Role of Consultants in the Regulatory Process
Good morning, my name is Driss Benmhend. I'm a regulatory action leader with the Biopesticide and Pollution Prevention Division (BPPD). This morning I will be talking about how the Agency and BPPD sees the role of consultant in the regulatory process.
First, I would like to like to reiterate what was said yesterday, especially by Janet Andersen's presentation regarding how EPA strives to do everything it can to promote the registration and use biopesticides and other safer alternative in pest management.
As you know, there are all kinds of incentives for registering biopesticides. One is them is simplified regulatory process and also an accelerated registration of biopesticides. However, the registration of biopesticides is still complicated, which requires deep knowledge and expertise of pesticide's regulations. At BPPD we usually urge new applicants to schedule a meeting and come talk to us during a peer registration conference, in order to give us the chance to explain to them the regulatory process in general, and talk about data requirement and what needs to be done in order to have a smooth going work relationship during the registration of their products.
I would like to take a minute to talk about the preregistration meeting even though it's really out of the subject about consulting. This is the first opportunity for us to explain pesticide regulations and the registration process to the applicants, and at the same time learn about the "new" active ingredient, and get an idea about the risks and hazards that may be involved from its use. This also give us a chance to also give the applicants advice on the data required for that particular action, and explain how to prepare waiver requests and the kind of data that could actually be waived. The meeting is usually concluded by a discussion on the timing required to complete the action.
However, a one or two-hour preregistration meeting, is really not enough to explain this long and complicated process. That's why, we usually advise new applicants to seek outside help and hire regulatory consultants to assist all the way through the registration process.
In order to achieve that, BPPD expects consultants to have a strong knowledge and extensive experience in several areas for:
| 1 | FIFRA, FFDCA, FQPA, and other statues that regulate pesticides. |
| 2 | The 40 CFR, (Code of Federal Regulation), 150 to 189 where the data requirements for biochemicals are listed in part 158.690 and in part 158.740 for microbials |
| 3 | Up-to-date knowledge of the PR Notices, that are published by the Agency with new rules and regulations on pesticide registration. |
| 4 | Guidelines on performing studies and generating data, and drafting adequate labeling requirements with proper precautionary statements and format. |
| 5 | Registration package assembly which was actually stressed several times yesterday: How to assemble the package, the number of copies, the forms to sign, where to submit the application, et cetera is important information to know. |
With this knowledge and experience, BPPD believes that consultants should be able to give sound advice and assistance to their clients. Primarily, in selecting the proper action to pursue. Consultants, in theory, should tell the applicants exactly what kind of action to apply for, an EUPs, me-too registration, amendments, etc. Secondly, we expect consultants to explain to applicants what kind of data to provide, how to gather it, how to organize the data before submitting it to the Agency. Third, assisting in the preparation of waiver requests which should be based on sound scientific rationales. During earlier presentation, especially during the panel discussion on the pitfalls, there was a great deal of talk about product labeling. At BPPD, we hope that by hiring a knowledgeable consultants, applicants will be able to avoid the pitfalls and prepare a proper label that reflect the proper precautionary statements and easy to understand directions for use, etc. Finally, at BPPD, we see consultants as liaison between the applicant and the Agency, keeping them informed on the development of the registration process and, also, giving them realistic expectations.
For conclusion, I would like to add that using a good consultant could be beneficial to applicants because they can avoid probably most of the pitfalls that we heard about yesterday, and also, beneficial to the Agency because it can help to keep the wasted time and the frustrations that one can generate by reviewing sloppy and incomplete application. In my experience the use of consultant in most cases has been a win-win situation for applicants and EPA. This is not to say that companies cannot do that by themselves. I've been very happy working with several companies that prepared their applications and submissions by themselves.
Finally, I would like to stress that the Agency does not endorse any consultants. We offer a list of consultants on our web site for anybody who wants to use it, and we welcome consultants who want to add their names to the list.
Thank you. I will be happy to answer questions you may have regarding this presentation.