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Chicago Chem Consultants Corporation

Bringing New Chemicals to Market

The following comes from a presentation made on the subject of New Chemical Production. An abstract of the presentation is followed by the PDF links to the three presentations made the authors listed below. The genesis for this was taken from actual successful CCC project work for the Specialty Fertilizer Company.

SFP http://www.specialtyfertilizer.com/ develops fertilizer enhancements that increase crop yield while reducing chemical fertilizer use. Illustrated is the need to coordinate chemical manufacturing, intellectual property rights and US Environmental Protection Agency regulations regarding Pre-manufacturing Notification (PMN) requirements. We are indebted to USEPA and Ryndak & Suri for assistance throughout the project and permission to publish this material.

Joint Meeting
American Institute of Chemical Engineers
Academy of Certified Hazardous Materials Managers
Chicago Illinois February 2005

Bringing New Chemicals to Market

Presented by

Miriam Wiggins-Lewis, U.S.E.P.A.
Roger Masson, Esq., Ryndak & Suri
Jeffery P. Perl, PhD.,PE., CHMM and Stanley Yoslov, ChE, Chicago Chem Consultants Corp.

ABSTRACT

When bringing a new chemical to market, companies have a myriad of challenges to deal with. This is never an easy task even for mature companies. We will examine some of the technical issues common to production of a new chemical, namely, permitting, protecting intellectual property, and production through the story of a startup that was stretched to the limit when it tried to produce a niche chemical for use in commodities.

Not all new chemical developers can afford a manufacturing facility to enter into production at first. This is particularly challenging for startups, small companies, and large companies moving far afield from their central product line. The use of outsourced "Toll Manufacturing" is a common, but not well understood way to avoid large sunk capital investments.

The US Environmental Protection Agency requires all new chemicals to be approved prior to production under the Toxic Substances Control Act (TSCA) and the Pre-Manufacturing Notice Program. Obtaining approval can be a perplexing roadblock to overcome.

All this development and permitting is expensive. Without intellectual property laws, developing new chemicals would not be profitable. Along the pathway to production, many intellectual property decisions have to be made, which can all be vital to the success of the enterprise.

Chemical Engineering is the discipline that allows profitable manufacturing of products from raw materials on a large scale...but all this must be done within a regulatory framework designed to protect workers and public alike. The Certified Hazardous Materials Manager (CHMM) program arose to address the complexities of the Environmental, Safety and Occupational Health (ESOH) system that all companies, large and small must deal with daily.

Presentations in PDF Format:

USEPA New Chemicals - USEPA

Intellectual Property Rights - Ryndak & Suri

Bringing New Chemicals to Market - Chicago Chem Consultants

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