The Public Health Information System (PHIS), a dynamic, comprehensive data analytic system, was launched as part of our effort to collect, consolidate and analyze data in order to improve public health.
FSIS is providing foreign governments, as well as importers and brokers of meat, poultry, and egg products, the following letters regarding the final rule, Electronic Import Inspection Application and Certification of Imported Products and Foreign Establishments; Amendments To Facilitate the Public Health Information System (PHIS) and Other Changes to Import Inspection Regulations.
- Letter to Foreign Governments
- Letter to Importers and Customs Brokers
- FSIS Partner Government Agency (PGA) Message Set Compliance Guide
- Revised FSIS Form 9540-1
- Fact Sheet: FSIS Import Inspection and Failure to Present (FTP)
FSIS also provided the following information prior to implementation of the import component of PHIS.
Official import inspection establishments are required to have an e-Authentication account to be able to access the PHIS. Interested parties are required to obtain an eAuthentication level 2 account from USDA as the first step in the access process. FSIS encourages interested parties to complete this step as soon as possible.
- Letter to Establishments
- USDA eAuthentication System
"eAuth" is the secure system that allows web-based access to USDA applications and services.
- FSIS Guidance for Importing Meat, Poultry, and Egg Products in the United States
- Prior Notification and Failure to Present: Compliance Guidance for Importing Meat, Poultry and Egg Products to the United States
This guidance is designed to help importers of record (IOR), U.S. Customs brokers, and Official Import Inspection Establishment management understand and comply with the Food Safety and Inspection Service’s (FSIS) import inspection regulations for meat, poultry, and egg products on prior notification and explains regulatory actions taken when products fail to present for FSIS reinspection, known as "Failure to Present" (FTP).
- Import Related FSIS Directives (9000 Series
Conference Call with National Customs Brokers & Forwarders Association of America, Inc. (NCBAA) and Meat Import Council of America (MICA) (May 2, 2012)
Conference Call with Industry and the Canadian Food Inspection Agency (May 3, 2012)
The entry filed with Customs and Border Protection (CBP) through the Automated Broker Interface (ABI) will provide FSIS mandatory prior notice of the shipment. If industry does not file the entry electronically with CBP, such as immediate delivery shipments, then the importer (or agent) would provide a paper copy of FSIS form 9540-1 and the foreign inspection certificate to FSIS import inspection personnel at the official import inspection establishment.
2. In order for data to flow to USDA we would have to do a summary certified for release. Just release data alone would not give enough info for advance notice of arrival. Is that correct?
FSIS will receive entry/entry summary data from CBP at the implementation of PHIS. If possible, FSIS recommends that the entry summary certified for cargo release be filed at entry. That summary will provide the most accurate shipment data available and require fewer data adjustments (i.e., time savings) in PHIS when the shipment is presented for reinspection at the official import inspection establishment.
3. What is the expected impact on brokers submitting data when PHIS implements on May 29, 2012?
On May 29 effectively, you will do nothing different. You will continue to file your entries with CBP as you have been doing, and you will continue submitting the same FSIS Form 9540-1 to FSIS. The only difference is that entry and entry summary information will be coming to PHIS from the Automated Commercial Environment (ACE) or the Automated Commercial System (ACS).
4. If an entry summary isn't filed for a week, would that be the first time the inspector is going to see the data in PHIS?
No, the data is transferred to PHIS when the entry is filed. FSIS will proceed with the reinspection, and will monitor any changes made by the broker when filing the entry summary that would impact FSIS reinspection activities.
5. Can you clarify where you want the e-mail address on FSIS Form 9540-1?
FSIS is requesting two pieces of information in "Box 31 Remarks" of FSIS Form 9540-1: (1) the e-mail address of the importer (or agent) and (2) the estimated date of arrival of the shipment at the official import inspection establishment.
6. Will FSIS inspectors continue to stamp FSIS form 9540-1 with the U.S. mark of inspection?
FSIS will continue to stamp FSIS Form 9540-1 for the present time. Once the PGA Message Set is implemented, replacing the paper applications, industry will be able to request a copy of the application. PHIS is designed to generate a paper copy of FSIS form 9540-1 (or an electronic image).
7. Will the Canada exporter no longer provide the 9540-1 to the import inspector 72 hours in advance, typically requiring FedEx overnight delivery?
The Canada exporter will no longer submit FSIS Form 9540-1 to the FSIS import inspector 72 hours in advance of the shipment. Advance notification will be when the importer files entry with CBP through ACE and the entry/entry summary data is transmitted to PHIS. The importer of record or designee is responsible for providing FSIS Form 9540-1 to the import inspector.
8. Can the importer send a scanned copy of FSIS Form 9540-1 (import inspection application) directly to the import inspector?
FSIS will accept an electronic copy of the FSIS Form 9540-1.
9. On the draft FSIS Form 9540-1, are we expected to complete each block individually?
Yes, FSIS expects each lot certified on the official inspection certificate to be included on the application. However, the revised application will not be used until Customs and Border Protection (CBP) implements the PGA Message Set, which will provide the ability for FSIS specific data to be collected through ACE. At that time, brokers filing through ACE will no longer use a paper application, as the data will transmit electronically directly into PHIS. FSIS will notify stakeholders in advance of the PGA Message Set implementation, which is estimated sometime in fall 2012.
10. What is the timeframe of messaging coming from CBP into PHIS? Is that real-time or batched?
FSIS will pull the information from ACE into PHIS at a frequency that will ensure that FSIS inspection personnel will be able to retrieve data in a timely manner to alleviate delays.
11. In terms of any messages that come from the PHIS itself, are they standardized messages?
There will be standardized messages from PHIS to the importer (or agent) identified on FSIS Form 9540-1 for such things as failures to present (FTP) warnings, FTP notifications and refused entry notifications as well as "free text" e-mail exchanges from the import inspector for such things as questions or needed corrections to FSIS Form 9540-1.
12. If PHIS uses e-mail communication between FSIS and the importer (agent), is it one e-mail or can it be multiple e-mails in the e-mail address block?
Until two-way capability become available in ACE, PHIS is designed to accommodate an electronic exchange of communication between the FSIS import inspector and the importer (or agent). FSIS expects a single point of contact for this electronic exchange to resolve any issues with the application (FSIS Form 9540-1) or to resolve issues with the shipment itself.
13. Is there a timeframe for status message that will be going from PHIS to ACE?
The two-way communication between FSIS and the importer (or agent) through ACE is on CBP's timetable. Additional details will be forthcoming at a later time.
14. Will the process for failures to present stay the same starting on May 29?
With the entry data transmitting directly to PHIS, FSIS will be aware of the shipment's entry with CBP and the estimated date of arrival of that shipment at the official import inspection establishment. This additional information will enable better tracking and enforcement, which should minimize the number of failures to present.
15. Currently, there are FSIS Form 9540-1s that are submitted and do not match inspection certificates. With everything being submitted to PHIS, how is that handled in terms of inspection purposes?
Discrepancies between FSIS Form 9540-1 and the foreign inspection certificate must be rectified by the importer (or agent) before FSIS reinspection takes place just as it is currently. PHIS allows this process to take place electronically between the importer (or agent) and the FSIS import inspector. FSIS requires product to be presented for reinspection in lots certified on the foreign inspection certificate. Importers (or agents) are expected to correlate the lotting of product with the exporting establishment in the foreign country in advance of the foreign government certifying the shipment.
16. Currently, there are entries filed with multiple custom entry numbers that do not align with the lots identified on the foreign inspection certificate. How are these going to be handled by PHIS?
FSIS is researching this issue with CBP and will be posting a response soon.
17. If we need certificate guarantees, how will that be processed?
When PHIS implements on May 29, FSIS will no longer accept the foreign government's guarantee to replace the non-compliant inspection certificate. FSIS will require replacement certificates in order to continue with the reinspection of the shipment. For countries that have a government-to-government electronic certification exchange in PHIS, replacement certificates are issued through that process. For countries that do not have electronic certification, FSIS will accept replacement certificates in alternative format, such as a facsimile or through e-mail (e.g. digital image) from the foreign government to the import inspector.
18. Will PHIS affect current jurisdiction of egg products standards (e.g. U.S. Food and Drug Administration versus FSIS)?
There will be no changes in the jurisdiction of egg products.
19. How will egg products import procedures be affected by PHIS?
When the Public Health Information System (PHIS) is implemented on May 29, the FSIS Form 5200-8 Import Request Egg Products will be replaced with the current FSIS Form 9540-1 Import Inspection Application. This form will be used for all imported shipments of meat, poultry and egg products. Canadian exporters will no longer be responsible for providing FSIS with advance notification. This notification will occur when the importer (or their designated agent) files entry with CBP, provided this entry is made through ACE. ACE will transmit data to PHIS, including the Customs Entry Number (CEN), Bill of Lading (BOL) number and the Harmonized Tariff Schedule (HTS) number, which will provide FSIS with advance notice of the egg products shipment. PHIS Import implementation interim procedures require the importer to continue to submit FSIS Form 9540-1 to FSIS no later than when filing entry with CBP. FSIS will complete the data entry for the shipment prior to generating the inspection assignments. By submitting FSIS Form 9540-1 and the inspection certificate to the import inspector when the Customs entry is filed but prior to shipment arrival at the import inspection establishment, FSIS can pre-enter data to avoid unnecessary shipment delays.
Specific to egg products:
All pasteurized egg products must stop at an official import inspection establishment. The importer must provide FSIS Form 9540-1 and the foreign inspection certificate (with microbiological testing results) to the import inspector for data entry into PHIS. FSIS reinspection will occur at the official import inspection establishment or the establishment/plant designated on the FSIS Form 9540-1. Following reinspection at an official import inspection establishment, pasteurized egg products may also proceed to end user facilities.
Non-pasteurized egg products are not required to stop at an official import inspection establishment. Non-pasteurized egg products must proceed directly to an official egg plant in the United States. PHIS Import implementation interim procedures require the importer to continue to submit, when the Customs entry is filed but prior to shipment arrival, (e-mail or fax) the FSIS Form 9540-1 and the foreign inspection certificate for non-pasteurized egg products to FSIS, OIA, IID Headquarters for reinspection assignment in PHIS. FSIS reinspection will occur at the official egg plant designated on the FSIS Form 9540-1.
Visit the PHIS Compliance Guidance section to access the User Guide and other helpful resources.
FSIS began implementing the PHIS Export Component on June 29, 2018, with a limited number of countries (Phase 1), and is gradually expanding the PHIS Export Component to additional countries, regions, and territories. Implementation dates for each phase to date are listed below. Sign up for FSIS’ Constituent Update for the latest information.
- Phase 1 (June 29, 2018): Afghanistan, Andorra, Bahamas, Bolivia, Burundi, Cape Verde, Cook Islands, Ethiopia, French Guiana, Gambia, Guinea, Liberia, Mozambique, San Marino, Tanzania, Uganda.
- Phase 2 (May 20, 2019): Angola, Antarctica, Aruba, Bhutan, Botswana, Bouvet Island, Brunei Darussalam, Christmas Island, Comoros, Eritrea, Falkland Islands, Faroe Islands, French Southern and Antarctic Islands, Greenland, Guernsey, Heard Island and McDonald Islands, Isle of Man, Jersey, Lesotho, Liechtenstein, and Vietnam
- Phase 3 (January 27, 2020): China
- Phase 4 (July 26, 2021): Bangladesh, Bermuda, British Indian Ocean Territory, British Virgin Islands, Bosnia and Herzegovina, Burkina Faso, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Djibouti, Equatorial Guinea, Gabon, Georgia, Guinea-Bissau, Laos, Libya, Madagascar, Malawi, Maldives, Mauritania, Micronesia, Cocos (Keeling) Islands, Palau, Samoa, Sierra Leone, Togo, and Tonga.
- Phase 5 (August 30, 2021): Benin, Cambodia, Cayman Islands, Curaçao, Grenada, Guyana, Honduras, Macao, Myanmar, Panama, Qatar, Sri Lanka, St. Kitts and Nevis, and the United Arab Emirates (UAE).
- Phase 6 (June 13, 2022): Canada.
- Phase 7 (September 26, 2022): French Polynesia (Tahiti), St. Vincent & the Grenadines, and Turks & Caicos Islands.
Phase 8 (March 6, 2023): Albania; Antigua and Barbuda; Armenia; Bahrain; Bonaire; Colombia; Congo, Republic of (Brazzaville); Dominica; Dominican Republic; Ecuador; Egypt; Fiji; Ghana; Guatemala; Haiti; India; Indonesia; Jamaica; Jordan; Kenya; Kiribati; Kuwait; Kyrgyzstan; Lebanon; Malaysia; Mauritius; Moldova; Namibia; Nicaragua; Oman; Pakistan; Paraguay; Saba; Seychelles; Senegal; Sint Maarten; Solomon Islands; St. Eustatius; St. Lucia; Sudan; Suriname; Thailand; Timor-Leste; Trinidad and Tobago; and Uruguay will be added to the PHIS export module on March 6, 2023.
For Export Policy Questions (e.g., clarifying a FSIS notice, directive, or form, or guidance on countries’ export requirements, etc.)) visit: https://www.fsis.usda.gov/askFSIS
For Export Technical Issues/Questions (e.g., submitting/deleting applications, batching upload, etc.):
Call 800 473-9135 or
- FSIS Form 9060-5 - Meat and Poultry Export Certificate of Wholesomeness
- FSIS Form 9060-5B - Meat, Poultry and Egg Products Export Certificate of Wholesomeness Continuation Sheet
- FSIS-Form 9060-5A - Meat and Poultry Export Certificate of Wholesomeness Continuation Sheet
- FSIS Form 9060-5S - Fish and Fish Products Export Certificate of Wholesomeness
- Sample of the new Application for Export Certificate (9060-6) for programming purposes and system updates:
- Application for Export Certificate (9060-6) (May 22, 2018; PDF Only)
Accessing and Using the PHIS Component
USDA eAuthentication System
"eAuth" is the secure system that allows web-based access to USDA applications and services. This USDA site tells you how to obtain a Level 2 USDA eAuthentication account. All Users MUST have eAuthentication “Level 2” to access PHIS:
- USDA eAuthentication System
- Register for an eAuth Account
- Identify Verification: Find a Local Registration Authority
- PHIS Industry User Guide
- Quick Reference Guide for Corporate and Establishment Management
- Export Batch User Guide
- PHIS Batch Export (XML Schema File (Jan 28, 2020; XSD)
Click the link to download the file. Use the Save As option to copy the file to your computer or Open to view the file. For technical questions on use of the XML files, e-mail PHISTechnicalQA@usda.gov.
- Batch XML Validation Tool
- Export Batch XML Validator Quick Reference Guide
- PHIS Batch Export (XML Schema File (Jan 28, 2020; XSD)
- Establishment Search Guidance
- Canada and PHIS: Industry Testing Guidance
- FSIS to Update PHIS
- Reminder: FSIS Will Add the People’s Republic of China to Public Health Information System
- Reopening the Public Health Information System Industry Test Environment
- FSIS Announces New Date for PHIS Export Component’s Second Country Group
- FSIS Announces PHIS Export Component’s Second Country Group
- FSIS Shares Revised Export Certificates for Industry Awareness
- FSIS Announces Plan for Industry Testing of PHIS Export Component
- PHIS Export Webinar Videos for Industry Available Online (archived)
- FSIS Delays Implementation of PHIS Export Module (archived)
- PHIS Export Roundtrip Testing for Industry Webinar (Mar 30, 2018)
- PHIS Export Testing Teleconference: Transcript
- PHIS Export Training Webinar (Feb 14, 2017)
- PHIS Export Technical Webinar (Mar 27, 2017): Part 1 | Part 2 | Part 3
- Request a DVD copy by emailing email@example.com
- PHIS Industry Help: Export Applicant
- Consolidate 9060-5 Certificates/Approved Applications | Script
- Delete a Submitted 9060-6 Application | Script
- Print a Submitted 9060-6 Application | Script
- Replace a 9060-5 Certificate or Approved Application | Script
- Split an Approved 9060-5 Application | Script
- Submit a 9060-6 Application | Script
- Submit a Batch Application | Script
- Unlock and Edit a Submitted 9060-6 Application | Script
- 9080-3 Application Submission | Script
- Create Non-Disclosure/Information Security Awareness Agreement (NDA/ISA) | Script
- Edit and Delete a Service Account | Script
- PHIS Industry Help: Enrollment
- For additional PHIS Help Videos:
Officials of countries in the PHIS export component can register to view and validate digitally signed, FSIS Form 9060-5 series export certificates for product intended for their country in PHIS, using the Certificate Signature Viewer (CSV) role. PHIS-generated FSIS Form 9060-5 series certificates can also be printed on plain, watermarked paper with a secure digital signature to accompany each shipment. For countries in PHIS, all required information documented in the FSIS Export Library is included on the FSIS Form 9060-5 certificate series, eliminating the need for country-specific letterhead certificates.
Officials of countries in PHIS who are interested in the CSV role, or countries interested in being included in PHIS, should contact FSIS’ Office of International Coordination at firstname.lastname@example.org.
- Sample Digitally Signed FSIS Form 9060-5
- WTO Notification on PHIS Export Component
- Steps for Country Officials to Register for the CSV
- Certificate Signature Viewer User Guide
- eAuthentication System
"eAuth" is the secure system that allows web-based access to USDA applications and services.
FSIS will use the Export Component to electronically inventory and track export certificate information, and enable IPP to review exact images (i.e., PDF) of export certification documents before approval.
- Docket No. FSIS-2017-0008
Public Health Information System (PHIS) Export Component Country Implementation