Program product safety

Monsanto, like many chemical firms, had a product safety program in place long before passage of TSCA. The Monsanto program from its inception embraced the spirit and in many cases the letter of what later appeared as the law. In some situations TSCA has improved the focus of Monsanto s information management and has been beneficial. In other cases we have provided constructive criticism of EPA proposed rules which required information submission and management with no specific objective. 

Operating under the Second Restatement of Torts, Section 402A, a plaintiff in a strict liability lawsuit does not have to prove negligence. The behavior of the defendant is irrelevant. The defendant caimot show how well he operated his quality control or product safety program to prevent defects. A defendant caimot present how a quality design process created a safe product. Those may all be good practices, but they are defendant behaviors and do not apply in strict liability cases. 

Audits Product safety programs work well when there are planned and scheduled reviews of for aU aspects. There should be periodic audits to assure that participants meet all program details. 

A supplementary and advisory document to SEMI S2-0706 is Related Information 1—Equipment/Product Safety Program. It makes an interesting statement... 

SEMI S2-0706. Environmental, Health, and Safety Guideline for Semiconductor Manufacturing Equipment. San Jose, CA Semiconductor Equipment and Materials International, 2006. (Related Information 1—Equipment/Product Safety Program is an adjunct to these guidelines.)... 

Basic elements of product safety programming are designed to identify and evaluate potential product hazards for systematic control, using the techniques of safety management and safety engineering (Table 4.19). 

Product safety is the process applied to develop and build a safe product. For many types of products, this is achieved by ensuring the product design meets government standards and requirements for that family of products (i.e., compliance-based or prescriptive safety). When the requirements are met, it is assumed the product is safe. A more effective product safety program would be to combine the prescriptive safety requirements with an SSP that implements the system safety process. 

Safety, System Safety Program for Modernization and Expansion Projects," DRC-PBM Memorandum No. 385-3, Office of the Project Manager for Munitions Production Base Modernization and Expansion, Dover, NJ, April 1978. 

It is the responsibility of the Central Safety Testing Lab staff to scan test results into the database and to serve as database administrators. 2. It is the responsibility of the Product Safety and Product Regulatory Programs to develop MSDSs and Workplace Precaution Statements. 3. It is the responsibility of the project/process leader to ensure the Survey Sheets have been completed, and that MSDSs or workplace precaution statements have been requested. ... 

As it is imperative that the plant-derived hiopharmaceutical product must be obtained repeatedly and on a consistent basis, a master cell culture bank, seed bank for transgenic plants, or virus seed stock for transient expression systems must be constantly maintained. Storage conditions must therefore he optimized to prevent contamination and ensure viability. Both transgene stability (e.g., reversion to wild type or sequence drift of plant virus expression vectors) and protein expression levels must be monitored in a representative plant of a given bank or stock to minimize any possible variation in expression levels that may affect safety and consistency of the hnal product. A program that monitors lot-to-lot consistency of the hiochemical and biological properties by comparing the product with appropriate in-house reference standards could he implemented as a fundamental component of product development. 

To validate change in equipment, packaging, formulation operating procedure, or process that could impact product safety, efficacy, or potency. It is important to establish a revalidation program for critical equipment to maintain validity. 

The function of the chemical industry is to turn scientific knowledge into useful products. Like all other human activity, discharging this function requires that companies and people in the industry deal successfully with a wide range of risks. Most of these risks are common to nearly all production activities some are unique to the chemical industry. The successful chemical plant or laboratory safety program must address both the common risks and those which are unique to it, such as ones which arise out of the reactivity, toxicity, or other hazards inherent in many of the industry s processes and products. 

The Quality Assurance and Laboratory Inspection Section at DCLS consists of a staff of five, and is responsible for a number of functions in addition to its QA function. Staff members inspect and certify independent and municipal laboratories in Virginia that conduct analyses covered by EPA s Safe Drinking Water Act. In addition, the section is responsible for administering the safety program for the laboratory. Another function of the section is to evaluate a number of products for compliance with bid specifications in support of procurement activities for the Division of Purchases and Supply. Because of these... 

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