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COST-BENEFIT ANALYSIS ASKS, "Is this harm justified by related benefits?" If the answer is yes, or even if the answer is unknown, the harm is allowed to continue. The precautionary principal asks, "Is this harm avoidable?" http://www.multinationalmonitor.org/mm2009/032009/interview-montague.html View in LinkedIn

UNSCIENTIFIC? "U.S. industry representatives see the EU regulations as a pure trade obstacle and criticize the European arguments as unscientific. They claim there is no proof that the amounts of chlorine used to sanitize chicken meat harms the consumer. They point out that 120 other countries around the world accept the U.S. practice." http://lnkd.in/dDwxBBi View in LinkedIn

THE ROOT CAUSE of the enormous divide between the U.S.and EC food safety regulators and which us behind the enormous gulf in TTIP food harmonization talks: the Precautionary Principle which charges governments to safeguard the people and Cost-Benefit or risk based analysis that assumes that economic good trumps all other goods. View in LinkedIn

CRITIC OF PRECAUTIONARY PRINCIPLE. "Attempts to apply this concept to "proof of safety" for new food ingredients or products has led to the impossible demand of establishing the "absence of harm," with a level of evidence that avoids uncertainty. Any requirement to establish safety with no uncertainty will increase costs unnecessarily, and will prove futile." http://www.agbioforum.org/v3n4/v3n4a13-hathcock.htm View in LinkedIn

PETER MONTAGUE will be extensively quoted in the next sections because of his clear-sighted analysis of the issues at stake, and the consequences, when we are guided by the Precautionary Principle versus Risk-Benefit analysis in regulation of potentially harmful products. View in LinkedIn

GREAT SPOKESPERSON. "Peter Montague is director of the Environmental Research Foundation ... longtime editor of Rachel’s Environment and Health News ... He has co-authored two books on toxic heavy metals in the natural environment and is presently writing a book about the precautionary principle." http://www.multinationalmonitor.org/mm2009/032009/interview-montague.html View in LinkedIn

QbD FOR DRUG MANUFACTURING AT FDA. "In FDA’s Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding." http://en.m.wikipedia.org/wiki/Quality_by_Design View in LinkedIn

QUALITY BY DESIGN (QbD) by the FDA: "The focus of this concept is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks." http://en.m.wikipedia.org/wiki/Quality_by_Design View in LinkedIn

SPLIT POLICY AGENCY. The FDA employs completely divergent philosophies for the regulation of pharmaceuticals versus food additives. This contrasts with the USDA regulation of meat, which is both permissive, light-handed, and based entirely risk assessment, not need. The WTO is also based on similar permissive risk-assessment principles. View in LinkedIn

US FOOD AND DRUGS ARE TREATED DIFFERENTLY. The FDA nominally has jurisdiction over food and drugs. The regulation of meat products is led by USDA, with FDA giving guidance, and food additives by the FDA, who also has exclusive preview over drugs. The Precautionary Principle is rigorously applied to drugs. In food additives, the approach is risk management, when applied at all. View in LinkedIn