MeBr Alternatives: Winding Their Way Through EPA

Since the announcement that methyl bromide would be phased out due to its role as an ozone-depleter, the focus has been on finding new alternatives and getting them to market for use by industry. Throughout that time, the Environmental Protection Agency (EPA), the lead Federal regulatory entity, has been responsive to the needs of commercial growers by working with methyl bromide researchers, who are identifying viable alternatives, and the companies that are developing the data to support registration of these alternatives.

The need of the Nation's growers to have an effective replacement, or combination of replacements, for methyl bromide, remains the focus of the USDA-EPA Methyl Bromide Alternatives Working Group. USDA's Cooperative State Research, Education, and Extension Service (CSREES) and ARS sponsored research programs with IR-4s methyl bromide alternatives research efforts to identify efficacious alternatives. EPA's role is to identify data that needs to be generated and review it to make registration decisions in a timely manner.

The Review Process

To that end, EPA decided an expedited review of methyl bromide alternatives was warranted. The normal time required to review an application for a new ingredient chemical, from receipt to decision, is approximately 31 to 36 months. An expedited review process is completed in about 18 to 22 months.

The long time frame, however, intrudes on the patent-protection period. Since many companies apply for patents before the formal application review process, it is imperative to proceed as quickly as possible. Generally, patents are in force for 7 years, and the amount of time taken for review and approval reduces that patent-protection time. Also, since the product is not on the market during part of the patent-protected period, there is unrecoverable lost revenue during that time.

The path to approval can prove long and laborious. EPA establishes review priorities and schedules for new active ingredients and other submissions for each fiscal year. Because of the extraordinary circumstances surrounding the methyl bromide phaseout, applications for alternatives are expedited—given top priority for review in the scheduling process and are reviewed before other scheduled submissions.

Under the current process, new chemical registrations first undergo front-end processing, for about a month, which includes screening by staff for adherence to format and by scientists for scientific viability. Next, in-depth science reviews, lasting 14 to 22 months, are conducted for health effects, residues on crops, lab validation of analytical methods for detecting residues, worker and residential exposure, ecological and environmental effects, and potential drinking water exposures. Following this, peer review and risk assessments are executed, during which safety factors, hazards, and risks are examined; this takes about 5-1/2 to 8 months to complete. The process then continues with risk management and a regulatory decision—risk assessors review risk-mitigation measures and work out solutions with the registrants. This step takes from 1 to 3 months. If approved, the Federal Register notice is prepared, programwide concurrence is obtained, management signatures are affixed, and the notice is published for public review.

As cumbersome as this may seem, it is speedy by normal standards, but those in industry would like to see an even swifter pace. Bruce Houtman is the global regulatory leader for Dow AgroSciences' methyl bromide alternatives products, including Telone (1,3-dichloropropene) and Vikane/Profume (sulfuryl fluoride). Houtman says, "It is important to understand what an expedited review is and what it isn't. An expedited review shortens the period that the registration package waits for review, but it doesn't shorten any aspect of the review itself. An expedited review is as thorough, complete, and comprehensive as all other EPA reviews. In the case of all regulatory reviews, the process could be made more efficient and provide new agricultural tools to the grower community more quickly by applying additional resources."

EPA Steps To Improve Process

EPA has made considerable efforts to become service-oriented. "EPA has approached perceived inadequacies by knowing and working with our customers—the registrants," says Peter Caulkins, associate director of EPA's Registration Division. Preregistration conferences have proven quite useful to EPA and registrants.

"The chance to sit down face-to-face with agency representatives resulted in better results and an overall positive experience," according to Dr. Randy Deskin, director of regulatory affairs and toxicology for Cytec Industries, Inc. Cytec Industries, based in New Jersey, is a specialty chemical manufacturer with about $1 billion a year in sales and a successfully registered phosphine gas fumigant called Eco2Fume.

Caulkins also believes information provided to registrants can be empowering. For instance, the average rejection rate for data submitted by registrants was 33 percent in 1988. "EPA provided each registrant with their company-specific rejection rate, as well as the rejection rates of their competitors, which provided a tremendous incentive for them to improve," he explains.

"A huge amount of time and resources were being wasted in rework," says Caulkins. "Studies often had to be returned to be upgraded and resubmitted, or studies needed to be repeated." EPA identified the rejection factors that most frequently occurred for each study required, and they, along with company scientists, worked together to find solutions.

This was the first time many of the company scientists were involved with EPA to address specific rejection factors. The cooperation allowed EPA and commercial scientists to identify and solve prevalent rejection factors. The sharing of this information also allowed companies to benefit from each others' experiences in a noncompetitive fashion. By 1998, the industry-wide average rejection rate had been reduced from 33 percent to 3.6 percent. Through a combination of such information and services, registrants have shown an enhanced ability to be successful with their data submissions the first time around.

What's Next?

EPA will continue working with registrants to approve those chemicals which are acceptable to their standards. But the pace of approvals is still slow, according to many chemical companies. "While the agency has been very responsive and communicative, industry feels the process could still be faster," says Deskin.

Houtman says, "The industry recognizes that the limiting factor is EPA resources." To that end, a fee-for-service program, like one in place at the Food and Drug Administration, is being discussed by industry executives. Fee-for-service would involve registrants paying EPA to hire additional staff and contractors to review the applications. However, industry representatives would have to appeal to their congressional representatives to get such a system and the necessary funds, with accountability, in place.

Even with the long registration process, registrants are encouraged. "This is a good deal for the agricultural community because registering methyl bromide alternatives is a high priority for EPA, as well as for registrants," says Houtman.

Last Updated: March 22, 2001