Document Em8bRVaLzvvqV76QoK0JzD4wb

News URL 03605 Being practical over carcinogens Is the Food and Drug Administra tion's (FDA) decision on lead acetale 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 0.5 micrograms of lead acetate that might be absorbed through the scalp from use of hair dyes is not significant. The agency plans t o 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 1973. "By any reasonable standard, lead acetate must be regarded as safe foT 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. b Clusters of pesticides; the BPA way to registration 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 Acl. EPA is suppose^ 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. But clustering is only the firsl step. The whole idea here is to rank these pesticides so that the over worked EPA can decide where to start. The ranking w ill 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 based 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, first reviewed Under the EPA scheme, a cluster is a group of chemicals and a group of sites that are related. For examples, the 10 insecticides registered for use on citrus and grapes make up a cluster. 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 duatt' ptoups o< pest'ciOas to mm rite button ot performing salary rears. auen as this analysis of biooO samples from last animals, on the 36.000 pesticides Currently ragiatereO 10 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 diamidfot 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 designing the clusters is only the first step in CPA's 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=*f2E,+El fP>: E,is human exposure, E* 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 lbs/year) ranks a 5. medium a 3, and low (under 25.000 lbs/yean 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 Che right to move on other chemical pesticides that msy 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 The matter of splicing genes to manufacture biological entities never before produced to ac complish tasks never before done (or done as well.i is still stirring up some interesting business arrange ments. Allied Chemical has bought a 10% interest in Bio Logicals. 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 has been formed with 130 mil lion in investments from private and public interests. But while all 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 1980). The equity Allied will put into Bio Logicals 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 pan 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 Logicals specialty is the application of genetic engineering techniques to yeasts. It has yet to produce a commercial product. .Also with no products of its 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 capital and operating costs, market potential and financing alternatives. The two companies will, together, assess application of bioengineering developments resulting from Genentech's 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 labs in the United Kingdom. The company will be owned 44% by the public corporation the Na tional Enterprise Board. The re mainder of the 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 sear to a new concern. Can univer sities maintain their positions in society while pursuing the potential profits from the research they arc 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 he no go. - H INDUSTRIAL CHEMICAL NEWS A BILL PUBLICATION VOL 2 NO. 1 1BITOIIAL KUtorUI Director Malcolm V. Riley Bdltor Irvin J. Schwartz Assistant Bdltor Busan Struthers Waihla|ton Ndltor Dorothy Smith Art Director Charles . Garb eoatrltntlai Bdltor* William Bennetta Joseph Hixson Gray weaver Board of Advisory Bditora: John Amey. Ph.D. John Babcock. PhD. Alfred E Brown, Ph.D. Bussell Drago, Ph.D W. Alec Jordan David Sheets. Ph.D. 2isi APMIWIBTNATION AMD PBODUCnOV PobUaher Raymond H Lewis Director of Production Leonore Temllak Protection Assistant Susan Bngeimeyer Buketlnf iai lcea Manager Joan K. Balsam aadere' Bervlee Florence Isola Dlroetor of Glrenlatiem John S rragaJe Aaaletant Circulation Manager Judith Giordano Business Manager Charles Indich lantiiw Ctiewteel Meet is puWeiwd monthly by BiB Communicslion* Wic . SJ3 Thirt Ae . N V.. N Y 10017' Twsphofx 2is.ase.4Soc iao by mhm CSmmleel Mae*. All nghu mearveo Subscription* m the U.S ns pres--ions end Cwwdt Ms. MewiMrs 140 Sinoi* eepet in the U.S. w>d Cenede. S3; elsemeis S5 Appiieetien to meil et Controlled Circulation ran a pending at Eset Stroudsburg. PA lent Poetnuswr Send form tsra to CircwtdMnOepL.leeusMal CSilddSdl Mm*. 633 Third Are. N Y . N>. 10017 VxABP JANUARY 2061 Cover Oomputer chips, revolution in chemical aaalysls For analytical chemistry, the introduction of microelectronics has caused revolutionary changes in the manner, speed and depth of chem ical analysis. And the revolution is still going on. Improved microprooessor-based instruments for chemical analysis are lowering costs, and improving capabilities and ease of operations. Patent rightii Whin does an employee own an invention? The rights of employer and employee to an invention made by an employee during employment gives rise to some prickly problems. Was a contract entered into between the parties assigning inventions from employee to employer? If not, was the employee specifically "hired to Invent." or was the employee merely a 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: Soma eats of rules All the public turmoil over occupational and environmental effects from cheoiie&) hazards appears now to be filtering down to the labora tory level. OSHA is preparing a set of criteria for safe operation of chemical labs, including guidelines for controling exposure to car cinogens. And the NRC has prepared a new report that offers detailed pradices for all types of laboratories where chemicals are used. IB Crystal ball asaa Washington boosting MB'S, blasting regu lation How will the new Reagan administration Impact on the life of the industrial ohemist? 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 BO Why does the yj. lag In Innovation? The results of a Conservation Foundation study examining a per ceived lag in technological innovation in US. lndustiy are pre sented here. The study lays the blsme partly on government regu lation and recommends regulatory reforms and information gathering. IB Baaardoua wastes at Love Canal: What arc the offoote? This presentation of a study done by a panel appointed by New York state to review the scientific studies of the health effects of & chemical waste dump at Love Canal contains some criticisms of government agencies and the original studies which conclude that the chemical dump adversely affected the health of some Love Canal residents. 6 Opinion Reader's Respond T Meetings B News; Chemicals/Equipment 10 News BB Washington Wire BB FUN Roundup 81 Patents Review BB Research Reports BB Books 8? Readers' fiervioe Card 99 Classified URL 03606