Registration Terms for CRW IRM

– final version 1

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The following is a listing of the new registration terms that were implemented for Bt corn products as part of EPA ’ s new Insect Resistance Management framework for corn rootworm

. Please note that is not a complete list of all the terms and conditions for the registration s ; for specific terms for each registered pro duct, please consult the Pesticide Product Label System (PPLS ; https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1 ).

1) IPM

Integrated Pest Management Stewardship Program

a) [ Company ] must implement an IPM

- based stewardship program for [ PIP product ] . This

program must be designed to reduce selection pressure for CRW resistance by

encourag ing growers to engage in a multi

- year crop rotation strategy involving the use of one or more of the following: a non

- CRW host crop (e.g., soybean), pyramided Bt corn Plant Incorporate d Protectants ( PIPs ) , other PIP corn products with different modes of

action , and /or non

- Bt or non

- CRW protected Bt corn

. As part of the stewardship

program, [ company ] must update the technology use guide/grower guide and other grower educational materials to indicate that the use of SAI with [product] is not recommended for control of CRW except under limited circumstances and in consultation with extension, crop consultants or other local experts. [For pyramided products add: Grower education materials should also state that SAIs should not be necessary for CRW control with pyramided CRW trait Bt corn product(s). ] A copy of the revised grower educational materials must be provided to EPA by January 31, 2017

. As part of the stewardship program

, [Company] must promote the ABSTC/NCGA Best Management Practices (BMPs) for CRW control. Implementation of the IPM strategy

can include :

o G rower education initiatives or ince ntives ;

o O utreach to extension and consultant groups

.

b) [ Company ] must submit an annual report to EPA documenting activities conducted under the IPM stewardship program. This report must include a n anonymous survey of grower practices, including adoption levels of the various crop rotation options (if employed) and other elements of the stewardship program

. [C ompany ] may combine this product with other registered products to submit one annual report. The re port must be submitted by January 31 st each year, beginning in 2017

. The 2017 report will serve as a baseline

unless [ company ] wishes to submit a separate baseline report prior to January 3 1, 2017

.

2) Unexpected Damage Reports

Investigation of Reports of Unexpected Levels of Damage (UXD) by Corn Rootworm (CRW): Performance Inquiriesa) [Company] is required to investigate "performance inquiries" (i.e., reports of unexpected corn rootworm damage to [PIP product] corn) from growers. Fields ( defined as a tract separated by permanent boundaries such as fences, permanent waterways, woodlands

, croplines not subject to change because of farming practices, or other similar features) with unexpected damage that meet both of the criteria below must be subjected to the

follow

- up actions in part b) below:

i. The affected plants are confirmed to be [PIP product] plants (t ake leaf samples to determine the presence of the CRW

- active Bt protein ) ; and

ii. Corn rootworm feeding caused root damage with a Node Injury Score (NTS) > [1.0 for single trait or 0.5 for pyramid] on at least 50% of plants s urveyed in a transect sampling of the damaged site with in the field

.

b) Follow

- up actions (performance inquiries). For [PIP product] fields meeting the criteria in part a) above, [Company] mus t take the following actions:

• Collect at least 250 (ideally 500 or more) CRW adult individuals from the damaged site within the field in question. Collections may be extended to the

whole field , if necessary to obtain sufficient CRW adult individuals. Collected populations must be subjected to the steps described for "investigation of populations of concern" (section 3 ) below).

o If collections are unsuccessful, v isit affected farm or field the following year (assuming the grower continues to be a customer and repurchases

seed and does not rotate the field to a non

- host crop ) and attempt to collect

corn rootworm adults . If beetle s are not present the subsequent year, see

section 3 ) ( c ) ( 3).

• Review with the grower their CRW management practices and provide CRW management recommendations inc luding an assessment of corn fields with similar trait(s) adjacent to the affected corn field that are managed by the same

grower.

• Use of single trait products containing the CRW trait in fields with unexpected damage in previous years should be discouraged. Recommended management

o ptions include, but are not limited to

, the following:

o Primary option: Rotation to non

- host crop (e.g., soybean)

o Secondary options:

 U se of pyramided Bt corn products with multiple CRW PIP traits

 Use of diff erent single

- CRW PIP traits (i.e., an alternative corn

rootworm

- active PIP )

 Use of non

- Bt or non

- corn rootworm protected corn

o Tertiary options: If additional pest management need is determined beyond the secondary options listed above, additional corn rootworm control tools (e.g., soil insecticides, seed

- applied insecticides, chemigation) should be used• I f field(s) with UXD is /are planted to a non

- host crop (e.g., soybean ) the following year, then the area will be considered “ mitigated ” (as discussed in

section 3) ( c) ( 4 ) below) even if subsequent bioassay results show that the population was resistant . No further action will be required by [company] for the

UXD case.

c) [Company] must submit an annual report to EPA detailing activities related to investigations of unexpected damage (UXD). This report will include the information

from the most recent and previous corn growing seasons : i. Information from the most recent seas on:

• T he number of UXD reports investigated

.

• L ocation (by county and state)

.

• CRW sampling (number and location of populations collected)

. ii. Information from the previous season:

• The final disposition of UXD fields from the previous season (i.e., the management practices employed in response to UXD if the grower continues to

be a customer

.

• Results from bioassays conducted on CRW populations from UXD fields where

the primary management option

, rotation to non

- host crop

, was not used

. iii. Grower information, such as farm addresses or other personally identifiable information, or other sensitive business/customer information must not be included in this report. This report must be submitted by November 30 th each

year.

3 ) Resistance Detection Assa ys

Investigation of Populations of Concern

a) [Company] must conduct investigations of all CRW populations collected as part of the performance inquiry process in section 2 ) above. These investigations must include the

use of an EPA

- approved bioassay to determine if sampled CRW populations are resistant to [PIP toxin]. Acceptable assays must be able to function as diagnostic tools capable of distinguishing resistant populations from susceptible ones. Unless previously approve d, [company] must consult with EPA on their bioassay prior to its use.

b) A CRW population will be considered by EPA to be resistant to [PIP toxin] if the following criteria are met and additional collections and testing are not deemed to be necessary ( based on part c ) below ):

1. An initial performance inquiry investigation results in a finding of Unexpected Damage; and

2. Where green tissues are available and if plants are unusually stressed due to agronomic and/or environment al factors , Bt protein levels in affected plants are found to be within the documented range for that hybrid (if data are available);

and3. Either (A): On

- plant b ioassays of insect collections from the UXD fields result in the following two statistically relevant c omparisons

i. A statistically significant difference in measures of either mortality or sublethal effects (growth/development) between the field population and a relevant susceptible control population (i.e., one that responds as a typical susceptible field population) on Bt corn and /or lack of a statistically significant difference in measures of mortality or sublethal effect between the field population and a resistant positive control population † ; and

ii. A lack of a statistically significant difference in the same measur es of the field population raised on Bt corn and non

- Bt corn plants. Or (B): Sublethal seedling bioassay of insect collections from the UXD fields result in two statistically relevant comparisons

i. A statistically significant difference in measures of sublethal effects (growth/development) for populations on Bt corn (normalized using

non

- Bt) seedlings between the field population and a relevant susceptible control population where available or histor ical field populations and/or lack of a statistically significant difference in measures between the field population and a resistant positive control population † ; and

ii. A lack of a statistically significant difference in the same measures of the field popu lation raised on Bt corn seedlings and non

- Bt corn seedlings. Or (C): Diet

- based bioassays of insect collections from the UXD fields result in two statistically relevant comparisons

i. A statistically significant difference in measures of lethal or sublethal effects (growth/development) on diet containing the Bt protein (diagnostic concentration or concentration

- response measures) between the field population and a relevant susceptible control population where available or historical field populations and/or lack of a statistically significant difference in measures between field population and a

resistant positive control population † ; and

ii. Either a lack of a statistically significant difference in the same measures of the field population exposed to diet conta ining the Bt protein (diagnostic concentration) and diet not containing the Bt protein and/or lack of a statistically significant difference in measures between the field population and a resistant positive control population, or lack of a statistically si gnificant concentration and/or lack of a statistically significant difference in concentration response between the field and a resistant positive control population †

.

c) Mitigation, as detailed in section 4 ) below, is required for any CRW population that

meets EPA’s resistance criteria above , unless the circumstances described below are applicable.

† If a resistant positive control population is not available or accessible to [Company], [Company] must consult with EPA prior to initiating bioassays and work to develop an appropriate resistant positive control population.1. To minimize the potential for incorrectly reaching a conclusion of resistance, another year of CRW adult collections and additional testing is needed to

determine resistance if:

i. The results of the bioassays are inconclusive (e.g., the results of the statistical analysis are unclear because of low sample sizes) or

ii. Another reasonable explanation for the unexpected damage exists (e.g., high pest pressure and/or high plant stress).

2. In these cases, [Company] and EPA will discuss and align on next steps before reaching any resistance conclusion.

3. If CRW collections are not possible in the current year or subsequent year due to successful management practices, then no further investigation is needed. The population would be considered "mitigated" meaning, in this case, that the population is suppressed or extirpated for the UXD field

. However, EPA

recommends that [Company] continue to be vigilant in areas where CRW populations were successfully mitigated.

4. If a UXD field receives non

- host crop (e.g., soybean ) rotation the following year (as described in Section 2) ( b ) above), no additional mitigation is subsequently required

.

4 ) Mitigation Action

Mitigation of CRW Populations Meeting EPA’s Resistance Criteria

a) For any CRW population found to be resistant under EPA’s criteria described in section 3)(b) above, [Company] must take the following steps:

1. [Company] must inform EPA of the results of the bioassays as soon as possible, but at least within 30 days if measures are triggered.

2. T he mitigation action area (MAA) is defined as the growers’ farming operation up

to a 1⁄2 mile radius from the damaged site that produced the resistant population

. 3. Within 30 days of informing EPA of the results of the bioassays , the [Company] must notify state extension agents and crop consultants who operate within the county in which resistance was identified. Information sha red must include identification of the county in which resistance was detected and trait(s) affected

. 4. Within the MAA, [Company] must do the following:

i. P rior to finalizing the grower’s seed order for the following season, inform the affected grower and other registrants that hold registrations containing the affected trait. [Company] must also inform neighboring growers if those growers are customers of [Company]. Information shared must
include identification of the county in which resistance was detected and trait(s) affected ; ii. Discontinue sales /planting of single trait product containing the compromised trait until resistance has been demonstrated to have been mitigated ; iii. [Company] must monitor resistant population in the MAA, as long as

grower rem ains a customer of the company, until mitigation has beendemonstrated as described in part 5 below unless otherwise agreed with

EPA

. iv. Require any pyramids sold by [Company] containing the compromised trait be planted with a 2 0% refuge until resistance has been demonstrated to have been mitigated

. Other Bt registrants selling pyramided products in the MAA are encouraged, but cannot be required by this term of registration, to follow suit ;

v. For [Company]’s affected customer ’ s field ( s )

, the mitigation goal is to control the resistant CRW population. W ithin the MAA [Company] shall encourage the use of “ Mitigation Practices” including:

1. Primary option: Rotation to a non

- host crop ( e.g., soybean);

2. Secondary o ptions:

a. Use of pyramided Bt corn products with multiple CRW PIP

traits ; b. Use of different single

- CRW PIP traits (i.e., an alternative

corn rootworm

- active PIP);

c. Use of non

- Bt corn or non

- corn rootworm protected corn (with/without soil

- applied insecticide) ; 3. Terti ary options:

d. If additional pest management need is determined beyond the secondary options listed above, a dditional corn rootworm control tools (e.g., soil insecticides, seed

- applied insecticides, chemigation) should be used

.

e. Use of foliar applications t o control adults (when appropriate economic thresholds have been met ) may be

used in conjunction with one or more of the above ; 5. A resistant CRW population in the MAA will be considered mitigated if one of the following criteria is met:

i. Corn fields within the MAA are rotated to a non

- host crop (e.g. soybean) for one growing season

. ii. After implementation of mitigation practices (part 4 .v above), resistance monitoring (sampling) is conducted but few CRW are found (i.e., <0.1 adults per plant) and environmental conditions (e.g., weather) are unlikely to be responsible for the lack of adult CRW presence. If environmental conditions are a factor, then monitoring should continue for another

season. iii. After implementation practices (part 4. v above), res istance monitoring (sampling) is conducted, CRW are found and collected, and bioassays (section 3 )(b) above) show that the population susceptibility to the

identified trait has return ed to baseline levels

. 6. T he mitigation actions in part 4 above can be lifted

, and growers can resume the use of [PIP product] as a primary tool for CRW management in the MAA

, only when [ C ompany] demonstrates that successful mitigation as described in part 5

above has been achieved

.b) Based on further research to understand CRW resistance to Bt PIPs, EPA will consider refinements to the resistance mitigation program. Such research may include characterizing the genetics of resistance (e.g., number of genes, functional dominance, mechanism of resistance, and cross

- resistance) and the biology of resistant insects (e.g., fitness in the presence and absence of the product ), and other control tactics

.

5 ) Annual Reporting

The following annual reports must be submitted

.

X ) IPM Stewardship Program ( CRW toxins only): Activities conducted under the IPM stewardship program, including an anonymous survey of grower practices, adoption levels of the various crop rotation options (if employed) and other elements of the stewardship program, on or before January 31 st of each year.

X ) Unexpected Damage Investigations ( CRW toxins only): Activities related to investigations of unexpected damage (UXD), including number and location of UXD cases, insect sampling, bioassays, and final disposition of UXD fields from the most recent and previous corn growing seasons, on or before November 30 th of each year.