APHIS GUIDELINES FOR EXPORTERS
Originally Presented: October 17, 2007
Joyce Bowling-Heyward, DVM, MS
Assistant Director
Export Animal Products Staff
USDA/APHIS/VS

Goals
Understand the APHIS role in export certification from start to finish
Understand exporter's role in export certification from start to finish
Know how to access the appropriate resources to accomplish your export certification with the minimal amount of headaches

Acronyms
APHIS-Animal and Plant Health Inspection Service
VS-Veterinary Services
FAS-Foreign Agriculture Service
IS-International Services
NCIE-National Center for Import and Export
IREGS-International Regulation Retrieval System
FDA-Food and Drug Administration
CVM-Center for Veterinary Medicine
EU-European Union

SECTION 1: APHIS ROLE
1. Our main role is to assist the exporter in meeting the import requirements of the foreign country.
2. APHIS negotiates new or different export requirements with foreign governments.
3. If an issue is outside of APHIS jurisdiction (such as residues), APHIS will collaborate with another agency or division.
4. We inspect exporting facilities if required by importing country.
5. We maintain lists of approved facilities as needed and provide this information to foreign governments.
6. We assist exporters when products are placed on hold overseas.
7. We explain APHIS policies to foreign officials and the general public.
8. Export requirements are posted on our web site provided earlier. Some countries will change their import requirements without notice so we do not guarantee that these requirements are up to date!
9. Export certificates are signed by Area Offices in accordance with APHIS policies .

APHIS Trade Ban Web Sites
When certain diseases occur in the United States, such as Avian Influenza, foreign countries will suspend the import of certain products from part, or all of the U.S. Because these actions may be temporary and occur in rapid succession, this information is not always available on the IREGS. APHIS will post a web site that is updated daily to inform exporters and VS field personnel of bans in effect. At this time there are no active trade ban web sites. All current information should have been posted to the APHIS IREGS or the FSIS export library. In the unfortunate event that we have another disease outbreak, we will start the procedure again if needed.

Regional Import/Export Coordinators
- Coordinators provide training and day to day assistance to Area Offices.
- They help improve consistency between Area Offices.
- This has enabled NCIE staff to focus on negotiations and policy issues.

Area Office Inconsistencies
1. If you have a concern that area offices are using different procedures, you should contact Regional Import/Export Coordinator.
2. If you have a concern that an area office is not following a proper procedure (for instance, you have been told that a product cannot be exported, but you know that is incorrect), contact NCIE.

SECTION 2: EXPORTER'S ROLE
It is the exporter's responsibility to make sure they are using the most current export requirements.

Finding The Requirements
Mechanisms to obtain export requirements:
1. Importer requests import permit from government
2. Check NCIE IREGS
3. Contact FAS foreign service offices
4. Contact APHIS, IS foreign service offices

Unsuccessful Search
If you are unsuccessful in obtaining import requirements, or if country is unspecific about what is required after exhausting these sources, your options are:
1. Ship with no certification. Some countries may have no requirements (although the number of these countries is quickly disappearing).
2. Offer a certificate that would be used for another country (the less detailed, the better), or a certificate of free sale.
3. NCIE can enter into formal negotiations to see what the country will accept.

Shipping At Your Own Risk
If you have information (but not in writing) that a foreign country will accept documentation different from that provided on the IREGS, you may ship at your own risk IF:
1. The foreign country has not told APHIS that the product is prohibited, and
2. You are willing to sign a statement indicating that you are willing to ship at your own risk.

Sample Statement (for shipping at your own risk)
I have been advised by APHIS that this shipment of _______does not meet with the Agency's understanding of (name of country) import requirements for this commodity. As a result, I understand that this shipment may be refused entry, destroyed, and/or returned to the United States. If such a situation does occur, I understand that APHIS may not be able to provide assistance in getting the shipment released. I understand that if APHIS signs the export certificate for this commodity, I am shipping at my own risk.

Obtaining the Proper Export Certificate
- VS Form 16-4
- Letterhead certificate
- Proper use of affidavits
- Certificate of free sale issued by FDA/CVM

User Fees
- APHIS currently charges a user fee for export certification and/or inspection
- Fees are found in Title 9, Code of Federal Regulations, Part 130
- Current fee for export certificate is $32
- Contact for user fee account questions:1-877-777-2128

General Requirements
Export certificates must be in English. If a bilingual certificate is required, it is the exporter's responsibility to have the certificate translated. Translations should be line by line or paragraph by paragraph. They should NOT be two separate certificates. If APHIS already has a bilingual version of a certificate, it will be available on the IREGS.
Certificates must be typed. Products listed on a certificate must be exported from a port in the United States.
Many countries (including EU countries) require export certificates to be endorsed prior to the date of export. APHIS will date a certificate using the current date. Certificates may not be predated or postdated. Certificates may NOT be altered after they are signed and sealed. We will discuss obtaining amended certificates later in this presentation.
One export certificate per shipment. Cannot have a 16-4 AND a letterhead certificate for the same shipment. This does not apply to different documents such as SRM statements. These additional documents are numbered and signed as part of the original export certificate.

How APHIS Evaluates Certification Statements
APHIS officials may not sign statements about genetically modified organisms unless they are provided on the IREGS.
Any certificate that indicates that a product has been tested may not be endorsed until the test results have been verified. If a negative result is cited or a product is said to be "free" of something, lab results are needed.
Test results must clearly support the statement listed on the certificate and relate to the lot of material being certified.

Lab Results
- Test results may be in the direct attestation or in the affidavit section of the certificate.
- General statements such as, "materials are not likely to contain harmful levels…" may be supported by affidavit without including test results.

Certification Statements
Some statements can be made as direct attestations without additional documentation or verification by inspection:
1. Statements about the animal health status of the US or a region
2. Statements that refer to APHIS regulations
3. General statements about products being produced under rules and regulations of the US.
4. Statements that products are fit for animal consumption.

Circumstances under which APHIS can endorse statements that a facility was inspected and approved:
1. APHIS has inspected and approved the facility
2. Facility can prove in writing that it has been approved by another government agency (affidavit not sufficient)

Statements that a product meets regulations of another agency or authority must be signed by that authority.
For example: a statement that a product meets all FDA regulations must be signed by FDA.
Rarely will APHIS sign a statement that "animals used to produce a product were born and raised in the United States" or "the animals were of US origin." Due to imported animals it is difficult to make this statement. We can certify that a product is of US origin if it was made in the United States.

Which Area Office Can Sign My Certificate?
You may go to an Area Office in a state where:
- The product was manufactured or produced
- The product was shipped/exported
- The product was processed
- The broker or shipper is located.

When Are Inspections Required?
- If a statement on an export certificate is not based on an affidavit, it must be confirmed by inspection
- If the importing country requires the exporting facility to be inspected prior to export
- If the AVIC or signing official is not comfortable signing the document without an inspection

European Union Inspections
Many facilities must be inspected and approved to meet EU import requirements
INSPECTION DATE: The date the facility was physically inspected.
APPROVAL DATE: The date the facility was actually approved as meeting all the requirements.
Facility must be reinspected one year from inspection date.

EU Inspections
Confusion has been generated because facilities are not aware of both dates. Area offices have this information, make sure you are aware of both dates. In order to prevent lapses in approval, you should start the reapproval process approximately 2 months before the anniversary of your INSPECTION DATE. APHIS prepared web based training for our field people regarding the EU inspection and approval process. We will be updating the course during the next year to provide information on changes to EU regulations.

VS FORM 16-4
This is the generic export certificate for animal products.
ONLY used for products that contain animal origin ingredients.
Contains animal health statements about the United States, and a blank area to add additional declarations.
Some countries will not accept this form.

Electronic Versions of 16-4
At this time, exporters can generate their own electronic version of a 16-4, but it must be an exact copy (colors, font sizes, etc).
Not all countries will accept electronic versions.

Instructions for VS Form 16-4
The text in the "additional declarations" section should not be spaced to allow the addition of information after the certificate is endorsed. No text should appear over the USDA seal.
The document must be typed. Information must be in English, bilingual documents are acceptable.
In the box for product quantity and type, enough information must be provided to identify the animal species of origin.
Information on the animal health status of the United States or any other direct attestation should precede any additional statements supported by affidavit.
Statements supported by affidavit should be placed below the affidavit line, "This office has on file a notarized affidavit from [company name] verifying the accuracy of the statements below."

Affidavit Format
- Must be made on company letterhead
- Must be endorsed by a person in a position of authority within the company, and should explain the signer's position or qualifications to make the statements.
- Must contain the information that the exporting company wishes to have included on it's export certificate
- The statement, "I certify that the statements listed above are true to the best of my knowledge and belief" must appear at the end of the affidavit above the signature.
- The name and title of the signing official must be typed under his/her name.
- The affidavit must be notarized and renewed at least once a year.

More on affidavits
If the exporter is not the producer or manufacturer of a product, the affidavit provided may be from the producer or manufacturer. The affidavit line on the export certificate will reference the producer.
If the exporter does not want the producer name to show up on the export certificate, they must provide a two part affidavit.

Improper Use of Affidavit
An affidavit may NOT be used for
1. Animal health statements
2. Anything requiring a test result
Area Offices will not sign obviously untrue statements, even on the basis of an affidavit.

Letterhead Certificates
Used for countries that do not accept a VS Form 16-4 or for exports that are NOT of animal origin in the following circumstances:
1. Certification is required about the animal health status of the United States, or
2. Certification is required that the product does not contain any animal origin ingredient
The certificate should be printed on Area Office stationery.
Exporter should complete the letterhead certificate and submit it to the area office. If the certificate has multiple options (such as for processing), incorrect options should have a line drawn through them. They should not be deleted from the certificate. The area office will copy it onto their letterhead, add certificate number, sign and seal.

Last Minute Information
- Items such as weight, port, container number, seal number
- Submit certificate to area office without this information so that they can review certificate
- Call Area Office with additional information that needs to be added
- Area Office can add information and finalize certificate
- Area offices have been authorized to date export certificates with the date that they are received in their office.
- Offices will usually complete certificates in 24-48 hours. Occasionally this may be delayed due to workload or movement of personnel.

Summary of Exporter's Role
1. Make sure you are using the most current export requirements.
2. Properly prepare export certificate and affidavit (if needed) for submission to Area Office.
3. Have other documents as needed (test results).
4. Ensure that certificate is obtained prior to the date of export.
5. If applicable, request reinspections of export facilities in a timely manner (2 months prior to export).
6. Have as many export inspections done at one time as possible.

SECTION 3: APPROPRIATE RESOURES
1. Replace or amend certificate
2. Product on hold overseas
3. You have obtained the import requirements and APHIS is unable to sign the required certificate because of our policies, or because the product does not meet the requirements.
4. You have been informed that a country will not accept a US origin product for reasons that you do not feel are scientifically justified.

Free Sale Certificates
APHIS does not issue certificates of free sale. Contact FDA, CVM to obtain these.
APHIS may sign a free sale statement if it is part of an animal health certificate.

Amended Certificates
Two methods:
1. Create a new certificate with required changes. This certificate will be given the same number as the old certificate and "REISSUE" will be typed underneath the number.
2. Issue a letterhead certificate with the same certificate number and indicate that it is an addendum or correction to the original certificate.
Lost Certificates?
The area office will make a copy of the old certificate, make a statement that it is the exact copy of the original, and sign and seal it.

Registration Certificates
Many exporters have requested advance certificates for registration purposes. NCIE has given some guidelines to the Area Offices to facilitate this process and harmonize procedures. The same policies apply to registration certificates as stated previously. For instance, if APHIS would not normally sign the certificate, they will not sign it for registration purposes.

Product On Hold Overseas
Product shipped overseas may be refused entry by receiving officials and put "on hold".
Exporter can contact FAS or IS office that covers that country for assistance. The following information should be provided and copied to the area office:
1. Container number, vessel name and shipping date.
2. Port where the material is on hold
3. Name, title, and contact information of foreign port official
4. Copy of original export certificate.
5. An English translation of any documentation explaining why the product was refused entry.
APHIS and/or FAS will contact foreign government to determine problem. If problem relates to APHIS, we will work with exporter to resolve issue if possible.

Other Technical Difficulties
1. You have obtained the import requirements and APHIS is unable to sign the required certificate because of our policies, or because the product does not meet the requirements.
2. You have been informed that a country will not accept a US origin product for reasons that you do not feel are scientifically justified.
CONTACT NCIE FOR ASSISTANCE