local Laws

The Society believes that the principal focus of this Act, in its relationship to other federal laws, should be to provide authority in those areas where other laws provide it only partially or not at all. The specific aspects of Section 9, concerning other federal laws, appear reasonable and balanced.

However, with due regard for the advantages of uniformity, the Society views with some concern the pre-emptive nature of Section 19, despite the possible exemption of local jurisdictions under Section 19(b). The United States is not environmentally homogeneous, and substances tolerable in one part of the country may be damaging in other parts. It might be preferable to provide explicitly for the delegation of enforcement to states and other local jurisdictions that demonstrate, to the satisfaction of the Administrator, tha their own laws and regulations will accomplish the purposes of the Act, thereby avoiding the need for such a large federal inspectorate.

Authorization of Appropriations

Section 26 authorizes the appropriation of $11,100,000 for the implementation of the Act, a reasonable budget for the early stages of such a new program. However, the Society is aware of the recent history of the Environmental Protection Agency where a number of new programs have been initiated within that Agency without authorization to increase the number of personnel. The result has been a continuous reshuffling of staff with the inevitable deterioration of morale and fragmentation of work. Programs of this sort have been necessarily contracted out, which is not wrong in itself, but there has frequently been insufficient manpower even to monitor those contracts effectively.

If the work required by this Act is to be carried out in the manner prescribed, there will apparently need to be an explicit authorization for enough additional employees to do the work. The Society believes that this increased staff should be highly trained technically, and the Administrator shoud be able to designate the appropriate number of new employees required.

Summary

In summary, the American Chemical Society strongly supports the need for controlling toxic substances in our environment. The authority vested in the Administrator is substantial. We believe that careful exercise of these powers, based on the best scientific judgment, will allow substances to be introduced into commerce without the threat of significant hazard to human health or the environment and without undue interference to innovation. In compliance with its National Charter responsibilities, the Society would be pleased to identify experts or otherwise cooperate in the implementation of legislation to regulate toxic substances.

STATEMENT OF ENVIRONMENTAL ACTION, WASHINGTON, D.C.

COMMENTS ON TOXIC SUBSTANCES CONTROL LEGISLATION TO THE SUBCOMMITTEE ON CONSUMER PROTECTION AND FINANCE OF THE HOUSE INTERSTATE AND FOREIGN COMMERCE COMMITTEE

Environmental Action appreciates this opportunity to comment on the toxic substances control legislation now before the Subcommittee on Consumer Protection and Finance, H.R. 7229, H.R. 7548, and H.R. 7664. Rather than contribute more data to the abundant supply submitted to the record by various interested parties, this commentary will attempt to highlight some of the main issues which were raised in the course of the recently concluded hearings.

Testimony before the Subcommittee on Consumer Protection and Finance indicated that most witnesses thought some sort of toxic substances control legislation is necessary. Although there is some latent disagreement concerning testing criteria and data development in section 4 of all three bills, no major objections were raised.

Clearly, the most controversial section and the provision which appears to have the most profound impact is section 5. It requires pre-market notification and testing of new chemicals and new uses of old chemicals. (The circumstances of such testing vary, depending upon the bill to which one refers.) The industry position is that the Administrator should have such authority, with the power to prevent manufacture or distribution, only if it can be shown that such new chemical or new use poses an unreasonable hazard to health or the environment. Since most witnesses testified with respect to H.R. 7229 and not the other bills, the failure of that bill to contain a defintion of "unreasonable risk" prevented witnesses from attaching the same meaning to the same terminology. The industry witnesses view unreasonable risk from a cost/benefit standpoint. In other words, from an economic viewpoint, an unreasonable risk is not reached until the

cost of compensating or correcting injury from a hazardous substance exceeds the commercial benefit derived from the use of such substance.

This is a practical business point of view. Environmental witnesses concentrated on the likelihood that an unreasonable risk would be posed; consequently, from the environmentalist viewpoint, section 5 should be formulated to reduce the likelihood of achieving an unreasonable risk before the question of the desirability of acting from a purely economic standpoint is considered. Industry witnesses would only permit the Administrator to act when it became economically advisable to do so. Industry would restrict the Administrator's ability to obtain information concerning a new chemical or use until it was apparent that the consequences arising from the use of a toxic substance were sufficient to demonstrate the existence of an unreasonable risk. He would then act to prevent more dire consequences from taking place. Environmentalists would empower the Administrator to prevent any adverse consequences from taking place, since a risk still exists owing to the inability of the Administrator to consistently ascertain the consequences of introducing a new chemical or use. Requiring the Administrator to show that a new chemcal or use poses an unreasonable risk before he can require information and testing clearly defeats the purpose of preventing the identification and control of toxic substances before they become widely disseminated in the environment. In all too many cases, the Administrator could only demonstrate that a new chemical or use was posing an unreasonable risk after distribution and injury had occurred.

Thus, the Subcommittee has a clear choice as to the type of provision and type of toxic substance control scheme it desires to endorse. It can choose a provision and bill which seeks mainly to prevent economic loss, which imprecisely considers intangible benefits to a limited degree. Or it can choose to attach more significance to the occurance of human and environmental damage caused by the use of toxic substances than can be achieved by translating human and environmental damage into economic terms. Environmental Action urges the Subcommittee to give greater recognition to human suffering and often irreparable environmental damage than can be achieved by following the provision recommended by the industry witnesses.

There is another factor to consider. Industry is not being completely forthright in its position regarding measuring the cost/benefit of introducing new chemicals or chemical uses. Industry would allow such introduction to occur before sufficient information could be obtained to adequately assess whether a reasonable risk was being posed. This, of course, increases the cost of prohibiting or restricting such introduction, making it less likely that a cost/benefit measurement will result in an unreasonable risk being found.

Another question that has been raised is whether there will be overlap between toxic substances control legislation and other environmental and occupational safety laws. Current laws are only useful in controlling toxic substances after they have spread in the environment and exposed workers, their families, and the public at large. Enforcement can only take place after the toxic substance can be measured as it occurs in the work and general environment, injury has occurred, and a causal relationship is shown between exposure to measurable amounts of a substance and the incidence of injury. Preventing such hazards before they start is a more effective and, in the long run, cheaper approach to reducing the national health and environmental threat posed by the widespread use of toxic substances. Moreover, Environmental Action submits that the Administrator should not be required to use other legislation before he can utilize toxic substances control authorities. The Administrator should be authorized to choose whatever legislation is the most effective in preventing or eliminating a threat to human health or the environment. Certainly, the Administrator should not be prevented from requiring data development and testing until after he has attempted to use other legislation to eliminate a potential risk, since such data and testing may reveal a potential risk which could not be addressed through the use of existing legislation. If the Subcommittee finds that some limitation in this area is desirable, Environmental Action suggests that such limitation be restricted to actions taken by the Administrator under section 6. In other words, the Administrator would be required to find that the potential risk involved cannot be adequately dealt with under existing law before taking action pursuant to section 6 against a substance already in commercial distribution. This approach would be consistent with the testimony given by labor witnesses which expressed concern that the Occupational Safety and Health Act not be pre-empted by toxic substances control legislation. In addition, the Administrator should be prevented from using two authorities unless such us is clearly justified.

The release of greater numbers of potentially hazardous chemicals into the environment makes one of the principal concepts behind this legislation all the more important that is the concept of prevention. The prevention of environmentally caused disease in this country is critical during this time of vastly increasing health care costs. Members of the Interstate and Foreign Commerce Committee must be abundantly aware of rising health care costs, since important health care legislation is currently before the Committee. The alleged high cost of implementing effective toxic substances control legislation must be balanced against the potential savings which should result in health care costs, as well as the reduction in damage to the environment on which we all depend. As pointed out by the witness from Health Research Group, environmentally induced disease incurs costs of $35 billion annually, all of which is preventable. This legislation can play an important part in such prevention.

As previously noted, the controversy surrounding the cost of toxic substances control legislation involved primarily the provision requiring the performance of tests. Industry witnesses were in an enviable position, since industry alone has the data concerning how many substances are produced annually, the current cost of testing, how many new uses are introduced annually, and the value of such new substances and uses introduced. Only members of industry are able to accurately verify or deny the figures cited by industry witnesses, which is one of the reasons this legislation is before the Subcommittee for consideration; to ensure industry health and safety data is shared with the affected public. Moreover, it is far easier to identify the cost of testing substances and foregoing the use or introduction of such substances than it is to identify the countervailing costs of society associated with the dissemination of toxic substances throughout the environment. Indeed, the causal link between known injury and exposure to toxic substances is difficult to establish. As noted during the testimony, the wide variation between the cost estimates submitted by the Manufacturing Chemists Association (MCA) and those performed by EPA are largely attributable to the much greater number of new chemicals and uses alleged to be introduced annually by MCA. Environmental Action was impressed by the apparent fact that although this drastically higher number of new chemicals and uses may mean higher costs in implementing toxic substances control legislation, it likewise means that the risk to human health and the environment is correspondingly higher than was originally estimated when such legislation was first proposed.

When all the costs of chemical production and introduction, including the social costs, are borne by the consumer only after having first been initially paid by the manufacturer and distributor, Environmental Action fully expects that the industry will exercise greater care in the development, use, and dissemination potentially toxic chemicals.

Although Environmental Action is not in a position to conduct a detailed analysis of the MCA cost estimates, we note that during the discussion of the need to maintain the level of introduction of new chemicals through significantly greater investment in R&D, no mention was made of the likelihood of product longevity increasing, which will increase the value of each chemical produced, allowing chemical producers to maintain income level of capital investment.

Environmental Action also noted with interest that no mention was made of the prospect for technological innovation improving the efficiency and decreasing the cost of testing. Such innovation is frequently cited as our best solution to the problems related to our increasingly scarce resources.

We hope these comments will be useful to the Committee during its consideration of this legislation which, if it adopts the major provision of H.R. 7548, can be a break-through in the area of environmentally caused disease prevention. Environmental Action supports the Committee in its efforts to formulate this legislation and we urge them to act on its as expeditiously as possible.

STATEMENT OF NATIONAL ASSOCIATION OF PRINTING INK MANUFACTURERS

The National Association of Printing Ink Manufacturers (NAPIM) is the trade association representing printing ink makers in the United States. Local affiliate associations are located in Chicago, Los Angeles and New York. International affiliates are located in Australia, Canada, Britain and Venezuela.

Today, printing inks comprise a wide variety of synthetic chemical formulations for coating such surfaces as plastics, foil, boxboard, glass, textiles, metal and, of course, paper of a wide variety of types. Printing ink technology has kept

pace with the printing revolution by providing inks for the various printing processes as they have evolved and become more sophisticated.

As a result of this technology, nearly a million new formulas of printing inks are produced each year in the United States alone using about 2,000 different basic ingredients. Currently, there are an estimated four to five million ink formulations in use.

Our association supports the creation of a regulatory mechanism to assure that chemical substances are adequately tested with respect to their potential effects on health and the environment. Further, we recognize the concerns of the Congress in doing everything necessary to protect the public health and the environment.

However, there are certain problems in this legislation that we would like to discuss further in some detail. One of our concerns is that the essentially harmless mixing of chemical components by mechanical blending and dispersing which comprises the vast majority of printing ink manufacturing in the U.S. will be unduly burdened by this legislation.

I. MIXTURES

We feel the bill introduced by Representative McCollister (H.R. 7664) takes a generally sensible approach in dealing with the protection of the health and the environment. However, Sec. 3(2) of H.R. 7664 would expand the definition of "chemical substance" to include mixtures. In Section 3 (3) of the bill, “mixture" is defined as meaning "any mixture (A) which occurs naturally; or (B) which is produced by an industrial chemical process and which is marketed or used without separation into its constituents."

The House bill (H.R. 5356) in the 93rd Congress contained the same language as is now contained in Section 3(3), and for this reason we have given serious consideration to this wording and its impact on our industry.

There is some question whether "mixtures" which are produced by blending or dispersing through mechanical means, without a chemical reaction taking place, are deemed to be the result of an “industrial chemical process." In our view, this is a physical non-synthetic process and should not be covered under the definition of mixtures in Section 3 (3) of the bill.

This point is very important since the production of inks is based mainly on combinations of pigments, oils, resins and solvents by a process of blending or dispersing.

We have had previous discussions with individuals working in the Toxic Substances section of EPA and they advised us informally in 1974 that the production of printing inks by physical rather than chemical processes would appear to lie outside the intent of the legislation as it was drafted in the 93rd Congress. We would strongly urge that the Committee make it clear that mixtures which are produced by blending, or dispersing through mechanical means, without a chemical reaction taking place, not be included within the definition of "mixtures".

To accomplish this technical amendment, we would suggest that the following language be added at the end of Section 3(3) of H.R. 7664 after the word "constituents"; ", but excluding mixtures formed by mechanical blending and dispersing where no chemical reaction takes place."

A further technical problem has been brought to our attention involving the manufacture of printing inks. A great number of printing ink formations include vegetable oils, linseed oil. etc. to assist the ink in drying by oxidation. Although this "after the fact" oxidation is technically a chemical reaction, it was probably not intended to be covered by the drafters of toxic substances control legislation.

The Senate Staff Working Draft of June 6, 1975, on this legislation appears to have dealt with this problem. We would suggest that the definition of "chemical substance" in Section 3 (2) of H.R. 7664 be changed to conform to the Senate Staff Working Draft by adding the following language at the end of Section 3(2) after the word "mixture": "or category of mixtures specified by the Administrator in his discretion with respect to any provision of this Act. In specifying a mixture or category of mixtures under subparagraph (c), the Administrator shall consider the extent to which actions taken with respect to a mixture or mixtures so specified could be reasonably and as efficiently taken with respect to the component chemical substances which comprise such mixture or mixtures."