BIOPESTICIDES WORKSHOP 2001
Janet L. Andersen, Ph.D., Director Biopesticides and Pollution Prevention Division
Jim Jones has welcomed you on behalf of the U.S. EPA and the Office of Pesticide Programs (OPP) and Bob Holms has welcomed you for IR-4, so it is now my turn to welcome you on behalf of the Biopesticides and Pollution Prevention Division. Many of the staff of BPPD are here today or will be over the course of the next two and half days of this workshop and I hope you will take this opportunity to meet them.
The last biopesticides workshop six years ago also was co-sponsored by IR-4. Today we are pleased to have the Pest Management Regulatory Agency of Canada as a co-sponsor and to have the California Department of Pesticide Regulation join us too. At times over the last two months we wondered if this workshop would happen. Our focus has often been elsewhere because of the events of September 11th. Some of us has lost family or friends and everyone has been touch by the events that day and since. There certainly was some fear of traveling and some fear of coming to Washington, D.C. But I knew that biopesticide folks were a tough lot–dedicated to their mission–and today we have an overflow crowd for this workshop. I thank all of you who have been willing to spend your time and money to come. I thank the people who have prepared the materials and the people who will give the many presentations over the next three days. In addition, I thank the Biopesticides Industry Alliance and their members who have made possible a reception tonight to allow for more informal exchange. And let me add that as a way of recognizing the importance of this workshop, Marcia Mulkey, the Director for the Office of Pesticide Programs plans to attend the reception this evening. Saving probably the most important note of appreciation for last, I especially thank Jerry Barron of IR-4 and Brian Steinwand of BPPD for their tremendous efforts to make this event happen. It couldn't have been done without them.
For my introductory remarks today, I am going to look back on the history of biopesticide regulation and look into the future for biopesticides, at least from my perceptive. I think it is especially appropriate to do this today because tomorrow marks the seven year anniversary of the founding of BPPD. Biopesticide registrations in the United States date back to the 1940s and the beginning of FIFRA. The first record I find for a biopesticide is for oil of mustard as a repellent and the first microbial pesticide registered was Bacillus papillae for control of Japanese beetles. Products with these first biopesticides are still around today. But it was not until late in 1994 that there was a Division just for biopesticides. Before that time, OPP staff often had to steal away time from registration activities for synthetic chemical pesticides to work on registering biopesticides. BPPD was established as a pilot to determine how an organization with a streamlined staff to management ratio would work in OPP and EPA. The pilot was given the mandate from our Assistant Administrator for Prevention, Pesticides, and Toxic Substances to expedite the registration and reregistration of biopesticides and to encourage the adoption of safer pest management practices including the use of biopesticides. During the pilot, we proved we could live up to the challenge of expedited registration and that an organization with an increased staff to management ratio could indeed function. Thank goodness, it was also determined that the Division needed Branch Chiefs as well as a Division Director and Associate Director in order to function.
In 1994, BPPD began with 30 people and we had responsibilities for about 125 biopesticide active ingredients as well as leading OPP's pollution prevention activities. The first active ingredient registered by BPPD was a genetically engineered microbial pesticide; Mike Mendelsohn was the Regulatory Action Leader for that product and I am pleased that he and several of the scientific reviewers for that action are still members of BPPD today. Today, there are 55 people working in BPPD including 20 of the charter members of the Division.
Allow me to pause a moment here and introduce the current management team for BPPD. Kathleen Knox is the Associate Director; Phil Hutton is the Chief of the Microbial Pesticides Branch and Willie Nelson is the Team Leader for Microbial Pesticides Branch; and Sheryl Reilly is the Chief of the Biochemical Pesticides Branch and Linda Hollis is the Team Leader for the Biochemical Pesticides Branch.
In the last seven years BPPD has registered 88 new biopesticide active ingredients and competed the actions to reregister all but two biopesticides first registered before 1984. Today BPPD has responsibility for over 215 biopesticide active ingredients and increased responsibilities for pollution prevention such as the Agricultural Initiative important for adoption of biopesticides that I will cover a bit later. That means that in just seven years alone we have increased the number of registered biopesticides by over one-third compared to the number registered over the previous 53 years. Clearly we have achieved the goal of expediting the registration of this class of pesticides. We are providing safer alternatives to many of the more toxic pesticide products and I believe the future for biopesticides is very good. However, I do recognize that there are constraints to adoption of biopesticides such as new techniques farmers have to use, the difficulties a small company has in providing field support to farmers compared with major pesticide manufacturers, and some resistance to use of biopesticides because they might not be as effective as chemical pesticides. I applaud the work of BPIA to address the issue voiced by some that biopesticides are not effective.
Let me also mention some of the additional accomplishments and innovations over the last seven years as well as changes to our program. These are not in particular order of importance or chronology, but taken as a whole, show significant advancements made to expedite registration of biopesticides and to encourage the adoption of safer pest management practices including biopesticides.
| • | The RAL Coffee Club as it is called by the BPPD staff. This is not a social activity, but the BPPD regulatory staff meeting to ensure consistency in approach and in regulatory decisions, establish policies for actions, educate each other about the newest policies, and answer questions for new regulatory staff and sometimes existing staff. This group provide a better understanding of existing regulations and policies for us all. It is a highly empowered group who only occasionally come to management for decisions and our input. |
| • | BPPD has a web site just for biopesticides that has received many compliments from users and has inspired other Divisions in OPP to establish web sites too. |
| • | Joint reviews with Canada for microbial pesticides and pheromones. |
| • | IR-4 has established and is running a research grant program just for biopesticides. EPA staff participate as part of the review process for those grants. |
| • | Joint reviews with Canada for microbial pesticides and pheromones. |
| • | The first plant-incorporated protectants (then called plant-pesticides) were registered and we have just successfully completed a major reevaluation of these products including an unprecedented insect resistance management program aimed at protecting the future use of microbial Bt pesticide products. |
| • | There is a much broader range of biopesticide products used in market place today than there was seven years ago and the interest of growers as well as home owners, in such products is growing. |
| • | The workload of the Division has greatly increased as we now must manage the amendments, me-too registrations, and data requirements for conditional registrations of the 215 rather than 125 active ingredients. |
| • | Pollution prevention activities like the Pesticide Environmental Stewardship Program and the EPA Agricultural Initiative have established partnerships between the EPA, food processors, and growers that encourage the use of biopesticides. We have especially seen success stories where these partnerships have resulted in the use of pheromone products to replace reliance on organophosphate insecticides. |
| • | The joint effort between PMRA and EPA to harmonize our data requirements for microbial pesticides and pheromones is a success in itself, but this effort has moved on to result in adoption of our harmonized data requirements by OECD. |
| • | We have the establishment of the Biopesticides Industry Alliance. |
| • | The Food Quality Protection Act requiring higher standards for all pesticides in establishing tolerances and tolerance exemptions, but also giving us a mechanism to rely on FDA regulation for certain inerts. |
| • | The 25(b) rule was finalized. |
| • | The PIP rules, proposed just days before BPPD was established, has just recently become final. |
| • | And the National Organic Standards Rule is final. BPPD is working with USDA during the implementation phase of this rule to establish a program to identify those pesticide products which meet the criteria set forth in the Rule. |
Currently, our registration numbers are down over our goals and the length of time it takes to make a registration decision has increased. There are several reasons I can see contributing to the slowdown, although certainly not all of these apply to all cases. The last year to eighteen months have been challenging for BPPD with the concentration on biotechnology products, especially what we call the PIPs or plant-incorporated protectants. In addition, the increase in the number of active ingredients we manage has greatly increased the workload in BPPD. Another factor is some changes in certain EPA policies and practices that have impacted our registration of new active ingredients. BPPD has been begun analyzing our internal processes to make improvements and working with others in EPA to examine some of the new practices that seem to be slowing our outputs so we can make some changes.
However, not all of the reasons are internal. The quality and completeness of submissions coming to BPPD are not what they should be. For example, we have had applications for a new product containing a new active ingredient with no indication in the package that it was for a new active ingredient involved. This kind of omission makes us do a lot of rework. We get partial submissions. Let me make it clear, we start counting the time to registration on the day we have a complete, acceptable package, not the day the first pieces arrive. Back and forth discussions about missing pieces really slows our progress. One additional item I want to mention is the time it takes away from moving forward to have a registrant repeatedly disagree with us on the data requirements for a product or new active ingredient. I certainly don't mean to single out any company, but rather to put forward my commitment to work with industry to improve submission and frankly reduce frustrations for both EPA and registrants. One of the ideas recently discussed with BPIA is to conduct an analysis of the common problems and determine methods for improvements. One of our first steps here, is for BPPD to provide to those of you attending this conference the internal checklist used by BPPD in some of our regulatory actions. I believe that by working together improvements can be made in all of these areas.
Another frustration I have heard is that some of our guidelines for data requirements are not realistic for what is happening in the field and these guidelines cause the laboratories performing the studies to have significant difficulties. I have heard from BPPD scientists that they believe there needs to be some improvements and in some cases whole new guidelines developed. This is a good area for collaborative work.
Let me spend a few final minutes looking at some of the activities currently going on and some that we can do in the future. First with respect to resources for BPPD, last Spring, BPPD received for the first time significant amounts of contract money to help the registration of biopesticides. It takes some time to establish the necessary infrastructure to effectively use these new funds, but I guarantee there will be improvements from these resources. The funds support not only data reviews, but other activities that can improve our process. This workshop is part of that effort and I plan on have more, especially focused workshops, in the near future. One outcome we plan from this workshop is a guide to registering a biopesticide. We gained a bit in staff numbers last year, but we cannot at this point expect that to continue because OPP is slated to go from 835 staff in 2001 to 816 staff by the end of 2002. We hope for one or two hires this year, but recognize that some of the attrition in reducing OPP by 19 is likely to come from BPPD too. Being able to promote our staff can help us retain them, but there are limitations imposed on us on the number of advanced promotions that can be given. The management team in BPPD is committed to promoting our staff whenever possible and appropriate.
There are good things happening which are not resource driven. As I said, we are looking at some of our internal processes and have made improvements in our front end process as well as changes to our final decision making process. There is a new fast track group working in the Biochemical Pesticides Branch that is really starting to make a difference in the turn around times for fast track actions. Our joint reviews with Canada on microbial pesticides and pheromones continue to receive high level management attention and typically meet our timeline goals. PMRA and BPPD have agreed on a pilot to reduce the time it takes to make decisions on pheromones to six months. Both PRMA and BPPD are active in OECD work for a common format for submission and decision documents. Wendy will cover that more next. Another area where I encourage a pilot project is in an electronic submission of the registration application and data package. For conventional pesticides, the estimates are about 25 percent reduction in review time for their pilot project on electronic submission. In addition, BPPD is starting to do joint reviews with California. We are also planning and working on a major revision to our web page that should make it easier to find information on biopesticides.
Finally, the most important asset we have are the dedicated staff and management team in BPPD. So I am closing by thanking the 20 or so original BPPD staff still with us for their years of dedication and hard work, the new people who have joined us since 1994 for their contribution to our efforts, and finally all those involved the partnerships we are building and strengthening with PRMA, IR-4, and California's Department of Pesticide Regulation.
Thank you for coming and I hope you have a productive workshop.