Poultry processing plants may soon evaluate new technologies for their food safety program. Using a new technology, however, requires an understanding of the federal regulatory process.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS) has issued revised guidelines to assist poultry establishments in controlling Salmonella and Campylobacter in raw poultry, so plants are likely considering new technologies for food safety. The following overview summarizes the components of the FSIS’s New Technology Procedure and the factors to consider when implementing new technologies.
New technologies
The FSIS defines new technology as “new or new applications of, equipment, substances, methods, processes or procedures affecting the slaughter of livestock and poultry or processing of meat, poultry or egg products.” New substances are sometimes referred to as new ingredients.
This definition is so broad that it can be difficult to know when a review is required. A simple guideline is that anything outside previously reviewed parameters must be re-evaluated. For example, a new review would be required to use a substance at a concentration or location outside the originally evaluated parameters.
In contrast, as long as adjusting concentration or changing nozzles remains within the original parameters, no new review is needed. When in doubt, review FSIS guidelines or submit a question using AskFSIS (see sidebar).
In recent years, new technologies have improved the safety of poultry products. In particular, novel antimicrobials and antimicrobial application methods have been reviewed and implemented at multiple stages of poultry processing.
FSIS doesn’t approve new technologies. It reviews information submitted and then issues a Letter of No Objection if it has no concerns regarding the use of the technology.
Requesting a review
New technologies can be proposed by technology owners, processing plants or other interested parties, and are submitted to the FSIS using the notification process.
A notification should include sufficient information for the FSIS to determine the suitability, safety and regulatory compliance of the new technology. Components include:
- A description of how the technology will be used, containing items such as application method and operational parameters.
- Scientific support to describe the usefulness of the technology within the processing plant system. Examples of types of scientific support are published processing guidelines, peer-reviewed scientific data, well-controlled challenge studies, a pathogen modeling program or data gathered by an establishment.
- Safety of inspection program personnel: either documentation that the technology is safe or a description of the safety measure to be implemented (shields, ventilation, personal protective equipment, etc.).
- Documentation that product safety and wholesomeness aren’t adversely impacted. When the technology is a substance, the Food and Drug Administration (FDA) is responsible for determining safety. Examples of acceptable safety information include a FDA safety determination, generally recognized as safe (GRAS) notice, food contact notification (FCN) or data from prior approvals from other organizations such as the Environmental Protection Agency or the Occupational Safety and Health Administration.
- For substances, documentation that the substance is consistent with the FDA’s processing aid definition or whether it will be added to product labeling.
- Information supporting the technology will not interfere with inspection procedures.
- Confirmation that the technology complies with humane slaughter guidelines.
- An explanation of how the new technology fits into existing regulations. If technology doesn’t fit into current regulations, a waiver request is submitted. The FSIS is allowed to grant a waiver for a limited period of time in order to permit experimentation or while regulations are amended.
- Protocols may be submitted to provide guidance for executing the technology in establishments (see sidebar).
Results of a review
After submission, FSIS will review the application, usually within 60 days. Primary FSIS responses are:
- Issuance of a No Objection Letter stating the FSIS has no objection to the new technology. In addition, FSIS Directive 7120.0 will be updated with new substances and on-line/off-line processing technologies.
- Issuance of a Grant Permission Letter allowing an establishment to conduct in-plant trials.
- Issuance of a No Objection Letter with Waiver that will allow the establishment to use the new technology per waiver conditions until the regulation is amended.
- Proposal of temporary suspension to allow the submitter to provide additional scientific support.
Implementation
Establishments are responsible for implementing new technologies in a manner that ensures continued product and worker safety. Implementing new technologies requires careful pre-planning to evaluate the impact of the new technology within the establishment.
When deciding whether to use a new technology, establishment personnel should
- Discuss whether the new technology will be replacing or adding to the current procedures.
- Closely review the new technology operating parameters to confirm they work within the establishment.
- If the new technology would be used under a regulatory waiver, discuss whether the establishment is willing to fulfill the extra obligations.
- If the establishment exports product, determine whether the technology is acceptable to other countries.
- If new substance requires a label change, determine whether this is acceptable to customers.
Once a decision is made to implement a new technology, it must be assessed within the establishment’s infrastructure, Hazard Analysis Critical Control Point (HACCP) plan and food safety system.
- The scientific and technical data included in the New Technology Notification should be used to design the appropriate validation plan.
- Each processing plant must obtain in-plant validation data demonstrating the new technology performs as expected within the HACCP system control measures, and that the new technology satisfies its intended food safety objective.
- Establishments must maintain scientific supporting documentation for as long as the technology is used.
- New technology effectiveness evaluation should be incorporated into the on-going food safety system verification and record keeping.
SIDEBAR: When processing plant data is required
Sometimes, the confirmatory data to approve a new technology can only be obtained in a federal inspected establishment under commercial conditions. These in-plant trials are conducted using protocols reviewed by the FSIS.
Protocols contain scientific technical support and describe in detail the implementation process for new technologies. While a protocol may be submitted with any notification, it is required prior to in-plant trials.
The in-plant trials are conducted using the reviewed protocol. Upon completion of in-plant trials, the FSIS will review the results and determine whether the data provides sufficient evidence to issue a no objection letter or whether additional in-plant trials are needed. When the in-plant trial is associated with a waiver of regulatory requirements, conditions of the waiver remain in effect until the regulation is changed or the technology is removed.
FSIS New Technology References
Additional information can be obtained at the following locations:
- The Food Safety and Inspection Service's New Technology Website contains links to multiple other references, including a summary table of the most recently issued no objection letters and a complete listing of new technologies: https://www.fsis.usda.gov/inspection/compliance-guidance/new-technology
- AskFSIS may be used to submit questions. For new technologies, use the inquiry type of “New Technology, Innovation.” https://www.fsis.usda.gov/contact-us/askfsis
