I'm so pleased that there was interest in the presentation! I've worked with Abe Inouye on our team to provide written responses to the questions I answered during the webinar
- How this new system will affect industries that sell products to do the US?
It will affect all participants in the food industry who are selling products into the US. It affects them in two ways: directly, and indirectly. Directly, the registration requirement (which entails giving FDA permission to inspect your facility) and the Foreign Supplier Verification Program (which entails compliance with the Preventive Controls Rule and the Produce Safety Rule) will directly affect a lot of companies. But even if you are exempt, or are competing with products that are going to comply with these new rules, then indirectly, the marketplace could favor goods that comply with the new standards.
- Is there a process to assist the US Government for inspections in Mexico & Central America?
FDA has already begun expanding its international capacity. New FDA posts have been established in many countries around the world, including some in Mexico and Central America. Although FDA’s foreign offices have been and will continue to inspect foreign facilities (for compliance with US food safety laws), these foreign offices are shifting more resources towards helping the host government increase their technical, scientific, and regulatory capacities. FDA will continue to do inspections but the 3rd party accreditation program could result in other non-FDA individuals conducting audits in support of FDA requirements. They will not replace FDA inspections. Details on how this will work are not yet available.
The GFSI certified companies will be recognized as reliable for exporting U.S. without another party audit/inspection?
FDA has not officially recognized GFSI and just because a facility is certified to a GFSI scheme it does not get special treatment or any kind of exemption from FDA requirements or inspections. It is unknown at this time whether or not GFSI schemes will be sufficient evidence of compliance with the FSMA rules, by themselves or how much they will need to change what they are doing to be complaint. It is likely that GFSI certified companies will already be in compliance and will only need to make minor record-keeping adjustments. Through the third Party Certification Rule, GFSI benchmarked schemes and their certification bodies may be accredited by FDA to certify FSMA compliance as well. Again, this will not replace an FDA inspection.
- The 3rd party certificates would be expedite by a Government? Or by a certification body?
FSMA allows for accrediting several different types of entities who may serve as accreditation bodies, including the following: foreign governments, agents of foreign governments, foreign cooperatives, and other third parties (which could include private certifiers).
Once an entity has been accredited by FDA, then it can independently accredit third party auditors to go out and perform the audits using their own auditors. So the actual certificate of compliance may come from an pre-existing, private certification body that has been accredited by an FDA accredited body (like a foreign government).
- I am a third party auditor working for certification body and I live in Mexico. I would like be an auditor of FDA, to whom I must contact? Thanks a lot.
This question has not been answered yet. But, I would keep a closely follow the actions of at least three groups: the Produce Safety Alliance (which is developing the training requirements for the Produce Safety Rule), the Food Safety Preventive Controls Alliance (in charge of the Preventive Controls Rule), and the Association of Food and Drug Officials (AFDO). AFDO has been tasked with developing “train the trainer” materials. And of course, Leavitt Partners will always provide up-to-date notifications of new FSMA developments.
- Dear Jennifer, after listening to you I have the impression that European regulations are, currently, stricter, modern and more complete than in USA. I usually hear how hard is for the Spanish food companies to export to USA, so I do not understand why that happens. What is your opinion? Maybe the problem is not regarding food safety requirements, but a long time consuming process. Thanks
While some foreign importers may have complaints about the time consuming nature of importing food into the US, the new FSMA rules should reduce that burden. Under the Voluntary Qualified Importer Program, importers who can provide evidence that their goods go above and beyond the required food safety measures (which some EU regulated food companies may be able to show) will get a “green light” and will be able to move their goods through US customs more quickly.
- What is role in FDA for food safety of countries like South Asian?
FDA is continually expanding its presence throughout Asia by establishing foreign posts. These foreign posts will assist the host governments to expand scientific, technical, and regulatory capacity. The goal is to be able to help these foreign governments develop the expertise necessary to implement a regulatory system on par with the US standards.
- Does this included food contact packaging
Yes, the new FSMA rules do address food contact packaging. In the Preventive Controls Rule, chemical contamination from food contact packaging may be a hazard that needs to be controlled for through a Food Safety Plan. This would need to be controlled by the food facility using the packaging. While the packaging manufacturer may not be directly impacted by FSMA, their customer may be.
- Are foreign food manufacturers allowed to submit comments to the draft?
Yes. Comments must be in English, but FDA is interested in hearing from anyone who is affected by the rules.
See this webpage for more information on what Dockets are open for comment and how to make those comments. http://www.fda.gov/F...A/ucm261689.htm
Comments on the proposed preventive control rule and produce safety rule are open until Sept 16.