[Information on how to import a food product in USA]

■ Outline

The United States is the largest food import country in the world, and strict and thorough regulations are enforced on import food products.

Regardless of food manufactured in the United States or food imported into the United States, which manufactured in foreign country, all imported food products are available for importation or distribution only if corresponding products meet required standards and requirements of the United States.

General process, regulations, requirements for food importation in the United States will be outlined below, and present specific information in a separate document of corresponding products.

■ Jurisdiction

There are a variety of agencies for controlling food import in the United States, some of which are responsible for performing important roles are as follows:

ㅇ Food and Drug Administration : FDA - an agency of the United States Department of Health and Human services

ㅇ Environmental Protection Agency : EPA

ㅇ Animal and Plant Health Inspections Service : APHIS - an agency of the United States Department of Agriculture

ㅇ Food Safety and Inspection Service : FSIS - an agency of the United States Department of Agriculture

■ Law and regulations on importation of food product

There are a lot of direct and indirect laws with respect to import of food product in the United States. Only direct laws are outlined as below.

ㅇ Federal Food, Drug and Cosmetic Act (FD&C Act)

ㅇ Public Health Security and Bioterrorism Preparedness and Response Act

ㅇ Food Safety Modernization Act (FSMA)

ㅇ Fair Labeling and Packaging Act

ㅇ Nutrition Labeling and Education Act

ㅇ Food Allergen Labeling and Consumer Protection Act (FALCPA)

ㅇ U.S. Federal Law (USC), U.S. Federal Regulation (CFR) Title 21, etc.

■ Food product of regulating object

In Federal Food, Drug and Cosmetic Act, the term "food" means ① articles used for food or drink for man or animals, ② chewing gum, and ③ articles used for components of any such article.

However, the control rang of food product is slightly different by each control agency. e.g. some meat, poultry, egg product are under the jurisdiction of the United States Department of Agriculture (USDA) and excepted from the jurisdiction of U.S. Food and Drug Administration (FDA).

Feeders, food manufacturing facility, etc are also regulated in accordance with food related laws in some countries, but it is excepted from regulating object of the food related law in the United States.

■ Import process of food and main points

It is necessary to get through general import process and customs clearance for importing food product to the United States. However, food product requires much more preparation beforehand and need to implement corresponding process for each importation. e.g. all the manufactures in the foreign countries must register corresponding facility and provide prior notice while shipment.

In addition, inspection process is followed to check whether meet the requirements of various regulations after arrival at the United States. If does not conform to rule, corresponding food product is subject to seizure or failure to make entry.

There are many systems for regulating and controlling of import food product in the United States, of which main regulations that applied to generally are as follows.

1. Regulations of the Bioterrorism Act

The Bioterrorism Act entered into enforcement for protect food supply as a direct response to terrorist attacks in wake of 9/11 terrorism, and the main content is as follows.

1) Facility registration

The Bioterrorism Act requires that food facilities producing, storing, or handling food products intended for sale in U.S. interstate commerce or importing to the United State be registered with FDA. Registration of facilities can be performed on the internet, and is free of charge.

If not registered or renewed necessary information, corresponding importation will get refused.

※ Food Safety Modernization Act

Food Safety Modernization Act (FSMA) was effective on January of 2011. It will strengthen vastly control on food facility registration. the main point are as below.

ㅇ It requires re-register existing facility registration every two years with renewal of necessary information of food facility.

ㅇ It directs the FDA to increase its inspection of foreign food facility FDA.

ㅇ It requires manufactures to install hazard analysis and preventative control systems.

ㅇ It requires that imported food be certified to ensure compliance with U.S. laws.

ㅇ It requires to register e-Mail address, product and accessories thereof. It also grants FDA with authority of registration and suspension of registration.

2) Prior notice

The Bioterrorism Act requires prior notice be provided to FDA for each imported food. Manufacture, exporter, broker, importer, international carrier, U.S. agent are available to submit prior notice. Prior notice can be submitted on the internet, and is free of charge.

Imported food product or food product to be imported is not allowed to entry without prior notice. rejected food product will be seized unless change its destination.

3) Administrative detention

Once determined evidence or material that bring serious adverse health consequence or death to human or animals, FDA has authority to detain for maximum 30 days.

4) Facility recordkeeping

The Bioterrorism Act contains food facility recordkeeping requirements. It requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Thus FDA can track contaminated food rapidly once occur food terrorism.

Company name, address, telephone number, e-mail, category of food product, date of deliver, production number, quantity, etc are recorded as content of record and issuer can control the form of record by himself/herself.

If a food item were believed to pose a danger to humans or animals, FDA has authority to request to provide relevant records within 4 hours during business hours or 8 hours at other times.

2. Labeling requirement for imported food product

Labeling, it is used to indicate regulatory description on the product for guaranteeing consumer's health, safety, right of choice. All the imported articles are required to attach correct label, especially for food product. It is also regarded as important reason to result in failure of customs clearance.

Exporter and importer should be fully and correctly aware of labeling requirement for handling article since there are general labeling requirements for all the food product and additional labeling requirement for each classification of food product.

Labeling of food products must be marked in English and the basic principle is as follows.

ㅇ The name of food product must be marked in common name at principal display panel of container and type size must be at least larger than half of the largest print size of the label.

ㅇ Net weight must appear in the lower 30% of principal display panel by U.S. measurement units and the metric units. The name and address of manufacture, packager, distributer must appear the same side of component. If no exception, full address must be marked.

ㅇ Ingredient statement may be marked at principal display panel, side face or back side of information description part, however, must appear at the same panel with information of manufacture, packager or distributer. Component must be listed in descending order of predominance by weight or volume with common name, also main component that have potential to cause allergy must be marked.

3. HACCP

1) What is HACCP

HACCP, which is abbreviation of Hazard Analysis Critical Control Point, is referred as systematic preventive approach to control safety and health of food product.

HACCP system is firstly introduced in the United States, and then adopted internationally. HACC is referred as prevention of hazard, which is scientific and systematic approach and critically controls point. HACCP system is used to analyze hazard factors on safety of food product and set important control points for ensuring safety at all the stages of a food chain, including food production, processing, packaging, storing, and distribution.

2) Application field

Following classification of articles are required HACCP in the United States.

ㅇ all meat and poultry - under jurisdiction of the United States Department of Agriculture (USDA)

ㅇ juice - under jurisdiction of U.S. Food and Drug Administration (FDA)

ㅇ seafood - under jurisdiction of U.S. Food and Drug Administration (FDA)

ㅇ FDA has authority to request HACCP on all the food field in accordance with the Food Safety Modernization Act, which was effective in 2011.

3) Effectson customs clearance in U.S.

ㅇ It is not necessary to check articles requiring HACCP whether implementation of HACCP or not while import in the United States. So it is not required to present HACCP certification for customs clearance every time.

ㅇ However, importer is obligated to certify safety of imported articles at any time according to standard of U.S. food safety, the crucial evidence is implementation of HACCP.

ㅇ Therefore, HACCP is mandatory program for exporter and U.S. importer those who handling articles requiring HACCP.

4) Effects of HACCP implementation in foreign countries

Unless HACCP, which recognized in the United States in accordance with the standard of the United States by principle, HACCP is not really effective. When articles of implementation of HACCP imported to the United States, it is much favorable to pass FDA inspection of import duty, FDA inspection on the stage of distribution after entry, etc.

For the countries established MOU with the United States on certain articles, MOU can replace HACCP in the United States. It is regarded as implementation of HACCP plan provided that foreign exporter performed well the content of MOU. But there are few countries that signed MOU with the United States and so far, there is no country signed a mutual recognition agreement yet that unifying HACCP certification of foreign country and HACCP of the United States.

4. Registration for low-acid and acidified food

Low-acid canned and acidified food for exported to the United States must be registered food facility and process method additionally on the basis of regulations on food product since such food product has potential health hazard.

Such registration of food facility is another system, different from basic registration of food facility required by the Bioterrorism Act. Please note that not a single one can be omitted.

1) Object of registration

① Low-Acid Canned Food (LACF)

Requirements for low-acid canned food are as follows.

ㅇ heat treated to achieve a thermally processed product

ㅇ and packed in a hermetically (air tight) sealed container, here canned is not only referred as package container of metal, but also including glass package, plastic package, etc.

ㅇ with an acid content above pH 4.6 and

ㅇ containing enough water ("water activity) greater than 0.85 and

ㅇ normally stored and distributed under non-refrigerated conditions.

② Acidified Food (AF)

An acidified food is referred to low-acid food, which processed by certain method to make it pH of 4.6 or below and a Acidified Food.

In the other word, some processors "acidify" their low-acid canned food products by adding acidic ingredients in order to inhibit microbial growth.

2) Preliminary steps

It is essential to get through the following two preparatory steps for import low-acid and acidified food.

ㅇ Retain FCE number after registration of manufacturing facility (of plant)

Exporter must be assigned food canning establishment number (FCE No.) by registration of manufacturing facility with providing FDA relevant information, such as address, contact number, product list of the manufacture, etc.

Registration of low-acid or acidified food facility is accomplished by document inspection and takes approximately 3 weeks.

ㅇ Issue SID after process filing

Submission identifier (SID) will be assigned after process filing, on the basis of FCE No. which retained after registration of food facility.

3) Effect of registration or non-registration

Articles assigned FCE or SID by establishment and process filing, which stands for general import eligibility of designated article is recognized, however it doesn't refer to import license.

Therefore, import of low-acid or acidified food is not allowed without such registration. Based on the basis of registration, separate regulations for corresponding articles are implemented as well.

5. Regulations of food additives, color additives

1) Food additives

Food additives are substances added in the stages of production, processing, package, transportation, storing of food to preserve or enhance its quality.

Each country has different regulations with respect to permit, allowance of food additives. Approximately 1500 kinds of food additives are permitted by U.S. FDA.

Food additives, which are not outlined by the FDA, are prohibited to import. There are rigid regulations on acknowledged additives as well, such as usable category, maximum usage, marking method of label, etc.

In order to use a new food additive that not existing in permitted list of FDA, it is required to apply for its permission with the FDA. It is required to testify non-hazard to health of human body by animal experimentation data, etc.

It is required to attain separate approval from the United States Department of Agriculture (USDA) for additives added in food product of meat, poultry.

2) Color additives

Color additives are used in food, drug, and cosmetics as a kind of food additives and can divide into natural and artificial color additives. But only artificial color additives listed by FDA can be usable, if use color additives not exist in the list of FDA, it is required to get separate approval from FDA.

3) In case of using non-approval additives

Provided that non-approval additives are used or label is marked with incorrect component, imported food with such additives is subject to failure of customs clearance in the United States in spite of permitted in exporting country. Exporter or importer is recommended to check whether a noncompliance of additives regulations and label marking beforehand as it is fact that these are common reasons to get detention while importing.

6. The food defect action levels (DALs)

There are the food defect action levels for detailing acceptable levels of food contamination in the United States, which providing levels of natural or unavoidable defects in foods when handling contaminated food from foreign matter.

The FDA established the food defect action level (DALs) in line with U.S. Federal Regulations (Title 21 part 110).

If any defect on the food, regardless of domestic or overseas manufacturing, FDA will define as defective food while exceed the DALs. Legal action will be followed then.

Acceptable limit, action level, analysis method are defined on 20 kinds of defects among approximately 120 kinds of existing list. If not listed, FDA will evaluate sample and determine according to case.

Major defect in the food defect action levels (DALs) are referred as food contamination from source, such as insect and mammalian feces, larva, tick, mold, parasite, degree of corruption, foreign matters like sand, etc.

However, such Food Defect Action Levels (DALs) is not defined for all the food. Even food with such regulations is within action level, it does not mean allowed for distribution. Food that does not meet the criteria of Food Defect Action Level will be regarded as unqualified food by FDA. If required, FDA will take administrative measures.

Food Defect Action Levels (DALs) by classification can be found at following site.

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm056174.htm

7. Action Levels for Poisonous and Deleterious Substances, Residual of Pesticide

In the United States, action levels of poisonous and deleterious substances, residual of pesticide for food are defined as below. If exceed tolerance, regardless of domestic or oversea manufacturing food, it is subject to failure to entry or being prohibited in domestic distribution.

1) Action levels for poisonous and deleterious substances

Poisonous and Deleterious Substances is referred to toxic, pathogenic, carcinogenic substances for human and animal.

U.S. FDA is responsible for controlling regulations of imported food that containing poisonous and deleterious substances, FDA Action Levels for Poisonous and Deleterious Substances is established as well.

Defined poisonous and deleterious substances are as below, and respective action level and tolerance are defined by classification of poisonous and deleterious substances, food (feed).

Defined poisonous and deleterious substances are as follows, the tolerance is measured with ppm (parts per million), ppb (parts per billion).

2) Action levels for residual of pesticide

U.S. Environmental Protection Agency (EPA) is responsible for establishing tolerance for residual of pesticide on the basis of the Federal Food, Drug, and Cosmetics Act (FD&C Act).

The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is responsible for controlling meat, poultry, milk, etc with the defined tolerance. Inspection of pesticide residue on all the rest of food is responsible for FDA.

If pesticide residue on the imported food exceeds the tolerance, it can be rejected import in the United States.

8. Regulations on quarantine of animal, plant and the product thereof

Quarantine system of import, it is a system to inspect relevant articles and reject defective entry for preventing the introduction of harmful pest, disease.

Object of quarantine is plant, animal and byproduct, products of plant and animal, and so on. Food product is allowed for entry, it must meet the requirement of both FDA regulations and Animal and Plant Health Inspection Service (APHIS), an agency of the United States Department of Agriculture (USDA).

For import of articles that requiring quarantine, it is essential to obtain import permit of the United States, sanitary certificate of exporting country and go through specific procedures beforehand. It is required to be subject to quarantine every time while import of such articles.

U.S. importer notifies Animal and Plant Health Inspection Service (APHIS) after arrival of cargo. The relevant cargo is subject to quarantine at the airport or the port of the APHIS office. However, quarantine is completed by material inspection occasionally, physical cargo inspection is not required always.

If articles requiring quarantine do not possess import permit, sanitary certificate or other required material; articles requiring quarantine are not qualified at the stage of quarantine; the relevant articles will be prohibited for entry, scrapped or returned.

1) Acquisition of import permit

In order to import articles that requiring quarantine to the United States, it is required to apply for import permit with the United States Department of Agriculture (USDA) and obtain the relevant import permit, except, prescribed articles from specific country are determined no pest and disease risk by administrative policy. It takes approximately 3 months from application to acquisition. When any change of article or importer, it is required to apply for separate import permit.

2) Acquisition of sanitary certificate (quarantine certificate) of exporting country

It is required to acquire sanitary certificate (for animal or animal product), plant quarantine certificate (for plant or plant product), which issued from exporting country, for importing articles requiring quarantine to the United States. Sanitary certificate and plant quarantine certificate is guaranteed document, which is issued from exporting country as legal document up to U.S. standard.

Some articles requiring sanitary certificate of exporting country prior to shipment for the United States, also some articles require it after shipment. Since sanitary certificate for articles requiring sanitary certificate prior to shipment is never issued after shipment, importer should ask exporter for obtaining sanitary certificate of exporting country in advance.

Since sanitary certificate is required for import each time, it need get the certificate issued from exporting country at the time of export.

Original sanitary certificate must be submitted with CBP, the copy of sanitary certificate is not accepted by CBP. Therefore, exporter should send original sanitary certificate to U.S. importer or agent of customs clearance to ensure smooth process of entry after receipt of sanitary certificate.

■ Other term for reference

It is not easy to import foreign food product to the United States ( or export food product to the United States) as it costs too much time, expense, and several complex procedures.

However, if want to entry largest food consuming market of the world, it is required to comprehend some associated regulations and master the knowledge of the procedure and system that specially existing in the United States. At present, due to demanding U.S. regulations, professional consultants are entrusted to perform the process for import of food product, but there are still a lot of matters to handle by the export or importer.

Compared with other countries, there are quite a few specific import regulations in the United States. The core of the U.S. import regulations is <Preliminary and preventive action>.

Thus, foreign exporter or U.S. importer, those who want to involve food product in the United States, it is recommended to make checklist by this TCS system or other methods and settle it one by one. If it is the first time to handle the relevant articles, it is better to make preparation with about 6 moths beforehand.