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Elizabeth Sullivan
Extension Associate /
Process Authority
Dept. of Food Science
December 7, 2015
The NYS Food Venture Center:
Extension Outreach and Research
NYS Food Venture Center
• Mission: provide comprehensive technical assistance to farmers, entrepreneurs and food companies pursuing new food products for the marketplace, to enhance food safety and promote economic development
• Established in 1988, became a regional center through USDA grant in 2000 (Northeast Center for Food Entrepreneurship – NECFE)
• Funding: Cornell, state and federal grants, subsidized fees
The FVC Team• Dr. Olga Padilla-Zakour, Director and Process Authority• Elizabeth Sullivan, Extension Associate and Process Authority• Andy Humiston, Extension Support, extensive science experience• Shannon Prozeller, Extension Aid• Herb Cooley, “technical expert emeritus”, > 35 years in Food Science
On-going support from • Dr. Randy Worobo, Food Microbiology Expert• Chris Gerling, Extension Associate in wine and alcoholic foods
Education and Outreach
• Website, educational materials, workshops• Links to other Cornell, University resources
Provide lists of labs, co-packers, commercial kitchens, labeling design, nutrition labeling, packaging suppliers, etc.
• Provide links to consultants for Product Development
Product Safety and Stability• Expertise in fruit and vegetable based products• Review and Approve recipes for safety and stability and
issue Scheduled Processes/Product Reviews– Regulatory Compliance: state, FDA and USDA
• Direct Technical Support: one-on-one consultations, 99% via phone/email– Work with processors to tweak formulations –> processing
parameters, packaging preferences, available equipment, etc.– Troubleshoot/Evaluate processing concerns
Product Safety and Stability
• In 2013: 3500 client contacts; 412 business received assistance for commercialization of 1200 food products
• In 2014: 7,000 client contacts; 437 clients received assistance for commercialization of 1276 food products
YTD 2015 • 1001 scheduled processes• 262 amendments
• Over 670 samples analyzed
• States served:• New York (70%)• New England area if no • service available within state• Pennsylvania• New Jersey• Ohio• Others: CO, MN, MI, IL, FL, MD, etc.
Processing Authority Service – Ensure Safety and Regulatory Compliance of Foods
Based on regulations, a Processing Authority is a person or institution that has
o expert knowledge, o experience
o adequate facilities (equipment and resources)
to make determinations about the safety of a food process and formulation
Schedule Process
• Detailed procedure issued by a Processing Authority that includes:– Formulation– Critical Control Points – Processing steps– Storage, distribution, selling conditions/restrictions
• Required in New York and in many states for approval of most new food products; required by FDA for shelf-stable low acid, water-activity controlled and acidified foods
Example of a process authority
“schedule process” for an acidified food
*FDA required information
Science-based guidelines
*re-evaluating for new 2541e and 2541f
forms
Typical Small-Scale Fruit/Vegetable Based Food Products• Baked Goods• Confections• Sauces: BBQ Sauce, Hot Sauce, Pasta Sauces• Dressings• Pickles, Relish, Chutney• Jams & Jellies• Chocolate & Caramel Sauces
Increased client interest in:
• Simple syrups/cocktail syrups• Lacto-fermented foods (sour pickles, kimchi)• Kombucha, water kefir, SCOBY-produced beverages• Artisanal charcuterie– sausages, jerky, pastrami, etc.
Sample of Products Produced With FVC/NECFE Assistance
Research – The Basic Conflict
• Small-scale processors rely on quality (nutrition, color, ingredients, etc) to justify price BUT can rarely finance the research to support safety, stability of atypical processing methods
• Regulatory agencies increasingly require a)research or b) peer-reviewed literature as proof for things long considered common knowledge within field– What is acidified?– Is the processing adequate for safety? Stability?
Challenge: develop a body of research to support the majority of processing recommendations and requirements
Research• Graduate research:
– Acidification rate for pickled eggs under various conditions– D and z-values @ various pH values in acidified juice– Challenge study for cold-filled pickled eggs– Stability of acidified juice
Much research is focused on
intersection of Regulatory
requirements and processor
desires/realities
Research – Pickled Eggs
1. Acosta, O, XF Gao, EK Sullivan, OI Padilla-Zakour. 2014. Pickled Egg Production: Effect of Brine Acetic Acid Concentration and Packing Conditions on Acidification Rate. J. Food Prot, 77(5):788-795
• Acid diffuses through egg white very rapidly; slowly through yolk
• Acidification faster with hot fill brine, boiling water bath
• Higher concentration of acid in brine = faster acidification
• Texture changes are because of acidification rather than packing conditions
Research – Pickled Eggs
2. Sullivan, EK, DC Manns, JJ Churey, RW Worobo and OI Padilla-Zakour. 2013. Pickled Egg Production: Inactivation Rate of Salmonella, Escherichia coli O157:H7, Listeria monocytogenes, and Staphylococcus aureus during Acidification Step. J. Food Prot. 76(11): 1846-1853.
• 2% AA , equilibrium pH 4.0 - 5 days to 4.6 at yolk center; 41ºF; 13 days to equilibrium
• 1% AA , equilibrium pH 4.4 - 9 days to 4.6 at yolk center; 41ºF; 16 days to equilibrium
Research – Pickled Eggs
2. Pickled Egg Production continued• No pathogens detectable after 14 days• No difference in pathogen die-off rates between brines
with chemical preservative and those without• S. aureus survived refrigeration, died quickly once eggs
removed from refrigeration• 1% aa – 10-14 days to achieve non-detect.• 2% aa – E. coli O157:H7, L. monocytogenes and
Salmonella non-detect in 72 hours; S. aureus non-detect in 7 days (2 days after removal from refrigeration)
Research – Pickled Eggs
2. Pickled Egg Production conclusions• Pathogens begin to die off under refrigerated storage• Heat treatment (ambient temperature storage) required to
reach non-detect levels– 2% AA total system: particularly for S. aureus on
eggs; lids okay under refrigeration– 1% AA total system: all pathogens on eggs;
S. aureus on lids
Research
3. Usaga, J., RW Worobo, OI Padilla-Zakour. 2014. Thermal Resistance Parameters of Acid-Adapted and Unadapted Escherichia coli O157:H7 in Apple-Carrot Juice Blends: Effect of Organic Acids and pH. J. Food Prot. 77(4): 567-573.
• D- and z-values to determine lethality calculated for acidified juice at pH 3.3, 3.5, 3.7 and 4.5
• Samples pH adjusted through addition of lactic, acetic or malic acids; pH 4.5 through addition of NaOH.
Research
3. Thermal Resistance Parameters continued• E.coli more tolerant (D-values higher for given
temperature) in samples acidified with malic, followed by lactic and acetic acids
• D- and z- values given for fluid acidified food with pH values lower than 3.9.
• Pasteurization rather than commercial sterility
Research – Awaiting PublicationStability of acidified juices (pH 3.3, 3.5, 3.7) in PET, Glass, both w/ lid capable of hermetic seal, fill temps of 63, 71, 77ºC
Initial Results:• Large cooling difference between PET and Glass = very
different thermal treatment during hold time post sealing• Confirms acetic acid better against spoilage than malic
acid
Research – Awaiting PublicationStability of acidified juices (pH 3.3, 3.5, 3.7) in PET, Glass, both w/ lid capable of hermetic seal, fill temps of 63, 71, 77ºC
Positive results for:• Acetic acid/PET all pHs, fill temps (63, 71, 77ºC) • Malic acid/PET all pHs, fill temps 71, 77ºC• Acetic acid/Glass pH 3.3, fill temp 71, 77ºC
• Malic acid/Glass – no combo of pH/fill temp worked
More comprehensive Schedule
Process Documentation to Meet
FSMA Preventive Controls:
• Include hazard analysis per product
category
• Include controls for biological,
chemical and physical hazards
NEW DEVELOPMENTS & INITIATIVES
5. Review & Adjust
1. Identify Hazard2. Understand Cause
3. Implement Preventive Controls
4. Monitor Effectiveness
• Expanded use of pilot plant in partnership with the Cornell
Agriculture and Food Technology Park & Start-Up NY
• Small scale commercial production for tenants/members of the
Park
NEW DEVELOPMENTS & INITIATIVES
• Satellite office, lab and training room for the FVC/NECFE in
NYC
• Possible location in Brooklyn
NEW DEVELOPMENTS & INITIATIVES
• HPP Unit for process validation
NEW DEVELOPMENTS & INITIATIVES
Continued research leading to peer-reviewed publication relevant
to increased FDA scrutiny for Acidified, Water Activity Controlled
Foods
• ingredient buffer capacity and effect on pH
• hot hold time/temperatures for shelf stability
ONGOING INITIATIVES
Thank you very much for your time and interest
• For additional information:• Email: [email protected]
(Andy Humiston)• Phone: 315-787-2273