Animal and animal products
- Document symbol
- G/LIC/N/3/USA/21
- Original language
- English
- Published on
- 16/10/2024
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Import permits are required for the importation of certain animals and animal products/by products, organisms and vectors, and veterinary biological products, to protect U.S. livestock and poultry against the introduction of diseases that do not exist in the United States.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Permits are required for:
Live animals, including:
- Livestock and poultry and other species (e.g., zoo animals, pet birds, aquatic animals) that may carry diseases that could affect U.S. livestock and poultry;
- animal semen, ova, embryos;
- hatching eggs.
Certain animal (livestock and/or poultry) derived products for any reason, commercial or research uses;
Animal Products:
- for human consumption (e.g., meat, milk, eggs, casings, processed products containing meat);
- processed animal proteins (rendered meals, digests, hydrolysed proteins) derived from any animal;
- animal by-products not for human consumption (e.g., bones, hides/skins, fetal bovine serum);
- for animal consumption (pet food/treats and animal feed ingredients, etc.);
- organisms and vectors able to transmit or harbour animal diseases;
- related materials that have been exposed to animal products capable of contamination with disease agents: containers, carriers, straw and hay, meat covers;
- Animal and avian specimens, tissues or blood products, monoclonal antibodies
- meat, poultry and egg products samples destined for laboratory examination, research, evaluative testing, or trade show exhibition.
Veterinary Biologics (for research, transit, general distribution):
- Livestock and poultry pathogens (e.g., bacteria, viruses, fungi, TSE agents, protozoa);
- Derivative of livestock and poultry pathogens (e.g., recombinants, attenuated);
- Vector of livestock or poultry pathogen (e.g., arthropods, animal tissues);
- Vectors and organisms exposed to animals or animal products outside the United States (e.g., eggs, fetal bovine serum).
Q3. The system applies to goods originating in and coming from which countries?
The permit system applies to regulated live animals coming from all countries (with some exceptions for Canada and Mexico) with some variation based on the species and the country of origin's disease status. Permits for animal products apply to all countries depending on disease status, species of animal, type of product, and intended use.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The permit system is not used to restrict the quantity or value of imports, but only to protect domestic agriculture from the introduction or entry of animal diseases or disease vectors.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The permit system is not a statutory requirement except for veterinary biological products permits and live animal permits. The pertinent regulations are contained in Title 9 CFR., Parts 92, 93, 94.7, 94.16, 95.4, 95.18, 95.19, 95.20 through 98, 104 and 122; and in the following laws as codified: 21 U.S.C. 102 to 105, 111, 134, 135, 151-159.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
The amount of time in advance of importation within which a permit must be applied for is not specified in the regulations.
Q7.b. Can a licence be granted immediately on request?
A permit cannot be granted immediately upon request. Prior review of the application is required.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
There are no limitations as to the period of the year during which permit applications may be made.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
For animal products, by-products, and organisms and vectors, the permits are effected by one office. For Live animals, permits can be effected by one office and jointly with Port Services. The application is not passed on to other offices for visa, note or approval, and the importer does not have to approach more than one administrative office.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
In general, there are no circumstances other than failure to meet ordinary criteria under which a permit may be refused. In the case of live animals or animal products, a permit for a particular time period could be refused if space at a Quarantine Station is not available. An outbreak of a particular disease in the exporting country could be a cause to revoke a permit which was issued prior to the disease outbreak. Reasons for refusal are given to the applicant. No appeal procedures are specified in the legislation or regulations. Applicants must bring documentations/products into compliance within a specified time, after which refusal is final.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
All persons, firms, and institutions in the United States are eligible to apply for permits. There is no published list of authorized importers. While there is no system of registration, applicants are encouraged to electronically file their applications for most permits through the APHIS eFile system. Applicants must first have a valid login credential to use this system.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
The information required in applications is set forth in VS forms 16-3 and 16-7, 16-79, 17-129, 17-128, FSIS form9540-4, and APHIS form 2005.
Q11. What documents are required upon actual importation?
In the case of live animals, copies of the import permits must accompany the shipment as well as an original health certificate issued by the national veterinary services (competent authority) of the country of origin. Depending on the import requirements for a specific commoditiy, copies of the import permit should also be accompanied by either a health certificate issued by the national veterinary services (compentent authority) of the country of origin or processing, or shipper's declaration, for certain shipments of animal products, and organism and vectors. Copies of the import permit should accompany shipments of veterinary biological products.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There are import-related user fees associated with permit application review, inspections required for imports, testing and quarantines. Facilities manufacturing veterinary biologicals for importation are inspected under cooperative service agreements.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
Reservation fees for quarantine space are required for live animals and birds. The amount of the fee varies according to the animal and the bird.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Permits for animal products/by-products and organisms and vectors vary in length of their validity, but are generally for about one year. Permits for live animals and birds are valid for seven to 60 days, depending on the species. Permits for veterinary biological products for importation for distribution and sale do not have expiration dates.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization of a permit. Application user fees and quarantine reservation fees are not refundable.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Permits are not transferable between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
In the case the permit outlines import conditions, the applicant must comply with the terms of the permit. The importer certifies that the information on the application is accurate.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures required prior to importation.