Using the TRI to Assess Application of Green Chemistry Practices by the Pharmaceutical Industry in Achieving Sustainability

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Using the TRI to Assess Application of Green Chemistry Practices by the Pharmaceutical Industry in Achieving Sustainability Stephen C. DeVito, Ph.D., R.

1 Using the TRI to Assess Application of Green Chemistry Practices by the Pharmaceutical Industry in Achieving Sustainability Stephen C. DeVito, Ph.D., R.Ph. Toxics Release Inventory Program U.S. Environmental Protection Agency Washington, DC April, /19/ U.S. Environmental Protection Agency

2 Sustainable Development: An Ongoing Priority Meeting the needs of the present generation without compromising the ability of future generations to meet their own needs. ( From: C.G. Brundtland. Our Common Future. The World Commission on Environmental Development, Oxford Univ. Press, Oxford, 1987.) 4/19/2012 U.S. Environmental Protection Agency 2

3 National Academy of Sciences Sept. 2011: Report on EPA and Sustainability 4.1. Key Recommendation: EPA should develop a sustainability toolbox that includes a suite of tools for use in the Sustainability Assessment and Management approach. 4/19/2012 3

4 Green Chemistry That sub-discipline in chemistry that strives to develop environmentally friendly chemical products through synthesis pathways that neither use or generate hazardous chemicals or wastes; Evolved in EPA/OPPT s Industrial Chemistry Branch in the early 1990s following passage of the Pollution Prevention Act (PPA) of 1990; The practice of Green Chemistry is a primary means of achieving sustainable development. 4/19/2012 U.S. Environmental Protection Agency 4

5 Example: Commercial Synthesis of Acetophenone Time-Honored Synthesis of Acetophenone (a TRI chemical): CrO Cr 2 (SO 4 ) 3 OH + 3 H 2 SO 4 O + 6 H 2 O Phenethyl alcohol Acetophenone This synthesis: 5

6 Example: Commercial Synthesis of Acetophenone Time-Honored Synthesis of Acetophenone (a TRI chemical): CrO Cr 2 (SO 4 ) 3 OH + 3 H 2 SO 4 O + 6 H 2 O Phenethyl alcohol Acetophenone This synthesis: - requires the use of two TRI chemicals (one of which is a known human carcinogen); 6

7 Example: Commercial Synthesis of Acetophenone Time-Honored Synthesis of Acetophenone (a TRI chemical): CrO Cr 2 (SO 4 ) 3 OH + 3 H 2 SO 4 O + 6 H 2 O Phenethyl alcohol Acetophenone This synthesis: - requires the use of two TRI chemicals (one of which is a known human carcinogen); - generates a TRI chemical (also a known human carcinogen) as a waste and in large quantity; 7

8 Example: Commercial Synthesis of Acetophenone Time-Honored Synthesis of Acetophenone (a TRI chemical): CrO Cr 2 (SO 4 ) 3 OH + 3 H 2 SO 4 O + 6 H 2 O Phenethyl alcohol Acetophenone This synthesis: - requires the use of two TRI chemicals (one of which is a known human carcinogen); - generates a TRI chemical (also a known human carcinogen) as a waste and in large quantity; - is only 42 % efficient. 8

9 Example: Commercial Synthesis of Acetophenone Time-Honored Synthesis of Acetophenone (a TRI chemical): CrO Cr 2 (SO 4 ) 3 OH + 3 H 2 SO 4 O + 6 H 2 O Phenethyl alcohol Acetophenone overall synthesis efficiency only 42 % "Green Chemistry" Synthesis of Acetophenone: OH catalyst O 2 O + H 2 O Phenethyl alcohol Acetophenone overall synthesis efficiency = 87 %!! 9

10 The Practice of Green Chemistry has Become Widespread in Some Industry Sectors Particularly in the pharmaceutical manufacturing sector; Examples of drugs made from green syntheses: Sitagliptin phosphate (Januvia ) Pfizer received EPA s Presidential Green Chemistry Challenge Award Pregabalin (Lyrica ) See the Green Chemistry Institute s Pharmaceutical Roundtable website for more information. 4/19/

11 Total Releases Reported to EPA s TRI From Pharma Industry vs Manufacturing Industry Millions of Pounds (Pharma) % 2,500 2,000 1,500 1,000 Millions of Pounds (Manufacturing) % Pharmaceutical Industry - Absolute Value Manufacturing Industries - Absolute Value Pharmaceutical Industry - Normalized Manufacturing Industry - Normalized 11

12 Total Production Related Waste Managed (Sections ) Reported to EPA s TRI from Pharma Industry vs Manufacturing Industry Millions of Pounds (Pharma) % -26% -68% -73% 25,000 20,000 15,000 10,000 5,000 Millions of Pounds (Manufacturing) - - Pharmaceutical Industry - Absolute Value Manufacturing Industries - Absolute Value Pharmaceutical Industry - Normalized Manufacturing Industries - Normalized 12

13 Release Reductions are Sector-Wide: Decline in releases is seen amongst the top ten pharmaceutical companies as well as the rest of the industry 16 Releases* of Top Ten Pharmaceutical Companies Millions of Pounds Pharmaceutical Industry Top 10 Companies All other Pharmaceutical Facilities 4/19/

14 Preliminary Conclusions & Next Steps The results of our analyses indicate that the implementation of green chemistry by the pharmaceutical industry is reflected in the TRI data. The results more broadly suggest a potential for the use of TRI data as a practical tool to track environmental progress (or lack thereof) within all manufacturing sectors. We are currently identifying those TRI chemicals for which the pharmaceutical industry reports fewer quantities. 4/19/

15 Abt Associates Dana Lazarus Cheryl Keenan Becca Fink Acknowledgements 4/19/

Pharma and Suppliers: Collaborating on Green Chemistry. Launch of PMI tool. ACS Green Chemistry Institute Pharmaceutical Roundtable

Pharma and Suppliers: Collaborating on Green Chemistry. Launch of PMI tool ACS Green Chemistry Institute Pharmaceutical Roundtable Dave Hughes 08-Feb-2011 2011 Copyright American Chemical Society Green