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FDA GUIDANCE DOCUMENTS PRETAINING TO THE NOW REGULATED BIOTERRORISM ACT

Required Bioterrorism Act records:

  • IPS (Immediate previous source) – who you got ingredients from (bulk, bagged, liquid or bulk).
  • Who transported it to you – who delivered it to you (company, email, address, rail or trailer #).
  • What you received – as specific as possible, to include specific lot / date code of an ingredient, not just product description.
  • What bin it originally went into (bulk only).
  • What you subsequently did with each ingredient - blended, co-mingled, processed, etc.
  • During production process, link each ingredient to specific batches INCLUDING all food contact packaging.
  • What you shipped – as specific as possible – must include lot code information.
  • Who transported if from you – who you contracted to ship it from you (company, email, address, rail or trailer #).
  • ISR (Immediate subsequent recipient) – who you sold it to.

Timing:

  • Facilitates under one corporate personhood, have only one 24-hour period, regardless of the steps in product transfer or processing, to supply the information from ingredient origin, through processing to final product release – linking together the entire chain of custody.
  • A facility or company MUST supply the above information to the FDA, “As soon as possible, but no more than 24 hours.”
  • Records must be kept up to 2-years based on the shelf life of the ingredient or product.

Information contained below has been sourced from the FDA Guidance to Industry, the Federal Registry and the FDA Town Hall meetings.  Please refer to http://www.fda.gov/oc/bioterrorism/bioact.html  for additional information.

LOT CODE SPECIFICITY – lot code information is REQUIRED by the FDA to be maintained and linked to specific batches of production.  For bulk receipts (flour, oil, etc.,) scale ticket numbers are a unique identifier and must be linked to production as well.

FDA GUIDANCE DOCUMENT - 32.8 Q: [Added November 2005] If a lot or code number or other identifier exists, but is not being used by a manufacturer, processor, or packer as part of current business practice, is this business required to include that identifier in the records it establishes and maintains?

A: Yes. 21 CFR 1.337(a)(4) and 1.345(a)(4) require the inclusion of a lot or code number or other identifier if it exists, regardless of its use in current business practice.

FDA GUIDANCE DOCUMENT - 32.2 Q: If a manufacturer receives ingredients that have a lot number but that lot number is not provided to the manufacturer by the ingredient supplier, is the manufacturer required to actively obtain the lot number for each ingredient?

A: Yes.  21 CFR 1.337 requires that persons who manufacture, process, or pack food must establish and maintain records that include the lot or code number or other identifier for all food they receive, if that information exists.  The manufacturer must obtain the lot numbers for each ingredient received from the ingredient supplier.

FDA GUIDANCE DOCUMENT - 32.1 Q: A food processor records the lot codes on pallets of food, which are then delivered to customers by truck.  Currently, the processor does not link lot codes with specific customers.  Is this required by this regulation?

A: Yes.  Persons who manufacture, process, or pack food are required by 21 CFR 1.345 to identify the lot or code number or other identifier of the food that they release to each immediate subsequent transporter and nontransporter recipient, if that information exists.  If there is a lot code on both the pallet and the food, and only the lot code of the pallet is recorded, the processor must be able to link each pallet to the lots of food it contains.  However, as discussed in the response to comment 112 in the Final Rule preamble, food placed directly on the shelves of a retail store by a manufacturer, processor, or packer upon delivery (direct store delivery) is excluded from the requirement to record lot or code numbers.

FDA GUIDANCE DOCUMENT - 32.9 Q: [Added November 2005] Is a food processor required to physically examine each food product it receives in order to obtain the lot or code number information required under 21 CFR 1.337(a)(4), or can the processor rely on information provided by its immediate previous source? If the processor's immediate previous source fails to provide this information, must the processor obtain it by physical inspection of the food?

A: Manufacturers, processors, and packers are required to record lot or code numbers or other unique identifiers of the food they receive if this information exists, as provided by 21 CFR 1.337(a)(4). These persons must ensure that they meet the requirement regardless of whether the information is provided by their nontransporter immediate previous source. FDA does not intend to specify the manner in which these persons ensure that they have the required information, which may be obtained in various ways including direct physical inspection and contractual obligations.

FDA GUIDANCE DOCUMENT - 29.4 Q: A manufacturing firm may handle over a thousand different ingredients on the same day, and three or four lot codes of the same ingredient from the same supplier may be used on a particular day.  Assuming the ingredients arrive at the manufacturing facility with lot codes, does the manufacturer have to track each lot code and link it to a finished product?

A: Yes.  The manufacturer is required by 21 CFR 1.337(a)(4) to establish and maintain records for each ingredient it receives, including the lot codes of each ingredient received if they exist.  When the manufacturer releases a food, it must also establish and maintain records for that food.  The records must include both the lot code of the finished product if it exists and the specific source of each ingredient used to make every lot of finished product, to the extent that information is reasonably available, as required by §1.345(b).

FDA Federal Register - Comment 111) A comment states that lot numbers are not scannable or machine readable, and manual transcription of these numbers would introduce errors. The comment states that small businesses would be buried in a mountain of paperwork and this would make it impossible for them to track products accurately.

(Response) As explained in response to comment 108, FDA recognizes the difficulties in tracking lot/code numbers or other identifiers.  This final rule reflects those considerations. FDA has balanced the need to provide information that would expedite a traceback in a food-related emergency with the ability to record lot numbers. Because food almost always passes through at least one small business in the distribution chain, FDA cannot exempt small businesses entirely from this important requirement. The final rule, however, does give small and very small businesses more time to comply with its requirements. FDA is aware that technology is developing that will enable lot/code number tracking in the future to be cost efficient for all of the food industry.

 

MANUFACTURING / PROCESSING – You must link your ingredient lot numbers to production batch lot numbers. 

FDA GUIDANCE DOCUMENT - 29.6 Q: A manufacturing firm has multiple suppliers of particular ingredients and packaging materials.  Is it sufficient to simply record all the potential suppliers that an ingredient or packaging material might have come from?

A: Persons who manufacture, process, or pack food are required to establish and maintain records regarding receipt of the lot or code number or other identifier of each ingredient and any finished container that they place in contact with food, if a lot or code number or other identifier exists, in accordance with 21 CFR 1.337 and 1.327(k).  When the food is released, records must be established and maintained that include the specific source of each ingredient used to make every lot of finished food and any finished container placed in contact with food, to the extent that the information is reasonably available (e.g., does not require physical reconfiguration of the manufacturing facility), in accordance with §1.345.  "Packaging" is defined in § 1.328 as "the outer packaging of food that bears the label and does not contact the food."  The manufacturer, processor, or packer does not have to establish and maintain records for any packaging or for finished containers that it does not place in contact with  the finished food, as stated in §1.327(j).  All existing relevant records must be made available as soon as possible to FDA on request, not to exceed 24 hours, as required by §1.361 and §1.363, if FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.  If information is reasonably available when food is released to narrow the possible sources of an ingredient, it is not sufficient to record all potential suppliers that an ingredient or packaging material might have come from if there is no expectation that that supplier's product would be in the finished product (e.g., no shipments have been received from a vendor for months and onsite supply has been depleted).

FDA GUIDANCE DOCUMENT - 32.4 Q: If a firm is a manufacturer, processor, and packer of a single product, would all lot numbers associated with this process (e.g., lot numbers for individual cans, lot numbers for pallets, etc) have to be tracked?

A: 21 CFR 1.345 requires persons who manufacture, process, or pack food to establish and maintain records when releasing the food to another person that include the lot or code number or other identifier (to the extent this information exists).  FDA recommends that a vertically integrated company which generates several lot or code numbers or other identifiers in the course of its operations use the most specific one.  As explained in the preamble to the Final Rule, more specific information about the food helps FDA narrow its investigation and increase the speed of the trace in the event that there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.  However, another acceptable alternative would be for the firm to record identifiers of larger packages (such as pallets) but retain the ability to link these to lots of cans when necessary.

FDA Open Forum Q & A Baltimore, SPEAKER: I represent a pet food company, and I think I'm asking the same question. For product that goes out of the plant, manufactured product, we have to supply batch codes that go to specific distributors?

MS. FRASER: And you're a manufacturer?

SPEAKER: Yes.

MS. FRASER: Yeah.

SPEAKER: Okay. Thank you.

MS. FRASER: Lou is just clarifying, you have to keep the record, you don't have to send them the record, you have to keep the record, yes.

FDA Open Form Q & A, Atlanta, GA   MR. : With regard to a food manufacturer that sells to a retailer, a very large retailer that has several distribution centers, would the lot tracking records require us to know which distribution centers receives which lot?

MS. FRASER: Yes. From the manufacturing standpoint, you would have to track by lot number the release of your product to the

FDA Open Form Q & A, Atlanta , GA   MS.  My name is Christy Scott, and I work for ESAY America, a Blair Company, and we ship multiple lots to customers. Do we need to keep records that give us quantity of those multiple lots, like 20 cases of lot No. 058, or whatever it is?

MS. FRASER: You a manufacturer, processor, or packer?

MS. : Uh-huh.

MS. FRASER: Yes.

FDA Open forum Q & A, Kansas City, KS MR. : Mark Warner again. Most of the ingredients we receive into our company came from food plants that already are regulated by FDA. There does our recordkeeping need to begin? We take those products, transform them into feed ingredients. But they came from a regulated facility to begin with.

 

MR. CARSON: Well, again, yours is no different than the food manufacturer. You need to maintain records from both the nontransporter and the transporter of all of those incoming goods. And then the process that you conduct on those products to make your finished product, you need to tie the incoming ingredients to your finished product, and then tell us when it's been released and who it's going to, and what is the transporter of those goods to the recipient. So it's no different.

 

PACKAGING - All food contact packaging must be linked to specific batches of product manufactured – BY LOT IDENTIFIER.  PathTracer can link ingredients – bulk or bagged / dry or liquid, trace elements and packaging into specific batches!  

FDA Open forum Q & A, Baltimore, MD    MS. DeMARCHI: Okay, great. And on the packaging, what if the food contact packaging is actually stored for more than two years?

MS. FRASER: You know, this becomes the interesting piece of it, because while --and again, this is just strictly the limitations in the bioterrorism act, but you could receive a product, you know, since records are --you have to create records at the time the transaction occurs, so either when you receive food or release food.

 So you might receive the packaging material, you create a record, you keep it for two years, that's gone, but now you've released the product, the obligation to link incoming ingredients to outgoing products is created at that time, so you still have the obligation because you've created --you've released the new product, and so it's now triggered by your outgoing obligation, not your incoming duty to keep a record that we can see. So there's --this other obligation I think is going to drive you to think about whether you really want to retain those records past two years separate and apart from that requirement there, because you have an independent obligation to tie it on the outgoing product.

FDA Open Form Q & A, Atlanta, GA    MR. Jeff Stevens from McKee Foods. We are a manufacturer. My question is about food contact packaging, and I understand that it applies only to the packaging that the consumer receives. In some cases we make an ingredient ourselves by combining several things and then store it in a bag or a box for a few days or up to a week, and then it becomes added to something else, it becomes our final product. So do these intermediate packagings have to be recorded?

MS. FRASER: No. We only require you to record the package that the consumer is going to receive the product in. If you are the person putting that product into that package, then you have to identify for us the immediate previous source of that packaging material. If you are a manufacturer, processor, packer, the lot number of that packaging material, the date you received it, everything else. All those other intermediary containers are not subject to that because that's not what the consumer is going to receive it in. You would be subject to records access requests for any of that other material. And if not subject of any of these requirements except for the records access provision. So for people with packaging material through contact substances, just recognize that while you don't have to establish and maintain records, that are tracing that information, you are subject to the records access provisions, and you do need to be able to turn over within 24 hours the information related to that product, assuming we met the standard for the serious health--adverse health consequences.

MR. . I think this is my last question. Regarding food contact substances, in our bakeries in our stores, in-store bakeries, we create a wedding cake. We put nice little things on top of it. A lot of those are a little bit on the expensive side, so they are not sold with the cake, they are, quote, rented. So those things are--they contact food, they go out the door with the consumer, but they come back from that same consumer and get sanitized and reused. Is that consumer considered the immediate previous source of that food contact substance? Are we going to have now record every one of those consumers returning those items?

MS. FRASER: The consumer is the immediate previous source of that, and that is a question that came up--it comes up in other places, too. Bottled water. You know, you reuse the bottled dater over and over again, and you know, you put your jugs out on your porch, they come by and pick it up, and bring you a new one. Those are your immediate previous sources. Now for a retail store, you know, those are all the specifics that--the devil is in the details. You know, we thought about the bottled water and said yes, clearly we do expect that to be captured. The same principle would say it should apply to your little wedding toppers, and you probably have a record of that, anyway, because you want to make sure you get it back or you are going to charge them $50, $100, or whatever the topper cost that you held as security. So it is similar to me to the bottled water, the empty bottled water gallon, five-gallon thing that you leave out on your porch.

 

VERTICIALLY INTREGRATED COMPANIES.  PathTracer can track all shipments, BY LOT CODE of ingredients, packaging and finished product between multiple facilities under one company’s ownership.  A specific example would be if a company owned their own grain elevators, flour mill and parboiled bakery, PathTracer could link all of the faciltites together and provide a trace back in 5 minutes!

FDA Guidance Document - 1.2 Q: It is possible that an investigation may lead FDA to suspect that a product may have been tampered with inside a vertically integrated operation, for example en route between two facilities.  If company systems are set up to establish records as a vertically integrated operation, what would be FDA's expectations if intra-company records were requested?

A: Sections 414(a) and 704(a) of the Act provide access for existing records relating to manufacture, processing, packing, transportation, distribution, receipt, holding, or importation.  If FDA requests intra-company records under the Bioterrorism Act, FDA expects a vertically integrated operation to provide access to such existing records as soon as possible, not to exceed 24 hours from the time of receipt of the official request, as required by 21 CFR 1.361.

FDA – Federal Register – Recordkeeping Section (Comment 135) One comment states that records should be retained for 2 years from the date they are created, and not for 2 years from the date of shipment of the product. The comment points out that wine

may be shipped several years after it has been manufactured, and that establishing the timeframe from the date of shipment of the product would be an unwarranted burden. One comment suggests that the minimum record retention periods should be stated as time from the date of production, e.g., a minimum of 2 years after the date of production of the food, except perishables, and a minimum of 1 year after the date of

production for perishables.

 

(Response) FDA does not agree with the comment's suggestion, as this will not ensure that FDA has access to the requisite records at the time of a traceback investigation. Often, a traceback begins after consumers become sickened or die. In the comment's example, if the wine was adulterated and presented a threat of serious adverse health consequences or death to humans, FDA may not know this until the wine has been consumed, i.e., after the product was released by the manufacturer into commerce and consumers became seriously ill. If the record retention period began at the time of production, but the wine was aged at the manufacturer's facility 2 years before distribution into commerce, the record retention period would have expired before the wine entered commerce. In the final rule, FDA retains the requirement that records required under subpart J must be established at the time food is received or released and maintained from that time until the end of the time period specified in Sec.  1.360 of this final rule.

UNIQUE IDENTIFIERS -  Bulk “food” (animal or human) has identity as defined via “other identification” documentation (scale tickets, etc.) and thus must be isolated and traced through the elevator to meet the FDA specificity requirements.   

32.8 Q: [Added November 2005]  If a lot or code number or other identifier exists, but is not being used by a manufacturer, processor, or packer as part of current business practice, is this business required to include that identifier in the records it establishes and maintains?

A: Yes. 21 CFR 1.337(a)(4) and 1.345(a)(4) require the inclusion of a lot or code number or other identifier if it exists, regardless of its use in current business practice.

FDA GUIDANCE DOCUMENT - 29.4 Q: A manufacturing firm may handle over a thousand different ingredients on the same day, and three or four lot codes of the same ingredient from the same supplier may be used on a particular day.  Assuming the ingredients arrive at the manufacturing facility with lot codes, does the manufacturer have to track each lot code and link it to a finished product?

A: Yes.  The manufacturer is required by 21 CFR 1.337(a)(4) to establish and maintain records for each ingredient it receives, including the lot codes of each ingredient received if they exist.  When the manufacturer releases a food, it must also establish and maintain records for that food.  The records must include both the lot code of the finished product if it exists and the specific source of each ingredient used to make every lot of finished product, to the extent that information is reasonably available, as required by §1.345(b).

 

 

The FDA has NOT softened it’s stance on what the expectation of what is reasonably available from an information standpoint. (Information taken from the Bioterrorism section at www.fda.gov )

 

 

INFORMATION SPECIFICITY

 

FDA Q & A Question - So I do have one here and it says that if there are three elevator lines, A, B, and C, and there are ten individual loads of  grain in each, and if a person loads a rail car out of bin A, does the FDA just want the info from bin A?

 

Dr. Leslye Fraser FDA. Yes. Well, I'll answer that in two ways. As you receive each load of grain in each of those A, B and C elevator lines, you will need to keep records for the media preview source of that food. That is all food received. So as you're receiving the food, then you will need to keep track of all of that.

 

If the question is really related to as you're distributing it to a rail car, or as you are using that elevator to make a product, what do we want connected to the information for each lot of finished product must be linked to incoming ingredient, then that is with specificity as to what you reasonably expect is in that finished product container, and if you're only pulling it from elevator A, then it should just be the ten lines for that data element that's going into what's in the finished container.

 

So it is with as much specificity as to what you reasonably expect. We do expect some diligence with that, not just give us the smorgasbord of it's A, B and C, and it could be up to thirty, when you know full well that rail car had no expectation of having anything in B and C, if you're only pulling from elevator A.

FDA Guidance Document - 29.3 Q: A firm uses raw agricultural commodities to manufacture its products.  What are the recordkeeping requirements: (1) if the firm receives its ingredients directly from farms and commingles them in storage bins on site, and (2) if the firm receives ingredients that already have been commingled by a distributor?

A: The source of each shipment that enters a particular storage bin must be recorded in accordance with 21 CFR 1.337.  If the commodities are commingled on site, there will be more sources for a given bin.  In both cases, incoming sources of ingredients must be linked to finished products leaving the site to the extent that the information is reasonably available in accordance with §1.345.  For example, if a lot of a product incorporated an ingredient from a particular bin and that bin was filled with a commodity derived from five immediate previous sources, then those five sources would be the reasonably available information for that ingredient.  If the bin was refilled before being emptied and now may contain ingredients from up to ten immediate previous sources, then this is the information that is reasonably available.  If the firm receives ingredients that already have been commingled by a distributor, the firm only has to record the lot numbers of the food, as received, to the extent that information exists, and link incoming sources of ingredients to finished products leaving the site to the extent that the information is reasonably available in accordance with §1.345.

 

 

FDA Q & A Question - You receive 5,000 bushels of grain. That grain goes into bin A, and then after that, it could be transferred, in-house, many times, over a period of time before it's loaded out and shipped to someone.

 

Is it then, under the sort of reasonable expectation, that you could, in loading a unit train of grain, hundreds of thousands of bushels of grain, that the source, the previous source could be everybody you purchased grain from over a period of time?

 

MS. FRASER: It could be. I would think--you know, again, as I said, this rule does not require you to reconfigure your manufacturing operations. You may choose to think about is a there more efficient business practice than having to record thousands of grain, and if, again, you're looking at the perspective of the purpose of this regulation is to allow for an effective trace back by the FDA in a public health emergency, or whether you want to do an effective trace back, even if we're not in a public health emergency on your own, how effective is that going to be if you think your reasonable expectation is five grams that might be left or five pounds that might be left, and yes, this regulation may require recordkeeping practices that you currently are not doing .

 

But there is a requirement to link outgoing product with ingoing received product , and when we say to the extent reasonably available, that is tied to how specific the information is. It is not saying you don't have to do it at all.

 

FDA GUIDANCE DOCUMENT  - 29.2 Q: A feed mill receives ingredients and commingles individual shipments into bins which are never completely empty. Over the course of a year, a hundred or more lots could theoretically be part of any food drawn from a bin.  Would the feed mill have to provide all these lot numbers for food it releases?

A: Yes.  Manufacturers are required to establish and maintain records for each food received, including the lot number if it exists, in accordance with 21 CFR 1.337.  When a food is released by a manufacturer, the firm must establish and maintain records that include information reasonably available to identify the specific source of each ingredient used to make every lot of finished product in accordance with §1.345.  In the response to comment 94 in the Final Rule preamble, FDA acknowledges that certain business practices are not amenable to linking incoming ingredients with specificity to the outgoing product, and that it may not always be possible to identify the specific source of an ingredient that was used to make a lot of finished product.  Because shipments of incoming material are commingled in the storage bin, the record created for every lot of food released by the manufacturer that incorporates material from the bin would include all possible sources of the material placed in that bin. 

PathTracer® is the ONLY solution that allows you to link your outgoing product back to your incoming product.  NO ACCOUNTING SOFTWARE PROGAM CAN CAPTURE BLENDS, MOVEMENTS, CORING, CO-MINGLING!

 

BROKERS / TRADERS

17.5 Q: [Added November 2005] A firm purchases a food ingredient from a broker who does not take actual possession of the food. Is the immediate previous source of the food the broker or the ingredient manufacturer (from whom the broker obtains the food)?

A: The purchasing firm may identify either the broker or the ingredient manufacturer as its nontransporter immediate previous source in establishing and maintaining the records required by 21 CFR 1.337. Section 1.328 defines a nontransporter as a person who owns food or who holds, manufactures, processes, packs, imports, receives, or distributes food for purposes other than transportation. A person who enters into a contract to hold, manufacture, process, pack, import, receive, or distribute food is considered a nontransporter, even if that person subcontracts the actual performance of the covered action to another entity. In this example, the broker enters into a contract to distribute the food and in addition may own title to the food. For this reason, the broker is subject to the rule and an acceptable nontransporter immediate previous source for the purchasing firm.

FDA Q & A MR. : My question is the commodities market and I buy 100,000 grain, it's my understanding if I don't enough, I am actually the owner and they deliver it to me. Do any of these rules apply to me if I own 100,000 bushels of grain in writing. Or is my answer that for the records, “stump me if I play bushels of see it fast will apply to the commodities market”?

FDA Q & A MR. CARSON: If you are the owner of food, if you are the manufacturer, processor, packer or holder of food, then you are required to comply with these rules.

MR. : Well, then, my question would be how would I possibly get the information on where my grain is?

MR. CARSON: But again--well, if you are a commodity person, then someone is holding your commodity and that person is already complying because they're the ones that's holding it, and YOU I by purchasing it, have purchased that information. So if you're a big poohbah, you're a big poohbah with the information. I mean--

MR. : Okay. From the broker?

MR. CARSON: Right.

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