UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES, AN D

TOXIC SUBSTANCES

APR 15 2009

MEMORANDUM

DP Barcode: 363945

Decision: 389745

SUBJECT: EPA Review of ABSTC's 2007 and 2008 Com Insect Resistance

Management Compliance Assurance Program [EPA Registration Nos. 524-

489,68467-2, 67979-1, 29964-3,524-528,524-55 1, 68467-5,67979-5,

29964-4, 524-545, 524-552, 68467-6,67979-8, and 29964-5; MRlDs

4733396-01 and 476633-01J

TO: Mike Mendelsohn, Senior Regulatory Action Leader

Microbial Pesticide Branch

Biopesticides and Pollution Prevention Division (7511P)

Jeannette Martinez, Ecologist 6-

Bi

M

opes

icrobia

ticides

l Pesticide

and Po

Bran

lluti

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on Prevention Division (7

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511P)

L--=a--- ......

FROM :

REVIEWED Alan Reynolds, Entomologist

BY: Microbial Pesticide Branch

Biopesticides and Pollution Prevention Division (7511P)

ACTION REQUESTED:

BPPD1was asked to review ABSTC's IRM CAP for com borer and corn rootwonn protected

single corn PIPs and corn borer and corn rootworm protected stacked corn PIPs.

I The use of BPPD in this review refers to the BPPD IRM team consisting of Jeannette Martinez and Alan Reynolds.
CONCLUSIONS AND RECOMMENDATIONS

Compliance with refuge requirements for ECB protected single and/or stacked com PIPs:

1. The 2007 and 2008 online survey results show that grower compliance with refuge size

requirements for single ECB protected com PIPs has reached the lowest level (see Figure I )

since 2002 (in the 70thand 80th percentile). ABSTC is correct that most growers continue to

adhe re to the refuge requ irements and that a portion of non-compliant growers attempted to

plant a refuge although not large enough in size. However, it is concerning to see compliance

decrease despite registrants working together with the National Corn Grower Association

(NCGA) with more outreach tools, increased educational efforts, and more avenues than ever

with which to reach growers. BPPD notes that the increase in non-compliance may in some

instances reflect willful non-compliance with requirements rather than a lack of knowledge.

2. The 2007 and 2008 on-farm assessment showed that 91% and 86% of growers, respectively,

were compliant with refuge requirements. While this is still a high degree of compliance , BPPD

notes that there has been a visible declining trend in compliance since 2003. The percent of

non-compliant growers and growers with significant deviations was at the highest level in 2008

(13.7% and 10.2%, respective ly) since on-farm assessments started in 2003 (see Figure 4).

Compliance with refuge requirements for com rootwonn protected com PIPs:

3. Overall compliance (per grower) with refuge requirements has further declined in 2008 and

dropped from 93% and 87% for refuge size and distance, respectively, in 2005 to 74% and 63%

in 2008 (see Figure 2). The percent of growers who can recall the correct refuge requirements

(unaided) has drastical ly declined to the lower 70th and 30th

percentiles for refuges size and

distance, respectively. Compliance with refuge distance requireme nts for rootwonn-protected

Bt com products might be more challenging because the refuge must be deployed either within

the CRW-protected Bt field or immediately adjacent to a corn rootwonn-protected Bt field.

Further education with respect to refuge distance, especially, may be needed fOr growers who

plant corn rootworm protected Bt corn.

. 4. From the 2007 and 2008 on-farm assessment results it can be concl uded that growers'

compliance was relatively high in both years (90% and 86%) but that overall compliance has

decreased from previous years. The percentage ofsignificant dev iations (9%) also increased i n

2008 compared to 2007 (2.8%) and 2006 (6.5%). BPPD notes that compliance results from onfarm assessments are higher than from on-line surveys (74% for refuge size and 63% for refuge

distance). The reasons for this discrepancy are not clear. The phone/internet survey may be a

statistically representative sample (600), while the on-farm survey is not (134). BPPD

recommends increasing the sample size fOr on-farm assessments targeting growers who plant

corn rootworm protected Bt corn. Since 2006 the sample size has decreased each year; this

brings into question whether the survey results are still representative of growers' compliance.

across all regions. Furthermore, ifregional data had been provided fOr the 200 7 and 2008 CAP,

BPPD could verify where regional non-compliance from the two assessment methods did not

correspond Ifthese data are in tact available fOr 2007 and 2008, BPPD recommends that

ABSTC submit the additional infOrmation to the Agency. BPPD recommends fO cused sampling

(on-farm assessments) fOr areas ofhigh Bt corn adoption (i.e. the "red zone " fOr CR W and

2
where there have been anecdotal reports ofhigh-noncompliance). These areas will have high

selection pressure for resistance; high non-compliance will further increase that risk.

Compliance with refuge requirements for stacked ECB and CRW protected com PIPs:

5. 2008 compliance results for refuge requirements (stacked com PIPs) were similar to the 2007

results. While the majority of growers planted a refuge and observed the correct refuge

distance, a large percentage of growers did not comply with requirements. Compliance with

refuge distance dropped from 92% in 2006 to 66% in 2007 and 2008 (see Figure 3). Only 36%

of the surveyed growers in 2007 and 2008 could recall the correct refuge distance for CRW.

BPPD recommends that ABSTC 's educational effOrts target growers who plant stacked Bt

products for HCB and CRW to further improve compliance with refuge requirements, especially

if one considers how the number of growers who have started planting stacked com PIPs has

increased since 2006.

6. The on-farm assessment results demonstrate that the surveyed growers who planted stacked Bt

corn hybrids in 2007 were approximately equally compliant (89%) as growers who planted com

borer-protected Bt corn hybrids (9 1%) and coleopteran-protected Bt com hybrids (90%). Like

the survey results for com rootwonn protected Bt com, the on-farm compliance results for

stacked ECB and CRW products (90.3%) do not directly correspond with the on-line

compliance results for stacked products (70% and 66% for refuge size and distance,

respectively). The on-farm survey results showed higher compliance rates than the online

survey results. The reasons for this discrepancy were not obvious (both online and on-farm

samples were statistically representative) but could be further investigated if regional data had

been provided for both survey methods (see #8 below). IU hese data are in fact available for

2007 and 2008, BPPD recommends that ABSTC submit the additional intormation to the

Agency. Part of this deviation between on-line and on-farm survey results could be due to the

switch in survey methodology in 2007.

DEFICIENCIES

7. ABSTC's reported results from the on-farm survey for growers who planted stacked ECB and

CRW com PIPs stated that the number of significant and non-significant deviations were 86

and 36, respectively. BPPD notes that these numbers do not add up to the total number of noncompliant growers (253) reported by ABSTC. It is unclear at this point what the correct

numbers were for 2008; BPPD requests that the corrected on-farm results tor stacked corn

PIPs be submiued.

8. The online survey results (single and stacked Bt products) were not broken down for the four

regions assessed as was done in previous years, and therefore, it is impossible for BPPD to

determine in which regions the non-compliance with refuge requirements dominated or

occurred. BPPD recommends that if the online survey is not set up to gather regional data that it

be re-designed for this purpose. In addition, it is useful to be able to tabulate results in a

historical context for each ofthe four regions (a. Eastern Iowa, Northern Illinois region; b.

South Dakota, Minnesota, Nebraska, Western Iowa region; c. Kansas, Oklahoma, Texas

Panhandle region; and d. North Carolina, South Carolina, Southeast Missouri, Tennessee,

Mississippi region). BPPD requests that this information be provided in future reports so that

3
ABSTC and BPPD may determine where non-compliance is the highest. where hot spots fOr

resistance could occur and the risk orresistance evolution is the highest. and in which

geographic regions registrants could fOcus their resistance monitoring effOrts (Or ECB and

CRW

9. The 200712008 online surveys did not include results for 'adherence to refuge size and distance

requirements' for the Com and Cotton Belt as was reported in previous years (i.e. see Table I).

Such details should be provided if the data are available. Otherwise BPPD suggests that the

on-line part orthe grower survey be redesigned so that results can be grouped by Corron or

Corn Belt/regions/states. Similarly (Or on-farm assessment surveys, BPPD recommends that

compliance with 'refuge size and refuge distance ' be included in future CAP reports.

10. It is possible that by switching from phone surveys to on-line surveys, variability was

introduced into the results of 2007 and 2008 when compared to earlier years. In order to

determine whether compliance has declined due to the switch in methodology and/or other

factors, BPPD suggests that ABSTC reanalyze their data from 200 7 and 2008 and assess

whether non-compliance is randomly dislributed (error due to new methodology) or clustered

a.e. regional non-compliance increased). This analysis should provide furthe r insight into why

compliance might have declined in the last two years.

4
I. BACKGRO UND

As a condition of registration for the com borer-protected 81 (Bacillus rhuringiensis) com products

(EPA Reg . No s. 524-489. 68467-2. 67979-1 and 29964-3), com rootwonn-protected Bt com

products (EPA Reg . Nos. 524-528. 524-55 1, 68467-5, 67979-5, and 29964-4), and stacked (comborer/com rootworm-protected] BI com products (EPA Reg. Nos. 524-545, 524-552, 68467-6,

67979-8, and 29964·5), the registrants must work together thro ugh their self-appointed Agricultural

Biotec hnology Stewardship Tec hnical Comm ittee (ASSTe ) to implement.an Insect Resistance

Management (IRM) Compliance Assurance Program (CAP). The IRM CAP is designed to promote

compliance with refuge requirements amo ng all Bt com growers irres pective of [ann size. The

program is composed ofseveral parts: grower agreements, annual grower affirmation ofIRM

requirements, grower education, tips and comp laints to identify non-compli ant growers, third-party

grower survey (telephone and since 2007 also on-line), on-farm assessments, and follow-up actions

(phased comp liance program) should non-compliant growers be identified through the on-farm

assessments. Individual registrants, however, are responsible for implementing the requi rements

agreed upon by the ABST nse Resistance Management Stewardship Subcommittee's

Compliance Ass urance Program and EPA. The results of the year's program are to be reported to

EPA in an annual compliance assurance report (January 31

st

each year). Th is review addresses the

ABSTC - Insect Resistance Management Stewardship Subcommittee's 2007 and 2008 Insect

Resistance Management Compliance Ass urance Program Report for Com Borer-Protected BI Com.

II. SUMMARY OF 200712008 CAP

The 2007 and 2008 ABSTC CAP contained a summary ofthe following activities: I) 2007 and

2008 third party grower surveys for single and stacked PIPs for both ECB and CRW, 2) 2007 and

2008 on-farm assessments, and 3) tips and complaints, 4) CAP activities for 2007 and 2008, and 5)

plans for the CAP during 2008 and 2009. Grower agreements and annual grower affirmation

systems are reviewed as part of eac h registrant's annual lRM report.

1. Third-Party Grower Phone and Online Survey

The grower survey functions to measure compliance adherence to refuge size and distance

requirements at a regional level and to identify educational opportunities in these four regions to

increase grower compliance with IRM requirements. As a condition of each individual BI com

registration, the registrant must perform an annual third-party survey of a statistically representative

sample ofBt com growers. Beginning with the 2002 growing season, >500 growers from four

separate regions were anonymously surveyed. The methodology for conduct ing the grower survey

has remained virtually unchan ged since it was first cond ucted by Marketing Horizons, Inc in 2000.

Past results (including data from 2006) were weighted to reflect the actual distribution of com acres

in each region. However, starting in 2007 due to an increasing complexity of growers' Bt com

planting practices and a need to standardize the grower survey across insect-protected traits,

Marketing Horizons utilized an internet-based survey approach. BPP D notes that it is unclear at this

point what kind of bias, if any, entered the data due to this change in methodology. In other words,

a repo rted increase in non-compliance may or may not be partly due to the change in the survey

methodology.

There are four sampling regions that differ by pest and level of adoption: a) regions with high rates

ofBt com adoption; b) areas where insecticides have historically been sprayed for control of com

5
boring insect pests; and c) areas where Bt com and Sf cotton may be grown simultaneously. To

participate in the survey, respondents had to be identified as decision-makers. not employed by the

agrichemical or seed industries, who farmed a minimum of 200 acres of com (100 acres in the

com-corton growing region ofthe South), and at least 50 acres of their total com acreage had to be

planted with Bt com (the registered products 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 analyze whether there was a difference in compliance between the Cotton Belt and Com 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.

The ABSTC compliance surveys were conducted for com borer-protected, com rootwormprotected, and stacked (com borer- and rootworm-protected) Bt com. The objectives ofthe surveys

were to (i) determine the level of grower adherence to IRM requirements; (ii) measure changes in

grower awareness of IRM requirements; (iii) obtain grower feedback for improvement of

educational and compliance programs; and (iv}evaluate the potential biological significance of

non-adherence to the requirements.

Growers were recruited for the survey between August 23 and September 20, 2007; the internet

based portion ofthe survey remained open for completion until October 2, 2007. A total of611

growers completed the internet survey, some of whom had multiple Bt com varieties on their

farms. The internet survey, therefore, resulted in 467 survey entries for single com borer (ECB)

protected PIPs, 132 entries for single com rootwonn (CRW) protected PIPs, and 456 entries for

stacked com PIPs protected against ECB and CRW.

In 2008, growers were recruited for the survey between August 20 and October 2; the internet

based portion of the survey remained open for completion until October 9, 2008. A total of 600

growers completed the internet survey, some of whom had multiple Bt com varieties on their

farms. The internet survey, therefore, resulted in 317 survey entries for single ECB protected PIPs,

103 entries for single CRW protected PIPs, and 556 entries for stacked com PIPs protected against

ECB andCRW.

a. Corn Borer-Protected Bt Corn Registrations

2007 Data:

Of the 611 growers who completed the online survey, 467 growers planted a com borer protected

Bt product in 2007 (single and/or stacked PIP products). Reported results showed that adherence to

the refuge size and distance requirements were 80% and 88%, respectively, and remained relatively

high. Eighty-nine percent ofthe growers surveyed planted at least a 15% com borer refuge, while

95% planted at least a 10% refuge. The 88% for compliance with refuge distance refers to the

growers that could recall the layout of all their ECB protected Bt com fields (447/467). Ofthe 140

growers who planted a singJe com borer protected Bt product, 89% adhered to refuge size and 87%

ofthose growers who recalled the layout oftheir Bt fields complied with refuge distance

requirements. These compliance numbers for single ECB protected com PIPs correspond the

compliance numbers obtained in 2006 more closely than the pooled results for single and stacked

PIPs.

6
Ninety-six percent of growers surveyed were aware ofIRM requirements, the same as in 2005 and

2006. On an unaided basis, 63% of those surveyed across all regions provided the correct refuge

size requirements for their area. Further, on an unaided basis, 79% of the growers across all regions

identified the correct refuge distance.

The education portion of the survey provided similar results to prior years. Growers indicated that

seed companies and their dealers were the most important sources of IRM information (92% and

95%, respectively). Ninety-three percent of growers stated that they received information from

multiple sources (e.g., technical guide, conversation with company representative). Eighty-eight

percent of growers stated that they had enough information at the time ofto plantin g to establish

and manage a Sf com refuge.

2008 Data:

Of the 600 growers who completed the online survey, 317 growers planted a com borer protected

Bt product in 2008 (single and/or stacked PIP products). Reported results showed that adherence to

the refuge size and distance requirements were 78% and 88%, respectively, and remained relatively

high. The 88% for compliance with refuge distance refers to the growers that could recall the layout

of all their ECB protected Bt com fields (298/317). Eighty-six percent of the growers surveyed

planted at least a 15% com borer refuge.

Table l. Summary of telephone survey res ults for corn bo rer-protected Bt corn growers (Da ta from 2002-2006)

and online survev results 'Data from 2007 and 2008\

Survey Year

Survey Question 2002 2003 2004 2005 2006 2007 2008

------- %respondents--

Adh erence to Refuge Size

Weighted average across all four regions surveyed 86 92 91 92 89 80 78

NC/SC/SE MOffNlMS 77 82 78 82 80

(50% refuge in cotton-growing areas)

E lAIN IL (20% refuge) 88 96 95 94 N/A NlA

89-99

SDIMNINEJW IA (20% refuge) 85 93 90 91

KS/OKJTX (20% refuge) [High Plains1 81 82 93 95 82

Adherence to Distance Requirem ents

Weighted average across all four regions surveyed 89 93 96 96 96 88' 88'

NC/SC/SE MO!TNIMS [Cotton Belt} 78 83 84 80 80

E lAIN IL 95 96 96 97

89-99 N/A N/A

SDIMNJNEJW IA 89 94 98 97

K S/OKfTX [High Plains1 79 92 94 94

Awa reness of IRM Requirements

7
All gro wers 88 93 92 92 92 96 98

Unaided Recall of IRM Requireme nts

Refuge size 42 52 53 59 NJA 63' 79'

(weighted averag e across all four regions surv eyed)

Refuge distance 37 49 55 53 49 79' 89'

(weighted average across all four regions surv eyed)

Refuge size (Com Belt and High Plains) I 61 N/A N/A

Refuge size (Co tto n Belt)2 31 N/A N/A

Com belt and high plains Iowa, IlImOiS, South Dakota, Minnesota, Nebraska, Kansas, Oklahoma, Texas, r.e., three of four

regions surveyed

lCmton belt = North Carolina, South Carolina, south-eastern Missouri, Tennessee, and Mississippi

l Cotton Bell numbers are not separated from Com Belt survey results

• Percent reflects only those growersthat could remember the layout of all their 8t fields; 447 out of 467 (95.7%) in 2007; 298 out

of3 17 (94%) in 2008.

BPPD Review (2007):

Based on the third-party grower survey results from 2002 through 2007 , grower compliance for

(average weighted) refuge size fell from 89% to 80% overall and (average weighted) refuge

distance from 96% to 88%. The reported numbers include farmers who planted single com PIPs

and stacked com PIPs. However, when compliance among growers planting a single Lepidoptera

protected com PIP in 2007 was compared to the compliance results obtained in 2006 , then

adherence to refuge size did not change, while compliance with refuge distance declined from 96%

to 88%. This still represents a reduction in ECB refuge compliance for 2007. Unfortunately, the

online survey results were not broken down for the four regions, as was done in previous years, and

therefore, it is impossible for BPPD to determine which region had greater non-compliance with

refuge requirements. BPPD requests that this information be provided in future reports so that it can

be determined in which farming regions the registrants need to focus their educational outreach.

BPPD recommends that the online survey be conducted in a manner that will be comparable with

the phone survey set up ofthe past years, so that results can be put into historical context for each

of the four regions (a. Eastern Iowa, Northern Illinois region; b. South Dakota, Minnesota,

Nebraska, Western Iowa region; c. Kansas, Oklahoma, Texas Panhandle region; and d. North

Carolina, South Carolina, Southeast Missouri, Tennessee, Mississippi region). By providing

geographic/regional information about refuge compliance, the registrants and the Agency can

become aware of problematic regions and determine what the underlying causes could be. Regions

of non-compliance could also indicate potential hot spots for resistance in the future.

Approximately 79% of growers surveyed in 2006 across all regions knew (unaided) the correct

distance requirements and approximately 63% of the growers surveyed during this same timeframe

knew the correct refuge size requirements. The 79% of growers remembering the correct refuge

requirements represents an increase from the 49% reported in 2006. IRM awareness among

growers in 2007 (96%) appears to be highe r than in 2006 (92%). This suggests that an increase in

non-compliance is not due to lack ofeducation but may rather be a reflecti on of growers' attitudes

to willful non-compliance towards refuge requirements.

The 2007 ABSTC report did not report details of adherence to refuge size and distance

requirements for the Corn and Cotton Belt (see Table I above). Such details would be preferable to

8
have, and should be provided if the data is available. Otherwise BPPD suggests that the on-line part

ofthe grower survey be rede signed so that results can be grouped by Cotton or Com

Belt/regions/states.

Results from the education portion of the 2007 survey indicate that seed companies and dealers are

by far the most important sources ofIRM information for growers (92% and 95%, respectively).

Growers also indicate that they receive multiple sources ofIRM information (93%) and that they

had enough information at the time of planting to establish and manage a Bt com refuge (88%).

BPPD Review (2008):

The 2008 survey results show that grower compliance with refuge size requirements for single ECB

protected com PIPs has further declined and is now at the lowest level since 2002 (see Figure 1).

ABSTC is correct that most growers continue to adhere to the refuge requirements; however, it is

reason for concern that compliance decreased while registrants and NCGA have more outreach

tools and iricreased educational efforts than ever to reach growers. BPPD reiterates that the increase

in non-compliance may reflect growers' attitudes toward refuge requirements rather than a lack of

knowledge, especially if one considers that the IRM awareness has consistently increased since

2002 and up through 2008.

As in 2007, the online survey results were not broken down for the four regions assessed in

previous years, and therefore, it is impossible for BPPD to determine in which regions the noncompliance with refuge requirements dominated or occurred. BPPD requests that this information

be provided in future reports so that it can be extracted where specifically non-compliance occurs

and what the potential drivers are. BPPD recommends that the online survey is re-designed in such

a manner that it will match the phone survey set up ofthe past years, and that results can be put into

historical context for each of the four regions (a. Eastern Iowa., Northern Illinois region; b. South

Dakota, Minnesota, Nebraska, Western Iowa region; c. Kansas, Oklahoma, Texas Panhandle

region; and d. North Carolina, South Carolina, Southeast Missouri, Ten nessee, Mississippi region).

In this manner, ABSTC and BPPD may determin e whether an increase in non-compliance is, for

example, due to higher pest pressures in particular regions or due to other outside factors.

The 2008 ABSTC report did report details of adherence to refuge size and distance requirements

for the Com and Cotton Belt (see Table I above). Such details would be preferable to have, and

should be provided if the data is available. Otherwise BPPD suggests that the on-line part of the

grower survey be redesigned so that results can be grouped by Cotton or Corn Belt/regions/states.

Results from the education port ion ofthe 2008 survey indicate that seed companies and dealers are

by far the most important sources ofIRM information for growers (89010 and 90%, respectively).

Growers also indicate that they receive multiple sources of IRM information (94%) and that they

had enough information at the time of planting to establish and manage a Bt com refuge (86%).

- 9 -
CorrpIiance Wth Refuge Rec:,.Ji1 etIerasfer ECB prctected

BtComPlPs

60 +-- - - _ j :t--- - - -

2002 2008 2008 2010

60 +--~--_ -~

2000

Planting Season

FIgure I. Compli ance Tre nd from 2002 - 2008 for ECB protec ted Cor n PIPs

b. Corn rootworm-protected Bt corn registrations

2007 Data:

Ofthe 611 growers who completed the online survey, 132 growers planted coleopteran-protected

Bt com (single andlor stacked PIPs) and were randomly selected from the com growing regions.

All respondents planted a minimum of200 acres of com on their land in 2007 (100 acres in the

corn-cotton growing region of the South), with a mini mum of 50 acres ofroctworm- protected com.

Reported results showed that adherence to the refuge size was 80%. This number does not

differentiate between growers that planted a single com rootworm protected PIP andlor stacked

PIPs. Eighty-six percent of all the growers surveyed planted at least a 15% com rootworm refuge.

Adherence to the refuge distance requirement was similar to adherence to refuge size (79%).

Ninety-seven percent ofthe growers surveyed were aware of IRM requirements. Sixty-three

percent and 33 %, respectively, of the growers were able to provide the correct refuge size and

distance requ irements on an unaided basis (Table 2).

Growers indicated that the seed companies and their dealers were the most important sources of

information on IRM. Agrochemical retailers, crop consultants, grower guide s/technology

guide/use agreements, cooperative extension/uni versity, and farm publications were also cited as

being important by more than 80% ofthe respondents.

2008 Data:

Of the 600 growers who completed the online survey, 103 growers planted coleopteran-protected

Bt com (single andlor stacked PIPs) and were randomly selected from the com growing regions.

All respondents planted a minimum 0£200 acres of com in 2008 (100 acres in the com-cotton

growing region of the South), with a minimum of 50 acres of rootworm-protected com.

- 10 -
Repo rted results showed that grower adhe rence to the refuge size and distance requirement was

74% and 63% (but 81% on a field basis), respectively. These numbers do not differentiate between

growers that planted a single com rootwonn protected PIP and/or stacked PIPs. A total of 84% of

growers planted at least a 15% refuge for CRW. Ninety-six percent of the growers surveyed were

aware ofIRM requirements. Seventy-two percent and 34 %, respectively, of the growers surveyed

were able to provide, on an unaided basis, the correct refuge size and distance requirements for

their area (Table 2).

Growers indicated that the seed companies and their dealers were the most important sources of

information on IRM (85% and 95%, respectively). Agrochemical retailers, crop consultants,

grower guides/technology guide/use agreements, cooperative extension/university, and fann

publications were also cited as bein g important by more than 80% of the respondents.

Table 2. Summa ry of Telep hone (2005-2006) and Online Sur vey (2007-2008) Results for Rootworm-Protected Bt

Corn Growers

Surv ey Question) 2005 1 2006 2 2007 2008

Y. Respo ndents Y. Respondents 0/. Respondents Responde nts

Adhe rence to Refuge Size 93 g9 gO 74

Adhere nce to Distance Requ irem ents g7 82 79 63

Awa reness of IRM Requiremen ts 97 93 97 96

Unaided retail of refu ge size 51 57 63 72

Unaided recall of refuge distan ce 58 55 33 34

V.eldGard RW and Yu:ldGard Plus com gro..... ers

2YieldGard RW, YiddGard Plus, Herculex RW, and Herculex XTRA com growers.

JWeighted average across all four region s surveyed

BPPD Review (2007):

Across all the years surveyed, grower adherence in 2007to refuge distance requirements across all

regions was lower for rootwonn-protected than for ECB protected Bt com. Adherence to refuge

distance has further dropped since the surveys began in 2005 . Conve rsely, compliance with refuge

size appeared to be the same for CRW and ECB protected PIPs accordi ng to 2007 survey results.

None theless, compliance for refuge size has furth er declined. Awareness of IRM requirements was

comparable to that for growers of com borer-protected 81com. Sixty-three percent ofthe growers

could correctly recall the correct refuge size requirement for CRW; this result was similar to what

was found in 2006. However, growers' ability to recall the correct refuge distance requirements has

dropped drastically compared to the prior year (from 55% to 33%). Compliance with refuge

distance for rootworm-protected BI com products might be more challenging because the refuge

must be deployed either within the CRW-protected BI field or immediately adjacent to a com

rootwonn-protected BI field . This suggests that further education with respect to refuge distance

may be needed for growers who plant com rootwonn protected Bt products. Unfortunately, the

survey does not indicate in what regions the compliance deviations occurred. The 2007 ABSTC

report did not report sufficient details with respect to geographic or regional non-compliance of

refuge size and distance (see Table 2 above). Such details should be provided for future reports.

- 11 -
This will help the registrants, seed dealers, and seed companies to figure out which regions need to

be targeted with increased educational efforts.

BPPD Review (2008):

Overall compliance (pe r grower) with refug e requirements has continued to decline since 2007 and

has dropped to 74% and 63% in 2008 for refuge size and distance (see Figure 2). Grower awareness

of IRM requirements is as high as ever (96%), but only 72% of the growers surveyed were able to

recall the correct refuge size requirement. In 2007 and 2008 there has been a drastic decline in the

percent of growers who co uld remember the correct refuge distance . As stated above, compl iance

with refuge distance requirements for rootworm-protected BI com products might be more

challenging because the refuge must be deployed either within the CRW.protected SI field or

immediately adjacent to a com rootworm-protected Bt field. Further education with respect to

refuge distance but also refuge size may be in place for growers who plant com rootwonn protected

Bt products.

The 2008 ABSTC report did not include sufficient details with respect to geographic or regional

non-compliance of refuge size and distance (see Tab le 2 abo ve). Such details should be provided

in future reports. This will help the registrants, seed dealers, and seed companies to determine

which regions need to be targeted with increased educational efforts.

CcnpIiance wth Refuge ~renvntsfor CRNpic:Aected

Bt Corn PIPs

100 '

90

I 60

I 70

60

50

2004 2005 2000 200l 2008 2009

Figure 2. Compliance Tre nd from 2005-2008 for CRW protected PIPs

c. Stacked Bt corn registrations

2007 Data:

Ofthe 6 11 growers'who completed the online survey, 456 planted stacked Bt corn (for ECB and/or

CRW control). All respond ents planted a minimum of200 acre s of com in 2007, with a minimum

of 50 acres of stacked BI com.

- 12 •
Reported results showed that adherence to the refuge size and distance requirement was 70% and

66% (ofthose that could recall the layout of all their Bt fields; 449/456), respectively. Eighty-two

percent ofthe growers who planted stacked PIP products planted at least a 15% refuge for ECB and

CRW. Ninety-six percent ofthe growers surveyed were aware of lRM requirements. Sixty-two and

55% ofthe growers surveyed were able to provide. on an unaided basis, the correct refuge size for

ECB and CRW. respectively. On an unaided basis, 77% and 39% ofthe growers surveyed stated

the correct refuge distance for ECB and CRW, respectively (Table 3). The education portion ofthe

survey provided similar results as those described in the com borer-protected and com rootwormprotected 81 com sections (see above).

2008 Data :

Ofthe 600 growers who completed the online survey, 556 planted stacked Bt com (for ECB and/or

CRW control). Seventy-two percent ofthese growers reported that they adhered to refuge size. A

total of 8 1% of growers who planted stacked Bt products reported that they planted at least a 15%.

Ofthe growers who recalled the layout of their stacked Bt com fields (543/556), 66% had the

correct refuge distance for CRW and ECB. On a per field basis, adherence to refuge size and

distance was 73% and 76%.

Overall awareness ofIRM requirements was 97%. Eighty-one percent ofthe growers remembered

the correct refuge size, while only 36% remembered the correct CRW refuge distance.

Ta ble 3. Summary of Telephone and On -Line Survey Results for Stacked Bt Co rn Growe rs (Data from 2006-

2oo8l

2006 2007 2008

Survey Question

·/0 Respondents Of. Respondents ./0 Respondents

Adhere nce to Refuge Size 78 70 72

Adherence to Distance Requirements 92 66 66'

Awareness of IRM Requirements 95 96 97

Una ided recall of refuge size 59 62 and 551 8t

Una ided recall of refuge distance CRW 48 39 36

Unaided recall of refuge distance ECD 32 77 86

Weighted average across all four regions surveyed

2First number listed is for ECa and the second number for CRW refuge compliance.

) on a per field basis, adherence was76%

on a per field basis, adherence was 7)"1.

BPPD Review (2007) :

Grower adhe rence to refuge size requi rements (70%) across all regions was lower in 2007 than in

the previous year (see Figure 3). Compliance with refuge distance (across all regions) has dropped

from 92% in 2006 to 66% in 2007. The degree of non-compliance is likely due to the added amount

of complexity of planting refuges for stacked products. Unaided awareness of refuge distance was

low for CRW refuge size and distance (55% and 39%, respectively) and indicates that educational

outreach needs to focus on this area ofrefuge deployment. 2007 results for unaided awarene ss of

- 13 -
(ECB) refuge size and distance requirements were comparable to the 2006 results.

The 2007 ABSTC report did not report sufficient details of the adherence to refuge size and

distance requirements for all four surveyed regions (see Table 3 above) but rather provided average

results. More detailed reports should be submitted in the future .

BPPD Review (2008):

2008 compliance results for refuge requirements (stacked com PIPs) were similar to the 2007

results (see Figure 3). While the majority of growers planted a refuge and observed the correct

refuge distance, a large pe rcentage of growers did not comply with requirements. Compliance with

refuge distance drop ped from 92% in 2006 to 66% in 2007 and 2008 . Only 36% of the surveyed

growers in 2007 and 2008 could recall the correct refuge distance for CRW. It appears that

ABSTC's educational efforts should target growers who plant stacked Bt products for ECB and

CRW to furthe r improve compliance with refuge requirements especially if one considers how the

number of growers who have started planting stacked com PIPs has increased since 2006.

carpriance Wth Reflge Re<Prerrentsfor Stacked BtCom

PIPs

icc , - --- - - --- - - - -,

'" 00 t-- - - - - - - - - -----1

5OJ--__ _--_-

2005 2006 2lXJ7 aoce

Planti ng Season

Figure 3. Compliance Trend from 2006-2008 for Stac ked Cor n PIPs

2. On-Farm Assessment Program

The on-farm assessment porti on of the Compliance Assurance Program identifies individual noncompliant growers (large and small farms) and is believed to enhance registrant and seed dealer

understandings of the obstacles that hinder growe r implementation ofiRM requirements. The onfarm assessment program was fully implemented for com borer-protected BI com products in 2003

and for com rootworm-protected products in 2004 and stacked BI com products in 2006.

In 2007, registrants and their seed company partners conducted 2083 on-farm assessments. The

number of growe rs assessed for each type of BI com varied depending on the market share of the

product type . Growers from a range offann sizes, located acro ss 33 states, were selected at random

- 14 -
for assessment from registrants' customer lists. Twenty-five percent ofthe growers in the on-farm

assessments were determined to be " small growers" (planting less than 250 acres of com).

In 2008, one-thousand-three-hundred-twelve on-farm assessments were conducted with growers

from across 35 states, of which 33% fell into the category of "small growers" .

Company representatives we re trained to conduct on-farm assessments. Topics covered in these

trainings included IRM requirements, messages that should be comm unicated to growers, followup actions if growers are found to be out of compliance and how to use the IRM assessment form.

All assessment forms contained the same questions, but the introductory paragraphs and company

representative sections were customized to suit the needs of each registrant. Registrants responded

to all compliance dev iations identified in the 2007 and 2008 on-farm assessments according to the

common set ofstandards outlined in the PCA (see Appendix).

a. Corn borer-products Bt corn registrations

2007 Data:

Ofthe 2083 growers assessed in 2007, 9% were found to be out of compliance; 129 growers (6.2%)

had "significant deviations", and 59 (2.8%) had "i nsignifican t deviations" from the refuge size or

distance requirements (Table 4). Assessments were randomly conducted across a range of farm

sizes with approximately 25% ofthe farms catego rized as " smaller growers" with less than 250

acres of com. ABSTC reports that compliance among smaller growers (87%) was similar to the

level of compliance obse rved among larger growers (91%).

In 2006 , 90 growers were found, via the on-farm assessment process, to be out of compliance with

the IRM program. Of these growers, 45 deviated significantly from the requirements and were

responded to with the pe A, which includes reassessment the following year. None of the growers

reassessed in 2007 were found to have deviated significantly from the established IRM program;

therefore, access to Bt corn seed was not revoked for these growers. Some re-assessed growers did

not longer farm or plant Bt com in 2007 .

2008 Data:

Of the 1312 on-farm assessments conducted in 2008, 86% revealed that growers complied fully

with refuge requireme nts for single Lepidoptera Bt products. Ofthe 14% of growers that were out

of compliance, 10% had significant deviations. On-farm assessments were randomly conducted

across a range of farm sizes with approximately 33% of growers categorized as "small growers"

with less than 250 acres ofcom. Results of the assessme nt indi cate that compliance among small

and large growers were similar (82% vs. 89%).

In 2007, 188 growers were out of compliance of which 129 had significant deviatio ns and were

reasse ssed during the 2008 growing season. None ofthe growers lost access to the techno logy.

Some farme rs were no longer farming or did not plant Bt corn in 2008.

- 15 -
Table 4. Cumula tive Results l or- the Fjrst-Time On-Far-m Lepidoptera n-Protected BI Cor-n Assess ments (Da ta

lor- 2003-2oo8l

Issue Addr-essed Numbe r- 01growers

2003 2004 200S 2006 2007 2008

G rowers assessed 196 1 2130 2215 2020 2083 1312

Compliant growers 1,789 2032 2089 1930 1895 1132

(9 1%) (95.4%) (94.3%) (95.5%) (9 1.0%) (86.3%,)

Noncompliant growers 172 98 126 90 188 180

(9%) (4.6%) (5.7%) (4.5%) (9.0%) ( 13.7%)

Refuge size deviations" 64 (3%) 27 (1.3%) 33 (1.5%) 33 (1.6%) NIA NIA

Reluge distance deviations 127 (7%) 69 (3.2%) 68 (3. 1%) 64 (3.2%) NIA NIA

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

Significant deviations" 104 (5%) 39 ( 1.8%) 75 (3,4%) 45 (2.2%) 129 (6.2%) 134 (10.2%)

Some growers had compliance deviations other than refuge Size or distance or some growe rs may have had both a refuge size and a

refuge distance deviation; thus. the total of refuge distance and size deviat ions does not equal the number of non-eompliant growers.

J Significant deviations are defined as: A Bt com grower who planted less Ihan 15% non- Bt com refuge (except in certain cotton

growing areas in which case it would be less than 400/0 000- BI com refuge); or planted fewer than 213 of the Bt com fields are

planted within 2 mile of a non- Bt com refuge.

BPPD Revi ew (2007):

The cumulative results ofthe 2007 on-farm assessments showed that 91% of the growers fully

complied with the refuge requirements (9% or 188 out of2083 were found to be out of

compliance). The overall compliance with refuge requirements slightly decreased in 2007 (91%)

compared to 2006 (95.5%). The percentage of non-significant deviations was similar in 2007 (3.5%

or 46/1312) compared to 2006 (2.2% or 5912083); the percentage ofsignificant deviations

increased in 2007 (6.2% or 12912083) compared to 2006 (2.2%).

No information was provided for compliance with refuge size and distance specifically. Hence

BPPD cannot compare the 2007 data with on-farm assessments conducted in previous years. BPPD

recommends that ABSTC provide this information with their next report in order to be consistent

with previously collected data and so that all parties involved (registrants and Agency) understand

more thoroughly why non-compliance might occur.

BPPD Review (2008):

Of all the growers assessed during the on-farm visits, 86% were compliant with refuge

requirements. While this is still a high degree of compliance, BPPD notes that there is a clear trend

in declining overall comp liance since 2003 (see Figure ...). The percent of non-eompliant growers

(13.7%) and growers with significant deviations (10.2%) was highest in 2008 since on-farm

assessments began .in 2003.

As stated previously, BPPD recommends that ABSTC provide refuge size and refuge distance

compliance individually, as was done in prior years, for the same reasons stated above.

- 16 -
..

~with Refuge~forECBprotected at

Com PIPs (on fam ass! 55 ,iBi Its)

--.

/ ----- \

I

'\-

-,

...."

Planting Sea80n

Figur r 4. Declining Trend in Rd ugr Compliancr as supportrd by On.Flrm Assessment Survry Data

h. Corn rootworm-active Bt corn registrations

2007 Data:

In 2007, ABSTC determined that 90% ofthe growers complied fully with refuge requirements. Of

the 247 growe rs assessed, a total of 24 were non-compliant of which 16 (6.5%) were identified as

having "significant deviations" and & (3.2%) as having insignificant deviations from the refuge size

or distance requirements in 2006 crable 5).

Twenty-four non-compli ant growers in 2007 were subject to the Phased Compliance Approach.

These growe rs were be revisited in 2008.

In 2006, 21 growers were found , via the on-farm assessment process, to be out of compliance with

the IRM program. Of these growers, 11 deviated significantly from the requirements and were

responded to with the PCA. which includes reassessment the following year. None of the growers

reassessed in 2007 lost access to the technology.

2008 Data:

On-farm assessments were randomly conducted across a range of fann sizes wi th approximately

33% of growers categorized as "small growers" with less than 250 acres of com. Results ofthe

assessment indicate that compliance among small and large growers were similar (82% vs. 89%).

Of the 134 on-farm assessments, 86% ofthe growers complied fully with refuge requirements for

single Coleopteran Bt products. Ofthe 14% of growers that were out of compliance. 9% had

significant deviation s.

In 2007, the 24 growers that were found to be out of compliance were reassessed in 2008. None of

these growers met the criterion for revocation of access to the Bt technology.

- 17 -
Table 5. Cumulative Results for the On-Fa rm Coleonteran-Protected Bt Corn Assessment' (2006-2008 data)

2006 2007 2008

Growers assessed 395 247 134

Refuge dista nce 13' N/A N/A deviations

Refu ze size deviations 7 N/A N/A

Sillnificant deviations II 2.8%) 16 6.5%) 12 9.0

Insillnificant deviations 10 4.0%) 8 3.2% 7 5.2%

Compliant arowers 374 94.7% 223 90.3% 115 85.8%

Non-compliant arowers 21 5.3%) 24 9.7%} 19 14.2%)

Table adapted from page 12 of MRJD 470444-01

2 Some growers had compliance deviations other than re fuge size or d istance; thus. the total ofrefuge distance and size

deviations does not equal the number of non-compliant growers.

J Significant deviation s are defined as: A Bt com grower who planted less than 15% non - Bt com refuge (except in certain

cotton growing areas in which case it would be less than 40-;' non- Bt com refuge); or planted fewer than 213 of the BI com

fields are planted within 2 mile o r a non - Bt com refuge .

BPPD Review (2007):

From the on-farm assessment results, it can be concluded that grower compliance with corn

rootworm-protected refuge requirements appears higher (90%) than that of com borer-protected

refuge requirements in 2007 (80%). However, the number of non-compliant growe rs (9.7%) in

2007 has almost doubled compared 10 2006 (5.3%). This should be a reason for concern. BPPD

notes that it is important to analyze why compliance has dec lined in 2007. Compliance should be

broken down for the four regions (discussed earlier in this report), so that it can be assessed

whether non-compliance is a regional phenomena or not.

Results for non-eompliance were not broken down for refuge size and refuge distance. BPPD

recommends that ABSTC provide this information again in their next report.

BPPD Review (2008):

From the on-farm assessment results it can be concluded that growers' compliance was relatively

high (86%) in 2008 but that compliance continues to steadily decrease. The number ofsignificant

deviations (9%) increased further compared to 2007 and 2006. BPPO notes that comp liance results

from on-farm assessments are higher than from on-line surveys (74% for refuge size and 63% for

refuge distance ). The reasons for this discrepancy are not clear. The phone/internet survey may be a

statistically repre sentative sample (600), while the on-farm survey is not (134). BPPD recommends

increasin g the sample size for on-farm assessments targeting growers who plant com rootworm

protected Bt com. Since 2006 the sample size has decreased with each year; this brings into

question whether the survey results are still representative of growers' compliance. Furthermore, if

regional data had been provided for 2008 online and on-farm assessments by ABSTC, BPPD could

confirm whether regional non-compliance from these two assessment methods had similar patterns.

Results for non-compliance are not broken down for refuge size and refuge distance . BPPD

requests that ABSTC provide this information again in their future reports.

- 18 -
c. Stacked Bt corn registrations

2007 Data:

Ofthe 1069 growers assessed, 959 (89.7%) were in compliance with refuge requirements, while

110 (10 .3%) were identified as having been out of compliance. Ofthose growers identified as

having been out of compliance. 77 (7.2%) were identified as having "significant deviations" G able

Q). On-farm assessments were conducted at random across a range offarm sizes with about 25% of

growers identified as "small growers" planting less than 250 acres with com. The data show that

"small growers" (86%) are about as compliant with refuge requirements as " larger growers" (91%).

In 2006 , 61 growe rs were found, via the on-farm assessment process, to be out of compliance with

the IRM program. Ofthese growers, 45 deviated significantly from the requirements and were

responded to with the Phased Compliance Approach, which includes reassessment the following

year. No growers were found to be out of compliance during the 2007 reassessment. Some ofthose

growe rs that were reassessed for compliance did not farm or plant Bt com in 2007.

2008 Data:

In 2008, the on-farm reassessments revealed that 86% ofthe growers complied with refuge

requirements and that 14% were out of compliance. The data suggest that the level ofcompliance

was comparable between small growers (82%) and larger growers (88%) in 2008 . ABSTC reports

that 86 growers had significant deviations, while 36 had insignificant deviations.

Of the 110 growers found to be out ofcompliance for stacked Bt com in 2007. seventy-seven met

the 'significant deviations' category. None ofthose growers reassessed in 2008 had the technology

revoked; a small portion of growers who were out of compliance in 2007 did not fann or plant Bt

com any longer.

Table 6. Cu mulative Results of the First Time On-Fa rm Stacked Br Corn Assessment ' (Data for 2006-2008l

2006 2007 2008

Growers assessed 600 1069 1799

Refuge d istance 5 1z N/A N/A devia tions

Refuse size deviations 8 N/A N/A

Slan iflcant deviations 45 (7.5% 77 7.2%) 86 '

Inslonifica nt deviations 16 33 (3.1% 36'

a n rowers 539 (89.8% 959 89.7% 1546 (85.9%

Non-comnltant erowers 61 (10.2% 110 (10.3% 253 14.1%)

Table adapted from page 12 of MRlD 4704-t4-01

1 Some growers had compliance: deviations other than refuge size or distance; thus, the total of refuge distance and size deviations

docs not equal the number of non-compliant growers.

aSignificant deviations are defined as: A Bt com grower who planted less than 15% non- BI com refuge (except in certain cotton

growing areas in .....hich case: it would be less than.fO% non- BI com refuge); or planted fewer than 213 ofthe BI com fields are

planted within 2 mile of a non- Bt com refuge.

• The numbers of deviations to not add up to the 253 non-ccmpnam cases reponed.

- 19 -
BPPD Review (2007) :

Growers who planted stacked 8/ com hybrids in 2007 were approximately equall y compliant (890A»)

as growers who planted corn borer-protected Bt com hybrids (91%) and coleopteran-protected Bt

com hybrids (90%).

It is unclear from the data provided in 2007 whether compliance deviations were more common for

refuge distance than for refuge size. This information was not provided by ABSTC for 2007.

BPPD reconunends that this information is once more included in future CAP reports.

BPPD Review (2008):

Compliance with stacked Lepidopte ran and Coleopteran protected Bt products appeared to be

slightly lower in 2008 compared to 2006 and 2007; the number of non-compliant growers has

increased. BPPD notes that the number ofsignificant and non-significant deviations (86 and 36,

respectively) did not add up to the reported number of non-compliant growers (253). It is unclear at

this point what the correct numbers were for 2008 . BPPD requests that corrected on-farm results for

stacked com PIPs be submitted . Results for all on-farm assessments, single Lepidopteran, single

Coleopteran, and stacked ECB/CRW protected products, suggest that compliance was equally high

among growe rs independent ofthe com PIPs planted. This is in direct contradiction to what the

results of online surveys convey. For online survey results. refuge compliance (size and distance)

for stacked PIPs and coleopteran PIPs is similar but in the 70mand 60m

percentiles. while

compliance for ECB PIPs is higher. It is unclear why there is a discrepancy between on-farm and

.online survey results. Part ofthis deviation between survey results could be due to the change in

survey methodology (swi tch from phone to on-line surveys).

It is unclear from the data provided in 2008 whether compliance deviations were more common for

refuge distance than for refuge size. This information has not been provided by ABSTC since 2007.

BPPD recommends that this information is once more reported in future CAP reports. .

3. Tips and Complaints

2007 Data:

In 2007, the registrants received 14 "tips and complaints." Any legitimate tips and complaints were

managed in accordance with the Compliance Assessment Program. Any grower found to be out of

compliance based on a legitimate tips and complaint received an on-farm IRM visit. If there were

any growers found to be out of compliance during the visit then these growers were responded to in

a manner consistent with the Phased Compliance Approach. There were no legitimate tips and

complaints reported in 200 3 or 2004.

ble 7. Anonymous Tips a nd comel atnts about Non-Compliance with JR."I requirements

Year Number ofTips and

Complaints

2008 5

2007 14

2006 3

2005 5

2004 0

2003 0

Ta

- 20-
BPPD Review (200712008):

EPA has required that the registrants have a "ti ps and complaints" system as a mec hanism for

individuals (e.g. growers, sales representatives, etc.) to report alleged instances of lRM

noncompliance to them (see EPA 2001). Such a system was developed by the ABSTC-IRM

Subcommittee. The program was implemented for the first full-season in 2003. It allows each

registrant to develop a tip s and complaints' system that is compatible with their business

operations..." The registrants have developed mech anisms (e.g., customer service numbers) to

receive alleged instances of non-compliance with the JRM requirements. The tips and complaints

number is publicized through a variety of IRM communications mechanisms (e.g. technical

bulletins, grower guides, letters, seed catalogs, newsletters, etc.).

There were no legitimate tips and complaints in 2003 or 2004; however, there were five legitimate

tips and complaints in 2005 , three in 2006, and 14 in 2007 . Each ofthese growers identified

through the tips and complaints mechanism were visited as part of the on-farmassessment

program. It is not possible to determine whether any of the non-compliant growers identified via

the tips and complaints route were subject to the Phased Compliance Approach. It appears that the

Tips and Complaints program was properly implemented in 2007.

4. Publicizing the Compliance Assura nce Program

The registrants publicize the CAP, including the Phased Compliance Approach as part of each of

their grower education programs , company literature, internal training sessions, and meetings with

growers and dealers. ABSTC members also work with the National Com Growers Association.

The registrants work to provide the growers a consistence message about compliance with IRM

requirements.

5. BPPD Concluding Statements

BPPD concurs with ABSTC that the majority of farme rs complied with the refuge requirements in

2007 and 2008 and that a portion of non-compliant growers attempted to plant a refuge although

not large enough in size. However, the number of significant deviations repon ed from the on-farm

assessments increased for single lepidopteran as well as com rootwonn protected com products in

2007 and 2008. The online portions of the survey also indicated a decline in awareness of refuge

requirements for com rootwonn and stacked products but not for single ECB protected Bt products.

Furthermo re, BPPD notes that the overall compliance with refuge requirements appears to have

declined for single and stacked com PIPs compared to prior years in 2007. Like ABSTC, BPPO

questions if some ofthe non-compliance may be due to changing the methodology of surveys,

name ly switching part ofthe phone surveys to online surveys. BPPO recommends that ABSTC

investigate this fun her and look at the distribution of non-compliance to see if non-compliance is

randomly or non-randomly distributed across the regions. The laner could indicate that there may

have been a higher degree of non-compliance; the former could ind icate that the increase in noncompliance was influenced by the change in the survey's methodology. BPPO recommends, as

- 21 -
stated several times throughout this review, that ABSTC break down the compliance report for

each geographic region of interest as was done before 2007. This allows BPPD as well as ABSTC

to assess whether or not non-compliance is a local/regional phenomenon. It also alerts ABSTC and

BPPD to potential hot spots of resistance and where monitoring for resistance could focus.

- 22 -
III. REFERENCES

Lance Bailey. 2008.2007 Insect Resistance Management Compliance Assurance Report for Com

Borer-Protected Bt Com, Com Rootwonn-Protected 8t com. and Com Borer/Com RootwormProtected Stacked Bt Com. Unpublished report submitted by ABSTC to the Agency. MRID

473396-0 1

Lance Bailey. 2009. 2008 Insect Resistance Management Compliance Assuranc e Report for Com

Borer-Protected 8t Com. Corn Rootwonn-Protected Bt com, and Com Borer/Com RootwormProtected Stacked Bt Com. Unpublished report submitted by ABSTC to the Age ncy. MRID

476633-01

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

Document: Bacillus thuringiensis Plant-Incorporated Protectants (10/16/01), posted at

hUp://www.epa.gov/pesticideslb iopesticides/pipslbt_brad.htm.

·23·
APPENDIX: Phase Compliance Approach (PCA)

The ABSTC • IRM Suhconun ittee has developed a standard set of procedure s (Table 8)

known as the Phased Compliance Appro ach (peA). The peA requires that registrants 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 consec utive years) for noncompliant growers identified through the on-farm assessment program. The peA proposes to

suspend sales to individual growers for one year afte r two years ofsignificant deviations.

Following the one-year suspension. growers may be re-qualified to purchase seeds.

Table 8. Phased Compliance Approach (PCA)

Mandatory Responses Additional Responses

Significant Deviations • IRM education • Invoice monitoring

• Warning Jetter

• Compliance assistance contact prior to • Techn ical assistance

planting

• Compliance assessment contact for the • Grower IRM training

following growing seaso n

• Deny access to the S t com product for • Reaffinn ation of IRM

any significant deviation two years in a obligations

row

• Deny access to the Bt com

Other Deviations • IRM education product for other deviations

• Letter and/or compliance assistance that are repeated over a

contact prior to planting period of years.

• Compliance assessment contact in the

following growing season

·24·