NEWS OF THE WEEK
BIOTECHNOLOGY SETBACK: USDA suspends vaccine license The efforts of biotechnology companies to bring live genetically modified organisms to the marketplace suffered yet another setback last week. In response to a petition by biotechnology opponent Jeremy Rifkin, the Department of Agriculture last Tuesday suspended a license it had granted Jan. 16 for a biotechnologically produced animal vaccine. The product, manufactured by Biologies, an Omaha-based division of TechAmerica, is the first living genetically altered vaccine approved for use. The suspension closely follows recent Environmental Protection Agency actions both to fine Advanced Genetic Sciences and to withdraw its permit for field tests of a modified bacteria strain (C&EN, March 31, page 6) and to postpone approval for field tests of different modified bacteria by Monsanto (C&EN, April 7, page 5). Those developments along with last week's USDA action lead many sources to believe that federal regulatory agencies in general will now be taking a harder line toward applications to introduce recombinant DNA organisms into the environment. As a result, commercialization of agricultural biotechnology products could be delayed. In a nearly concurrent development, the General Accounting Office three weeks ago released a report that says that USDA "needs a clearer definition of its regulatory structure, particularly with regard to approving requests to deliberately release genetically engineered organisms into the environment/' The specific issue raised by Rifkin last week concerns a live genetically modified vaccine for swine pseudorabies, a herpes virus that causes large losses each year in U.S. pig herds. The issue centers on the 4
April 14, 1986 C&EN
question of whether USDA regulators properly followed their own procedures for testing and licensing a recombinant DNA product. Less prominent in the petition was the question of the product's safety. Rifkin's petition charged that the Animal and Plant Health Inspection Service (APHIS), the USDA agency that oversees licensure of veterinary vaccines, violated the National Institutes of Health guidelines for research involving recombinant DNA products. According to Rifkin, the licensing application should have been brought before Agriculture's Recombinant DNA Research Committee, a review body formed in 1976 to oversee and coordinate biotechnology matters among USDA's agencies and with outside bodies, but which has no statutory authority. In addition, he said that a formal assessment of environmental impact should have been conducted. In a letter to Rifkin explaining the license suspension, APHIS administrator Bert W. Hawkins said that, although the agency still believed it had proceeded properly in licensing the vaccine, it would formally document an environmental impact assessment of the product, something that was done informally before, according to USDA sources. The formal impact assessment, which will be compiled from data already in the agency's possession, will be completed by April 22, the date on which the license suspension is set to expire. In reply, Rifkin sent APHIS a letter charging that this measure was insufficient. "This has to go before the Recombinant DNA Research Committee," Rifkin said in an interview. "It can't be a matter of APHIS acting above the law. This has to be reviewed from scratch,
and there has to be a formal impact assessment." Rifkin also said that APHIS personnel should be held accountable for violating the law by "surreptitiously approving field tests and licensing without the appropriate procedures." Rifkin has given USDA until 5 PM April 14 to respond to these demands. At the core of the issue is divergent interpretation of such matters as whether use of the swine vaccine constitutes an environmental release and how different the product is from conventional porcine pseudorabies vaccines already on the market. According to David A. Espeseth, senior staff veterinarian in APHIS's veterinary biologies unit, APHIS does not consider use of the vaccine to be an environmental release, because the material was shown in tests not to spread beyond
Pig herds in US. each year suifer large losses because of swine pseudorabies
the vaccinated pig. For that reason, he says, department procedure did not require a formal impact assessment. In addition, he says, APHIS considers the vaccine to be extremely close to conventional products. "It is similar to other modified livevirus vaccines," he says. "The only thing different is the mechanismbiotechnology instead of isolation and selection." According to Michael Bartkoski, vice president for operations at Biologics, the amount of genetic change in the company's product, OmnivacPRV, is far less than that in the conventional vaccines currently on the market. In New York Times accounts, which first reported Rifkin's charges last week, non-APHIS USDA officials were quoted condemning the licensing of the product and more or less agreeing with Rifkin's charges that
procedures were not followed. The comments all came from personnel on the research side of USDA. APHIS is on the regulatory side of the department. Several sources remark that the negative comments may stem as much from intradepartmental rivalry as from scientific disagreement. The recent GAO report, for example, comments that "there have been signs of struggle between USDA's regulators and researchers over who will be given prime responsibility for regulating biotechnology." Nonetheless, the issue has created anxiety in APHIS regarding its ability to classify any biotechnologically produced vaccine as so close to conventional products that it can be reviewed using conventional procedures. "The policy could be altered pending the outcome of the current challenge," APHIS's Espeseth concedes. D
Ralston to buy Carbide's battery business Divestitures were the news at Union Carbide last week as the company disclosed that Ralston Purina would buy its battery business and that it would divest itself of another $1 billion worth of assets over the next 18 months. Carbide also said it would be cutting another 1200 jobs from its work force. The battery sale involves substantially all of Carbide's worldwide battery products business. The only operation excluded is the battery products business of Union Carbide India Ltd. Earlier, it sold its interest in Sony Eveready to Sony Corp. for $12 million. The sale to Ralston Purina is for $1.4 billion, a figure that analysts say is reasonable. The company still has the rest of the consumer products businesses to sell. When that is complete, the proceeds, exceeding the book value of the operations of $1.1 billion, will be distributed to holders of a special right that was distributed to shareholders as part of the successful fight against takeover by GAF. The additional divestiture program disclosed by Carbide involves the company's 611-acre Danbury, Conn., headquarters site. Carbide
president Robert D. Kennedy says the company will retain its headquarters at the site, but the property will be developed as a commercial complex over the next several years. Just what form divestiture of the headquarters site will take has not been specified. In addition to the headquarters site, the company will divest further, but unspecified, assets over the next year and a half. On staff reductions, Kennedy says corporate and company staff, both in the U.S. and overseas, will be cut by about 1200 people in addition to personnel directly associated with divested businesses. He says that special severance programs will be available for the 1200. The personnel cuts are necessary, according to Kennedy, to reduce the 25% of overhead formerly borne by the company's divested businesses. Kennedy also forecasts 1986 capital spending of $675 million, up from $670 million in 1985 and $649 million in 1984. For 1987, planned capital spending, following the divestitures, will be about $570 million. R&D spending in 1986 will be about $191 million, down from $207 million in 1985. G
U.S., Soviet science academies renew ties After more than a year of negotiations, amidst criticism from some quarters, the National Academy of Sciences has signed a new agreement on scientific cooperation with the Soviet Academy of Sciences. The two-year agreement calls for exchange visits of scientists, bilateral workshops, yearly meetings of leaders of the two academies, and development of cooperative research activities. NAS is in the vanguard of a movement to resume ties with Soviet scientists by a number of U.S. scientific groups and federal agencies, including the American Chemical Society (see page 24). Those organizations and individual U.S. scientists drastically cut back such ties in early 1980 in response to Soviet occupation of Afghanistan and actions against Andrei Sakharov and other dissident Soviet scientists. NAS let its agreement with the Soviet academy expire in 1979, dropped bilateral seminars and official meetings with Soviet academy leaders, and confined its ties to exchange of individual scientists and semiannual meetings of a joint committee on arms control. The pact differs significantly from previous NAS-Soviet agreements. Its provisions likely will satisfy most critics of NAS-Soviet ties, NAS president Frank Press tells C&EN. It should ensure mutual benefit and access to the best Soviet scientists and research in a number of areas, he says. The pact states that the programs will adhere to the principles of the Helsinki Accords (which include free scientific communication and respect for human rights). Programs and participants will be selected jointly. But special emphasis is put on invitations—for example, U.S. scientists inviting specific Soviet scientists to visit—rather than just leaving choice of scientists to the sending side. Programs can be suspended or canceled if one side believes the pact's principles are being violated. Annual meetings of academy leaders will review programs. Press stresses that the agreement April 14, 1986 C&EN
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