SECTION: IN THE NEWS

LENGTH: 1210 words

HEADLINE: PREPARED STATEMENT OF
WAYNE CARLSON
BEFORE THE HOUSE AGRICULTURE COMMITTEE
DEPARTMENT OPERATIONS, OVERSIGHT, NUTRITION AND FORESTRY SUBCOMMITTEE

BODY:


Good Afternoon, Mr. Chairman, ladies and gentlemen. My name is Wayne Carlson. I am Vice President of Regulatory Affairs and Field Development for Bayer Corporation's Agriculture Division, headquartered in Kansas City, Missouri. I'm pleased to have the opportunity to address this committee.
Bayer Corporation is one of the manufacturers of azinphosmethyl, an organophosphate insecticide widely used for the control of insects infesting tree crops. It also is used to a lesser degree in cotton and several other crops.
Azinphos-methyl is procedurally the furthest along of the products being evaluated under the step-wise process laid out in the Tolerance Reassessment Action Committee (TRAC) process. I have been asked to come before you today to describe some of our technical and procedural observations and experiences as our product has gone through the FQPA process.
I'd like to group these comments into three areas - first, science and policy issues, second, the complexity of the process, and, third, the critical importance of carefully implementing FQPA according to procedures discussed during the TRAC process.
Relative to science and policy, experience with our product clearly shows how critical science and policy are to the FQPA implementation process and to future availability of pest control products. The importance of science and policy were recognized early by the FQPA Implementation Working Group (IWG), a coalition of 66 commodity, grower and pesticide-related organizations. In its April 1997 publication called "The FQPA Roadmap," IWG outlined 8 critical science policy areas which needed to be clarified prior to the FQPA-decision- making process moving forward. This list of science-policy issues has grown to 9 as a result of further investigation in the TRAC Process.
There are now some 20 individual science policy papers generated, detailing issues in these 9 areas. Only one of those has been issued as final. Several are only scheduled and won't be issued yet for some time. These science policies represent the foundation of decision- making under FQPA. Without them, decisions are at best interim, which could have a negative effect on some user groups.
There has been much discussion surrounding the use of default or screening level assessments for products being used while these science policy issues are being finalized.
This committee saw, during the April hearings, the differences between a dietary risk assessment based upondefault assumptions versus a refined risk assessment- a difference of 10,000% of the risk cup versus about 130% of the risk cup for the most sensitive sub- population in the FQPA risk assessment.
That 130% is still, even with the refined dietary exposure values, influenced by other policy issues still under debate and discussion: in fact, no fewer than 11 policy documents, plus the use of human data in the risk assessment, another policy that is under debate in U.S. EPA. Bayer Corporation has recently submitted two human studies to EPA and CDPA (California). California has reviewed and accepted the results of these studies in its risk assessment process. U.S. EPA still has not, and we are awaiting its policy decision.
The most critical of all of the policy decisions in question is the 99.9 percentile policy. 99.9 is considered by some to be a default or screening level value; by others, it is considered to be a regulatory point. The azinphos-methyl risk assessment involving dietary exposure showing about 130% of the risk cup for the most sensitive sub- population becomes about 80% at the 99.75 percentile; 35% at the 99th percentile; and only about 14% of the 95th percentile, the level normally used to establish significance in scientific studies and the level at which FDA regulates food additives.
Use of human data could even further reduce these values several fold. In short, it is entirely possible that one of several policy decisions could result in a risk level well below that of the current assessment of 130%.
This brings me to my second concern - the complexity involved in the FQPA process. FQPA requires that all available and reliable data be employed in the process. In the case of the azinphos-methyl dietary risk assessment, 52 crops were included, with some 261 specific food forms, each one requiring separate scientific judgements forapplication of the 133,708 number of data points and 40 separate processing factors. This just includes dietary exposure from food. We need to keep in mind that FQPA requires food exposures be combined with water exposures and with exposures resulting from applications in the home, in restaurants, etc., for chemicals which are approved for such uses, into what is called an aggregate risk assessment for a single chemical. Finally, exposure from that chemical needs to be added to other chemicals, if they are deemed to share a common mechanism of toxicity, into what is called a cumulative risk assessment.
How to conduct a cumulative assessment is very complicated, and as you can imagine, a critical factor in determining the future of families of important pesticides. If it's done too hurriedly or in an overly conservative manner, pesticide availability will suffer needlessly.In addition to what we've learned relative to the critical aspects of the science policy issues and the complexity involved in the proper exposure and risk assessment, we've learned the importance of adhering to the process of FQPA implementation as outlined in the TRAC.
In their April testimony before this committee, Jim Aidala and Keith Pitts described a 6-phase pilot process, which, among other things, was to "provide for public participation on risk mitigation measures and practical transition strategies."
Azinphos-methyl, the product furthest along in the process, has just completed Phase 5, a phase in which risk mitigation proposals were to be submitted by the registrant and other interested parties. Phase 6 was to allow EPA and USDA to work together on risk management strategies. Near the end of the Phase 5 period, Bayer Corporation found itself in intense negotiations on risk mitigation issues. It was very difficult, in a limited amount of time, to contact the many interested grower and user groups to get their full input to be sure that their needs were being considered in the risk-benefit assessments required under FIFRA-regulated mitigation proposals. It is critical that the 6th Phase of the process be included - a process of up to 60 days, wherein EPA, along with USDA, work together to develop risk management strategies, to assure that the users' needs are not ignored.
In conclusion, despite the complexities of FQPA, it is still a good law, one which requires us to bring our best science and data to the process of regulating pesticides. It also is really a powerful law, and it must be implemented with responsibility and reason. EPA and USDA have a responsibility to use the best science available and consult with growers and applicators. We favor legislation thatfurthers this objective. We have a safe, abundant, and economical food supply. We must act carefully to be sure that it is even safer, more abundant, and more economical in the future.
END


LOAD-DATE: August 5, 1999