Food labels review for entry to the US, EU and UK markets.
Current good manufacturing practice and hazard analysis and risk-based preventive controls for food for humans
This rule applies to food facilities - registered with section 415 of the Food, Drug, & Cosmetic Act - and requires them to have a food safety plan implemented that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.
The concerned facilities are required to have and implement a written food safety plan that includes a number of points:
Standards for the growing, harvesting, packing, and holding of produce for human consumption
The Produce Safety Rule applies to covered farms and “establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.”
However, these standards don’t apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity.
Also, the main requirements involve the following:
Sanitary Transportation of Human and Animal Food
The main goal of this rule is to keep food safe from contamination during transportation by preventing issues such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.
Its requirements apply to shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food. Nonetheless, these requirements don’t apply to transportation by ship or air due to limitations in the law.
On the whole, the rule establishes several requirements:
Accredited third-party certifications The rule establishes “the framework, procedures, and requirements for accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification bodies seeking accreditation.”
These entities will be able to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.
Also, the FDA published a public registry of recognized accreditation bodies on their website, as well as a list of accredited third-party certification bodies.
FSMA mentions two uses for certifications under this program:
Foreign Supplier Verification Program (FSVP)
The Foreign Supplier Verification Program regulation applies to importers of food (human and animal) into the United States. It requires said importers to perform certain risk-based activities to check that the food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
According to this regulation, an importer is defined as “the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.”
Moreover, importers are responsible for actions such as:
Current good manufacturing practice and hazard analysis and risk-based preventive controls for food for animals
The requirements of this rule apply to animal food facilities as well, and oblige them to have a food safety plan in place as in the case of the previous rule mentioned.
Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic Act must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies).
Apart from the safety plan which is similar to the food facilities producing human food, covered facilities must follow Current Good Manufacturing Practices (CGMPs) for animal food production that have been created while taking into consideration the unique aspects of the animal food industry.
Mitigation strategies to protect food against intentional adulteration
This rule is concerned with “preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.” Its requirements apply to both domestic and foreign companies that are required to register with the FDA as food facilities - the rule doesn’t, however, cover very small businesses and farms.
All the facilities covered by the rule must develop and implement a written food defense plan that includes an analysis of vulnerabilities, implementation of mitigation strategies, procedures for food defense monitoring, corrective actions, and verification.
Dima completed her assignment successfully and timely providing an informative report and participated actively in enriching discussions during a related Expert Group Meeting. She is among the best consultants we have had the privilege to work with in recent years.
Dr. Faour-Klingbeil contributed to our project by highlighting the gaps and identifying areas for improvement and development in the standards and criteria of the Quality Mark application. We highly recommend her as a skillful consultant.
Thank you once again for your input and the tips. I really enjoyed the training and I feel well prepared to implement the missing parts to be fully compliant
Dima did a great job, the training was very interesting!
Interesting and helpful discussions! Thank you for the professional PCQI training
I enjoyed the three days in the PCQI training. You did it very well and explained it so good that everyone could understand
Thanks Dima for the PCQI training. The explanations and references you have given, will be helpful to improve our Food Safety Plans.
I recommend the PCQI training. I really appreciate the clear explanation of the terms and a lot of examples.
I like Dima´s checking in on the participants during the course to really make sure that they follow and grasp the concepts discussed. Lots of practical examples are given and make it easier to translate the often "dry matter"
Very clear explanation of the requirements for PCQI. We have had good and helpful discussions during this training.
I do recommend this course for QA peoples with general kowledge in HACCP. Not having a certified HACCP (according to IFS or others) isn't a handicap. I have joined this online training and presentation has been well prepared and clearly communicated. Also assessments in groups has been well organized
It was a nice insight into FDA requirements and regulations as well as good communicated by Dima. She is clearly a professional on this topic and can answer questions very well while also mentioning examples that are easy to understand. The challenge of doing this class online was mastered and presented in an interactive way to the given circumstances.
Dima has been a perfect trainer. It was a very useful training with a great oveview on the whole topic - clear intructions and clear understanding of the FDA requirements.
One of the best training in my life. Intense and very instructive and exciting.
Excellent PCQI course with very detailed topics and excellent examples.
If we have a need, we will be happy to contact Ms. Faour-Klingbeil as a consultant
Many thanks to this nice training! I got many useful information needed for this topic
Thanks so much for your very valuable training. I really enjoyed it, and appreciated that you made it fun! I feel much better prepared to deal with uncomfortable issues. Thank you for experience and personable presentation. Good course setup, nice trainer and good group discussions.
Dima is an outstanding trained and very patient instructor. Her interdisciplinary knowledge is impressive. She was very encouraging and answered all questions in a precise way. I surely will keep her contact details for further trainings.
The PCQI course was a very intense 2.5-day course to get a good overview and a feeling for establishing a food safety plan. I also got the impression, that the course leader (Dima) is an absolute expert on this field.
Great instructor and trainer! giving a lot of examples and taking her time to answer the individual questions.
The lead instructor Ms. Faour-Klingbeil is well-prepared person and has a lot of knowledge in regard to the subject.
Dima is really skilled. Interesting course to attend for any PCQI!
Interactive training with a highly motivated and knowledgeable instructor. Great materials, including links to current regulation texts for each topic.
I highly recommend this course with Dima Faour-Klingbeil. She provides really good training material and clear explanations with many examples. She manage to provide a really interesting course that I was pleased to follow until the end!
Participating in this PCQI training you definitely deal with an extraordinary trainer. Dima has a real expert status.
Mrs. Dima Faour-Klingbeil is a great Teacher. She is very clear during the explanation. Always she tries to add examples in order to make it easier. It was a pleasure working together with her and learning about this regulation.
Dima is a very professional trainer and instructor and is perfect for explaining sometimes difficult requirements in easy-to-understand sentences. Very useful training, very helpful, good trainer! We appreciate working with her.
The lead instruction showed a broad knowledge of the FDA regulations, shared additional support links, and encouraged all participants to a lively discussion.
Food labels review for entry to the US, EU and UK markets.
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