20 July 2011
2.2 Sanitary and Hygienic Measures
A. Agricultural Commodities
The US has extensive requirements for the importation of animals and animal products and plants and plant products. Additional restrictions or complete prohibitions may be imposed on countries where certain plant and animal diseases are deemed to exist. These diseases include, but are not limited to, high pathogenicity avian influenza (HPAI), exotic Newcastle disease (END), rinderpest, foot-and-mouth disease (FMD), swine vehicular disease (SVD), bovine spongiform encephalopathy (BSE), exotic Alternaria, a broad range of plant pests, etc.
In addition to any restrictions and prohibitions enforced by the USDA and other government agencies, the FDA oversees and enforces the Bioterrorism Act. Among other things, this law requires domestic and foreign facilities to register with the FDA if they manufacture, process, pack or hold food for human or animal consumption in the US. Imports from non-FDA-registered facilities are prohibited.
a) Plants and Plant Products
The importation of plants and plant products is subject to USDA regulations and may be restricted or prohibited. Plants and plant products include fruits, vegetables, plants, nursery stock, bulbs, roots, seeds, certain fibres including cotton and broomcorn, cut flowers, sugarcane, certain cereals, elm logs and elm lumber with bark attached.
APHIS regulates the importation of plants and plant products through phytosanitary (plant health) certificates, permits, importation rules, import prohibitions and inspections. A phytosanitary certificate is an official document issued by an exporting country certifying that the shipment conforms to US phytosanitary import requirements and is free of pests and diseases that do not exist in the US. Anyone wishing to import certain plants and plant products into the US is required to have a phytosanitary certificate. Also, certain endangered species of plants may be prohibited or require permits or certificates for entry.
Import permits are required for certain plants and plant products, including fruits and vegetables. APHIS can take up to 30 days to issue a permit. It is not necessary to apply for a permit for each importation, provided that the original permit (a) specifies all import requirements for all the commodities that will be imported and (b) has not expired.
To monitor plants, cuttings and seeds entering the country, APHIS has established 17 plant inspection stations at or near major ports of entry throughout the country. At these stations, inspectors work with specialists to locate, examine, and identify exotic pests, diseases and noxious weeds.
Certain agricultural commodities (including avocados, dates, filberts, grapefruit, table grapes, kiwifruit, olives, onions, oranges, Irish potatoes, plums, raisins, tomatoes and walnuts) must meet US import requirements relating to grade, size, quality and maturity. These commodities are inspected and an inspection certificate must be issued by the FSIS to indicate import compliance.
The FDA also regulates plants and plant products, particularly fruits and vegetables.
In December 2003, APHIS indefinitely suspended importations of Ya pears from mainland China due to the presence of a fungal disease. This prohibition was lifted in February 2006. Current US regulations permit the importation of Ya pears from the mainland Chinese provinces of Hebei and Shandong if those pears have been grown, harvested, and packed for export under certain conditions and if China’s national plant protection organisation certifies that those conditions have been met. The requirement that Ya pears from Shandong Province undergo cold treatment for the Oriental fruit fly was eliminated on 31 March 2008.
In December 2005, APHIS amended the fruits and vegetables regulations to allow the importation of fragrant pears from China under certain conditions. To be eligible for importation, the pears must be grown in the Korla region of Xinjiang Province at a production site that is registered with the national plant protection organisation of China. In addition, the pears must be packed in insect-proof containers that are labelled in accordance with the regulations and safeguarded from pest infestation during transport to the US.
In August 2007, APHIS amended the fruit and vegetable regulations to establish a notice-based process that streamlines and expedites approvals for new fruits and vegetables. These changes did not alter which fruits and vegetables are eligible for importation or how the risks associated with those commodities are evaluated or mitigated. The new process still requires that a pest risk analysis be conducted; however, if this analysis shows that the commodity’s risk can be sufficiently mitigated by one or more of four designated phytosanitary measures (i.e., inspection upon arrival, certified origin from a pest-free area in the country of origin, treatment for pests in accordance with the regulations and/or inspection and certification by the national plant protection organisation of the exporting country that the commodity is pest-free in the country of origin), the commodity is eligible for a more streamlined approval process. Commodities whose risk cannot be sufficiently mitigated by one of these measures continue to be subject to the regular rulemaking process.
In 2005, APHIS suspended the importation of all mainland Chinese handicrafts made from wooden logs, limbs, branches or twigs greater than one centimetre in diameter until a more thorough evaluation of the pest risk associated with those articles could be conducted. The reason for the ban was the increased infestation with live wood boring beetles and other pests of a range of handicraft imports from the mainland, including artificial trees manufactured from a composite of natural and synthetic materials, garden trellis towers, home and garden wood décor and craft items. However, APHIS determined in 2009 that these articles can be safely imported from the mainland provided certain conditions are met, including treatments, phytosanitary certificates and inspection and box identifications. Accordingly, APHIS issued a proposal that would lift the ban on the following handicrafts where wood is present: carvings, baskets, boxes, bird houses, manufactured Christmas trees, garden and lawn/patio furniture, potpourri, silk trees (typically artificial ficus trees), trellis towers, garden fencing and edging, and other items composed of wood. The proposal was still under consideration as of 15 March 2011.
Seeds must be free from pulp and require a phytosanitary certificate from the country of origin. Importations may or may not require a written permit and treatment, depending on the seed in question. Shipments are detained pending the drawing and testing of samples.
Coated or pelleted seeds may enter the US only if each lot is accompanied by an officially drawn and sealed seed sample drawn from the lot before the seed was coated or pelleted. Seeds whose importation is prohibited include bamboo seeds (prohibited from all sources), peanut seeds (prohibited from China and various other countries), potato true seeds (prohibited from most countries), wild rice seeds (prohibited from most countries), barberry seeds (prohibited from all sources), coconut seeds (prohibited from most sources), cutgrass seeds (prohibited from all sources), sprangletop seeds (prohibited from all sources), mahoberberis seeds (prohibited from all sources), mahonia seeds (prohibited from all sources), mango seeds (prohibited from most sources), prunus seeds (prohibited from all sources not meeting certain importation conditions), Rutaceae genera seeds (prohibited from China and other locations where citrus greening or citrus variegated chlorosis is present), seeds of all kinds when in pulp, etc.
c) Livestock and Animals
A permit for importation must be obtained from APHIS before the following items can be shipped from the country of origin: (1) all cloven-hoofed animals (ruminants), such as antelope, camels, cattle, deer, sheep, and giraffes; (2) swine, including the various varieties of wild hogs, and the meat from such animals; (3) horses, asses, mules, and zebras; (4) all avian species including poultry and pet birds; (5) animal by-products, such as bones, bone meal, blood meal, glands, hair, untanned hides, wool or secretions of ruminants and swine; (6) animal germ-plasm, including embryos and semen; and (7) hay and straw. In addition, all animal imports must be accompanied by a veterinary health certificate. Entry of animals is restricted to certain ports that have been designated as quarantine stations. All non-domesticated animals must meet the requirements of the Fish and Wildlife Service (FWS).
d) Meat, Poultry and Egg Products
The FSIS is responsible for ensuring that domestic and imported meat, poultry, and egg products are safe, wholesome and accurately labelled. Foreign countries that export meat, poultry and egg products to the US are required to establish and maintain inspection systems that are equivalent to those of the US. The FSIS audits foreign inspection systems and re-inspects meat and poultry at the port of entry to ensure that foreign countries have maintained equivalent inspection systems.
If the FSIS deems the foreign country’s inspection system to be equivalent to the US system, a proposed rule is published in the Federal Register announcing this determination and the FSIS’ intent to list the country as eligible to export meat, poultry or egg products to the US. After consideration of public comments, a final decision is made on country eligibility and, if favourable, a final rule is issued. That foreign country’s inspection system is then responsible for certifying individual exporting establishments to the FSIS and for providing annual re-certification documentation. The FSIS regularly conducts on-site audits of the eligible foreign inspection systems to ensure that they remain equivalent to the US system.
Foreign inspection certificates are required to accompany all imported meat, poultry and egg products. These certificates must indicate the product name, establishment number, country of origin, name and address of the manufacturer or distributor, quantity and weight of contents, list of ingredients, species of animal the product was derived from and identification marks. The certificate must also bear the official seal of the foreign government agency responsible for the inspection along with the signature of an agency official. This certificate must be in both English and the language of the foreign country.
Occasionally, some circumstances could result in the suspension of eligibility and an interruption of trade. One example is if an emergency sanitary measure is implemented by the FSIS to address a hazard that is so severe that no product can enter the marketplace from a foreign establishment until the control is in place. A second example could be if an exporting country does not provide satisfactory documentation of an equivalent sanitary measure. A third example could be if a system audit reveals that an exporting country is not implementing a public health sanitary measure in the manner that the FSIS initially determined to be equivalent.
Permanent withdrawal of eligibility, like initial approval of eligibility, can only be accomplished by rulemaking. The FSIS may, however, take action to ensure that products from a particular country are not admitted into the US if they are adulterated or misbranded based on specific findings during on-site audits, because of port of entry re-inspection failures, or other means.
Mainland China is not eligible to export to the US poultry products that are slaughtered in domestic establishments. The FSIS issued in April 2006 a final rule allowing processed poultry products from mainland China to be imported into the US if they are processed in certified establishments from poultry slaughtered in certified slaughter establishments in other countries eligible to export poultry to the US. Among other things, this regulation requires that those poultry products be subject to re-inspection at the pertinent port of entry for transportation damage, labelling, proper certification, general condition, accurate count, defects and microbiological contamination. However, no mainland Chinese facilities had been certified to export to the US as of 1 February 2011 partly due to efforts by the US Congress to block the implementation of the FSIS final rule. These efforts were abandoned in September 2009 with the approval of an agricultural appropriations bill for fiscal year 2010 that allowed the USDA to move forward with the implementation of the final rule provided it complied with certain conditions.
APHIS issued an interim final rule that, effective 24 January 2011, prohibits or restricts the importation of bird and poultry products from regions where any subtype of HPAI is considered to exist. The new restrictions cover bird and poultry products from mainland China and Hong Kong, as well as Afghanistan, Albania, Azerbaijan, Bangladesh, Benin, Burkina Faso, Cambodia, Cameroon, Djibouti, Egypt, Ghana, India, Indonesia, Iran, Iraq, Israel, Ivory Coast, Japan, Jordan, Kazakhstan, Kuwait, Laos, Malaysia, Myanmar, Nepal, Niger, Nigeria, Pakistan, Palestinian Autonomous Territories, Romania, Russia, Saudi Arabia, South Korea, Sudan, Thailand, Togo, Turkey, Ukraine and Vietnam. While previous import restrictions were limited to regions where the more dangerous H5N1 strain of HPAI had been deemed to exist, APHIS indicates that it had already been applying a de facto ban on imports from regions with any HPAI subtype because all foreign regions where HPAI is considered to exist are also regions where Exotic Newcastle Disease is considered to exist. The separate import restrictions for regions with any HPAI subtype will allow APHIS to better protect against the introduction of END and HPAI and allow the agency to remove countries from one disease list but keep them on the other list if necessary.
Regions will be added to this list immediately after APHIS receives reports of outbreaks in commercial birds or poultry from veterinary officials of the national government of the region and/or the World Organisation for Animal Health. A region will be removed only after APHIS completes an evaluation, makes it available for public comment through a notice published in the Federal Register and responds to any comments received.
Under the new regulations, carcasses of game birds, if eviscerated with head and feet removed, may be imported from regions where END is considered to exist but may not be imported from regions where any HPAI subtype is deemed to exist. Carcasses or parts or products of carcasses, including meat, of poultry, game birds or other birds, may be imported from END/HPAI regions if packed in hermetically sealed containers and if cooked by a commercial method after such packing to produce articles that are shelf stable without refrigeration. Additionally, carcasses and parts or products of carcasses may be imported if they are accompanied by a certificate that is signed by a fulltime, salaried veterinarian of the government agency responsible for animal health in the region and that specifies that the articles were cooked throughout to reach a minimum internal temperature of 74°C (165°F).
APHIS also replaced the previous prohibition on the importation of birds that had been vaccinated for END with a prohibition on imports of live poultry, birds (including hatching eggs) and ratites that have been vaccinated for any H5 or H7 subtype of avian influenza. Furthermore, APHIS has banned the importation of live birds and poultry that transit regions where HPAI of any subtype is considered to exist because there could be significant risks of these animals contracting HPAI en route to the US.
The US has determined that Hong Kong and mainland China are not free of rinderpest or FMD. As a result, there is a prohibition, with certain exceptions, on importations of ruminants, swine and any fresh (chilled or frozen) meat of any ruminants or swine from Hong Kong and mainland China. Restrictions are also placed on imports of swine, pork and pork products from Hong Kong and mainland China because US authorities believe that classical swine fever and swine vesicular disease is present in those locations.
APHIS amended the US import regulations in April 2008 to allow the importation of uncooked pork and pork products from regions where CSF is considered to exist if those products originate in a region free of CSF and meet certain other conditions with respect to processing and shipping. CSF-free regions include Australia, Brazil (Santa Catarina State only), Canada, Chile, Fiji, New Zealand, the Trust Territory of the Pacific Islands, a number of European countries and certain Mexican states.
APHIS further amended the US import regulations effective from 14 January 2010 to allow imports of cooked pork skins (pork rinds) from Hong Kong, mainland China and other regions affected with CSF, SVD, FMD and/or African swine fever under certain conditions. These conditions include:
- cooking using specified methods (i.e., pork rinds must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114°C, or they must be dry-cooked at 260°C for approximately 210 minutes after which they must be cooked in hot oil at 104°C for an additional 150 minutes);
- processing at an approved facility eligible to have its products imported into the US under the Federal Meat Inspection Act; and
- a requirement for pork rinds to be packed in clean new packaging that is clearly distinguishable from packaging used for pork or pork products not eligible for export to the US.
In addition, shipments of foreign products must be accompanied by a certificate issued by a government official who is authorised to issue the foreign meat inspection certificate required under USDA regulations.
APHIS also amended effective from 14 January 2010 the regulations governing the importation of animal by-products to require that bird trophies from regions with END meet certain requirements or go directly to an approved establishment upon importation into the US. As a result of this amendment, bird trophies from Hong Kong, mainland China and other regions not free of END may be imported into the US provided they are treated after arrival at certain approved facilities. Bird trophy imports from Hong Kong and mainland China would also require a permit obtained from APHIS prior to importation because those two locations are not deemed by the US to be free of HPAI.
e) Cheese, Milk and Dairy Products
Cheese and cheese products are subject to USDA and FDA requirements. Most importations of cheese require an import licence and are subject to quotas administered by the USDA. The importation of milk and cream is subject to the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Import Milk Act. These products may be imported only by holders of permits issued by the Department of Health and Human Services and the USDA.
The US imposes additional restrictions on imports of milk and certain milk products of ruminants and swine from countries where rinderpest or FMD has been deemed to exist, including Hong Kong and mainland China.
With the exception of importations made for scientific purposes, USDA regulations prohibit the importation of live insects that may pose a danger to agricultural crops (e.g., vegetables, fruits, trees and field crops), as well as any eggs, pupae or larvae of such insects. Packages containing live insects (or their eggs, pupae or larvae) that are not pernicious to crops or trees are permitted entry into the US only if they are covered by a permit issued by APHIS and not prohibited by the FWS.
B. Restrictions on Wildlife and Pets
The importation of live wildlife (i.e., game animals, birds, plants) and of birds’ eggs is subject to certain prohibitions, restrictions, permits, and quarantine requirements imposed by several government agencies. Imports of wildlife and their parts or products must be declared at designated FWS ports unless an exception is granted prior to the time of import. Commercial importers of wildlife must obtain an FWS licence. Certain mammals, reptiles, amphibians, fish, snails, clams, insects, crustaceans, molluscs, other invertebrates and plants may be prohibited entry without the prior issuance of a permit either from the foreign wildlife authority or from the FWS.
The importation into the US of any wildlife or its parts or products is prohibited if the wildlife was captured, taken, shipped or possessed contrary to the laws of the foreign country. Endangered species of wildlife and certain species of animals and birds are generally prohibited entry into the US and may be imported only under a permit granted by the FWS.
Imports of birds (pets, migratory birds, falcons) are subject to the quarantine requirements of the USDA and the Centers for Disease Control (CDC)’s Public Health Service. Quarantine space must be reserved in advance of import. Prior to export, health certificates must be obtained. As mentioned above, the US has established a prohibition on the importation of unprocessed bird and poultry carcasses, parts, and products (i.e., chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans and turkeys) from countries where HPAI has been found to exist, including mainland China and Hong Kong. This prohibition also covers live birds and poultry that transit regions where HPAI is considered to exist or that have been vaccinated for any H5 or H7 subtype of avian influenza, as well as any hatching eggs of vaccinated live birds or poultry.
The importation of feathers or skins of any bird, except for scientific and educational purposes, is generally prohibited. This prohibition does not apply to fully manufactured artificial flies used for fishing or to personally taken, non-commercial game birds. Feathers or skins of the following species are permitted entry: chickens, turkeys, guinea fowl, geese, ducks, pigeons, ostriches, rheas, English ring‑necked pheasants, and pea fowl not taken from the wild.
The importation of birds, cats, dogs, monkeys and turtles is subject to the requirements of the CDC’s Public Health Service, Quarantine Division; APHIS’ Veterinary Services; and the FWS. The importation of live turtles, tortoises and terrapins with a carapace length of less than four inches, and the viable eggs of turtles, tortoises and terrapins, is allowed by the CDC’s Public Health Service only under strict requirements as to purpose and quantity. The Public Heath Service does not allow the importation of live, non‑human primates, including monkeys, as pets.
The importation of marine mammals and their products into the US is prohibited, unless specifically exempted under an international treaty. The importation of live lions, tigers, leopards, snow leopards, clouded leopards, cheetahs, jaguars or cougars, or any hybrid combination of any of these species, is also prohibited unless certain exceptions are met.
The FWS enforces a ban on the importation of most African elephant ivory and any products made from it. The ban covers all commercial and non-commercial shipments, although there are limited exceptions for antiques, trophies and personal household effects.