Frank Schreurs answers to the questions raised during the webinar.
1. Mark
Sec.112 is Allergens and it starts off with the following early childhood education program.--The term "early childhood education program"?
I suspect this is a generic term to encompass all pre-school types of programming and if a manufacturer has contracted to provide food to such a program then the need for allergen control would be required.
2. Thies
The risk categories are still under proposal and not final. How can we still lobby to get a material included or excluded?
The best avenue would be through your relevant trade associations as they have an already established conduit to FDA for commenting. The public comment period for the specific documents (Docket) has ended and is no longer available through the FDA website.
3. Antonella
Hi, Frank. Is the FSMA strategic for the upcoming trade agreements between EU and North America, such as the TTIP?
I have not seen anything to suggest it is a major player in the negotiations of any of the trade agreements. There may be some upcoming trade dispute cases if any country exporting to the U.S. feels that it imparts an unfair trade barrier. The dispute resolution aspect of trade agreements is intended to handle specific cases.
4. Rajesh
Is inspection will be mandatory?
Inspection by FDA or a recognized representative of FDA is part of FMSA. The frequency and who will do it has not been published, other than FMSA does require FDA to partner with various stakeholders to accomplish this requirement.
5. Mahmoud
Are any of GFSI RECOGNIZED SCHEME enough for supplying from outside USA?
They will not initially be “enough” to gain automatic entry. The future application of the Voluntary Quality Importer Program (VQIP). Below is an excerpt from FDA site: The FDA will use certifications issued by accredited third-party auditors for two purposes under FSMA. First, section 302 of FSMA authorizes the FDA to create the Voluntary Qualified Importer Program (VQIP), which provides for expedited review and entry of food into the United States. In order to participate in VQIP, importers must import food from certified facilities. The criteria and procedures for VQIP participation are outside the scope of the third-party auditor rulemaking. The FDA will issue a draft guidance establishing VQIP in the future and will solicit public comment on VQIP at that time.
6. Jon
Any information about when the lamb meat export ban will be lifted to export it from the UK please?
None that I can comment on.
7. nourreddine
Did FDA had capacities to ensure the compliance of all products (domestics products, importer, exporter..)
It is a publically known fact that FDA does not currently have the capacity to monitor compliance to all products produced in the U.S. or imported to the U.S. Hence the FSMA requirement that FDA seek partnerships to assist in this.
8. Bruce
Where can I find risk categories for various foods? And the difference in FSMA requirements for each.
A definitive list has not been published since the methodology to classify a product/process has high risk has not yet been implemented. One could make their own preliminary determination by reviewing the draft methodologies. Here is a link to get the pdf document:
http://www.fda.gov/F...A/ucm380210.htm
9. Murali Krishna Bujji
What is the difference between import alert and import refusal
Import Alert: The alert lets FDA field staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. Veneziano says there are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on import alert. For example, questions could have been raised in an inspection of the manufacturing site or flags could have been raised by a recall of products already on store shelves. There could be a history of problems with no signs that appropriate actions were taken to remedy the cause, or problems related to production, such as harvesting from water that appears polluted. Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.
Import refusal - FDA can refuse admission into the U.S. of imported products if, among other reasons, the product appears to be adulterated or misbranded.
10. Mark
I can't find real clear cut info about adding radioactive into the HACCP program.
The proposed rule would include a radiological agent in the definition of “hazard” because FSMA includes radiological hazards as an example of known or reasonably foreseeable hazards that may be associated with the facility.
11. Andrea
What about BRC issue 7, with its new requirements on food defense, adulteration?
These changes align well with FSMA requirements and are not a duplication.
12. Javier
Isn't HARPC only in the USA?
The inclusion of preventative controls is a requirement in all HACCP plans for any company that will be exporting to the U.S.
13. Jeremy
With the limited funds available to the FDA they cannot immediately cover all areas discussed today; do you know of their priorities? What areas should companies prioritise first?
The FDA compliance approach will not be parceled out in terms of parts of any specific regulations. Hence companies should be prepared to meet all of the requirements that would apply to their type of operation.
14. Carlos Armas
Simon/Frank: What could be some impacts on 3rd Party Auditing firms, as it relates to FSMA
Auditors may be required to be approved specifically by FDA either through a competency exam or other assessment methods. Auditors, through their associated CB’s, may be approved through the CB accreditation process, similar to how it is currently applied to specific schemes that a CB is licensed to.
15. Kip
Have the thresholds for who is exempt been finalized? I work with many small/medium sized farms and packing houses, and all of them think they're exempt
The exemption thresholds are illustrated in the final few slides of the presentation, as they have currently communicated by FDA.
16. Brian Heldt
If FDA doesn't have the finances for increased personnel, why do they think that state, municipal, or foreign entities will?
Some of these other entities will look to sub-contract to FDA through various shared financing models.
17. Kirsten
Does FSVP apply to primary (food contact) packaging as well as ingredients?
Applies only to ingredients and finished product production facilities. These facilities may require food contact packaging suppliers to also comply as part of their supplier monitoring programs.
18. Kirsten
If manufacturing private label products, and the customer wants to send in their own ingredients (perhaps from out of USA), what is the manufacturer's obligation for verification
Kirsten supplier (foreign or domestic) -- will being certified to a GFSI scheme be sufficient or will the company buying the ingredient have to do their own audit?
There would need to be clear lines of responsibility spelled out in the contract with the customer as to who is the importer. It is the importers responsibility to ensure the ingredient manufacturer is compliant.
19. Rajesh
Is inspection gonna be mandatory for importers
Yes, they will be subject to some frequency of inspection/audit.
20. Magdalena
How it will affect manufacturers of food processing machinery? Any new req?
FMSA does not regulate equipment manufacturers. They will still need to meet the requirement of their customers, who may be under FSMA regulations.
21. Mark
WHAT ABOUT LEGAL WISE ARE WE AS AUDITORS HELD ACCOUNTABLE FOR OUR AUDITS IF ASKED BY FDA? NO IT MENTIONS THAT IN THE FIRST SENTENCE IN FSMA ACT
If the auditor is contracted to a CB, industry will need to include language in client contracts that states that if there a imminent risk to consumer safety the auditor may be required to report this directly to FDA. At issue is or legal right to do so if not stated in a business to business contract.
