|Comments to EPA on Compliance Assurance Programs submitted by registrants of Bt corn and cotton crops
March 1, 2002
By Fax, Electronic Mail, and Regular Mail
Ms. Marcia E. Mulkey
Director, Office of Pesticides Program
Environmental Protection Agency
1200 Pennsylvania Ave. N.W. (7501-C)
Washington, DC 20460
Re: Comments on Compliance Assurance Programs for Bt Crops Submitted by Registrants to Environmental Protection Agency on January 31, 2002.
Dear Ms. Mulkey:
On September 29, 2002, and October 15, 2002, the Environmental Protection Agency (EPA) issued a Registration Action Document (RAD) for the Bt cotton and Bt corn pesticidal plants. In those documents, EPA conditionally renewed the registration of those products with numerous conditions that are required as a condition of the registration. One of those conditions was that the registrants implement an insect resistance management program (IRM). IRM is extremely important to the future of these crops because it will prevent resistance from developing in the target insects, will quickly identify and address any resistance that does develop, and will bolster public confidence in this controversial technology. Protection of insect susceptibility to Bt protects a public good and EPA was justified in imposing stringent IRM requirements with the re-registration of the Bt corn and Bt cotton products.
One condition of the IRM program was that the registrants prepare and submit a Compliance Assurance Program (CAP) that sets forth in detail (1) how the registrants will determine if an individual grower is complying with IRM requirements, and (2) what actions and responses the registrant will take to bring the noncompliant grower back into compliance. Thus, while EPA re-registered the Bt pesticidal plants in October, 2002, it left some details about those registrations to a later date after the registrants submitted additional information.
On January 31, 2002, the CAP for Monsantos Bt cotton and the CAP for all the Bt corn products were submitted to EPA. The Center for Science in the Public Interest (CSPI)1 has reviewed these submissions and hereby submits comments on the CAPs.2 Although the compliance assurance and enforcement conditions set forth in the RAD showed promise as an effective means of assessing and responding to noncompliance, the actual implementation of those conditions in the CAPs is grossly inadequate.
As set forth in more detail below, the registrants have neither followed the spirit nor the letter of the RAD in setting forth their CAPs. The CAPs do not put in place any adequate methods to actually assess the compliance status of individual growers. There is no statement that the telephone surveys will be used to assess individual grower compliance nor is a good faith effort made to conduct on-farm compliance visits or to investigate legitimate tips and complaints. In addition, the CAPs do not set up a phased compliance approach that corresponds to the RAD. The CAPs define significant violation so narrowly that only the most egregious violations are covered and dont address when all growers in a specific region will lose access to Bt seeds. In addition, the mandatory responses for deviations dont include the required field visits to assess compliance in the year following the documented violation. Therefore, EPA should take action to modify the CAP so that it better reflects EPAs decisions in the RAD.
I. The CAP Needs to Have Methods for Determining Individual Grower Compliance with IRM Requirements.
Individual determinations of grower compliance are essential to achieving the highest possible rates of compliance. For an effective CAP, there must be several methods to identify individual non-compliant growers, because the lower the likelihood of detection, the lower the compliance rates. The CAP submitted by the registrants, however, does not set forth a credible plan for assessing and identifying non-compliant growers. Therefore, EPA should modify the CAP to incorporate the compliance monitoring activities and comments set forth below.
A. Field Inspections and Annual Certifications are the Best Methods for Assessing Grower Compliance.
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. Until growers understand that their non-compliance actually may be detected, some growers will continue not to plant appropriate refugia. 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 Growers Agreement, and past history of noncompliance (i.e. any grower found in noncompliance should be inspected for at least the next two years afterwards).
In addition to random inspections, 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. The Certification would perform two compliance monitoring functions: (1) it is an 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. This reporting system would not be burdensome to growers because growers already need to keep their own records identifying Bt and non-Bt crops and the registrants are already required to collect and retain individual documentation from each grower on a yearly basis.
B. The CAP Should Specify That the Grower Survey Will Be Used for Determining Individual Compliance.
Although the CAPs annual grower survey may be a useful tool in determining general compliance trends among growers, there is no statement in the CAP that it will be used to assess individual grower compliance. The registrants should be required to implement the actions set forth in the Phased Compliance Approach for all growers who are determined to be out of the compliance from the annual survey. In other words, the registrants should be required to follow-up with specific non-compliant growers identified in the annual survey by bringing them into compliance or penalizing their noncompliance.
C. The CAPs Training of Company Representative to Conduct On-Farm Compliance Assessments (Section 2.4) is Inadequate.
As a condition of registration, EPA decided that Each registrant shall train its representatives who make on-farm visits with Bt corn growers to perform assessments of compliance with IRM requirements. (Paragraph d. 11 on page V 14)) Section 2.4 of the CAP, however, does not properly carry out that obligation.3
First, the CAP states that the training of company representatives will not occur until late 2002 (which is assumed to mean after the growing season) or early 2003. Nothing in EPAs RAD, however, indicates that this obligation is not expected to occur immediately. For many obligations, the RAD specifically states when that obligations effective date is delayed. For example, on page V11, paragraph (3), the requirement that growers affirm annually must occur by the 2003 growing season. Thus, the fact that the RAD does not specifically delay implementation of this obligation, means that it should be accomplished in time for the 2002 growing season. The interpretation that the obligation to train representatives and perform assessments is effective immediately is also consistent with the annual reporting obligations for activities carried out under the CAP in paragraph d. (14) on page V 15. Under those obligations, the registrant needs to report on January 31, 2003, about grower interactions in 2002, including but not limited to on-farm visits,.... If EPA believed the training for on-farm visits would not occur until the 2003 growing season, reporting these activities would not be necessary in early 2003. Therefore, EPA should require that the registrants immediately train their representatives to conduct on-farm compliance assessments and ensure that these assessments are performed during the 2002 growing season.
Second, the CAP does not identify the specific methods that will be used to determine compliance during on-farm visits. A good compliance assessment should include a field inspection, a review of planting maps, a review of relevant documents at the farm, and a verbal discussion with the farmer and/or farm workers. Instead, the CAP states only two possible methods for assessing compliance, both of which are unsatisfactory for different reasons. The CAP states that one method for assessing compliance may be invoice monitoring, yet in another section, the CAP states that invoice monitoring does not necessarily show noncompliance because growers can purchase seeds from other companies (see footnote 6 on page 9). If the on-farm visits includes a review of seed invoices to assess compliance, then that review must include all seed invoices at that farm, irrespective of the seed company (something that should not be hard to do if the representative is at the farm). The CAPs second method for determining compliance, a verbal or written questionnaire, may be a starting point for assessing compliance but is not sufficient by itself. The value of an on-farm visit is that the assessor can review documents, walk the fields, or collect other evidence that cannot be collected in a questionnaire. If all the compliance assessor does is provide a written questionnaire to the grower, the advantages of an on-farm visit for assessing compliance have been lost. Therefore, EPA should require that the company representative conduct a thorough on-farm inspection to determine IRM compliance, not the collection of limited information that may or may not provide a clear determination of the compliance status of that farm.
D. The CAPs Investigation of Tips and Complaints (Section 2.3) is Inadequate.
As a condition of Registration, EPA decided that each registrant must carry out a program for investigating legitimate tips and complaints that its growers are not in compliance with the IRM program. (Paragraph d.(12) on p. V. 15) The CAP submitted by the registrants does not adequately satisfy that requirement for several reasons.
First, the registrants have not set forth how these tips and complaints will be received. While the biotechnology companies have not hesitated to provide toll-free numbers for tips and complaints about intellectual property violations, they do not propose a similar procedure for IRM violations. In fact, they do not propose any methods for letting people know that they will collect and investigate legitimate tips and complaints. Instead of announcing this policy in growers agreements, in literature about IRM, and at IRM meetings with growers and seed dealers, the CAP is silent about publicizing this part of the CAP. Therefore, EPA should ensure that each registrant has an adequate system for collecting tips and complaints and that the system is adequately publicized so that people will use it to provide information about potential noncompliance to the registrants.
Second, the CAP defines legitimate tips and complaints too narrowly. That may result in the registrants being able to avoid investigating numerous instances of potential noncompliance. The CAP states that a tip or complaint is legitimate only if the tip or complaint indicates with specificity the particular IRM requirements that have not been complied with. (emphasis added). EPAs RAD, however, discusses investigating tips and complaints where the grower is not in compliance with the IRM program. Thus, the CAP narrows the scope of legitimate tips and complaints by adding that the tip or complaint specify the particular IRM violation.4 Under the CAP, if someone calls up Monsanto, identifies himself, identifies his next door neighbor as a grower of Bt corn, and says that his neighbor told him he is not in compliance with the IRM requirements, but cannot say specifically what part of the IRM requirements his neighbor is not in compliance with, that tip is not considered legitimate and will not be investigated. Therefore, the CAP should be changed to eliminate the third criteria needed to make a tip or complaint legitimate. A tip or complaint should be investigated even if the informant cannot state what specific aspect of the IRM requirements is being violated.
Third, the CAP does not adequately explain how legitimate tips and complaints will be investigated. The CAP only states that the registrant will contact the grower. Instead, the CAP should specify that the registrant, or one of its agents, will visit in-person with this grower, investigate the allegation, and inspect the farm to ensure it is in compliance with IRM requirements.
Finally, in order for a tip or complaint to be deemed legitimate, the CAP requires that the person making the tip identify himself and provide contact information. Although requiring this information may be justified, the CAP should specifically state that this information will be kept confidential. Without an explicit statement that the identity of persons providing tips will remain confidential, many people will not provide information about instances of noncompliance. Therefore, the CAP should be modified to state that the identity of the informant will remain confidential.
II. Once Noncompliance Has Been Identified, the CAP Needs to Appropriately Address the Violations in a Consistent Manner.
Although the registrants agree that there should be serious responses to incidents of noncompliance with IRM requirements, the CAP, as drafted, has too many narrow definitions and second and third chances to effectively curb noncompliance. The specific aspects of the CAP that need changing in this area are set forth below.
A. The CAP Defines Significant Violations Too Narrowly.
Although CSPI agrees that not all violations of IRM requirements are equal, the CAP defines significant deviations too narrowly. Under the CAP, only planting no refuge or planting none of the refuge within 1/2 mile of Bt corn qualify as significant deviations. Under that definition, many serious violations of IRM requirements will not be treated as significant. For example, a farmer with a 1000 acres of corn who plants only 100 acres of non-Bt corn (10% instead of the required 20%) does not qualify as a significant deviator. Similarly, a farmer with a 1000 acres of corn who plants 150 acres of non-Bt corn (15% instead of the required 20%) and only plants 50 acres within 1/2 mile of the Bt corn (a second violation) does not qualify as a significant deviator. Both of these examples should be considered significant deviations because both growers have farms that are not even close to compliance and both situations could have biological significance, particularly in areas of high Bt corn penetration.
EPA should require the CAP to redefine significant deviators much more broadly. The best method of differentiating minor or technical violations from serious violations is to specifically define the types of violations that are deviations and consider all remaining violations as significant. A proposal definition of deviation might be: (1) where the grower plants at least 15% but less than 20% of the required refuge; (2) where the grower plants at least half but not all of the required 20% refuge within 1/2 mile of Bt corn; or (3) where physical constraints on the farm prevented the grower from complying with the refuge requirements.
B. The CAP Needs to Broaden the Situations That Result in Denial of Access to Bt Seeds.
Although a grower who has two deviations (as narrowly defined Section II.A. above) need not lose the right to purchase Bt corn seeds, a grower who has a significant deviation the year after a deviation should not be allowed to purchase Bt corn seeds. After a grower has been found in noncompliance and receives the mandatory responsive measures to help him correct his violation (a letter or visit, a copy of the phased compliance approach guidance document, and education and/or technical assistance), the next year that grower should be able to comply with the IRM requirements or come very close to complete compliance. If, however, that grower goes from a deviation to a significant deviation, clearly there is a problem with that grower and seed access should be denied. Therefore, the CAP should be modified to state that if a grower has two deviations, his gets one more chance, but if the second deviation is significant, then that grower loses his right to plant Bt corn seeds for one year.5
C. The CAP Needs To Address When Growers in a Specific Region Will Lose Access to Bt Seeds.
In EPAs RAD, paragraph (5a) and (5b) on page V.13 specifically state that the options for responding to instances of non-compliance shall include withdrawal of the right to purchase Bt corn ... for all growers in a specific region. The CAP makes no mention of this option or the general criteria that will be used to determine if this penalty should be imposed. Thus, EPA should require the CAP address the criteria under which a registrant will deny Bt corn to growers in a specific region due to widespread noncompliance with Bt refuge requirements.
D. The Mandatory Response to All Deviations Should Include On-Farm Compliance Visits, Information About Future Penalties for Continued Noncompliance, and Education and/or Technical Assistance.
In the CAP, the mandatory response for a deviation differs in several ways from the mandatory response for a significant deviation. These differences are inconsistent with the RAD and should not be allowed.
In the RAD, EPA stated that if a grower has not been in compliance during the previous year, the registrant shall visit with the grower and evaluate... compliance for the current year. (Paragraph (14) on p. V 15) (emphasis added). This language is important for two reasons. First, for that obligation, EPA did not make a distinction between being out of compliance and being significantly out of compliance as it did in other parts of the RAD (see paragraph (5a) for example on p. V 13). Second, it stated that the registrant shall visit the farm the next year to evaluate compliance. The CAP, on the other hand, states that the registrants will only conduct in-person (which is assumed to mean on-farm) compliance visits for farms where significant deviations occurred the previous year and that compliance assessment visits for other deviations can be accomplished by telephone. Thus, the CAP is inconsistent with the RAD because it does not require conducting physical visits the following year to determine compliance for all farms where there has been evidence of noncompliance the previous year. Therefore, EPA needs to correct this inconsistency. On-farm compliance visits should occur the next year at all non-compliant growers, whether or not the deviation is significant.
The CAP also distinguishes the response between significant and other deviations by only providing significant deviators with information about what will happen if another violation occurs. As part of the mandatory response to noncompliance, all violators should receive the guidance document (referred to in paragraph (5a) on p. V 13) on how the registrant will address instances of non-compliance. This will put the grower on notice of what penalty could be imposed if noncompliance continues and will publicize the phased compliance approach to the people who most need to know it.
Finally, education and/or technical assistance should be made a mandatory response to any deviation. Throughout the re-registration process, the registrants advocated to EPA that the best method to achieve compliance with IRM requirements is not enforcement, but additional education. Yet, in the CAP, the registrants state that additional IRM education and technical assistance is only an optional response to a deviation. If the registrants truly believe that education, not enforcement, will lead to greater IRM compliance, they should be required to conduct IRM education and technical assistance for all growers who have any deviation from the IRM requirements.
E. The CAP Should Specify How The Phased Compliance Approach Will Be Publicized (Section 2.5.4).
The CAP does not adequately explain how the Phased Compliance Approach will be publicized to growers, seed dealers, and sales representatives. EPA should require that information about the approach be included in the growers agreement and all IRM educational material (both written material and oral presentations).
F. The CAP Needs To Address What Happens to Seed Dealers Who Do Not Fulfill Their IRM Obligations (Section 2.5.3).
As the primary mechanism for providing information to growers about IRM requirements, the seed dealer is extremely important to ensuring compliance with IRM obligations. The section on responding to delinquent seed dealers, however, is grossly inadequate. First, the requirement that the registrants investigate tips and complaints should include tips and complaints about seed dealers who are not fulfilling their obligations. Second, the CAP should specify how it will investigate these tips (interviews with seed dealer, interviews with customers, attending seed dealer presentations, etc...). Third, the CAP should not temper EPAs determination that seed dealers who do not fulfill their obligations will lose their opportunity to sell Bt corn (RAD, paragraph (5a) and (5b) on page V 13). As currently written, the CAP states that a seed dealer will be given a reasonable amount of time to fulfill their obligations before losing access to Bt corn seeds and does not define what is reasonable. In addition, the CAP states that a seed dealer not fulfilling its responsibilities will have the authority to sell seed suspended for one or more growing seasons. EPA could have decided to treat seed dealers the same as growers and give them two years to comply with their obligations before denying access to the technology for a limited period of time, such as one year, but did not do that. Instead, EPA stated that seed dealers not fulfilling their obligations lose their right to sell Bt corn seed without a second chance. Therefore, EPA should see that the CAP treats seed dealers who are not fulfilling their obligations as required by the RAD.
If each issue raised in this letter is adequately addressed in a revised CAP, then EPA and the biotechnology industry will have taken a large step toward serious enforcement of the IRM obligations for Bt crops. I look forward to your response to each of the specific points raised above.
If you have any questions about the contents of this letter, I can be reached at 202-332-9110, Ext. 369.
Co-Director, Biotechnology Project
||Janet Andersen (by electronic mail)|
||Phil Hutton (by electronic mail)|
||Leonard Cole (by electronic mail)|
||Michael Mendelson (by electronic mail)|
||Sharlene Matten (by electronic mail)|
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. Both the CAP and the conditions of registration found in the RAD are almost identical for Bt cotton and Bt corn products. Thus, the comments contained in this letter apply equally to both Bt cotton and Bt corn. For simplicity purposes, the remainder of this letter refers to the Bt corn RAD conditions and the Bt corn CAP. If there is a difference in the analysis for Bt cotton, that difference and its significance is addressed in a footnote.
3. The cotton CAP differs significantly from the corn CAP when addressing the training of company representatives to conduct on-farm assessments of compliance. The cotton CAP properly states that the training and assessment process will occur in 2002. The cotton CAP, however, does not specify what this training will entail nor what methods the company representatives will use to perform the compliance assessments. Thus, although the timing of this obligation seems consistent with the RAD, the specifics about how it will be implemented need to be expanded.
4. When the CAP says the complaint must specify the particular IRM violation, that is assumed to mean that the informant must state something such as the grower planted less than 20% refuge or planted the refuge more than 1/2 mile from Bt corn.
5. The result of this change would be that Examples 4 and 6 in Attachment 2 would result in seed sale denials after year 2 instead of year 3.