The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. Sanitary Transportation is one of seven foundational rules proposed under FSMA since January 2011 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.
How much do you know about the Sanitary Transportation Rule? Test your smarts by taking the FSMA IQ Test hereSpecifically, the Sanitary Transportation rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers. It applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicles. Additionally, it impacts shippers in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico) or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or distributed in the United States. These requirements took effect April 2017 for shippers, carriers and receivers subject to the rule.
As the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and to develop programs for compliance, including Sanitary Transportation. This requires companies to document specific verification steps to satisfy regulations and meet food safety transportation requirements.
Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing Sanitary Transportation Requirements. To complete your own assessment, review and compare your programs to the questions in Table I.
Companies must have the appropriate systems in place to comply with FSMA Sanitary Transportation of Human and Animal Food requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their Sanitary Transportation programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.
This year is a big year for food safety at FDA. All seven of the FSMA rules have been finalized, and the first compliance date is right around the corner (compliance with the Preventive Controls for Human Food rule starts in September for large companies). Stephen Ostroff, M.D., just took the helm from Michael Taylor as the agency’s deputy commissioner for foods and veterinary medicine. And finally, FDA is taking a hard line in both improving the tools and methods used to detect outbreaks as well as working with the Department of Justice to prioritize enforcement actions against companies that introduce adulterated foods into the supply chain.
Yesterday Ostroff provided an update on FDA’s recent initiatives and its plan of action to achieve success in FSMA implementation and pathogen detection at the IAFP annual meeting in St. Louis. Ostroff highlighted several tenets of FSMA:
Keys to FSMA success will be dependent upon achieving high rates of compliance
Domestic and import parity
Education before and while regulating (establishment of training and education networks)
Taking a risk-based approach to inspection and planning
Partnerships are critical
Industry can expect three more rulemakings as required by FSMA in the areas of lab accreditation, a reportable food registry and product tracing. In addition, FDA is working on guidances related to the preventive controls, produce, and foreign supplier verification program rules. “We’re tantalizingly close so stay tuned,” Ostroff said.
Expect to see more program alignment with the Office of Regulatory Affairs as well. The inspection and compliance staff will be trained as specialists and there will be horizontal integration of programs between field activity and agency headquarters. Although the next fiscal year will be a transition year, Ostroff is hopeful that changes that need to be made at the agency, along with program alignment, will be in place by fiscal year 2018.
Other notable actions at FDA over the past year include:
In response to the OIG’s conclusion that FDA’s food recall program is not efficient or effective, the agency is ramping up its use of the strategic CORE (Coordinated Outbreak Response and Evaluation) network in order to examine recalls that might not be moving as smoothly or quickly as the agency prefers. FDA is also leveraging greater application of whole genome sequencing (WGS).
GenomeTrakr network and WGS. More than 50,000 genome sequences have been added to the database (largely Salmonella). Ostroff called WGS a game changer that holds the opportunity to more quickly identify problems and detect outbreaks while they’re still quite small. In partnership with the CDC, FDA set up a successful module for WGS of Listeria and the agency hopes to expand the model for use with other pathogens.
Nutrition (Not just what consumers are eating, but how much of it): The move that declared partially hydrogenated oils as no longer GRAS with compliance required by 2018. The agency also issued a final guidance on menu and vending labeling in May, issued levels for arsenic in infant rice cereal, made determination for folic acid fortification in corn/masa, made revisions to nutrition facts labels that takes effect in 2018, issued a draft guidance on voluntary sodium reduction, and will continue to exam the terms “natural” and “healthy”.
Genetic engineering. FDA approval of GE salmon following one of the longest reviews in the history of FDA (20-year review), along with issuing voluntary labeling guidance.
Monitoring antimicrobial resistance through NARMS (National Antimicrobial Resistance Monitoring System). FDA will be collecting antimicrobial sales by species and, in cooperation with USDA, hopes to release farm-based data about antimicrobial use at the farm level.
Ostroff emphasized FDA’s strategic 10-year plan, released this year, pointing to public health as a first priority, maintaining partnerships as a key to success (including re-establishing overseas offices), continuing research as a foundation, and maintaining transparently.
How will FDA enforce the new FSMA rules? It’s a question that has been circulating throughout industry over the past few months, and it will be answered at this year’s annual Food Safety Consortium conference next month. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA will deliver the opening plenary presentation on November 18, which will be followed by an “Ask the FDA” interactive town hall meeting. During the afternoon,
Roberta Wagner, deputy director of regulatory affairs at CFSAN will discuss FSMA implementation and FDA’s strategies for gaining and maintaining industry compliance with the new rules. The agency will also be participating in several conference sessions dedicated to the FSMA rules that will be finalized by November, including:
Foreign Supplier Verification
Preventive Controls in Human Foods
Preventive Controls in Animal Foods
Voluntary Qualified Importer Program
During the event, USDA’s Food Safety and Inspection Service (FSIS) will also be answering questions related to regulatory compliance and food safety issues at a Small Plant Help Desk.
Beyond FSMA-related topics, the Food Safety Consortium conference will feature several concurrent food safety and quality assurance tracks, workshops and training programs in compliance, food manufacturing and operations, supply chain management, food labs, and foodservice and retail. Food Safety Culture is an especially hot topic right now, and the conference will address the practical ways to actually measure behavior and start taking action. Frank Yiannas, vice president of food safety at Walmart will deliver a keynote presentation, “Food Safety = Behavior” on Wednesday, November 18.
You can adjust all of your cookie settings by navigating the tabs on the left hand side.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Analytics to collect anonymous information such as the number of visitors to the site, and the most popular pages.
Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!
We also use a Tracking Beacon from our email services provider Act-On that allows us to track interest in articles and subject areas of interest to our Newsletter Subscribers.
Keeping this beacon enabled helps us in deciding the topics that are of interest to our Newsletter Subscribers.
Please enable Strictly Necessary Cookies first so that we can save your preferences!
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.