United States Administration

Table 5 presents typical operating conditions and cell production values for commercial-scale yeast-based SCP processes including (63) Saccharomjces cerevisae ie, primary yeast from molasses Candida utilis ie, Torula yeast, from papermiU. wastes, glucose, or sucrose and Klujveromjces marxianus var fragilis ie, fragihs yeast, from cheese whey or cheese whey permeate. AH of these products have been cleared for food use in the United States by the Food and Dmg Administration (77). 

Eorensic science laboratories may have different missions and therefore conduct different types of testing on samples (21,22). Eor example, the United States Department of Justice, Dmg Enforcement Administration (DEA) forensic laboratories assist authorities ia criminal intelligence-gathering efforts. As such, DEA chemists routinely analyze both the iUicit dmg and excipient, the material used ia the cutting or diluting of the pure dmg, ia a given specimen. The excipient may provide information as to where the sample was produced. 

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

For chemical faciUties in the United States, hazard analysis is not an option if inventories of hazardous chemicals are maintained in amounts greater than the threshold quantities specified by the Occupational Safety and Health Administration (OSHA) regulation 1910.119. Many faciUties are finding that hazard analysis has many benefits. The process or procedure often works better, the quaUty of the product is improved, the process experiences less down time, and the employees feel more comfortable in the work environment after a hazard analysis has been completed. 

It is good practice to keep concentrations of airborne nickel in any chemical form as low as possible and certainly below the relevant standard. Local exhaust ventilation is the preferred method, particularly for powders, but personal respirator protection may be employed where necessary. In the United States, the Occupational Safety and Health Administration (OSHA) personal exposure limit (PEL) for all forms of nickel except nickel carbonyl is 1 mg/m. The ACGIH TLVs are respectively 1 mg/m for Ni metal, insoluble compounds, and fume and dust from nickel sulfide roasting, and 0.1 mg/m for soluble nickel compounds. The ACGIH is considering whether to lower the TLVs for all forms of nickel to 0.05 mg/m, based on nonmalignant respiratory effects in experimental animals. 

Rosin has a low order of toxicity foUowing ingestion or skin contact. Rosin and its numerous derivatives have a number of permitted food packaging and other direct and indirect food contact uses throughout the world. Sanctioned uses appHcable in the United States are outlined in U.S. Food and Dmg Administration (U.S. FDA) Regulations (2). Material Safety Data Sheets (MSDSs) for specific rosins and thein derivatives should be consulted before thein use. 

Iodized Salt. Iodized table salt has been used to provide supplemental iodine to the U.S. population since 1924, when producers, in cooperation with the Michigan State Medical Society (24), began a voluntary program of salt iodization in Michigan that ultimately led to the elimination of iodine deficiency in the United States. More than 50% of the table salt sold in the United States is iodized. Potassium iodide in table salt at levels of 0.006% to 0.01% KI is one of two sources of iodine for food-grade salt approved by the U.S. Food and Dmg Administration. The other, cuprous iodide, is not used by U.S. salt producers. Iodine may be added to a food so that the daily intake does not exceed 225 p.g for adults and children over four years of age. Potassium iodide is unstable under conditions of extreme moisture and temperature, particularly in an acid environment. Sodium carbonate or sodium bicarbonate is added to increase alkalinity, and sodium thiosulfate or dextrose is added to stabilize potassium iodide. Without a stabilizer, potassium iodide is oxidized to iodine and lost by volatilization from the product. Potassium iodate, far more stable than potassium iodide, is widely used in other parts of the world, but is not approved for use in the United States. 

Surgical sutures are sterile, flexible strands used to close wounds or to tie off tubular structures such as blood vessels. Made of natural or synthetic fiber and usually attached to a needle, they are available ia monofilament or multifilament forms. Sutures are classified by the United States Pharmacopeia (USP) (1) as either absorbable or nonabsorbable. The USP also categorizes sutures according to size (diameter) and Hsts certain performance requirements. Sutures are regulated by the Food and Dmg Administration (FDA) as medical devices under the Food, Dmg, and Cosmetics (FDC) Act of 1938, the Medical Device Act of 1976, and the Medical Device Reporting regulation of 1995. 

Hydrogen chloride is produced when PVC bums. A series of tests for the Federal Aviation Administration studied this issue. In those studies, test animals were able to survive exposures to hydrogen chloride reaching 10,000 ppm (190). More recent studies indicate less of a potential for delayed effects on lung function than expected (191). In a typical fire, hydrogen chloride levels rarely exceed 300 ppm, a fact confirmed by the Boston Fire Department and Harvard University (192). In hundreds of autopsies conducted on fire victims in the United States, not one death has been linked to the presence of PVC. 

Water-use data and withdrawal rates for public water-supply systems are well documented by municipalities. The U.S. PubHc Health Service (USPHS) (5), American Water Works Association (AWWA) (6—10), and Federal Housing Administration (FHA) (11) have compiled statistics at regular intervals for >23, 000 municipalities in the United States. 

Code of Federal Regulations, Tide 21 Eood and Dmgs, Part 172.515, United States Pood and Dmg Administration, Washington, D.C., Apr. 1, 1989. 

Food and pharmaceutical grades of calcium carbonate are covered by the Food Chemicals Codex (7) and the United States Pharmacopeia (8) and subject to U.S. Food and Dmg Administration Good Manufacturing Practices (9). Both purity requirements and test methods are available (7,8). Calcium carbonate is listed in the U.S. Code of Federal Regulation as a food additive, and is authorized for use in both paper and plastic food contact appHcations. 

Cellulose esters are considered nontoxic and may be used in food-contact appHcations. However, since cellulose esters normally are not used alone, formulators of coatings and films for use in food packaging should ensure that all ingredients in their formulations are cleared by the United States Food and Dmg Administration for such use. 

Approaches to cytotoxic chemotherapy iaclude special emphasis on dmg targeting and toxicity alleviation. The directions ia which new dmg discovery strategies are moving and the criteria used for advanciag compounds iato clinical trials (2) are discussed hereia, as are all of the dmgs approved by the United States Food and Dmg Administration (FDA) for the treatment of cancer as of this writing and those compounds ia clinical trials. 

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