In last week\u2019s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to \u201cavoid an afterthought approach to regulatory compliance.\u201d<\/p>\n
As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive involved with biobased chemicals at a session titled \u201cCommercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process,\u201d presented by Bergeson & Campbell, P.C. and the Biobased and Renewable Products Advocacy Group (BRAG), a D.C.-based industry consortium focusing on making the commercialization of biobased and renewable chemicals a reality by anticipating and minimizing the challenges federal and state regulatory systems can pose.<\/p>\n
The speakers gave a high-level overview of one of the most significant regulatory requirements for new biobased chemical products \u2014 new chemical review under Toxic Substances Control Act Section 5. TSCA is a bit of a misnomer to many in this commercial space. After all, biobased chemicals are not \u201ctoxic.\u201d TSCA, however, regulates all chemical substances in commerce, regardless of toxicity unless exempt.<\/p>\n
Dr. Tracy Williamson, Chief of the Industrial Chemistry Branch, Office of Pollution Prevention and Toxics, EPA, noted that EPA encourages the development of safer and greener new chemicals. It also serves as pre-market gatekeeper for new chemicals and must ensure no chemical poses an unreasonable risk to health or the environment.<\/p>\n
By law, the review process is to occur in 90 days. This timeframe can be extended and the process can take much longer as it often does if a Premanufacture Notification (PMN) is not carefully prepared. Delay can invite catastrophic consequences, particularly for a small company with its commercial hopes and dreams hinged on the successful commercialization of its new chemical product.<\/p>\n
1. Schedule a pre-notification meeting with EPA. A pre-notification meeting is a terrific opportunity to meet EPA scientists, familiarize them with your company and its products, and to establish a positive relationship with an important \u201cclient\u201d \u2014 the federal government! It also allows a newcomer to the TSCA world a chance to ask questions about the review process and the required elements on the form. This tip was echoed by Dr. Frank Pacholec of Stepan Company, another of the panelists.<\/p>\n
2. Pay attention to the \u201cnaming\u201d of the chemical substance. This is relevant to biobased chemical producers, and requires the services of a chemist familiar with the sometimes arcane rules of chemical nomenclature.<\/em><\/em><\/p>\n<\/div>\n <\/p>\n","protected":false},"excerpt":{"rendered":" By Kathleen Roberts,
\nExecutive Director, Biobased and Renewable Products Advocacy Group
\nIn last week…<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"","nova_meta_subtitle":"","footnotes":""},"categories":[5572],"tags":[],"supplier":[2194,4861,1214],"class_list":["post-20685","post","type-post","status-publish","format-standard","hentry","category-bio-based","supplier-biotechnology-innovation-organization-bio","supplier-industrial-biotechnology-journal","supplier-united-states-environmental-protection-agency-epa"],"_links":{"self":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/20685","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/comments?post=20685"}],"version-history":[{"count":0,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/20685\/revisions"}],"wp:attachment":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/media?parent=20685"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/categories?post=20685"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/tags?post=20685"},{"taxonomy":"supplier","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/supplier?post=20685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}