Allergen Controls FAQ
What are some dry-area cleaning techniques for human food allergen control?
Dry cleaning techniques may include vacuuming, scraping and wiping with dry cloths. Dry cleaning techniques may be product specific.
Food Safety Systems FAQ
How will the existing GFSI certifications of companies be affected by preventive controls?
Firms that have received GFSI recognized certifications will need to comply with FDA’s Preventive Controls regulation (unless they are subject to one of the exemptions) regardless of their certification. Third party audits and certifications will not be accepted in lieu of an FDA inspection; however, private audit certifications may be considered by FDA as they assess a firm’s performance history for work planning purposes. GFSI audits may also be useful with respect to supplier verification.
Can I use my existing HACCP plan and just add the things required for Preventive Controls?
Yes, your HACCP plan includes controls such as process controls applied at CCPs. Other controls such as sanitation controls may apply to your products, but you do not need to rewrite your HACCP plan to include these. In fact, you may already have programs in place in addition to your HACCP plan that address the Preventive Controls rule requirements. As long as these programs meet the requirements of the rule, you can use them and the existing records. You can also supplement your HACCP plan with other things required by the rule, such as a recall plan.
Why is it a good idea to include a product description and flow chart in my Food Safety Plan even though not required?
A product description and flow chart provide basic information and an organizational structure for conducting a hazard analysis. Documenting the information makes it easier to proceed through the hazard analysis without forgetting something. This information is also useful for explaining the decisions made during hazard analysis to others who may be reviewing your Food Safety Plan.
Do I need to validate my Recall Plan?
No, recall plans are not subject to the requirements for validation.
Do I have to use a certain format for the Hazard Analysis? What HACCP formats are accepted?
No, there is no required format. The company can choose the format that they wish as long as the format addresses the requirements of the regulation.
Do I have to split every variation of a product I make into separate Food Safety Plans or can I combine them?
A Food Safety Plan may cover multiple products when the hazards and controls are the same for the foods or any differences are clearly identified in the Food Safety Plan.
FSPCA Background FAQ
What is the Food Safety Preventive Controls Alliance (FSPCA)?
The Food Safety Preventive Controls Alliance (FSPCA) is a public-private partnership of key stakeholders from the food industry, academia and government. The Alliance seeks to develop an industry-oriented food safety training program to help firms producing human and animal food for the U.S. market to comply with preventive controls regulations required by the Food Safety Modernization Act (FSMA).
What prompted the creation of the FSPCA?
The food safety preventive controls regulations that will be issued by the U.S. Food and Drug Administration (FDA) will require facilities that manufacture, process, pack or hold food for humans and animals put measures in place to help prevent foodborne illness by implementing preventive controls for hazards. The FDA funded FSPCA to develop training that will help industry, particularly small- and medium-sized companies, to comply with the new preventive controls rules.
How was the FSPCA created?
FSPCA was created from a one-year, $1 million partnership grant funded by the FDA Office of Foods to the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH). The FSPCA Organizing Committee consisting of key stakeholders representing food industry trade organizations, state and federal regulatory agencies and extension specialists from academic institutions was formed and the FSPCA Coordinator was appointed. In addition, the Organizing Committee, the FSPCA Coordinator and ad hoc advisors held discussions resulting in the development of the management structure of the Alliance and established the Executive and Steering Committees. Ad hoc advisors were selected based on their experience in previous industry-wide alliances such as the Seafood HACCP Alliance and/or with expertise in the development and delivery of seafood and juice HACCP training.
What is the mission of the FSPCA?
To support safe food production by developing and delivering educational programs that assist the food industry in complying with the preventive controls regulations that will be promulgated in response to the FSMA.
How will the FSPCA meet its mission?
The Alliance will develop, deliver and facilitate training curriculum for food industry personnel and state and federal regulators. Modules will also include train-the- trainer instruction.
What are the scope and roles of the FSPCA?
The FSPCA includes human and animal foods regulated by the FDA. The FSPCA will focus on all major food commodities and sectors, with the exception of those excluded by the preventive controls regulations.
The roles of the Alliance are to:
- Develop a standardized training curriculum on preventive controls for food.
- Serve as the network hub for preventive controls knowledge database.
- Assist FDA in disseminating to the food industry the science and technical element relevant to the hazard analysis and preventive controls aspects of the preventive controls regulations.
- Serve as a bridge between FDA and food companies to communicate technical elements of preventive controls regulations.
- Develop example control models for major industry sectors.
- Provide science-based interpretation of hazard analysis and preventive controls for major industry sectors.
- Help provide guidance for preventive controls for the food industry.
What are the main outcomes and deliverables of FSPCA?
The primary outcomes and deliverables of FSPCA include:
- Development and delivery of a standardized hazard analysis preventive controls training curriculum. The training curriculum will be made available through FDA and IIT IFSH’s websites to all who wish to use it as a basis for training.
- Development of a technical assistance network for the U.S. food industry, with emphasis on small- and medium-sized companies.
- Assist in development of commodity/industry sector-specific hazards guides.
- Identification and translation of knowledge gaps and needs assessment for further enhancement in preventive controls.
- Evaluation of efficacy and impact of FSPCA programs.
What is the structure of FSPCA?
The governing organizational components of FSPCA include the FSPCA Coordinator, Executive Committee, Steering Committee and various subcommittees and task-, commodity- and sector-specific Working Groups formed to conduct specific needs. The FSPCA Steering Committee includes members representing food industry trade organizations, state and federal regulatory agencies and extension specialists from academic institutions. The Alliance is managed by IIT IFSH and by the FSPCA Coordinator with the aid of the Executive Committee and ad hoc advisors.
What is the Status of the FSPCA Working Groups?
The FSPCA Working Groups have been formed and are currently filled to capacity. If the need arises, the FSPCA will make a call for additional Working Group volunteers.
Will there be a Working Group specifically focused on a commodity or product in which my company is interested?
Five initial working groups have been created by FSPCA:
- Hazard Identification and Preventive Controls Core Curriculum Development
- Food Categories and Representative Processing
- Allergen Management and Control
- Sanitation, Current Good Manufacturing Practices and Environmental Monitoring
- Supply Chain and Ingredient Management
Additional FSPCA Working Groups will be formed as deemed necessary by the Steering Committee and will consist of members nominated by (or appointed in consultation with) the Steering Committee.
How can I participate in FSPCA activities?
Although FSPCA Working Groups are currently filled to capacity, there may be a need for additional FSPCA volunteers in the future. If the need arises, the FSPCA will make a call for additional Working Group volunteers who are subject experts in their field.
FSPCA Courses FAQ
Will the Food Safety Preventive Controls Alliance Course be an online training course or will trainees be required to attend a formal classroom study?
For now the FSPCA’s Standardized Curricula for the human food and the animal food Hazard Analysis and Preventive Controls for participants courses will be instructor-led and are expected to last 2 ½ days each. There has been discussion of training that will consist of an online portion followed by an in-person portion lasting a day or less, but development will begin after in-person courses are launched.
Will there be a Certificate issued after successful completion of the Food Safety Preventive Controls Alliance course to prove I’ve completed the course?
Yes, there will be a certificate of completion for the course. A unique number will be associated with each valid certificate.
How much will it cost to attend the Food Safety Preventive Controls Alliance human food or animal food course?
The cost of the courses will be set by the entity offering the course. The FSPCA training certificate will cost $50. Course offerings and prices will be included on the FSPCA website when information is available.
Will I need to pass an exam in order to successfully complete the FSPCA course? AFDO seafood HACCP courses don't require a final test to evaluate knowledge.
At the present time, an exam is not required by FSPCA to assess proficiency. In order to receive a certificate of completion, students must attend the class and actively participate in the exercises. However, an instructor may choose to use an evaluation tool such as a test to assess successful completion of the course.
When will the Food Safety Preventive Controls Alliance Training be offered?
Course offerings will be included on the FSPCA website when information is available.
FSPCA Lead Instructor FAQ
How can I become a Food Safety Preventive Controls Alliance Lead Instructor?
Visit the FSPCA homepage and click on “Apply to become an FSPCA Lead Instructor”. To become a lead instructor you must meet the selection criteria posted on the website, attend the FSPCA standardized curriculum training (participant course) for Hazard Analysis and Preventive Controls for Human Food and / or Animal Food (whichever is applicable), AND attend an FSPCA train-the-trainer course.
Will the Food Safety Preventive Controls Alliance instructor training be limited to independent consultants, or will food companies be allowed to get their own internal instructors trained as FSPCA certified instructors?
Anyone can become an FSPCA Lead Instructor course if they meet the selection criteria posted on the FSPCA website, attend the FSPCA standardized curriculum training (participant course) for Hazard Analysis and Preventive Controls for Human Food and / or Animal Food (whichever is applicable), AND attend an FSPCA train-the-trainer course.
Can an extension faculty in a university be an instructor for both animal and human food preventive controls?
Yes, extension faculty can become an FSPCA Lead Instructor for each course if they meet the selection criteria posted on the FSPCA website, attend the FSPCA standardized curriculum training (participant course) for Hazard Analysis and Preventive Controls for both Human and Animal Food, AND attend the FSPCA train-the-trainer course for both Human and Animal Food.
FSPCA and Other Training FAQ
Would completion of the FSPCA course satisfy requirements to become “qualified individual”?
The definition of a preventive controls qualified individual in 117.3 of the final preventive controls rule is as follows:
Preventive controls qualified individual means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
The FSPCA course is the standardized curriculum that FDA considers adequate; taking the FSPCA training will meet the requirements in the rule for training of a preventive controls qualified individual.
How does the FSPCA training integrate with other existing training such as better process control school, GAPs etc.?
These are all separate types of training directed at specific industry segments.
Do companies subject to both USDA and FDA requirements need to take the FSPCA training?
The rule indicates that training is one way to become a qualified individual, but experience is another. The qualified individual must be familiar with all of the requirements of the FDA Preventive Controls regulations and some components of a Food Safety Plan differ from USDA HACCP requirements.
FSPCA Train-the-Trainer FAQ
Will there be a separate train-the-trainer process for the animal food curriculum?
Yes, there will be a separate train-the-trainer course for the animal food curriculum. We want to ensure that individuals teaching the animal food course are familiar with the specific information that is applicable to the animal food industry, so we will ensure that there is a separate train-the-trainer from the human food training course.
Will there be a Food Safety Preventive Controls Alliance train-the-trainer training for instructors?
Yes, train-the-trainer course will be offered in the Fall of 2015 after the Preventive Controls regulations are published and the human and animal food curricula are revised.
Will State Departments of Agriculture staff be eligible to provide the Food Safety Preventive Controls Alliance training for industry?
Yes, state officials can become FSPCA Lead Instructors and teach the FSPCA course if they meet the selection criteria posted on the FSPCA website, attend the FSPCA standardized curriculum training (participants course) for Hazard Analysis and Preventive Controls for Human Food and / or Animal Food (whichever is applicable), AND attend an FSPCA train-the-trainer course.
When will the FSPCA train-the-trainer applicants hear from the FSPCA after the application is turned-in?
Applications are being actively reviewed by the Alliance Review Committee and timeframes have been established for delivery dates if you are accepted as a candidate.
To keep you informed, here is a TENTATIVE timeline:
|
August 31, 2015 |
Final PC Rules for human food and animal food sent to Federal Register |
|
September 2015 |
Anticipate FSPCA standardized curriculum training (participants course) for Hazard Analysis and Preventive Controls for Human Food will be finalized |
|
March 2016 |
Anticipate FSPCA standardized curriculum training (participants course) for Hazard Analysis and Preventive Controls for Animal Food will be finalized |
|
November 2015 |
Multiple deliveries of FSPCA Standardized curriculum training (participant courses) for Hazard Analysis and Preventive Controls for Human Food and Train-the-Trainer courses to meet demand |
We will notify selected applicants when training dates have been determined. Please keep checking the FSPCA website for announcements regarding these future training sessions.
Process Control FAQ
Is there a right way to use a Process Control vs. an Allergen Control or can I decide which one to use?
There is flexibility provided to apply preventive controls as appropriate to the food, the facility and the nature of the preventive control and its role in the facility’s food safety system. It does not matter what you call a preventive control.
Can you really calibrate a metal detector?
The definition of “calibration” is evolving. For a Food Safety Plan if metal is identified as a significant hazard, you must determine the parameters that will enable detecting metal in your product and package, which will also depend on belt speed, aperture, etc. This is usually conducted by the metal detector supplier. Ongoing verification by the facility to ensure that the detector continues to operate as it was set up is required.
Sister Alliances FAQ
What’s the alliance for produce safety?
The Produce Safety Alliance is a collaboration between Cornell University, FDA, and USDA to prepare fresh produce growers to meet the regulatory requirements included in the United States Food and Drug Administration’s proposed Food Safety Modernization Act (FSMA) Produce Safety Rule. For more information about the Produce Safety Alliance including national produce safety collaborators, educational materials, and FSMA updates visit the Produce Safety Alliance website at: producesafetyalliance.cornell.edu.
How is FSPCA working together with the Produce Safety Alliance? There are similarities and involves some of the same individuals.
We do things differently, because the FSPCA is responsible for such a wide variety of different regulative food as opposed to the PSA but we have the same goals, we do things little bit differently but we do share materials with that. We keep in very close contacts. There are a few overlaps and there are some places where we can leverage each other and one of the things that we have come up with is some of the universities and extension folks maybe in a position to not only be a part of both alliances but be instructors for both PSA and FSPCA. So, we see a lot of overlap there.