Legislation recalls

The Toxic Substances Control Act (TSCA) was signed into law in late 1976. It was a bitterly-debated piece of legislation it arose at the height of the combined environmental concern and "cancerphobia" fears distinctive of that time. In order to understand how corporations have responded to TSCA, it is important to recall the situation at that time in the knowledge of carcinogenesis, in the environmental movement, in the political scene and, finally, in the corporations themselves. 

The manufacturer and/or importer of a new surfactant in Japan is required to register it beforehand under the Chemical Substances Control Law, a law to regulate chemical substances, and the Industrial Safety and Health Law, a law to protect the health of workers. A chemical substance that is not registered beforehand or is not exempt from the registration under the laws cannot be handled as a chemical substance in Japan. If you use such a substance without registration, you must not only pay a penalty but also recall your products in the worst case. This legislation is applicable to all chemical substances including surfactants. 

If results were correlated with effort, women chemists would have changed academia a lot more by now than has been the case. Although important legislation was passed in 1972 affecting education and employment, a law is only as strong as its enforcement, and fighting powerful institutions in court can be a slow, expensive, and painful process. Nevertheless some women chemists have been quite active in this area. Recall Sharon Johnson, who earned a Ph.D. in chemistry from MIT, was an assistant professor of biochemistry in the medical school at the University of Pittsburgh, and sued her employer... 

The U.S. issued specific distribution requirements in 1990 to complement the basic provisions established earlier in its GMPs. Although computer validation is not specifically identified as a requirement, separate electronic record/signature legislation (21 CFR Part 11) requires computer systems handling defined distribution records to be validated. Records should be sufficient to track the origin and destination of medicinal products primarily in support of possible customer returns and product recall. Key GDP topics identified in the U.S. legislation that validation should address in relation to computer systems include ... 

We may also recall that there is a further problem in that the data are, in general, highly sensitive and thus fully protected. To address the security requirements and to comply with the legislation for protection of personal privacy, certain personal information must be kept at the initial collection point in the original medium and is prohibited from being copied to or stored in another medium at another location. This was the reason why many workers in medical IT believed that the personal lifetime health record needs to be dynamically assembled out of the information retrieved on demand from various sources. 

GMP Chap. 8 Complaints and Product Recall refers, for licensed medicines, to legislation as the principle of a procedure to be followed in case of a potential defective product All complaints and other information concerning potentially defective products must be reviewed carefully according to written procedures. In order to provide for all contingencies, and in accordance with Article 117 of Directive 2001/83/EC and Article 84 of Directive 2001/82/EC, a system should be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market. GMP is listing in Chap. 8 all actions that have to be part of a recall procedure. 

New terms entered into the legislation for the first time including serious risk , recall and withdrawal . Calls have been made for these to be fully defined in guidance information. 

In relation to transfers of scheduled chemicals to or from States not Party, the Second Review Conference recalled the prohibitions on any such transfers of Schedule 1 chemicals and, from 29 April 2000, of Schedule 2 chemicals. It also noted that an increasing number of States Parties had put in place the necessary measures on transfers of scheduled chemicals. It urged all States Parties to implement the necessary legislative and administrative measures, and to share experiences about the implementation of these provisions. 

US legislation, the TREAD Act, which was passed in October 2000 after the Firestone tyre recall, establishes early-earning reporting requirements of safety-related tyre and automotive defects, and criminal penalties for falsifying or withholding information on vehicle safety-related defects. This article examines in detail the impact this new legislation will have on businesses in the US, products sold, and how the law could even affect a company s survival. 

As we also saw in Section 6.10, the layer of ozone in the upper atmosphere plays an important role in the absorption of harmful ultraviolet radiation from the sun. It absorbs the UV radiation and breaks apart to O2 and O. This oxygen atom will often react with another O2 molecule to re-form as ozone. During this cycle, each ozone molecule absorbs many ultraviolet photons. Recall also from Section 6.10 that the ozone layer has been depleted by chlorofluorocarbons (CFCs). However, legislation has banned CFCs in the hope that their reduction will help the ozone layer to recover. 

---