Page 1 of 18 May 28 , 2015 

# EPA’s Propos al to Mitigat e Exposure to Bees from Acutely Toxic Pesticide ProductsPage 2 of 18 May 28 , 2015



# Table of Contents

1 Executive Summary

................................ ................................ ................................ ............................... 3

2 Background

................................ ................................ ................................ ................................ ........... 4

3 Problem Statement

................................ ................................ ................................ ............................... 6

4 Desired State

................................ ................................ ................................ ................................ ......... 6

5 Proposed Mit igation Approach and Rationale

................................ ................................ ...................... 8

5.1 General Approach

................................ ................................ ................................ ......................... 9

5.2 Application to sites with bees present under contract for pollination services

......................... 10

5.3 Application to sites that are not under contracted pollination services

................................ .... 11

5.3.1 State and Trib al Managed Pollinator Protection Plans (MP 3 s)

................................ ........... 12

6 Uncertainties

................................ ................................ ................................ ................................ ....... 13

6.1 Non

- acutely toxic insecticides and insect growth regulators

................................ ..................... 13

6.2 Insect Growth Regulators and Fungicide Tank Mixes

................................ ................................ . 14

6.3 Systemic Pesticides and Prolonged Resi dual Toxicity

................................ ................................ . 14

6.4 Indeterminate Bloom

................................ ................................ ................................ .................. 14

6.5 Microbial Pesticides

................................ ................................ ................................ .................... 15

7 Implementation

................................ ................................ ................................ ................................ .. 15

8 Summary

................................ ................................ ................................ ................................ ............. 15
Appendix A

– List of registered active ingredients that meet the acute toxicity criteria

........................... 17
Appendix B

– Proposed Labeling

................................ ................................ ................................ ................. 18Page 3 of 18 May 28 , 2015



# 1 Executive Summary

Today, EPA is proposing additional mandatory pesticide label restrictions to protect managed bees under contract pollination services from foliar applications of pesticides that are acutely toxic to bees on a contact exposure basis. These restrictions would prohibit applications of pesticide products

, which are acutely toxic to bees

, during bloom where bees are known to be present under contract ; these
restricti ons will apply to most insecticides and some herbicides

. Today’s proposed requirements would not supersede existing, more restrictive product use specifications.

EPA is also encouraging the efforts currently made by states and tribes to reduce pesticide exposures through develop ment of locally

- based measures. Specifically, EPA has been working with its state and
tribal partners to develop Managed Pollinator Protection Plans (MP 3 s). Such plans were discussed in the June 2014, Presidential Memorandum 1 (th e Memorandum or directive) and the National Strategy to Promote the Health of Honey Bees and Other Pollinators 2 (the Strategy) which identifies public/private partnerships as one means of addressing pollinator declines. These MP 3 s would include local and customizable mitigation measures to address certain scenarios that can result in exposure to pollinators.

EPA will monitor the success of these plans in deciding whether further label restrictions are warranted.

Today’s proposal addres ses only acute exposure to pesticides from foliar applications under specific
conditions. While the proposed mitigation focuses on managed bees under contract pollination services, EPA believes that in protecting managed bees in these circumstance

, these measures w ould
also protect native solitary and social bees that are also in and around treatment areas. Moreover, EPA recognizes t here are concerns associated with potential exposure to chemicals that are not classified as acutely toxic by contact , inclu ding chemicals used in combination which may result in enhanced toxicity,
and crops which incorporate pesticide residues in pollen/nectar. Future EPA actions will address these

situations. EPA will continue to conduct chemical

- specific risk assessment s f or bees and will consider
additional product

- specific mitigation as needed in the Office of Pesticide Program’s (OPP ’s ) registration and registration review programs

.

T oday’s proposal, as well as EPA’s support for development of state and tribal MP 3 s , is consistent wi th the President’s directive and the National Strategy to Promote the Health of Honey Bees and Other Pollinators, which addresses the multiple factors affecting honey bees and pollinator health. The Strategy explains the need to expand f e deral efforts to reverse pollinator losses and calls for the development of new public

- private partnerships across various sectors (state, tribal and local
government s , industry, and non

- governmental organizations) to reverse pollinator losses and restore populations to healthy levels.

1 White House. 2014. Presidential Memorandum Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollin ators. Memorandum for Heads of Executive Departments and Agencies. June 20, 2014. http://www.whitehouse.gov/the

- press

office/2014/06/20/presidential

- memorandum

- creating

- federal

- strategy

- promote

- health

- honey

- b

2 White House. 2015. N ational St rategy to Promote the Health of Honey Bees and Other Pollinators . May 19, 2015. https://www.whitehouse.gov/sites/default/files/microsit es/ostp/Pollinator%20Health%20Strategy%202015.pdfPage 4 of 18 May 28 , 2015



# 2 Background

EPA has taken steps , starting with the development of improved scientific tools to assess risks, to manage potential risks from pesticides to pollinators. EPA has routinely required toxicity tests with
hon ey bees and has used these data as a surrogate for assessing risks to terrestrial invertebrates in general

. I n recent years there has been increasing uncertainty regarding whether these acute toxicity data are adequate to evaluate the role that pesticides play i n pollinator declines . Consequently, EPA began to explore whether a broader suite of studies w as needed to evaluate potential risks to bees. In response, EPA, Health Canada’s Pest Management Regulatory Agency (PMRA), and the California Department of Pest icide Regulation (CDPR) develop ed a harmonized risk assessment framework that

was presented to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) in 2012 3

. After considering the SAP’s advice, t he EPA now has formalized its scientific process for quantifying potential risks to bees 4

. D ata required for the risk assessment framework
informs EPA risk assessors of the potential for adverse effect s to individual bees

, as well as bee colonies

, from exposure that may result from the labeled use of a pesticide . This framework is now an integral part of the registration a nd r egistration r eview programs

. L aboratory and field

- based tests are also being developed for additional species of solitary and social bee s 5 6

.

P esticide labels have routinely included bee advisory statements as outlined in 40 CFR 156.85(b)(5) 7 and
the Label Review Manual 8 based on data from a cute contact toxicity tests ( e.g ., OCSPP Guideline
850.3020 9 ) and studies on the toxicity of residues on foliage (OCSPP Test Guideline 850.3030 10 ) using honey bees

. T he D irections for U se section s of the label of some products have also included more specific restrictions to protect pollinators, based on EPA’s analysis of pot ential exp osure and effects of the particular pesticide

. However, stakeholders have continued to emphasize the need for greater clarity and stronger protections 11 12

.

3 USEPA. 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific Advi sory 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 Managem ent Regulatory Agency, Health Canada, Ottawa, CN; Califo rnia Department of Pesticide Regulation http://www.epa.gov/oppfead1/cb/csb_page/updates/2012/sapmtg

- sept.html

4 USEPA. 2014 a . 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/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

5 ICP

- PR. 2012. Proceedings of the 11 th International Symposium on the International Commission for Plant

- Pollinator Relationships (ICP

- PR) Bee Protection Group. Wageningen, Netherlands, November 2

– 4, 2011. Published in P.A. Oomen and H. Thompson eds, Julius K ü hn Archiv
437.

6 ICP

- PR. Proceedings of the International Commission for Plant

- Pollinator Relationships (ICP

- PR) Bee Protection Group 12 th International Symposium Hazards on Pesticides to Bees. Ghent, Belgium. September 15

– 17, 2014. In preparation

7 CFR. 2014. Code of Federal Regulations. Title 40 (Protection of Environment), Chapter 1 (Environmental Protection Agency) Subchapter E (Pesticide Programs) Part 156 (Labeling Requirements for Pesticides and Devices) Subpart E (Environmental Hazard and Precauti onary Statements) §156 .85 (Non

- target organisms) http://www.ecfr.gov/cgi

- bin/text

idx?SID=511673be0c81c693acae95773c696225&node=se40.24.156_185&rgn=div8

8 USEPA. 2012. Label Review Manual. http://www.epa.gov/oppfead1/labeling/lrm/

9 USEPA. 2012 a . Ecological Effects Test Guidelines. OCSPP 850.3020 Honey Bee Acute Contact Toxicity. EPA 712

- C

- 019. Janu ary 2012. http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm

10 USEPA. 2012 b . Ecological Effects Test Guidelines OCSPP 850.3030 Honey Bee Toxicity of Residues on Foliage. EPA 712

- C

- 018. January 2012. http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm

11 USDA. 2013 b . Report on the National Stakeholders Conference on Honey Bee Health. Natio nal Honey Bee Health Stakehold er Conference Steering Committee. October 17

– 17, 2012. http://www.usda.gov/documents/ReportHoneyBeeHealth.pdf

12 Ibid USEPA 2014 bPage 5 of 18 May 28 , 2015

In August 2013, EPA develop ed new label language for certain neonicotinoid insecticides 13 in response to concerns from various stakeholder groups that these compound s represented a particular hazard to managed bees

. At that time

, EPA rec ognized that different exposure scena rios following foliar applications of the neonic o tinoid pesticides war rant ed different degrees of mitigation . In one scenario (Scenario 1)

, large numbers of managed bees may be directly exposed to pesticide spray because they
have been intentionally placed with in or adjacent to the area being treated ( i.e

., under a contract to pollinate a crop). In a second scenario (Scenario 2) , managed bees may be direct ly exposed to pesticide spray via off

- site pesticide drift, or because the bees are within forage range of the application area

.

T he label language developed 14 for the neonicotinoid pesticides reflected the likelihood of different

exposure s for managed bees in S cenario 1 and S cenario 2 . Given the intentional placement of colonies into or adjacent to the application area , the managed bees under contract pollination servi ces (Scenario 1) are nearly certain to be exposed if an application is made. Consequently, to protect managed bees under contract pollination services at the application site, EPA prohibited application of neonicotinoid products while bees are foraging an d until flowering is complete with the single exception of 48

- hour
notification to the beekeepers prior to foliar applications . For managed bees not under contra ct pollination services (Scenario 2) , EPA prohibited application while bees are foraging and u ntil flowering is complete but with more exceptions to enable growers and beekeepers to reduce potential exposure to bees while affording growers some flexibility to apply pesticides for crop protection

. EPA concluded, consistent with the statutory mandate under FIFRA 15 , that these modifications of the neonicotinoid labels reduced the risks to bees in a manner that improved the overall balance of risks and benefits from using these pesticides.

Fo llowing issuance of the August 2013 letter 16 directing label changes for neonicotinoid p roducts, EPA
announced its intention to follow a similar approach with other pesticides that are applied to the foliar surfaces of plants and are acutely toxic to bees on contact
, i.e., those pesticides with an acute ly leth al dose to 50% of the bees tested ( abbreviated LD 50 ) of less than 11 micrograms per bee (<11 μ g/bee)

, based on either t he acute contact toxicity test following OCSPP Guideline 850.3020 17 or its equivalent test in Europe ( i.e ., OECD 214 18 ) . These acute toxicity data

, which have been routinely required for pesticides, are frequently corroborated with bee kill incident data reported to EPA

. The use of incident

13 Neonicotinoids are a class of insecticides with a common mode of action that affects the central nervous system of insects, causing paralysis and death.

14 USEPA. 2014 c . New Labeling for Neonicotinoid Pesticides. http://www2.epa.gov/pollinator

- protection/new

- labeling

- neonicotinoid

- pesticides

15 The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides feder al control of pesticide distribution, sale and use. All pesticides used in the United States must be registered (licensed) by EPA. For more information, see: http://www.epa.gov/agriculture/lfra.htm l

16 USEPA. 2013 c . Memorandum to Registrants of Neonicotinoid Products on Pollinator Protection Labeling for nitroguanidine neonicotinoid products. http:// www2.epa.gov/sites/production/files/2013

- 11/documents/bee

- label

- info

- ltr.pdf

17 Ibid USEPA. 2012 a

. 18 OECD. 1998. 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_97892640701 89

- en;jsessionid=43gvto47wnue9.deltaPage 6 of 18 May 28 , 2015

data as a line of evidence in evaluating the potential risks associated with pesticides is disc ussed in associated guidance documents 19 20 21 22

.



# 3 Problem Statement

Pesticides

, particularly those intended to control insect pests

, can harm bees . P esticides have also be en identified as one among multiple factors negatively impacting pollinator health

, i ncluding declines in honey bees specifically 23 24

. Through discussions with various stakeholders and based on reported bee
kill incidents contained within the EPA Incident Data System ( IDS ) and the Ecological Incident Information System ( E IIS ) database s for a large number of pesticides that have been classified as moderately or highly toxic to bees on an acute exposure basis

, EPA has concluded that additional

measures would provide better protect ion for bees from acute contact exposures. EPA is also aware

t hat there are often inadequate relationships and a lack of suitable communication mechanisms in place
at the local level between and among beekeepers, growers

, and pesticide applicators to assure that pesticide s needed to protect crops can be applied in wa ys that are not ha rmful to bees. Therefore,
clear er and more consistent mandatory label restrictions could reduce the potential exposure t o bees
from pesticides categorized as acutely toxic to bees, i.e ., those compounds with an acute contact
LD 50 <11 μ g/b ee , in situations where large numbers of managed bees are intentionally positioned under

contract in or close to pesticide application sites

. In addition, EPA believes that state and tribal managed pollinator protection plans provide a means of developing localized and customized mitigation measures to reduce exposure of bees to pesticides in certain scenarios.



# 4 Desired State

A common theme from discussions about pesticides and pollinators with one of EPA’s federal advisory committees, the Pesticide Program Dialogue Committee (PPDC) 25 , and with other stakeholder groups 26
has been the need for clearer communications between growers/applicators, beekeepers and
enforcement authorities. Stakeholders have indicated that more direct lines of communication are

19 USEPA 2011. Memorandum from Donald J. Brady, Director on Guidance for Using Incident Data in Evaluating Listed and Non

- listed Species under Registration Review. http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/terrestrial_biology_tech_team/honeybee_data_interim_g uidanc e.pdf

20 Ibid USEPA 2004

21 Ibid USEPA 2012

22 Ibid USEPA 2014 a

23 Ibid USDA 2013

24 vanEngelsdorp, D., J. D. Evans, C. Saegerman, C. Mullin, E. Haubruge, B. K, Nguyen, M. Frazier, J. Frazier, D. Cox

- Foster, Y. Chen, R. Underwood, D. R. Tarpy, J. S. Pettis. 2009. Colony Col l apse Disorder: A Descriptive Study. PLoSONE 4(8): e6481. Doi:10.1371/journal.pone.0006481 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0006481

25 A description of the USEPA Pesticide Program Dialogue Committee Pollinator Protection Workgroup can be found at http://www2.epa.gov/pesticide

- advisory

- committees

- and

- regulatory

- partners/pesticide

- program

- dialogue

- committee

26 Ibid USDA. 2013 b

.Page 7 of 18 May 28 , 2015

neede d at the local level. Groups such as the State FIFRA Issues Research and Evaluation Group (SFIREG 27 ) have echoed these concerns.

As directed by the Presidential Memorandum and described in the Strategy

, EPA is working with state s and tribes to increase the communication among all local stakeholders that have a part in protecting bees from exposure to pesticides and to promote implementation of integrated pest management (IPM 28 )

. The EPA see s collaboration on M anaged P ollinator P rotection P lans ( MP 3 s) as a m eans to enhance communication and risk mitigation

. The purpose of a n MP 3 with respect to pesticide use is to utilize local expertise to identify customizable solutions to effectively mitigate risk from acutely toxic pesticides to managed bees 29

.

EPA is aware of concerns that approach es to assess and mitigate risk to managed honey bees may not be protective of un managed bees ( i.e ., “native” or “wild” bees)

. EPA’s ecological risk assessment
framework documents 30 31 32

, discuss the uncertainties associ ated with the use of surrogate species ( e.g ., the use of the honey bee ) for determining the potential for adverse effects to untested insect pollinator species as a result of exposure to pesticides. Using the honey bee as a surrogate species is
consistent with both its established use in risk assessment and the currently available science. EPA
believes that the approach taken to protect managed honey bees will also decrease the risks to wild
bees since pesticides are generally likely to affect w ild bees and managed bees in a s imilar manner. Moreover , EPA believes that additional measures to protect managed bees will provide protections to other pollinators as well. For example, measures designed to ensure that applications are only made when managed bee s are not likely to be foraging will also be effective for other pollinators with similar foraging behavior and will reduce potential exposure to wild bees as well

. T his effort is also consistent
with the Presidential directive and the Strategy which seek s to promote the health of honey bees and other pollinators to “ ensure the sustainability of our food production systems, avoid additional economic impact on the agricultural sector and protect the health of the environment .” 33

27 The State FIFRA Issues Research and Evalu a tion Group (SFIREG) is comprised of State, Federal, Tribal and Association representatives, and meets periodically to identify and discuss issues related to pesticides that affect the states /tribes

. A description of SFI R EG can be found at the following link: http://www.aapco.org/sfireg.html

28 Integrated Pest Management (IPM) programs use current, comprehensive information on the life cycles of pests and their inter action with the environment. This information in combination with available pest control methods, is used to manage pest damage by the m ost economical means while minimizing potential hazards to people, property and the environment.

29 Managed bees inclu de those for purposes of pollination services and honey production (i.e., honey bees, bumble bees, alfalfa leaf cutters, and blue orchard bees). Managed bees may be managed by hobbyists or commercial beekeepers.

30 Ibid USEPA 2004

31 Ibid USEPA 2012

32 Ibid USEPA 2014 a

33 Ibid White House. 2014Page 8 of 18 May 28 , 2015

Over the last few years, s ev eral states, such as California 34 35 , Colorado 36 , Florida 37 , Mississippi 38

, North
Dakota 39 and others

, have independently developed state

- specific pollinator protection plans to enhance communication between stakeholders ( e.g ., beekeepers, growers, applicators) which in turn is intended to reduce the potential exposure to bees from pesticides

. In some cases, states have completed rule

- making ( e.g. , Iowa 40 and California 41 ) which has established mandatory mitigation measures where beekeepers must be notified in advance of applications or applications may not take place during times when bees are likely to be foraging on the treated crop. These states have developed these plans in response to the needs of the growers and beekeepers of th eir state s

. The plans are aimed at identifying measures to mitigate potential exposure to bees from pesticides while providing flexibility to growers and beekeepers. A common element of each of the plans has been that they are founded on stakeholder engagement and consensus building; therefore, th e state pollinator plans foster communication and collaboration between growers and the beekeepers. Feedback from state lead agencies

, which have developed pollinator pr otection plans

, indicates that the plans have been effective in increasing communication and mitigating risk . This result is evident from decreased numbers of bee kill incident reports, an increase in the number of bee hives registered in apiary registrie s, and an increased number of requests for advice when landowners cannot reach beekeepers. Although there are areas of commonality in the state

- specific plans

, they take many different approaches , since each
reflects local conditions and local solutions.

One eleme nt of the Strategy is for EPA to engage with states and tribes and others on the development of pollinator protection plans. EPA’s initial discussions about pollinator protection plans have been with

co

- regulators through the SFIREG, the Associa tion of American Pesticide Control Officials (AAPCO 42 ) and the Tribal Pesticide Program Council (TPPC). These discussions have led to the realization that additional guidance is needed for states and tribes in the development of such plans

, and state lead agencies are developing such guidance . As discussed in section 5.3.1, a draft guidance document has been circulated for wider review by states and w ill be made available following in corporation of their feedback.



# 5 Proposed Mitigation Approach and Rationale

EPA is proposing label changes to provide additional protections to managed bees under contract pollination services and is encouraging local solutions in the form of state and tribal MP 3 s for managed

34 California Department of Food and Agriculture. 2014. Bee and Beehive Information. http://www.cdfa.ca.gov/plant/PE/interiorexclusion/bees. html

35 California Food and Agricultural Code Section 29040

- 29056 http://www.leginfo.ca.gov/cgi

- bin/displaycode?section=fac&group=29001

- 30000&file= 29040

- 29056

36 Colorado Environmental Pesticide Education Program

. Pollinator Protection 2013. http://www.cepep.colostate.edu/Pollinator%20Protection/index.html

37 Florida Department of Agriculture and Consumer Services. 2014. Florida Bee Protection. http://www.freshfromflo rida.com/Divisions

Offices/Agricultural

- Environmental

- Services/Consumer

- Resources/Florida

- Bee

- Protection

38 Mississippi Honeybee Stewardship Program. 2014 http://www.msfb.o rg/public_policy/Resource%20pdfs/Bee%20Brochure.pdf

39 North Dakota Department of Agriculture. 2014. North Dakota Pollinator Plant. A North Dakota Department of Agriculture Publi cation. http://www.nd.gov/ndda/files/resource/NorthDakotaPollinatorPlan2014.pdf

40 Iowa Department of Agriculture. Advancing Iowa’s Agricultural Interests. See Iowa Administrative Code Chapter 21

- 45.31(206). http://www.iowaagriculture.gov/horticulture_and_farmersmarkets/sensitivecropdirectory.asp

41 California Department of Pesticide Regulation. Food and Agriculture Code Section 29040

- 2905 6. http://www.leginfo.ca.gov/cgi

bin/displaycode?section=fac&group=29001

- 30000&file=29040

- 29056

42 APPCO. 2014. Association of American Pesticide Control Officials. http://www.aapco.org/Page 9 of 18 May 28 , 2015

bees not under contract services

. EPA will work with state and tribal lead agencies to facilitate adoption
of and compli a n ce with MP 3 s that reflect public stakeholder processes. EPA will monitor the success of these plans in mitigating risk to bees from acutely toxic pesticides on an ongoing basis and deter mine
whether additional EPA action is warranted. In the following section

, the scope of these changes is
discussed.



## 5.1 General Approach

EPA continues to believe that bees are likely to be exposed from application of acutely toxic pesticides

, although the ce rtainty such exposure will occur differs in ways that warrant different approaches to risk mitigation. When managed bees are on site under contract to pollinate the crop, which can also be the application area, relatively large numbers of bees are intenti onally placed in or near the crop area

, i.e

., managed bees are a direct input to the production of the crop . Consequently, large numbers of bees are likely to be directly exposed to pesticide spray during a pesticide application

. Underscoring the potential magnitude of colonies that may be present at an application site requiring contracted pollination services, t he EIIS database contains reports from commercial beekeepers of adverse effects to roughly 20,000 colonies contracted to support pollination services in almonds and roughly 2,000 colonies contracted to support pollination services in blueberries purportedly due to pesticide applications made while large numbers of colonies were in or near treatment areas in 2014 alone. In addition, EPA has heard claims of tens of thousands more colonies in almonds and blueberries being
affected in 2014 . (EPA notes

, however, that it is not clear whether these adverse effects were acute or chronic with respect to the timing of pesticide appl ications relative to when bees may have been actively foraging, since those incidents have not been formally reported to EPA and/or investigated by state lead agencies responsible for enforcing compliance with pesticide label restriction s. ) Although
the E IIS contains numerous bee kill incident reports from beekeepers who were not providing contracted pollinations servi ces at the time of the incident

, those individual reports have not been of
similar magnitude ( i.e ., simultaneously impacting thousands of hi ves) as those reported by commercial beekeepers providing contracted pollinator services

W hen managed bees are not providing pollination services at a site that is being treated with a pesticide, they may still be direct ly exposed because the application site is within forage range of those
bees

. In such circumstances, EPA considers the likelihood of exposure to large numbers of managed
bees to be somewhat lower since large numbers of colonies are not intentionally placed within or near the treatment area. EPA believe s that the likelihood of exposure between the two scenarios is significant ly different and that

, given their proximity to the treated crop, large numbers of managed bees under contract pollination services are nearly certain to be exposed and potentially adversely
affected if an application with a n acutely toxic pesticide is made. Further, in evaluating these t wo scenarios (where bees are brought on site under contract vs. when bees may be present but the grower

may not derive a benefit from t he presence of bees on his or her property), EPA believes it is also appropriate to consider the benefit or lack of benefit that bees are providing to the grower in determining the nature and scope of mitigation. Consequently, EPA is proposing different m itigation approaches for the se two scenarios ; however, EPA will continue to evaluate the efficacy of these efforts
to determine whether additional action is needed

.Page 10 of 18 May 28 , 2015

The proposed restrictions outlined in the following sections would not replace more restrictive
chemical

- specific , bee

- protective pro visions ( e.g ., pre

- bloom restrictions) that may already be on a product label. For example, based on chemical

- specific assessment, EPA may have determined that the persistence of toxic residues in pollen an d nectar require s that an application be prohibited for a period of time prior to bloom , in addition to prohibitions during bloom, in order to ensure that residues in pollen and nectar be below levels of concern when bees are likely to be exposed ( i.e. , a pre

- bloom
restriction )

. T hese more restrictive prohibitions would not be superseded by the proposed mitigation
described below. As discussed previously, EPA will continue to conduct comprehensive chemical

specific risk evaluations and take appropriate ac tion to further mitigate identified risks through the registration and r egistration r eview programs based on the available science.



## 5.2 Applic ation to sites with bees present under contract for pollination services
As discussed above, contracted pollination services result in a heightened exposure potential where a large number of honey bee colonies are intentionally placed at a use si te, and the application of a toxic pesticide in this scenario is near ly certain to result in adverse effects to pollinators

. Although t h e likely

outcomes are c ounter

- productive for b oth the beekeeper (l os s of honey bee stock) and the grower ( diminished pollination services )

, many beekeepers and growers have not found ways to avoid such

outcomes

. Consequently, EPA believes that strong regulatory measures should be in place for the
contracted service scenario to mitigate these potential problems . Therefore

, EPA proposes the following:

 T o prohibit the foliar application of acutely toxic products during bloom for sites with bees on

site under contract , unless the application is made in accordance with a government

- declared public health response

. ( See proposed label language in Appendix B

. )

There would be no other exceptions to the bloom prohibition in the contracted

- services sce nario.
Current neonic o tinoid product label s include a 48

- hr notification exception to the bloom prohibition

. However, as part of this mitigation proposal, the 48

- hr notification exception for crops under contracted pollination services during bloom for al l neonicotinoid product labels w ould be removed.

The proposed mitigation applies to all products (FIFRA Section 3 and 24(c) Special Local Need registrations and where applicable Section 18 emergency exemption petitions * ) that have:

(1) liquid or dust for mulations as applied; and,

(2) foliar use directions for use on agricultural crops with bees onsite under contract for pollination services ; and,

(3) active ingredient(s) that have been determined via testing to have an acute contact toxicity
value less t han 11 micrograms per bee (LD 50 <11 μg/bee)

. The active ingredients that meet this criterion are listed in Appendix A. EPA will also consider as a line of evidence those active ingredients that have resulted in bee kill incidents that were investigated and determined to result from the proper use ( i.e ., were not the result of a misuse) of a product.

*depending on the nature of the emergency for which a Section 18 petition has been submitted, the at

- bloom restriction may not apply. This determination will be reached on a case

- by

- case evaluation.Page 11 of 18 May 28 , 2015

The mitigation measures proposed for when bees are present under contract pollination would not apply to applications made in support of public health such as use for wide area mosquito control. EPA recognizes that a wide area mosquito control application can impact large numbers of bees if the application co

- occurs in areas with pollinator

- attractive plants; however, such applications utilizing products classified as acutely toxic to bees are used to protect p ublic health through mosquito
abatement

. Also, EPA encourages p ollination service contracts established between grower s and beekeepers that
take into account the increased likelihood of bee colony exposure by including provisions to ensure that
colonies will be protected and pollination services secured. If EPA receives evidence during the public comment period and /or through outreach at stakeholder meetings that such contract provisions are
common or that there are other effective and mutually agreed up on stakeholder ( i.e.

, beekeeper

- to

grower) practices indicat ing that application of acutely toxic pesticides is not of risk concern for bee s under contract

, then EPA will consider th is evidence in determining whether this scenario needs the mitigation indicated in the proposed language

.



## 5.3 Application to sites that are not under contract ed pollination services

EPA believes that managed bees not under contracted services (and other unmanaged bees) may also
be exposed to acutely toxic pesticides when they ar e within forage range of the application site. W hile pesticide exposure under th is scenario is possible, it is less certain than in situations where a pesticide is applied to a site when large numbers of managed bees have intentionally been positioned at the site for the purposes of providing pollination services

. EPA believes that the lower likelihood of exposure for large numbers of managed bees in this scenario may warrant, in the future, a more flexible approach toward mitigation such as that afforded by state or tribal M anaged P ollinator P rotection P lan s (MP 3 s)

. Further, feedback provided by multiple stakeholder s ( including growers, applicators, beekeepers

, and state lead agencies ) indicate s that there is a wide range of local conditions which milita te against a single regulatory approach to providing protections for non

- contracted managed bees . Many

, however, have recognized that the success of pollinator protection efforts will depend on clear communication among affected stakeholders to design eff ective, localized approaches.

Accordingly, E P A will encourage states and tribes to develop MP 3 s that are effective in reducing the likelihood of bees being present in the treatment area at the time a pesticide application is to be made

. EPA will work wit h state and tribal lead agencies to facilitate adoption of and compliance with MP 3 s that reflect local agronomic practices

. T his can be best achieved through state or tribal MP 3 s which results
from a public stakeholder process. EPA will monitor success of these MP 3 s in mitigating risk to bee s from acutely toxic pesticides on an ongoing basis and determine whether additional EPA action is
warranted. Therefore, for managed bees not under contact pollination services, no further changes to product labels, including the neonicotinoid pesticides, are proposed at this time.Page 12 of 18 May 28 , 2015

5.3.1 State and T ribal M anaged P ollinator P rotection P lans (MP 3 s) Through discussions with the PPDC

, AAPCO

, and SFIREG

, EPA recognizes that several states ( e.g

. , California 43 44

, Colorado 45

, Florida 46 , Mississippi 47 , and North Dakota 48 ) have developed MP 3 s by productively engaging stakeholders within their respective states. These plans serve as examples of
effective collaboration between stakeholders at the local level that can lead to broader awareness of needs and increased cooperation between stakeholders to reduce pesticide exposure for bees while maintaining the flexibility to protect crops. The common element in these plans has been the increased
communication between stakeholders

, and an ecdotal reports from the stakeholder groups suggest that the plans are effective at increasing communication and cooperation

.

The EPA is generally promoting the development of state and tribal MP 3 s that cover use of acutely toxic pesticides sites where there are no bees onsi t e under contract pollination services ; however, the scope of such plans is not limited to a specific scenario

. States and tribes have the flexibility to determine the scope of an MP 3 that best responds to pollinator issues in their region. For example, the scope c ould
include applications to crops

, and commercial applications to ornamentals in commercial , public, and residential settings , and other scenarios

. SFIREG has drafted guidance for states to consider in developing MP 3 s , which identifies several elements for establishing a framework for communication and cooperation between beekeepers and growers and reducing pesticide exposure for managed bees. Tribes are also encouraged to consider this guidance in developing the ir own MP 3 s , as appropriate. In general, these elements include a public stakeholder participation process for the development of a MP 3 to encourage local solutions based on improved communication and cooperation ; a method for growers/applicators to know if there are managed bees near treatment sites, and to identify and contact beekeepers prior to application that will enable the grower/applicator to communicate about any planned treatments and how best to protect the colonies ; inclusion of best management practices that both the grower/applicator and beekeeper can undertake to limit exposure of the managed bees to the proposed pesticide application ; a clear defined plan for public outreach to promote robust adopti on of the plan; a process to periodically review and modify the plan as needed ; and a mechanism to measure the effectiveness of the managed pollinator protection plan. In addition, other recommendations are included in the guidance document for considerat ion in developing MP 3 s

. This draft guidance document has been circulated by SFIREG for wider review by

states and is , therefore, subject to change . The final guidance document is expected to be made available following incorporation of their feedback.

While EPA’s proposed label statement would address risks to managed bees present at a site under

contract for pollination services , s tate and tribal MP 3 s may address pesticide

- related risks to all pollinator s , including managed bees, whether or not they ar e present under a contract, as well as wild pollinators. As noted earlier though, the scope of state and tribal MP 3 s is not limited to a particular

43 California Department of Food and Agriculture. 2014. Bee and Beehive Information. http://www.cdfa.ca.gov/plant/pollinators/index.html

44 California Food and Agricultural Code Section 29040

- 29056 http://www.leginfo.ca.gov/cgi

- bin/d isplaycode?section=fac&group=29001

- 30000&file=29040

- 29056

45 Colorado Environmental Pesticide Education Program

. Pollinator Protection 2013. http://www.cepep.colostate.edu /Pollinator%20Protection/index.html

46 Ibid Florida Department of Agriculture and Consumer Services. 2014

. 47 Ibid Mississippi Hon eybee Stewardship Program. 2014.

48 Ibid North Dakota Department of Agriculture. 2014.Page 13 of 18 May 28 , 2015

scenario for managed bees nor would such plans be limited to agricultural practices but could exten d to a broader number of pollinating species and habitats. EPA has worked collaboratively with the U.S. Department of Agriculture and Michigan State University, as well as consulted published sources 49 50 51

, to identify plants that are pollinator attractive and which require managed pollination services. The list of pollinator

- attractive plants is based in part on those plants contained in the European Food Safety Authority ( EFSA ) guidance for assessing risks of pesticides to bees 52 ; however, USDA has include d a broader number of plant species in its assessment and has provided references to support the attractiveness classification. Based on the list, most crops categorized as attractive to native bees are attractive to honey bees as well; EPA recognizes tha t there are exceptions ( e.g ., tomatoes). States and tribes are encouraged to consider this list of pollinator

- attractive plants when it becomes available for developing their MP 3 s

.



# 6 Uncertainties

While the intent of the proposed label changes and state a nd tribal MP 3 s is to reduce exposure of managed bees to pesticides that are acutely toxic on contact , uncertainties remain regarding chemicals that may not fall within the domain of the propos al . These uncertainties are discussed below.



## 6.1 Non

- acutely toxic insecticides and i nsect growth regulators
EPA recognizes that in addition to causing acute lethal effects, pesticides may cause sublethal chronic
effects and effects to insect pollinators at various life stages and at various levels of biological organization (individual and colony

- level). Specifically, non

- acutely toxic insecticides such as insect growth regulators (IGR s ) generally target early developmental stages ( e.g ., larva e , pupa e ) and have varying degrees of specificity to target pest species. The determination of whether or not a specific IGR will have activity on honey bees and non

- Apis pollinator species needs to be made on a chemical

- specific basis. For example, EPA has a full suite of effects data for methoxyfenozide, a chemical which mimics the molting hormone ecdysone, and these data show that the chemical does not adversely affect larval and adult honey bees, either at the individual level or at the whole colony level. How ever, there are preliminary data for other IGRs ( e.g ., diflubenzuron) which suggest possible adverse effects to honey
bee larval and pupal development. As discussed previously, t o address these concerns, EPA will continue to require a suite of effect s and residue studies, conduct comprehensive chemical

- specific risk evaluations according to the Guidance for Assessing Pesticide Risks to Bees

, 53 and take appropriate action to further mitigate identified risks through the registration and registration review p rograms based on the available science.

49 McGregor SE, 1976. Insect pollination of cultivated crop plants. Agricultural Handbook No. 496. Ed USDA Agricultural Research Service W, D.C,
USA.

50 Free JB. 1993. Insect Pollination of crops, 2 nd edn. Academic Press: London, UK.

51 Delaplane, K. S. & Maye r, D. F. (2000). Crop Pollination by Bees.

– New York, Oxon (CABI Publishing).

52 European Food Safety Authority, 2013. EFSA Guidance Document on the risk assessment of plant protection products on bees ( Apis mellifera

, Bombus spp. and solitary bees). Appe ndix D. EFSA Journal 2013; 11(7):3295, 266 pp., doi: 10.2903/j.efsa.2013.3295.

53 Ibid USEPA 2014Page 14 of 18 May 28 , 2015



## 6.2 Insect Growth Regulators and Fungicide Tank Mixes
EPA is also aware of concerns regarding the potential effects to honey bee larvae and queen development reported in connection with bee incidents following tank mix ed applications of certain fungicides with insecticides (including IGRs that are not acutely toxic to adult bees ) . Field reports from beekeepers allege that applications of these tank mixes during almond bloom are having colony

- level effects. However, th ere are also beekeepers reporting little to no effects on bees located close to the sites of tank

- mixed applications in question. Additionally, EPA is aware of research that is being conducted to quantify the level of interaction between some IGRs and som e fungicides 54 55 . The research to date is limited and specific to diflubenzuron (Dimilin®) and a subset of fungicides ( e.g ., boscalid and pyraclostrobin ( Pristine® ) ), but this research has shown no synergistic effects at environmentally relevant concentrations. Additional research to evaluate the interaction between Dimilin® and other fungicides ( e.g ., propiconazole, Tilt® and iprodione, Roval®) and other IGRs ( e.g ., methoxyfenozide, Intrepid®) at environmentally relevant concentrations is under way 56 . EPA will continue to evaluate the open literature as part of the registration and registration review programs and may require additional testing on specific IGR

- fungicide combinations to address specific uncertainties identified in the open literat ure and through reported incidents. Additionally, EPA requests that additional scientific information regarding the effects of tank

- mixed IGRs and fungicides be submitted in response to this proposal.



## 6.3 Systemic Pesticides and Prolonged Residual Toxicity EPA recognizes the concern surrounding systemic pesticides and those with prolonged residual toxicity. Systemic pesticides that have prolonged residual toxicity may not be adequately addressed by the proposed mitigation discussed in this proposal. When a pplied using methods other than foliar treatments ( e.g., soil, seed treatment, and tree injection applications)

, systemic pesticides and/or pesticides with prolonged residual toxicity may result in residues in pollen and nectar at levels that can impact be es and hive health. However, the likelihood of this occurring is highly dependent on the specific properties of the pesticide ( i.e. , the degree to which the pesticide is transported in the plant, the persistence of the pesticide residues, and the levels a t which lethal and non

- lethal effects occur). As discussed previously, to address these concerns, EPA will continue to require a suite of effects and residue studies, conduct comprehensive chemical

- specific risk evaluations according to the Guidance for
A ssessing Pesticide Risks to Bees 57 , and take appropriate action to further mitigate identified risks through the registration and registration review programs based on the available science.



## 6.4 Indeterminate Bloom

EPA understands that there are some flowerin g crops and ornamentals that have an indeterminate period of bloom

, i.e

. , t he se crops flower, set fruit and continue to flower throughout the year , and that for these crops bees are present under contract for pollination services for extended periods of
ti me

. Examples of indeterminate blooming crops which involve commercial pollination services include: cucurbits, strawberries, etc

. EPA recognizes that the proposed prohibition on application of acutely toxic pesticides during the time when bees are present under contract may cause significant issues for

54 DeGrandi

- Hoffmann, G., Y. Chen and R. Simonds. 2013. The Effects of Pesticides on Queen Rearing and Virus Titers in Honey Bees (Apis mellifera L.). Insects 4(1): 71

– 89 doi 10.3390/insects4010071

55 Johnson, R. M. and E. Percel. 2012. Pristine Effects on Queen Rearing Process. Final report to Project Apis m.

56 Johnson, R.M., E.G. Purcell. 2013. “Effect of ‘Bee

- Safe’ Insecticides and Fungicides on Honey Bee Queen Development and Survival.” Poster presented at 2nd International Conference on Pollinator Biology, Health and Policy, Aug. 14

– 17, 2013, Pennsylvania State University.

57 Ibid USEPA 2014Page 15 of 18 May 28 , 2015

the growers of these crops. Therefore

, EPA requests input during the comment period o n alternative mitigation approaches for these pollinator

- attractive crops with indeterminate periods of bloom

.



## 6.5 Microbial Pesticides
EPA recognizes that microbial pesticide toxicity values are not typically expressed in terms of micrograms per bee or deter mined from contact exposure which is typically seen with conventional pesticides. However, the mitigation measures/approach described in this proposal may be appropriate for microbial products that are acutely toxic or pathogenic to bees. Before determini ng whether mitigation would be appropriate for any microbial pesticide, EPA would need to evaluate whether the honeybee toxicity/pathogenicity studies it receives for microbial pesticides can yield some equivalent information about acute toxicity that is p resented by the contact toxicity tests done for conventional chemicals. If not, EPA would need to determine whether additional data are needed to more fully evaluate microbial pesticides’ risks to bees, and what regulatory triggers are appropriate for det ermining the need for this proposed mitigation. These data and resulting triggers might vary based on factors such as the type of microbial pesticide (e.g., insect pathogens, live microbes, killed microbes) and expected routes of exposure.



# 7 Implementation

P roposed label language that reflect the prohibit ion of foliar application of acutely toxic products during
bloom for sites with bees on

- site under contract is provided in Appendix B. I nstruction s to registrants are to be developed that will describe the s pecific changes that are to be made to product labels that

are c onsistent with the se changes , including the select neonicotinoid products labels that were previously modified to reduce risks to bees.



# 8 Summary

As discussed in this paper and consistent with p revious actions by the EPA and t he Strategy , EPA is proposing additional restrictions for pesticide applic ations to blooming crops where managed bees are present under a contract, for pesticides that are acutely toxic to bees ( i.e ., those chemicals with an acute
contact LD 50 <11 μ g/bee ). For applications of acutely toxic pesticides at bloom where bees may be present other than from contracted pollination

, EPA is e xpecting the development of state and tribal managed MP 3 s contoured to reflect local needs and conditions to address exposure of managed bees in

non

- contracted scenarios . EPA will be evaluat ing on an ongoing basis the effectiveness of these plans at reducing exposure of bees to pesticides

. After state or tribal MP 3 s have been in place for several years, EPA will then determine whether additional label revisions are appropriate . The s e action s are intended to reduce the likelihood of acute exposure of honey be es following application of acutely toxic pesticides . In being protective for managed honey bees, these action s are believed to be protective for other solitary and social bees and other pollinators that may be at or near the application site at bloom.

The Agency has relied on multiple lines of evidence ( e.g ., acute toxicity studies as well as bee kill incident data when available ) to support its understanding of the acute exposure to and toxicity of the pesticides in question. The proposed mandatory language in the D irections for U se is based on the availab le science and the expect ation that larger numbers of bees will be present in or near application sites under contracted pollination services

. The proposed mitigation is intended to enhance pollinator protection for particular application scenarios and is not intended to sup ersede more restrictivePage 16 of 18 May 28 , 2015

product

- specific use prohibitions. Through both the registration and r egistration r eview programs

, E PA will continue to conduct chemical

- specific risk assessment for bees that will address other potential

routes of exposure ( e.g ., ingestion of pesticide residues in pollen and nectar) and other potential effects ( e.g ., chronic effects) and will consider additional , appropriate product

- specific mitigation as needed

.Page 17 of 18 May 28 , 2015



# Appendix A

– List of registered active ingredients that meet the

acute toxicity criteria

Abamectin Dicrotophos Momfluorothrin Acephate Dimethoate Naled Acetamiprid Dinotefuran Oxamyl Aldicarb Diuron Permethrin Alpha

- cypermethrin D

- trans

- allethrin Phenothrin
Amitraz Emamectin benzoate Phorate Arsenic acid Endosulfan Phosmet Azadirachtin Esfenvalerate Pirimiphos

- methyl Bensulide Ethoprop Prallethrin
Beta

- cyfluthrin Etofenprox Profenofos Bifenazate Fenazaquin Propoxur Bifenthrin Fenitrothion Pyrethrins Carbaryl Fenpropathrin Pyridaben Carbofuran Fipronil Resmethrin Chlorethoxyfos Fluvalinate Rotenone Chlorfenapyr Fosthiazate Sethoxydim Chlorpyrifos Gamma

- cyhalothrin Spinetoram Chlorpyrifos methyl Imidacloprid Spinosad Clothianidin Imiprothrin Sulfoxaflor Cyantraniliprole Indoxacarb Tefluthrin Cyfluthrin Lambda

- cyhalothrin Tetrachlorvinphos Cypermethrin Malathion Tetramethrin Cyphenothrin Metaflumizone Thiamethoxam Deltamethrin Methiocarb Tolfenpyrad
Diazinon Methomyl Zeta

- cypermethrin DichlorvosPage 18 of 18 May 28 , 2015



# Appendix B

– Proposed Label ing

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

FOR FOLIAR APPLICATIONS OF THIS PRODUCT TO SITES WITH BEES ON

- SITE FOR COMMERICAL POLLINATION SERVICES : 

### Foliar application of this product is prohibited from onset of flowering until flowering is complete when bees are on site under contract , unless the application is made in association with a government

- declared public health response

. If site

- specific pollinator protection/pre

- bloom restrictions exist, then those restrictions must also be followed.