Biotechnology Project
Center for Science in the Public Interest

September 10, 2001.

By Regular Mail and Electronic Mail
Public Information and Records Integrity Branch
Information Resources and Services Division [7502C]
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460

Re: Comments Regarding Bt Crop Reassessment, Docket # OPP-00678B.

     The Center for Science in the Public Interest (“CSPI”) hereby submits comments to the Environmental Protection Agency (“EPA”) on the Revised Bt Crop Reassessment.(1) CSPI’s comments solely address compliance monitoring and enforcement issues surrounding the Insect Resistance Management Program (“IRM”). CSPI agrees with EPA that “protection of insect (pest) susceptibility of Bt to be in the ‘public good’”(Bt Plant-Pesticides Biopesticides Registration Action Document at IID2) and thus EPA should impose stringent IRM requirements with any registered Bt product.

     CSPI believes that EPA should require registrants of Bt crops to strive for 100% compliance with IRM. As stated by EPA and other scientists, “it is not known what level of grower non-compliance will compromise the risk protection of current refuge requirements.” (Bt Plant-Pesticides Document at IID9). Given this uncertainty, it is essential that EPA require that each registration include an IRM plan with a strong enforcement structure that addresses compliance and penalizes noncompliance.

     The current levels of compliance are unacceptable. According to recent data from the registrants, at most, 71% of corn growers are in compliance with IRM requirements. Similarly, in the past few years, there has been as much as 10% noncompliance among Bt cotton growers. Therefore, when re-registering these products, EPA should establish additional conditions that achieve higher levels of compliance, with the goal of 100% compliance. These comments suggests requirements that should be imposed on registrants to make sure than IRM is implemented by every grower of a Bt product.(2)

Obligations Necessary for a Strong and Enforceable IRM System(3)

I. A Clear Statement About the IRM Obligation in the Technology Agreement

     All Grower Technology Agreements used to date specifically mention that when planting Bt seeds the grower must implement an IRM program. In some agreements, however, that statement has not been placed prominently within the document, but is identified as just one of the many different obligations on a grower who uses this technology. See Monsanto 2001 Technology Agreement (Attachment A).

     Given the importance of the IRM obligation, CSPI believes that this obligation needs to be highlighted in the Technology Agreement so that the grower will focus attention on this obligation. For example, the Mycogen Grower’s Agreement (found on page 57 of 27/OPP# 00678) has a detailed statement about why IRM is needed and spells out in four sentences, the specific obligations of the grower. With a prominent explanation, it is less likely that the grower will misunderstand his obligation. Therefore, for each Bt registration, EPA should require that the registrant provide a clear and prominent statement of the grower’s obligation to carry out an IRM program. EPA should review and approve the statement of the obligation and its placement in the Grower’s Agreement before it can be used by the registrant. This will ensure a consistent message about IRM from registrants to growers.

II. The Need for Clear Statements about What Happens if a Grower Does Not Comply

     Under the current registration system, it is unclear what happens if a grower does not comply with his IRM responsibilities. Fairness requires that the grower understand what will happen if he fails to comply with IRM requirements and under what conditions any penalty will be imposed. Therefore, each Bt registration should require the registrant make a clear statement in the Grower’s Agreement, the Technology Use Guide, and all other documents explaining IRM requirements about the penalty for noncompliance and under what conditions that penalty will be imposed.

     A review of the re-registration docket makes clear that although growers are told that they need to comply with the IRM requirements, they are not adequately told what are the consequences of noncompliance. For example, most of the Grower Agreements state somewhere that violating the agreement will result in termination of the agreement and forfeiture of future rights. (See Monsanto 2001 Technology Agreement). This passage, however, refers not just to IRM requirements but also patent violations, seed reselling, seed saving, and so forth. There is rarely a specific statement about what will happens if the grower does not comply with IRM responsibilities.

     Similarly, a review of Grower Guides and Technology Guides in the docket found that each one discusses in detail what IRM is required, why it is required, and how it should be carried out, but almost never discussed what would happen if a grower did not comply. An exception is the Monsanto 2001 Bollgard Refuge Guide, which specifically states the penalties for noncompliance for growers using the Community Refuge Plan option. That brochure states that if there is noncompliance the first year,

“then either all of the member of that community will be denied the option of a Community Refuge Plan the following year, or, at a minimum, all of the members of that community plan will be inspected the following year by a Monsanto representative to ensure community compliance. If there are any instances of noncompliance in that community the second year, all the members of the community will be ineligible to license Monsanto technologies the next year.”
(emphasis added) (Bollgard Guide is Attachment B). It is unclear why the Bollgard Guide does not have a similar statement for growers planting their own refugia nor why other guides do not have comparable statements.

     EPA should require in each Bt registration that there be a clear statement in the Grower Agreement and the Technology Guides about the consequences to a grower for noncompliance with IRM, stating both the penalty (loss of future use of the technology) and under what conditions that penalty will be imposed.

III. Recalcitrant Growers Who Do Not Carry Out Satisfactory IRM Programs Must Not Be Allowed Future Use of the Technology.

     Unless registrants actually take away the rights to purchase the technology from recalcitrant growers, some growers will not be deterred from violating IRM requirements. EPA should specify that the registrant must stop selling seeds to any grower that fails to comply with the IRM requirements for any two years in a five year period,(4) except where the registrant applies for and receives a grower-specific waiver of this requirement from EPA.(5)

     A. Registrants Currently Penalize Virtually No Growers

     Based on a review of the docket, it is unclear if any registrant has ever penalized a grower who violated the IRM requirements. For example, in responding to questions from EPA regarding Bt cotton, Monsanto states in one place that they “have only had to take this action with a few growers,” (93/OPP#00678 at p. 25) but they states later on page 27 of that same document that it has withheld “a license from a grower who was in noncompliance for two consecutive years.” With over 6000 Bollgard growers and a compliance rate estimated to be as low as 90% (i.e. 600 noncompliant growers), taking action against one of them amounts to taking action against approximately 0.17% of noncompliant growers. The penalty is hardly a deterrent if such a small number of growers are actually penalized. Similarly, it is unclear if any corn grower has ever had their right to purchase seeds suspended by any registrant for IRM noncompliance.

     CSPI also has made inquiries with both Monsanto and Pioneer Hy-Brid to find out how many growers have been denied seeds because of IRM noncompliance. These inquiries have resulted in general statements about penalizing a very small number of growers without any specific evidence.

     The only conclusion that can be reached from this inquiry is that the registrants are not suspending use of the technology to noncompliant growers. Therefore, each registrant must be required to enforce its IRM obligations and not sell any Bt seeds to growers who do not comply with IRM requirements.

     B. Two Years is the Appropriate Time Period for Losing Rights to Bt Seeds

     CSPI believes that if a grower does not comply two years in a row without an explanation justifying a waiver, that grower should not be allowed to use this special technology. Two years allows for the grower to be educated by the registrant after non-compliance has been identified.(6) EPA proposed a two year grace period before denying sales of the product in its Discussion Paper (p. 11). In addition, two years has been used by some registrants before restricting seed use. As stated above, Monsanto makes it clear that for anyone involved in the Community Refugia Plan, it is two strikes and you are out. Also, Monsanto stated to EPA that it gave Bollard growers one more chance (a second year) after their inspectors had found the grower did not comply with IRM requirements. (93/OPP#00678, at p.25). Given the importance of IRM and the industry’s emphasis on grower education, if a grower cannot be educated between growing seasons about his IRM obligations after being identified to be out of compliance, then that grower should not be able to use this technology.(7)

     The industry’s vague references to restricting future access to the technology after some period of repeated noncompliance is inadequate. For example, in a submission to EPA from the Bt corn registrants, the registrants stated that “As a consequence of repeatedly ignoring the IRM Plan requirements, identified growers will be restricted from future access to this technology.” (53/OPP#00678 at p. 15). Similarly, the most recent Bt Corn Resistance Management Stewardship Plan (dated July 23, 2001) states that

“In the event that some growers do not implement IRM plan requirements despite continued education efforts, action would be taken at the regional and/or individual level. Identification of these growers would trigger a graduated response to bring them into compliance, including letters, visits, certification requirements, and/or restrictions on future purchases of Bt corn seed.”

     (Attachment C at p. 3). These statements strongly suggest that the registrants will allow three to five years of noncompliance by a grower before there will be restrictions on seed purchases. Allowing noncompliance to go on for this long jeopardizes the benefits of the technology to compliant growers and growers using microbial Bt products.

     C. Each Registrant Needs a Clear Plan to Address Noncompliance

     EPA should require that each Bt corn registrant provide a clear plan about how they will rectify noncompliant situations that are identified to them. The Compliance Response Plan section of the registrants’ proposed “Bt Corn Insect Resistance Management Stewardship Plan” dated July 23, 2001, is inadequate.

     The Bt Corn IRM Stewardship Plan (Attachment C) discusses a “graduated compliance response plan, in order to avoid restrictions on future purchases of Bt corn yet maximize compliance.” The plan describes the first step after finding noncompliance is “intensified education.” (CSPI assumes this would occur after the first year of noncompliance and before a second planting season). Then, if some growers do not implement IRM “despite continued education efforts, action would be taken at the regional and/or individual level.” Finally, if noncompliance continued, a “graduated” response would be used to achieve compliance, which would include letters, visits, certification requirements, and finally restrictions on future purchases. This “graduated” plan describes a program that involves at least three and maybe as many as five years before a grower loses access to the technology. In the meantime, insect resistance could occur due to this noncompliance. EPA should require each registrant submit to EPA a detailed plan that identifies the specific steps the registrant will take to rectify noncompliance and then implement that plan after it is approved by EPA.

     D. Reporting of Actions Taken Against Noncompliant Growers.

     EPA should require registrants to identify in their annual report to EPA the number of growers (by state) who have lost their rights to the technology. This reporting will provide a deterrent to growers because they will realize that losing the technology can and does happen if one does not comply with IRM requirements. It will also allow the public and EPA to measure the effectiveness of the registrant’s compliance program. In addition, non-compliance should be identified on a local (county) level and by acreage to facilitate the evaluation of the effectiveness of the IRM program. That information is important because non-compliance at those local and regional scales may be sufficient to accelerate the development of resistance.

     E. Industry-wide Database of Noncompliers.

     To ensure that a grower who has had his technology agreement terminated due to noncompliance cannot purchase other Bt corn seeds from a competitors, the Bt corn registrants should be required to establish a confidential database to share information about noncompliant growers. This would not be expensive to maintain and would make sure that growers cannot take advantage of the fact that there are several registrants selling similar products.

IV. Each Registrant Needs a Program to Identify and Assess Individual Farmer Compliance.

     Under the current Bt registrations, registrants do not actually check the IRM compliance status of individual growers. The registrant must make sure each grower signs a Grower Agreement, gets a Technology Use Guide that explains his obligations, and educate the grower about IRM. The registrants then survey growers anonymously to determine levels of compliance and tailors continuing educational efforts based on survey results. All of these actions are done to achieve IRM compliance but there are no activities by the registrants to determine if individual growers are actually in compliance. As stated by the SAP, “while education is likely to increase compliance, it will not ensure compliance.” (SAP November 2000 report at p. 29).

     Individual determinations of grower compliance are essential to achieving the highest possible rates of compliance. The registrants have stated that “If individual noncompliant growers are identified, they will be restricted from future purchases of Bt seed corn.” (54/OPP#00678 at p. 9). Currently, however, these registrants have no mechanisms to identify individual non-compliant growers, making this a hollow promise. The EPA SAP stated that “the smaller the likelihood of detection, the lower the compliance rates will be.” (SAP November 2000 Report at p. 30). Under the current registrations, there is virtually no likelihood of detection. Therefore, EPA should require each registrant to establish their own individual compliance monitoring program that incorporates the compliance monitoring activities set forth below.(8)

     A. Grower Surveys are Useful for Education but are Inadequate as a Compliance Tool

     For Bt corn products, the primary mechanisms to measure compliance have been through grower surveys conducted by industry or academics. These surveys may be useful as a tool to get general trends on grower compliance and to target educational efforts, but they do not always provide accurate compliance levels nor do they serve as a compliance monitoring tool.

     First, these surveys are not always reliable for determining actual grower compliance. As stated by EPA and EPA’s SAP, there may be numerous “false positives” because mail or telephone interviews may encourage non-compliant growers to misrepresent their actions or “cheat” in their responses. (Reassessment Report at IID10-11). Thus, these surveys may report higher compliance rates than actually exist. In addition, these surveys cannot be utilized as a compliance tool because they are anonymous. The survey does not allow the registrant to follow-up with specific non-compliant growers by bringing them into compliance or penalizing their noncompliance. Finally, even the industry admits that the greatest advantage of surveys is to “provide critical information about ways to communicate and improve their IRM plans.” (06/OPP#00678-1 at p. 18). Therefore, the registrants currently do not use nor could they use surveys to ensure individual grower compliance. Some other mechanism must be utilized to detect noncompliance.(9)

     B. Certifications.

     Current compliance with IRM requirements (71% in corn, 91% in cotton) needs improvement. One way to improve IRM compliance is to require annual documentation from growers setting forth how the grower complied with their IRM responsibilities that year. Currently, most growers only sign the Technology Agreement the first season that they purchase their seeds acknowledging that they understand the conditions of the agreement. Annual certifications would remind growers about their obligations on an annual basis and require them to affirmatively state how they complied that year.

     CSPI proposes that each registrant should be required to collect from growers a Certification after the growing season has begun that contains the following: (1) a statement that the grower has complied with his IRM obligations; (2) which IRM option he chose (if more than one is allowed for that particular crop); and (3) and either a map or written description of where the Bt and non-Bt crops are located on his farm. If the grower did not return this Certification in a timely fashion, then the registrant would follow-up with telephone calls or visits by seed salesman trying to get the Certification completed. If these actions were not successful, the registrant might schedule an inspection for IRM compliance later that season. Thus, the Certification would perform two compliance monitoring functions: (1) it is a inexpensive method to get individual compliance information, and (2) it can be a screening mechanism to determine which growers might need field investigation for possible noncompliance.

     In addition to collecting Certifications from its growers, the registrant should be required to make those certifications available to EPA or its agents for inspection. The registrant also should be required to report summary results from the certifications (number of certifications received, number of farmers certifying compliance, methods of compliance, and so forth) in its annual report to EPA.

     CSPI believes this reporting system would not be burdensome to growers. First, growers meeting IRM requirements will need to keep their own records identifying Bt and non-Bt crops. Thus, copying this information to a simple form will not involve much time or effort. Second, the registrants are already required to collect and retain individual Grower Agreements from each grower so it would not be burdensome to require them to review and maintain annual certifications.

     In fact, the Bt Reassessment record has several documents where the registrants agree that Certifications are a useful compliance tool. In their Management Stewardship Plan, the registrants of Bt corn products specifically state that “certification requirements” is a tool that they would use to bring noncompliant growers into compliance. In addition, Monsanto already uses certifications for a subset of growers of Bt cotton. For growers who choose to comply with IRM requirements using a Community Refugia, those members must send in compliance certifications with similar information. Also, when Monsanto implemented a 1999 refuge incentive program in several counties in Alabama and Tennessee with high percentages of Bt cotton growers, they required certifications to ensure compliance. Thus, these example show that the registrants clearly understand the value of this type of information for compliance monitoring and demonstrate that growers will provide it when required.(10)

     C. Field Inspections.

     To ensure that all growers comply with IRM requirements, EPA should require that each registrant hire a third-party to inspect a statistically-sound random sample of farmers growing its seeds on an annual basis. Under current practices, growers understand that field inspections are rarely, if ever, conducted and that the likelihood that anyone will detect non-compliance is extremely small. As pointed out by the EPA SAP, “The smaller the likelihood of detection, the lower compliance rates will be.” Therefore, until growers understand that their non-compliance actually may be detected, some growers will continue not to plant appropriate refugia.

     Conducting field inspections would not be too burdensome or expensive to the registrants. From 1996 to 1999, Monsanto conducted field inspections of between 1,000 and 2,300 growers per season, well more than a statistically-sound random sample. In addition, Monsanto conducted field inspections of over 90% of the growers in its sales incentive program in North Alabama and Giles County, Tennessee. Thus, it is clear that inspections can be conducted to determine compliance with IRM requirements in a cost-effective manner.

     Each Bt registration should state that the registrant hire an independent party to conduct annual inspections of growers for IRM compliance. The inspection targets should be selected based on results from the grower surveys, tips received by the registrant or seed providers about noncompliance, review of certifications and field maps provided with the Grower’s Agreement, and past history of noncompliance (i.e. any grower found in noncompliance should be inspected for at least the next two years afterwards). Summary results of these inspections should be included in the registrant’s annual report to EPA.

V. There Must Be Consequences to Individual Registrants for Noncompliance with IRM Requirements.

     It is imperative that each registration identify specific consequences to the registrant that will occur if the registrant does not achieve the necessary IRM compliance among growers of its seeds. The current registrations are inadequate because they do not identify any penalties or restrictions on the individual registrants if IRM is not carried out. Currently, the registrant is only required to get signed Grower Agreements from growers which mention IRM obligations, provide growers with Technology User Guides that discuss IRM requirements, conduct educational activities with growers, and survey growers for compliance. The registrants are currently in compliance with these requirements and yet for Bt corn, compliance with IRM obligations may be no higher than 71%. They would also be in compliance if compliance rates were 50% or even only 25%. This is unsatisfactory, especially since any level of noncompliance may lead to resistance.

     The individual registrants need to be held accountable for the IRM compliance of the growers of their seeds. The registration must ensure that each registrant, using the compliance monitoring tools suggested above, provide EPA with IRM compliance rate for growers using their particular Bt product.(11) If the compliance rate for a particular registrant goes below 80%(12) in a particular region of the country (for example in a state) for two years in a row, then the registrant should have a restriction imposed on the selling of Bt seeds in that region (such as allowing the sale of only 50% as many seeds as in the previous year) until compliance rates improve.(13) In addition, if compliance rates in a particular region continued to remain below 80% for two more years (four years total), then the registrant would be permanently prevented from selling any Bt seeds in that region.

VI. Specific Comments on Compliance Monitoring and Enforcement Issues Presented in EPA Discussion Paper.

     A. Grower Agreements.

     On page 9 of the Discussion Paper, EPA discusses several items that might be included in the registrations regarding Grower Agreements. CSPI agrees that all of these items should be made conditions of registration. First, the Grower Agreements should be submitted to EPA for approval before use. As stated earlier in this letter, EPA should ensure consistency among different registrant’s Grower Agreements and also ensure that the IRM obligations are prominently discussed in the document. Second, if the Certification process proposed in this letter is not adopted, then Grower Agreements should be signed annually to remind growers of their obligations and help ensure compliance. Third, the registrant should make available to EPA or its agents the Grower Agreements and other documents identifying growers and IRM obligations.

     B. A Tiered Approach to IRM Compliance.

     CSPI has several comments on the potential tiered approach to IRM compliance set forth in pages 11-12 of the Discussion Paper. On the proposed First Tier, CSPI believes that each individual registrant should be responsible for compliance monitoring of its own growers instead of industry-wide compliance monitoring. It would be preferable for this monitoring to be paid for by the registrant but conducted by a third party. In addition, the compliance surveys referred to in this tier would be useful to require if they are not anonymous and can be used by the registrants to identify specific growers who are in noncompliance. Finally, as discussed above, CSPI believes the First Tier should include field inspections and grower certifications.

     On the Second Tier, CSPI believes that growers found to be out of compliance two years in a row “must” (instead of “could”) be denied sales of the product the next year, except for extenuating circumstances.

     On the Third Tier, as stated above, CSPI believes the registration must contain specific consequences to a registrant if IRM conditions are not being met by its growers. The proposed consequences discussed above in Section V differ from the third tier in several important aspects. First, this letter identifies what would constitute a large number of growers (less than 80 % for corn) whereas the EPA proposal left that term undefined. CSPI believes it is important to define when compliance becomes unacceptable so that the registrant knows its registration is in jeopardy. Second, imposing an increased refuge size does not make sense since it is highly unlikely that noncompliant growers who did not plant the initial refuge will then plant a larger refuge. Third, if a registrant has growers out of compliance for a number of years, CSPI believes that sales restrictions “must” (instead of “might”) be imposed on the company, except for extenuating circumstances.

     C. Annual Reports

     CSPI believes that each annual report should provide detailed compliance monitoring and enforcement information, all of which should be publicly available. The annual reports should provide compliance survey results, summaries of the certification information (number received, compliance rates, method of compliance where there are several compliance options), field inspection results, number of growers out of compliance by region, and number of growers who have had seed sale suspensions.

     CSPI appreciates this opportunity to submit comments on the Bt crop reassessment. CSPI understands that EPA has worked hard to address the human health and environmental risk issues surrounding these crops. If EPA would like additional information from CSPI about these comments, we would be happy to meet with you at your convenience.



Gregory Jaffe
Co-Director, Biotechnology Project
Center for Science in the Public Interest


1. CSPI is a nonprofit education and advocacy organization that focuses on improving the safety and nutritional quality of our food supply and on reducing the damage caused by alcoholic beverages. CSPI seeks to promote health through educating the public about nutrition and alcohol; it represents citizens’ interests before legislative, regulatory, and judicial bodies; and it works to ensure advances in science are used for the public good. CSPI is supported by the 900,000 member-subscribers to its Nutrition Action Healthletter and by foundation grants. CSPI receives no funding from industry or the federal government.

2. CSPI comments are based on what is currently contained in the reassessment docket, OPP# 00678. When that was reviewed, CSPI could not find any of the correspondence from EPA to the registrants registering their products, including the initial Notice of Registration and any amendments to it. CSPI believes these are essential documents that were missing from the docket. On June 15, 2001, CSPI sent a information request for this information pursuant to the Freedom of Information Act. Despite regulations requiring a response within 20 working days, CSPI has not received a response to this date. Therefore, CSPI reserves the right to supplement these comments when it receives that information.

3. Unless specifically stated, these comments apply to the re-registration of both Bt corn and Bt cotton products. Although there are very different markets for these products with a different number of registrants and growers, most of the suggested changes discussed in this letter, would help increase compliance for Bt products.

4. The reasons for restricting sale of Bt seeds to a grower after two years of noncompliance are discussed below in Section III.B.

5. Some conditions that might justify a waiver might include acts of nature (such as floods and weather problems), unintentional mistakes (such as miscalculations of acreage), and so forth. The registrants and EPA could come up with specific criteria for waivers.

6. Two years of documented noncompliance is extremely lenient when a grower may be out of compliance for several years before an inspection or grower survey uncovers the noncompliance.

7. EPA states in its Discussion Paper on Possible Options for Risk Mitigation for Bt Plant-Incorporated Protections (“Discussion Paper”) at page 11 that “as a corrective measure, growers found out of compliance two years in a row could be denied sales of the product in the next year” (emphasis added). CSPI does not understand why this should be an option for the registrant. Instead, this should be required unless there is a good reason not to do it.

8. It is very important that each registrant establish its own compliance monitoring plan to assess compliance of growers of its seeds. This allows each registrant to be held accountable for its seeds and the farmers who have signed its technology agreement. The current system which treats the industry collectively makes it very difficult to penalize an individual registrant for IRM failures by its growers.

9. Although the registrants do discuss the fact that they have suspended sales of at least some noncompliant growers, it is unclear how those growers were identified. For Bt cotton, they may have been identified from the field inspections. There was no mention in the record of any mechanisms to identify noncompliant Bt corn growers.

10. It is unclear why the registrants have not suggested this as an inexpensive and noninvasive compliance monitoring mechanism, other than that they don’t really want to know if individual farmers are not in compliance.

11. As stated earlier, it is important that each individual registrant be held accountable for the compliance rate of its growers. Industry-wide information is useful to determine compliance trends and target educational efforts, but the Bt product registrations are individual to a particular company and product. Thus, individual compliance rates for individual products is necessary to ensure that the particular registrant is complying with its individual obligations. The industry would obviously prefer industry-wide compliance monitoring activities so that they can avoid individual responsibility for their product complying with IRM conditions in their registration.

12. The “80%” refers to Bt corn compliance. For Bt cotton, that number should be at least 90%.

13. It should be noted that although a region might be a state, it could also be the whole country if the individual registrant’s compliance rate was less than 80% nationwide.


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