Chapter 21
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Electronic State Submissions Charles H. Koopmann Stewart Agricultural Research Services, Inc., P.O. Box 509, Macon, MO 63552
Electronic submission of state pesticide registrations has been slow to gain acceptance at the state level. Primary reasons include; a) inability to receive and process data due to limitations of the current state databases, b) restrictive state regulations, c) costs, and d) apathy. Just as EPA scientists are reluctant to give up the paper trail, state officials are more secure in hard copy processing and filing procedures. The conversion to electronics has to prove its value and reliability before there will be acceptance. A few states are striving to be leaders in this effort and are proving that Internet publishing of information saves them time and improves service to their customers. As more registrants create labels, reports and supporting documents in transmittable electronic format there will be more pressure for states to accept such documents, including pressure to accept electronic payment of registration fees.
Just as the US Environmental Protection Administration (EPA) controls, approves, and monitors pesticide products for the federal government, there is a corresponding regulatory agency in the state government of each of the 50 states, District of Columbia and Puerto Rico. These state agencies, be they in the Department of Agriculture, Environmental Aflairs, or elsewhere, are
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160 charged with protecting the citizens of their respective statesfromunlawful use of pesticides. Put yourself in the position of the State Pesticide Administrator. He/She must conform with federal laws and regulations and state laws and regulations, while satisfying a clientele that includes every citizen and registrants who range from giant chemical conglomerates with hundreds of dynamic registrations to local/regional companies with one registration that never changes. Each of the 50 states, the District of Columbia and Puerto Rico have specific registration procedures, no two of which are alike. Every state application and renewal form is unique. State fees varyfromzero (0) to $350 per product per year. The majority of the state registrations is good for one year and expires on December 31. However, in Connecticut products are registered for 5 years. Washington, Texas, and Hawaii register products for two years. Seven states renew products in June, one in August and one in November. And that's just a small example of the state differences. Imagine yourself as the registrant, trying to satisfy the pressures of management and, of course, the marketing department by having products registered on "their" schedule, no matter when "they" get them to you. At the same time you are trying to satisfy the differences of 52 registration entities some of which can return your product approval within two days, some of which have a set review schedule with specific deadlines and still others that can take up to three months to a year to grant approval. Do You Surrender?
Enter the electronic age, where computers will solve all time and data management problems. If you believe that, we have a bridge you might like to buy and ACS could have chosen a different theme for this book. Now that I have laid out a complicated and time consuming picture, lets look at where we stand as a pesticide industry in the matter of electronic state submissions. We know that demand for electronic data management activity is increasing dramatically, reaction time and capability have a long way to go, and websites are popping up all over the place. One company, Kelly Registration Systems (KRS), had the foresight approximately 6 years ago to try to get ahead of this curve. KRS has a registrant version and a state version software that will allow registrants and states to communicate with each other electronically and confidentially. KRS's software database system calculates the individual state fees, completes and prints the individual state forms and facilitates electronic transfer of the required supporting documents in PDF file format. However, only one state
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(Oklahoma) can receive the completedfileselectronically and only seven states will accept supporting documents in PDF format either via diskette or e-mail.
What Are the Obstacles to Electronic Data Submission?
The biggest obstacle is incompatibility at all levels. Remember the differences in federal and state laws and regulations, state forms, state fees, supporting data requirements, etc. Then add to that a multitude of computer systems (or lack thereof). The dynamics of each state's pesticide division and state computer department plays heavily on progress and change. Also, it wouldn't be government if politics were not involved. And, of course, with people involved there are turf and job security concerns. The ideal system would allow the registrant to complete the state registration and renewal forms, attach the supporting documentation, make the payment and send the data rightfromtheir desk. On the state side they would be able to receive, review, accept and notify the registrant of their registration decisionfromthe state office desk within 24 to 48 hours. One real problem, just now being addressed by Congress, involves the acceptance and legal ramifications of electronic signatures and the transfer of cash in support of the applications and/or renewals. For years federal and state governments have been able to pay civilian and military personnel via a bank transfer to the payees bank. However it is still almost impossible for the "Registration Division" to receive an application or renewal without a paper check attached. The problem is lack of confidence in the payment process. The physical check means the money has been received and in some states allows them to return the check, with the application, if the application is rejected for being incomplete. Incomplete data and documentation usually cause these rejections and the return of the entire application. Change is hard to accept.
What Does it Take to Register an EPA Approved Product in AH 52-State Entities?
It takes paper work, money and time (in that order). There are 52 different state forms with fees ranging from $0 to $350 per year as of June 30, 2000 (totaling $6,600 for one product in all states). Timing is critical regarding the date of receipt and acceptance in a few states. Some states will set the approval date as the date the money was received even though it may have taken them two months to process the forms. Still other states have a submission deadline
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to correspond with the planned meeting dates of their approval authority (Board, Commission). Still another (CA) can be even more time consuming than the EPA.
What Do You Need to Support Your Registration Application? Fortunately, with the exception of California, you do not generally have to duplicate the large number of studies that you were required to submit to EPA. The EPA approval letter and the final EPA approved "master" label authenticates the EPA decision. Once you have the EPA approval letter, you must look at the 52 state entities individual registration requirements. These may include the completed application form (one to six copies), the "incommerce" label (actual label or printer proof), the Material Safety Data Sheet (MSDS), and/or the Confidential Statement of Formula (CSF). In the case of California, you may be required to submit efficacy, toxicity and/or chemistry studies in support of your registration application. Supplemental distributor registrations are handled differently. A subregistration is obtained from the EPA with the permission of the basic registrant through the submission of EPA Form 8570-5, "Notice of Supplemental Distribution of a Registered Pesticide Product". In this case, the paper flow through EPA and the States is somewhat faster because the basic product has undergone prior scrutiny and the approval process. When sending these registrations to the states there is generally less paper to submit, but this is oflset by some states requiring a CSF and/or an authorization to cite prior documents in support of your application. The basic registrant has usually supplied these supporting documents directly to the state. End result: More coordination of paper. Once this is all done, you set back and wait for approval, denial, or requests for more information and/or justification. As you can see, the process is one of attention to detail and differences. In spite of the differences there is some semblance of order being exerted and some improvement in information flowfromregistrant to state to registrant and consumers. The Internet and state websites are helping information flow since now some states are making the status of pesticide registrations available for public access. California uses the Internet and e-mail for extensive communications. You can check registrations and search their website, www.cdpr.ca.gov, for your product registration status. In addition, you can receive a weekly e-mail message listing the products entering and exiting their evaluation process. You can also check product registration status online for Alaska, Hawaii, Idaho,
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Nebraska, Nevada, New York, Oklahoma, Oregon, South Dakota, West Virginia and Washington. State registration regulations, forms, and instructions are also available online in about 20 states. In the case of those states using the online connection of Kelly Registration Systems, at http://w^w.kellvsolutions.com/. a linking of the State information with EPA information makes it possible to search for products by approved site or pest (or combination thereof) as well as by chemical ingredient. These are but a few examples of how states are trying to do a better job of communication in order to become more efficient. Recently, the need to enhance Internet publication of registration data has received a boost from industry concerns about the rapid growth of e-sales of pesticides. Companies such as XSAg.com, Rooster.com, etc., indicate that they are, in feet, attempting to check for state registration approval prior to confirmation of the sale. Their activities have increased the inquiries to state registration offices. Phone call verifications are time consuming and interrupt thé normalflowof office paperwork. This area has many legal bridges to cross and is already consuming considerable time at State offices. Change is happening daily. If you want to explore added sites for more related information check out websites of the: US EPA (http://www.epa.goW). Etoxnet (http://ace.orst.edu/info/extoxnet/), CDMS (http://www.cdms.net), KellySolutions (http://www.kellvsolutions.com), NPIRS (http^/cOTS.purdue.edu/npirs/), and websites of the individual chemical and distributor companies or the websites of State Extension Offices. There are more data out there than can be absorbed. The challenge is tofindwhat you need and understand it.
Conclusion Even though the state registration system of pesticides may be complicated and slow to change, the dynamics of the industry, Internet communication, and e-commerce are causing states to evaluate their present systems. Uniformity will not happen, but similarity is always there. The electronic age will reduce the pressure for uniformity because data capture is easier, fester and less cumbersome than compromise. The challenge for the registrant is to know the basics, recognize similarities and work toward uniformity while at the same time complying with federal and state Laws and regulations, since the penalties for sale of unregistered products can be high.
Garner et al.; Capturing and Reporting Electronic Data ACS Symposium Series; American Chemical Society: Washington, DC, 2002.
