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) CSPIs
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 Growers 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 growers obligation to carry out an
IRM program. EPA should review and approve the statement of the obligation and its placement
in the Growers 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 Growers 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
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
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
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 industrys
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 industrys 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 registrants 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 EPAs 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
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
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 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). Summary results of these inspections should be
included in the registrants 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 registrants 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
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
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
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.
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
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 dont 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
13. It should be noted that although a region might be a state, it could also be the whole
country if the individual registrants compliance rate was less than 80% nationwide.