CONCLUSIONS AND RECOMMENDATIONS

BPPD concurs with ABSTC that the majority of growers who planted si ngle trait and stacked ECB/CRW PIP products were comp liant with the refuge requirements in 2009 when national average results from the on-line su rvey were considered. Although the degree of non-compliance in 2009 was in some instances lower than in 2008, these differences were not st atistically significant. When on-line compliance results were evaluated on a regional basis, however, it was evident that southern corn growers were up to 2.4 times less compliant than their northern counterparts. BPPD is concerned with these findings and recommends that ABSTC propose alte rnative approaches to increase refuge compliance in the southern corn growing regions of the U.S.

ABSTC concluded that compliance with CRW protected PIPs has seen some improvements. It is correct that compliance with re fuge size and distance was somewh at higher in 2009 compared to 2008. However, the margin of error for adherence w ith requirements was ±12%, and the increase in compliance seen in 2009 was below that reported margin of error. Hence, the difference in adherence to refuge requirements for single CRW corn PIP was not st atistically significant between

2008 and2009.

In contrast to the online survey program, ABSTC states that “t he on farm assessment program is

not a statistical tool for measuri ng the level of adherence to the IR M requirements”, and that rather, “this program helps identify obstacles that hinde r grower implementation of IRM requirements”. BPPD notes that a comparison betw een year-to-year on-farm survey results then should be made with caution because, among other things, th e growers were not randomly selected from companies’ customer lists. Nonetheless, it is diff icult to ignore that that on-farm compliance for CRW protected traits was 85.8% in 2008 and 69% in 2009, and that the per centage of significant

violations was 9% in 2008 and 26.4% in 2009. BPPD is aware that companies do not share their

clientele list with each other and that name s and locations of non-compliant growers are confidential and anonymous for the Agency. Yet, BPPD proposes that ABSTC compile and maintain, through a neutral third party, maps showing the distribu tion of on-farm non-compliance pooled across registrants so th at it is clear to the BPPD IR M team where these non-compliant regions are in the Corn Belt. It may then be pos sible for ABSTC to increase compliance in these regions with increased educational outreach by th e registrants or other ap propriate new measures.

It is recommended that ABSTC conti nue to work with BPPD to deve lop future steps that could be implemented to address low compliance for southern corn growers (on-line survey) and adherence to refuge requirements for, especially, single CR W PIPs as seen in last year’s on-farm survey.

It is recommended that ABSTC address the newl y approved refuge requirements in the 2010 CAP: 5% and 20% structured refuge in the Corn Be lt and cotton growing regi ons, respectively, for pyramided lepidopteran traits. Future survey results for 5% and 20% structured refuge in the Corn Belt should be separately collected, analyze d, and provided to BPPD (as for 20% and 50% structured refuge requirements in the cotton growing regions).

- 2 -I. BACKGROUND

As a condition of registration for the corn borer-protected Bt ( Bacillus thuringiensis ) corn products (EPA Reg. Nos. 524- 489, 68467-2, 67979-1 and 29964-3), corn rootworm-protected

Bt corn products (EPA Reg. Nos. 524-528, 524-551, 68467-5, 67979-5, and 29964-4), and stacked (corn-borer/corn rootworm-protected) Bt corn products (EPA Reg. Nos. 524-545, 524- 552, 524-576, 68467-6, 67979-8, and 29964-5), the registrant s must work together through their self-appointed Agricultural Biotechnology Stewardship Technical Committee (ABSTC) to implement an Insect Resistance Management (IRM) Compliance Assurance Program (CAP). The IRM CAP is designed to promote comp liance with refuge requirements among all Bt corn growers irrespective of farm size. The program is composed of several parts: grower agreements, annual grower affirmation of IR M requirements, grower education, tips and complaints to identify non-compliant growers, third-party grower surv ey (telephone and, since 2007, also on-line), on-farm assessments and fo llow-up actions (phased compliance program) should non-compliant growers be identified thro ugh the on-farm assessments. Individual registrants, however, are responsible for im plementing the requirements agreed upon by the ABSTC-Insect Resistance Management Stewar dship Subcommittee’s Compliance Assurance Program and EPA. Yearly results of the program are to be reported to EPA in an annual compliance assurance report (January 31 st each year). This review addresses the 2009 Insect Resistance Management Compliance Assurance Program Report for Corn Borer-Protected Bt Corn submitted by the ABSTC - Insect Resistance Management Stewardship Subcommittee.

II. SUMMARY OF 2009 CAP

The 2009 ABSTC CAP contained a summary of the following activities: 1) 2009 third party grower surveys for single and stacked PIPs targeting ECB and CRW, 2) 2009 on-farm assessments, 3) tips and complaints, 4) CAP activities for 2009, and 5) plans for the CAP during 2011. Grower agreements and annual grower affirmation systems are reviewed as part of each registrant’s annual IRM report.

1. THIRD-PARTY GROWER PHONE AND ON-LINE SURVEY The grower survey functions to measure comp liance adherence to refuge size and distance requirements in the Corn Belt and Cotton Belt and to identify educational opportunities to increase grower compliance with IRM require ments. As a condition of each individual Bt corn registration, the registrant must perform an annual third-party survey of a statistically representative sample of Bt corn growers. Beginning with the 2002 growing season, >500 growers from four separate regions were anonymously surveyed. The methodology for conducting the grower survey has remained larg ely unchanged since it was first conducted by Marketing Horizons, Inc in 2000. Past results (i ncluding data from 2006) were weighted to

reflect the actual distribution of corn acres in each region. Howe ver, starting in 2007 due to an increasing complexity of growers’ Bt corn pl anting practices and a need to standardize the grower survey across insect-prote cted traits, Marketing Horizons utilized an internet-based survey approach. BPPD notes that it is unclear at this point what kind of bias, if any, entered the data due to this change in methodology. In ot her words, a reported increase in non-compliance may or may not be partly due to the change in the survey methodology.

- 3 -There are several sampling regions that differ by pest and level of adoption: a) regions with high rates of Bt corn adoption; b) areas where insecticid es have historically been sprayed for control of corn boring insect pests; and c) areas where Bt corn and Bt cotton may be grown simultaneously. To participate in the survey, respondents had to be id entified as decisionmakers, not employed by the agrichemical or seed industries, who farmed a minimum of 200 acres of corn (100 acres in the corn-cotton growi ng region of the South), a nd at least 50 acres of their total corn acreage had to be planted with Bt corn (the registered pr oducts identified in the subject heading). Due to the random nature of the survey, the sample size from cotton growing regions was too small in 2007 and 2008 to an alyze whether there was a difference in compliance between the Cotton Belt and Corn Belt. ABSTC reported in its 2008 CAP that it will work with Marketing Horizons to improve the response rate in the cotton-growing regions for the 2009 surveys.

On May 21, 2009 BPPD requested from ABSTC that survey data be co llected on a regional basis and results subsequently reported as such. The regions and target number of growers from each region are outlined below:

• Eastern Corn Belt (250 growers): primarily Indiana, Illinois, Wisconsin, Ohio, and Michigan

• Western Corn Belt (250 growers): primar ily Iowa, Nebraska, Minnesota, South Dakota, Missouri, and Kansas

• Cotton-growing region (100 growers): as de fined by EPA in Bt corn registrations To obtain statistically valid national results, survey results from the three regions were weighted according to the proportion of total US corn acres in each region. The number of growers needed to participate in the survey to ensure a statistically significant representation for overall sample size and product type were a minimum of 600 growers for the internet survey, and a minimum of 200 growers for both co rn borer protected Bt corn and stacked Bt corn, as well as a minimum of 50 grow ers for rootworm protected Bt corn.

Growers were recruited for the survey between August 24 and October 11, 2009; the internet based portion of the survey remained open for completion until October 18, 2009. A total of 920 growers completed the internet survey in 2009, some of whom had multiple Bt corn

varieties on their farms. The internet survey, therefore, resu lted in 296 survey entries for single corn borer (ECB) protected PIPs, 61 entries fo r single corn rootworm (CRW) protected PIPs, and 563 entries for stacked corn PIPs protected against ECB and CRW. A total of 2981 on-farm assessments were conducted in 2009 with growers re presenting a range of farm sizes and states.

The ABSTC compliance surveys were conducted for corn borer-protected, corn rootwormprotected, and stacked (corn bor er- and rootworm-protected) Bt corn. The objectives of the surveys were to (i) determine the level of grow er adherence to IRM requi rements; (ii) measure changes in grower awareness of IRM require ments; (iii) obtain grower feedback for improvement of educational and compliance pr ograms; and (iv) evaluate the potential biological significance of non-adhe rence to the requirements.

- 4 -a. CORN BORER-PROTECTED Bt CORN REGISTRATIONS

2009 Data : Of the 920 growers who completed the online su rvey, a total of 296 growers planted a corn borer protected Bt product in 2009 (single PIP but possibly al so stacked PIP products). The compliance results listed here (Table 1) had a margin of error of ±5.7% . The survey results

showed that adherence to th e refuge size and distance requirements were 74% and 79%, respectively. An additional 10% of growers planted more than a 15% refuge but less than 20%, and 7% of growers surveyed failed to plant a refuge at all. Res ponses to survey questions about

each field on a grower’s farm revealed that 92% of all fields plante d to corn borer protected Bt corn had a refuge planted within the required 1⁄2 mile distance. Tw o percent of all fields had a refuge beyond 1⁄2 mile, and 5% of all fields had no refuge associated with them.

On a regional basis, 77% and 76% of growers planted the corre ct refuge size and 84% and 79% adhered to the distance requirements in the ea stern and western regions of the Corn Belt, respectively. In the cotton grow ing regions, 40% of growers me t the refuge size requirements and 63% adhered to the distance requirements.

When growers were asked on an unaided basis what they recalled a bout IRM requirements, 64% and 82% correctly identified the refuge size and distance requirements, respectively.

Table 1. Summary of telephone survey results for corn borer-protected Bt corn growers (Data from 2002- 2006) and online survey results (Data from 2007 and 2009)

Survey Question Survey Year

Telephone Online

2002 2003 2004 2005 2006 2007 2008 2009

-----------% respondents-----------

Adherence to Refuge Size

Weighted average across all four

regions surveyed 86 92 91 92 89 80 78 74%

NC/SC/SE MO/TN/MS

( 50% refuge in cotton-growing

areas) 77 82 78 82 80

N/A N/A 40%

E IA/N IL (20% refuge) 88 96 95 94
89-99 77%

and

76%* SD/MN/NE/W IA (20% refuge) 85 93 90 91

KS/OK/TX (20% refuge) [High

Plains] 81 82 93 95 82

Adherence to Distance Requirements

Weighted average across all four

Regions surveyed 89 93 96 96 96 88 4 88 4 79% 5

NC/SC/SE MO/TN/MS [Cotton 78 83 84 80 80 N/A N/A 63%

- 5 -Region]

E IA/N IL 95 96 96 97

89-99 84%

and

79%* SD/MN/NE/W IA 89 94 98 97

KS/OK/TX [High Plains] 79 92 94 94

Awareness of IRM Requirements

All growers 88 93 92 92 92 96 98 95%

Unaided Recall of IRM Requirements

Refuge size (weighted average

across all four regions surveyed) 42 52 53 59 N/A 63 3 79 3 64%

Refuge distance (weighted average

across all four regions surveyed) 37 49 55 53 49 79 3 89 3 82%

Refuge size (Corn Belt and High

Plains) 1 61 N/A N/A N/A

Refuge size (Cotton Belt) 2 31 N/A N/A N/A

1 Corn belt and high plains = Iowa, Illinois, South Dakota, Minnesota, Nebraska, Kansas , Oklahoma, Texas, i.e., three of four regions surveyed

2 Cotton belt = North Carolina, South Carolina, s outh-eastern Missouri, Te nnessee, and Mississippi

3 Cotton Belt numbers are not separated from Corn Belt survey results

4 Percent reflects only those growers that could remember the la yout of all their Bt fields; 447 out of 467 (95.7%) in 2007; 298 out of 317 (94%) in 2008.

5 on a per field basis, adherence was 92% in 2009; 5% of the fields had no refuge. *States in the eastern region were primarily Indiana, Illinois, Wisconsin, Ohio, Michigan; states in the western region were primarily Iowa, Nebraska, Minnesota, South Dakota, Missouri, and Kansas..

b. CORN ROOTWORM-PROTECTED Bt CORN REGISTRATIONS

2009 Data : Of the 920 growers who complete d the online survey, 61 growers planted coleopteran-protected Bt corn (single PIP but possibly also stacked PIP products) and were ra ndomly selected from the corn growing regions. All respondents planted a minimum of 200 acres of corn in 2008 (100 acres in the corn-cotton growing region of the South), with a minimum of 50 acres of rootworm-protected corn. The compliance results listed here (Table 2) had a margin of error of ±12.6 %.

Reported results showed that grow er adherence with planting the correct refuge size and observing the correct distance requirement was 79% and 71%, respectively. An additional 7% of growers planted more than a 15% refuge bu t less than 20%, and 9% of grow ers surveyed failed to plant a refuge at all.

Responses to survey questions about each field on a grower’s farm revealed that 76% of all fields planted to corn borer protected Bt corn had a ref uge planted within the Bt field or adjacent. Ten

- 6 -percent of all fields had a ref uge not near the Bt field, and 14 % of all fields had no refuge

associated with them.

A regional breakdown of rootworm protected Bt co rn responses was not available because of an insufficient sample size of respondents.

When growers were asked on an unaided basis wh at they recalled about IRM requirements, 58% and 31% correctly identified the refuge si ze and distance requirements, respectively.

Table 2. Percent Respondents for Di fferent Questions of Telephone (2005-2006) and Online Survey (2007-2009)

for Rootworm-Protected Bt Corn Growers

Survey Question 3 2005 1 2006 2 2007 2008 2009

Adherence to Refuge 93% 89% 80% 74% 79%

Adherence to Distance

Requirements 87% 82% 79% 63% 71% 4

Awareness of IRM

Requirements 97% 93% 97% 96% 92%

Unaided recall of

refuge size 51% 57% 63% 72% 58%

Unaided recall of

refuge distance 58% 55% 33% 34% 31%

1 YieldGard RW and YieldGard Plus corn growers

2 YieldGard RW, YieldGard Plus, Herculex RW, and Herculex XTRA corn growers.

3 Weighted average across all four regions surveyed

4 on a per field basis, adherence was 76% in 2009; 14% of the fields had no refuge.

c. STACKED Bt CORN REGISTRATIONS

2009 Data :

Of the 920 growers who completed the online survey, 563 planted stacked Bt corn (for ECB and/or CRW control). The compliance resu lts reported in Table 3 had a margin of error of ±4.2 %. Reported results showed that adherence to the re fuge size and distance requirements were 71% and 67%, respectively. ABSTC reported that this was a significant improvement compared to the survey results obtained in 2008. An additional 8% of growers planted more than a 15% refuge but less than 20%, but 11% of gr owers surveyed failed to plant a refuge at all.

Responses to survey questions about each field on a grower’s farm revealed that 78% of all fields planted to corn borer protected Bt corn had a re fuge planted within the required 1⁄2 mile distance. Ten percent of all fields had a refuge beyond 1⁄2 mile, and 12% of all fields had no refuge

- 7 -associated with them.

On a regional basis, 74% and 73% of growers planted the corre ct refuge size and 66% and 70% adhered to the distance requirements in the ea stern and western regions of the Corn Belt, respectively. In the cotton grow ing region, 31% of growers met th e refuge size requirements and 63% adhered to the distance requirements.

When growers were asked on an unaided basis wh at they recalled about IRM requirements, 66% and 59% correctly identified the refuge size for ECB and CRW, respectively. On an unaided basis, 83% and 32% of growers corre ctly identified the ECB and CRW distance requirements, respectively.

Table 3. Percent Respondents from Different Question of Telephone and On-Line Survey for Stacked Bt Corn Growers (Data from 2006-2009)

Survey Question 2006 2007 2008 2009

Adherence to Refuge Size 1 78% 70% 72% 4 71%

Adherence to Distance

Requirements 92% 66% 66% 3 67% 3

Awareness of IRM Requirements 95% 96% 97% 95%

Unaided recall of refuge size 59% 62% and 55% 2 81% 66% and 59% 2

Unaided recall of refuge distance

CRW 48% 39% 36% 32%

Unaided recall of refuge distance

ECB 32% 77% 86% 83%

1 Weighted average across all four regions surveyed

2 First number listed is for ECB and the se cond number for CRW refuge compliance.

3 on a per field basis, adherence was76% in 2008 and 78% in 2009

4 on a per field basis, adherence was 73%

d. BPPD REVIEW OF ON-LINE GR OWER SURVEY RESULTS (2009)

The survey results (see Figure 1 ) show that average compliance across all corn growing regions with refuge size requirements for ECB protected corn expressing sing le PIPs is lower than in the previous two years (74% in 2009, 78% in 2008, and 80% in 2007). Growers repo rted to be out of compliance deviated from the 20% requirement in one way or another. Further analysis of noncompliance numbers revealed that most farmers ( 84%) planted a refuge that was at least 15%, and that only 7% of farmers neglected to plant a refuge at all. Growers’ adherence to the 1⁄2 mile refuge distance requirement decreased from 88% in 2007 and 2008 to 79% in 2009. The margin of error for 2009 single ECB PIP results is ±5.7%, and th erefore, 2009 compliance results do not differ significantly from the 2007 and 2008 results. A regi onal analysis revealed that growers planting single ECB PIP expressing corn in eastern and western regions of the Corn Belt adhered about

- 8 -equally to refuge size (77% a nd 76%) and distance requirements (84% and 79%), while the corn growers in the southern U.S. ha d significantly lower adherence perc entages (40% with refuge size and 63% with refuge distance). Some of this obs erved difference could be due to differences in sample sizes. The sample size for southern corn growers was 60% reduced compared to growers in the eastern and western regions of the US who took the online survey. Other explanations for such lower compliance in the south could be attribut ed to some possible confusion with different requirements between various PIP products or simply blatant disr egard of refuge requirements by growers who plant both Bt corn and Bt cotton. AB STC stated in their 2009 CAP report that these regional results provided them w ith the opportunity to intensify fu ture educational efforts in the southern corn growing regions. BPPD notes that if higher non-complian ce among southern corn growers reflects a willingness to vi olate refuge requirements rather than a lack of knowledge, then increased efforts to educate them may not be frui tful. Other methods to br ing these growers back into compliance may need to be considered.

Figure 1. Compliance Trend from 2002 - 2009 for ECB protected Corn PIPs

Overall compliance (per grower) with refuge re quirements for single PIPs targeting CRW is displayed in Figure 2 . Average compliance in 2009 with ref uge size (79%) and refuge distance (71%) , respectively and was unchanged from prio r years (margin of error = ±12.6%). On a per field basis, 100% compliance with refuge size was similar to pe r-grower results. When the number

of Bt fields that had at least 15% refuge associated with them were considered, then compliance

increased to 86%.

Grower awareness with IRM requirements in 2009 was unchanged from 2008, but only 58% of growers surveyed were able to recall the correct ref uge size requirement in 2009, a decline of 14% compared to 2008. BPPD believes that this declin e is reason for concern. Educational efforts may need to target growers planting single CRW PIPs.

- 9 -Figure 2. Compliance Trend from 2005-2009 for CRW protected PIPs

Overall compliance (per grower) with refuge requir ements for stacked corn PIPs is displayed in Figure 3 . In 2009, the margin of error for adherence with requirements was ±4.2%; therefore, BPPD concludes that the latest average compliance re sults for refuge size a nd refuge distance were similar to those reported in prior ye ars. A regional analysis of survey results revealed that growers planting stacked corn PIPs in eastern and wester n regions of the U.S. a dhered about equally to refuge size (74% and 73%) and di stance requirements (66% and 70 %), while the corn growers in the southern U.S. had significantly lower adheren ce percentages (31% with refuge size and 63% with refuge distance). Adherence percentages with refuge size in eastern and western US corn growing regions were similar for stacked and si ngle ECB PIPs, while percentages for refuge distance with stacked PIPs were lower. Greater educational efforts may have to focus more on the refuge distance requirement for stacked PIP products due to the increased requirement complexity for stacked products; the lower co mpliance with stacked IRM requirements could also include other factors such as challenges with planting a refuge due to weathe r. On the other hand, growers’ adherence with refuge size and distance requiremen ts was again much lower in the south compared to the northern growers’ compliance. As stated ear lier in this review, ABST C may need to consider other methods, aside from increased education, to bring southern growers into compliance with IRM requirements. Higher non-compliance among s outhern corn growers could reflect willful noncompliance rather than a lack of knowledge.

BPPD notes that the number of gr owers who were able to correc tly recall IRM requirements on an unaided basis was relatively low for stacked pr oducts. This provides further opportunity for ABSTC to increase grower education.

- 10 -Figure 3. Compliance Trend from 2006-2009 for Stacked Corn PIPs

2. On-Farm Assessment Program

The on-farm assessment portion of the Complianc e Assurance Program identifies individual noncompliant growers (large and small farms) and brings them back into compliance through the Phased Compliance Approach. This part of the CA P is believed to enhance registrant and seed dealer understandings of the obst acles that hinder grower implem entation of IRM requirements. Unlike the online grower survey, the on-farm asse ssment program is not a statistical tool for measuring the level of adheren ce to the IRM requirements.

Registrants and their seed company partners in dependently coordinate the on-farm assessment activities each year. Growers receiving “first-tim e” on farm assessments (i.e. not assessed the previous year) were selected from individual comp any customer lists and in cluded a range of farm sizes across a number of key states. Growers f ound to be out of compliance in 2008 received a follow-up on-farm assessment in 2009.

Company representatives were trained to conduct on-farm assessments. Topics covered in these trainings included IRM requirement s, messages that should be co mmunicated to growers, followup actions if growers are found to be out of comp liance and how to use the IRM assessment form. All assessment forms contained the same questi ons, but the introductory paragraphs and company representative sections were cust omized to suit the needs of each re gistrant. Registrants responded to all compliance deviations identified in th e 2007 and 2008 on-farm assessments according to the common set of standards outlined in the PCA (see Appendix ).

The number of growers of each type of Bt corn w ho were assessed varied due to the market size of each product type. In 2009, 2981 growers r eceived a first time assessment.

In 2008, 452 growers were found to be out of complia nce, of which 331 had significant deviations. All compliance deviations were responded to in accordance with the Phased Compliance Approach,

- 11 -including reassessment in 2009. Three growers met th e criterion for revocation of access to stacked Bt corn according to EPA requirements. Grower s planting single and stacked ECB and CRW Bt corn and who were out of compliance in 2008 were either successfully brought back into compliance in 2009, or no longer farmed or planted Bt corn in 2009.

a. On-farm assessment results for growers planting ECB protected Bt corn products

2009 Data : Of the 1082 growers planting corn borer protected Bt corn and having received a first-time on-farm assessment in 2009, 83.6% were fully compliant with refuge requirements (see Table 4). Of the 16.4% non-compliant growers, 10.8% had signifi cant deviations. On-farm assessments were conducted across a range of farm sizes with approxi mately 33% of growers categorized as “small growers” with less than 250 acres of corn. As with previous years, the data suggest that farm size

should not be a selection criterion when trying to identify non-compliant growers.

Table 4. Cumulative Results for the First-Time On-Far m Lepidopteran-Protected Bt Corn Assessments (Data for 2003-2009)

Issue addressed Number of growers

2003 2004 2005 2006 2007 2008 2009

Growers assessed 1961 2130 2215 2020 2083 1312 1082

Compliant

growers 1,789

(91%) 2032

(95.4%) 2089

(94.3%) 1930

(95.5%) 1895

(91.0%) 1132

(86.3%) 905

(83.7%)

Noncompliant

growers 172

(9%) 98

(4.6%) 126

(5.7%) 90

(4.5%) 188

(9.0%) 180

(13.7%) 177

(16.4%)

Refuge size

deviations* 64 (3%) 27 (1.3%) 33 (1.5%) 33 (1.6%) N/A N/A N/A

Refuge distance

deviations 127 (7%) 69 (3.2%) 68 (3.1%) 64 (3.2%) N/A N/A N/A

Insignificant

deviations 68 (4%) 59 (2.8%) 51 (2.3%) 45 (2.2%) 59 (2.8%) 46 (3.5%) 60 (5.6%)

Significant

deviations 2 104 (5%) 39 (1.8%) 75 (3.4%) 45 (2.2%) 129 (6.2%) 134 (10.2%) 117 (10.8%)

1 Some growers had compliance deviations other than refuge size or distance or some gr owers may have had both a refuge size and a refuge distance deviation; thus, the tota l of refuge distance and si ze deviations does not equal the number of non-compliant gr owers.

2 Significant deviations are defined as: A Bt corn grower who planted less than 15% non- Bt corn refuge (except in certain cotton growing areas in which case it would be less than 40% non- Bt corn refuge); or planted fewer than 2/3 of the Bt corn fields are planted within 2 mile of a non- Bt corn refuge.

- 12 -b. ON-FARM ASSESSMENT RESULTS FOR GROWERS PLANTING CRW

PROTECTED Bt CORN PRODUCTS

2009 Data : Of the 110 growers planting corn borer protected Bt corn and having received a first-time on-farm assessment in 2009, 69.1% were fully compliant with refuge requirements. Of the 30.9% noncompliant growers, 26.4% had significant devi ations. On-farm assessments were randomly conducted across a range of farm sizes with approxi mately 33% of growers categorized as “small growers” with less than 250 acres of corn. As with previous years, the data suggest that farm size

should not be a selection criterion when trying to identify non-compliant growers.

Table 5. Cumulative Results for the On-Fa rm Coleopteran-Protected Bt Corn Assessment 1 (2006-2009 data)

Issue addressed 2006 2007 2008 2009

Growers assessed 395 247 134 110 Refuge distance

deviations 13 2 N/A N/A N/A

Refuge size deviations 7 N/A N/A N/A Significant deviations 11 3 (2.8%) 16 (6.5%) 12 (9.0) 29 (26.4%) Insignificant

deviations 10 (4.0%) 8 (3.2%) 7 (5.2%) 5 (4.5%)

Compliant growers 374 (94.7%) 223 (90.3%) 115 (85.8%) 76 (69.1%) Non-compliant

growers 21 (5.3%) 24 (9.7%) 19 (14.2%) 34 (30.9%)

1 Table adapted from page 12 of MRID 470444-01

2 Some growers had compliance deviations other than refuge size or distance; thus, the total of refuge distance and size deviations does not equal the number of non-compliant growers.

3 Significant deviations are defined as: A Bt corn grower who planted less than 15% non- Bt corn refuge (except in certain cotton growing areas in which case it would be less than 40% non- Bt corn refuge); or planted fewer than 2/3 of the Bt corn fields are planted within 2 mile of a non- Bt corn refuge.

c. ON-FARM ASSESSMENT RESULTS FOR GROWERS PLANTING STACKED Bt

CORN PRODUCTS

2009 Data : Of the 1789 growers planting corn borer protected Bt corn and having received a first-time on-farm assessment in 2009, 83.3% were fully compliant with refuge requirements. Of the 16.7% noncompliant growers, 11.4% had significant devi ations. On-farm assessments were randomly conducted across a range of farm sizes with approxi mately 33% of growers categorized as “small growers” with less than 250 acres of corn. As with previous years, the data suggest that farm size

should not be a selection criterion when trying to identify non-compliant growers.

- 13 -Table 6. Cumulative Results of the Firs t Time On-Farm Stacked Bt Corn Assessment 1 (Data for 2006-2009)

Issue addressed 2006 2007 2008 2009

Growers assessed 600 1069 1799 1789 Refuge distance

deviations 51 2 N/A N/A N/A

Refuge size deviations 8 N/A N/A N/A Significant deviations 45 3 (7.5%) 77 (7.2%) 86 * 193 (10.8) Insignificant

deviations 16 33 (3.1%) 36* 106 (5.9%)

Compliant growers 539 (89.8%) 959 (89.7%) 1546 (85.9%) 1490 (83.3%) Non-compliant

growers 61 (10.2%) 110 (10.3%) 253 (14.1%) 299 (16.7%)

1 Table adapted from page 12 of MRID 470444-01

2 Some growers had compliance deviations othe r than refuge size or distance; thus, the total of refuge distan ce and size deviati ons does not equal the number of non-compliant growers.

3 Significant deviations are defined as: A Bt corn grower who planted less than 15% non- Bt corn refuge (except in certain cotton growing areas in which case it would be less than 40% non- Bt corn refuge); or planted fewer than 2/3 of the Bt corn fields are planted within 2 mile of a non- Bt corn refuge. * The numbers of deviations to not add up to the 253 non-compliant cases reported.

d. BPPD REVIEW OF ON-FARM ASSESSMENT RESULTS (2009)

ABSTC states that “the on farm a ssessment program is not a statisti cal tool for measuring the level of adherence to the IRM requirements”, and that ra ther, “this program helps identify obstacles that hinder grower implementation of IRM requirement s”. BPPD notes that a comparison between year-to-year on-farm survey results then should be made with caution because, among other things, the growers were not randomly selected from comp anies’ customer lists. N onetheless, it is difficult to ignore that that on-farm compliance for CRW protected traits in 200 8 was 85.8% and 69% in 2009, and that the percentage of significant viola tions in 2008 were 9% and 26.4% in 2009. BPPD is aware that companies do not share their client ele list with each other and that names and locations of non-compliant growers are confiden tial and anonymous for the Agency. Yet, BPPD proposes that ABSTC compile and maintain, thro ugh a neutral third party, maps showing the distribution of on-farm non-complia nce pooled across registrants so th at it is clear to the BPPD IRM team where these non-compliant regions are in the Corn Belt. It may then be possible for ABSTC to increase compliance in these regions with increased edu cational outreach by the registrants or other appropriate new measures.

On-farm compliance results for stacked lepidopte ran and coleopteran protected PIP as well as single ECB PIP products continue to be lower each year as is evident from the results listed in Tables 4 and 6. The percentage of non-comp liant growers and grow ers having significant deviations is increasing each year as well. BPPD notes that this slight downward trend in on-farm compliance should be taken seriously. The decreasi ng compliance since 2006 is relatively small yet steady. As is visible in Table 6 , on farm assessments for stacked products showed that 89.8% of growers (sample size 600) were compliant in 2006, while by 2009 the pe rcentage reached 83.3% (non-random sample size of 1789). Likewise, Table 4 shows that there has been a steady and decreasing trend in on-farm non-compliance with single PIP products targeting ECB: in 2006

- 14 -compliance was 91% (sample size 1961) and re ached 83% in 2009 (non-random sample size of 1082).

On-farm compliance results for single PIP products targeting CRW are cause for increased concern: grower compliance has dwindled from 85.8% in 2008 (sample size 134) to 69.1% in 2009 (non-random sample size of 110). That is more than a 15% decrease in compliance in just one year (although the numbers likely do not represent an aver age of the same population). Percentage of significant deviations was 9% in 2008 and 26% in 2009. Since on-farm assessments have been implemented in 2006, compliance has decreased each ye ar and is now 20% less in 2009 than it was

in 2006. BPPD recommends that ABSTC meet with th e BPPD IRM team to address future steps to improve compliance.

Additional compliance requirements (i.e. bag ta gs) were implemented with the 2010 Bt corn extensions. These measurements could improve fu ture compliance beginning in the 2011 growing

season.

3. TIPS AND COMPLAINTS

2009 Data : In 2009, the registrants received four “tips and comp laints.” Legitimate tips and complaints were managed in accordance with the Compliance Assessm ent Program. Any grower found to be out of compliance based on a legitimate tips and complaint r eceived an on-farm IRM visit. If there were any growers found to be out of compliance during th e visit then these grower s were responded to in

a manner consistent with the Phased Compliance Approach.

Table 7. Anonymous Tips a nd Complaints about Non-Comp liance with IRM requirements

Year Number of Tips and Complaints

2009 4

2008 5

2007 14

2006 3

2005 5

2004 0

2003 0

4. PUBLICIZING THE COMPLI ANCE ASSURANCE PROGRAM

The registrants publicize the CAP, including the Phased Compliance A pproach as part of each of their grower education programs, company literature , internal training sessions, and meetings with growers and dealers. ABSTC memb ers also work with the Nationa l Corn Growers Association. The registrants work to provide the growers a consistence messa ge about compliance with IRM requirements.

- 15 -5. ABSTC OVERAL CONCLUSIONS

The registrants who are part of the ABSTC concl ude that based on the 2009 third party internet survey and registrant conducted on-farm assessmen ts, the different programs of the CAP continue

to be effective. In 2009 between 70 and 80% of a ll growers surveyed planted the required size refuge and between 67 and 78% of growers planted a refuge within the require d distance of their Bt fields. The survey indicates that the vast majority of all Bt corn fields (86% to 95%) have an associated refuge. These findings are similar to those obtained in 2007 and 2008; there appears, however, to be a small improvement with adheren ce to refuge requirements for CRW protected Bt corn. Overall compliance percentages continue to be lower for ECB protected Bt corn in recent years than historically ob served in 2002 through 2006.

The data suggest that the occurr ence of significant areas of Bt co rn planted without a refuge was rare. When the refuge requirements were establis hed, the EPA recognized that 30% (or higher) of non-compliance could be a reasonable expect ation (USEPA 2001). Resistance monitoring programs based on field observations and population sampling continue to show that the key target pests of the Bt corn products remain su sceptible to the insecticidal proteins.

A regional analysis of the grower survey results presented no clear differences in adherence to the refuge requirements between growers of the eastern and western Corn Belt. However, the growers in the southern cotton-growing region showed lowe r levels of adherence. Several reasons for lower adherence to refuge requirements in the South ha ve previously been proposed including practical limitations resulting from the larger refuge size required for ECB protected Bt corn, smaller farm sizes, greater diversity and complexity in farm operations, a different pest spectrum, and the smaller role that corn plays in overall agricultural production of the South. The 2009 survey results also indicated that a greater pr oportion of growers were unaware of refuge requirements compared to their northern counter-parts, and fewer were able to recall the specific refuge requirements on an unaided basis. These findings present an oppor tunity for ABSTC and member companies to strengthen grower IRM educat ion efforts of that region.

6. BPPD REVIEW OF OVERALL CAP

BPPD concurs with ABSTC that the majority of growers who planted si ngle trait and stacked ECB/CRW PIP products were comp liant with the refuge requirements in 2009 when national average results from the on-line survey were considered. Although the degree of non-compliance in 2009 is in some instances lower than in 2008, it is not clear that these differ ences are statistically significant. When on-line compliance results were evaluated on a regional basis, however, it was evident that southern corn growers were up to 2.4 times less compliant than their northern counterparts. BPPD is concerned with these findings and recommends that ABSTC propose alternative approaches to increase refuge compliance in the southe rn corn growing regions of the

U.S.

ABSTC concluded that compliance with CRW protected PIPs has seen some improvements. It is correct that compliance with re fuge size and distance was somewh at higher in 2009 compared to 2008. However, the margin of error for adherence w ith requirements was ±12%, and the increase in

- 16 -compliance seen in 2009 was below that reported margin of error. Hence it is not possible to conclude that there was an actual improvement w ith adherence to refuge requirements for single

CRW corn PIPs.

In contrast to the online survey program, ABSTC states that “t he on farm assessment program is

not a statistical tool for measuri ng the level of adherence to the IR M requirements”, and that rather, “this program helps identify obstacles that hinde r grower implementation of IRM requirements”. BPPD notes that a comparison betw een year-to-year on-farm survey results then should be made with caution because, among other things, th e growers were not randomly selected from companies’ customer lists. Nonetheless, it is diff icult to ignore that that on-farm compliance for CRW protected traits in 2008 was 85.8% and 69% in 2009, and that the percen tage of significant

violations in 2008 were 9% and 26.4% in 2009. BPPD is aware that companies do not share their

clientele list with each other and that name s and locations of non-compliant growers are confidential and anonymous for the Agency. Yet, BPPD proposes that ABSTC compile and maintain, through a neutral third party, maps showing the distribu tion of on-farm non-compliance pooled across registrants so th at it is clear to the BPPD IR M team where these non-compliant regions are in the Corn Belt. It may then be pos sible for ABSTC to increase compliance in these regions with increased educational outreach by th e registrants or other ap propriate new measures.

- 17 -REFERENCES

Bogdanova N, D Guyer, MJ Smith, and N Storer. 2009. Insect Resistance Management Compliance Assurance Report for Corn Borer-Protected Bt Cor n, Corn Rootworm-Protected Bt corn, and Corn

Borer/Corn Rootworm-Protected Stacked Bt Co rn. Unpublished report submitted by ABSTC to the Agency. MRID 479710-01

U. S. Environmental Protection Agency (E PA) 2001. Biopesticides Registration Action

Document: Bacillus thuringiensis Plant-Incorporated Protect ants (10/16/01), posted at http://www.epa.gov/pesticides/biopesticides/pips/bt_brad.htm.

- 18 -- 19 - APPENDIX: Phase Compliance Approach (PCA)

The ABSTC - IRM Subcommittee ha s developed a standard set of procedures (Table 8) known as the Phased Compliance Approach (PCA). Th e PCA requires that regi strants take specific actions (primarily, remedial grower education and then loss of access to the technology if an individual grower is found to have significant deviations in two consecutive years) for noncompliant growers identified through the on-fa rm assessment program. The PCA proposes to suspend sales to individual growers for one ye ar after two years of significant deviations. Following the one-year suspension, growers ma y be re-qualified to purchase seeds.

Table 2. Phased Compliance Approach (PCA)

Mandatory Responses Additional Responses

Significant Deviations • IRM education

• Warning letter

• Compliance assistance contact prior to planting

• Compliance assessment contact for the following growing season

• Deny access to the Bt corn product for any significant deviation two years in a

row • Invoice monitoring

• Technical assistance

• Grower IRM training

• Reaffirmation of IRM obligations

• Deny access to the Bt corn product for other deviations that are repeated over a period of years Other Deviations • IRM education

• Letter and/or compliance assistance contact prior to planting

• Compliance assessment contact in the following growing season