Dirk D. Shoemaker- Nebraska Department of Agriculture

-Residue/FERN-Chemical Laboratory -Feed, Fertilizer, and Ag Lime Laboratory -Dairy and Food Laboratory -Seed Laboratory– located on UNL East Campus Staff of 20- Predominantly state-funded but perform work under 3 different FDA grants and 1 USDA grant

Routine food testing program for nutritional label accuracy and pathogen testing for over 30 years. Pathogens tested include Salmonella, Shigella, E. coli 0157:H7, shigatoxin- producing E. coli, Listeria monocytogenes, and numerous bioterror agents. Also test foodborne illness cases in Nebraska. Became USDA/FERN Lab in 2006.

RFA (Request for Grant Applications) opportunity was posted on February 28 th, 2012 for a MFRPS grant and March 2 nd for a ISO laboratory accreditation/MFRPS enforcement grant. “Dual” grants

 After internal deliberation with Department Administration, we applied for both RFA’s in April 2012  We also participated in a FDA Contract process in the interim and submitted potential deliverables in May 2012

 Only laboratory in the state performing food testing  Must be participating in the FDA Contract process  Must be a FERN laboratory. Nebraska Dairy and Food Laboratory has been a USDA/CAP laboratories since 2006

 In the NDA Food Laboratory, we felt that receiving an ISO Laboratory accreditation grant was crucial to our future.  It was very obvious that we needed to be a part of FSMA and partner with FDA or we would be “left at the platform” if we missed the FSMA train.  The benefits in additional personnel, equipment, and training opportunities will be a huge benefit to our Food Laboratory.

 We were notified of grant award on 9/6/2012 and were given permission by the Nebraska State Department of Personnel on November 25 th to fill two new positions (Chemist III, Chemist II) that hadn’t previously existed and would be FDA-funded in our Food laboratory.  This also required permission from the Governor’s office fill these new positions.

 Change from “running away” from ISO 25 in the 1990’s, to embracing ISO laboratory accreditation. For your laboratory to be relevant in the future, you need ISO accreditation.  A current State Lab Director told me…”once you have completed ISO accreditation, you will be become a better laboratory and it will all be worth it”

 1. Obtain approval from the highest management in your agency to proceed with ISO laboratory accreditation. (should have been done prior to applying for RFA)  2. Utilize Partnership for Food Protection Task Force document (if available)

 3. Research job descriptions from other states. In Nebraska, we created two “new” positions based on the unique duties of the two positions.  4. Advertise nationally for both positions through Indeed.com, an aggregator job website. <$200/position- #1 job website in the U.S.

 Chemist II hire January 15 th,2013 – Chemist III hire on March 4 th, 2013  5. Identify scope of accreditation- minimum one microbiological and one chemical method to enforce MFRPS

 Nebraska Department of Agriculture has begun with four microbiological methods (8 total-4 screening, 4 confirmation) based on the ABI 7500 FAST or BAX platforms and one chemical method- Total Arsenic in Foods (ICP/MS)  Arsenic speciation (HPLC/ICP/MS) will eventually be added also, perhaps prior to initial accreditation application

 FDA/FERN-Chemical laboratory began the ISO accreditation process in March Much less FDA “hands-on” help compared to ISO/MFRPS grant.  Most assistance has come from FDA-Kansas City and Minnesota Dept. of Agriculture.  Estimate that we will ask for an official audit for ISO laboratory accreditation in early 2014.

 In the beginning, panic from not understanding the ISO system. Until you take a training course, you won’t completely understand it  Quote from Ken Stoub (A2LA Instructor). “You need to take the ISO and Laboratory Accreditation course 7 times to really understand it”  It’s an overwhelming process in the beginning but if you hire great people who are self-starters, task-oriented with an attention for detail, your chances of success increase immeasurably.

 Attend A2LA, ACLASS, etc. training courses.  Schedule in-house ISO training for all analysts ASAP  Attend A2LA training at FDA District Offices (two offered at Kansas City-FDA)  Set up in-house instrument training on mass spectrometers if applicable (ICP/MS for example)  Attend any applicable FERN training courses

 Hire QA Manager’s who are smarter than you are and empower them to succeed. It is a key position and she or he needs good writing skills, organizational skills, and presentation skills.  Purchase AOAC/ALAAC manuals (ALACC required for Food laboratories) and also electronic web access through AOAC for your entire laboratory. (one-time fee $500)

 Sell ISO lab accreditation to the rest of your “non-QA Committee” employees as a positive process.  Use normal good management practices such as setting deadlines. As Lab Director you are the key player in making the process happen.

 Network with other states and don’t be afraid to ask dumb questions. If your FDA grant coordinator doesn’t know the answer, she/he will help you find it. Other states have been extremely helpful to us at this point  Spend the money! Be proactive and find useful ways to spend your grant funds and avoid future carry-over issues

 Write Quality Manual. Use other state’s and FDA’s examples and re-write in your unique format  Write necessary SOP’s. Again, ask other states to share. Don’t reinvent the wheel  Begin using system as outlined in Quality Manual

 After using system for 6 months or more, hire a consultant to identify problems and offer solutions  Schedule an official pre-audit with your accreditation provider  Fix all problems found in pre-audit and prepare for official audit  Schedule official audit with your chosen accreditation organization

 If you haven’t done so already, join AFDO  Join APHL as an organizational Member  ISO training opportunities are currently available on APHL’s website, and more are on the way along with numerous other benefits

 APHL- Promote food safety in the public health arena  10 State Department’s of Agriculture are currently APHL Members (including Nebraska)  APHL’s Emerging Leaders program is excellent for training future Administrator’s/Director’s

 Attended in St. Louis March 18 th -21 st,  AFDO invited Lab Directors from The AFDO Laboratory Managers Steering Committee  Takeaway- the MFRPS program is a parallel Quality Management System to ISO Lab Accreditation. Once these quality management systems are in place, FDA will be able to “trust” our results and take regulatory action accordingly

 3,000 deaths/year foodborne illness- CDC  Reduce Listeria monocytogenes, Salmonella, shigatoxins, and other pathogens from food manufacturing facilities  Listeria monocytogenes- 20% fatality rate  Leading cause of death among foodborne pathogens

 The result of children being affected by shigatoxins is now apparent  CDC-265,000 cases of shigatoxin poisoning/year  Leading cause of kidney failure in children Lifelong kidney damage

 What we will enforce for the MFRPS in Nebraska?  How will FSMA be implemented in light of recent changes from the White House Office of Management and Budget?  Will food testing still be required in FSMA?

 Dirk D. Shoemaker  Nebraska Dept. of Agriculture Laboratories  