United States Food Safety Washington, D,C. 

Department of and Trlspectim 20250 

Agriculture Service 

MAR 2 0 2012 

TO: SEE DISTRIBUTION 

SUBSECT: Public Health Infomation System 

The United States Departmenf of &cube (USDA), Food Safety and Inspection Service 

(FSB) is impIementingthe importcomponents of the Public. Health Information System WS), 

effective May 29,2012. The PHIS is a web-based applicationthat will replace the existing 

Automated Import Informalion System (AIIS). Many of the changes asso~iatedwith thisnew 

system were outlined during the outreach sessions held in2011 and ate highlighted below. 

CertificationReauhments 

The competent authority of the foreign inspection service will continue to be responsiblefor 

completingthe certificationofeligible establishments, as outlined in 9CFR 327.2 and 38 1.196 

(a)(3), as well as the certification of shipmentsofproduct to the United States, as outlined in 9 

CFR 327.4(a) and @I,381,197, and 590.915. Inthe near future, FSIS will publish proposed 

revisionsto the import replations in the FderaI Register that will include changes to the 

certificationrequirements and data required for cdfybg eligible foreign establishments and 

inspectioncertificates accompmyingthe shipmentsof product to the United States. One 

significant change is that the import wmponmt of the PHISwill provide for a government-togoverament electronic transmissionofthe certificate data as an alternativeto the paper 

certification, which will continue tabe acceptedby FSIS. Inthe fmtphase of implementation, 

electronic certificationwill be limited to two countries,Aushalia and New ZeaIand, both of 

which already have agreements in place for the use of electroniccdfiates. Other foreign 

govements interested inpursing electronic certification should contact the FSIS Office of 

Intdond AfWs (ON)for Mer guidance and requirements. Foreign countries exporting 

to the United States may still usepaper inspection certificates. 

Regardless ofthe fcnmat ofthe annual establishment c&cation, the following data elements 

will be requimk foreign establishment's name and address, control number (e.g.establishment 

number) assignedby the foreign itlspdon system, typeof operations conducted at the 

establishment (e.g. slaughter*processing, storas, or qod certification), and eligibility status 

(e.g. new,listed as eligible the previous year, deiiste& relisted (if previously delisted). Slaughter 

and processing estabtishznents must identify the speeia and types ofproducts produced in the 

establishment, as well as the process categories for products produced. The process categories 

include raw nonintact; raw -intact,thermallyprocessed -cornmially sterile; not heat treated 

-shelf stable;heat treated -shelf stable fully cooked-not shelf stable;heat treatedbut not fully 

mked -not shelf stable; and, pmhcts wifh secondaryinhibitors -not shelf stable, and egg 

products. 

FSIS Form 2630-9 18/86) EQUAL OPPORTUNITY IN EMPLOYMENTAND SERVICES 
Whether a paper or dectronic certificate is ussd, each consignment ofmeat, poultry or egg 

products certifiedfor export to the United States must be accompanied with an inspection 

certificate, preparedin.English, and containthe following information: 

Name of country, the date the certificate is issued, and if applicable,the foreign 

establishment number where the certificatewas issued 

Name and foreign establishmentnumber that produced the product 

Speciesused to produce the product and the source country, establishmentnumber, if the 

source ofthe meat,poultry, or eggproducts originate fkom a countryother than the 

exporting country 

Name and address of exporter or consignor 

Name and address of importer or consignee 

Number of units 

Net weight for each lot 

Shipping or identificationmark on units 

The product's description, including the product'sprocess category, product category, 

product group (see Attachment 1) 

Production dates, when applicable 

Name (including signature)and title of person authorized toissue inspection certificates 

for products exportedto the United States (paper certificatesonly). 

FSIS no longer prescribes the specific statements that are to appear on the foreign inspection 

certificates,though the competent authoritymust dfy that anyproduct described on the 

official certificate was produced inaccordance with the regulatoryrequirements in9 GFR 327.2 

(meat), 9 CFR 381.196 197 (poultry)or 9CFR 590.910 (egg products). Further, FSIS no longer 

requires the certificateto be printed in the language ofthe foreign countryof origin, though 

foreign countrieshave the optionto include this. 

FSIS has previously allowed foreign countries to guaranteethe rep1acmmt ofthe foreign 

inspectioncertificate,which would allow continuation of FSS reinspection pending the arrival 

of thecertificatewithin 30 days of the guarantee. FSIS will discontinuethis policy when the 

PHIS is implemented. FSIS will refuse entry to any shipmentthat has not been properly 

certified. Replacement certificateswill be accepted, either datronically (e.g. scanned copy 

transmittedby email or replacementthrough ecertification)or paper, at which time FSTS will 

continuewith the reinspection. 

Presentation for importrehmectionand.sampling at mrt ofmtrv POEI 

U.S. importerswill continue to apply for FSIS import impectiotl of any meat, poultry or egg 

products offered for entry into the United States. When implementedin May, the PHIS will 

interface with the U.S.Customs and Border Protection's (CBP)Automated Commercial 

Environment (ACE), which is the U.S. commercial trade processing system that automates entry 

of products into U.S. commerce. The interface between ACE and PHIS will permit the direct 

electronic transfa of FSIS-specifi.ed shipment datawhen the applicant files entry with the CBP. 
This electronic lramk will provide FSIS with prior notice of the shipment's arrival intothe: 

United States. 

When the PHIS import component is implemented,FSIS will be able to monitorthe movement 

of importedproduct more effwtively and rnciently. In the event that the shipment fails to 

present for FSISreinspection at an official import inspection establishment, FSIS will consider 

that shipment as ineligible for entry and a request for redelivery will be initiated through CBP. 

The importer maybe subject to apprupriate @ties associatedwith this enfoxcement action. If 

the shipment is returnedto the official import inspection establishment, the shipment will be 

refrtsed entry. Ifthe shipment is delivered to &e end user in the US., the importedproduct, or 

any product produced fromthe ineligible product maybe subject to FSIS recall or destruction. 

The Agency's focus will remain on the perfomce of the foreign inspection system, rather than 

an individual establishment. FSIS will continue to perfom a variety of inspection activities to 

verify on-going equivalence ofthe foreign inspection system. Every shipment will receive visual 

inspection including verification for physical attributes such as transportation damage, and 

accurate box count, certification, and labeling. ShipmentsmdumIy selected by the PHIS for 

more in-depth reinspectionwill be subjected to applicabletypes of physical inspections, such as 

product examination, checkingthe condition of the container of thermally processed product, as 

well as laboratory analyses for hodchmhy, pathogens (microbiologicaltesting), and residues. 

The FSIS import inspector will verify the accuracy of data h m the import application filed by 

the importer with the foreign inspection cerlificate on every shipment presented for reinspection. 

When product failsto meet U.S. requirements,the lot(s) will be refused entry. 

Designation of Rady-to-33at versus Not Rdy-to-Eat Products NTEl 

The FSIS import inspector will use certain labeIing features, such asthe product name and the 

presence of cooking or heating instructionsto verify the ~lassificationof the process and product 

categories. As an example, label features on NRTEproducts would conveythat the product 

needs to be Mer cookedprior to consumption, e.g., "wokand serve," "uncooked," "wok 

thomughly," validated cooking instructions and insome cases safe handling instructions. It is 

essentid that the product is properly categorized, as this impacts whether the shipment is 

subjected to mimbiologicd testing. 

Unless defined by a standard ofidentity at RTE, such as hotdogs, frankfurters, pork with 

barbecue sauce, etc., FSIS permits meat or poultry products traditionally considered to be fully 

cooked to be identified as NRTE provided the product is intended to receive a lethality treatment 

by the consumer. As described above, the product must have proper labeling features and 

validated cooking instructionsto discern that the product must be cooked for safety by the 

purchaser. Ifthe product has historicallybeen viewed by the consumers as a RTE product, e.g., 

"heat and wt",it is especiallyimporhit for the establishmentto make the distinction between 

the RTEproduct and the NRTE product. In addition, the 4tcookhginstructions" should not be 

the same "healing"instructionsthat were previously used on labeling forthe RTE products. 

Cooking instructions should explicitlystatethe product needs to be cooked for safety, e.6, "for 

safety cookto.." and would need b include the internal temperature towhich the product is 

expected to reach for the consumer to eat the:product safely. 
Implementation 

Effective May 29,2022, the PHI5 will be operational in all U.S. import inspection 

&abIishments handling shipments &omdl eligible countries eligibleto export meat, poultry, 

and egg products. FSIS will replace the existing Import Manual ofProcedures, which provides 

guidance to the FSB @don personnel, with FSIS Djr8cEives. FSIS will provide Wer 

guidance and infomation toboth foreign governments as well as industry regardingthe PHIS 

prior to the implementation date. The updates to infomation relatedto PHIS will be available 

on the PSIS web page, which canbe accessed at h~:/lwww,fsis.usda.govlPHISlindex.asp. 

If you have specific questions about PHIS implementation, please contact FSB Office of 

htemtional Affairs (OLA), Impori Inspection Division at (202) 720-9904or by e-mail at 

immrtins~ection@fsis.usda.gov. 

Sincerely, 

4.Ronald K Jones 

Assistant Admitlistrator 

OfficeofInternational Affairs 

Attachment 

Distribution List: Argenh Australia, Aha, Belgium, Brazil, Crtnada, Chile, China, Costa 

Rich Croatia, CzechRep, Denmark, Finland, France, Gumany, Great Britain, Honduras, 

Hungary, Iceland, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zedand, Nicaragua, 

Northem Ireland, Polmd, Romania, Sm Marino, Spain, Sweden, Uruguay 
FSIS Product Categorization

April 23, 2012 Page 1

FSIS has developed this document to assist with accurate identification of the meat, poultry, and 

egg products certified for export to the United States.

Process Category: 

There are nine (9) process categories identified in 9CFR 417.2(b). Of the nine (9) listed, 

Slaughter is considered an internal process that occurs in establishments where the animals or 

birds are slaughtered. This category is not used for imported products. An additional process 

category that is not contained in 9CFR 417.2(b) is Egg Products. 

Note that FSIS has recently renamed two process categories: Raw Product – Ground and Raw 

Product – Not Ground are now referred to as Raw Product – Non-Intact and Raw Product –

Intact, respectively. However, use of either terminology will be acceptable to FSIS.

Note that official foreign inspection certificates should reflect the process category name, rather 

than the obsolete coding previously used by FSIS (e.g. 03B, 03C, etc.). These codes have 

been included in the table as some countries previously certified the process categories on the 

inspection certificates with this coding. 

Raw Product – Non-Intact: This process category applies to establishments that further process 

by using processing steps such as grinding, comminuting, injecting product with solutions, or 

mechanical tenderization by needling, cubing, pounding devices or other means of creating nonintact product. Examples of finished products in this category include raw products 

reconstructed into formed entrees, mechanically separated species and advanced meat 

recovery product. If the establishment produces bench trim or pieces of meat produced from 

non-intact meat, then the bench trim or pieces are also considered non-intact. 

Raw Product – Intact: FSIS considers raw products to be intact unless they have undergone 

any of the processes associated with the Raw Product – Non-Intact process category. 

Thermally Processed – Commercially Sterile: This process category applies to establishments 

that use a thermal processing step. Thermally processed, commercially sterile finished products 

are products in cans or flexible containers such as pouches, or semi-rigid, as in lunch bowls. 

Thermally processed, commercially sterile products are addressed in Subpart G, 318.300 – 311 

for meat food products, and Subpart X, 381.300 to 311, for poultry products. 

Not Heat Treated – Shelf Stable: This process category applies to establishments that further 

process by curing, drying, or fermenting processing step as the sole means by which product 

achieves food safety. Establishments in this process category may apply a low-level heat 

treatment as long as the heat treatment is not used as means to achieve food safety. The 

finished products produced under this Process Categories are shelf stable. FSIS does not 

require shelf stable products to be frozen or refrigerated for food safety purposes. 

Heat Treated – Shelf Stable: This process category applies to establishments that further 

process by using a heat treatment processing step to achieve food safety in combination with 

curing, drying, or fermenting processing step to achieve food safety. The finished products 

produced under this process category are shelf stable. FSIS does not require shelf stable 

products to be frozen or refrigerated for food safety purposes. If the establishment produces 

using the processing steps applicable under this process category and the product is not shelf 

stable, then establishment is producing product under the process category Fully Cooked – Not 

Shelf Stable. 
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April 23, 2012 Page 2

Fully Cooked – Not Shelf Stable: This process category applies to establishments that further 

process products by using primarily a full lethality heat process step (e.g. cooking) to achieve 

food safety. The finished products that establishments produce under this process category are 

not shelf stable. FSIS requires the products to be frozen or refrigerated for food safety 

purposes. These products also meet the definition of Ready to Eat (RTE) as defined in 9 CFR 

430.1. 

Heat Treated but Not Fully Cooked – Not Shelf Stable: This process category applies to an 

establishment that further processes products that are (1) not ready-to-eat products (NRTE) or 

(2) raw otherwise processed products that are refrigerated or frozen throughout the product’s 

shelf life. Meat and poultry products are produced using a heat process that meets one of the 

following criteria: 

a. The heat processing step is not adequate to achieve food safety. Products may be 

partially cooked or heated to set batter on a raw product. 

b. The heat processing step applied to meat or poultry component was adequate to 

achieve food safety, however product is further processed, assembled, or packaged so 

that cooked meat or poultry products contacts non-ready to-eat product ingredients. In 

this case, the final product is in a form that is not edible without additional preparing to 

achieve food safety. An example of this product is pot pie product that contains cooked 

chicken and raw dough. 

Products with Secondary Inhibitors – Not Shelf Stable: This process category applies to 

establishments that further process by using a curing processing step or a processing step 

using other ingredients that inhibit bacterial growth. These products are generally refrigerated or 

frozen throughout the product’s shelf life. Depending on the process and ingredients, these 

products may or may not meet the definition of RTE as defined in 9 CFR 430.1. 

Eggs/Egg Products: This process category applies to shell eggs and egg products. 

Product Category (with Applicable Species)

The Product Categories are shown in the FSIS Product Categorization table with the 

appropriate species indicated for each. 

The Species designations FSIS is using for PHIS are: for Meat: Beef, Veal, Pork, Lamb, Mutton, 

and Goat, including for Equine: Horse, and Equine other than horse; for Poultry: Chicken, 

Turkey, Duck, Goose, Guinea, and Squab, including for Ratites: Emu, Ostrich, and Rhea; for 

Eggs: Chicken, Turkey, Duck, Goose and Guinea; and for Egg Products: Chicken, Turkey, 

Duck, Goose, and Guinea. For each product, the certification must indicate which species is 

predominant in the product to assure the appropriate regulations are applied to the product 

when applicable.

Product Group. The product group defines the product down to a level that FSIS can program 

appropriate types of inspections (TOI) for examinations and laboratory sampling. Regulatory 

references are added where applicable for clarification. While these appear to be selfexplanatory, for Raw Product – Intact, Cuts are cuts of meat (e.g., steaks, chops, etc.) that are 

below the Primal and Subprimal level.
FSIS Product Categorization

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The following table displays the process categories and the types of finished products that can 

be present in a process category.

Finished Product Types by Process Category

Process Categories Finished Products

Raw

Product

NRTE

Product

RTE

Products

Thermally 

Processed

Product

Slaughter ●

Raw –Non Intact (Raw Ground) ●

Raw – Intact (Raw Not Ground) ●

Thermally Processed –

Commercially Sterile 

●

Not Heat-Treated - Shelf Stable ● ●

Heat Treated – Shelf Stable ● ●

Fully Cooked – Not Shelf Stable ●

Heat Treated but Not Fully Cooked 

– Not Shelf Stable 

●

Product with Secondary Inhibitors –

Not Shelf Stable 

● ●

Eggs/Egg Products Not Applicable

Ready to Eat applies to any product intended for human consumption without further 

preparation steps. Note: Products that appear fully cooked or are customarily consumed 

without further preparation, but the label does not include cooking instructions, are by default 

considered RTE.

RTE fully cooked means that the products have been sufficiently cooked so that they are safe to 

eat as they are, with no further preparation required by the consumer. Note: Many of these 

products are customarily eaten hot, and heating instructions may be included on the label. This 

does not affect the classification of these products as RTE.

Some frozen RTE products require reheating for palatability. These frozen products are still safe 

to eat without this further preparation by the consumer and are therefore still considered RTE. 

Some examples include: fully cooked hams, cooked beef, roast beef, pastrami, corned beef, hot 

dogs, meat loaves, meat and poultry salads, sliced luncheon meats, baked chicken, frozen 

entrees, and poultry rolls. These finished products must labeled in a manner that identifies 

them as RTE by the consumer.

Fresh or frozen entrees with fully cooked meat or poultry portions combined with fully cooked 

sauces, vegetables, pasta, or other ingredients are RTE products. These products are 

designed to be re-heated by the consumer, and may include instructions for re-heating. 

Not Ready to Eat applies to products with cooking instructions or labeled with statements on 

the principal display panel such as “Cook Thoroughly, Cook and Serve, Not Ready to Eat, or

For Safety and Quality- follow these cooking instructions.” These products are considered 

NRTE. 
FSIS Product Categorization

April 23, 2012 Page 4

Some NRTE finished products are heat treated but are not fully cooked. These NRTE products 

are required to have sufficient labeling information to inform the consumer that the product must 

be cooked for safety. This information may be contained within the product name on the 

principal display panel, as well as bear cooking instructions that refer to cooking the product for 

safety rather than heating the product for best quality. The product often times may bear a safe 

handling instruction.

Some NRTE finished products are prepared with both meat/poultry components that have 

received a lethality treatment in combination with non-meat/poultry components that need to 

receive a lethality treatment. These multi-component products, e.g., meals, dinners, and 

entrees, have labeling features which are conspicuous so that intended users are fully aware 

that the product must be cooked for safety. The principle display panel on the label defines

these products, e.g., “Cook and Serve, “Must be thoroughly cooked,” “Cook before eating”, and 

the product must include cooking instructions.
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