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By Pat Rizzuto
Feb. 19 — Two industrial solvents commonly used to make electronic goods and plastics would be strictly limited if countries vote in March to add them to the 1971 UN Convention on Psychotropic Substances.
The World Health Organization has recommended two chemicals—1,4-butanediol (BDO; CAS No. 110-63-4) and gamma butyrolactone (GBL; CAS No. 96-48-0)—be added to the Schedule 1 list of the Psychotropic Substances convention.
“Industrial uses would essentially be prohibited,” Aaron Goldberg, an attorney with Beveridge & Diamond P.C., told Bloomberg BNA Feb. 19.
If ingested, the body converts both chemicals into a nervous system depressant called gamma-hydroxybutyric acid (GHB), FDA's notice said. GHB is a Schedule 1 controlled substance under U.S. Drug Enforcement Administration rules.
More than 583 million pounds of 1,4-butanediol and 249 million pounds of gamma butyrolactone were either manufactured in or imported into the U.S. in 2012, according to information chemical manufacturers reported to the U.S. Environmental Protection Agency
European companies make or import between 100,000 metric tons and 1 million metric tons (220 million-2.2 billion U.S. pounds) of BDO annually and between 10,000 metric tons and 100,000 metric tons (22 million-220 million U.S. pounds) of GBL annually, according to information they reported to the European Chemicals Agency.
Ashland Inc., BASF Corp. and the Lyondell Chemical Co. are among the U.S. and European manufacturers of both chemicals.
The Food and Drug Administration is accepting comments through Feb. 26 as it works with other federal agencies to craft the U.S. position on the recommendation, it said in a Jan. 27 Federal Register notice (80 Fed. Reg. 4283).
The U.S. is preparing for a possible vote on the inclusion in the convention of these two solvents and other compounds with veterinary, food additive and other uses.
National representatives will gather to discuss and possibly vote on these and other issues during the UN's Commission on Narcotic Drugs meeting March 9-17 in Vienna.
In addition to the body's conversion of the two chemicals into GHB, illegal laboratories can use gamma butyrolactone to make compounds used for their intoxicating effects, as bodybuilding drugs and as “date rape” drugs, according to information from federal agencies, including the Drug Enforcement Administration.
The DEA already regulates gamma butyrolactone under the Controlled Substances Act.
“The American Chemistry Council strongly urges the U.S. government to reject the WHO recommendations to list 1,4-butanediol and gamma butyrolactone under the 1971 Convention,” the council told BNA in a Feb. 19 e-mail.
BDO and GBL are high-volume industrial chemicals with multiple uses that touch nearly every sector of the economy, the council said.
A key use of both chemicals is to make other widely used industrial compounds, according to an ACC website.
A significant use of GBL, because of its strong solvency properties, is in applications such as circuit board cleaning in electronics and high technology industries, and paint stripping, the council said. Other GBL applications include the production of herbicides and as a processing aid in the production of pharmaceuticals, the website said.
Chemicals BDO is used to manufacture include polyester polymers, which are used to make car bumpers and other auto parts. BDO is also used as a plasticizer, a carrier solvent in printing inks and a cleaning agent, the council's website said.
The World Health Organization, which has recommended the two chemicals be added to the Schedule 1—or most restrictive—list of the Psychotropic Substances convention, recognizes the widespread and important industrial uses of the chemicals, the FDA said in its Federal Register notice.
The convention requires that companies making, trading or distributing Schedule 1 substances have licences, Beveridge & Diamond's Goldberg said in an online summary.
Except for scientific uses and very limited medical purposes, nearly all uses are prohibited, he wrote. A country can notify the U.N. that it's unable to prohibit the chemical as a result of “exceptional circumstances, but, even then, the country is required to address the treaty's prohibition as far as possible,” Goldberg wrote.
The U.S. is a party to the Convention on Psychotropic Substances.
Schedule I listing could effectively eliminate legitimate, economically important industrial uses of the two chemicals, including, but not limited to, elastane fibers for stretchable fabrics, processing solvents for the semiconductor industry, heat-resistant plastics for computers and electrical components and PVC pipe cements, ACC told BNA.
The potential for illicit use of BDO and GBL is already well-recognized and controlled within the U.S., both by the DEA and through voluntary product stewardship safeguards established by manufacturers, the American Chemistry Council said.
“The WHO recommendations are highly disproportionate and would disrupt, if not eliminate, legitimate commercial uses,” it said.
The gamma butyrolactone and butanediol website ACC maintains offers guidance to companies on actions they should take to help ensure the proper use of their chemicals.
“As good product stewards, industry takes significant steps to educate its customers and coordinate with regulators and law enforcement authorities to help prevent diversion and misuse of its products,” the council told BNA.
Comments, due Feb. 26, should be marked Docket No. FDA-2015-N-0045 and filed at http://www.regulations.gov.
To contact the reporter on this story: Pat Rizzuto in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Larry Pearl at email@example.com
FDA's Federal Register notice is available at http://op.bna.com/env.nsf/r?Open=prio-9tvsen.
Beveridge & Diamond's summary of the issue is available at http://www.bdlaw.com/news-1698.html.
The American Chemistry Council's gamma butyrolactone and butanediol website is available at http://www.americanchemistry.com/ProductsTechnology/GBLBDO.
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