Pitch Perfect: Harmonizing MRL's and the Global Marketplace - Presented By Joe Simrany, President Tea Association of the USA CropLife America & ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Pitch Perfect: Harmonizing
MRL’s and the Global
Marketplace
Presented By
Joe Simrany, President
Tea Association of the USA
CropLife America & RISE
Spring Conference 2013
Historical Perspective
Pesticide Residues in Tea
History
For nearly 100 years the USA Tea Industry had its
own law regulating the importation of tea
It was in place for nearly 100 years, formed in
1897 and abolished by the Clinton Administration
in 1996
It insulated the tea industry from virtually all other
government regulatory involvement
A sample of every shipment of tea coming into the
country had to pass federal inspection
The Tea Act of 1897 was almost entirely funded
by industry
Historical Perspective
Pesticide Residues in Tea
Industry Position Post Tea Act
For the next 12 years, tea was only infrequently
inspected by the FDA with no major detentions
There was also a mistaken perception that in the
absence of a specific pesticide registration for tea
that the FDA would default to a similar vegetable
Consequently, there was little reason for the
industry to take aggressive actions to update the
handful of pesticide MRL’s that were currently in
place for decades
Cost of registering new pesticides was also
certainly a contributing factor to maintaining the
status quoRecent History
Pesticide Residues in Tea
2008 Incident
In March 2008 the Tea Association was asked by
one of its importers to intercede with the FDA who
had detained 30 containers of tea because of
illegal pesticide residues
The number of detained containers quickly rose to
over 40; essentially stopping the flow of tea into
the country
The earliest detention concerned the presence of
“high” levels of lead with all the others concerning
pesticide levelsRecent History
Pesticide Residues in Tea
2008 Incident
3 pesticides were detected; Lamda-
cyhalothrin, Bifenthrin, and Fenvalerate
The Association commissioned a
scientific study demonstrating that the 3
pesticides, at the level found on the tea
samples, posed zero risk to human
healthRecent History
Pesticide Residues in Tea
Immediate Penalties Imposed
Despite reaching agreement with the
FDA, They rejected the 30 containers of
tea that had already been inspected but
released the 10 containers that had
been detained but not yet inspected
We argued that the 30 containers posed
zero risk to health and the FDA
responded that it was a matter of law
not public safetyRecent History
Pesticide Residues in Tea
Agreement Reached with the FDA
The Tea Association met with FDA
officials & over the ensuing weeks
worked out an agreement that they
would use enforcement discretion
provided we put forth good faith efforts
to fix the problems
Our legal bill for 2008 exceeded $80,000Current Pesticide Standards
for Tea
Vary by country Are constantly
Many are outdated changing & can be
Many are out of confusing to the
patent producing countries
Do not reflect Are difficult to
current practices in communicate to
the USA farmers
Many do not Require redundant &
adequately consider costly testing in
transference from each country
the leaf to the cupRationale for Pesticide
Harmonization
We quickly learned that harmonization
of pesticides between countries was
incredibly challenging because:
Different regulatory agencies have
different ways of evaluating risk
Consumption patterns varied widely
between countries
Countries were reluctant to release
“proprietary” test dataPesticides Authorized for Use on
Tea in the USA in 2008
Dicofol 50 ppm
Pyriproxyfen .02 ppm
Glyphosate
Tea – dried 1 ppm
Tea – instant 7.0 ppm
Chlorfenapyr .01 ppm
Endolsulfan 24 ppm*
Carfentrazone .1 ppm
*Combined residues of several pesticidesCurrent Pesticide Registrations
in the USA 2013
Most Recent Federal
Pesticide PPM
Register Date
Acetamiprid 50 2/10/2010
Bifenthrin 30 9/14/2012
Buprofezin 20 10/17/2012
Carfentrazone .1 3/31/2004
Chlorantraniliprole 50 7/27/2011
Chlorfenapyr .01* 7/16/2003
Clothianidin 70 3/29/2013
Dicofol 50 9/26/2012
Dinotefuran 50 9/12/2012
Endosulfan 24** 6/2/2013
Ethiprole 30 4/6/2011
Etoxazole 15 4/13/2011
Fenpropathrin 2 11/28/2012
Fenproximate/Fenpyroximate 20 12/12/2012
Glyphosate
Tea: Dried 1 10/1/1980
Tea: Instant 7.0 10/1/1980
Propargite 10 8/1/2007
Pyriproxyfen .02 8/22/2007
Spiromesifen 40 1/16/2013
Thiamethoxam 20 3/27/2013Pending Pesticide Registrations
in the USA as of April 2013
Pesticide Expected Tolerance Year
Azoxystrobin 2013
L-Cyhalothrin 2016
Cypermethrin 2013
Propiconazole 2013
Tolfenpyrad 2013Current Status of Pesticide
Registrations for Tea in the USA
Status of Agreement with the FDA/EPA
Enforcement discretion is generally holding.Codex Initiative
As part of our International initiative
started about 8 years ago in
conjunction with the FAO, we started a
Working Group to encourage a change
in how pesticide residues are measured
in tea from the leaf to the cup
A proposal was made to Codex
Aliamentarius at their April 9, 2011
meeting to consider making the changeCodex Initiative
While the proposal was not accepted the
concept of minimal transference from the leaf
to the cup was firmly established
As part of a short to mid-term strategy, we
recommend the tea producing countries to
use the best water insoluble pesticides
available to them
Also, we will move to register those pesticides
on a priority basis with our regulatory
agenciesCodex Initiative
Our longer term goal is to encourage
the tea producing countries to use the
more environmentally friendly water
soluble pesticides but it will take several
years before the pesticides will be in
wide-spread use by the Tea Producers.Major Current Projects
Pesticide Residues in Tea
Next Steps
Continue working with IR4 & the EPA to
minimize costs by combining with other
registrants
Identify priority chemicals
Communicate to producing countries those
pesticides they should immediately discontinue
Encourage producers to use water insoluble
chemicals over the short term
Work with pesticide manufacturers to develop
better pesticides for use on tea and to register
those pesticides in the USA
Greater involvement of all stakeholdersMajor Current Projects
Pesticide Residues in Tea
First Pesticide Summit Meeting
Seattle, WA March 16, 2012
Objectives of the Meeting
Agree and Articulate our Challenges
Variety of Agro Chemicals needed
Different Pests
Different OriginsMajor Current Projects
Pesticide Residues in Tea
Lack of Unified Voice by Producing Nations
Tea Trade Organizations
Difficult to respond to all consuming country needs
Unshared research
Lack of incentive by Chemical Companies to register
outside of user areas
Lack of Unified Voice by Consuming Countries
Data not shared
MRL’s not aligned
Default position by Regulators not aligned
Difficult to incentivize Chemical Companies
Lack of consistency in Interim StandardsMajor Current Projects
Pesticide Residues in Tea
Develop Way Forward – Actions that can
be taken by
Producing Countries
Consuming Countries
Regulatory Agencies
FAO
Background
USA – Joe Simrany/Peter Goggi
Canada – Louise Roberge
Europe – Katie DonnellyMajor Current Projects
Pesticide Residues in Tea
Current Activities
FAO – Katie Donnelly
Minor Use Meeting – Joe Simrany
Chemical Companies – Louise Roberge
IR-4 – Dan KunkelMajor Current Projects
Pesticide Residues in Tea
Challenges
FSMA – Richard Enticott
Need for Harmonization – OJ Incident
From the Producers Viewpoint – Joydeep
Phukan?
Sensitivity of Detection Methods – Dr.
Frank FarrellMajor Current Projects
Pesticide Residues in Tea
Open Discussion
Corporate Concerns
Sharing of Data
Sharing of Lobbying Resources
Chemical Companies
Consider use for tea in applications
Register current popular chemicals in use at
originsMajor Current Projects
Pesticide Residues in Tea
Regulatory Agencies
Communicate on-going efforts
Harmonization (Codex?)
Satellite office inclusion - communication
PR Issues
Discussion of Pesticides not popular
Pressure by Customers
Questions by Consumers
Legal Issues
Aligning Actions Across the Tea Industry
Conscious of anti-trustMajor Current Projects
Pesticide Residues in Tea
Untapped Resources
How to duplicate/improve partnerships with
Governments
U.S. Tea Association / FDA/EPA as model
Producing Nations and their governments
How to create more powerful synergies from
Consuming and Producing Countries
Continue progress in sharing data
Improve dialogue between consuming and producingSecond Pesticide Summit Meeting
April 17-18th, 2013
Glendale, CaliforniaTea Association of the USA, Inc.
Pesticide Meeting Output
Tea Association of the USA, Inc.
Seattle Meeting held on March 16,
2012
Updated July 10, 2012External Pressures Media & Government
Media
Media
Government
Progress Since 2012
Formation of Pesticide Steering
GroupStructure & Function of the Working Group
Four Sub-Committees have been established under the headings of:
Science & Technology
Regulators
Stakeholders
Stewardship
Volunteers have been assigned to each sub-committee based on their expertise and interest. Each sub-committee should
elect a Chairperson whose role it is to coordinate activities within their committee, set goals & time-lines, identify specific
members to execute specific tasks, and to keep the Tea Association of the USA & Canada apprised of their progress.
Additionally, the Chairperson will become a member of the Steering Committee.
A Steering Committee comprised of 7 people including the Chairperson of each of the sub-committees plus the Presidents
and Executive Vice President of the Tea Association of the USA and the Tea Association of Canada.
If required, the Tea Association will identify a means to promote frequent communications between the sub-committee
members & the Steering Committee using dedicated conference lines and private rooms on the Association websites.
The Steering Committee will meet regularly according to a schedule established by the Tea Associations and/or as dictated
by the flow of information from the sub-committees.
The role of the Steering Committee will be to evaluate proposals requiring specific funding and/or changes in strategic
direction that may require funding or approval by the Board of Directors.
Peter Goggi will serve as the liaison with the sub-committee chairs and will be responsible for bringing all matters of
importance to the attention of the Tea Association presidents.
The Tea Association presidents will be responsible for reviewing specific proposals brought forth by the sub-committees and,
where necessary, seeking approval from their respective Boards of Directors.
The Tea Associations will maintain frequent communications with all sub-committees, their respective Boards of Directors,
and with Regulatory authorities as dictated by the progress of the Working Group.Agreed Structure
Pesticide
Steering
Committee
Science & Leveraging Working with
Stewardship
Technical Stakeholders RegulatorsPesticide Steering Committee
Members Roles & Responsibilities
Monitor and review project at regular Steering
Joe Simrany – President Tea Association of the Committee meetings
USA, Inc. Provide assistance to the project as required;
Louise Roberge – President Tea Association of Control project scope as emergent issues force
Canada changes to be considered; ensuring that scope
Peter F. Goggi – Exec. VP Tea Association of aligns with the agreed actions from each
the USA, Inc. subcommittee
Formal acceptance of project deliverables
Committee Head – Stewardship Prioritization of project objectives and
outcomes
Committee Head – Science & Technical Deliverables as agreed by Sub-Committees
Budget, ensuring that effort, expenditures and
changes are appropriate
Committee Head – Leveraging Stakeholders
Schedule
Holding Committees accountable to Timelines
Committee Head – Working with Regulators
and deliverablesStewardship
Members Activities
Tim Pangburn – Coca Cola Company CSR (Corporate Social Responsibility)
Influence Behavior
Training
Louise Roberge – Tea Association of Education
Canada Communication
Branding Program
John Smith, Jr. – H.P. Thompson Target Large Producers/Importers
Link to Stakeholders
TRI at Origin
Joe Doyle – S & D Coffee, Inc.
Large Producers
Pesticide Manufacturers
Petra Tanos – Martin Bauer US Group Link in Harmonization
New Technology
GSMA/RCC initiatives
Keith Hutjens - Tazo Prioritization
Gain Agreement & Promote unified approach
to gain compliance
TBD - UnileverScience & Technology
Members Activities
• Prioritization of Pesticides Needed
Reach higher level of compliance with established
Katie Donnelly – Tata •
MRL’s
• Data mine Codex for US /Canada / EU / ETC
Frank Farrell, PhD – Tea Association • Work with Registrant to determine if can be
Consultant submitted
• Short Term
Dovetail with other crop submissions to see if Tea
John Mwangi, PhD – Nestle’ USA
•
data exists
• Working with Registrant Canada/US
Lori Fix, PhD, DABT – Unilever • Scientific review of pesticides
• Continue to leverage IR4 (www.saveir4.com)
• Registrations
Chris Smith, PhD – Coca Cola Company • Field Trials
• Continue to push consideration of Codex by
regulators
Janine Neils – Starbucks
Long Term
• Support AOAC pesticide methodology for tea
James Calberson – Finlays
• New Technology (Looking Forward not Back
• Industry to Provide Granted Position to work
Sven-Erik Nielsen - Starbucks on Agenda
• Leverage TRI at OriginLeveraging Stakeholders
Members Activities
• GMA – Participate in their FSMA Program /
Working Committee
Joe Simrany - Tea Association of the USA, Inc. • Preventive Working Group
• Food Trace Committee (Nancy Rachman – Chemical
Louise Roberge – Tea Association of Canada Management Committee sub-Group)
• Share point on their website
Dan Kunkel, PhD - IR4
• Access documentation / attend their meeting
Need to determine what we want to achieve w/ GMA
Patrizia Barone, PhD – Unilever
•
• Science & Technical: Tap into resource / data
collection
Tim Jackson, PhD – Nestle’ USA
• Other Associations
Jem McDowall – Universal Commodities (Tea) • Produce Association
Trading, Inc. • Beverage Association
• Juice Association
Robin Lavooij - Van Rees North America • European Tea Committee
• Rainforest Alliance
Richard Enticott – Martin Bauer NA
• Ethical Tea Partnership
Minor Crop
Michael McGuffin – AHPA •
• Blinded Survey
Mike Fitzgerald – SNA NA • What is the gap
• How much tea has the problem (country of origin /
Rona Tison – Ito En (North America) Inc. identify pesticide, etc.
• Pesticide Management
Keith Hutjens - Tazo
• Who are the Manufacturers
• What is being used and where?Working with Regulators
Members Activities
Joe Simrany - Tea Association of the • Dovetail with existing pesticide reviews
USA, Inc. underway by EPA & PMRA
• Working with Registrants to support MRL’s
• Finding tea data to support MRL applications
Louise Roberge – Tea Association of
• Working with Codex delegations to put tea
Canada pesticides on priority review list
• OECD
Peter F. Goggi – Tea Association of USA, • Liaise with Sci/Tech & Reg committees
Inc. • Coordinating with Leveraging Stakeholders
Committee to ensure coordinated messaging
to regulators
Sven-Eriksen Neilsen - Starbucks • Coordinate with Science & Technology
Committee on potential IR-4 Projects
Kyoshi Ito – Ito En Ltd. • Identify Opportunities to push for adoption
of Codex MRL’s by regulators
• Ensure political activities do not harm
Patrizia Barone, PhD – Unilever positive relationships with regulator /
continue activate positive relationship with
regulators
Tim Jackson, PhD – Nestle’Progress Since 2012
Formation of Pesticide Steering Group
Created Broad List of “To Do’s”Other Recommended Actions
Prioritize and Register Chemicals
Identify & confirm priority chemicals for USA & Canada
Verify IR-4’s ability to register priority chemicals and at what cost
Work directly with EPA/PMRA to register specific priority chemical deemed inappropriate for IR-4 to
handle
Explore reduction in Registration fees by determining what the regulators requirements are
Use Tea Tech resources to prepare data packages & do initial safety assessments
Promote harmonization
Canadian & US Regulators
Organize meetings between the two
Australian Regulators & US/Canadian
Set up Producer Working Groups
Identify one member from each producing country to liaise with our committees to keep each
other updated, informed and create synergies around issues of importance
Stewardship – Establish communication directly to producers re: GMP and Pesticides
(application, timing, worker safety, etc.) by working with
Rainforest Alliance
ETP
Fair Trade, etc.Pre-Meeting Proposed Actions
Harmonization
(Cross Acceptance of MRL’s and testing
Methodologies)
How
Urge Regulatory Bodies to utilize Codex
Standards
Sharing Risk Assessment/Test Data
Join with other organizations, e.g., ETC,
Producer Tea Associations
Open relationship with regulatory bodies:Pre-Meeting Proposed Actions
Certify More Pesticides
How
Continue working with IR4/EPA/Manufacturers
to minimize costs by combining with other
registrations
Saveir4.org
Crop Grouping
Extrapolation
Prioritize Chemicals
Encourage water insoluble chemicals
Register in USAPre-Meeting Proposed Actions
Drive Compliance with Producers
How
Continue to work with key importing countries
Argentina
India
Sri Lanka
Kenya
Malawi, etc.Progress Since 2012
Formation of Pesticide Steering Group
Created Broad List of “To Do’s”
Increase Number of MRL’s for TeaRegistrant Engagement
Bayer
Tebuconazole
Spirotetramat
Spiromesifen
Syngenta
Propiconazole
Azoxystrobin
BASF
Chlorphenapyr
Alphacypermethrin
FlufenoxuronProgress Since 2012
Actions Taken to Raise Awareness
Registrant Engagement
CODEX
ETC
IR-4Sub-Committee Reports
Stewardship
Tim Pangburn – Coca-Cola
Leveraging Stakeholders
Sam Zeller – Unilever
Science & Technology
Katie Donnelly – Tata
Working With Regulators
Sven-Erik Nielsen - StarbucksDecisions and Discussions
Sub – Committees
Confirm Leadership / Team Structure
Confirm Team Membership
PRIA (Pesticide Registration Improvement
Act Process)
Partnering and Leveraging IR-4 / Crop Life
Funding / Co-Funding Registrations
Consultant to Lead Process
Committee StructureDecisions and Discussions
How to Continue to leverage the IR-4
relationship
How to grow Crop Life Relationship
Joe Simrany presentingDecisions and Discussions
Funding / Co-Funding Registrations
Is the Tea Industry open to funding
registrations?Decisions and Discussions
Is the Tea Industry Open to Hiring
Consultant to Lead Process?
Core Competencies:
Intimate knowledge of US EPA pesticide regulations, especially with regard to
MRL submissions. Previous experience interacting with EPA staff in response to
regulatory submissions and ability to persuasively interact with EPA on data
adequacy and submission fee issues.
Ability to interpret pesticide field trial data to determine if data will be sufficient
to meet US EPA requirements for tea. Ability to possibly compile and submit US
MRL petitions on behalf of USTA.
Strong relationships with pesticide registrants to further USTA's mission of
establishing additional US tea MRLs. Ability to persuade registrants to support
our MRL needs and negotiate with registrants on possible work and/or fee
sharing.
Must be able to keep tea industry top of mind with registrants to ensure the
development of a strong pipeline of MRL submission for new compounds.
Familiarity with Codex process a plus.Summary and Next Steps
You can also read
