Final Rule for Sanitary Transportation

welcome and thank you for standing by your lines will be in listen-only mode until today's question and answer session the queue up to ask a question you may press star and then one today's conference is being recorded if you have any objections you may disconnect I would now like to turn the call over to Jason Thurman you may begin thank you good morning everyone and thank you for joining today's call and webinar my name is Jason Thurman and I am with the communications and public engagement section of FDA's office of food and veterinary medicine and I will be serving as your moderator today the purpose of today's call is to provide information on the FISMA final rule on sanitary transportation of human and animal food this webinar will be an opportunity for you to hear information on this rule and ask questions you may have if you have not already done so please make sure that you're logged in to the my meetings link provided so that you can view the slides as we are presenting during this morning's call we are extremely fortunate to have as today's speaker dr. Mike cash talk consumer safety officer at FDA's Center for Food Safety and applied nutrition who will discuss in more detail this final rule after its presentation we will open the call up and take your questions during a question and answer session and then with closing remarks before we get started I would like to remind callers that your lines will be in a listen-only or mute mode during the presentation until the question-and-answer session at this time I would like to turn the call over to our speaker dr. Mike cash talk thank you Jason and good morning to everyone on the webinar wherever you are listening from I'd like to get right into the presentation and as Jason mentioned the title of this rule is called sanitary transportation of human and animal food the rule is now final it was proposed on February 5th of 2014 then followed a comment period we received about 240 comments we developed the final rule taking those comments into consideration that final rule went on display on April the 5th and published on the following day this final rule I should say is based primarily on not the 2011 Food Safety Modernization Act but instead the 2005 sanitary food transportation act the 2011 law the FISMA did not directly address transportation but recognize that Congress had passed a transportation law six years prior and anticipated that upon completion of the rulemaking based on the 2005 law the regulations that we're talking about today would be part of an integrative or an integrated food safety system based on preventive principles the 2005 law is based on preventive principles and thus we can say that these regulations which are built upon preventative concepts build upon the safeguards and vision in the 2005 law there are four regulated categories of persons covered by the these regulations they are shippers receivers loaders and carriers who transport food in the United States by motor vehicle or rail vehicle whether or not the food is offered for or enters interstate commerce so the rule does apply then to intrastate shipments the final rule in some cases also applies to shippers who are outside of the United States and those cases would be when they ship food into the United States directly by motor vehicle or rail vehicle for instance from Canada or Mexico or when they ship a container to the United States by ship or by air over ocean and in either of these cases the foreign shippers from abroad arrange for the transfer of the intact container or the continuation of the rail or truck shipment in commerce within the US if the food will be consumed or distributed in the US so to visualize this if a foreign originated shipment has had the transportation arrangements for its overland segment by rail or motor vehicle in the US made by the foreign shipper in other words if he does not simply address transportation to the court of entry but makes arrangements for overland transportation within the u.s. than that for an individual as a shipper under this rule we have some categories of persons and activities that are not covered by this rule first shippers receivers are carriers with transportation operations less than $500,000 in average annual revenue are defined within the rule as a non-covered business transportation activities performed by a farm are not subject to this rule transportation activities involving transshipment of food through the United States for instance by truck originating in Canada through the US and then ending in Mexico that is a transshipment those types of shipments are addressed in regulations administered by Customs and Border Protection they are not subject to the requirements of this rule food that is imported in the US or for instance reprocessing and subsequent export that is not intended to be consumed in the US this is import for export is a specific category of activity that is addressed in other FDA regulations also continuing with activities not covered by this rule the transportation of any food that is fully enclosed by a container except if the food requires temperature control and we should have added here for safety if it requires temperature control for safety continuing on not covered is any transport of live animals except for the transportation of Y molluscan shellfish also not covered the transportation of compressed gases and the contact substances also not covered the transportation of human food byproducts for use as animal food or feed without further processing so now what is covered by the rule and what you see here are the three primary focal areas of coverage of this rule whereby if sanitary transportation practices were not adhered to we believe that there would be some potential for risk created number one any food transported in bulk meaning transport by tanker for instance where the food is in direct contact with the walls of the vehicle secondly transportation of packaged food that is not fully enclosed by a container that is covered example being trip much of the transportation of fresh fruits and third the transportation of food that requires temperature control for its safety there is a section in the rule one point nine oh six that states requirements for vehicles and transportation equipment summarizing some of the key requirements in that section vehicles and transportation equipment their design maintenance maintenance and storage must be appropriate to prevent – from becoming unsafe during transportation operations and if requires temperature control the vehicles and transportation equipment must be equipped as necessary to provide adequate temperature control we have another section in the rule 1.90 8 which states requirements for transportation operations here are some of the key requirements for transportation operations they must be conducted to prevent the food from becoming unsafe during transport including ensuring adequate temperature control preventing contamination of food by contact with rocky or with non-food items protection of whom from cross contact that would be from a protection against the incorporation of a food allergen into the food the unintentional incorporation of a food allergen and again protection of who transported in bulk we recognize in the rule that a person subject to this rule for instance as a shipper they also have operation of the carrier not everyone involved in transportation only does one thing and we have a section in the rule that actually creates some streamlined requirements for firms that do more than one thing that makes the firm subject to this rule so for instance if a shipper has his own fleet functions of the carrier for what he ships they may be able to take advantage of these streamlined procedures in the rule the rule has many general responsibilities that are applicable at all times in all circumstances and also has some designated respond abilities that are assigned for instance to the shipper or to the carrier and to that party alone however the designated responsibilities can be reassigned in a written agreement to another party subject to the rule again we recognize that in the transportation world the role that individuals play can be fluid that sometimes the carrier does things that in a specific circumstance that the shipper might do in other circumstances and we allow for the shipper for instance to reassign a designated responsibility to the carrier but we want to be able open that we even see the written agreement so we are able to determine who has accepted that responsibility one of the general responsibilities that again applies at all times and for all persons if the shipper loader receiver or carrier becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation the food shall not be sold or otherwise distributed and these persons must take appropriate action including as necessary communication with other parties to ensure that the food is not sold or otherwise distributed unless the determination is made by a qualified individual that the temperature deviation or other condition is not rendered the food unsafe and that is the general responsibility again applicable at all ons to all individuals and circumstances addressed within this room I'm going to now talk about some of the designated responsibilities here are the key requirements applicable to the shipper and they are significant ones the shipper must develop and implement written procedures subject to the records requirements adequate to ensure and then we have three situations in fact these written procedures need to be directed to number one that vehicles and equipment are in appropriate sanitary condition number two that a previous cargo does not make we transported in bulk unsafe and number three requiring temperature control for safety is transported under adequate temperature control the responsibilities for loaders receivers and carriers are on this slide the primary responsibility of the loader is inspection at the time of loading is the vehicle clean and inappropriate condition for loading has the vehicle been pre cooled if the shipper has directed pre-cooling for a food that requires a temperature control to ensure its safety the receivers responsibility on receipt is to assess food for temperature of use again this is applicable to food that requires the temperature control or safety the carrier is responsibility upon request is agreed to by contract then I'll talk a little bit about that in just a minute upon request that agreed to by contract demonstrate that the shippers operating temperature requirements have been met and to disclose the identity of the most recent prior bulk cargo and cleaning information so as you can see if you compare this slide with the last slide the bulk of responsibility in this rule lies with the shipper there are some responsibilities for the other parties but the responsibility to develop the written procedures addressing the three specific areas on the previous slide resides with the shipper we have a training requirement and it only pertains to the carrier and it states that when the carrier and shipper have agreed in a written contract that the carrier is responsible in whole apart from the sanitary conditions during transportation operations carrier personnel must be provided with adequate and documented training on sanitary transportation practices and awareness of potential food safety problems that may occur during free transportation and again I'll pick up in just a second on when the shipper and carrier have agreed in a written contract and they stand on that and and what we had stated in the previous slide about about the carrier there's a record requirement for shippers that demonstra tain records that demonstrate that they provide information and can think of this information really as instruction in many cases that they provide information to carriers about the necessary sanitary requirements for a vehicle and the necessary temperature conditions for a temperature control food so what we're envisioning here is any instructions the shipper may provide to the carrier about how the truck needs to be cleaned out and prepared or instructions the shipper may provide for the carrier about the operating temperature or the transport of food that requires temperature control for safety we want to see records here that demonstrate that the shipper does communicate in this way and provide this information to the carrier we do not want to see piles and piles of instructions for every shipment that the shipper out with every carrier that they do business with we want to see records that demonstrate that they have a communication process in place with the carrier the carrier is required records that they must develop written standard operation procedures for cleaning and inspection of vehicles and this is the counterpart to what I just said about the shipper communicating with the carrier how the carrier will meet requirements to provide information to shippers about temperature conditions and both cargo protection as appropriate so just like we envision the that shippers will communicate certain necessities to carriers we also anticipate that the carriers may at time communicate information back to these shippers if a question arises about temperature control during a shipment or the question arises about what was the prior cargo in that tanker and again here we do not want to see stacks of paper from carriers about time tip with time temperature recordings of every shipment or with cleaning procedures or every tanker that's been cleaned out the times and the dates and so on we want to know that the communication process is in place between the carrier and the shipper just as was the case between the shipper and the carrier and finally as I said we have a training requirement just for the carrier and we we have a Records requirement that would document that carrier training and the reason we did not have training requirements for the other persons covered by this rule is we believe that the their transportation operations would be adequately address through other training that they are required to undergo to comply with other FISMA regulations so that's why for instance we do not have a shipper training requirement there's a provision in the law that allows us to waive the requirements of this rule when we determine that such waiver will not result in the transportation approved under conditions that would be unsafe issue them they're animals and as you'll see in a minute we intend to invoke this provision for certain types of transportation operations that are already addressed in cooperative programs and you'll see what they are in just a minute the waiver provisions have not been finalized they will be finalized through the publication of actual waiver notices prior to the compliance date of this rule so those who will be subject to these waivers will have ample time to know precisely what provisions of the waivers are going to be the waivers were described in the proposed rule one of them pertains to operations that hold permits issued in accordance with the National Conference of Interstate milk shippers if you're involved in shipping grade a milk you know what that is and again the basis for these waivers is adequate controls already exist under these cooperative programs we're not going to try to regulate on top of existing controls that are in place that that we need to be adequate the second waiver will pertain to food establishments such as retail stores and restaurants again operating under valid permits issued by local authorities that carry out their responsibilities under under local laws that are patterned after the retail food code are the FDA Food Code and that overall mechanism is referred to as the cooperative program for for retail foods again same reason why we chose not to apply this rule in that circumstance and finally we've been asked to establish a third waiver for the transportation of molluscan shellfish by entities holding valid state permits issued under another one of our cooperative programs the national shellfish sanitation program that request came in the form of some comments on the proposal we have not made any determination on that one yet but we will be publishing a notice shortly where we will describe what our thinking is on this third requested waiver we are going to finalize the first two waivers there's no mystery or no secret there we did get some comments asking that we modify some of the provisions of the waiver that were described in the proposal and our thinking on those comments will also be addressed in the reasons published notice so what has changed from the proposed rule so several times when I spoke about with the requirements for foods requiring temperature control I stated in temperature control is required for safety and that is emblematic terms one of the significant changes from the proposed rule the focus on the final rule is is solely on sanitary transportation practices necessary to ensure that hmm remains safe during transportation any focus from the proposal on issues that are not safety issues such as food spoilage or food quality issues has been removed from the final rule so the focus of the final rule is on practices that create safety risks we have added a fourth category of persons covered that is loaders they were not one of the categories addressed in the proposed rule the responsibilities of loaders in the final rule would have rested with shippers under the proposed rule but what comments pointed out to us is that in many instances a a shipper is not going to be present at the site of load outs now if loading is taking place at a plant operated by the shipper yes the shipper is present and the shipper can do the load-out inspection but if the the shipping arrangements have been made by someone like a broker who was not present at the site of load out then the shipper is not able to shoulder those loader responsibilities so we have made the loader a person subject to the rule you now I've also mentioned in addressing the carriers that their requirements are applicable when when essentially when they have agreed to take responsibility in whole or part for sanitary conditions during transportation operation so there are some entities who could be carriers as defined by this rule but who have no sanitary maintenance responsibilities during transportation operations and they would not be subject to the carrier designated responsibilities nor the training responsibilities what caused us to consider this change was we learned for example that rail transportation often takes place in in a way where a rail car is delivered to a shipper the rail car owner or the rail line operator does not prepare or operate the equipment for instance the ax fridge of the refrigeration units the shipper cleans the car loads the car establishes the temperature settings maybe seals the car delivers it for transport and it's not open until it arrives at the receivers place of business so the carrier really only moves the car from point A to point B so for that reason we have designated the shipper or loader to be the primary entities responsible for sanitary conditions for instance inspecting a rail car unless reassigned in a written agreement and here is where the carrier could indeed come into play as one of the responsible entities under this rule if you expect the carrier to take on responsibilities for preparation and operation of the vehicle or equipment then that responsibility is conveyed on the carrier through a written agreement that is one of the required records under this rule and then the carrier becomes a full participant in meeting the designated responsibilities our compliance states I should say our effective date is actually 60 days after publication of the final rule the compliance is not required until 2 years for small businesses and you can see that the small business definition is a little different for carriers than it is for everyone else and that's because that's how the Small Business Administration defines the differing entities so we just went with their definitions but if you're not a small business your compliance date is one year out unless of course you're a non covered business under that 500 thousand annual revenue threshold we do plan on issuing a small entity compliance guide to assist small entities in complying with this rule we have a standing guidance that was issued in 2010 for sanitary transportation of food in anticipation of the publication of this rule that guidance will be revised to stand alongside this rule and it will have some content in it that addresses some transportation avenues that are not addressed in this rule so it will still stand as a complement to this rule for firms that are covered by this rule and as a guidance in its own right for firms that are not covered by the rule as far as the carrier training requirement that I mentioned FDA is going to develop an online course that would leave this training requirement it's going to be an hour in duration it's not going to require travel to a off-site location and it's not going to require a day of someone's time to go through the training module we also have integrated into our technical assistance network with the process of taking in and responding to questions about this rule that that highway is quite active with a lot of incoming traffic now and I encourage you to take advantage of that technical assistance network if you they're going to be some questions that we're going to want to have submitted in writing if they get into the weeds if they get specific rather than try to address them in a general form such as what we're doing here but that pan will be a source of information to support the industry not just for this rule but for all FISMA and you can submit your questions online into the tan I think there may be I guess this link is to linking to the tan here in the third bullet we have a FISMA website and a that has information again about this rule and all the other ones and a subscription feature available to keep you informed and that is the end of our presentation so I'm going to turn it back over to Jason momentarily great thank you Mike it is now time for our question and answer session I'll ask the operator to open the lines and provide instructions for our call of callers who have questions you would like to ask a question at this time please unmute your phone line and press star one you will be prompted to record your name which is used to introduce your question you may press star 2 to remove a question from Q again if you would like to ask a question at this time please press star and then one one moment while we see if there any questions the first question is from Eric Lieberman your line is open hi this is Eric Lieber and would leave in the TLC thank you for holding this webinar today very helpful under the regulation is a shipper loader receiver a carrier becomes aware of a possible material failure of a temperature control or other conditions that may render a food unsafe during transportation the food can't be sold or distributed and these persons must take appropriate action including as necessary communicating with other parties to ensure that the foods matter not sold or distributed unless there's a determination made by a qualified individual that the food is not unsafe how does this responsibility play out in the circumstance where a receiver receives a load the product has there's a there's a violation of a temperature-controlled operating temperature for example has been exceeded does that receiver have an obligation to prevent that loads from leaving their their premises and it's common practice right now for loads to just be rejected and turned away does the receiver now have an obligation that goes beyond that to ensure that that product does not enter or is not sold or distributed and if so what what is that obligation is it is communication adequate is there a requirement for the receiver to hold on to the shipment until there's a determination made one way or the other if you could discuss that further we would appreciate it sure are well first of all there has to be a material appearance of a problem say we're talking about temperature abuse that could affect the safety of the food so the mere deviation from operating temperature conditions may not rise to that threshold in many cases probably would not I mean we understand that refrigeration units cycle and the doors open and close and the operating temperature and the shipper would know this may have been set with some margin of safety between the operating temperature limit and what the shipper would consider to be a critical limit for that food so this is the type of thing that as shippers receivers and carriers of different foods come to better learn how the operating temperatures have been established and what the significance of some type of deviation might be it's really difficult to say now that every instance of operating temperature deviation is going to trigger this process in all likelihood many instances of deviation of would would not now what then would be the receivers obligation and and that's a good question if if they're in the retail industry in all likelihood they would be subject to whatever provisions govern these kinds of circumstances in in the local regulatory regime that the local authorities are administering through the food code because again of those entities when the waiver is is finalized going to be weighed so who may fall more under this rule in the receiving community would be things like distribution centers we're receiving a shipment who hold the shipment and then they ultimately send the shipment out again we've described in general circumstances what our concern would be I think if you wanted more specifics I mean other than to say that we don't want we don't want that food moving in any manner in which it could become diverted for consumption we think as time goes on where these lines are drawn will become more understandable I would suggest that if you wanted more specifics about how an FDA regulated receiver might be expected to function I would give us some specifics about you know here isn't it here is a food type and here's a condition of arrival in how do you think this would fall under your rule we want to be addressing those kinds of circumstances in the tan so our responses would be able to be searched and indexed and and available to the broader community when you are queuing up to ask questions please ask only one question the next question is from Matt Clark your line is open yeah I just wanted to try and clarify fully enclosed in a container the definition of fully enclosed in the container will dissipate any shelf-stable packaged food for example cookies crackers cans product every and so forth yes the container provides physical protection from contamination that we consider the food fully enclosed now the foods that you're mentioning are shelf-stable so they would qualify as not covered because they're fully enclosed by a container at least that's how I envisioned canned foods and crackers they're fully enclosed by container they do not require refrigeration for safety I would also add if there is full enclosure and the food is being refrigerated only to maintain quality or shelf life or or freshness that too would be not covered by the rule if it's fully enclosed and doesn't require refrigeration for safety it is not subject to the rule the next question is from Alan sailer your line is open yes thank you and that cash got very good information my question has to it LTL the companies I'm speaking of are companies I don't need exclude anybody like the US Postal Service ups that are suppressed these organizations should lots of food ingredients finished foods usually in fully enclosed containers but with along with this through their their distribution hubs and through their trucks their transport systems these foods which require refrigeration I am speaking just occurs can come into contact with just about anything have you had any discussions or you had any internal thoughts about how this is going to be managed one way of course is to simply have the shipper take take responsibility but what ship from the right minds going to take responsibility we have no control over these LTL a system so I'd appreciate any insights you might have thank you okay Alan so I understand your question really to be about what what we call small parcel carriers who are not generally functioning through interactive relationships with shippers such as dedicated food haulers we've exempted small parcel carriers from the we call them small parcel delivery services we've exempted small parcel delivery services from the definition of a carrier and again we we recognize that they don't generally have this interactive mechanism as you would have in dedicated food transport where the the shipper communicates cleaning requirements and operating temperature requirements to to the carrier they function under a different model and we have and you can find it in the preamble discussion in the final rule essentially said that the shipper bears responsibility under these circumstances to ship the food in a manner that would that would ensure its safety but that's a responsibility that's born under the general requirements of the Food Drug and Cosmetic Act and is not addressed by any specific requirements in this rule so if a shipper is relying on that type of small parcel delivery service perhaps they're going to use cooler packs and insulation in in things like that they're still subject to the requirements of the basic and we call it act that would have been the case a year ago five years ago ten years ago it's still the case now they are not subject in any new ways to these regulations the next question is from Dan Southard your line is open thank you good morning good afternoon this great webinar we're having this morning my question has to cover concerns food security as well as food safety and we were frozen food shippers um we're wondering we'll get the safety acts going to address the security of a load during transportation such as mandatory use of lock and key or seals well we have another rulemaking that is the last of the FISMA rule rule makings it addresses intentional adulteration in requirements that FDA is establishing to ensure that intentional adulteration of food does not take place I would encourage you to be on the lookout in the not-too-distant future for the finalization of that rulemaking I think you're going to find when that rulemaking is finalized that a lot of what we would call routine food security measures that pertain to many transportation operations that would be addressed under this rule are not going to be addressed in the intentional adulteration rule that rule is addressing certain specific things but it is not a cover the waterfront waterfront food security rule this rule that we're discussing today focuses on sanitary transportation practices and sanitation in the traditional sense meaning cleanliness it does not focus on routine food security preventive procedures we will continue to operate through guidance when it comes to this area other than what you will find in the intentional adulteration rule when it issues but I think again you're going to find that some of the things you're that that you have on your mind that you're asking about are not necessarily the subject that rule for a lot of routine shipments and we're going to continue to address those concerns through guidance the next question is from Eva where I know your line is open hi I'm this is Ellen I know it's Secretary's company and my question is basically a we shipped chocolates and we basically use refrigerated trucking just to maintain them from melty and I believe that would fall into the completely enclose is that correct well without having your package in front of me you know generally those kinds of products would be packaged in a way where we would say that the package fully protects the food from contamination and I would also say if you're using refrigeration solely to provide for quality or marketability you're not going to fall under the provisions of provisions of this rule that applied to temperature control because you're not applying temperature control to maintain safety so you know the typical product of the type that you describe would would indeed not be subject to this rule thank you the next question is from John Sampson your line is open yes good morning dr. Tash talk looking at the oversight of FDA on the sanitary transport rule and then the products ground beef eggs poultry from the FSIS there's some language in the final rule that talks about how FDA and FSIS are going to work together as far as falling under there requirements and then falling under FDA requirements could you elaborate a little bit more on exactly how that relationship is going to work from both requirement standpoint and then looking at it from an enforcement side as well sure if you can envision the lifecycle of a USDA regulated product if it's manufactured in a facility I think USDA calls it and inspected as an officially inspected establishment and then goes out onto the road and then maybe goes to a warehouse a refrigerated warehouse where FDA has jurisdiction for storage no further processing takes place so USDA does not have inspectional jurisdiction and then maybe leaves that warehouse that cold storage warehouse and goes to a market someplace so starting at the beginning this final rule clarifies something that was not clear in the proposal FDA does not have jurisdiction within the FSIS inspected establishment so no requirements of this rule apply to the shipping operation out from that establishment once the initial shipment is on the road it is subject to both FDA and USDA oversight there is an MoU that is reference 19 in our rule that explains how USDA and FDA interact if we become aware of a problem involving that product when it is when it is in transport and basically what it comes down to is we would interact with the USDA and determine which agency would most appropriately address the problem whatever it might be I should also say that when that truck is out on the road there is a potential the way that this rule is or the way that this law is crafted for d-o-t to do an on the road inspection if deokee does find a problem with that on the road inspection d-o-t is not going to enforce this rule or enforce any applicable USDA requirements DoD will call FDA and or USDA their function is not to take enforcement action but to notify the agencies that have jurisdiction of suspected incidents and then FDA and USDA would have that interaction if there is a problem notice that receipt at the control at the cold storage warehouse which is under FDA jurisdiction and not under FSIS jurisdiction FDA would have the authority to address that issue under the provisions of this rule however at the same time if it was that determined that the problem originated when the product was under this joint jurisdiction we could we could talk with USDA about the best way to address that but you know I would say if the receiver is not complying with the rule and that cold storage warehouse he is not complying with requirements that pertain to him then only FDA would address that problem the shipping out of that cold storage warehouse to the market would be subject to this rule the facility is not in any way under FSIS jurisdiction so I think that that covers most of the lifecycle and we would up I guess we would have to think a little bit about if it is the shipment to the market it is that segment of shipment under this dual jurisdiction addressed in the MOU I have to go back and see the receipt up at the market that would probably be subject to the jurisdiction of local parties operating under the food code all right great thanks Micah this is Jason again we want to thank everyone for their questions at this time we are concluding today's session of the presentation of the FISMA final rule on sanitary transportation of human and animal food we also record the continuing discussing implementation issues on a range of topics and stakeholders including the development of guidance documents as necessary and training the health industry implement these rules this concludes today's stakeholder call thank you for your participation and have a great day this concludes today's conference thank you for your attendance you may disconnect at this time

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