The Food and Drug Administration and the Consumer Product Safety Commission today announced steps to reduce nitrosamines found in rubber baby bottle nipples and pacifiers to the lowest possible level.
Nitrosamines are not intentionally added to such products, but rather are formed from accelerators and stabilizers, which are added during the manufacturing process to give nipples and pacifiers strength and resilience.
Neither FDA nor CPSC has reports of adverse health effects associated with the use of these rubber infant products, but the data show that nitrosamines can migrate into milk or other food or through direct saliva contact and be ingested. A class of carcinogens in animals, nitrosamines occur naturally at low levels in many foods and may be formed in the human gastrointestinal tract.
Both agencies said they will consider taking enforcement actions against nipples and pacifiers with nitrosamine levels of more than 60 parts per billion.
These action levels will be effective January 1, 1984, for consumer-use nipples and pacifiers, with a two month delay for hospital nipples, which are used once and discarded. This will permit FDA to obtain information on the availability of these special nipples.
The action level set by the FDA will require both kinds of nipples to achieve nitrosamine levels below ten parts per billion by January 1, 1985. The CPSC is continuing to work on a voluntary standard with the industry to determine the maximum reduction feasible for pacifiers while still maintaining their structural integrity.
These plans went out today in concurrent notices to the Federal Register.
FDA and CPSC became aware of the nitrosamine problem in the United States last year when they confirmed studies by German scientists. The early tests showed nitrosamine levels ranging between 51 and 390 parts per billion in nipples and between 11 and 1,431 parts per billion in pacifiers.
The FDA immediately notified the Rubber Manufacturers Association of their concern and sought alternative manufacturing procedures that would eliminate or reduce nitrosamines. As a result, changes in the manufacturing process have reduced nitrosamines. In November, industry tests revealed that all non-hospital nipples had achieved nitrosamine levels below 40 parts per billion. The levels of nitrosamines found in hospital nipples were considerably higher, up to 160 parts per billion. FDA expects that figure to drop appreciably through additional process changes by the industry.
In the case of pacifiers, most of which are imported, CPSC has met with individual manufacturers and importers to find possible solutions to the problem. More recently, CPSC has worked with the pacifier industry to reduce nitrosamines to the lowest feasible levels. The CPSC is presently doing a complete survey of all pacifiers sold in this country to determine the levels of nitrosamines present. The results of thSs survey will be used by the CPSC and the industry to determine the feasibility of further reductions in levels. ( Chairman Nancy Harvey Steorts, Commissioner Stuart M. Statler, and Commissioner Sam Zagoria voted to publish the Consumer Product Safety Commission policy on pacifiers. Commissioner Terrence M. Scanlon dissented. Commissioner Saundra Brown Armstrong was not present at the meeting at which this matter was decided and did not participate in the decision. Copies of a joint statement by Chairman Nancy Harvey Steorts, Commissioner Stuart M. Statler, and Commissioner Sam Zagoria, and a statement by Commissioner Terrence M. Scanlon are attached.)
| Statement of Nancy Harvey Steorts, Chairman Stuart M. Statler, Commissioner Sam Zagoria, Commissioner on Nitrosamines in Pacifiers December 23, 1983 |
Last year the CPSC was made aware of the fact that rubber pacifiers made for children contained nitrosamines. These chemicals have been shown to be carcinogenic in a large number of laboratory tests in different animal species. As a result, early last year, the Commission voted to designate this issue as a priority project for FY 1983. During this year the staff has worked with the Food and Drug Administration and the National Center for Toxicological Research to identify the specific nitrosamines present in rubber pacifiers and to determine the amounts of these substances that can be released under simulated conditions of use. During this same period the FDA has been investigating these same questions with regard to rubber baby bottle nipples. We notified the rubber pacifier industry of our results as soon as they became available. In discussions with members of this industry we have emphasized the need to reduce the levels of nitrosamines to the lowest level possible in these products , and have started efforts to achieve these reductions through cooperative efforts that may lead to a vo1untar.v standard. Most rubber pacifiers sold in this country are imported, coming from many countries in Europe and Asia. This makes the process of achieving consensus more difficult than if the pacifiers were all manufactured in this country. Nevertheless, and in spite of the difficulties, we are very hopeful that a voluntary standard that results in further reductions in nitrosamine levels can be achieved. We understand that significant reductions in nitrosamine levels have already occurred. Because of our concern, and in order to avoid unnecessary exposure of infants and young children to nitrosamines, we decided to vote in support of the staff recommended enforcement policy. This policy states that the Consumer Product Safety Commission will consider taking legal action in those instances where the nitrosamine levels in pacifiers exceed 60 parts per billion. This policy has been closely coordinated with the FDA who has published a compliance policy guide which establishes 60 parts per billion of nitrosamines in rubber nipples as a basis for regulatory action. We are extremely pleased with this example of how government agencies can work together to achieve a common policy and goal. We have voted to publish this policy not as a substitute for the voluntary standard process, but rather to notify the industry and the public of our intent to ensure that pacifiers with excessive levels of nitrosamines are not introduced into commerce. It is our belief that this combination of efforts will provide the greatest benefit to the consumer. |
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