The US Court of Appeals for the Second Circuit decision this month paved the way for the National Resources Defense Council (NRDC) to compel the Food and Drug Administration (FDA) to finalize its regulation of triclosan under the Over-the-Counter (OTC) Drug Review.
NRDC alleges that FDA has unreasonably delayed the publication of a final OTC drug monograph with respect to triclosan and triclocarban in violation of the Administrative Procedure Act.
The FDA argued in its brief that the Court should affirm an earlier 2011 judgement in the US district court for the Southern District of New York because the NRDC failed to establish injury-in-fact (that there is an actual and sufficiently serious risk of harm to human health from exposure to topical antimicrobial drug products containing triclosan and triclocarban).
Even if the NRDC did make such a move, argued FDA, it failed to show involuntary exposure to such products by its members, or that they suffered a cognizable harm in their efforts to avoid such exposure.
Meanwhile, triclosan (2,4,4’ –trichloro-2’-hydroxydiphenyl ether) is being investigated by the Netherlands and Denmark under the Community Rolling Action Plan (CoRAP) framework as a suspected endocrine disruptor, being potentially persistent, bioaccumulative and toxic.
Triclosan use
Dr Elis Owens, Birko's senior chemist/microbiologist, told us that triclosan, like any antimicrobial compound, should be used judiciously and only when and where necessary.
FDA said it is engaged in an ongoing scientific and regulatory review of this ingredient but that it does not have sufficient safety evidence to recommend changing consumer use of products that contain Triclosan at this time.
In its latest update at the end of August last year, the agency said: “Triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review.
“FDA is engaged in an ongoing scientific and regulatory review of this ingredient. FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.”
Birko produces several hand soaps that contain Triclosan; these are specialty products intended for use by food production facility employees before and after handling food items.
“Use of hand soaps containing antimicrobials can be an appropriate component of a facility's food safety plan,” said Owens.
“Birko tracks regulatory changes closely and will continue to follow the FDA’s review process.”
Debated history
Researchers from the University of California Davis, and the University of Colorado concluded that it hinders muscle contractions at a cellular level, slows swimming in fish and reduces muscular strength in mice.
They found the chemical impaired the ability of isolated heart muscle cells and skeletal muscle fibres to contract, in a study published last year.
In 2011, Microban won a case against the European Commission (EC) meaning a prospective ban on the chemical in food packaging was overturned in the EU General Court (ECG).
The EC adopted decision 2010/169/EU concerning the non-inclusion of triclosan on a positive EU list of additives that may be used in the manufacture of “plastic materials and articles” intended to come into contact with foodstuffs in 2010.
The ECG explained there was no longer a valid application for the inclusion of tricoslan on the additive list in March 2010, after Swiss firm Ciba, a subsidiary of BASF, withdrew its application for the chemicals use in food packaging manufacture in April 2009.