The company named it Harvade, a play on "harvest aid," and from all indications it looked like another great new agricultural chemical, just what farmers needed to make the cotton harvest easier.
Uniroyal Chemical Co., following federal requirements, sent results of a long series of laboratory tests on its product to the Environmental Protection Agency here with a request for registration approval.
EPA checked the lab data, decided Harvade posed no threat to public health and late last summer, just in time for the fall harvest, approved the compound for general marketing to cotton farmers.
But EPA's official evaluation, giving Harvade a clean bill, was a ringer. An agency scientist had copied Uniroyal's findings and passed them on as his own. A CHEMICALHARVEST PART 2
Officials insist that the fabrication was a freak event, even though they have detected phony reviews of other pesticides. But some EPA scientists and members of Congress call the Harvade case an inevitable result of the Reagan administration's approach to regulating public health effects of pesticides and herbicides.
Critics on Capitol Hill and in the environmental movement contend that the administration is bending over backward to placate industry, approving as many agricultural chemicals as possible without adequate review of their potential danger and moving subtly toward relaxation of policy on carcinogenic substances.
Environmental Protection Agency officials reject such charges, arguing that they have "streamlined" the regulatory process, reduced burdensome paperwork and removed "contention" from agency dealings with industry, while still respecting public health safeguards.
The arguments about agency policy are more than symbolic jousting. The agency's decisions on pesticide approvals and on foodstuff tolerance levels directly affect public exposure to chemicals that carry severe health and environmental consequences. At their worst, they cause cancer, nerve-system disorders, birth defects and other horrors.
But management "streamlining" by EPA associate administrator John A. Todhunter and his boss, Anne M. Gorsuch, has raised new questions about the agency's effectiveness.
Sharp budget and personnel cuts have increased the workload. Scientists are under greater pressure to process registration requests quickly and wipe out a mammoth paper backlog. Performance is rated in part by the amount of paper processed.
"There is an emphasis on numbers," one EPA scientist said. "People here will comply, but the numbers won't mean anything . . . . This pressure will take its toll. Science is becoming an assembly line. It is only a matter of time until errors start showing up in the reviews and on the registrations."
Todhunter rejects such ideas. He said in an interview that "buck-passing" has been reduced through EPA's emphasis on improved management. He said the Reagan administration is "no more lax or stringent" than its predecessor, although he stresses less "confrontation," a change that industry spokesmen agree they find now at EPA.
Said Luther Shaw of the National Agricultural Chemicals Association: "There's a much more positive atmosphere. You call EPA now, and they call you back . . . . They are very cooperative, willing to work out problems . . . . There don't seem to be many complaints from our members now."
Some examples of other changes in the EPA's approach:
* Even though the workload of the office of pesticide programs (OPP) has increased, the administration has reduced its overall budget to $51.5 million from $64.6 million when President Reagan took office.
* About $10 million of that came from the pesticide office's personnel budget, wiping out 160 jobs. At its peak, in fiscal 1980, the office had 829 employes; today there are 537. The fiscal 1984 OPP operations budget, exclusive of personnel, calls for $19.6 million, compared to $24.4 million two years ago.
* A report by the subcommittee staff of Rep. George E. Brown Jr. (D-Calif.) charged last month that the administration has relaxed regulation of cancer-causing pesticides, bypassing standard risk assessment procedures. EPA denies this, but a panel of nationally known scientists is reviewing the report at Brown's request.
* Approvals of state-sought "emergency" exemptions or "special needs," allowing pesticides on crops for which they are not ordinarily approved, increased from 180 in fiscal 1980 to 750 in fiscal 1982. Dozens of crops on millions of acres have come under this expanded coverage. Critics see this as an attempt by states and companies to skirt requirements that pesticides be registered for specific uses at specific tolerance levels.
* Pressure on scientists is exemplified by a headline on one internal agency document: "BACKLOG REDUCTION--OUR MOST IMPORTANT PRODUCT." The message apparently has sunk in. EPA records indicate that, by the end of September, all but 53 of 10,374 new and inherited registration, emergency exemption and tolerance actions--each requiring careful scientific review--had been processed.
* EPA professionals complain that performance standards--akin to contracts--have been imposed on them with little regard for work quality. "OPP has hard-working people," one scientist said, "but they are being pushed into the ground. There are different expectations now. Management has no understanding of the resource limits . . . morale stinks."
In line with that, the report prepared by Brown's House Agriculture subcommittee staff held that some EPA scientific reviews "have been superficial and may have missed important potential problems." The study recommended that scientists be given adequate time to do thorough work and that the agency expand its laboratory audit program to "act as a deterrent against shoddy science."
On another score, agency scientists complain that their work is sometimes ignored or speeded up so the administration can satisfy chemical companies' demands for quick action on requests for registrations or tolerance levels on their products.
"There is concern about scientific decisions being pushed on us by nonscientists," one scientist said. "There is a bending over backwards to help industry; we are taking more risks."
In one such case, involving a widely used and controversial fumigant called EDB (ethylene dibromide), an EPA toxicologist recommended in 1981 against a request for a tolerance level that would allow its use on soybeans. Too risky to humans, the scientist said.
But OPP director Edwin L. Johnson approved the permanent tolerance for EDB before the toxicology review was issued. He apparently never received the review. John Melone, head of the hazard evaluation division, ordered that the new risk assessment not be sent to Johnson.
"There is no need to prepare a formal nonconcurrence letter on the EDB soybean tolerance," Melone wrote in a February, 1981, memo. "Johnson has signed the permanent tolerance. Stop the presses (or typewriter)."
EDB, a known carcinogen, has been on the market for at least a decade, and more than 300 million pounds a year had been sold for use on grain and fruits and as a soil fumigant. In addition to these uses, the Brown subcommittee investigation found, 104 special local-needs approvals had been granted for other EDB applications around the country through last July.
Todhunter and other EPA officials assert that while EDB's toxicity is well known, its dangers are not unreasonable and its continued use is justified.
These and other examples are almost certain to be raised when Congress resumes consideration of an extension of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the law that governs pesticide regulation. The House passed an extension, but the effort bogged down in the Senate late last year in a dispute over industry's attempts to broaden the law.
A coalition of environmental, health, labor and consumer organizations has decided to mount a major effort this year to persuade Congress to tighten FIFRA and keep a closer eye on EPA regulatory changes. The coalition is planning more litigation and a public education campaign.
Al Meyerhoff, a California-based attorney for the Natural Resources Defense Council, said recently, "We have a sense that the strong House vote last year, rejecting major changes the industry had sought, and the November election results will give us a better chance on FIFRA."
He added, "The feeling in our coalition is that we have gone from a rather neutral Carter administration, which did no affirmative harm, to a period of gross malfeasance at EPA. The state exemptions, for example, are incredible--a complete subversion of the law, giving industry carte blanche to use pesticides on crops they are not registered for.
"EPA is simply looking at the needs of industry and getting as many new products on the market as quickly as it can."
The agency came under more criticism last week as a bipartisan group of 26 senators and congressmen demanded in a letter to Gorsuch that she rescind new rules, issued in December, limiting the release of pesticide health and safety data to the public and scientists.
The group, led by Sens. William Proxmire (D-Wis.) and Patrick J. Leahy (D-Vt.), told Gorsuch that her new policy was "unacceptable." They said the rules, ostensibly to protect industry trade secrets, ignore federal law and "violate the will of Congress."
The House of Representatives and the Senate Agriculture Committee last year rejected the same industry-sought disclosure limitations that EPA announced just before Christmas.
As Congress wrangled last year over FIFRA, the Environmental Protection Agency was going through its own wrangling over Harvade. The toxicologist assigned to review it copied the Uniroyal summary almost verbatim and sent it up the review chain. Like Uniroyal, he found no problems. And his superiors, assuming his thoroughness, raised no questions. Harvade was approved in August and promptly went on sale. But weeks after the product was approved, a red flag went up. An agency reviewer, M. Adrian Gross, spotted the fabricated report while conducting a random laboratory audit of the Uniroyal data. His audit found evidence that suggested Harvade could be a threat to public health.
The findings, sent through channels to higher-ups, touched off a furor inside the agency. EPA officials admit that this was not the first recent instance of "cut-and-paste" copying of company reports by toxicology reviewers, but they refuse to identify other cases involved.
Melone agreed that budget and personnel cuts have increased his division's workload, but he rejected the notion that scientific quality had been impaired or that the Harvade case evolved from new agency pressure on employes. He said strict orders had been issued against more cut-and-paste science.
In the case of Harvade, the reviewer was warned, but officials said no further disciplinary action was taken because of extenuating circumstances. EPA reopened the files and is piecing together more data on the health potential of Uniroyal's compound. Depending on the findings, registration of Harvade could be revoked or left intact.
Melone said danger was minimal because Harvade never reached the market and, in any case, could not be used until cotton harvest time this year. According to Uniroyal officials, Harvade went on sale after its registration last August and was used by farmers.
It remains on the market and, depending on the outcome of the new EPA review, Uniroyal is preparing to promote Harvade widely.