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FSMA
May 17, 2017
Hello Produce Safety Alliance Members:
In this issue of the newsletter, we've got lots of updates from the recent Soil Summit the PSA hosted along with the latest data on PSA trainings, job opportunities, information for trainers, and FDA & USDA notices. We hope that you will continue to find these newsletters informative, but please feel free suggest additional produce safety information we can provide that will be of value to you! We appreciate your continued support of the Produce Safety Alliance and please let the PSA staff know if you have any questions, concerns, or suggestions for how we can improve our outreach efforts and educational materials. 
Produce Safety Alliance Course & Trainer Report
The Produce Safety Alliance officially launched its' programs in September of 2016. We (and our PSA Trainers and PSA Lead Trainers) have had a busy 9 months. For more information about the latest course and trainer data, please review the reports posted below:
If you have any questions about the PSA's outreach or training activities, please contact  Gretchen WallThe Produce Safety Alliance does not share individual course participant information.   


Highlights from the Soil Summit - March 28-29, 2017
By Elizabeth Demmings, Gretchen Wall, Rob Way and Elizabeth Bihn
Produce Safety Alliance (PSA) and Institute for Food Safety (IFS@CU) personnel in collaboration with the U.S. Food and Drug Administration (FDA) convened a Soil Summit on March 28-29, 2017 to discuss the benefits and challenges of using soil amendments.

Soil amendments such as raw manure and compost offer clear benefits to agricultural production, but if they are not handled properly they can pose environmental and food safety risks. Raw manure has a higher potential to harbor foodborne pathogens than compost, but improper handling of raw manure during the composting process can increase or spread microbial risks. Consequently, untreated or improperly composted soil amendments can contaminate fruits and vegetables and if consumed, could lead to a foodborne illnesses or outbreak.

How does produce become contaminated from soil amendments? Either through direct or indirect contact. For example, if a soil amendment is not applied correctly, it could come into direct contact with fruits and vegetables causing contamination. Indirect contamination of produce could occur as a result of runoff from a soil amendment storage into irrigation water, produce fields, and packing areas. As a result of the potential microbial risks, the use of untreated soil amendments will be regulated under the FDA's Food Safety Modernization Act's (FSMA) Produce Safety Rule. The Soil Summit provided a platform for produce growers, educators, regulators, and researchers to discuss and identify benefits and challenges in using raw manure as well as the benefits and challenges associated with producing and using compost. Soil Summit participants also identified management strategies, resources, and additional assistance necessary to support growers in minimizing food safety risks on the farm.
 
 
FDA Consumer Safety Officer, Dr. David Ingram, and Senior Risk Modeler/DecisionAnalyst, Dr. Amir Mokhtari, delivered presentations on the first day of the summit to provide background information that provided a foundation of understanding for all participants. These presentations outlined the current standards regarding the use of biological soil amendments of animal origin and human waste in the FSMA Produce Safety Rule (Subpart F, 21 CFR ยง112) and provided information on how the FDA is conducting its risk assessment and research on the use of soil amendments. They also provided details about on-going research projects investigating the persistence, fate, and transport of foodborne pathogens in soil amendments. Combined, these presentations helped to define regulations, identify current methods being used to address risks, and describe on-going research efforts pertaining to the use of soil amendments.  Importantly, they also outlined the process of how all of this information will be employed to develop guidance documents and define the currently "Reserved" section in the Produce Safety Rule.

Following these foundational presentations, a group discussion was facilitated by Dr. Elizabeth Bihn, Director of the PSA and the IFS@CU, to address specific grower challenges regarding compliance with the FSMA Produce Safety Rule Subpart F and other federal, state, and local regulations associated with soil amendments. The session facilitated a dialogue between the farmers and extension educators with federal, state, and local government personnel. Discussions continued throughout the afternoon with two breakout sessions facilitated by team members from the PSA and the IFS@CU. These sessions aimed to identify and clarify current raw manure use practices and to discuss the challenges involved with using raw manure and transitioning to compost. A wrap-up session engaged the entire group allowing them to examine the day's presentations and discussions, and address questions raised during the summit.

Day two of the Soil Summit began with a group reflection of Day 1 with participants discussing what they learned, questions they still had, and key topics they wanted to discuss throughout the day. Following this discussion, Ms. Jean Bonhotal, Director of the Cornell Waste Management Institute, shared her expertise in compost quality and use, illustrating the diversity of compost types and the complexity of producing and using compost safely. Her presentation generated many questions yet again highlighting the need and value of working with individuals who have expertise in this area. The final breakout session charged participants with identifying educational materials, resources, and funding that would be needed further support training and implementation of practices to reduce risks associated with raw manure and compost use. The Soil Summit concluded midday with reflection on what was learned during the summit and what actions need to be taken moving forward.

One result from the two day summit was that it provided a platform for constituents including growers, composting industry personnel, educators, and researchers to openly converse and engage in a dialogue with federal, state, and local government representatives regarding the FSMA regulation and challenges associated with the use of soil amendments. Dr. Ingram commented, "The insights we received at this soil summit are invaluable to FDA. Throughout the process of drafting, amending and finalizing the Produce Safety Rule, we have relied on this kind of dialogue to shape our thinking on how best to regulate the use of biological soil amendments. Candid conversations with all participants have given us greater perspective on how they would be affected by such provisions and will help inform our risk assessment activities."

Evaluations indicated that participants benefited from the conversation, leaving the summit feeling more informed about the Produce Safety Rule requirements on soil amendments and the processes involved with developing guidance, as well as the many challenges related to complying with the rule itself. In a final note, there was a suggestion to hold additional summits in other regions of the U.S. since there are likely differences in cultural practices, commodities produced, and soil amendments used. "The Soil Summit was a success because of the level of participation from all attendees who engaged in the breakout sessions, providing discussion and details to really clarify the issues.  FDA's participation and willingness to respond to questions allowed us to maintain a very effective dialogue throughout the summit," said Dr. Bihn. Keep an eye on the PSA and IFS@CU websites for updates regarding additional Soil Summits.
New Job Opportunities
The Produce Safety Alliance is Hiring: Northwest Regional Extension Associate
As a key member of the PSA team, the Northwest Regional Extension Associate
will be responsible for planning, organizing, instructing, and evaluating PSA training programs for produce growers, extension educators, and regulatory personnel in their region. Review of applications will begin immediately and continue until the position is filled.
  • Apply at Academic jobs online: https://academicjobsonline.org/ajo/jobs/9090
  • Cover Letter, CV, transcripts, and three letters of reference are required to be submitted through the online portal. This position will specifically service the Pacific Northwest, but travel across the country is also likely to host trainings with other PSA Regional Extension Associates.
Kansas State - Extension Associate - Produce Safety
This position is responsible for assisting the State Extension Consumer Food Safety Specialist and other partners with coordinating produce safety extension activities in the state of Kansas, particularly to ensure that Kansas fruit and vegetable producers are aware of and compliant with the FDA Food Safety Modernization Act Produce Safety rule. Screening of applicants will began May 9, 2017, and will continue until position is filled.
 
Updates for Trainers & Educators
We have a few brief updates for PSA Trainers, PSA Lead Trainers, and other produce safety educators.
  • PSA Trainer & PSA Lead Trainer Directory - Get connected with other trainers in your region.Note: Not all individuals have chosen to be posted publicly on our website. The individuals listed have granted the PSA permission to post their contact information online. For additional information about total PSA Trainers and PSA Lead Trainers, explore the Training Reports resource discussed above. 
  • The Association of Food & Drug Officials (AFDO) has Moved!
    Please be sure to update your address books if you plan to mail any course paperwork or evaluations back to AFDO. Their telephone number will remain the same.
    New Address:  155 West Market Street, 3rd Floor, York, PA 17402
New Educational Resources

 Required Records by the FSMA Produce Safety Rule

The FSMA Produce Safety Rule (PSR) requires a few specific records. Thispublication summarizes the provisions requiring records and includes template records to help establish records to meet FSMA PSR requirements. Growers may want or need to keep additional records to ensure that required practices are being carried out correctly, to meet buyer requirements, and/or participate in a third party audit. Other documentation, such as Standard Operating Procedures (SOPs), may be helpful to support the implementation of practices on the farm. Be sure to utilize the template records document as well!
 
Additional educational resources are available at: https://producesafetyalliance.cornell.edu/resources/general-resource-listing
FDA Updates
The U.S. Food and Drug Administration (FDA) is exploring ways to simplify the microbial quality and testing requirements for agricultural water established by the Food Safety Modernization Act's (FSMA's) produce safety rule while still protecting public health.
 
Agricultural water can be a major conduit of pathogens that can contaminate produce. That is why FSMA's produc e safety rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  However, the feedback that the FDA has received is that some of these standards, which include numerical criteria for pre-harvest microbial water quality, may be too complex to understand, translate, and implement. These factors can be important to achieving high rates of compliance.
 
In response to these concerns, the FDA is considering how it might simplify the water standards. FDA intends to work with stakeholders as these efforts related to the water standards proceed.  It is important that as FDA implements FSMA, the agency strikes an appropriate regulatory balance and decreases regulatory burdens whenever appropriate. FDA remains committed to protecting public health while implementing rules that are workable across the diversity of the food industry. 

Several of the FSMA rules have provisions in which a value is adjusted for inflation and averaged over three years. The FDA has posted Implicit Price Deflators for Gross Domestic Product (GDP) on their website . The following adjustments apply to those who will need to comply with the Produce Safety Rule.
 
Qualified Exemption: A farm is eligible for a qualified exemption if the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, and sales to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers.

Baseline Value for Cut-offs (2011)
Value in 2012
Value in 2013
Value in 2014
Value in 2015
Value in 2016
Average 3 Year Value for 2014 - 2016
 $500,000
 $509,199
 $517,417
 $526,645
 $532,170
 $539,121
 $532,645

Not covered farm:  A farm or farm mixed-type facility with an average annual monetary value of produce sold during the previous 3-year period of less than $25,000 (on a rolling basis).
Baseline Value for Cut-offs (2011)
Value in 2012
Value in 2013
Value in 2014
Value in 2015
Value in 2016
Average 3 Year Value for 2014 - 2016
 $25,000
 $25,460
$25,871 
$26,332 
$26,608 
 $26,956
 $26,632

USDA Updates
On April 14, 2017, the USDA posted updates to the Produce GAPs Harmonized Food Safety Audit Checklists. The revised Produce GAPs Harmonized checklists go into effect on May 1, 2017.  More information on the checklists and the USDA Produce GAPs Harmonized program are available at https://w ww.ams.usda.gov/services/auditing/gap-ghp/harmonized

For more information, contact Kenneth Petersen, Chief, AMS Audit Services Branch (ASB), at (202) 720-5021; or Jennifer Dougherty, ASB Audit Program Coordinator and GAPs Team Lead, at (703) 328-7562.
Stay in Touch!
Our general listserve reaches over 3,000 growers, industry members, regulatory agents, and educators in the United States and around the globe. Signing up for the listserve is  the best way to stay in touch with the PSA. To sign up, please visit our website at  producesafetyalliance.cornell.edu  or use the link included at the bottom of this e-mail message
 
As always, please do not hesitate to contact us if you have any questions, comments, or ideas. We love feedback, so let us know! Good, bad, or otherwise - our ears (and e-mail inboxes) are always open!

Gretchen L. Wall, M.S.

Produce Safety Alliance Coordinator 

Elizabeth A. Bihn, Ph.D.

Produce Safety Alliance Director 

Cornell University - Dept. of Food Science

110B Stocking Hall

Ithaca, NY 14853

NEW Phone: 607.882.3087

Email: glw53@cornell.edu

Hedrick Hall - NYSAES
630 W. North Street
Geneva, NY 14456
Phone: 315.787.2625