IPR2024-00186, No. 1023 Exhibit - FSIS Directive (P.T.A.B. Jul. 16, 2024) (2024)

`

`IV. REFERENCES
`
`Federal Meat Inspection Act
`9 CFR 318.2, 325.10, 416, 417, and 500
`FSIS Directives 5000.1, Revision 1, 5000.2, and 8080.1, Revision 3
`Federal Register Notices: Policy on Beef Products Contaminated with E. coli
`0157:H7 (64 FR 2803, 1/19/99); Recent Developments Regarding Beef Products
`Contaminated with Escherichia coli 0157:H7; Public Meeting (65 FR 6881, 2/11/00);
`Availability of and Request for Comment on FSIS Draft Risk Assessmentfor
`Escherichia coli 0157:H7 in Ground Beef (66 FR 55912, 11/05/01); and E. coli 0157:H7
`Contamination of Beef Products (67 FR 62325, 10/7/02).
`
`V. BACKGROUND
`
`Non-intact raw beef products contaminated with E. coli 0157:H7 are adulterated.
`Non-intact beef products include ground beef; beef that has been injected with
`solutions; beef that has been mechanically tenderized by needling, cubing, Frenching,
`or pounding devices; and beef that has been reconstructed into formed entrees. Intact
`raw beef products contaminated with E. coli 0157:H7 that are intended to be processed
`into non-intact products are also adulterated. Establishment records and HACCP
`documents (e.g., the flow chart and hazard analysis) should identify the intended use of
`intact raw beef products. Manufacturing trimmings (e.g., pieces of meat remaining after
`steaks, roasts, and otherintact cuts are removed) are an example ofintact raw beef
`product that maybe intendedto be used for non-intact product. Raw beef products
`contaminated with E. coli O0157:H7 may, however,be further processedatofficial
`establishments to destroy the pathogen.
`
`On October 7, 2002, FSIS published a notice requiring establishments that had
`not already reassessed their Hazard Analysis and Critical Control Point (HACCP)plans
`for raw beef productsin light of relevant E. coliO157:H7 data to do so to determine
`whether E. coli 0157:H7 contamination was reasonablylikely to occur in their
`production process for raw beef products (67 FR 62329).
`In that notice, FSIS advised
`thatit intended to scrutinize very closely the hazard analyses and HACCP plans of
`those slaughter or deboning establishments that had conducted a reassessment and
`decided that an intervention was not necessary. Also in that notice, FSIS stated that
`establishments receiving product for grinding should address E. coli O0157:H7. FSIS
`explained that these establishments could employ validated Critical Control Points
`(CCPs)in their HACCP plansto address E. coli 0157:H7, or the establishments could
`incorporate purchase specifications in their HACCP plans, Sanitation Standard
`Operating Procedures (Sanitation SOPs), or other prerequisite programsto prevent E.
`coli 0157:H7-contaminated product from entering their establishments.
`
`This directive focuses on raw ground beef products and the beef products that
`are used to produce raw ground beef products. These products will be the focus of
`FSIS’ verification sampling program for E. coliO157:H7. Products that FSIS may
`samplearelisted in Parts Il and VI.
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`FSIS Directive 10,010.1, Revision 1
`
`This directive discusses the significance of a finding that a sample is
`“presumptive positive.” A sample is presumptive positive when analytical steps of
`microbiological analysis indicate the strong possibility that E. co/iO157:H7 is present,
`but additional steps are needed to confirm the presence or absence of the organism.
`
`Asample is confirmed to contain the bacterial isolate of E. coliO157:H7 through
`testing by either FSIS or non-FSIS laboratories when biochemical, serological, or
`genetic testing results in a finding of E. coli Serotype 0157:H7, 0157:H7:NM
`(nonmotile), or 0157:H7-indeterminate.
`
`FSIS recognizes that many establishments test their raw ground beef products,
`raw ground beef components, and raw beef patty componentsfor E. coli O157:H7. The
`Agency applauds and encouragesthis practice. FSIS points out, however,that if an
`establishmentfinds a sample of one of these products to be presumptive positive for E.
`coli 0157:H7, that product would only be allowed to moveoff site under appropriate
`controls for properdisposition at official establishments, landfill operations, or renderers.
`If the establishment's confirmation testing finds the sample negative for the pathogen,
`that product may be shipped in commerce under normal procedures. Productthatis
`confirmed positive for E. coliO157:H7, through FSIS or establishment testing, may also
`be movedoff site under appropriate controls for proper disposition.
`If productis
`confirmed positive, or is presumptive positive and no additional testing confirmed the
`product negative, such product destined for an official establishmentfor further
`processing that will destroy the pathogen would have to move under companycontrol
`(e.g., through companyseals) or under FSIS control (e.g., under USDA seal or
`accompanied by FSIS Form 7350-1). Such product destined for a landfill operation or
`renderer would have to move under companycontrol.
`
`According to 9 CFR 325.10, if product is found to be adulterated or misbranded
`after it has been transported from anofficial establishment, transportation back to the
`establishmentthat originally produced the product or to anotherofficial establishment
`must be authorized. According to 9 CFR 318.2(d), inspection program personnel must
`place a U.S. retained tag at the time of reinspection on all products suspected of being
`adulterated. FSIS will allow productthat is positive or presumptive positive for E. coli
`0157:H7 to move under companycontrol (e.g., through company seals) or under FSIS
`control (e.g., under USDAseal or accompanied by FSIS Form 7350-1), rather than as
`required in 9 CFR 325.10 and 318.2(d) to facilitate proper disposition of product that
`may be adulterated with E. coliO157:H7. FSIS intends to modify these regulations to
`reflect this policy.
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`Part Il -- Inspection Program Personnel Responsibilities for Collecting
`Raw GroundBeef Product Samples from Official Establishments
`
`A. What comprises raw ground beef products?
`
`Raw Ground Beef Products: Raw ground or chopped beef, hamburger, ground
`or chopped veal, veal or beef patties, and patty mix. Araw ground beef product that
`contains any amountof beef product derived from advanced meatrecovery (AMR)
`systemsis considered a raw ground beef product. Raw product comprised only of beef
`from AMR systemsis not considered a raw ground beef product. Raw product
`comprised only of beef from AMR systemsis considered a raw ground beef component
`or raw beef patty component(see Part VI of this directive). Ground or chopped
`products made from both beef and other meator poultry products and beef sausage
`products are not subject to FSIS’ E. coli 0157:H7 sampling and testing.
`
`B. Howis raw ground beef product sampling conductedatofficial
`establishments?
`
`1. Whenthe Office of Public Health and Science (OPHS) schedules samplesto
`be taken at an establishment, OPHS will send the Inspector-in-Charge(IC) FSIS Form
`10,210-3, “Requested Sample Programs.” OPHS will send the form electronically in the
`near future. Specific information for the sample to be collected will be included on the
`sample requestorin revisions to FSIS Directive 10,210.1, under the appropriate project.
`
`2. Inspection program personnel maybeinstructed to collect more than one
`sample perlot in certain circ*mstances(e.g., if FSIS has reason to believe that product
`is at high risk of being contaminated with E. coliO157:H7 becauseofillnesses or
`outbreaks that may have been associated with the establishment, or because the
`establishmentorits suppliers have previously produced product that tested positive in
`FSIS-collected verification samples for E. coli O157:H7).
`
`3. Before collecting samples, inspection program personnelare to notify official
`establishment managementthat they will be collecting a sample and are to provide
`enough timefor the establishment to hold the sampled lot. Inspection program
`personnelare to inform the establishment of the reason they are taking the sample
`(e.g., routine FSIS verification testing, follow-up sampling in responseto an E.coli
`0157:H7 positive, traceback sampling, or follow-up sampling in response to an E.coli
`O157:H7 outbreak).
`
`4. Inspection program personnel collect samples from the current day’s
`production, and the samples should be, whenever possible, in their final packages.
`Samples should not be sentto the laboratory until the establishment has completed pre-
`shipment review forthat lot.
`If product from final packagesis not available for
`sampling, inspection program personnel should collect an aseptic sample. Products
`should be held undersecurity following established Agency controls.
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`FSIS Directive 10,010.1, Revision 1
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`If a sample must be held overnight, it must be refrigerated.
`5.
`be held longer than overnight, it must be frozen.
`
`If a sample must
`
`6. After the establishment completes the pre-shipmentreview, inspection
`program personnel should prepare the sample to be sentto the laboratory onthefirst
`available Federal Express pick-up.
`
`Part Ill — Supplier Information
`
`A. Whatactions does FSIS take when there is an FSIS presumptive E. coli
`O157:H7 positive for a raw ground beef product sample?
`
`1. Every FSIS verification sample that is eventually confirmed positive by FSIS
`for E. coli O157:H7 goes through three stages of analysis. The results of each stage
`are reported to IIC’s on LEARN. These samplesareinitially screened and, as
`appropriate, are reported as “Potential Positives.” At the next stage, based on
`laboratory results, some samplesare reported as “Presumptive Positives.” Because
`most “Presumptive Positives” are eventually confirmed, the contact personin the District
`where the establishmentis located needs to immediately inform the establishment that
`the sample is a “Presumptive Positive.” At the same time, the District contact person
`also informs the establishment managementthatif the results are confirmed positive,
`FSIS will collect the following information regarding the suppliers of the source materials
`usedin the production of the product (9 CFR 320.1):
`
`a. nameof the supplying establishment, point of contact (name, title, e-mail
`address, and fax number), and phone numberof supplying establishment;
`
`b. supplier lot number; and
`
`c. production date, nameof supplied material, and any additional information to
`clearly identify the material used to the managementof the supplying establishment.
`
`2. If the source materials are from a foreign establishment, the District contact
`person should inform the establishmentthat FSIS will also collect the following
`information, should the product be confirmed positive for E. coliO157:H7:
`
`a. country of origin;
`
`b. foreign establishment number;
`
`c. shipping mark;
`
`d.
`
`I-house; and
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`e. barcoding or any otherinformation that identifies the origin of the product.
`
`3. The District contact person advises the establishmentthat it should begin to
`gather the information above, along with distribution information.
`
`B. What information does FSIS collect when a raw ground beef product
`sample collected by FSIS for verification testing at an official establishmentis
`confirmedpositive for E. coli0157:H7, and whom doesFSIS notify concerning
`the positive?
`
`1. When a sampleis confirmed positive, inspection program personnelcollect
`from the establishment the information in Part Ill. A.
`Inspection program personnel
`makenote of any information that the establishment is unable to provide.
`
`2. Inspection program personnel forward the information by e-mail to the
`designated DO contact, with a “cc”to the front-line supervisor.
`
`3. The DO will access the System Tracking E. coli 0157:H7 — Positive Suppliers
`(STEPS), open a casefile for the incident, and follow STEPS procedures.
`
`4. STEPSautomatically e-mails the DO that has jurisdiction over the supplying
`establishment. The DO notifies the IIC at the supplying establishment to perform a
`HACCP02 and otheractivities described in Part VI.
`
`5. The DO notifies all of the supplying establishments in the District, by
`telephone, of the positive finding and provides the suppliers the production date for the
`product that the supplier provided to the grinder, the lot numberof the supplied product,
`and otherinformation that would be useful to the supplier to help identify the E. coli
`0157:H7 positive lot. The DO documents the date and timeof this oral notification in
`the STEPS system.
`
`6. After all necessary information on the supplying establishment has been
`entered into the STEPS system, the DO reviewsthe information in the STEPS system
`and sends an e-mail notification to the supplier about the E. coli 0157:H7 positive
`product.
`
`7. The supplier information is maintained within the STEPS system and is
`maintained on FSIS’ network. Users must be given accesstothissite.
`
`NOTE: If the confirmed positive sample came from product which was made, in whole
`or in part from imported product, the DO provides information about the supplier to the
`Office of International Affairs (OIA), Import-Export ProgramsStaff, by telephone, and
`documents the date and timeofthis oral notification in the STEPS system. The DO
`then provides information about the supplier to OIA, Import-Export ProgramsStaff,
`through an e-mail message to importexport@fsis.usda.gov. OIA, in turn, forwards this
`information to the head of the inspection service in the country where the supplying
`establishmentis located.
`
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`FSIS Directive 10,010.1, Revision 1
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`Part IV — Enforcement Actionsin Official Establishments
`
`A. What actions do inspection program personnel take if an FSIS sample
`taken from an official establishment is confirmed positive for E. coli O0157:H7?
`
`1. The DOis notified of a positive through the Biological Information Transfer
`and E-mail System (BITES).
`
`2. Inspection program personnel, the DO, and Recall ManagementStaff (RMS)
`worktogether to determine the necessity of product retention, detention, or recall. The
`Technical Services Center (TSC) and OPHS mayalsoserve astechnical resources to
`assist in the decision making process. The DO will contact inspection program
`personnel and program investigators as necessary (see FSIS Directive 8080.1,
`Revision 3).
`
`3. As set out in FSIS Directive 5000.1, Revision 1, inspection program personnel
`
`are to:
`
`issue an NR underthe appropriate 03 ISP code using the “verification” trend
`a.
`indicator; and
`
`b. as soon as possible after the establishment has implementedits corrective
`action, perform a HACCP 02 procedurefor the specific production that tested positive
`for E. coliQ157:H7 and verify that the establishment implements corrective action that
`meets the requirements of:
`
`i. 9 CFR 417.3(a) if E. coliO157:H7 is addressed in the HACCPplan;
`
`ii. 9 CFR 417.3(b) if E. coliO157:H7 is not addressed in the HACCP planorifit
`is addressedin prerequisite programs; or
`
`iii. 9 CFR 417.3(b) and 416.15 if E. coliO157:H7 is addressedin the Sanitation
`
`SOPs.
`
`If disposition of the positive productwill be delayed, inspection program
`4.
`personnel should work with their front-line supervisors to determine how to work with
`the establishment to ensure proper and timely disposal of the product.
`
`If product disposition is to occur off site, inspection program personnel are to
`5.
`verify that the establishment that produced the positive product maintains appropriate
`control of the product by conducting the following activities when performing the 02
`procedure:
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`a. obtaining the identity of the official establishment or obtaining the name and
`address of any rendererorlandfill that will receive the product;
`
`b. notifying, through e-mail, the contact personin the District that covers the
`establishment that producedthe positive product that adulterated productis being
`transferred and providing the DO contact person the establishment numberof the
`establishment wheredisposition will occur or the name and addressofthe landfill
`operation or renderer. The District contact personwill notify the District where the
`establishmentthat will further process the product, landfill operation, or rendereris
`located, if the establishment, landfill operation, or renderer that is to receive the product
`is located in anotherDistrict;
`
`c. for product being transferred to a landfill operation or renderer, verifying that
`the establishmentwill maintain control of the positive product whileit is in transit
`(e.g., through companyseals);
`
`d. for product being transferred to an official establishment, verifying that either
`1) the establishment that producedpositive productwill maintain control of the product
`whileit is in transit (e.g., through company seals) or 2) the product will move under FSIS
`control (e.g., under USDAseal or accompanied by FSIS Form 7350-1); and
`
`e. verifying that records are available that show that the positive product
`received the properdisposition, including documentation evidencing proper disposal of
`the product from the official establishment, landfill operation, or renderer where
`disposition occurred. The HACCP 02 procedureat the establishment that produced the
`positive product cannot be completedfor this specific production until the establishment
`has conducted pre-shipmentreview of the corrective action record and has received
`documentation evidencing proper disposal from the official establishment where
`disposition occurredorlandfill operation or renderer where disposition occurred.
`
`If inspection program personnel find noncompliance with paragraph 5, they
`6.
`are to contact the DO. The DO will investigate to determine whether the establishment
`committed the prohibited act of selling or transporting adulterated articles that have not
`been inspected and passed.
`
`Part V — Follow-up Sampling
`
`A. Are FSIS follow-up samplestaken at official establishments after an
`FSIS-sample of raw ground beefis confirmed positive for E. coli 0157:H7?
`
`If inspection program personnelidentify no significant problems through the
`1.
`HACCP 02 procedure(see Part IV. A. 3. b.), inspection program personnelare to
`contact OPHS through an Outlook e-mail message to Sampling Forms —
`Headquarters mailbox, so a form can be sentfor the collection of a follow-up
`verification sample.
`Inspection program personnel should copy (CC)their front-line
`supervisor and the DO designated representative on their e-mail message. The request
`must include the establishment number, the number of forms(in this case 1), the type of
`sample to be collected (i.e., a product sample), the purposeof the request(i.e., follow-
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`FSIS Directive 10,010.1, Revision 1
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`up sampling in responseto a confirmed positive in raw ground beef), the sample form
`numberof the original positive sample triggering this request, and the DOofficial
`approving the request.
`Instructions for follow-up sampling will be provided on FSIS
`Form 10,210-3, Requested Sample Programs, orin revisions to FSIS Directive
`10,210.1, under the appropriate project.
`Inspection program personnel should collect
`the follow-up sample as soonafter the establishment hastakenits corrective action as
`possible. See Part V. A. 3., for actions to take if disposition of the positive productis
`delayed.
`
`If inspection program personnel identify regulatory noncompliance, they
`2.
`should document the noncompliance in accordance with FSIS Directive 5000.1,
`Revision1, Chapter IV.
`If inspection program personnel find that the establishment may
`have movedpositive product without appropriate controls or if they find the
`establishment may not have records showing that positive product received proper
`disposition, they should contact the DO.
`Inspection program personnel should also
`collect one follow-up sample as soon after the establishment has takenits corrective
`action as possible.
`Inspection program personnelare to contact OPHS so a form can
`be sentfor the collection of a follow-up verification sample. See Part V. A. 1., for
`information on e-mailing OPHS to request a follow-up sampling form. See Part V. A.3.,
`for actions to takeif disposition of the positive product is delayed.
`
`If disposition of the positive productwill be delayed, inspection program
`3.
`personnel should workwith their front-line supervisors to determine when it would be
`appropriate to collect the follow-up sample and how to work with the establishment to
`ensure properand timely disposal of the product.
`
`If the inspection program personnel have concerns regarding whether the
`4.
`design of the HACCP system is adequate to ensure food safety, they should not collect
`a follow-up sample. They should notify their front-line supervisor, who will determine
`whetherit is necessary to bring in an Enforcement Investigations and Analysis Officer
`(EIAO) to the establishment to conduct a comprehensive assessmentof the food safety
`systems.
`If the EIAO determinesthat the establishment's corrective actions appear to
`be appropriate and effective, the EIAO will contact OPHS so a form can be sent to
`inspection program personnelfor the collection of a follow-up verification sample. See
`Part V. A. 1., for information on e-mailing OPHS to request a follow-up sampling form.
`Inspection program personnelare to take the sample as soon aspossible after they
`receive the form. See Part V. A.3., for actions to take if disposition of the positive
`productis delayed.
`
`If a follow-up sample is found positive, the DO is notified through BITES, and
`5.
`the DO will determine the appropriate follow-up action.
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`If the EIAO determines that the corrective actions are inappropriate or
`6.
`ineffective, the EIAO will recommend an enforcementaction as described in
`9 CFR 500.3 or 500.4 (e.g., Notice of Intended Enforcement (NOIE), withholding, or
`suspension).
`
`If the District Office decides to either defer a decision on suspending the
`7.
`establishment, or a suspension action is taken and then put into abeyance (see FSIS
`Directive 5000.1, Revision 1, Chapter IV), FSIS will conduct follow-up sampling to verify
`that the corrective action taken by the establishmentis appropriate and effective. The
`DO will determine the numberof follow-up samples. Guidance on howto determine the
`number of follow-up samples will be provided to the DO. The DO should contact OPHS
`so the appropriate numberof forms can be sent to inspection program personnelfor the
`collection of follow-up verification samples. See Part V. A. 1., for information on e-
`mailing OPHS to requestfollow-up sampling forms. The guidance is designed to
`provide enhancedstatistical confidence for finding low levels of E. coli O157:H7 butis
`not designedto provide validation of the establishment’s food safety system.
`
`PARTVI - FSIS’ Verification Activities at Establishments Producing
`Raw Ground Beef Components or Raw Beef Patty Components
`
`If FSIS confirms raw ground beef productat an official establishment or
`A.
`retail facility positive for E. coliO157:H7, and a second official establishment
`supplied the product used to produce the ground product, whatverification
`activities does FSIS conductat the supplying establishment?
`
`TheIIC at the supplying establishment ensuresthat the inspection program
`personnel perform a HACCP 02 procedureto verify that the establishment met the
`applicable regulatory requirements at all CCPs in the HACCP plan (monitoring,
`verification, recordkeeping, corrective actions, and reassessment) for the production lots
`sent to the establishmentorretail facility wnere FSIS found the positive.
`If inspection
`program personnelfind noncompliance, they take appropriate action as describedin
`FSIS Directive 5000.1, Revision1, ChapterIV.
`
`If a grinding establishmentor retail facility receives incoming product
`B.
`for grinding, and FSIS finds the raw ground productpositive for E. coli 0157:H7,
`will FSIS test product from suppliers? If so, how do inspection program
`personnelcollect samples?
`
`1. When FSIS conducts sampling atofficial establishments oratretail, and a
`sample tests positive for E. coliO157:H7, FSIS maytest raw ground beef components
`and raw beef patty components at the supplying establishment.
`
`If inspection program personnel are requested to collect raw ground beef
`2.
`components or raw beef patty component samples, theyare to follow the instruction in
`Part Il of this directive and collect samples as described in Attachment 2. The types of
`product inspection program personnel maycollect are:
`
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`FSIS Directive 10,010.1, Revision 1
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`Raw Ground Beef Components: These components include raw esophagus
`(weasand) meat, head meat, and cheek meat; beef manufacturing trimmings
`(e.g., 90/10, 85/15, 75/25, 65/35, 50/50); boneless beef; beef from AMR systems; and
`lean finely textured beef (LFTB).
`
`Raw Beef Patty Components: These componentsinclude all the components
`listed above in Raw Ground Beef Components, as well as partially defatted chopped
`beef (PDCB), finely textured PDCB; heart; and partially defatted beeffatty tissue
`(PDBFT).
`
`3. Also, inspection program personnelare to only collect samples of raw ground
`beef componentsor raw beef patty components that are intended for use in raw non-
`intact product. To determine the intended use of the products, inspection program
`personnel are to review establishment records and HACCP documents.
`In cases where
`the establishment records and HACCP documents(e.g., flow chart and hazard analysis)
`are unclear aboutthe intended user, FSIS will handle the productasif it were intended
`for use in raw non-intact product.
`If the establishment has notidentified the intended
`use or consumersofthe finished product, the establishment is out of compliance with 9
`CFR 417.2(a)(2).
`
`C. If FSIS finds raw ground beef productat an official establishment
`positive for E. coli O157:H7, and the ground product was derived from raw
`ground beef components producedat the same establishment, would FSIS
`sample raw ground beef componentsat that establishment?
`
`FSIS may sample and test raw ground beef components at an establishmentthat
`produces raw ground beef products from such componentsif FSIS finds the ground
`beef productpositive.
`If instructed to sample such products, inspection program
`personnel should follow the sampling proceduresin Part VI. B.
`
`D. What enforcementactions do inspection program personneltakeif FSIS
`finds a raw ground beef componentor raw beef patty componentpositive for E.
`coli O157:H7?
`
`Inspection program personnelareto follow the instructions in Part IV. A. The
`enforcementactions inspection program personnel are to take whenFSIS finds a raw
`ground beef componentor raw beefpatty componentpositive for E. coliO157:H7 are
`the sameas the enforcementactions inspection program personnelare to take when
`FSIS finds a raw ground beefproductpositive for E. coliOQ157:H7. Similarly, the
`controls necessary for movementof presumptive positive or positive raw ground beef
`products are also necessary for movement of presumptive positive or positive raw
`ground beef componentsor raw beef patty components.
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`PART VII — Inspection program personnel responsibilities related to
`an establishment’s testing of product for E. coli O157:H7
`
`A. Can establishments conduct pre-shipment review for product
`that is not at the producing establishment?
`
`FSIS has taken a consistent position that establishments can conductpre-
`shipment review whenthe productis at locations other than at the producing
`establishmentprovided that the product does not leave the control of the producing
`establishment. Some establishments analyze samplesfor E. coliO0157:H7 while the
`productis being movedbutis still under the establishment's control. FSIS is providing
`the establishments theflexibility to move this productprior to pre-shipment review being
`conducted whenthe establishmentis conducting testing for E. coliO157:H7 and
`maintains control of the product. FSIS has instructed inspection program personnel that
`they have accessto the results of any testing and of any monitoring activities that are
`performed that may have an impact on the establishment's hazard analysis (FSIS
`Directive 5000.2).
`Inspection program personnel must review theseresults on at least a
`weekly basis.
`
`B. What do inspection program personnelverify if an establishment
`conducts verification testing for E. coli0157:H7?
`
`1. Inspection program personnel are to review the records associated with any
`E. coli 0157:H7 testing conducted by an establishment.
`If inspection program
`personnelfind a presumptive positive or confirmed positive E. coli O157:H7 result in the
`testing records, they should verify that the establishment is implementing corrective
`actions that meet the regulatory requirements as part of a HACCP 02 procedure as
`described in Part IV.
`
`2. If establishment records show that the establishment transports productthatit
`has found presumptive positive or positive for E. coliQ157:H7 to another establishment
`for appropriate disposition, or if establishment records show that the establishment
`movesproductbefore E. coli O157:H7 test results become available, inspection
`program personnelshould verify that the establishment—
`
`a. maintains recordsidentifying the official establishment, renderer, or landfill
`operation that received presumptive positive or positive product;
`
`b. maintains records identifying the official establishment that is to receive
`productfor which results are pending;
`
`c. maintains control of product that is destined for a landfill operation or renderer
`while the productis in transit (e.g., through company seals);
`
`d. maintains control of product that is destined for an official establishment while
`the productis in transit (e.g., through company seals) or ensures such product moved
`under FSIS control (e.g., under USDA seal or accompanied by FSIS Form 7350-1);
`12
`
`National Beef Ex. 1023
`
`National Beef Ex. 1023
`
`

`

`FSIS Directive 10,010.1, Revision 1
`
`e. maintains records that show that presumptive positive or positive product,
`including product that moved pendingtest results, received the properdisposition,
`including documentation evidencing proper disposal of the product from the official
`establishment, renderer, or landfill where disposition occurred; and
`
`f. completes pre-shipmentreview for product from a lot that has tested positive or
`presumptive positive and that was moved pendingtestresults only after it has the
`records described in paragraphe. for that particular product.
`
`If inspection program personnel are awarethat an establishment has found
`3.
`product presumptive positive or positive for E. coliO1