BIOPESTICIDE REGISTRATION WORKSHOP
COMMON PITFALLS IN SUBMISSION

         And now for something completely different. You know, the RALs have their coffee clubs, but us industrial regulatory types are more solitary in nature so we have to do things like form bluegrass bands and so on. So what I'm going to tell you today is how you can keep your own social life going by doing everything so proper that you'll get these registrations and promotions and you can live a nice life. Two things that are key: 1) It's been mentioned a couple times and I'd like to emphasize again. Use the BPPD web page. It is really very well done, and I recommend it strongly. There's excellent links to every place that you need just about. It's really good. Also, the California web page is quite good, too, and it has some very good links. The Canadian one is also excellent. So, really, all three of these groups have excellent web pages. Use them as a strong resource, it’s to your advantage. 2) The other thing is work with your RAL. You've heard the people on the panel – Mike, Brian and David speak about having these registration meetings and speaking with the RAL. I can say -- and Fred Betz will back me up in this as we speak from the industrial perspective -- that these regulatory action leaders are your best friends. They are really very good to work with. Your best interest is their best interest because you both want the same thing, which is a successful completion to the approvals.

         First and foremost, the preregistration meetings are critical. Everybody has mentioned that. I'm going to reemphasize that I can't even imagine sending in something, unless it's a very minor label amendment, without actually meeting with the specific agencies involved.

         I've even had the pleasure of having one meeting with all three agencies at one time (some of it was teleconferencing, but it was quite successful.. It worked out to be a very good meeting.

         You need to be reminded that if your active ingredient is a microbial you have to be aware of the history of your strain. You need to have that information in your dossier. If it's a biochemical -- and this was discussed several times this morning, then the biopesticide committee in the BPPD and U.S. EPA is very important. You want to be able to get it classified as biochemical. Because if it isn't, then you go through a lot of other rigmarole for possible for nothing. So it's very important for you, very quickly in the process, to establish that your product meets the criteria as a biochemical , i.e. naturally occurring, and nontoxic mode of action to the target. At one time, a low use rate was considered an important criterion, but I don't think that's the case anymore. So it's the two criteria mentioned above. It should be naturally occurring in nature and also nontoxic.

         And there is some flexibility there. Again, work with your RAL and you can discuss the ways that the requirements can be flexible.

         When possible -- and this has been mentioned several times today, but it's also good to reemphasize this, try to get involved with joint reviews. The joint reviews really are very good. They are to your benefit. I've had successful ones in the past when we've done joint reviews with California and U.S. EPA, and with Canada and U.S. EPA.

         As I say, learn who that RAL is -- and you can do that by talking to the branch chiefs -- and work with that person.

         You need to request waivers when appropriate, and has been mentioned today several times, you have to have good scientific rationale. Additionally, you have to understand, as Dave Subkoff mentioned, that even if you have a waiver which may be accepted by the U.S. EPA, it may or may not be accepted by the other agencies and vice versa. You have to understand that up front.

         And what I have found, from an industrial perspective, once we send in a waiver we also send it to the other agencies we're interested in. Let them have it up front because it's important to have their perspective on this as well. So, definitely, send it to the other agencies.

         Here's something that hasn't been mentioned yet. And maybe this takes on new meaning because of the horrific events of the last months. Send your dossier by courier; don't send it by U.S. Mail. If you have a consultant in Washington or Sacramento or Ottawa, use them to hand-deliver the package. . Hand-delivering is always a better way to do it.

         And this sounds very casual, but they'll send it back.. They'll send it back if you don't have the correct address or if you don't have the right department number. Even if that person’s is in the same building in Crystal Mall 2, they will not send it on if you don't have the right information. They may be having lunch with that person, but they don't know that person exists when you send mail.

         As to the dossiers themselves, it's been mentioned several times, but can never be reemphasized enough is that you need to format the dossier per PR Notice 86-5 and all the comparable ones in California. Use all the needed forms. As we indicated, the forms are in the web pages.

         You may wish to change the fonts from the US EPA forms. For some reason, unless you have perfect eyesight, it can happen that when you use those form and you put in even the name of the product, it goes to a font of 6 or one equally unreadable.. So you need to change that font and bold it and make it easier for you to read. Because if it's easier for you to read, then your RAL is going to have an easier time with it as well. So will the reviewer. And you can do that. It's not that tough to do. So use those forms but change the fonts.

         This next point should be logical, but it's not always the case. Use clean copies, Xerox it carefully, good margins, so on. If you make it easier for the reviewer and regulatory action leader, it's going to be easier for them to look at it. They're not going to put it on the bottom of the pile and say they can't work with this.

         As to the subject of confidential business information… keep it in a separate, clearly marked section. Don't put any confidential information on your cover letter. And you need to help the agency by keeping this to a minimum, because they do get questions from outside people who want more information. And if everything is marked confidential business information, it causes the Agency problems. If you cause the Agency problems, you cause yourself problems.

         Double check for errors and then triple check for errors.

         Use an independent person, such as an independent consultant, when you do the checking. It doesn't hurt to do it. It's money well-spent because you really need to make sure that you don't have any silly errors. One example I’ve heard is things come in all the time with the active ingredients on a confidential statement of formula not adding to 100 percent. It's inexcusable. You really ought to be able to work it out to 100. You don't need a computer for that.

         Regarding tolerances or exemptions from a requirement of tolerances, you need to know that you may be in a typical situation where you are eligible for a waiver of the tolerance fees. There is a formula worked out by the Agency, in which the financials of the company are reviewed. Many small companies do qualify for fee waivers. Luckily, we're in a situation -- I shouldn't say luckily -- but many of us are not doing all that well financially. So many of us may be eligible for a waiver of the fees for these tolerances or exemptions for tolerances. So check that out.

         And if you're doing a tolerance or an exemption from the requirement of a tolerance, by all means, look at what's already publish in the Federal Register. Take a look at successful ones (ones that have been published) and use that as template. Determine the style and verbiage of successful ones. See what's successful. Use what's successful, and do it.

         And, finally, we want to talk just a few seconds about efficacy. As has been mentioned several times today, it's required by BPPD, but they generally do not ask for it to be submitted except in cases of public-health products. The Agency has guidelines which we discussed this morning.

         Again, even on non public-health products, the BPPD may want to see your efficacy data. And one of the things as regulatory people we have to do is work with our marketing and sales and R&D is to make sure we don't send something in before it's ready. You don’t want to waste the Agency’s time nor your own company’s time and efforts, unless you’re confident the product is efficacious and will be used in the marketplace.

         One of the problems that has been discussed today is that with biopesticides we get things through the agencies a lot faster then conventional chemicals. And because of that, it’s certainly possible that we don't have two to three years of efficacy data. Well, it's incumbent upon us to have that data. You need to have it.

         You certainly are going to need it for Canada. You're certainly going to need it for California. You need to get it up front. And these data definitely will include phytoxicity information. You need to know if there are phytotoxicity issues with your product.. You may need up to two years of data. You may also be required to present dose-rate responses and some type of statistical significance, perhaps at the 5 percent level, perhaps at 10 percent level. You, again, have to work with the specific Agency..

         As I mentioned above, there can be flexibility associated with your specific requirements. And in some cases there is no flexibility. You need to work with them and understand that. If you do all the above, you will have a positive and a successful experience.

         Thank you for your time.