Process for Requiring Exposure and
Effects Testing for Assessing Risks to
Bees during Registration and
Registration Review
Office of Pesticide Programs
U.S. Environmental Protection Agency
August 15, 2016 (Revised)
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Table of Contents
1. Purpose ............................................................................................................................................ 4
2. Background ...................................................................................................................................... 4
3. Implementation ................................................................................................................................ 9
3.1 Conventional Pesticides in Registration Review ....................................................................................... 9
Registration Review DCI Issued Before January 1, 2015 and New Conventional Active Ingredients issued
between 2008 and the Date of this Process Document ............................................................................. 11
Registration Review DCI Issued After January 1, 2015 ............................................................................... 12
Cancel ed Pesticides and Pesticides with Use Patterns that do not result in exposure to bees ................ 12
Laboratory Capacity Considerations ........................................................................................................... 12
3.2 Registration Applications for New Active Ingredients and First Outdoor Uses for Conventional
Pesticides ........................................................................................................................................................ 13
3.3 New Additional Outdoor Uses for Conventional Pesticides .................................................................... 15
Appendix 1. Flow-Chart for Assessing the Need for Additional Pol inator Data for New Uses/Chemicals and
Registration Review. .............................................................................................................................. 16
Appendix 2. Data Call-in Table Footnotes for Exposure and Effects Studies with Bees ............................... 17
Appendix 3. Conventional Chemical Cases Potential y Subject to the Need for Additional Pol inator Data. 20
2
Disclaimer
This guidance is not a regulation and, therefore, does not add, eliminate or change any existing regulatory
requirements. The statements in this document are intended solely as guidance. This document is not intended,
nor can it be relied on, to create any rights enforceable by any party in litigation with the United States. EPA
staff may decide to follow the guidance provided in this document, or to act at variance with the guidance, based
on analysis of pesticide-specific risks and benefits. Deviations from this guidance shall not constitute grounds
for challenging pesticide registration decisions made by EPA. This guidance may be revised without public
notice to reflect changes in EPA’s policy.
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1. Purpose
The intent of this document (referred to as
Process document) is to provide interim guidance to the public
and staff within the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) for
determining when honey bee exposure and effects (toxicity) data identified in the EPA’s 2014 risk
assessment framework
Guidance for Assessing Pesticide Risks to Bees1 (hereafter referred to as the 2014
Guidance) and the 2016
Guidance on Exposure and Effects Testing for Assessing Risks To Bees are
required. This document is being made available to describe OPP’s plans for requiring these data to
assess chemical risks to bees. This document focuses on conventional pesticides; the agency discusses its
current approach for other types of pesticides in section 4 of the companion document, 2016
Guidance on
Exposure and Effects Testing for Assessing Risks To Bees.
2. Background
Assessing risks to bees is a complex matter. The scientific community is in general agreement that a
multitude of factors contribute to potential adverse impacts on bees, including lack of nutritional
resources, pests and pathogens, and pesticides, among others. To better understand the potential impacts
that pesticides might have on bee health, EPA has determined that additional bee toxicity and exposure
information are necessary to conduct its evaluations as part of its registration and registration review
programs.
In general, pesticides can only be sold and distributed in the United States if they have been registered by
the EPA. Prior to the agency granting a registration, each applicant must establish that its product meets
the standards set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5)
and/or 3(c)(7). These standards include finding that when a pesticide is used in accordance with
widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects
on the environment. FIFRA also provides for regular review of existing pesticide registrations. FIFRA
section 3(g) and its implementing regulations at 40 CFR Part 155 set forth the process for the reevaluation
of currently-registered pesticides (
i.e., registration review).
FIFRA’s implementing regulations at 40 CFR Part 158 set forth the data requirements for pesticide
registration. Additionally, these regulations discuss the flexibility the EPA has when requiring data for
pesticide registrations. Under 40 CFR 158.30, the EPA may determine to modify the data requirements on
an individual or case-by-case basis to fully characterize the effects of a pesticide product. Additionally,
these regulations make clear the data routinely required under Part 158 may not always be sufficient to
assess whether there are unreasonable adverse effects on the environment. Under 40 CFR 158.30(b) and
40 CFR 158.75, the EPA may require additional information to better characterize the potential risks.
Consistent with the EPA’s process for evaluating risk to various taxa, assessing risk relies on multiple
studies identified in Title 40 (Protection of the Environment) of the Code of Federal Regulations, Part 158
(Data Requirements for Pesticides; abbreviated as 40 CFR Part 158). However, where necessary, the
EPA has the authority to require data which may extend beyond the suite of exposure and effect data
identified in the 40 CFR Part 158. Pesticide registrants (
i.e., the regulated community) are required by
1 USEPA, PMRA, CDPR. 2014. Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs United States Environmental
Protection Agency, Health Canada Pest Management Regulatory Agency (PMRA), California Department of Pesticide Regulation (CDPR). June
19, 2014.
http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf (last accessed
06/27/2016).
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law to provide the data needed to assess the potential for adverse effects from exposure to pesticides. To
meet the data requirements, registrants will, in large part, depend on contract research organizations
(CROs) to conduct these studies since CROs have experience in conducting the studies and can provide
consistent and reliable data that meet the specification identified in the 40 CFR Part 158. The EPA
recognizes that the capacity of CROs to conduct new studies on behalf of the regulated community
depends on the nature of the studies and the laboratory’s familiarity with the test species and/or study
conditions.
In the absence of these data, risk assessors may not be able to fully determine the potential for exposure
and effects to bees. However, where the EPA determines that a pesticide use is not likely to expose bees
or in situations where acute and/or chronic toxicity is not expected based on other lines of evidence,
additional data may not be warranted to support regulatory decisions.
The EPA has developed guidance documents
2 for risk assessors that identify additional, relevant data in
evaluating exposure and effects of pesticides on honey bees. The agency is in the process of revising the
existing insect pollinator data requirements in 40 CFR Part 158 to codify the data necessary to complete
risk assessments consistent with the risk assessment framework. Having all required studies available to
the EPA at the time of application should reduce the potential for delays in the registration process.
Table 1 identifies the current data requirements for conventional pesticides codified at 40 CFR Part 158,
Subpart G for toxicity and exposure testing for insect pollinators.
Tables 2 and
3 list the additional types
of studies the EPA has determined are necessary to more fully evaluate the potential exposure and effects
to bees for various pesticide use patterns.
2
Ibid USEPA 2014.
5
Table 1. Toxicity Testing Requirements for Insect Pollinators as Specified in 40 CFR Part 158, Subpart G.
Use Pattern
Test
Guideline
Data
Residential Green-
Test
Note
Indoor
Number
Requirement
Terrestrial Aquatic Forestry Outdoor
house
substance No.
Insect Pollinator Testing
Honey bee adult
850.3020
acute contact
R
CR
R
R
NR
NR
TGAI
1
toxicity
Honey bee toxicity
850.3030
of residues on
CR
CR
CR
CR
NR
NR
TEP
2
foliage
Field testing for
850.3040
CR
CR
CR
CR
NR
NR
TEP
3
pollinators
Definitions: R = Required; CR = Conditionally Required; NR = Not Required; TGAI = Technical Grade of the Active Ingredient; TEP =
Typical End-Use Product
Test Notes:
1. Data using the TGAI are required to support all outdoor end-use product uses. Data are generally not required to support end-use products in
the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.
2. Data are required only when the formulation contains one or more active ingredients having an acute LD50 of <11 micrograms per bee as
determined in the honey bee acute contact study and the use pattern(s) indicate(s) that honey bees may be exposed to the pesticide. (Note that
in the regulatory text this is actually Test Note 24.)
3. Required if any of the following conditions are met: (Note that in the regulatory text this is actually Test Note 25.)
i. Data from other sources (Experimental Use Permit program, university research, registrant submittals,
etc.) indicate potential adverse
effects on colonies, especially effects other than acute mortality (reproductive, behavioral,
etc.);
ii. Data from residual toxicity studies indicate extended residual toxicity;
iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral effects.
6
Table 2. Additional Requirements a, b for Bee Exposure and Effects Testing
Study Type
Test substance
Test Note No.
Study
Non-Guideline Study
Honey bee adult acute oral toxicity
TGAI
1
(Tier 1)
(c)
Non-Guideline Study
Honey bee larvae acute oral toxicity
TGAI
1
(Tier 1)
(d
)
Non-Guideline Study Honey bee adult chronic oral toxicity
TGAI
1
(Tier 1) (e)
(g)
Non-Guideline Study Honey bee larvae chronic oral toxicity
TGAI
1
(Tier 1) (e)
(g)
Non-Guideline Study
Semi-field testing for pollinators (tunnel or colony TEP (tunnel) or
2
(Tier 2)
(f) (g)
feeding studies)
TGAI (feeding)
Definitions: TGAI = Technical Grade of the Active Ingredient; TEP = Typical End-Use Product
(a) Recommendations for bee toxicity data may be modified for certain types of outdoor residential uses for which exposure is considered
extremely limited (
e.g., crack and crevice treatment, spot treatment,
etc). In such cases, acute toxicity data may still be warranted but chronic
toxicity data may be of limited value in the risk assessment.
(b)
For greenhouse uses that involve bee pollination, Tier 1 and Tier 2 bee exposure and effects data may be required.
(c) Honey bee acute oral toxicity test protocol available through OECD TG 213. For aquatic uses, acute oral toxicity data are needed to evaluate
exposure of bees through drinking water and in evaporative cooling of the hive and for exposure through systemic transport into food items
(pollen/nectar).
(d) Honey bee acute larval toxicity test protocol available through OECD TG 237.
(e) Draft test protocols are currently being finalized through the OECD.
(f)
Semi-field tunnel study protocol available through OECD Guidance 75.
(g) Study protocol should be submitted for review prior to conduct of the study.
Test Notes:
1. Data using the TGAI are required to support all outdoor end-use product uses. Data are generally not required to support end-use
products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material. For greenhouse use patterns,
data are required for crops that require pollination (
e.g., tomatoes); for aquatic use patterns, data are required if bees are likely to be
exposed as a result of the proposed use.
2. Tier 2 studies may be required pending the results and evaluation of Tier 1 studies. Tier 2 studies may be required if the ratio of the EEC
and larval or adult bee acute LD50 >0.4 or the ratio of the EEC and chronic NOAEC >1. Tier 2 may be required if data from other sources
(Experimental Use Permit program, university research, open literature, registrant submittals, adverse effect incident reports,
etc.)
indicate the potential to adversely affect bee colonies, especially effects other than acute mortality (
e.g., reproductive, behavioral,
etc.).
Tier 2 studies may also be required if data derived from studies with terrestrial arthropods other than honeybees indicate potential
chronic, reproductive, or behavioral effects.
Table 3. Additional Requirements for Residue Data Measured in Pollen and Nectar.
Study
Study Type
Test substance
Test Note No.
Non-Guideline Study (Tier 3) Field trial of residues in pollen and nectar
TEP
1, 2
Definitions; TEP = Typical End-Use Product
1.
Field studies that quantify pesticide residues in pollen/nectar may be required to refine screening level exposure estimates, depending
on the results and evaluation of Tier 1 studies. Pollen and nectar residue studies may be required if the ratio of the EEC and larval or
adult bee acute LD50 >0.4 or the ratio of the EEC and chronic NOAEC >1. Incident data and/or compelling open literature studies can
also serve as rationale for requiring pollen and nectar residue studies. These data can be collected at any point during the tiered
process; prior consultation with the Agency is recommended to determine when to collect the data, and test protocols must be
submitted for Agency review prior to initiation of the study. For greenhouse use patterns, data are required for crops that require
pollination (
e.g., tomatoes); for aquatic use patterns, data are required if bees are likely to be exposed as a result of the proposed use
(
e.g., riparian vegetation).
2.
Protocol should be submitted for EPA review prior to initiating study.
7
The EPA initiated the rulemaking process in 2015 to codify all of the data required to support each tier of
the risk assessment process for bees in 40 CFR Part 158. Depending on the timing of the proposed rule
and the number and complexity of the comments received, as well as other external factors, the EPA
projects the new rule to be effective by mid-late 2017. In the meantime (before promulgation of the new
data requirements), the agency will on a case-by-case basis determine whether these data are needed for
individual registration actions.
The EPA’s data requirements are established to provide the information needed to determine whether a
new pesticide product and new uses on currently registered products meet the standard for registration. In
general, registrants must address the established data requirements in 40 CFR Part 158. However, the
EPA sometimes determines that special studies or additional data beyond those codified in 40 CFR Part
158 are required to make a finding of no unreasonable adverse effects finding under FIFRA.
As part of the re-evaluation of pesticides, the EPA may determine that additional data are needed to
support the continued registration of a pesticide. In such cases, the EPA first issues a Preliminary Work
Plan (PWP) that outlines the expected timeline for the registration review, the likely risk assessments that
will need to be conducted, and the data the agency expects to be necessary to fully evaluate the pesticide
during the re-evaluation process. Subsequent to taking comment on the PWP, the EPA issues a Final
Work Plan (FWP). If additional data are needed as part of the registration review, the EPA issues a Data
Call-In Notice (DCI) under FIFRA section 3(c)(2)(B). The DCI requires each affected registrant to
provide evidence within 90 days that the affected registrant is taking appropriate steps to respond to the
DCI. Additionally, the DCI sets deadlines for data submission and may specify interim deadlines. In
accordance with the terms of clearance for the information collection request (ICR) approved by the
Office of Management and Budget (OMB) under
OMB Control Number 2070-0174, the EPA must
provide OMB with prior notice and opportunity to review each DCI before issuance. Once OMB has
approved the DCI, OPP may issue the order. As noted earlier, the DCI may include studies which are not
codified in 40 CFR Part 158, and these studies are subject to the same authorities covered by the ICR. In
some circumstances, subsequent to issuing a DCI as part of the registration review program, the agency
may identify the need for additional data to support the continued registration of a pesticide. In these
circumstances, the EPA, after receiving approval from OMB, will issue a follow-up DCI to require the
submission of these additional data.
The next sections discuss what additional data are needed, the timing of when the EPA may request
additional data, and describe how the EPA will integrate the pollinator risk assessment methods into its
overall regulatory approaches for both registration and registration review.
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3. Implementation
As previously discussed, the EPA has initiated the rulemaking process to codify the pollinator toxicity
and exposure testing in 40 CFR Part 158. In the interim, OPP has developed a plan for evaluating when
these data may be required on a case-by-case basis, consistent with the 2014
Guidance and the 2016
Guidance on Exposure and Effects Testing for Assessing Risks to Bees. Specifically, this plan
summarizes OPP’s approach for addressing the new bee testing needs in the context of three types of
regulatory actions for conventional pesticides:
• Registration Review of existing pesticides;
• Registration of pesticides containing new active ingredients and first outdoor uses; and
• Registration of new additional outdoor pesticide uses.
Appendix 1 contains a flowchart depicting the general process the Agency will follow in determining
whether additional pollinator data will be necessary for different registration and registration review
actions.
When the data described in the 2016
Guidance on Exposure and Effects Testing for Assessing Risks to
Bees are not available, there will likely be aspects of the potential for exposure and effects to bees which
are not known. In these situations, registration and registration review decisions will consider:
• the nature of the uncertainties (
e.g., which data are not available);
• the extent to which mitigation measures can reduce exposure/effects from the pesticide
undergoing the action;
• the benefits associated with the use; and,
• whether there are alternatives and the potential comparative risks associated with those
alternatives.
3.1 Conventional Pesticides in Registration Review
FIFRA Section 3(g) mandates that the EPA periodically review the registrations of all pesticides to ensure
that they do not pose unreasonable adverse effects to human health and the environment. This periodic
review is necessary in light of scientific advancements, changes in policy, and changes in use patterns that
may alter the conditions underpinning previous registration decisions. In determining whether the
likelihood and magnitude of adverse effects (
i.e., risk) to taxa from exposure to pesticides are
unreasonable, FIFRA requires that the Agency consider the risks and benefits of any use of the pesticide.
9
During registration review, OPP may determine that data from the types of studies discussed in this
document are necessary before a final decision is issued pursuant to 40 CFR Part 155. The way in which
the pollinator data may be required during registration review will depend on the stage of the agency’s
review of the chemical in the review process. The EPA’s approach will depend on when the initial
registration review DCI was issued and whether the agency may have required the submission of
additional pollinator data. The DCI is generally issued early on in the registration review process after the
EPA has reviewed and summarized existing data and considered anticipated data needs (
e.g., acute and/or
chronic bee toxicity data) necessary to conduct a risk assessment and formulate a registration review
decision.
Because the need for additional pollinator data was determined subsequent to the initiation of registration
review program in 2007, the registration review process for many conventional pesticide active
ingredients is already well underway. With a few exceptions, registration review DCIs issued after
January 1, 2015, generally required the submission of all of the pollinator testing identified in the 2014
Guidance, unless the agency made a determination that a subset of these data would not be needed to
complete the re-evaluation of that specific pesticide
. The agency has reviewed all conventional pesticide
active ingredient cases and categorized them based on where they are in the registration review process.
We have categorized registration review cases into 3 Bins:
Bin #1:
Cases that may need a subsequent pollinator DCI because the initial registration review
DCI was issued before January 1, 2015 or the chemical was first registered with the
agency between 2008 and the time of issuance of this
Process document
Bin #2:
Cases in the first 15-year cycle of registration review where EPA either considered or
will consider whether the pollinator data identified in the 2014
Guidance are needed to
complete registration review. The registration review DCI for these cases was/will be
issued after January 1, 2015.
Bin #3:
Cases in the first 15-year cycle of registration review that have either been cancelled or
have or registered use patterns that do not result in exposure to bees
For those pesticide cases where the EPA determines that the pollinator data identified in the 2014
Guidance are necessary for the registration review, a DCI will be issued requiring the appropriate
pollinator studies. Generally, Tier 1, 2 and 3 studies will be required in the DCI, but the need for Tier 2
and 3 data and study protocols will be determined based on the results from Tier 1 studies and other lines
of evidence.
Appendix 2 contains footnotes that can be used to support DCI tables for registration
review.
10
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Registration Review DCI Issued Before January 1, 2015 and New Conventional Active Ingredients issued
between 2008 and the Date of this Process Document
Except for the pesticides imidacloprid, clothianidin, dinotefuran, and thiamethoxam
3, if the registration
review DCI was issued before January 1, 2015, it did not contain a request for the suite of new pollinator
data identified in Tables 2 and 3 because the EPA first established the need for these studies in the risk
assessment framework
Guidance for Assessing Pesticide Risks to Bees, published in June 2014. EPA has
determined that there are 298 conventional pesticide registration review cases that may need a subsequent
pollinator DCI because the initial registration review DCI was issued before January 1, 2015 (255 cases)
or the chemical was first registered with the agency between 2008 and the time of issuance of this
Process document (43 cases). The specific chemicals are listed in
Appendix 3, Table 1.
Therefore, if exposure to bees is considered relevant based on the pesticide’s use pattern, and the
registration review DCI was issued before January 1, 2015, then EPA will complete the risk assessment
consistent with the existing schedule and available data. Specifically, agency risk assessors will calculate
a risk quotient (RQ) for honey bees based on all available data, including pollinator data that may have
been submitted in the absence of a DCI, according to the 2014
Guidance, even if the additional data
summarized in
Tables 2 and 3 have not yet been submitted.
If risks of concern are identified, various factors will be considered to determine the most appropriate
regulatory determination. First, the EPA will evaluate the likelihood of exposure to bees considering
whether the registered uses involve bee-attractive crops (based on the USDA list
4), whether the directions
for use allow application when bees may be present (
e.g., application at bloom), whether expected usage
in agriculture is likely to lead to problematic pollinator exposure scenarios, and whether suitable measures
can be identified to mitigate exposure. As in every other registration decision, the EPA will also consider
the benefits associated with the registration action to determine whether those benefits outweigh the risks
of adverse effects. In order to facilitate the review and the FIFRA “no unreasonable adverse effects”
determination, the EPA may request that the registrant submit additional information including efficacy
data on key pest management claims, benefits and user alternatives assessments, and/or hazard
comparison data to other registered pesticide alternatives.
When all of the Tier 1 data are not available to evaluate potential exposure and effects to bees, it may be
difficult to develop suitable mitigation measures for some compounds (
e.g., systemic insecticides)
especially when the use is on an indeterminate blooming plant (
e.g., cotton, cucurbits) which is attractive
to pollinators.
After taking public comment on its proposed interim registration review decision, the EPA will consider
the comments received and then issue an interim registration review decision that, after consideration of
all risks and benefits, may include mitigation measures to address potential risks to pollinators.
Depending upon the nature and extent of any required mitigation, the EPA may require, through a
separate DCI, the additional pollinator data identified in the 2014
Guidance to adequately inform a useful
refinement of risk estimates in the final registration review decision
. If the risks can be appropriately
mitigated, additional data may not be necessary.
3 Registration Review DCIs were issued for imidacloprid, clothianidin, dinotefuran and thiamethoxam with requirements to submit pollinator
effects and exposure data consistent with the suite of studies listed in the 2014
Guidance. DCIs were issued on the following dates:
imidacloprid, November 10, 2010; dinotefuran, March 1, 2013; clothianidin, March 13, 2013; and thiamethoxam, March 14, 2013.
4 USDA 2015. Attractiveness of Agricultural Crops to Pollinating Bees for the Collection of Nectar and/or Pollen.
http://www.ree.usda.gov/ree/news/Attractiveness_of_Agriculture_crops_to_pollinating_bees_Report-FINAL.pdf (last accessed 06/28/2016).
11
Registration Review DCI Issued After January 1, 2015
If the registration review DCI was, or will be, issued after January 1, 2015 then the EPA considered (or
will consider) if exposure to bees is relevant to the registration review determination based on the
pesticide’s use pattern and the appropriate pollinator studies based on the 2014
Guidance. Registration
review DCIs issued after January 1, 2015, generally required the submission of all of the pollinator
studies identified in the 2014
Guidance, unless the agency made a determination that a subset of these
data would not be needed to complete the re-evaluation of that specific pesticide
. As a result, assessments
for these chemicals will be based on the pollinator studies and the risk assessment framework as described
in the 2016
Guidance on Exposure and Effects Testing for Assessing Risks to Bees. EPA has determined
that there are 134 conventional pesticide registration review cases that have considered or will consider
the need for pollinator data at the time of the initial registration review DCI. The specific chemicals are
listed in
Appendix 3, Table 2.
The EPA expects to complete the first round of registration review docket openings (completing
Preliminary Work Plans and Final Work Plans) and issuing registration review DCIs (which will include,
as appropriate, additional data necessary to address pollinator risks) for all conventional pesticide cases
subject to registration review in 2017.
Cancel ed Pesticides and Pesticides with Use Patterns that do not result in exposure to bees
At the time of issuance of this
Process document, the EPA has determined that there are 70 conventional
pesticide registration review cases that have either been cancelled since registration review started or have
registered use patterns that do not result in exposure to bees. For these chemicals, the new suite of
pollinator data will not be necessary. The specific chemicals are listed in
Appendix 3, Table 3 because
they have been voluntarily cancelled by their manufacturer or the use pattern of the chemical clearly
would not result in potential exposure to pollinators.
Laboratory Capacity Considerations
The EPA is aware that there may be practical constraints on laboratory capacity for conducting all of
these tests simultaneously given the large number of chemicals in Bin #1 and Bin #2. As a result, the
agency believes that it is appropriate to prioritize the submission of studies for those pesticides with the
greatest potential for bee exposure and adverse effects on bees. Decisions on when to issue subsequent
DCIs for pesticides in Bin #1 will be determined based on a consideration of the following factors:
• The toxicity of the pesticide to bees and/or related taxa;
• The mode of action of the pesticide (
i.e., some pesticides are not acutely toxic to adult bees but
may be chronically toxic to larval bees based on their mode of action);
• Information regarding bee kill incidents for the pesticide;
12
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• Information indicating the pesticide has been detected in honey bee colonies (
e.g., Mullin
et al.
2010
5, Stoner and Eitzer 2012
6 and USDA 2012
7);
• Pesticide use patterns with a high potential for contact exposure of bees (
e.g., applications at
bloom of bee-attractive crops identified through the USDA list
8);
• Pesticide use patterns that lead to a high potential for oral exposure of bees (
e.g., applications at
or prior to bloom for systemic pesticides); and
• Pesticide uses on crops that require commercial pollination with managed bees.
3.2 Registration Applications for New Active Ingredients and First Outdoor Uses
for Conventional Pesticides
Although the primary mechanism for collecting the bee exposure and effects data needed to develop an
updated risk assessment will involve the registration review program, the EPA has also begun to evaluate
potential risks to pollinators in an enhanced manner within the context of its registration programs (
i.e.,
registering new active ingredient and new uses of existing chemicals). This transition will occur in two
phases. The first phase involves an initial period prior to the codification of the new data requirements,
where the EPA will determine whether to require these data on a case-by-case basis as the agency reviews
applications for new active ingredients/new uses or will wait to require these data until registration
review. The second phase involves the period after which enhanced pollinator data requirements have
been codified. In this latter phase, applicants/registrants will be required to submit with applications for
registration for a new active/new use which include outdoor uses or the first outdoor use for an existing
registration the full suite of laboratory-based pollinator data and pending the outcome of the screening-
level assessment possible semi-field and full-field data on bee colonies. Since the EPA is providing early
notice through this guidance, and several other means, about its approach to implementing the updated
data requirements for pollinators, after promulgation of the final rule, new applications must address all
required bee data, without an extended phase in or start-up period.
Registrants have already begun to develop and submit data which are consistent with the
Guidance on
Exposure and Effects Testing for Assessing Risks to Bees. Prior to codification of the data rule, the EPA
strongly encourages registrants who submit applications for new conventional active ingredients or first
outdoor uses of conventional active ingredients to submit the full suite of studies identified in the 2014
Guidance.
If an application for registration of a new conventional pesticide or the first outdoor use for an existing
chemical is or has been submitted to the agency prior to the codification of the data requirements, the
EPA will review the submission package and consider it for registration. In that circumstance and
relative to the risk assessment for pollinators, the EPA will calculate risk quotients (RQs) for honey bees
based on the available honey bee data according to the 2014
Guidance.
5Mullin, C. A., M. Frazier, J. L. Frazier, S. Ashcraft, R. Simonds, D. vanEngelsdorp, and J. S. Pettis. 2010. High Levels of Miticides and
Agrochemicals in North American Apiaries: Implications for Honey Bee Health. PLoSONE 5(3): e9754.doi:10.1371/journal.pone.0009754.
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0009754 6 Stoner, K. A. and B. D. Eitzer. 2013. Using a Hazard Quotient to Evaluate Pesticide Residues Detected in Pollen Trapped from Honey Bees (
Apis
mellifera) in Connecticut. PLoS ONE 8(1): e77550.doi: 10.1371/journal.pone.0077550.
7USDA. 2012. APHIS 2011 – 2012 National Honey Bee Pests and Diseases Survey Report.
http://www.aphis.usda.gov/plant_health/plant_pest_info/honey_bees/downloads/2011_National_Survey_Report.pdf
8
Ibid USDA 2015.
13
link to page 14
If risks of concern are identified, various factors will be considered to determine the most appropriate
regulatory determination. First, the EPA will evaluate the likelihood of exposure to bees considering
whether the proposed uses of the registration action involve bee-attractive crops (based on the USDA
list
9), whether the directions for use allow application when bees may be present (
e.g., application at
bloom), whether expected usage in agriculture is likely to lead to problematic pollinator exposure
scenarios, and whether suitable measures can be identified to mitigate exposure. The EPA will also
consider the benefits associated with the registration action to determine whether those benefits outweigh
the risks of adverse effects. The burden to support an application for registration is always on the
registrant. Therefore, registrants are required to provide enough information on the registration action to
support a finding of no unreasonable adverse effects. In order to facilitate the review and any no
unreasonable adverse effects determinations, the EPA may request that the registrant submit a Public
Interest Finding, efficacy data on key pest management claims, benefits and user alternatives assessments,
and/or hazard comparison data, on the proposed chemical compared to registered pesticide alternatives.
When all of the Tier 1 data are not available to evaluate potential exposure and effects to bees, it may be
difficult to develop suitable mitigation measures for some compounds (
e.g., systemic insecticides)
especially when the use is on an indeterminate blooming plant (
e.g., cotton, cucurbits) which is attractive
to pollinators. If the EPA cannot evaluate the potential exposure and effects to bees, EPA may not be
able to make the necessary determination under FIFRA to register the pesticide or the new use.
For new chemical submissions and first outdoor uses where the EPA determines that the benefits
outweigh the predicted risks and registration can therefore occur, new bee data might be requested as a
condition of registration if it is deemed likely that additional data could adequately inform a useful
refinement of risk estimates. For new active ingredients, the EPA may determine it is appropriate to
register under FIFRA 3(c)(7)(C) authority, in part, because EPA had not previously determined these data
were necessary and the applicant would not have had time to generate the data. For approval of first
outdoor new uses and in consultation with the Office of General Counsel, the EPA may determine it is
appropriate to require the bee data conditionally under FIFRA 3(c)(7)(B). In determining whether to
grant a conditional registration, the risks to pollinators and the potential to mitigate those risks will be
considered. Identified risks, uncertainties resulting from any missing data and the anticipated benefits of
the new pesticide will be considered in making any conditional registration decision.
As with all new active ingredients, as well as other significant use expansion requests, the EPA will also
engage the public about its regulatory decisions as described in
http://www2.epa.gov/pesticide-
registration/public-participation-process-registration-actions. In this process, the EPA takes public
comments on a pre-decisional basis about regulatory positions for new chemicals and other significant
actions. The EPA will consider the comments received before making final determinations on these
actions. This will enable the EPA to engage the public on its approaches and progress in this area.
Applications submitted after the codification of the data rule will immediately be subject to the new data
requirements. Applications for new pesticide ingredients and/or a first outdoor use that are submitted
after codification of the final rule without a full set of the Tier 1 data (or alternatively an acceptable
waiver request) will be deemed to be incomplete and would fail the screens the EPA conducts for
completeness under the Pesticide Registration Improvement Act (PRIA) to determine whether the
package meets the necessary data requirements specified in 40 CFR Part 158.
9
Ibid USDA 2015.
14
PRIA contains both an Initial Content Screen and a Preliminary Technical Screen provision that enables
the agency to ensure that registration applications are complete and adequately address the data and
labeling requirements such that the EPA review teams would be expected to proceed with its regulatory
evaluation on that action. If the Technical Screen for a PRIA action identifies missing data which are
necessary and required, the EPA will provide that information to the registrant along with a 10-day
deadline for resolving that specific defect(s) or missing data. In the event that the registrant does not
adequately address the deficiency in the allotted time, the application would be rejected.
3.3 New Additional Outdoor Uses for Conventional Pesticides
Once the new data requirements are codified in 40 CFR Part 158, registration applications for a pesticide
which is already labeled for an outdoor use must contain the Tier 1 bee data, or provide an appropriate
waiver rationale as a way of addressing this requirement. Applications that are submitted after
codification of the new data requirements without the Tier 1 data will be deemed to be incomplete and fail
the completeness screen as previously described in Section 3.2.
If the application for an additional outdoor use is submitted before the issuance of the final rule amending
40 CFR Part 158, the EPA will review the submission package and consider it for registration. Similar to
the process described above for new chemicals and first outdoor uses in the preceding section, the EPA
will calculate RQs for honey bees based on the available honey bee data. The EPA may determine,
however, that it is not necessary to calculate RQs for honey bees if risk assessments for registered uses
adequately cover exposure scenarios expected for the new outdoor use. If the EPA decides that it is
necessary to calculate RQs for the new use and if risks of concern are identified based on the available
data, the nature of the missing data, the benefits, alternatives, mitigation options, and decision standards
under FIFRA will be considered as previously described in Section 3.2. In the interim period before the
final rule is issued, registration applications for existing chemicals will be considered under the current
data scheme for pollinators. For existing pesticides, which already have an outdoor use, it is anticipated
that additional bee data will be, or will have already been required as part of an existing or new
registration review DCI or as part of the conditional registration for the new active ingredient.
Label changes or mitigation measures can occur at any point during an application review or as part of
registration review. Implementing changes through the registration review program may avoid users
shifting to products that have either not yet adopted mitigation measures or that have not yet been fully
evaluated under registration review using the new pollinator data requirements. Notwithstanding the
EPA’s preference to use registration review to facilitate an orderly review of these data, if the EPA learns
of effects to bees that require more immediate attention, the EPA will take appropriate regulatory action.
15
Appendix 1. Flow-Chart for Assessing the Need for Additional
Pol inator Data for New Uses/Chemicals and Registration Review.
Registration Action or Registration Review?
ew
r N
ration
o
st
ration
st
ince 2008
Regi
Regi
Review
AI S
Is this application for a New Active Ingredient
DCI issued before January 1, 2015?
or the First Outdoor Use for an existing AI?
Yes
No
Yes
No
Was the Application
New outdoor use of
Proceed with re-
received before
an existing AI with
evaluation process, and
issuance of the final
other outdoor uses,
possibly require a
rule?
requiring EFED
separate catch-up
review?
pollinator DCI if the use
Yes
No
patterns could result in
Yes
No
exposure to bees.
Conduct review
Was new use
with existing
application
data, mitigate
received before
risks, and
or after
require new
publication of
pollinator
FR on pol inator
studies as a
data
Include new pollinator data
conditional
requirements?
requirements in registration
data
review DCI.
requirement
for registration.
If no, (i.e. if a me-too
application) no data
is required for
Conduct review with existing data and consider
registration, data will
benefits, extent of use, and mitigation where
Submissions without
be called-in and
appropriate to make safety finding. Data will
new pollinator data
evaluated under
be called in under registration review criteria or
will be considered
registration review
as part of a conditional registration for new
deficient.
criteria.
active ingredient.
16
Appendix 2. Data Cal -in Table Footnotes for Exposure and
Effects Studies with Bees
The following list of footnotes should be considered by OPP risk managers for inclusion in data call-in
tables for each of the exposure and effect studies identified below. Estimated time frames for study
submission are 12 months for all Tier 1 (laboratory-based) studies and 24 months for colony-level Tier 2
and Tier 3 (semi-field and full field colony-level) studies which include an overwintering component in
addition to field residue studies.
Tier 1 (Laboratory-based Studies)
850.3020 Acute Contact Toxicity Study with Adult Honey Bees
o USEPA. 2012
a. “Honey Bee Acute Contact Toxicity” Ecological Effects Test Guidelines OCSPP
850.3020. EPA 712-C-019
o See also OECD 214: OECD.1998
b. OECD Guidelines for the Testing of Chemicals. Test Number
214, Acute Contact Toxicity Test.
http://www.oecd-ilibrary.org/environment/test-no-214-honey
bees-acute-contact-toxicity-test_9789264070189-en;jsessionid=43gvto47wnue9.delta
Honey Bee Adult Acute Oral Toxicity
o See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral
Toxicity Test
. 213. http://www.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oral-
toxicity-test_9789264070165-en
Honey Bee Larvae Acute Oral Toxicity
o OECD Test Guideline 237 may be used to develop a protocol for this study (OECD. 2013
Guidelines for Testing Chemicals. Honey bee (
Apis mellifera) larval toxicity test, single
exposure.) See:
http://www.oecd-ilibrary.org/environment/test-no-237-honey-bee-apis-mellifera-
larval-toxicity-test-single-exposure_9789264203723-en
Honey Bee Adult Chronic Oral Toxicity
o OECD has not yet finalized test guidelines for chronic studies, and efforts are underway to
develop standardized guidelines for assessing the effects from chronic exposure to adult and
larvae in the laboratory. Discussion of the study design elements for the 10-day adult toxicity test
can be found in Appendix O of the European Food Safety Authority (EFSA) guidance document:
EFSA. 2013. Guidance on the risk assessment of plant protection products on bees (
Apis
mellifera,
Bombus spp. and solitary bees. EFSA Journal 2013;11(7):3295, 266 pp.
doi:10.2903/j.efsa.2013.3295.
Available online at:
http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2668.pdf
o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
17
Honey Bee Larvae Chronic Oral Toxicity
o OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft
guidance has is being developed, see OECD 2013
b. OECD Draft Guidance Document Honey Bee
(
Apis mellifera) Larval Toxicity Test, Repeated Exposure.
http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November
_2013.pdf
o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
850.3030 Honey Bee Toxicity of Residues on Foliage
o USEPA. 2012
b. “Honey Bee Toxicity of Residues on Foliage.” Ecological Effects Test
Guidelines OCSPP 850.3030. EPA 712-C-018.
Tiers 2 and 3 (Semi-field and Full Field Colony-level Studies)
Semi-field testing for pollinators (tunnel or colony feeding studies)
o The need for a semi-field test for pollinators (
i.e., either a field-feeding test or a tunnel test) will
be determined based upon lower-tiered tests and/or other lines of evidence, and the need for a
refined pollinator risk assessment.
o Formal guidelines for semi-field tests do not yet exist; however, information that can help guide
the development of either a semi-field tunnel test protocol can be found at OECD 75, see: OECD.
2007. Series on Testing and Assessment Number 75. Guidance document on the honey bee (
Apis
mellifera L.) brood test under semi-field conditions. Environmental Directorate Joint Meeting of
the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology.
ENV/JM/MONO(2007)22. 31-Aug-2007.
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2007)22
&doclanguage=en.
o For field-feeding studies see: Oomen
et al. 1992: Oomen, P. A. A. DeRuijter and J. Van der
Steen. 1992. Method for honey bee brood feeding tests with insect growth-regulating insecticides.
Bul OEPP/EPPO Bulletin 22: 613 – 616.
o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
18
850.3040 Field Testing for Pollinators
o The need for a field test for pollinators will be determined based upon lower-tiered tests and/or
other lines of data and the need for a refined pollinator risk assessment.
o See information and guidance identified in the EPA documents, (
i) USEPA. 2012. White Paper in
Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific
Advisory Panel for Review and Comment September 11 – 14, 2012. Office of Chemical Safety
and Pollution Prevention Office of Pesticide Programs Environmental Fate and Effects Division,
Environmental Protection Agency, Washington DC; Environmental Assessment Directorate, Pest
Management Regulatory Agency, Health Canada, Ottawa, CN; California Department of
Pesticide Regulation; (
ii) 2014 Guidance for Assessing Pesticide Risks to Bees. Office of
Pesticide Programs United States Environmental Protection Agency, Health Canada Pest
Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014.
http://www2.epa.gov/sites/production/files/201406/documents/pollinator_risk_assessment_guida
nce_06_19_14.pdf.
o USEPA. 2012
c. “Field Testing for Pollinators.” Ecological Effects Test Guidelines OCSPP
850.3040. EPA 712-C-017.
o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
Residues in Pollen and Nectar/Field Residue Analysis
o Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and/or
other lines of evidence, and the need for a refined pollinator risk assessment.
o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation. The
following elements could be considered when developing study protocol(s) for the monitoring of
residues in pollen/nectar.
• Consideration of the range of application methods and environmental conditions (
e.g., soil
and hydric regimes) that the target crop(s) may be under.
• Consideration of the attractiveness of the selected crop to pollinators
• Consideration of a collection schedule sufficient to allow for an understanding of the
character of residues, in the pollen/nectar and/or plant tissues, over time.
• Consideration of data sufficient to determine whether residues of the active ingredient and/or
degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a
following planting, and therefore result in potential exposure to pollinators.
• Consideration of the market proportion of the selected target crop(s).
o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
19
Appendix 3. Conventional Chemical Cases Potentially Subject to
the Need for Additional Pollinator Data.
Table 1. Conventional Chemicals Likely to Receive Follow-Up Pollinator Data Call-In (DCI) (case
name, case #) Chemicals in this table are subject to a DCI that will require the suite of pollinator data identified in the
EPA’s 2014 risk assessment framework
Guidance for Assessing Pesticide Risks to Bees.
• Shaded chemicals have already begun registration review but did not receive a registration review
DCI for various reasons. These cases will be reviewed to determine if use patterns would result in
exposure to bees and be subject to the subsequent pollinator DCI.
• Highlighted chemicals are those conventional cases that were first registered between 2008 and
the time this
Process document was issued and will be reviewed to determine if use patterns
would result in exposure to bees and be subject to the subsequent pollinator DCI.
• Based on currently registered use(s) for some chemicals, the likelihood of exposure to bees may be
considered low and additional pollinator toxicity testing may not be triggered.
1,3-Dichoropropene (1,3-D or Telone), 0328
Imazosulfuron, 7281
2,4-D, 0073
Imidacloprid, 7605
2,4-DB, 0196
Imiprothrin, 7426
2,4-DP-p, 0294
Indaziflam, 7278
2-EEEBC (Debacarb), 4031
Indoxacarb, 7613
Abamectin, 7430
Inorganic nitrate/nitrite, 4052
Acephate, 0042
Inorganic sulfites (sulfur dioxide), 4056
Acetaminophen, 7610
Iodosulfuron-methyl-sodium, 7253
Acetamiprid, 7617
Iprodione, 2335
Acetic acid, & salts, 4001
Iron salts, 4058
Acibenzolar-S-methyl, 7031
Isofetamid, 7071
Aldicarb, 0140
Isoxaben, 7219
Al ethrin stereoisomers, 0437
Isoxaflutole, 7242
Aluminum phosphide, 0025
Kasugamycin, 7045
Ametoctradin, 7066
Kresoxim-methyl, 7026
Ametryn, 7036
Lactofen, 7210
Aminocyclopyrachlor, 7279
Lambda-Cyhalothrin, 7408
Amitraz, 0234
Linuron, 0047
Antimycin A, 4121
Lufenuron, 7627
Asulam, 0265
Macleaya extract, 7024
Atrazine, 0062
Magnesium phosphide, 0645
Azoxystrobin, 7020
Malathion, 0248
Benfluralin, 2030
Maleic hydrazide, 0381
Bensulfuron-methyl, 7216
Mandipropamid, 7058
Bensulide, 2035
Mepiquat/mepiquat chloride, 2375
Bentazon, 0182
Meptyldinocap, 7061
Benzovindiflupyr, 7072
Mesosulfuron-methyl, 7277
20
Bicyclopyrone, 7284
Metalaxyl & Mefenoxam, 0081
Bifenazate, 7609
Methiocarb, 577
Bifenthrin, 7402
Methomyl, 0028
Boric acid & sodium borate salts, 0024
Methoxyfenozide, 7431
Bromacil, 0041
Methyl bromide,0335
Bromoxynil & esters, 2070
Methyldithiocarba.. (metam-Na), 2390
Buprofezin, 7462
Metofluthrin, 7445
Butralin, 2075
Metrafenone, 7052
Butylate, 0071
Metribuzin, 0181
Captan, 0120
Metsulfuron, 7205
Carbaryl, 0080
MGK-264, 2430
Carbon, carbon dioxide, saw, 4019
MSMA, 2395
Carfentrazone-ethyl, 7422
Naled, 0092
Chlorantraniliprole, 7449
Niclosamide, 2455
Chlorethoxyfos, 7410
Nicosulfuron, 7227
Chlorfenapyr, 7419
Nithiazine (2H-1,3-Thiazine…,7415
Chlorimuron, 7403
Nitrapyrin, 0213
Chloropicrin, 0040
Norflurazon, 0229
Chlorothalonil, 0097
Orthosulfamuron, 7270
Chlorpropham, 271
Oryzalin, 0186
Chlorpyrifos, 0100
Oxalic acid, 7466
Chlorpyrifos-methyl, 8011
Oxamyl, 0253
Chlorsulfuron, 0631
Oxathiaipiprolin, 7073
Clethodim, 7226
Oxydemeton-methyl (ODM), 0258
Clodinafop-propargyl, 7250
Oxytetracycline, 0655
Clofentezine, 7602
Paclobutrazol, 7002
Clomazone, 7203
Paraquat dichloride, 0262
Cloransulam methyl, 7243
Pendimethalin, 0187
Clothianidin, 7620
Penflufen, 7065
Copper compounds, Group II, 0649
Penthiopyrad, 7063
Copper salts, 4026
Permethrin, 2510
Copper sulfate, 0636
Phorate, 0103
Coumaphos, 0018
Phosmet, 0242
Cyanamide, 7005
Phosphine, 7608
Cyantraniliprole, 7462
Phostebupirim, 7606
Cyclanilide, 7018
Picoxystrobin, 7283
Cyflufenamid, 7068
Piperalin, 3114
Cyflumetofen, 7463
Piperonyl butoxide, 2525
Cyfluthrins, 7405
Pirimiphos-methyl, 2535
Cymoxanil, 7023
Polybutene resins, 4076
Cypermethrin, 2130
Prallethrin, 7418
21
Cyphenothrin, 7412
Primisulfuron-methyl, 7220
Cyprodinil, 7025
Prodiamine, 7201
Cyromazine, 7439
Profenofos, 2540
Daminozide (Alar), 0332
Prohexadione calcium, 7030
Dazomet, 2135
Prometon, 2545
DCPA (chlorthal dimethyl), 0270
Prometryn, 0467
DDVP (Dichlorvos), 0310
Pronamide (Propyzamide), 0082
Deltamethrin, 7414
Propamocarb, 3124
Demiditraz, 7461
Propazine, 7278
Denatonium saccharide (Benz…), 7625
Propetamphos, 2550
Desmedipham, 2150
Propionic acid & salts, 4078
Diazinon, 0238
Propoxur, 2555
Dichlobenil, 0263
Propylene oxide, (PPO) 2560
Dicrotophos, 0145
Prosulfuron, 7235
Diflubenzuron, 0144
Pymetrozine, 7474
Diflufenzopyr, 7246
Pyrethrins & derivs., 2580
Dimethoate, 0088
Pyridaben, 7417
Dimethomorph, 7021
Pyridalyl, 7451
Dimethyl disulfide (DMDS), 7454
Pyrifluquinazon, 7458
Dinotefuran, 7441
Pyrimethanil, 7059
Dioctyl sodium sulfosuccinate, (DSS) 4029
Pyrimidinone (Hydramethylnon),2585
Dipropyl isocinchomeronate, 2215 (MGK 326)
Pyriproxyfen, 7424
Diquat dibromide, 0288
Pyrithiobac sodium, 7239
Dithiopyr, 7225
Pyroxasulfone, 7282
d-Limonene, 3083
Pyroxsulam, 7275
Emamectin benzoate, 7607
Quinclorac, 7222
EPTC, 0064
Quinoxyfen, 7037
Esfenvalerate, 7406
Quizalofop, 7215
Ethaboxam, 7053
Rimsulfuron, 7218
Ethalfluralin, 2260
Saflufenacil, 7277
Ethephon, 0382
Sedaxane, 7070
Ethoprop, 0106
Silica & silicates, 4081 (silicon dioxide)
Etofenprox, 7407
Simazine, 7280
Fenarimol, 7001
Soap salts, 4083
Fenazaquin, 7447
Sodium acifluorfen, 2605
Fenbutatin oxide (Vendex), 245
Sodium cyanide, 8002
Fenhexamid, 7027
Sodium metabisulfite, 7019
Fenitrothion, 0445
Sodium tetrathiocarbonate, 7009
Fenoxaprop-p-ethyl, 7209
Spinetoram, 7448
Fenoxycarb, 7401
Spinosad, 7421
Fenpropathrin, 7601
Spirotetramat, 7452
22
Fenpyrazamine, 7459
Starlicide, 2610
Fipronil, 7423
Streptomycin, 0169
Flazasulfuron, 7271
Sulfentrazone, 7231
Fluazinam, 7013
Sulfometuron-methyl, 3136
Flubendiamide, 7450
Sulfosulfuron, 7247
Flucarbazone-sodium, 7251
Sulfoxaflor, 7460
Fludioxonil, 7017
Sulfuryl fluoride, 0176
Fluensulfone, 7464
Sumithrin (phenothrin), 0426
Flufenacet, 7245
Tau-fluvalinate, 2295
Flumetsulam, 7229
Tebufenozide, 7416
Flumiclorac-pentyl, 7232
Tebuthiuron, 0054
Flumioxazin, 7244
Tefluthrin, 7409
Fluopicolide, 7055
Temephos, 0006
Fluopyram, 7067
Terbacil, 0039
Fluoroacetic acid derivatives, 3073
Terbufos, 0109
Flupyradifurone, 7465
Tetrachlorvinphos, 0321
Fluridone, 7200
Tetramethrin, 2660
Flurprimidol, 7000
TFM/lamprecide, 3082
Fluthiacet-methyl, 7245
Thiamethoxam, 7614
Flutolanil, 7010
Thidiazuron, 4092
Flutriafol, 7060
Thiencarbazone, 7276
Fluxapyroxad, 7064
Thifensulfuron, 7206
Folpet, 0630
Thiobencarb, 2665
Fomesafen, 7211
Thiodicarb, 2675
Foramsulfuron, 7252
Tolclofos-methyl, 7069
Formetanate HCl, 0091
Tolfenpyrad, 7453
Fosamine ammonium, 2355
TPTH (fentin hydroxide), 0099
Fosetyl-Al (Aliette), 0646
Triasulfuron, 7221
Fosthiazate, 7604
Tribenuron methyl, 7217
Gamma-Cyhalothrin, 7437
Tribufos (DEF), 2145
Glufosinate ammonium, 7224
Trichlorfon, 0104
Glyphosate, 0178
Trifloxystrobin, 7028
Gonadotropin releasing hormone, 7800
Trifloxysulfuron-sodium, 7260
Halosulfuron-methyl, 7233
Triflumizole, 7003
Hexaflumuron, 7413
Trifluralin, 0179
Hexazinone, 0266
Triflusulfuron, 7236
Hexythiazox, 7404
Trinexapac-ethyl, 7228
Hymexazol, 7016
Undecylenic acid, (UDA) 4095
Imazalil & Imazalil sulfate, 2325
Urea sulfate (1:1), 7213
Imazapyr, 3078
Zonastat-H,7801
23
Table 2. Conventional Chemicals that Received or Wil Receive a Registration Review Data Cal -In (DCI)
after January 1, 2015 (case name, case #)
Chemicals in this table have already received or will receive a registration review DCI that received
consideration of the 2014
Guidance and contains the suite of pollinator data.
4-Aminopyridine, 0015
Ipconazole, 7041
Acequinocyl, 7621
Mancozeb, 0643
Acetochlor, 7230
MCPA, 0017
Acrolein, 2005
MCPB, and salts, 2365
Alachlor, 0063
Mecoprop-p (MCPP-p), 0377
Aliphatic alcohols C6-C16, 4004
Mefluidide, 2370
Aliphatic esters, 4005
Mesotrione, 7256
Aliphatic solvents, 3004
Metaflumizone, 7446
Amicarbazone, 7269
Metaldehyde, 0576
Aminopyralid, 7267
Metconazole, 7049
Anthraquinone, 6054 (122701)
Metiram, 0644
Bispyribac-sodium, 7258
Metolachlor & s-metolachlor, 0001
Boscalid, 7039
Momfluorothrin, 7457
Brodifacoum, 2755
Myclobutanil, 7006
Bromadiolone, 2760
Napropamide, 2450
Bromethalin, 2765
Naptalam, 0183
Bromuconazole, 7035
Napthalene, 0022
Butafenacil, 7261
Napthaleneacetic acid, 0379
Carbofuran
Nicarbazin, 7628
Carboxin, 0012
Novaluron, 7615
Chlorflurenol, 2095
Oxadiazon, 2485
Chlormequat chloride, 7069 (018101)
Oxyfluorfen, 2490
Chlorophacinone, 2100
PCNB, 0128
Cholecalciferol, 7600
p-Dichlorobenzene, 3058
Clopyralid, 7212
Penoxsulam, 7265
Cryolite, 0087
Phenmedipham, 0277
Cyazofamid, 7056
Picloram, 0096
Cycloate, 2125
Pinoxaden, 7266
Cyproconazole, 7011
Polyethoxylated alcohols, 3119
DCNA, 0113
Polypropylene glycol, 3123
Derivs. of benzoic acid, 4013
Propachlor, 0177
Dicamba, 0065
Propanil, 0226
Diclosulam, 7249
Propargite, 0243
Difenacoum, 7630
Propiconazole, 3125
Difenoconazole, 7014
Propoxycarbazone-sodium, 7264
Difethialone, 7603
Prothioconazole, 7054
Dikegulac sodium, 3061
Pyraclostrobin, 7034
24
Dimethenamid, 7223
Pyraflufen-ethyl, 7259
Diphacinone, & salts, 2205
Pyrasulfotole, 7272
Diphenylamine, 2210
Rotenone, 0255
Diuron, 0046
Sabadilla alkaloids, 3128
Dodine, 0161
Sethoxydim, 2600
Endothall, & salts, 2245
Siduron, 3130
Ethofumesate, 2265
Spirodiclofen, 7443
Etoxazole, 7616
Spiromesifen, 7442
Etridiazole (Terrazole), 0009
Spiroxamine, 7040
Famoxadone,7038
Strychnine, 3133
Fenamidone, 7033
Sulfur, 0031
Fenbuconazole, 7012
Tebuconazole, 7004
Fenpyroximate, 7432
Tembotrione, 7273
Ferbam, 2180
Tetraconazole, 7043
Flonicamid, 7436
Thiabendazole, and salts, 2670
Florasulam, 7274
Thiophanate-methyl & carbendazim, 2680
Fluazifop-butyl, isomers, 2285
Thiram, 0122
Flumethrin, 7456
Topramezone (BAS 670H), 7268
Flumetralin, 4119
Triadimefon, 2700
Fluometuron, 0049
Triadimenol, 7008
Fluoxastrobin, 7044
Triallate, 2695
Fluroxypyr, 1-methylheptylester, 7248
Triclopyr, salts & esters, 2710
Forchlorfenuron, 7057
Triforine, 2720
Furfural, 7050
Triticonazole, 7036
Imazamox, 7238
Uniconazole, 7007
Imazapic, 7234
Warfarin & Na salt, 0011
Imazaquin, 7204
Xylene (aromatic solvents), 3020
Imazethapyr, 7208
Zinc phosphide, 0026
Inorg. chlorates (Na chlorate), 4049
Ziram, 8001
Inorganic polysulfides, 4054
Zoxamide, 7032
Table 3. Chemicals that wil Not Receive a Data Cal -In (DCI) Requiring Pol inator Data (case name, case
#)
Chemicals in this table wil not receive a subsequent DCI because they either have no exposure potential
to bees, have no US registrations, or the pesticide case has been voluntarily cancelled.
1 RS, cis-permethrin, 7429
Maneb, 0642
2-Hydroxyethyl octyl sulfide, 8005
Mepanipyrim, 7042
4-CPA, and salts, 2115
Methamidophos, 0043
Aldoxycarb, 7624
Methidathion, 0034
alpha-Chlorohydrin, 7629
Methyl parathion, 0153
25
Amitrole, 0095
Mevinphos, 0250
Ancymidol, 3017
Milbemectin, 7623
Aquashade, 4010
Mitin FF, 3097
Azinphos-methyl (AZM), 0235
Molinate, 2435
Bitertanol, 8007
Neodecanamide, N-methyl, 7428
Bitrex, 8010
Noviflumuron, 7434
Cacodylic acid, & salts, 2080
Phosalone, 0027
Chloroneb, 0007
Picaridin, 7433
Clofencet, 7015
Pirimicarb, 7438
Cyhalofop-butyl, 7255
PT807-HCl (Diethyl-2-(4-meth. ), 7029
Cyhexatin, 0237
Pyrazon, 2570
Deet, 0002
Pyridate, 7214
Diclofop-methyl, 2160
Resmethrin, 0421
Dicofol, 0021
Sulfluramid, 7411
Difenzoquat, 0223
Sulfonic acids, C14-16-al & C-14-16 al, 7618
Dimethepin, 3063
Sulfosate, 7202
Disulfoton, 0102
Tall oil fatty acids, K salts, 7612
Dithianon, 7048
Tanol derivs. (furanones), 3138
Endosulfan, 0014
Tebufenpyrad, 7435
Ethametsulfuron-methyl, 7254
Tepraloxydim, 7257
Ethoxyquin, 0003
Terpineols, 3139
Fenamiphos, 333
Thiacloprid, 7622
Fenvalerate, 2280
Thiazopyr, 7240
Flufenoxuron, 7444
Thiophanate-ethyl, 0378
Flufenpyr-ethyl, 7262
Tralkoxydim, 7237
Halofenozide, 7425
Tralomethrin, 7400
Imazamethabenz, 7207
Tridemorph, 8009
Inorg. thiosulfates (Ca thio. ), 4057
Urea, 4096
Iodomethane (methyl iodide), 7321
Vinclozolin, 2740
Lindane, 0315
Yellow mustard seed, 7619
26
Document Outline
- Office of Pesticide Programs
- U.S. Environmental Protection Agency
- August 15, 2016 (Revised)
- Table of Contents
- 1. Purpose 4
- 2. Background 4
- 3. Implementation 9
- 3.1 Conventional Pesticides in Registration Review 9
- Registration Review DCI Issued Before January 1, 2015 and New Conventional Active Ingredients issued between 2008 and the Date of this Process Document 11
- Registration Review DCI Issued After January 1, 2015 12
- Cancelled Pesticides and Pesticides with Use Patterns that do not result in exposure to bees 12
- Laboratory Capacity Considerations 12
- 3.2 Registration Applications for New Active Ingredients and First Outdoor Uses for Conventional Pesticides 13
- 3.3 New Additional Outdoor Uses for Conventional Pesticides 15
- Appendix 1. Flow-Chart for Assessing the Need for Additional Pollinator Data for New Uses/Chemicals and Registration Review. 16
- Appendix 2. Data Call-in Table Footnotes for Exposure and Effects Studies with Bees 17
- Appendix 3. Conventional Chemical Cases Potentially Subject to the Need for Additional Pollinator Data. 20
- 1. Purpose
- The intent of this document (referred to as Process document) is to provide interim guidance to the public and staff within the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) for determining when honey bee exposure and effects (toxicity) data identified in the EPA’s 2014 risk assessment framework Guidance for Assessing Pesticide Risks to Bees (hereafter referred to as the 2014 Guidance) and the 2016 Guidance on Exposure and Effects Testing for Assessing Risks To Bees are required. This document is being made available to describe OPP’s plans for requiring these data to assess chemical risks to bees. This document focuses on conventional pesticides; the agency discusses its current approach for other types of pesticides in section 4 of the companion document, 2016 Guidance on Exposure and Effects Testing for Assessing Risks To Bees.
- 2. Background
- Assessing risks to bees is a complex matter. The scientific community is in general agreement that a multitude of factors contribute to potential adverse impacts on bees, including lack of nutritional resources, pests and pathogens, and pesticides, among others. To better understand the potential impacts that pesticides might have on bee health, EPA has determined that additional bee toxicity and exposure information are necessary to conduct its evaluations as part of its registration and registration review programs.
- In general, pesticides can only be sold and distributed in the United States if they have been registered by the EPA. Prior to the agency granting a registration, each applicant must establish that its product meets the standards set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5) and/or 3(c)(7). These standards include finding that when a pesticide is used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment. FIFRA also provides for regular review of existing pesticide registrations. FIFRA section 3(g) and its implementing regulations at 40 CFR Part 155 set forth the process for the reevaluation of currently-registered pesticides (i.e., registration review).
- FIFRA’s implementing regulations at 40 CFR Part 158 set forth the data requirements for pesticide registration. Additionally, these regulations discuss the flexibility the EPA has when requiring data for pesticide registrations. Under 40 CFR 158.30, the EPA may determine to modify the data requirements on an individual or case-by-case basis to fully characterize the effects of a pesticide product. Additionally, these regulations make clear the data routinely required under Part 158 may not always be sufficient to assess whether there are unreasonable adverse effects on the environment. Under 40 CFR 158.30(b) and 40 CFR 158.75, the EPA may require additional information to better characterize the potential risks.
- Consistent with the EPA’s process for evaluating risk to various taxa, assessing risk relies on multiple studies identified in Title 40 (Protection of the Environment) of the Code of Federal Regulations, Part 158 (Data Requirements for Pesticides; abbreviated as 40 CFR Part 158). However, where necessary, the EPA has the authority to require data which may extend beyond the suite of exposure and effect data identified in the 40 CFR Part 158. Pesticide registrants (i.e., the regulated community) are required by law to provide the data needed to assess the potential for adverse effects from exposure to pesticides. To meet the data requirements, registrants will, in large part, depend on contract research organizations (CROs) to conduct these studies since CROs have experience in conducting the studies and can provide consistent and reliable data that meet the specification identified in the 40 CFR Part 158. The EPA recognizes that the capacity of CROs to conduct new studies on behalf of the regulated community depends on the nature of the studies and the laboratory’s familiarity with the test species and/or study conditions.
- In the absence of these data, risk assessors may not be able to fully determine the potential for exposure and effects to bees. However, where the EPA determines that a pesticide use is not likely to expose bees or in situations where acute and/or chronic toxicity is not expected based on other lines of evidence, additional data may not be warranted to support regulatory decisions.
- The EPA has developed guidance documents for risk assessors that identify additional, relevant data in evaluating exposure and effects of pesticides on honey bees. The agency is in the process of revising the existing insect pollinator data requirements in 40 CFR Part 158 to codify the data necessary to complete risk assessments consistent with the risk assessment framework. Having all required studies available to the EPA at the time of application should reduce the potential for delays in the registration process.
- Table 1 identifies the current data requirements for conventional pesticides codified at 40 CFR Part 158, Subpart G for toxicity and exposure testing for insect pollinators. Tables 2 and 3 list the additional types of studies the EPA has determined are necessary to more fully evaluate the potential exposure and effects to bees for various pesticide use patterns.
- Table 1. Toxicity Testing Requirements for Insect Pollinators as Specified in 40 CFR Part 158, Subpart G.
- Use Pattern
- Test Note No.
- Test substance
- Green-house
- Residential Outdoor
- Data Requirement
- Guideline Number
- Indoor
- Forestry
- Aquatic
- Terrestrial
- Insect Pollinator Testing
- Honey bee adult acute contact toxicity
- 1
- TGAI
- NR
- NR
- R
- R
- CR
- R
- 850.3020
- Honey bee toxicity of residues on foliage
- 2
- TEP
- NR
- NR
- CR
- CR
- CR
- CR
- 850.3030
- Field testing for pollinators
- 3
- TEP
- NR
- NR
- CR
- CR
- CR
- CR
- 850.3040
- Definitions: R = Required; CR = Conditionally Required; NR = Not Required; TGAI = Technical Grade of the Active Ingredient; TEP = Typical End-Use Product
- Test Notes:
- 1. Data using the TGAI are required to support all outdoor end-use product uses. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.
- 2. Data are required only when the formulation contains one or more active ingredients having an acute LD50 of <11 micrograms per bee as determined in the honey bee acute contact study and the use pattern(s) indicate(s) that honey bees may be exposed to the pesticide. (Note that in the regulatory text this is actually Test Note 24.)
- 3. Required if any of the following conditions are met: (Note that in the regulatory text this is actually Test Note 25.)
- i. Data from other sources (Experimental Use Permit program, university research, registrant submittals, etc.) indicate potential adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.);
- ii. Data from residual toxicity studies indicate extended residual toxicity;
- iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral effects.
- Table 2. Additional Requirements a, b for Bee Exposure and Effects Testing
- Test Note No.
- Test substance
- Study Type
- Study
- Non-Guideline Study (Tier 1) (c)
- 1
- TGAI
- Honey bee adult acute oral toxicity
- Non-Guideline Study (Tier 1) (d)
- 1
- TGAI
- Honey bee larvae acute oral toxicity
- Non-Guideline Study (Tier 1) (e) (g)
- 1
- TGAI
- Honey bee adult chronic oral toxicity
- Non-Guideline Study (Tier 1) (e) (g)
- 1
- TGAI
- Honey bee larvae chronic oral toxicity
- TEP (tunnel) or TGAI (feeding)
- Semi-field testing for pollinators (tunnel or colony feeding studies)
- Non-Guideline Study (Tier 2) (f) (g)
- 2
- Definitions: TGAI = Technical Grade of the Active Ingredient; TEP = Typical End-Use Product
- (a) Recommendations for bee toxicity data may be modified for certain types of outdoor residential uses for which exposure is considered extremely limited (e.g., crack and crevice treatment, spot treatment, etc). In such cases, acute toxicity data may still be warranted but chronic toxicity data may be of limited value in the risk assessment.
- (b) For greenhouse uses that involve bee pollination, Tier 1 and Tier 2 bee exposure and effects data may be required.
- (c) Honey bee acute oral toxicity test protocol available through OECD TG 213. For aquatic uses, acute oral toxicity data are needed to evaluate exposure of bees through drinking water and in evaporative cooling of the hive and for exposure through systemic transport into food items (pollen/nectar).
- (d) Honey bee acute larval toxicity test protocol available through OECD TG 237.
- (e) Draft test protocols are currently being finalized through the OECD.
- (f) Semi-field tunnel study protocol available through OECD Guidance 75.
- (g) Study protocol should be submitted for review prior to conduct of the study.
- Test Notes:
- 1. Data using the TGAI are required to support all outdoor end-use product uses. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material. For greenhouse use patterns, data are required for crops that require pollination (e.g., tomatoes); for aquatic use patterns, data are required if bees are likely to be exposed as a result of the proposed use.
- 2. Tier 2 studies may be required pending the results and evaluation of Tier 1 studies. Tier 2 studies may be required if the ratio of the EEC and larval or adult bee acute LD50 >0.4 or the ratio of the EEC and chronic NOAEC >1. Tier 2 may be required if data from other sources (Experimental Use Permit program, university research, open literature, registrant submittals, adverse effect incident reports, etc.) indicate the potential to adversely affect bee colonies, especially effects other than acute mortality (e.g., reproductive, behavioral, etc.). Tier 2 studies may also be required if data derived from studies with terrestrial arthropods other than honeybees indicate potential chronic, reproductive, or behavioral effects.
- Table 3. Additional Requirements for Residue Data Measured in Pollen and Nectar.
- Test Note No.
- Test substance
- Study Type
- Study
- 1, 2
- TEP
- Field trial of residues in pollen and nectar
- Non-Guideline Study (Tier 3)
- Definitions; TEP = Typical End-Use Product
- 1. Field studies that quantify pesticide residues in pollen/nectar may be required to refine screening level exposure estimates, depending on the results and evaluation of Tier 1 studies. Pollen and nectar residue studies may be required if the ratio of the EEC and larval or adult bee acute LD50 >0.4 or the ratio of the EEC and chronic NOAEC >1. Incident data and/or compelling open literature studies can also serve as rationale for requiring pollen and nectar residue studies. These data can be collected at any point during the tiered process; prior consultation with the Agency is recommended to determine when to collect the data, and test protocols must be submitted for Agency review prior to initiation of the study. For greenhouse use patterns, data are required for crops that require pollination (e.g., tomatoes); for aquatic use patterns, data are required if bees are likely to be exposed as a result of the proposed use (e.g., riparian vegetation).
- 2. Protocol should be submitted for EPA review prior to initiating study.
- The EPA initiated the rulemaking process in 2015 to codify all of the data required to support each tier of the risk assessment process for bees in 40 CFR Part 158. Depending on the timing of the proposed rule and the number and complexity of the comments received, as well as other external factors, the EPA projects the new rule to be effective by mid-late 2017. In the meantime (before promulgation of the new data requirements), the agency will on a case-by-case basis determine whether these data are needed for individual registration actions.
- The EPA’s data requirements are established to provide the information needed to determine whether a new pesticide product and new uses on currently registered products meet the standard for registration. In general, registrants must address the established data requirements in 40 CFR Part 158. However, the EPA sometimes determines that special studies or additional data beyond those codified in 40 CFR Part 158 are required to make a finding of no unreasonable adverse effects finding under FIFRA.
- As part of the re-evaluation of pesticides, the EPA may determine that additional data are needed to support the continued registration of a pesticide. In such cases, the EPA first issues a Preliminary Work Plan (PWP) that outlines the expected timeline for the registration review, the likely risk assessments that will need to be conducted, and the data the agency expects to be necessary to fully evaluate the pesticide during the re-evaluation process. Subsequent to taking comment on the PWP, the EPA issues a Final Work Plan (FWP). If additional data are needed as part of the registration review, the EPA issues a Data Call-In Notice (DCI) under FIFRA section 3(c)(2)(B). The DCI requires each affected registrant to provide evidence within 90 days that the affected registrant is taking appropriate steps to respond to the DCI. Additionally, the DCI sets deadlines for data submission and may specify interim deadlines. In accordance with the terms of clearance for the information collection request (ICR) approved by the Office of Management and Budget (OMB) under OMB Control Number 2070-0174, the EPA must provide OMB with prior notice and opportunity to review each DCI before issuance. Once OMB has approved the DCI, OPP may issue the order. As noted earlier, the DCI may include studies which are not codified in 40 CFR Part 158, and these studies are subject to the same authorities covered by the ICR. In some circumstances, subsequent to issuing a DCI as part of the registration review program, the agency may identify the need for additional data to support the continued registration of a pesticide. In these circumstances, the EPA, after receiving approval from OMB, will issue a follow-up DCI to require the submission of these additional data.
- The next sections discuss what additional data are needed, the timing of when the EPA may request additional data, and describe how the EPA will integrate the pollinator risk assessment methods into its overall regulatory approaches for both registration and registration review.
- 3. Implementation
- As previously discussed, the EPA has initiated the rulemaking process to codify the pollinator toxicity and exposure testing in 40 CFR Part 158. In the interim, OPP has developed a plan for evaluating when these data may be required on a case-by-case basis, consistent with the 2014 Guidance and the 2016 Guidance on Exposure and Effects Testing for Assessing Risks to Bees. Specifically, this plan summarizes OPP’s approach for addressing the new bee testing needs in the context of three types of regulatory actions for conventional pesticides:
- Registration Review of existing pesticides;
- Registration of pesticides containing new active ingredients and first outdoor uses; and
- Registration of new additional outdoor pesticide uses.
- Appendix 1 contains a flowchart depicting the general process the Agency will follow in determining whether additional pollinator data will be necessary for different registration and registration review actions.
- When the data described in the 2016 Guidance on Exposure and Effects Testing for Assessing Risks to Bees are not available, there will likely be aspects of the potential for exposure and effects to bees which are not known. In these situations, registration and registration review decisions will consider:
- the nature of the uncertainties (e.g., which data are not available);
- the extent to which mitigation measures can reduce exposure/effects from the pesticide undergoing the action;
- the benefits associated with the use; and,
- whether there are alternatives and the potential comparative risks associated with those alternatives.
- FIFRA Section 3(g) mandates that the EPA periodically review the registrations of all pesticides to ensure that they do not pose unreasonable adverse effects to human health and the environment. This periodic review is necessary in light of scientific advancements, changes in policy, and changes in use patterns that may alter the conditions underpinning previous registration decisions. In determining whether the likelihood and magnitude of adverse effects (i.e., risk) to taxa from exposure to pesticides are unreasonable, FIFRA requires that the Agency consider the risks and benefits of any use of the pesticide.
- During registration review, OPP may determine that data from the types of studies discussed in this document are necessary before a final decision is issued pursuant to 40 CFR Part 155. The way in which the pollinator data may be required during registration review will depend on the stage of the agency’s review of the chemical in the review process. The EPA’s approach will depend on when the initial registration review DCI was issued and whether the agency may have required the submission of additional pollinator data. The DCI is generally issued early on in the registration review process after the EPA has reviewed and summarized existing data and considered anticipated data needs (e.g., acute and/or chronic bee toxicity data) necessary to conduct a risk assessment and formulate a registration review decision.
- Because the need for additional pollinator data was determined subsequent to the initiation of registration review program in 2007, the registration review process for many conventional pesticide active ingredients is already well underway. With a few exceptions, registration review DCIs issued after January 1, 2015, generally required the submission of all of the pollinator testing identified in the 2014 Guidance, unless the agency made a determination that a subset of these data would not be needed to complete the re-evaluation of that specific pesticide. The agency has reviewed all conventional pesticide active ingredient cases and categorized them based on where they are in the registration review process. We have categorized registration review cases into 3 Bins:
- Bin #1: Cases that may need a subsequent pollinator DCI because the initial registration review DCI was issued before January 1, 2015 or the chemical was first registered with the agency between 2008 and the time of issuance of this Process document
- Bin #2: Cases in the first 15-year cycle of registration review where EPA either considered or will consider whether the pollinator data identified in the 2014 Guidance are needed to complete registration review. The registration review DCI for these cases was/will be issued after January 1, 2015.
- Bin #3: Cases in the first 15-year cycle of registration review that have either been cancelled or have or registered use patterns that do not result in exposure to bees
- For those pesticide cases where the EPA determines that the pollinator data identified in the 2014 Guidance are necessary for the registration review, a DCI will be issued requiring the appropriate pollinator studies. Generally, Tier 1, 2 and 3 studies will be required in the DCI, but the need for Tier 2 and 3 data and study protocols will be determined based on the results from Tier 1 studies and other lines of evidence. Appendix 2 contains footnotes that can be used to support DCI tables for registration review.
- Except for the pesticides imidacloprid, clothianidin, dinotefuran, and thiamethoxam, if the registration review DCI was issued before January 1, 2015, it did not contain a request for the suite of new pollinator data identified in Tables 2 and 3 because the EPA first established the need for these studies in the risk assessment framework Guidance for Assessing Pesticide Risks to Bees, published in June 2014. EPA has determined that there are 298 conventional pesticide registration review cases that may need a subsequent pollinator DCI because the initial registration review DCI was issued before January 1, 2015 (255 cases) or the chemical was first registered with the agency between 2008 and the time of issuance of this Process document (43 cases). The specific chemicals are listed in Appendix 3, Table 1.
- Therefore, if exposure to bees is considered relevant based on the pesticide’s use pattern, and the registration review DCI was issued before January 1, 2015, then EPA will complete the risk assessment consistent with the existing schedule and available data. Specifically, agency risk assessors will calculate a risk quotient (RQ) for honey bees based on all available data, including pollinator data that may have been submitted in the absence of a DCI, according to the 2014 Guidance, even if the additional data summarized in Tables 2 and 3 have not yet been submitted.
- If risks of concern are identified, various factors will be considered to determine the most appropriate regulatory determination. First, the EPA will evaluate the likelihood of exposure to bees considering whether the registered uses involve bee-attractive crops (based on the USDA list), whether the directions for use allow application when bees may be present (e.g., application at bloom), whether expected usage in agriculture is likely to lead to problematic pollinator exposure scenarios, and whether suitable measures can be identified to mitigate exposure. As in every other registration decision, the EPA will also consider the benefits associated with the registration action to determine whether those benefits outweigh the risks of adverse effects. In order to facilitate the review and the FIFRA “no unreasonable adverse effects” determination, the EPA may request that the registrant submit additional information including efficacy data on key pest management claims, benefits and user alternatives assessments, and/or hazard comparison data to other registered pesticide alternatives.
- When all of the Tier 1 data are not available to evaluate potential exposure and effects to bees, it may be difficult to develop suitable mitigation measures for some compounds (e.g., systemic insecticides) especially when the use is on an indeterminate blooming plant (e.g., cotton, cucurbits) which is attractive to pollinators.
- After taking public comment on its proposed interim registration review decision, the EPA will consider the comments received and then issue an interim registration review decision that, after consideration of all risks and benefits, may include mitigation measures to address potential risks to pollinators. Depending upon the nature and extent of any required mitigation, the EPA may require, through a separate DCI, the additional pollinator data identified in the 2014 Guidance to adequately inform a useful refinement of risk estimates in the final registration review decision. If the risks can be appropriately mitigated, additional data may not be necessary.
- If the registration review DCI was, or will be, issued after January 1, 2015 then the EPA considered (or will consider) if exposure to bees is relevant to the registration review determination based on the pesticide’s use pattern and the appropriate pollinator studies based on the 2014 Guidance. Registration review DCIs issued after January 1, 2015, generally required the submission of all of the pollinator studies identified in the 2014 Guidance, unless the agency made a determination that a subset of these data would not be needed to complete the re-evaluation of that specific pesticide. As a result, assessments for these chemicals will be based on the pollinator studies and the risk assessment framework as described in the 2016 Guidance on Exposure and Effects Testing for Assessing Risks to Bees. EPA has determined that there are 134 conventional pesticide registration review cases that have considered or will consider the need for pollinator data at the time of the initial registration review DCI. The specific chemicals are listed in Appendix 3, Table 2.
- The EPA expects to complete the first round of registration review docket openings (completing Preliminary Work Plans and Final Work Plans) and issuing registration review DCIs (which will include, as appropriate, additional data necessary to address pollinator risks) for all conventional pesticide cases subject to registration review in 2017.
- At the time of issuance of this Process document, the EPA has determined that there are 70 conventional pesticide registration review cases that have either been cancelled since registration review started or have registered use patterns that do not result in exposure to bees. For these chemicals, the new suite of pollinator data will not be necessary. The specific chemicals are listed in Appendix 3, Table 3 because they have been voluntarily cancelled by their manufacturer or the use pattern of the chemical clearly would not result in potential exposure to pollinators.
- The EPA is aware that there may be practical constraints on laboratory capacity for conducting all of these tests simultaneously given the large number of chemicals in Bin #1 and Bin #2. As a result, the agency believes that it is appropriate to prioritize the submission of studies for those pesticides with the greatest potential for bee exposure and adverse effects on bees. Decisions on when to issue subsequent DCIs for pesticides in Bin #1 will be determined based on a consideration of the following factors:
- The toxicity of the pesticide to bees and/or related taxa;
- The mode of action of the pesticide (i.e., some pesticides are not acutely toxic to adult bees but may be chronically toxic to larval bees based on their mode of action);
- Information regarding bee kill incidents for the pesticide;
- Information indicating the pesticide has been detected in honey bee colonies (e.g., Mullin et al. 2010, Stoner and Eitzer 2012 and USDA 2012);
- Pesticide use patterns with a high potential for contact exposure of bees (e.g., applications at bloom of bee-attractive crops identified through the USDA list);
- Pesticide use patterns that lead to a high potential for oral exposure of bees (e.g., applications at or prior to bloom for systemic pesticides); and
- Pesticide uses on crops that require commercial pollination with managed bees.
- Although the primary mechanism for collecting the bee exposure and effects data needed to develop an updated risk assessment will involve the registration review program, the EPA has also begun to evaluate potential risks to pollinators in an enhanced manner within the context of its registration programs (i.e., registering new active ingredient and new uses of existing chemicals). This transition will occur in two phases. The first phase involves an initial period prior to the codification of the new data requirements, where the EPA will determine whether to require these data on a case-by-case basis as the agency reviews applications for new active ingredients/new uses or will wait to require these data until registration review. The second phase involves the period after which enhanced pollinator data requirements have been codified. In this latter phase, applicants/registrants will be required to submit with applications for registration for a new active/new use which include outdoor uses or the first outdoor use for an existing registration the full suite of laboratory-based pollinator data and pending the outcome of the screening-level assessment possible semi-field and full-field data on bee colonies. Since the EPA is providing early notice through this guidance, and several other means, about its approach to implementing the updated data requirements for pollinators, after promulgation of the final rule, new applications must address all required bee data, without an extended phase in or start-up period.
- Registrants have already begun to develop and submit data which are consistent with the Guidance on Exposure and Effects Testing for Assessing Risks to Bees. Prior to codification of the data rule, the EPA strongly encourages registrants who submit applications for new conventional active ingredients or first outdoor uses of conventional active ingredients to submit the full suite of studies identified in the 2014 Guidance.
- If an application for registration of a new conventional pesticide or the first outdoor use for an existing chemical is or has been submitted to the agency prior to the codification of the data requirements, the EPA will review the submission package and consider it for registration. In that circumstance and relative to the risk assessment for pollinators, the EPA will calculate risk quotients (RQs) for honey bees based on the available honey bee data according to the 2014 Guidance.
- If risks of concern are identified, various factors will be considered to determine the most appropriate regulatory determination. First, the EPA will evaluate the likelihood of exposure to bees considering whether the proposed uses of the registration action involve bee-attractive crops (based on the USDA list), whether the directions for use allow application when bees may be present (e.g., application at bloom), whether expected usage in agriculture is likely to lead to problematic pollinator exposure scenarios, and whether suitable measures can be identified to mitigate exposure. The EPA will also consider the benefits associated with the registration action to determine whether those benefits outweigh the risks of adverse effects. The burden to support an application for registration is always on the registrant. Therefore, registrants are required to provide enough information on the registration action to support a finding of no unreasonable adverse effects. In order to facilitate the review and any no unreasonable adverse effects determinations, the EPA may request that the registrant submit a Public Interest Finding, efficacy data on key pest management claims, benefits and user alternatives assessments, and/or hazard comparison data, on the proposed chemical compared to registered pesticide alternatives.
- When all of the Tier 1 data are not available to evaluate potential exposure and effects to bees, it may be difficult to develop suitable mitigation measures for some compounds (e.g., systemic insecticides) especially when the use is on an indeterminate blooming plant (e.g., cotton, cucurbits) which is attractive to pollinators. If the EPA cannot evaluate the potential exposure and effects to bees, EPA may not be able to make the necessary determination under FIFRA to register the pesticide or the new use.
- For new chemical submissions and first outdoor uses where the EPA determines that the benefits outweigh the predicted risks and registration can therefore occur, new bee data might be requested as a condition of registration if it is deemed likely that additional data could adequately inform a useful refinement of risk estimates. For new active ingredients, the EPA may determine it is appropriate to register under FIFRA 3(c)(7)(C) authority, in part, because EPA had not previously determined these data were necessary and the applicant would not have had time to generate the data. For approval of first outdoor new uses and in consultation with the Office of General Counsel, the EPA may determine it is appropriate to require the bee data conditionally under FIFRA 3(c)(7)(B). In determining whether to grant a conditional registration, the risks to pollinators and the potential to mitigate those risks will be considered. Identified risks, uncertainties resulting from any missing data and the anticipated benefits of the new pesticide will be considered in making any conditional registration decision.
- As with all new active ingredients, as well as other significant use expansion requests, the EPA will also engage the public about its regulatory decisions as described in http://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions. In this process, the EPA takes public comments on a pre-decisional basis about regulatory positions for new chemicals and other significant actions. The EPA will consider the comments received before making final determinations on these actions. This will enable the EPA to engage the public on its approaches and progress in this area.
- Applications submitted after the codification of the data rule will immediately be subject to the new data requirements. Applications for new pesticide ingredients and/or a first outdoor use that are submitted after codification of the final rule without a full set of the Tier 1 data (or alternatively an acceptable waiver request) will be deemed to be incomplete and would fail the screens the EPA conducts for completeness under the Pesticide Registration Improvement Act (PRIA) to determine whether the package meets the necessary data requirements specified in 40 CFR Part 158.
- PRIA contains both an Initial Content Screen and a Preliminary Technical Screen provision that enables the agency to ensure that registration applications are complete and adequately address the data and labeling requirements such that the EPA review teams would be expected to proceed with its regulatory evaluation on that action. If the Technical Screen for a PRIA action identifies missing data which are necessary and required, the EPA will provide that information to the registrant along with a 10-day deadline for resolving that specific defect(s) or missing data. In the event that the registrant does not adequately address the deficiency in the allotted time, the application would be rejected.
- Once the new data requirements are codified in 40 CFR Part 158, registration applications for a pesticide which is already labeled for an outdoor use must contain the Tier 1 bee data, or provide an appropriate waiver rationale as a way of addressing this requirement. Applications that are submitted after codification of the new data requirements without the Tier 1 data will be deemed to be incomplete and fail the completeness screen as previously described in Section 3.2.
- If the application for an additional outdoor use is submitted before the issuance of the final rule amending 40 CFR Part 158, the EPA will review the submission package and consider it for registration. Similar to the process described above for new chemicals and first outdoor uses in the preceding section, the EPA will calculate RQs for honey bees based on the available honey bee data. The EPA may determine, however, that it is not necessary to calculate RQs for honey bees if risk assessments for registered uses adequately cover exposure scenarios expected for the new outdoor use. If the EPA decides that it is necessary to calculate RQs for the new use and if risks of concern are identified based on the available data, the nature of the missing data, the benefits, alternatives, mitigation options, and decision standards under FIFRA will be considered as previously described in Section 3.2. In the interim period before the final rule is issued, registration applications for existing chemicals will be considered under the current data scheme for pollinators. For existing pesticides, which already have an outdoor use, it is anticipated that additional bee data will be, or will have already been required as part of an existing or new registration review DCI or as part of the conditional registration for the new active ingredient.
- Label changes or mitigation measures can occur at any point during an application review or as part of registration review. Implementing changes through the registration review program may avoid users shifting to products that have either not yet adopted mitigation measures or that have not yet been fully evaluated under registration review using the new pollinator data requirements. Notwithstanding the EPA’s preference to use registration review to facilitate an orderly review of these data, if the EPA learns of effects to bees that require more immediate attention, the EPA will take appropriate regulatory action.
- Appendix 1. Flow-Chart for Assessing the Need for Additional Pollinator Data for New Uses/Chemicals and Registration Review.
- Appendix 2. Data Call-in Table Footnotes for Exposure and Effects Studies with Bees
- The following list of footnotes should be considered by OPP risk managers for inclusion in data call-in tables for each of the exposure and effect studies identified below. Estimated time frames for study submission are 12 months for all Tier 1 (laboratory-based) studies and 24 months for colony-level Tier 2 and Tier 3 (semi-field and full field colony-level) studies which include an overwintering component in addition to field residue studies.
- Tier 1 (Laboratory-based Studies)
- 850.3020 Acute Contact Toxicity Study with Adult Honey Bees
- o USEPA. 2012a. “Honey Bee Acute Contact Toxicity” Ecological Effects Test Guidelines OCSPP 850.3020. EPA 712-C-019
- o See also OECD 214: OECD.1998b. OECD Guidelines for the Testing of Chemicals. Test Number 214, Acute Contact Toxicity Test. http://www.oecd-ilibrary.org/environment/test-no-214-honey bees-acute-contact-toxicity-test_9789264070189-en;jsessionid=43gvto47wnue9.delta
- Honey Bee Adult Acute Oral Toxicity
- o See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://www.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oral-toxicity-test_9789264070165-en
- Honey Bee Larvae Acute Oral Toxicity
- o OECD Test Guideline 237 may be used to develop a protocol for this study (OECD. 2013 Guidelines for Testing Chemicals. Honey bee (Apis mellifera) larval toxicity test, single exposure.) See: http://www.oecd-ilibrary.org/environment/test-no-237-honey-bee-apis-mellifera-larval-toxicity-test-single-exposure_9789264203723-en
- Honey Bee Adult Chronic Oral Toxicity
- o OECD has not yet finalized test guidelines for chronic studies, and efforts are underway to develop standardized guidelines for assessing the effects from chronic exposure to adult and larvae in the laboratory. Discussion of the study design elements for the 10-day adult toxicity test can be found in Appendix O of the European Food Safety Authority (EFSA) guidance document: EFSA. 2013. Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees. EFSA Journal 2013;11(7):3295, 266 pp. doi:10.2903/j.efsa.2013.3295.
- Available online at: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2668.pdf
- o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
- Honey Bee Larvae Chronic Oral Toxicity
- o OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance has is being developed, see OECD 2013b. OECD Draft Guidance Document Honey Bee (Apis mellifera) Larval Toxicity Test, Repeated Exposure.
- http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf
- o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
- 850.3030 Honey Bee Toxicity of Residues on Foliage
- o USEPA. 2012b. “Honey Bee Toxicity of Residues on Foliage.” Ecological Effects Test Guidelines OCSPP 850.3030. EPA 712-C-018.
- Tiers 2 and 3 (Semi-field and Full Field Colony-level Studies)
- Semi-field testing for pollinators (tunnel or colony feeding studies)
- o The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.
- o Formal guidelines for semi-field tests do not yet exist; however, information that can help guide the development of either a semi-field tunnel test protocol can be found at OECD 75, see: OECD. 2007. Series on Testing and Assessment Number 75. Guidance document on the honey bee (Apis mellifera L.) brood test under semi-field conditions. Environmental Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO(2007)22. 31-Aug-2007.
- http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2007)22&doclanguage=en.
- o For field-feeding studies see: Oomen et al. 1992: Oomen, P. A. A. DeRuijter and J. Van der Steen. 1992. Method for honey bee brood feeding tests with insect growth-regulating insecticides. Bul OEPP/EPPO Bulletin 22: 613 – 616.
- o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
- 850.3040 Field Testing for Pollinators
- o The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.
- o See information and guidance identified in the EPA documents, (i) USEPA. 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific Advisory Panel for Review and Comment September 11 – 14, 2012. Office of Chemical Safety and Pollution Prevention Office of Pesticide Programs Environmental Fate and Effects Division, Environmental Protection Agency, Washington DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, Health Canada, Ottawa, CN; California Department of Pesticide Regulation; (ii) 2014 Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs United States Environmental Protection Agency, Health Canada Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014.
- http://www2.epa.gov/sites/production/files/201406/documents/pollinator_risk_assessment_guidance_06_19_14.pdf.
- o USEPA. 2012c. “Field Testing for Pollinators.” Ecological Effects Test Guidelines OCSPP 850.3040. EPA 712-C-017.
- o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
- Residues in Pollen and Nectar/Field Residue Analysis
- o Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.
- o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation. The following elements could be considered when developing study protocol(s) for the monitoring of residues in pollen/nectar.
- Consideration of the range of application methods and environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under.
- Consideration of the attractiveness of the selected crop to pollinators
- Consideration of a collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time.
- Consideration of data sufficient to determine whether residues of the active ingredient and/or degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a following planting, and therefore result in potential exposure to pollinators.
- Consideration of the market proportion of the selected target crop(s).
- o A study protocol must be submitted to, and reviewed by the EPA, prior to study initiation.
- Appendix 3. Conventional Chemical Cases Potentially Subject to the Need for Additional Pollinator Data.
- Table 1. Conventional Chemicals Likely to Receive Follow-Up Pollinator Data Call-In (DCI) (case name, case #)
- Chemicals in this table are subject to a DCI that will require the suite of pollinator data identified in the EPA’s 2014 risk assessment framework Guidance for Assessing Pesticide Risks to Bees.
- Shaded chemicals have already begun registration review but did not receive a registration review DCI for various reasons. These cases will be reviewed to determine if use patterns would result in exposure to bees and be subject to the subsequent pollinator DCI.
- Highlighted chemicals are those conventional cases that were first registered between 2008 and the time this Process document was issued and will be reviewed to determine if use patterns would result in exposure to bees and be subject to the subsequent pollinator DCI.
- Based on currently registered use(s) for some chemicals, the likelihood of exposure to bees may be considered low and additional pollinator toxicity testing may not be triggered.
- Table 2. Conventional Chemicals that Received or Will Receive a Registration Review Data Call-In (DCI) after January 1, 2015 (case name, case #)
- Chemicals in this table have already received or will receive a registration review DCI that received consideration of the 2014 Guidance and contains the suite of pollinator data.
- Table 3. Chemicals that will Not Receive a Data Call-In (DCI) Requiring Pollinator Data (case name, case #)
- Chemicals in this table will not receive a subsequent DCI because they either have no exposure potential to bees, have no US registrations, or the pesticide case has been voluntarily cancelled.