Regulation Article

Obligations of clinical investigators of regulated articles," Fedl. Reg. (1978) 43, 35210. 

Predicate regulations Federal Food, Drag, and Cosmetic Act, the Public Health Service Act, or any FDA Regulation, with the exception of 21 CFR Part 11. Predicate regulations address the research, production, and control of FDA regulated articles. 

If after extensive review, APHIS determines that the unconfined release does not pose a significant risk to agriculture or the environment, the organism is deregulated. At this point, the organism is no longer considered a regulated article and can be moved and planted without APHIS authorization. 

Solid Waste Any discarded material not excluded by regulation (article 40CFR 261.2(a))... 

BCCR. 1990. Barclays California Code of Regulations. Article 5.5. Primary Standards-Organic Chemicals Article 7. No Significant Risk Levels. Title 22. Register 90, No.26-31. San Francisco, California. 

Table 7.4 1 = restricted and II = prohibited flavouring substances in Malaysian Food Regulations, Article 22, 8th Schedule... 

A second theme concerns the dedication of farm equipment and facilities to the production of such crops. First, APHIS requires planters and harvesters to be dedicated to the test site for the duration of the tests, and although tractors and tillage attachments do not have to be dedicated, they have to be cleaned in accordance with APHIS protocols. The equipment and regulated articles must be stored in dedicated facilities for the field test s duration. 

As APIs are regulated articles, their quality is determined not only by satisfactory test results, but adso the assiirance that the process was conducted according to a validated process. 

The requirements for the SDS are displayed in REACH regulation Article 31. Annex II guides the user on how to compile SDS (more about SDS can be found in Chapter 5). 

Under the Federal Plant Pest Act the definition of a regulated article is the definition of the scope of the regulatory process. In the March 31,1993 notice a regulated article was defined as ... 

The revised procedures include a list of regulated articles which may be introduced without a permit, but simply following notification of the BBEP Director. Principally six plant species have been placed in the notification category, corn, cotton, potato, soybean, tobacco, and tomato. It is anticipated that additional plant species will be placed in this list as the USDA gains additional experience. In addition to being on the above list, a number of other criteria are necessary for a product to fall under the notification umbrella. The criteria are spelled out in great detail in the Federal Register notice. 

NO 1,000 penalty for each offense charged in violation of the Motor Carrier Safety Regulation Article. 

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