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Data Quality Carroll M. Moseley,
Ph.D.  March 4, 2002 Center for Regulatory
Effectiveness Dear Sirs: Syngenta Crop Protection, Inc. wishes to comment on information posted on the Internet site for the Center for Regulatory Effectiveness. In particular, Syngenta wishes to comment on a letter from Cedar Chemical Corporation in which Cedar advocates for the reintroduction in the United States of an old herbicide, metolachlor, that has been replaced in the United States and many other countries by a reduced risk herbicide, called S-metolachlor. The registration of S-metolachlor and its replacement of metolachlor is the biggest environmental success story in the history of the United States Environmental Protection Agency's (EPA's) reduced risk pesticide program. The Agency required Syngenta to phase out the old metolachlor in order to realize the benefits of the largest risk pesticide reduction in its history. In addition, the old metolachlor does not meet the incremental risk standards for a me-too (generic) registration in the United States today. Moreover, it believes that a number of the statements made by Cedar are inaccurate or misleading. We appreciate the opportunity to express these views. Why Cedar And Syngenta Are Commenting On These Issues Cedar, along with at least two other companies, wishes to persuade the EPA to allow it to resurrect and sell the old pesticide, metolachlor, even though the old chemistry already has been taken off the market in the United States. Growers have already replaced the old metolachlor with the reduced pesticide S-metolachlor and the EPA database for old metolachlor is now incomplete. Syngenta developed the reduced risk pesticide replacement, S-metolachlor, specifically in response to EPA's Reduced Risk Pesticide Initiative and as an important part of Syngenta's commitment to innovation in reduced risk pesticides. We have also completely complied with EPA's requirement to phase out old metolachlor and stop its manufacture in 1999. Syngenta is this country's leading company in bringing reduced risk products to the marketplace and is very proud of that record. Environmental Achievements From S-Metolachlor's Replacement Of Metolachlor Cedar accuses Syngenta of waging an "environmental propaganda war." What Syngenta has done is deliver unprecedented reductions in pesticide risk - 17 to 22 million pounds of unnecessary pesticides are no longer entering the environment each year because of Syngenta's replacement of metolachlor with S-metolachlor. Syngenta's S-metolachlor:
Far from propaganda - these achievements are a concrete and substantial contribution to environmental protection and have resulted in the biggest success story of EPA's Reduced Risk Pesticide Initiative. The History Of S-Metolachlor's Replacement Of Metolachlor EPA's Reduced Risk Pesticide Initiative was launched in 1993 to encourage the registration of lower risk pesticide products that reduce the risks to human health and the environment. Syngenta applied for reduced risk status for S-metolachlor, EPA evaluated Syngenta's application, and then EPA designated S-metolachlor as a reduced risk pesticide. EPA confirmed S-metolachlor as a reduced risk pesticide because it provides equivalent season long weed control to metolachlor, but at 35% lower use rates. What makes S-metolachlor particularly unusual is that it accomplishes equivalent weed control at such a huge reduction in application rates, even though it is equivalent with regard to mammalian toxicity to the old chemistry when applied at the same rates. Thus, S-metolachlor has provided the significant exposure and risk reductions outlined above. S-metolachlor and metolachlor are related, but distinct, compounds. They both consist of two parts: an R-isomer pair and an S-isomer pair. The S-isomer pair is responsible for the vast majority of the compound's beneficial herbicidal effects. Both isomer pairs have equivalent mammalian toxicity. While metolachlor contains 50% of each isomer pair, S-metolachlor contains 88% of the more herbicidally-active S-isomer pair and 12% of the R-isomer pair. As a result, S-metolachlor is more effective at controlling weeds than metolachlor, and can therefore be applied at 35% reduced rates. There is no scientific basis for Cedar's suggestion about synergy between the two pairs. Syngenta identified the increased biological activity of the S-isomer pair of metolachlor and the technology to separate the isomers in 1982. However, separation as opposed to selective synthesis is inherently wasteful because it requires the disposal of the large volume of the less herbicidally active R-isomer pair that is not needed in S-metolachlor. Over the following five years, Syngenta worked diligently to selectively synthesize S-metolachlor, but despite its efforts a commercially feasible and environmentally viable technology for manufacturing S-metolachlor was not discovered. Syngenta's efforts to manufacture S-metolachlor were discontinued in 1987. Syngenta reinitiated its efforts to discover a commercially viable technology for selective manufacturing of S-metolachlor several years later, prompted by EPA's announcement of its Reduced Risk Pesticide Initiative. Syngenta scientists again concentrated on selective synthesis as opposed to separation technology because of the production waste issues. Syngenta succeeded in the 1990's where it had not in the 1980's. Its first breakthrough was the discovery of a novel catalyst that could be used to conduct a selective synthesis process for the more herbicidally active S-isomer pair. From there, Syngenta went on to accomplish what no company had done before --development of a selective synthesis technology using Ir/ferrocenyl-diphosphine catalysts coupled with yet another discovery, the "acid effect," which greatly increased the reaction efficiency, although a small amount of the R-isomer remains. By optimizing that technology, Syngenta developed a revolutionary selective isomer synthesis process that made manufacturing S-metolachlor commercially feasible and environmentally attractive. Syngenta then invested more than 100 million dollars develop the new S-metolachlor, to close down the old metolachlor production facilities and to build a new plant to manufacture the new, reduced risk, active ingredient in an environmentally more friendly way. Because S-metolachlor is effective at only 65% of the application rate used for old metolachlor, and S-metolachlor and metolachlor have the same mammalian toxicity at equal dose rates, EPA granted S-metolachlor reduced risk status due to reduced exposure in the environment in 1996. The next year, EPA granted Syngenta a license to make and sell S-metolachlor. EPA wanted to ensure that the full environmental benefits of S-metolachlor would be realized. To this end, EPA required Syngenta to cancel its old metolachlor registrations as a condition of S-metolachlor's registration. Syngenta complied with this requirement, even though metolachlor was at the time one of the most popular corn herbicides in the country and a very important part of Syngenta's product portfolio. After EPA announced to the public that the Syngenta registrations were being cancelled, and even though metolachlor had been off patent for several years by that time, Cedar, followed by two other companies, applied for registration to start making and selling the old chemistry again. These companies are, in effect, asking EPA and the public to elevate their companies' private interests above environmental considerations. We are hopeful that EPA and the public will continue to put the environment first. Syngenta took metolachlor off the market on a schedule approved by EPA. In accordance with EPA's requirements, Syngenta stopped manufacturing metolachlor in September 1999 and submitted the paperwork to formally take metolachlor registrations off the books. Because Syngenta was the only registered manufacturer of metolachlor technical, no new metolachlor products have entered the marketplace since September 1999. In accordance with EPA's policy on existing stocks of pesticides being cancelled, Syngenta sold existing stocks on hand, but stopped even these sales within a year. The reduction of pesticides applied to US farms from this single cooperative action of phasing out the older product is 17 to 22 million pounds each year. These reductions have in turn resulted in dramatically reduced dietary, water, worker and other exposures as outlined above. The registration of S-metolachlor is the single largest reduced risk pesticide action in the US. It contributes more reduction in pesticide loading than the reduction from all other reduced risk registrations combined. If EPA's 1997 decision is maintained, pesticide exposure will be reduced by over 200 million pounds by 2010. The unusual attributes of S-metolachlor, combined with the previous popularity of metolachlor and the fact that the marketplace has already embraced the new product at the lower rates, mean that it is highly unlikely that a reduction of this size will ever occur again in the reduced risk pesticide program. Cedar attempts to trivialize this achievement, but it is unprecedented. S-Metolachlor's Replacement Of Metolachlor Is Consistent With EPA's Environmental Protection Mission We agree that EPA's credibility is at stake. Administrator Whitman vowed on taking office that she would leave the environment cleaner than she found it. The potential re-introduction of old metolachlor would undermine her promise, the Reduced Risk Pesticide Initiative, as well as other EPA programs designed to encourage environmental progress. In addition to the Reduced Risk Pesticide Initiative, the Office of Pollution Prevention and Toxics' "Design for the Environment" (DfE) program is one of EPA's premier partnership programs. In that program, EPA works with individual industry sectors to compare and improve the performance and human health and environmental risks and cost of existing and alternative products, processes, and practices. Phase out and cancellation of metolachlor accomplishes that program's goals. By way of another example, the Presidential Green Chemistry Program advocates the design of chemical products and processes that reduce or eliminate the use and generation of hazardous substances. Green chemistry is a highly effective approach to pollution prevention because it applies innovative scientific solutions to real-world environmental situations. Promoting pollution prevention through the environmentally conscious design of chemical products and processes is the focus of EPA's Green Chemistry Program. S-metolachlor is consistent with EPA's Green Chemistry Program, and even meets the Program's difficult criterion of commercial acceptance. Ignoring such innovation in favor of the old higher risk product is contrary to EPA's Program objectives and reducing environmental risk. Cedar's And Others' Metolachlor Applications Are Incomplete One of the reasons why the old metolachlor does not qualify for registration today is that there are key data gaps in EPA's files. The missing data must be provided to allow EPA to conduct a comprehensive risk assessment. Despite the fact that Cedar and others have been on notice since at least 2000 that these data gaps exist, neither Cedar, nor any other company apparently has generated and submitted to EPA the health and safety data to fill these data gaps. This inaction and failure to invest even minimally in the health and safety data required by EPA signal clearly that the companies who wish to bring back the old chemistry not only are turning a blind eye to the environment, they are not even willing to invest a modest amount of money to address health and safety data needed by EPA to properly evaluate pesticide applications. Cedar's Efforts To Overcome The Deficiencies In Its Applications Are Misguided In an effort to try to overcome the obvious deficiencies in its applications to register the old metolachlor, Cedar made a second set of applications that apparently propose use of old metolachlor at the reduced rates at which S-metolachlor is sold. Thousands of field trials and 25 years of experience contradict the appropriateness of these rates. Moreover, Cedar appears to be attempting the same ruse that was used in the generic registration of metalaxyl. In that situation, the generic lowered the label rate until receiving the registration and then raised the rate back up to the old rate required for efficacy. Most importantly, no matter what rate of old metolachlor is applied, only 2/3 as much of the new S-metolachlor is needed to achieve the same efficacy. Thus, for every pound of metolachlor applied, unnecessary pesticide loading is occurring and there increased incremental to the public and the environment. Cedar's Promises Are Hollow Cedar's suggestions about the potential economic benefits of bringing back old metolachlor are baseless, and in any event, its pricing conjecture is superceded by concrete environmental achievements that are given primacy under the governing federal law, known as the Federal Insecticide, Fungicide, and Rodenticide Act or FIFRA. Cedar hypothesizes about the potential effect on prices based on hypothetical prices on hypothetical sales of the old metolachlor chemistry without concern for the delivered level of weed control. Even if this type of information were more important than the environmental considerations under the law, which it is not, every aspect of Cedar's hypothesis is based on faulty conjecture. Most fundamentally, Cedar ignores the fact that many products, including about 50 brands containing acetochlor, alachlor, dimethenamid, dimethenamid-p, or flufenacet, compete with S-metolachlor for corn herbicide sales, and that the long-term dynamics of these products competing with one another for corn herbicide sales have a much greater impact on prices than the unfounded market hypothesis suggested by Cedar. Moreover, the introductory price per acre for the new S-metolachlor was comparable to, if not lower than, the price of the old metolachlor. The grower cost of the new S-metolachlor will continue to be priced competitively with the competitive active ingredients listed above, because of the dynamics of the corn herbicide marketplace. There is no basis to conclude that reintroducing a product that no longer is sold in the United States would have the impact on corn herbicide prices and the vast benefits that Cedar suggests. Cedar's Business Descriptions Are Faulty And Misleading Cedar's use of the term "monopoly" is completely erroneous. Throughout its life, there were numerous products competing with metolachlor; similarly, there are numerous products that compete with S-metolachlor today. Cedar itself sells a number of other older competitive herbicides, including EPTC, alachlor, and pendimethalin. Moreover, Cedar's descriptions of the way Syngenta is organized and does business ignore the fact that Syngenta employs approximately 2500 people in the United States and formulates S-metolachlor products at a facility in Louisiana. In describing itself, Cedar omits information about its sister company's chemical facilities outside the United States and the fact that it is part of a large conglomerate called Trans-Resources, Inc., that apparently has annual sales of $500 million. EPA Should Stand Behind Its Reduced Risk Pesticide Initiative By upholding its prior decision to cancel old metolachlor and realize the benefits of the new reduced risk S-metolachlor, EPA will send a message that it means what it says about encouraging innovation that is good for the environment. As a responsible corporate citizen and pesticide registrant, Syngenta has made a significant investment in new technology to develop S-metolachlor in order to achieve the largest reduced risk pesticide initiative in EPA's history. The Environmental Protection Agency should do its part to maintain this most important and unprecedented risk reduction achievement. Sincerely
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