The U.S. Consumer Product Safety Commission voted Friday. July 31, to suspend its pending rulemaking procedures and decided instead to issue a statement of policy to require labeling of products containing methylene chloride, a widely used chemical solvent.
Commissioners Anne Graham and Carol G. Dawson who favored the decision indicated that they considered the labeling requirement, to which most manufacturers had already agreed in principle, to be one that could be accomplished more easily through the policy statement and without the prolonged and often complicated and expensive procedures which accompany formal rulemaking.
Methylene chloride has been studied by the CPSC staff for several years to determine whether its use in products such as paint strippers, adhesive removers, spray paints and other commonly used items, were hazardous to consumers.
An Advance Notice of Proposed Rulemaking was issued by the Commission in August, 1986, and its members were considering publication of a final rule. However, by a margin of 2 to 1, the Commission, on the motion of Commissioner Graham and supported by Commissioner Dawson, voted instead for a statement of policy. The Commissioners will specify the exact language of the policy statement later, and it will then be published in the Federal Register.
The purpose of the statement will be to notify manufacturers that provisions of the Federal Hazardous Substances Act require that their products be labeled to indicate that inhalation of methylene chloride vapor has produced cancer in certain laboratory animals, and specify precautions to be taken during use by consumers.
Chairman Terrence Scanlon had earlier moved the adoption of a final rule and cast the dissenting vote against the policy statement approach, because, in his view, the latter could be challenged on procedural as well as substantive grounds. Also, he argued, that the rulemaking procedure would result in more uniform enforcement of the rulemaking requirement and would lend itself more easily to consumer information and education campaigns designed to reduce human exposure to methylene chloride vapor.
NOTE: Editors, statements attached
STATEMENT OF TERRENCE SCANLON, CHAIRMAN
U.S. CONSUMER PRODUCT SAFETY COMMISSION
EXPLAINING HIS MOTION ON METHYLENE CHLORIDE
AT THE CPSC DCM DECISION MEETING
July 31, 1987
The motion I am now offering has one basic purpose -- to facilitate implementation of an already agreed-upon remedy (labeling). One of the great ironies of this whole debate is that there is general agreement on the idea of the chronic hazard labeling for products containing methylene chloride. Furthermore, there is a large degree of agreement on the wording of that label-and yet, for understandable reasons, we are having trouble developing the mechanism that will trigger it.
What I am proposing -- what my motion calls for -- is adoption of a revised version of the rule proposed by the staff on June 12, 1987. Its basic intention is to state the rule, and the rationale for it, in such a way that interested parties will not be inclined to challenge its implementation. To that end, this revised version makes clear that, while a cancer risk warning label will be required on products containing DCM, the risk itself is a-potential risk since methylene chloride hasn't been conclusively determined to be a human carcinogen. In addition, two complicated and potentially confusing sections of the methylene chloride risk assessment have been deleted, namely those dealing with linearity at low dose and the inapplicability of pharmacokinetic modeling to species-to-species extrapolation. Also, characterizations by both the staff of the 'National Coffee Association's study of methylene chloride were excised and a number of other changes have been made. Many of these changes, quite frankly, are directed at reducing either the frequency or intensity with which a position is stated, rather than at the substance of the position itself. The hope is that, by not unnecessarily belaboring the reasons for the action being taken, more people will be willing and able to go along with.
I would hate to see, after all the effort that has gone into the issue of methylene chloride labeling, procedural challenges arise during the course of which no labeling or consumer information is likely to occur. That outcome would benefit no one, least of all potential users of methylene chloride. Therefore, I move adoption of this revised rulemaking notice and urge my colleagues to give it their support.
DISSENTING STATEMENT OF CHAIRMAN TERRENCE SCANLON
U.S. CONSUMER PRODUCT SAFETY COMMISSION
CONCERNING CPSC ACTION ON METHYLENE CHLORIDE
July 31, 1987
Today, the Consumer Product Safety Commission voted 2-l to issue a "Statement of Enforcement Policy" concerning products containing methylene chloride. While I favor labeling these products to indicate there is a potential risk of cancer associated with the inhalation of methylene chloride vapor, I do not believe the enforcement policy approach is the best way to achieve that labeling. A better way would have been the adoption of a mandatory rule designed to reduce the likelihood of procedural challenges that would delay the start of labeling. After studying this issue for over two years, the majority of the CPSC staff has concluded that adoption of a rule would be the best way to protect the public. I share that view; hence my motion on behalf of a mandatory rule.
There are several other considerations that prompted my vote against this enforcement policy. One is that application of such a policy will necessarily be selective rather than uniform. As a consequence, manufacturers, retailers and other interested parties will not be quite as sure of where they stand than they would have been if an FHSA 3(a) rule had been adopted. Also, such an approach does not lend itself so easily to information and education efforts designed-to reduce-human exposure to methylene chloride vapor.
In addition, I feel more consideration should have been given to the legal precedents surrounding the use of enforcement policies by the CPSC. Not only have there been several court decisions, such as Spring Mills Inc. v. CPSC (1977), indicating that the CPSC should use The FHSA 3(a) rulemaking procedure to deal with cases like this, but every time an enforcement policy has been challenged in the courts, the CPSC's position has run into difficulty.
There are instances, of course, where the CPSC has issued enforcement policies that have not been challenged to date. Nitrosamines and consumer products containing asbestos are two that come to mind. Moreover, it is my hope that this enforcement policy will not be challenged either; it would be nice to get on with the labeling to which most everyone has conceptually agreed. However, those who may favor the enforcement policy approach do not speak for everyone who might be impacted by such a policy. Nor do they represent everyone who might view the CPSC's decision as establishing a bad precedent for chronic hazard labeling. As a consequence, I do not believe it can be assumed that this enforcement policy will not be contested. To make such an assumption not only takes too much for granted, but increases the likelihood of label delaying legal challenges based on procedural grounds.
Statement on Methylene Chloride
Anne Graham, Commissioner
July 31, 1987
The Commission's activities regarding methylene chloride clearly fall under the Federal Hazardous Substances Act which automatically places labeling requirements most hazardous household products. Rulemaking under Section 3(a) of the Consumer Product Safety Act (CPSA) is required only when needed to avoid or resolve uncertainty as to whether or not the substance is hazardous.
The information gathered by the Commission over the past four years Including questions recently answered during the Advanced Notice of Proposed Rulemaking (ANPR) leads me to conclude that products containing methylene chloride are hazardous substances which must be so labeled. Thus, I do not believe there is sufficient uncertainty to continue rulemaking. This is a classic example of the positive effects an ANPR can achieve. Further, this case demonstrates that by adhering to proper procedure a problem can be solved during the process.
In this case, rulemaking would be unnecessary, time-consuming, intrusive, and costly. The process would leave the consumer at risk, There is little doubt that rulemaking would put the Commission in an adjudicative hearing process and leave the consumer uninformed for years.
In this instance, an enforcement policy statement is the best solution. The statement can be achieved more expeditiously and provide the consumer with the necessary information about the products and the precautions needed for safe-tie. In sum, the Commission simply needs to enforce the existing law.
If a firm chose to ignore or refused to change its labeling, the Commission could request Federal District Court action. The company could contest the action and any differences in scientific opinion could be resolved. Nonetheless, while this process took place the consumers would still have the benefit of the labeling on all other products containing methylene chloride.
Prior to the initiation of rulemaking, the Commission established a positive dialogue with the chemical industry and consumer groups to develop ways of making consumers aware of the hazards of Ethylene chloride and its proper use. I believe that the development of an enforcement policy statement provides a form to re-establish that dialogue and to focus on taking together again to protect and inform the consumer.
On February 27, 1986, I voted with the majority to initiate a rulemaking proceeding under Section 3(a) of the Federal Hazardous Substances Act (FHSA) dealing with methylene chloride in consumer products. My preference was to adopt a statement of policy, as the Commission has finally done. As an alternative, and since my colleagues did not see the merits of my proposal at that time, I supported issuing an Advance Notice of Proposed Rulemaking as the next best way of addressing this matter. In my three years at the commission, I have frequently made reference to my philosophy of using the "least drastic means" of resolving safety issues. In my view, the statement of policy approach best meets that test.
The remedy proposed under the policy statement is minor in scope, involving labeling of products containing more than one percent methylene chloride. It is a remedy to which the major industry participants had already agreed. Section 2(p)(l) of the FHSA imposes a responsibility on the government to require appropriate warning labeling when there is reason to believe that consumers are being exposed to a hazardous substance. Thus, a simple statement of policy notifying manufacturers that the commission intends to require such labeling is sufficient. I take the position that this approach is preferable to adopting a final rule for two basic reasons:
1. Promulgating a final rule, as proposed by the staff, could lead to protracted legal challenges that would eat up massive amounts of staff resources and taxpayers' dollars, delaying implantation of the labeling and thus denying consumers adequate protection.
2. Issuing a statement of policy, on the other hand, achieves the same goal more quickly and with a minimum of legal red tape. A challenge to some future enforcement action does not seem likely since only labeling is involved, and the affected industry has already indicated a willingness to undertake such labeling.
If there are any concerns that this approach somehow violates due process, those concerns have already been met by the procedures we have used to obtain public input on this issue. Public hearings were held, a proposed rule was issued for public comment, and all relevant comments and suggestions were considered. The prolonged delay, expense, and complications which could arise from continuing with formal rulemaking are unnecessary wastes of tax dollars and might deny the public its right to make informed choices critical to its safety.
Common sense and the public interest demand that the Commission choose the least drastic means of federal intervention when acting to protect consumers. A statement of enforcement policy meets that criteria and achieves the goals we all seek.
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The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product-related incidents cost the nation more than $1 trillion annually. CPSC's work to ensure the safety of consumer products has contributed to a decline in the rate of injuries associated with consumer products over the past 50 years.
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