The U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) has issued a temporary policy that allows entities that are not currently registered drug manufacturers, such as ethanol producers, to produce alcohol to be used in hand-sanitizers.
According to the FDA:
“Because of the public health emergency posed by COVID-19, FDA does not intend to take action against alcohol production firms that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the Active Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:
Beyond alcohol, water, and denaturants (if added at the point of production), the alcohol production firm does not add other ingredients. Different or additional ingredients in the API may impact the quality and potency of the finished hand sanitizer product.
The alcohol production firm ensures the ethanol content in the finished API before being denatured is at least 94.9% by volume (see United States Pharmacopeia National Formulary [USP-NF] or Food Chemical Codex [FCC])). If the alcohol is to be distributed to another firm for producing the hand sanitizer, it is labeled with the ethanol content determined by an appropriate test so that the hand sanitizer can be reliably produced at the intended labeled strength. A simple record should be used to document key steps and controls.
WASHINGTON, D.C. – Today, Growth Energy CEO Emily Skor submitted written comments on the Internal Revenue Service’s (IRS) proposed regulations under section 45Q, a performance-based tax credit for carbon capture projects. In her letter, Skor called on the agency to offer credit for carbon dioxide captured for food and beverage purposes, which would promote investment […]
This week in our “Conversations with Biofuels Champions” summer video series, our CEO Emily Skor visited with one of our top champs in the House of Representatives: U.S. Congresswoman Cheri Bustos of Illinois. Born in Springfield, Illinois, Congresswoman Cheri Bustos comes from a long line of farmers and teachers and a deep appreciation for being […]
CEO @GrowthEnergy tells IRS how #ethanol plants can lead the way on #carbon capture https://t.co/xiHAipVJpI
As @RepCheri Bustos says here, the biofuels industry has a cascading effect on agriculture — it promotes strong supply chains and multiplies rural economic output. Abuse of the Renewable Fuel Standard through refinery exemptions only serves to harm the ag economy. https://t.co/pvW7P4yZ4F
The future of fuel — increased engine performance, lowering our carbon footprint, and eliminating toxic fuel additives — is already here. At @EESI's Clean Energy Expo, Growth Energy SVP of Regulatory Affairs Chris Bliley laid out the benefits that expanding ethanol can bring. https://t.co/aW5v9A4prB
In a letter to the IRS, GE CEO @EmilySkor proposes applying the 45Q performance based carbon tax credit to carbon capture projects at ethanol plants as a way to incentivize and expand their further use. Biofuel producers are ready to do more! See the letter here: https://t.co/MtEDPF0jKy