BIOPESTICIDE REGISTRATION WORKSHOP
BPIA OVERVIEW

         First, I'd like to thank Jerry Baron and the rest of the IR-4 group, as well as Dr. Janet Andersen and her group from EPA and Wendy Sexsmith and her group from PMRA, as well as David Supkoff and the people here from the Republic of California.

         I've had a several years experience in the biological regulatory business and I’m representing the entire industry right now. I've worked for 20-plus years at Abbott Laboratories, which is now Valent BioSciences. I now work as Regulatory Director for Emerald BioAgriculture out of Lansing, although my offices are in Placitas, New Mexico.

         When Jerry asked for a show of hands of domestic and international representatives at this meeting, I wasn't sure if I should raise my hand for international or national. A lot of people don't think that New Mexico is part of the United States. We really are part of the United States. And I can read and write English.

         From an historic perspective, biopesticides are very small piece of the overall pesticide use in the United States and globally. And back in 1988, 1989, when the Bt standards came out, a group of people got together to form a consortium. It was Abbott, Ecogen, Mycogen, Sandoz, DuPhar and Novo Nordisk who joined the consortium to work out the common problems that we saw.

         And one of the things we were pushing for was a branch of the registration division of the EPA that will just look at biologicals - microbials and biochemicals. We got our wish beyond any hope - an entire division for Biopesticides (BPPD) was formed, rather than just a branch. We felt that the NACA group - then called ACPA and now onto some other iteration, was really focusing on synthetic chemicals.

         The Bt consortium formed a biological group within the IBA - International Biotechnology Association, which then became Biotechnology Industry Organization, BIO. However, the last few years, much of their resources and time went to the Plant Incorporated Products PIP’s. So we formed a new group in May 2000 - the BPIA, Biopesticide Industry Alliance.

         We are a coalition of companies in the biopesticide industry; and we have ad hoc members, including people who are regulatory consultants. We have, as members, the IR-4 which has taken a very active role in our area. We also have USDA and Forest Service as ad hoc memberships.

         There are 32 voting members of the group – a voting membership is one company. With some companies we have more than one member in the committee. We have more than 32 members in addition to seven ad hoc members.

         Major criteria for membership -- and there is a lot of flexibility -- is that the company should have at least 50 percent of its business in biopesticides. And the reason why there is flexibility is because, for example, Valent BioSciences is a part of a larger corporation which is involved in synthetic chemicals. If you would like to speak about membership, just talk to one of us who are going to be here and will be at this reception this evening and we can talk to you further about it.

         We have a major mission in the BPIA. There is a global mis-perception that biopesticides, in some cases, are snake oils, and that they are not as effective as synthetic chemicals. Our mission is to improve the global market perception about biopesticides as effective products, which they are. And we also want to help facilitate successful registration of this product globally. We focus on two classes of biopesticides, the microbials and the biochemicals - biochemicals with the U.S. EPA also includes pheromones.

         First thing we want to do is to develop an industry seal of approval to demonstrate that biopesticides are effective and are high-quality alternatives to traditional chemicals. And this doesn't mean that a product has to be in a company that's a member of BPIA. This is not a criterion at all. But it will have to meet the seal of approval which I'll discuss later.

         We also have a very key goal which is to develop a strong working relationship with our government regulators. We've been able to do that so far with the U.S. EPA, with PMRA, with IR-4, and with other agencies as well. We want to disseminate guidelines, policies, procedures to the industry and to other stakeholders.

         As I said, there have been several offshoots of these various groups starting with Bt standards group back in 1988. But we had our first meeting on the 19th of April in the year 2000, a little over a year and a half ago.

         We met in D.C. with nine people representing seven different companies and one ad hoc regulatory person. Currently, we try to have three meetings a year, one in Washington, D.C., one in California, and we like to have one in Canada as well. We like to have that one in June if possible. Ottawa in June is quite lovely; it's lovely in December, too. But it is particularly lovely in June and a little warmer, too.

         We have five different formal committee which we've set up. One is, of course, the steering committee. Another is the legislative committee. We have a regulatory committee, a membership committee, and a standards committee.

         We also have two working groups, one of which is called the "Section 18 Working Group" Per that group, we feel very strongly within the biopesticide industry that when Section 18's are initiated and granted, that biological alternatives are not always looked at. We don't think that's right. There are a lot of very effective biological products out there and we want to make sure they are looked at, too. So we have a working group looking into Section 18’s - those that have been granted in the past and those that are hopefully -- not necessarily going to be granted.

         We also have a working group that works with California’s DPR right now looking at the efficacy guidelines of the DPR. Our regulatory committee has met with regulators, and we've met three different times with Dr. Andersen and her group here in Washington DC. We've also met with Wendy Sexsmith in Canada, and we've met it California as well. There’s been some very helpful and useful dialogue at these meetings..

         Our standards committee is the one that is working towards the set criteria for the industrial seal of approval, and we're not sure exactly how it is going to go. What we do know is that when this seal of approval is granted, it’s going to be on the product in some way, perhaps on the label. The seal will acknowledge that the product is efficacious.

         We've also secured membership in the Pesticide Program Dialogue Committee(PPDC). This is a group organized under the auspices of the Federal Advisory Committee Act. It's a public forum which has provided advice to the U.S. EPA regarding various types of regulatory, and scientific issues. The committee is meeting next month in Crystal City.

         And, finally, we want to have an open dialogue and discussions which we feel benefits everyone in the industry. One does not have to be a member of the BPIA to take advantage of the BPIA. We have open meeting and we want to be as open as possible. And I'd be delighted to open up discussions if you have any questions about the BPIA. There are several BPIA members in the audience.

         Dr. Andersen asked everyone in the audience who is a member of the BPIA to please raise their hands. She was pleased to see such a large turnout. Per Dr. Andersen, we've got good representation, which is a very positive thing.

         MS. SEXSMITH: Just a kind of a comment to Gary. At OECD, currently, it's the International Biocontrol Manufacturers Association that sits representing biopesticides. And I guess if BPIA isn't closely linked to them, I suggest they find a way to do that. So that's kind of my comment. I think in the next few years, there's probably going to be the potential for a lot more activity in that group which I think would be -- North American type things. IBMA tends to be a little bit more European-focused.

         MR. LIBMAN: That's an excellent suggestion. We even discussed this in our meeting last June in Ottawa. But we've going to discuss it in our next meeting which is in D.C.,

         Any other questions?

         AUDIENCE MEMBER: Do you have a web site?

         MR. LIBMAN: We do not have a web site. You know that we should, and we will. Since we don’t dues yet, the BPIA doesn’t have a lot of money. We are talking about a web site, potentially. If anybody has information, I can just give you my e-mail address. It's Glibman@att.net. And you can grab hold of one of us at the reception tonight and any of us can talk about this.

         And there any other questions? Thank you for giving me the opportunity to speak about this excellent organization.

         Gary Libman