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Reg WeekSM: CRE Regulatory Action of the Week

Public Commenters Ask: Is EPA Destroying Its Reduced-Risk Pesticides Initiative?
In a recent RegWeek article, CRE reported on EPA's unwillingness to cancel an existing registration for the pesticide Metolachlor, despite a requirement for the phase out of that pesticide as part of the registration of a new, reduced-risk alternative, S-Metolachlor. In addition, the agency is considering granting other companies the right the market the original, less environmentally-friendly product. CRE asked its readers for their thoughts, and there was clear consensus that EPA's approach: (1) threatens the agency's credibility in terms of protecting human health and the environment, and (2) provides a strong disincentive for companies to develop new, safer products. Such results are clearly at odds with goals of the Reduced-Risk Pesticides Initiative. EPA is strongly urged to reconsider its present course.

  • Click to read CRE's analysis of public comments received on the Metolachlor/S-Metolachlor issue.
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    Public Views on EPA Regulatory Actions
    Related to Metolachlor and S-Metolachlor

    Public Comments
    Introduction

    In its own words, the mission of the U.S. Environmental Protection Agency (EPA) is "to protect human health and to safeguard the natural environment...."1 In furtherance of this goal, the agency implemented its Reduced-Risk Pesticides Initiative in 1993 to "encourage the development, registration and use of lower-risk pesticide products containing new chemicals which would result in reduced risks to human health and the environment when compared to existing alternatives."2 This program has enjoyed wide support from environmentalists, growers, registrants, and the public because it seeks to accomplish objectives for which there is broad consensus - safeguarding the American food supply while protecting human health and the environment.

    However, EPA is currently contemplating regulatory actions that may jeopardize the agency's entire Reduced-Risk Pesticides Initiative. Specifically, a major U.S. corporation, Syngenta Crop Protection, Inc., has spent considerable funds to develop a more environmentally-friendly alternative for its currently registered product, Metolachlor. This alternative, S-Metolachlor, has reduced by 35% the amount of pesticide used on major food crops, compared to the original product.

    As part of EPA's conditions for registration of S-Metolachlor, the company was required to phase out Metolachlor. Syngenta has phased out Metolachlor. However, surprisingly, EPA has been reluctant to cancel the Metolachlor registration. In addition, EPA is currently considering new petitions for registration of the original product.

    The Center for Regulatory Effectiveness (CRE) believes that this situation undermines the Reduced-Risk Pesticide Initiative, the willingness to registrants to incur the expense associated with development of safer pesticides, and public confidence in the agency. However, CRE wanted to confirm its assessment of the current situation, so it reported on the Metolachlor/S-Metolachlor issue on its website (www.TheCRE.com) and requested public comments thereon.

    CRE received numerous public comments on this issue, and there was unanimous sentiment that EPA would be setting a significant negative precedent were it to maintain the registration for Metolachlor in light of the Reduced-Risk Pesticide, S-Metolachlor. EPA was urged to take regulatory action in this case which would further the goals of its Reduced-Risk Initiative and the agency's mission to protect human health and the environment.

    Public Opinion Regarding EPA Action on Metolachlor and S-Metolachlor

    The following points summarize the public comments submitted to the CRE website on the Metolachlor/S-Metolachlor issue. Please see the attached Appendix to review the comments (including name, title, and affiliation) in their entirety.

    • Granting renewed registration for Metolachlor to a competitor of that pesticide's original manufacturer and the developer of a reduced-risk alternative will send the wrong message to registrants and growers. Taken to its logical conclusion, fewer new products would be developed, thereby reducing choices to farmers in the field who need more, not less, pest control options.

    • To a certain extent, the agency's credibility is at stake, both with registrants and the public. If the agency espouses the goal of reduced pesticide use, a decision to grant a new registration for original Metolachlor appears to run counter to that objective.

    • EPA needs to be fair and consistent in its treatment of privately-funded research data. Companies need to be able to recoup the research and development costs associated with chemical products for agriculture. If this balance is upset, the market may not efficiently produce tools farmers need to ensure continuation of the currently abundant food supply.

    • Pesticides with lower application rates, such as S-Metolachlor, can reduce costs to farmers (by using less product) while maintaining the same level of weed control. This is good environmental stewardship.

    • Resolution of the Metolachlor/S-Metolachlor situation will serve as a test case of importance to both the government and the industry. Registration of old Metolachlor could threaten the agency-industry cooperation that is essential to the success of EPA's Reduced-Risk Pesticide Initiative.

    Conclusion

    Syngenta has met the requirements to phase out the original Metolachlor. If EPA does not agree to cancel the Metolachlor registration and deny other companies' "me-too" applications, then EPA will be sending a strong message to responsible companies that they cannot rely on the agency's commitment to the principles of its Reduced-Risk Initiative. Ultimately, the environment, the American people, and the agency itself lose under this scenario.

    Based upon the public response it has received, it is apparent that CRE is not alone in this conclusion. Consequently, EPA is urged to reexamine the current situation and to take responsible action to cancel Metolachlor's registration and to deny me-too applications that would promote that product's continued use.

    1 See http://www.epa.gov/history/org/origins/mission.htm

    2 See http://www.epa.gov/oppfead1/fqpa/rripmpp.htm


    Appendix

    Public Comment Submissions to CRE on the Metolachlor/S-Metolachlor Issue

    Comment #1
    Comment #2
    Comment #3
    Comment #4
    Comment #5
    Comment #6
    Comment #7
    Comment #8
    Comment #9
    Comment #10
    Comment #11
    Comment #12
    Comment #13
    Comment #14
    Comment #15
    Comment #16
    Comment #17

    Comment 1

    Name: Thomas Slunecka
    Affiliation: Farmer/National Corn Growers Association (NCGA)
    Title: Director of Development
    Date: August 3, 2001

    Metolachlor is one of the most cost-effective products available for farmers today. It is my professional opinion that the loss of this compound to producers will come at a cost not just to farmers, but to rural communities. The manufacturers of this product are working very hard to find the science-based answers needed to keep this and other products available for the producers. America has entrusted its most important product -- food -- to the farmers of the country, and we must use science, not politics and personal agendas, to drive our decisions on how they are to do their jobs.

    Comment 2

    Name: Jere White
    Affiliation: Kansas Corn Growers Association
    Title: Executive Director
    Date: August 3, 2001

    Metolachlor has been an excellent product for corn farmers in Kansas. We would argue that S-Metolachlor has been much better, in that it provides the efficacy of the old formulation in conjunction with a reduced rate of application. Why would any company invest precious resources into refining their products to meet EPA goals of reduced use when the EPA would actually consider providing a new registration of the old formula to a different registrant? This concept is absurd, sending the wrong message to both registrants and growers. We would not suggest that EPA should guarantee the profitability of S-Metolachlor to the registrant. On the other hand, if major EPA goals, such as reduced use, are not in fact defendable goals within the agency, how can the agency expect others, including growers, to represent these goals as valid?

    The new registration request for old chemistry metolachlor should be rejected.

    Comment 3

    Name: Markus Meier
    Affiliation: Guacamole Press, LLC
    Title: Managing Member
    Date: August 3, 2001

    I am opposed to EPA registering metolachlor! EPA should stand by their Reduced Risk Initiative.

    Comment 4

    Name: S. Whalen
    Affiliation: Hawaii Agriculture Research Center
    Title: President
    Date: August 3, 2001

    As an agent of the United States government, EPA must keep agreements made with any party to maintain the credibility of the government. If, as has occurred in other countries, the American public (which includes all parties) loses faith that its governmental agencies are making reasonable, fair, and informed decisions, then chaos and emotion will prevail and rule the regulatory process.

    EPA made it very clear that it was pursuing safer pesticides based on public concerns. If it has determined that a material is indeed of high risk and that a safer material has been developed that is equally or more efficacious and economically practical, then it should not be undermining its goal to provide safer pesticides by allowing companies to produce the riskier compound based on another company's data.

    I understand that arguments will be made by producers of low margin crops in economically tough periods for the cheapest product, especially if patents have run out. I realize that this can be a situation that needs to be balanced and can if the costs saved in reduced applications is taken into consideration with the costs of the products and the support commodities receive through the Farm Bill programs.

    In addition EPA needs to be consistent and fair in its use of privately-funded data, otherwise the current system to support [agriculture] with the chemical tools it needs will be destroyed. Companies developing tools for agriculture need to be assured that they can recover the costs for R&D just like pharmaceutical, electronic, computer, etc. companies. They need to be assured that the data they provide to the regulatory agencies to satisfy safety concerns is not freely used for companies who make no such commitment to the process.

    I would hope that EPA would weigh these factors carefully and objectively before failing to live up to agreements that they make in pursuing safer products.

    Comment 5

    Name: Charles Rivara
    Affiliation: CTRI, Inc
    Title: Director
    Date: August 3, 2001

    I strongly support the cancellation of metolachlor and the registration of s-metolachlor. We have a major problem in weed control and s-metolachlor is our best means of control.

    Comment 6

    Name: Darryl Bettencourt
    Affiliation: Woolf Farming Co.
    Title: Farm Manager
    Date: August 3, 2001

    I am in strong support of replacing Metolachlor with S-Metolachlor. It would allow the Agriculture community to further enhance its stewardship of the environment. By this, it would allow us to reduce the amount [of active ingredient] used, yet maintain the tools we need to remain competitive in the marketplaces.

    Comment 7

    Name: Henry Giclas
    Affiliation: Western Growers Association
    Title: Vice President
    Date: August 3, 2001

    EPA should support their reduced risk initiative decisions. The cancellation of metolachlor and subsequent development of S-metolachlor is an example of industry/agency interaction and cooperation that will result in reduced pesticide loading.

    Comment 8

    Name: Eleanor Zimmerlein
    Affiliation: Illinois Agri-Women
    Title: Legislative Chair
    Date: August 4, 2001

    Illinois Agri-Women is opposed to the registration of the old Metolachlor. The new product S-Metolachlor, which is a replacement for the old Metolachlor, reduces by 35% the amount of pesticide used on major food crops.

    Comment 9

    Name: Russel R. Weisensel
    Affiliation: Work with numerous Wisconsin Agricultural Associations
    Date: August 4, 2001

    Since a revised and improved Metolachor (S-Metolachlor) reduces pesticide use and will help the EPA to reach [the goals of] its "Reduced Risk Initiative," it seem to be very logical to not re-register the old form of Metolachlor.

    Comment 10

    Name: Rick Klemm
    Affiliation: Hawaiian Alliance for Responsible Technology & Science
    Title: Executive Director
    Date: August 4, 2001

    The EPA's position on metolachlor contravenes its Reduced Risk Initiatives and discourages pesticide makers from going to the trouble of finding better alternatives.

    We urge EPA to cancel the registration for metolachlor and give its support [to] the new, better alternative S-metolachlor.

    It's the rational thing to do and will signal to pesticide makers that EPA wants to act in accord with its Reduced Risk Initiatives.

    Mahalo nui loa for your attention.

    Comment 11

    Name: Glenn Smerdon
    Affiliation: AG Resources, Inc
    Date: August 4, 2001

    As a former pesticide regulator and as a consultant who works with many minor crops, I have been associated with this issue for many years. EPA has worked for years to decrease both volume and the risks associated with pesticide use. The replacement of metolachlor with s-metolachlor clearly fills both of these criteria without further losses in pest control available to agriculture. This is clearly the wrong place for EPA to change course since [it] permits a continued use of a compound without offering any new tools for pest control.

    Comment 12

    Name: Rodney M. Weinzierl
    Affiliation: Illinois Corn Growers Association
    Title: Executive Director
    Date: August 4, 2001

    The Illinois Corn Growers Association is opposed to EPA registering metolachlor.

    EPA should stand by their "Reduced Risk Initiative", that companies will be encouraged to continue to develop newer and safer products.

    Comment 13

    Name: Renee Rianda
    Affiliation: The Morning Star Packing Company
    Title: Pesticide Coordinator
    Date: August 5, 2001

    We are opposed to the EPA granting registration of metolachlor to Cedar Chemical Company.

    If the EPA registers metolachlor, it will go against their stand of "Reduced Risk." The purpose of the "Reduced Risk Initiative" was to encourage Corporate America to continue the development of [safer] products for the environment.

    S-metolachlor is a true "Reduced Risk" pesticide. By keeping this registration alive, pesticide use will be reduced by over 35% by not using the old registration of metolachlor.

    Syngenta took the opportunity of the "Reduced Risk" initiative to be good stewards of the land by finding a pesticide that could reduce pesticide exposure by over 200 Million pounds by the year 2010. In one year alone, Year 2000, by using the "Reduced Risk" pesticide S-Metolachlor, the environment was healthier by having 40 Million less pounds of exposure in it.

    If the EPA decides to keep metolachlor, it will set a precedent to eliminate any gains this county has made since DDT was banned in the 1970's. The whole purpose of forming the EPA in the first place was to make this county a safer place; thus how the "Reduced Risk" Initiative came about.

    Remember EPA stands for Environmental PROTECTION Agency.

    Corporate America is concerned and [is] spending millions upon millions of dollars to eliminate loading the environment with excessive pesticides. S-Metolachlor is a pesticide that is on the right track of reducing the load on the environment and making this country a safer place to live.

    Please reconsider your stand on granting [a registration for] metolachlor to Cedar Chemical Company. It will not benefit this country by having a chemical that does not work effectively, nor will it help the environment.

    DENY THE REGISTRATION OF METOLACHLOR.

    Comment 14

    Name: Renee Rianda
    Affiliation: Fort Romie Enterprises
    Title: Pest Control Advisor
    Date: August 5, 2001

    We are opposed to the EPA granting registration of metolachlor to Cedar Chemical Company.

    If the EPA registers metolachlor, it will go against their stand of "Reduced Risk." The purpose of the "Reduced Risk Initiative" was to encourage Corporate America to continue the development of [safer] products for the environment.

    S-metolachlor is a true "Reduced Risk" pesticide. By keeping this registration alive, pesticide use will be reduced by over 35% by not using the old registration of metolachlor.

    Syngenta took the opportunity of the "Reduced Risk" initiative to be good stewards of the land by finding a pesticide that could reduce pesticide exposure by over 200 Million pounds by the year 2010. In one year alone, Year 2000, by using the "Reduced Risk" pesticide S-Metolachlor, the environment was healthier by having 40 Million less pounds of exposure in it.

    If the EPA decides to keep metolachlor, it will set a precedent to eliminate any gains this county has made since DDT was banned in the 1970's. The whole purpose of forming the EPA in the first place was to make this county a safer place; thus how the "Reduced Risk" Initiative came about.

    Remember EPA stands for Environmental PROTECTION Agency.

    Corporate America is concerned and [is] spending millions upon millions of dollars to eliminate loading the environment with excessive pesticides. S-Metolachlor is a pesticide that is on the right track of reducing the load on the environment and making this country a safer place to live.

    Please reconsider your stand on granting [a registration for] metolachlor to Cedar Chemical Company. It will not benefit this country by having a chemical that does not work effectively, nor will it help the environment.

    DENY THE REGISTRATION OF METOLACHLOR.

    Comment 15

    Name: Mona Bond
    Affiliation: Iowa Alliance of Environmental Concerns
    Title: Executive Director
    Date: August 5, 2001

    Our association is opposed to EPA registering metolachlor and would suggest that EPA should stand by their "Reduced Risk Initiative," if they believe that we should encourage Corporate America to continue to develop these newer, safer products.

    Thank you for the opportunity to comment.

    Comment 16

    Name: Harry F Galloway
    Affiliation: Interested Citizen
    Date: August 5, 2001

    It seems logical to approve chemicals that are safer to our environment. If that logic is sound, then the EPA should stand by their "Reduced Risk" Initiative. Syngenta's alternative, S-Metolachlor, fits this thinking. Allowing the old Metolachor registration to stand -- let alone allow new applications -- flies in the face of EPA's stated objective of reducing pesticide usage.

    Comment 17

    Name: Dr. Dennis W. Hoffman
    Affiliation: Texas Agricultural Experiment Station
    Title: Research Scientist
    Date: August 6, 2001

    I have over 11 years of research experience in the area of pesticide losses in storm water runoff. I strongly support the development of S-Metolachlor to replace the original product. The reduction of environmental pesticide loading into our nation's drinking water supply will have positive benefits for years to come.