Red Tape and DNA

Genetic Research Regulation Keeps Lobbyists Busy

The fight to establish guidelines for recombinant DNA research has raised hackles in every quarter--in Washington over a series of legislative and administrative maneuvering, in Cambridge over the way universities conduct their DNA research, and in the academic community over charges of conflict of interest and exploitation of DNA research.

The furor over recombinant DNA research stems from two considerations--its possible adverse impact on the environment and on health conditions, and its potential lucrativeness. Recombinant DNA experiments involve creating new combinations of genetic material by injecting a piece of DNA into bacteria, possibly giving them new characteristics. Environmentalist critics of recombiant DNA experiments fear inadvertent development of harmful bacteria strains that could not be controlled.

Other critics in the academic community and elsewhere fear exploitation of recombinant DNA research for profit. George S. Wald, Higgins Professor of Biology Emeritus, mentioned a recent court ruling allowing researchers--whether affiliated with academic institutions or industry--to patent any new micro-organisms they develop. The pharmaceutical industry in particular is conducting intensive research, and would stand to gain from any products it develops as a basis for new antibiotics. Proponents of legislation to regulate recombinant DNA cite this possibility of industry profiteering as a rationale for nationwide legislation.

Wald and Jonathan King, assistant professor of biology at the Massachusetts Institute of Technology, also fear academic exploitation of DNA research. Wald says that some "pioneers" of recombinant DNA research are also on the boards of corporations that wish to use the fruits of such research to develop new products, and which fund scientists' experiments. By accepting private, rather than government, funding, researchers do not have to abide by NIH guidelines.

These arguments have persuaded many people that national legislation is needed to prevent exploitation of recombinant DNA research and to lessen the possibility of damage. The existing NIH guidelines apply only to researchers who use government grants to fund their experiments. Private industry can conduct recombinant' DNA experiments with no imposed restrictions or safeguards.


The legislation now before both the House and Senate would extend the NIH guidelines to all recombinant DNA research. The bills have a rocky legislative history. Most of the controversy surrounding the bill revolves around how the federal guidelines would affect the status of state and local governments' restrictions on DNA research. The House bill contains a clause providing for uniform national standards for regulation that would override any local regulation. If a local government wished to apply a stricter standard than the federal guidelines, it would have to apply to the Secretary of Health, Education and Welfare (HEW), who would administrate the guidelines. Critics of this clause protest it would not give local governments enough leeway to regulate DNA research in their own communities.

Harvard firmly believes the federal government, not the local governments, should control standards, and has lobbied intensively to ensure that the House and Senate bills contain this clause. The current House bill is a compromise between congressmen's diverging views on this clause and Harvard's determination to see federal control of DNA regulatory standards. Much of Harvard's determination stems from friction with Cambridge over recombinant DNA experimentation. City Councilor and then-Mayor Alfred E. Vellucci spearheaded a drive to ban all recombinant DNA research here. After a series of public meetings, the Cambridge City Council imposed in the summer of 1976 a three-month moratorium on all recombinant DNA research, later extended for four more months. The city council also set up a citizens' board to review and evaluate recombinant DNA research, which recommended permitting research following the NIH guidelines. During a stormy session in February 1977, the council approved the recommendation, ending the moratorium.

Many Harvard professors bitterly resented the moratorium, which they felt slowed the progress of their research while scientists from other universities made significant discoveries. An example occurred in the spring of 1977, when researchers at the University of California made a discovery that workers in a Harvard DNA lab said they could have pursued if they had not been banned by the regulations.

Wald says the moratorium was "unprecedented," but unlike many of his colleagues, he believes it accomplished a useful purpose in bringing the issue of recombinant DNA to the public's attention. This is as unusual as it is important, "because everything possible is done to make them think the issue is beyond their comprehension," Wald says, adding that many professors did not support his position. "People in the Biology and Biochemistry department were exceedingly eager--passionately anxious, in fact--to get on with their research," he says.

But he adds there exists a group of professors who supported the public's right to check the research who nonetheless remained silent in the face of University administrators' lobbying for the federal override clause.

The original bill, sponsored by Rep. Paul D. Rogers (D-Fla.), contained strong language on federal standards, but when an amendment softened the bill's language, Harvard withdrew its support. Rep. Harley O. Staggers (D-W. Va.), chairman of the House Interstate and Foreign Commerce Committee's subcommittee on Health and Environment, asked a Harvard lobbyist to draw up a new bill. Staffers associated with drafting the DNA legislation said the Harvard bill contained errors in procedural language, and said Rogers developed an alternative bill. Rogers persuaded Staggers to accept this bill, which restored the strong federal override clause. The bill has now passed out of committee and should be considered by the full House shortly.

The history of the Senate bill is equally convoluted. Unlike the House version, the bill does not contain a provision for strong federal override. Sen. Edward M. Kennedy '54 (D_Mass.), the bill's sponsor, is a strong supporter of local governments' right to enforce guidelines more stringent than the federal ones. Kennedy's strong stand against total federal control of standards may be one reason for the legislative confusion presently surrounding the bill. Knowledgeable aides say many influential senators do not support Kennedy's position and that the bill will probably not pass the Senate without some form of the federal override clause. Aides' predictions vary, but rumor on Capitol Hill has it that Kennedy is growing less and less enthusiastic about the bill, and may withdraw it altogether.

Kennedy and Sen Adlai Stevenson III '52 (D-Ill.) have already explored an alternative to legislation. They sent a letter in late May to Joseph A. Califano Jr., secretary of HEW, asking him to consider the possibility of using section 361 of the Health and Public Safety Act, which would enable him to impose the NIH guidelines on all DNA research without special legislation.

HEW has already taken a position against such a proposal. In a letter sent to Kennedy a few weeks ago, signed by Hale Champion, Harvard's former financial vice president and now undersecretary for HEW, he expressed his support for new legislation, and explained that department lawyers had advised that the secretary might exceed his authority if he invoked section 361. However, a source involved in monitoring DNA legislation, who asked to remain unidentified, says there are indications that Califano may reconsider the policy, especially if legislation is tied up indefinitely in Congress, a situation Kennedy's inaction on the bill may precipitate.

There were other pressures to ensure that some kind of bill passes, including White House and university lobbying. Joseph Oneck '62, associate director of domestic policy staff, said last week the administration's original bill contained no federal override clause. Now, he says, the administration may settle for a moderate federal override clause that would allow local government more say. "We take a pro-environmental stance," Oneck explained. "Cambridge seems to have worked out a liveable compromise, and we'd hate to override the work of the community," he added.