US EPA bars manufacture of rubber additive

The US EPA has ruled that a rubber additive cannot be manufactured in the country, unless the company submits additional animal testing data.

Alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (generic), was to be used as an additive to improve the compatibility of the dispersibility of inorganic fillers in industrial rubber formulation, according to its pre-manufacture notice (PMN). The EPA "predicts irritation and lung effects to unprotected workers from repeated inhalation and dermal exposures", it said in a notice published in the 19 October Federal Register.

The decision is one of 29 significant new use rules (Snurs), issued this month by the EPA regarding substances subject to TSCA section 5(e) consent orders.

In the case of 12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic), the EPA is concerned about both danger to human health and toxicity to aquatic organisms. The Snur limits manufacture of the substances to a "confidential production limit", unless the manufacturer submits data from specified toxicity tests. The substances are to be used in the production of industrial paints and coatings.

Snurs more commonly require protective measures to limit worker exposure, restrict how a substance is manufactured or otherwise mitigate potential risks, as is the case with most of the 29 published on 19 October.

Consent orders are only binding on the original pre-manufacture notice (PMN) submitter. The EPA typically promulgates a Snur that mimics the 5(e) order so that all subsequent manufacturers and processors of the substance will be bound to the same requirements.

The EPA will accept comments on the Snurs until 20 November. The rule will take effect on 18 December if no adverse comments are received.

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