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Kews URL 05054 Beiii^ practical ovr carcinoftni Is the Food and Drug Administra tion's (FDA) decision on lead ace tate a precedent-setting move for all regulatory agencies? That remains to be seen. But it is certainly the first attempt by an agency to deal practically with a substance that has been labelled carcinogenic. Tests with animals indicate that high doses of ingested lead will lead to excess numbers of cancers among the animals. The approach for agencies in the environmental and occupational health field has been to put restrictions on the sub stances and lower the allowable ex posure to the lowest possible level. As with vinyl chloride, those agencies have been known to con sider practicality in reaching limits. But in the consumer area, the ans wer to exposure limits has usually been absolute. The archetypal rule is the Delaney amendment, which bans any carcinogens from food ad ditives. ignoring the fact that some foods contain carcinogens natur ally. But now the FDA has decided that since humans receive 100 to 500 micrograms of lead daily from food sources and another 20 to 400 micrograms from airborne sources each day. the 0.S micrograms of lead acetate that might be absorbed through the scalp from use of hair dyes is not significant. The agency (dans to approve the use of lead ace tate as a color additive in hair dyes. The petition for the white lead crys talline compound has been pending since 19?3. "By any reasonable standard, lead acetate must be regarded as safe for hair dye use." says FDA. Whether reasonable standards will be the rule rather than the excep tion for regulatory agencies dealing with alleged carcinogens remains to be seen. But the FDA action could be a precedent that will make it easier for others to follow. Q ticides, herbicides, and fungicides were too many to place in a single cluster. Eventually. EPA decided on clusters of one to 26 chemicals, with most clusters limited to less than 20 chemicals. EPA has proposed 13 groupings of insecticides, from 23 chemicals used on cotton, soybeans, peanuts, wheat and tobacco to 13 for miscel laneous uses, such as diamidfos and methyl trithion. There are 10 herbi cide groups, including 15 chemicals used on sorghum, rice and small grains. There are also 10 groups of fungicides. And 15 other groups round out the categories. There are 48 clusters all together. But desiring the clusters is only the first step in EPA'* effort to schedule the pesticides for review. To assign point values to chemicals within each cluster, the agency has developed an equation in which the rating X*(2Ei-eEd IP); Ej is human exposure, Et is fish and wildlife ex posure and P is production of the chemical. EPA didn't include a risk factor in the equation because they didn't have enough toxicity data and because they say they found it didn't make any difference because exposure was so highly weighted. EPA is proposing to assign number values in the equation based on a variety of factors. For example, high production lover 1 million Iba/year) ranks a 5. medium a 3. and low (under 25.000 lba/year) a 1. Similarly, exposure numbers depend on persistence data, method of application and use. EPA says the system appears to work. That remains to be seen. Even EPA qualifies the system by reserving the right to move on other chemical pesticides that may grab the public limelight. For now. they are just trying to get a handle on what appears to be almost a lifetime job of reviewing the existing pes ticide registrations. Q Biotechnology into profits: Some first and second thoughts There are over 38,000 pesticide products now registered with the Environmental Protection Agency (EPA). And, according to the amended Federal Insecticide. Fun gicide and Rodenticide Act, EPA is supposed to review each and every one of them. That's a monumental task that the agency proposes to handle by clustering the active ingredients in the pesticides by similar uses and then, if that doesn't make the clus ter manageable enough, they intend to break the groups down even further by sites on which they are applied. Bui clustering is only the first step. The whole idea here is to rank these pesticides so that the over worked EPA can decide where to start. The ranking will be based on such factors as production and ex posure. The agency has developed a simple equation, with its own inter nal complexities, to give point val ues to each of the more than 600 active ingredients that go into the pesticides. It was in December of 1979 that EPA first proposed that it would re view the products baaed on their active ingredients, so that products with the same active ingredients can be registered under the same standard. Despite all this planning and prioritizing. EPA estimates that it may take 15 years for review of all registered pesticides. First come, Aral reviewed Under the EPA scheme, a cluster is a group of chemicals and e group of sites that are related. For examples, the 10 insecticides registered for use on citrus and gripes make up a duster. But even before this kind of grouping, the agency made some use categories. Chemicals were di vided into insecticides, herbicides, growth regulators, and preserva tives for example. But. while growth regulators was a small group, insec- EPA plans to chfjter groups of pssfwdM to ass tf>e btir&n of performing safety lusts. such as tn<s anafysi* of Otooa samples from rsat ammeJ*. on ffi* 36.000 p+st'ciOm currently Joprtterefl. The matter of splicing genes to manufacture biological entities never before produced to ac complish tasks never before done (or done as well) is still stirring up some interesting business arrange ments. Allied Chemical has bought a 10% interest in Bio Logical*, a one and one-half year old Toronto-based biotechnology firm. Genentech, one of the hottest new stock issues last year, has an agreement with Fluor, the engineer ing and construction firm, to examine applications of genetic en gineering to process and plant con struction. The first British biotechnology firm hss been formed with |30 mil lion in investments from private and public interests. But while aQ this maneuvering is going on to take advantage of the financial potential of genetic en gineering, Harvard University is having second thoughts about get ting too involved (ICN, December I960). The equity Allied will put into Bio Logical* reportedly will be used to fund research into the uses of bio technology in the production of in dustrial specialty and agricultural chemicals. It is all part of Allied's "long range plan to accelerate and direct research and development into high technology areas." says Richard Ashley, president of Al lied's Chemicals Company. Bio Logical* specialty is the application of genetic engineering techniques to yeasts. It has yet to produce a commercial product. Also with no products of it* own. Genentech will explore with Fluor the process engineering applica tions of genetic transfer techniques. Fluor will supply Genentech with data on the economics of new plant construction, including estimates of capita) and operating costs, market potential and financing alternatives. The two companies will, together, asses* application of bioengineering developments resulting from Genentech'* technology. Celltech, the first British bio technology company, has an agree ment with the Medical Research Council that provides the company with a "framework" to give it ac cess to research the lab is carrying on. The new company also has an arrangement with the National Re search Development Corp.. the public corporation that is the re pository for all patent rights for re search done at university and public laba in the United Kingdom. The company will be owned 44% by the public corporation the Na tional Enterprise Board. The re mainder of die shares will be di vided equally between the Pruden tial Assurance Co., the Midland Bank. British and Commonwealth Shipping and TDC. a venture capi tal firm- The concern over the environ mental ramifications of genetic en gineering has now taken the back seal to a new concent. Can univer sities maintain their positions in society while pursuing the potential profits from the research they are sponsoring? It is an old question but it has received a new emphasis by the great potential of genetic en gineering. Nevertheless, the answer from the universities appears to be no go. S i n in iu"'utst r|triiurrc'sT urttQ nwm A BILL PUBLICATION VOL. NO. 1 BDITOUA2. Hllortil UrNtor Malcolm W. RUey Mllar Irvin J. Bohwerts AMinut Editor Susan Struthers ViiUa|loa Bdltor Dorothy bwhia Ait Unatar Charles E. Garb OoaMtattal MUw William Bennett* Joseph Hixson Gray Weaver BouS at AMiery Mtteni John Amsy, PhD. John Babcock, Ph_D. Alred B. Brown, Pb-D. BuaaeU Drago, PhD W. Alec Jordan David Sheets, PhD. ItHialMt Raymond H. Lewis Dll*eta N Trm--no Leonora temllak Susan anfiiMy* Joan R. Balsam IhAui' Service Florence Isola Dlreetor ofMraltttea John S. Predate Assistant Olieilattn BM|W Judith Giordano BasInTBT Ms--<sr Charles Indloh OwsSeW Sees e suStknad wawssr by uMeabcni Ine.. 03 ThM A**.. M.Y.. H.Y. lephona; MSI SOC e tWO by taH Nmm. At nee rmtrma tifminimi* m * pieiweiani M Cenede. tSl: JmiiUti A aspMi >n he US. M Cotta. tl Ora`firrifrr in msi n rnnniiHM nm--rn n*M o Caet tan--wrg. M mi tamd ftnw 7SW Oeataan Pta. tap ' Mta, asa tom --.. m y.. mV inn f^ABP JANUARY 1081 Oevtr Oo--etir chlji, a molatlaa 1a chemical analysis Tor analytical chemistry, the introduction of microelectronics hm caused revolutionary changes In the manner, speed and depth of chem ical analysis. And the revolution Is still going on. Improved micro processor-based Instruments for chemical analysis are lowering ooets, and improving capabilities and easa of operations. Patent rights: When do-- an employes own an invention? The rights of employar and employee to an invention by en employee during employment gives rise to soma prickly problems. Wes e contract entered into between the parties assigning inventions from employee to employer? If not. was the employee specifically "hired to invent," or was the employes merely s general employee? if a general employee, did he make the invention on company time, using company materials or labor? The issues are examined in this pieoe by a noted patent attorney. Chemical lab safety: Borne ssts of ml-- All the public turmoil over occupational and environmental effects from chemical ha--rds appears now to be filtering down to the laboratory level. 06HA is preparing a set of criteria for safe operation of chemical labs, including guidelines for oontrollng exposure to car cinogens And the NRC has prepared a new report that offers detailed praotaoee for all types of laboratories where chemicals are used. It Orystal ban se-- Washington boosting in, blasting rega- lotlon How win the new Reagan administration impact on the Ufa of the Industrial chemist? This analysis of the new administration's ex pected policies toward research and development spending and regulatory reform contains some good news and some bad news. to Why Bo-- the VJ. lag In innovation? The results of a Conservation Foundation study examining a per ceived lag In technological innovation in HR. industry are pre sented here. The stud? lays the mum partly on government regu lation and reoommends regulatory reforms and information gathering. IV Bmrtew west-- at Lora flsnsli What are the offsets? This presentation of a study done by a panel appointed by Hew York state to review the scientific studies of the health effects of a chemical waste dump at Love nenei contains some criticisms of government agendas and the original studies which conclude that the nbimiBii dump adversely affected the health of some Love residents. V Opinion V Reader's Respond T Hews Chemlcale/Xqulpmant 10 Hews VS Washington Wire M PMN Roundup II Patents Review BB Research Reports BB Books I? Readers' Servloe Card BB Classified URL 05055