Page 1

FSMA Update – What’s the Latest?


Agenda ยง ยง ยง ยง ยง

#SFC2018

Produce Safety vs. Preventive Controls Produce Safety Rule Updates Preventive Controls Updates Supply Chain & FSVP Updates Key Resources & Tips


#SFC2018

Produce Safety vs. Preventive Controls


Produce Safety or Preventive Controls?

#SFC2018

ยง Long-standing debate since draft rule ยง Possibly most significant FSMA enforcement issue ยง Determines how FDA regulates an operation ยง Based on activity, ownership ยง Packing houses, Hullers, Dehydrators, and some Packers impacted


Categorizing Activities § Farm Activities § § § §

Fumigating Hulling Sizing / screening Drying

#SFC2018

§ Processor Activities § Roasting § Cutting, chopping § Grinding, extruding

§ Both § Holding (storing) § Packing § Transporting


Enforcement Discretion

#SFC2018

§ January 2018 § What is enforcement discretion? § For PC requirements as applicable to some facilities § Currently fall under PC rule due to ownership, coloring activities, or dried commodity § Conduct farm activities

§ Future rulemaking expected to modify definition of “farm”


What’s Changed

#SFC2018


Examples

#SFC2018

§ Grain elevators (were already exempt) § Facility storing, coloring, and packing oranges § Huller / sheller or dehydrator processing mostly products owned by others § On-farm storage, packing of dried fruit – considered processed; enforcement discretion in place § Packing produce RACs is still required to comply with GMPs (was already in place under 110)


#SFC2018

Produce Safety Rule Updates


Water Testing – The Big One!

#SFC2018

September 2017 - FDA published a Proposed Rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E” § Reasoning: “to address questions about the practical implementation of compliance with certain provisions” § “…consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.”


Compliance Dates Extended ยง Four Year Delay for water

#SFC2018


Additional Testing Methods

#SFC2018


Enforcement Update

#SFC2018

§ Enforcement delayed an extra year § Starting date January 2019 § Currently conducting voluntary “On-Farm Readiness Reviews” § In CA, we largely expect CDFA to enforce


On The Horizon

#SFC2018

ยง FDA & PSA actively discussing soil amendments ยง Some discussion on animal controls as well ยง Research still being done to further define some items ยง E.g. guidance on raw manure pre-harvest interval


#SFC2018

Preventive Controls Updates


Human Food By-Products

#SFC2018

§ Current requirements for processors: § Clear labeling § Proper storage (under GMPs) § Not commingled with waste / trash

§ After the human food facility, products become part of animal food chain § Many later activities will fall under animal feed PC rule (21 CFR 507)


Human Food By-Products (At The Processor) § Enforcement discretion in place for:

#SFC2018

§ Drying, dehydrating, pressing, chopping, etc. to reduce bulk § Mixing / combining components

§ NOT in place for: § Process to address pathogens (e.g. heating, cooling) § Pelleting, extruding, or formulating § Further processing by human food facility § Processes which may introduce a hazard


#SFC2018

Supply Chain & FSVP Updates


First Things First

#SFC2018

§ FSMA rules consider FSVP rule equivalent to PC rule supply chain requirements (Subpart G) § A broker is not a supplier! “Supplier means the establishment that manufactures/ processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/ processing that consists solely of the addition of labeling or similar activity of a de minimis nature.

§ A customer is a commercial customer (not a consumer)


Who Controls The Hazard?

Supplier

• Manufacturer, processor • Raise the animal • Grow the food

Receiving Facility • Manufacturer, processor

#SFC2018

Customer

• Manufacturer, processor or preparer

*Transparency & Communication* Source: Microsoft Office Clipart


FDA’s View on Controlling Hazards

Food

Identify Hazard (i.e. Salmonella)

#SFC2018

Controlled by Supplier (e.g. pasteurized)

Verify their program (validation, on-site audit, lab tests)

Controlled by my process (e.g. baking)

Control it (validate, monitor temp, lab tests, etc)

Controlled by My customer (e.g. roasting)

Documentation required (some deadlines delayed)


Written Assurances

#SFC2018

ยง PC Human Food, PC Animal Food, FSVP, and Produce Safety all include them ยง Communication from supplier is still required ยง Guarantee from customer to supplier is under enforcement discretion ยง FDA is reconsidering due to complexity of supply chain


How to Describe the Hazard

#SFC2018

§ Draft Guidance § Biological hazards, general is ok – “microbial pathogens”; “microorganisms of public health significance” § Chemical, physical should be specific – “stones”, “mycotoxins”, “aflatoxin”

§ ABC Example for Salmonella: § “Almonds are not processed to adequately reduce the presence of microorganisms of public health significance”


Food Contact Substances

#SFC2018

§ In contact with food but not expected to have any “technical effect” § Regulated as food under current definition § Requirement: hazard analysis, supplier evaluation, supplier verification § Enforcement discretion in place § FDA considers its existing premarket review to be adequate oversight


Co-Manufacturing & Supply Chain

#SFC2018

§ Human & Animal Food Preventive Controls, FSVP apply § The issue: co-manufacturers often do not manage their customer’s suppliers


Co-Manufacturing & Supply Chain

#SFC2018

ยง FDA has decided not to enforce supply chain provisions until Nov. 2019, if: ยง 1) Brand owner conducts supplier approval and verification activities ยง 2) Co-manufacturer describes this in its plan ยง 3) Any additional required activities are conducted

ยง Receiving controls still required!


Accredited Third Party Certification

#SFC2018


#SFC2018

Supply Chain Resources


FDA Resources

#SFC2018


Guidance & Scientific Support § Food safety plan templates § Known potential hazards § FDA’s minimum expectation

§ Pathogen growth & toxin formation § Heat Treatment guidance § Control of Listeria

#SFC2018


Other Resources

#SFC2018

§ USP § Foodfraud.org § Food Chemicals Codex

§ Codex Alimentarius (EU) § USDA, other regulators as applicable § GMA, Almond Board, CFFA, PMA, and other guidance


#SFC2018

Thank You! Jon Kimble Senior Food Safety Manager Safe Food Alliance JonK@safefoodalliance.com

Corporate Office 710 Striker Avenue Sacramento, CA 95834 P. 916.561.5900

SFC2018 - FSMA Update  
SFC2018 - FSMA Update  
Advertisement