ASTA Update Cheryl Deem Executive Director ASTA Update Allergens - - PowerPoint PPT Presentation

ASTA Update

Cheryl Deem Executive Director

ASTA Update

 Allergens – very low levels, not EMA  Codex Committee on Spices & Culinary

Herbs

 FSMA…specifically FSVP

Allergens – low levels

 FDA unlikely to set thresholds, despite

legal authority to do so

 Best option is prevention of cross-

contact

 Determine where cross-contact is occurring  Educate farmers/others in supply chain in

effort to prevent

 Provide tools to prevent

Allergens – low levels

 Until source found, provide industry with

information

 Understand regulation  Guidance on incidental cross-contact

○ FDA says labeling not necessary for residue

• r trace amounts that are the result of

incidental cross-contact

 Use of risk assessments

Allergens – testing

 FARRP study on peanut in cumin

 ELISA Kits: no false positives, adequate job

detecting presence of peanut, variability

 Lateral Flow: no false positives, variability  PCR – extreme variability

 ASTA/FARRP Hands On Workshop

Codex

 Issue at Sept. 2015 meeting - scope:

“applies to …offered for industrial food production, as a condiment and for direct human consumption or repackaging if required. It does not apply to the product when indicated as being intended for further processing.”

 Standard applies at import and as

written, essentially only apply to RTE

Codex

 US estimates that covers <5% of

imports

 US and Canada oppose current scope –

widely supported by others

 Narrow scope means a lot of time,

money being spent to develop standards that basically won’t apply to anything

 US developing definition of “further

processing”

Foreign Supplier Verification Program

 What is FSVP?  Who is responsible for implementing

FSVP?

 When is the foreign supplier covered by

FSVP?

 What will foreign suppliers be required

to do?

 What resources are available to help me

comply with FSVP?

What is FSVP?

 Program designed to ensure that food

imported into the U.S. is produced in a manner that meets U.S food safety standards

 Is not adulterated  Is not misbranded with respect to

allergen labeling

Who is responsible for implementing FSVP?

 The person in the U.S. who either owns

the food, has purchased the food or who has agreed to purchase the food at the time of entry into the U.S.

The Importer’s FSVP Plan

 Evaluate imported food for potential

hazards

 Evaluate performance of each foreign

supplier

 Plan and perform periodic and

appropriate supplier verification activities

When is the foreign supplier covered by FSVP?

 Depends on where in supply chain

hazard is controlled

 If hazard controlled before import,

foreign supplier subject to FSVP

 If hazard controlled downstream in U.S.

by facility subject to Preventive Controls, FSVP does not apply

What will foreign suppliers be required to do?

 The importer – your customer – will

contact you about their FSVP and what they will require

 Develop and implement Preventive

Controls system for your facility

Example

 Facility outside of US provides steam

treatment for pathogens (Salmonella)

 Overseas facility is controlling hazard –

subject to FSVP – must implement Preventive Controls – Food Safety Plan

 U.S. importer required to verify food

safety plan, including annual audit because Salmonella considered a serious health or safety issue

Example

 If supplier overseas sells spice to U.S.

company and pathogen treatment takes place in U.S., supplier is not subject to supplier verification for that hazard (Salmonella)

 May still be subject to supplier

verification for other hazards (eg. foreign material) identified by U.S. company that are controlled by foreign supplier

ASTA Resources

 Clean, Safe Spices Guidance: best

practices for industry

 Good Agricultural Practices Guide  Good Manufacturing Practices Guide  HACCP Guide  FSMA Webinar Series

www.astaspice.org

FDA Resources

 Draft guidance to be released in 2016  Technical Assistance Network (TAN)  Frequently Asked Questions – will

expand based on questions asked by industry

www.fda.gov

ASTA Annual Meeting

April 10 – 13, 2016 360 attendees