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Latest FDA policy on ethanol for hand sanitizer still falls short

June 03/2020

MOSCOW (MRC) -- The Food and Drug Administration (FDA) in a guidance document late Monday updated its policy on the use of ethanol in hand sanitizers for a third time in the last two months as part of its effort to ensure adequate supply of the product during the coronavirus disease 2019 (COVID-19) pandemic, reported Chemweek.

The agency says its updated guidance further clarifies the manufacturing and compounding of certain alcohol-based hand sanitizer products to prevent harmful levels of impurities from making their way into sanitizers.

Biofuels advocates - including US Senators Chuck Grassley and Joni Ernst, both Iowa Republicans - have urged the FDA to ease restrictions on allowing ethanol producers to supply alcohol for hand sanitizer production.

In a letter last week, the senators called the FDA's 15 April revision of its 27 March guidance on the use of ethanol for sanitizer production "inexplicable" and said submitted samples of ethyl alcohol have been rejected, possibly based on levels of acetaldehyde, a substance that occurs naturally in the distillation process.

FDA's March guidance declared that ethanol used for hand sanitizer production does not need to meet the U.S. Pharmocopeia (USP) or Food Chemical codex (FCC) standards provided that other purity standards were satisfied. The senators said that based on that guidance, biofuels producers made investments and began production of alcohol for hand sanitizer.

However, the agency's April revision said ethanol used in hand sanitizers must adhere to USP or FCC standards unless otherwise approved. FDA asked that ethanol companies submit data regarding any impurities.

FDA on Monday said the temporary guidance from April was based on concerns that at least some fuel ethanol products may contain harmful chemicals, including gasoline and benzene. FDA said it is working with the industry to ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer products.

"Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer," FDA says.

Renewable Fuels Association (RFA) president and CEO Geoff Cooper says the latest guidance is still too restrictive.

"While we appreciate that FDA responded to RFA's request for more clarity and specific interim impurity limits, we do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way," Cooper says. "We welcome the specificity in the new guidance, but the new interim limits for certain impurities are overly restrictive and create a roadblock for producers who could otherwise supply huge volumes of safe, clean, high-quality ethyl alcohol to hand sanitizer manufacturers."

"For example, FDA's new limits for certain impurities are eight times more restrictive than what is typically found in a glass of red wine and twenty times more restrictive than what has been allowed in hand sanitizer by other countries, including Canada, during the COVID-19 pandemic," according to a statement.

Cooper adds that the US has had to ramp up imports of hand sanitizer from China and other countries, calling the imports "unfortunate" considering abundant supplies of "high-purity American-made ethanol could be used instead."

As MRC informed earlier, the US ethanol industry is showing some signs of recovery as government officials ease stay-at-home orders that depressed fuel demand, while a vote Friday in Congress could bring the industry one step closer to federal aid, industry officials said in late May. Fuel demand collapsed by about a third with the spread of the novel coronavirus this spring, and US ethanol production capacity halved as around 150 facilities either idled or reduced rates. Now as restrictions ease and gasoline demand inches higher, about 140 facilities are idled or running at reduced rates, Renewable Fuels Association President Geoff Cooper said on Friday.

Earlier this year, BP said the deadly coronavirus outbreak could cut global oil demand growth by 40 per cent in 2020, putting pressure on Opec producers and Russia to curb supplies to keep prices in check.

We remind that, in September 2019, six world's major petrochemical companies in Flanders, Belgium, North Rhine-Westphalia, Germany, and the Netherlands (Trilateral Region) announced the creation of a consortium to jointly investigate how naphtha or gas steam crackers could be operated using renewable electricity instead of fossil fuels. The Cracker of the Future consortium, which includes BASF, Borealis, BP, LyondellBasell, SABIC and Total, aims to produce base chemicals while also significantly reducing carbon emissions. The companies agreed to invest in R&D and knowledge sharing as they assess the possibility of transitioning their base chemical production to renewable electricity.

Ethylene and propylene are feedstocks for producing polyethylene (PE) and polypropylene (PP).

According to MRC's ScanPlast report, Russia's estimated PE consumption totalled 721,290 tonnes in the first four month of 2020, up by 4% year on year. Low density polyethylene (LDPE) and linear low density polyethylene (LLDPE) shipments grew partially because of the increased capacity utilisation at ZapSibNeftekhim.  At the same time, PP shipments to the Russian market totalled 347,440 tonnes in January-April 2020 (calculated by the formula production minus export plus import). Supply exclusively of PP random copolymer increased.
Author:Margaret Volkova
Tags:Europe, PP, PE, LLDPE, crude and gaz condensate, PP random copolymer, propylene, LDPE, ethylene, petrochemistry, adhesives, BASF, Borealis, BP Plc, LyondellBasell, Sabic, Total Petrochemicals, Rossiya, USA.
Category:General News
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