Food Law & FDA/USDA Import Law
U.S. Food Law Attorneys • Food Import and Safety Regulations
The Bayne Law Group is dedicated to providing a full spectrum of legal services to businesses in highly regulated industries, representing and looking after our clients in the food, wine and beverage sectors of the industry. We have considerable industry knowledge in the food and viticulture sectors to assist United States business owners and international business owners doing business in the U.S. who are subject to the regulatory authority of the Food & Drug Administration, the US Department of Agriculture and related agencies and customs authorities.
Contact The Bayne Law Group for assistance with complex food import and safety compliance matters, including:
- Food producer and distributor representation
- FDA and USDA regulatory compliance
- Health and wellness legal counsel and compliance
- Distribution and distributor contracts
- State health and food storage license and permits
- Starting a food business
- General permit applications
- Federal and state brand label compliance
- Import and export agreements
- Brand, logo and label trademark registrations
- Brand and product licensing
- Food imports, exports and wholesale
- Defense of Federal Supplemental Nutrition Assistance Program (SNAP) EBT Retail Violations or Claims
- Industry assistance for the sale of perishable and non-perishable foods
We use our nationwide database of compliance requirements for multistate registration for industry clients. Our lawyers and staff can provide general counsel services to assist with your daily business demands.
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Through the delivery of knowledgeable, accessible and responsive representation, we aim to be your firm and legal consultant of choice for years to come. The Bayne Law Group has the industry knowledge and sophisticated business acumen to serve local and international clients, including small, mid-market and Fortune 500 companies.
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Our clients come to us from states throughout the nation and countries throughout the world, including New Zealand, India, Canada, Australia, China, Europe, the Middle East and South America. Business owners, entrepreneurs, investors and business professionals rely on us for their legal needs, big and small.
Summary of Typical Food and Safety Compliance Regulations
The Bayne Law Group LLC has prepared this summary of important FDA and USDA regulations and guidelines concerning importing beef, dairy and general perishable and non-perishable foods into the United States for resale. It is our pleasure to provide excerpts from our informational brochure online as a guide to some of the general steps to obtain the necessary permissions for food importation for resale in the United States of America.
Disclaimer: The following information is provided for general guidance only. No person should rely on the following information contained in this summary and all food producers and food handlers for importation and distribution of food in the United States of America should obtain the advice of competent legal counsel at all times.
In the United States, food safety is a shared responsibility; several departments of the U.S. government share jurisdiction over ensuring safety of the American food supply. The U.S. government has instituted several laws and procedure to ensure food safety. In addition to strict regulations, safety and wholesomeness of U.S. food products are safeguarded through pre-market clearances, mandatory production practices, inspections and random ongoing sampling. The food safety standards that apply to domestically produced foods also apply to imported foods.
1. U.S. Federal Register System
Under Federal Register Act (44 U.S.C. Chapter 15), a uniformed system for handling agency regulations was established in 1930’s. It requires filing of documents with the Office of the Federal Register, placement of documents for public inspection, publication of documents in the Federal Register, and codification of the rules in the Code of Federal Regulations. Along with another legislation, The Administrative Procedure Act, which became law on June 11, 1946, these two Acts define the basic functions of the Federal Register system and provide the framework for promulgation of U.S. government legislations.
2. The Food and Drug Administration (FDA)
As part of the Department of Health and Human Services (DHHS) and the Public Health Service (PHS), the Food and Drug Administration is a scientific regulatory agency responsible for the safety of all foods (except meat, poultry, frozen and dried eggs and the labeling of alcoholic beverages and tobacco), cosmetics, drugs, biologics, medical devices, and radiological products. It is one of the oldest federal agencies whose primary function is consumer protection.
FDA’s activities are directed toward the health of the Nation against impure, unsafe, and fraudulently labeled foods, drugs, medical devices, cosmetics, and potential hazards from radiation-emitting equipment.
Under provisions of the U.S. law contained in the U.S. Federal Food, Drug and Cosmetic Act, importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. FDA is not authorized under the law to approve, certify, license or otherwise sanction individual food importers, products, labels or shipments. Importers can import foods into the United States without prior sanction by FDA, as long as the facilities that produce, store or otherwise handle the products are registered with FDA, and, prior notice of incoming shipments is provided to FDA. Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements.
3. U.S. Department of Agriculture (USDA)
USDA’s regulatory activities are primarily enforced by the Animal and Plant health Inspection Service (APHIS), the Food Safety Inspection Service (FSIS), Grain Inspection Packers and Stockyards Administration (GIPSA)/Federal Grain Inspection Service (FGIS), and Agricultural Marketing Service (AMS). In addition, the U.S. Customs Service participates in this effort by detaining of imports when USDA requirements have not been met.
With the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation, are subject to examination by FDA when they are being imported or offered for import into the United States. Most meat and poultry products are regulated by USDA.
4. The Food Safety Inspection Service (FSIS)
FSIS is responsible for ensuring that meat (derived from cattle, sheep, swine, goats, and horses) and poultry products moving in interstate and foreign commerce are safe, wholesome for consumption, and accurately labeled. Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS inspects all meat and poultry sold in interstate and foreign commerce, including imported products. Approximately 7,400 Federal inspectors carry out inspection laws in some 6,200 plants. Inspectors check animals before and after slaughter. They prevent diseased animals from entering the food supply and examine carcasses for visible defects that can affect safety and quality. FSIS also inspects products during processing, handling, and packaging to ensure that they are safe and truthfully labeled. To address specific concerns, inspectors can test for the presence of pathogenic microorganisms and violative drug and chemical residues. The Agency operates three field laboratories to provide analytical support.
5. The Agricultural Marketing Service (AMS)
AMS carries out a wide range of programs aimed at facilitating the marketing of agricultural products, assuring consumers of a quality food supply, and assuring ensuring fair trading practices. AMS offers voluntary grading service to provide the industry with an impartial, third-party certification of quality and condition of any fresh or processed product. This certification can help to provide a basis for assuring a quality product, verify compliance with contract terms as an aid to selling, and/or help settle claims for damage incurred in transit or storage. The Agricultural Marketing Service (AMS) provides the following services: (a) Quality Standards: In cooperation with industry, AMS develops and maintains quality standards for hundreds of products. Products include: fresh fruits, vegetables, and specialty crops, processed fruits and vegetables, milk and other dairy products, cattle, hogs, and sheep, poultry and eggs, cotton, tobacco, organic products; (b) Grading and Certification: Quality grading (a user-fee service) based on the standards developed for each product. Grading services are often operated cooperatively with state departments of agriculture. Certain agricultural commodities (including fresh tomatoes, avocados, mangoes, limes, oranges, grapefruit, green peppers, Irish potatoes, cucumbers, eggplants, dry onions, walnuts and filberts, processed dates, prunes, raisins, and olives in tins) must meet United States import requirements relating to grade, size, quality, and maturity (7U.S.C. 608(e)). These commodities are inspected and an inspection certificate must be issued by the AMS to indicate import compliance.
6. U.S. Custom Service, U.S. Department of Treasury
The U.S. Customs Service is an agency of the U.S. Department of Treasury responsible for the assessment and collection of import duties and taxes and the control of carriers, persons, and articles entering or departing the United States. The field organization consists of seven geographical regions further divided into 44 districts with ports of entry within each district. Customs enforces the provision of the Tariff Act of 1930, as amended, in addition to more than 400 laws of other agencies governing international traffic and trade. Title 19 USC 1304 and 19 USC1201 of the U.S. Code of Federal Regulations governs Customs.
1. Facility Registration
The U.S. FDA requires all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States must be registered as “food facility”.
The U.S. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 require that food facilities (other than private homes and individual farms) producing,
storing or otherwise handling food products intended for sale in U.S. interstate commerce be registered with FDA. Registration of facilities can be performed on the internet, and is free of charge. Please note that a U.S. agent residing in the United States must be listed for each foreign facility being registered. The Bayne Law Group LLC is available to assist in working with and counseling our clients’ U.S. agents.
2. Prior Notice of Incoming Shipment
The Bioterrorism Preparedness Act of 2002 also requires importers to provide prior notice to FDA for each import shipment of food products. A bar-coded Prior Notice Confirmation Number issued by FDA must accompany most shipments. Prior notice of shipments must be performed over the FDA website. The Bayne Law Group LLC is available to assist our clients in meeting the Prior Notice requirements.
3. Safety and Sanitation
The FD&C Act requires that foods imported into and sold in U.S. commerce not bear or contain any poisonous or deleterious substances which may render them injurious to health, nor consist in whole or in part of any filth, putrid, or decomposed substances, or otherwise be unfit for food. (Examples include evidence of rodent or insect infestation, or the presence of pesticides prohibited in foods or amounts of allowable pesticides in excess of established tolerances.) Foods must not be prepared, packed, or held under unsanitary condition whereby the products become contaminated with filth, or rendered injurious to health.
FDA helps ensure the safety of imported food. In order to implement the Food Safety Modernization Act (FSMA), FDA issued on July 26, 2013 two proposed rules aimed at helping to ensure that imported food meets the same safety standards as food produced in the United States. These proposals are part of the FSMA approach to modernizing the food safety system for the 21st century. FSMA focuses on preventing food safety problems, rather than relying primarily on responding to problems after the fact.
Under the proposed rules, importers would be accountable for verifying that their foreign suppliers are implementing modern, prevention-oriented food safety practices, and achieving the same level of food safety as domestic growers and processors. The FDA is also proposing rules to strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains. The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents.
Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importer would, for the first time, have a clearly defined responsibility to verify that their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.
FSMA also directs the FDA to establish a program for the Accreditation of Third-Party Auditors for imported food. Under this proposed rule, the FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.
Importers will not generally be required to obtain certifications, but certifications may be used by the FDA to determine whether to admit certain imported food that poses a safety risk into the United States.
4. Labeling Requirements
According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), a food label must contain specified information, displayed conspicuously and in terms that the ordinary consumer is likely to read and understand under ordinary conditions of purchase and use (403(f)). Details concerning type sizes, location, etc., of required label information are contained in FDA Regulations which cover the requirements of both the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. U.S. food labeling requirements are summarized as follows:
Statement of Ingredients: In addition to name, and net quantity, the ingredients in a food must be listed by their common names in order of their predominance by weight unless the food is standardized, in which case the label must include only those ingredients which the standard makes optional. Most ingredients in standardized foods are optional and therefore must be listed on the label. The word ingredients does not refer to the chemical composition, but means the individual food components of a mixed food. If a certain ingredient is the characterizing one in a food (e.g., shrimp in shrimp cocktail) the percent of that ingredient may be required as part of the name of the food.
Food Additives and Colors are required to be listed as ingredients, but the law exempts butter, cheese, and ice cream from having to show the use of color.
Nutrition Information: The Nutrition Labeling and Education Act (NL&E Act) is a comprehensive revision of the food labeling requirements of the FD&C Act. Under the NL&E Act, nutrition labeling must appear on the food label or in accompanying labeling. FDA has specified a uniform format which must include the serving size, the number of servings per container and the nutrition content of the food per serving, including the amount of each of 11 nutrients specified in the statute, such as calories, sugars, and sodium. The law adds a new section to the FD&C Act which requires nutrition labeling for virtually all food products, replacing the existing FDA nutrition labeling regulations. The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents.
5. Good Agricultural Practices for Fresh Fruits and Vegetables
FDA recommends that fruit and vegetable growers producing products intended for introduction into U.S. commerce follow certain practices to avoid contamination of the products with disease-causing organisms. The Bayne Law Group LLC is available to assist our valued clients with compliance with Good Agricultural Practices. The FDA regulation of food safety has been strengthened through the Food Safety Modernization Act (FSMA), which aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The details of the standards on good agricultural practices are contained in the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Proposed Rule,” 2013.
6. Meat and Meat Products
All commercial shipments of meat and meat food products offered for entry into the United States are subject to the regulations of the Department of Agriculture and must be inspected by the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) prior to release by U.S. Customs. Meat products from other sources (including, but not limited to wild game) are subject to APHIS regulations and the provisions of the Federal Food, Drug, and Cosmetics Act, enforced by the Food and Drug Administration.
Meat and poultry (including game and fowl), products can only be imported from countries and plants approved by the United States. The Federal Meat Inspection Act requires countries that export meat and poultry to the United States to impose inspection requirements at least equal to U.S. requirements. Imported meat and poultry products are inspected in the country of origin just as domestic products are inspected in U.S. slaughter and processing plants. FSIS reviews foreign inspection systems to ensure that they are equal to the U.S. system. FSIS also re-inspects imported meat and poultry products on a sample basis as they enter the United States. Data derived from import re-inspection constitute a check on the effectiveness of foreign inspection systems.
To determine if a country is eligibility to export meat to the U.S., FSIS evaluates the country’s entire inspection system. FSIS reviews the country’s laws, regulations, directives, and other written materials that govern its inspection program; reviews administration; and conducts an on-site review of the country’s inspection operations. A multidisciplinary team, typically composed of a veterinarian, chemist, food technologist, microbiologist, statistician, and compliance officer, conducts the review. After a country is granted eligibility to export its products to the United States, FSIS relies on the exporting country to certify plants and carry out daily inspection. Individual plants must apply to the country’s national inspection authorities for certification to export to the United States. In turn, the chief inspection official in the country certifies to FSIS those plants that meet all applicable standards and are authorized to export to the United States. The numbers of re-inspections in a given year are determined by the country’s adherence to the requirements. There may be up to four inspections per year by FSIS.
At the U.S. port of entry all meat products are checked for transportation damage, labeling, general condition, and proper certification and residue level. Residue levels must have certification. U.S. requirements also require foreign countries to impose controls equivalent to those of FSIS to prevent species substitution. A product labeled beef, for example, must be beef and cannot contain a less expensive product. FSIS scientists have developed verification tests which are quick and inexpensive. The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents in compliance with meat and meat products import requirements.
7. Milk and Cream
The importation of milk and cream is subject to requirements of the Food, Drug and Cosmetic Act and the Import Milk Act. These products may be imported only by holders of permits from the Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Labeling and the Department of Agriculture.
The Federal Import Milk Act (FIMA) was passed by Congress to “regulate the importation of milk and cream into the United States for the purpose of promoting the dairy industry of the United States and protecting the public health” (Public Law 69-625, codified as 21 U.S.C. 141-149). Under the FIMA, only the holder of a valid import milk permit may “ship or transport” milk or cream into the United States.
Under the FIMA, FDA issues import permits, which expire in 1 year. Prior to such permit being issued the FIMA requires that: (1) all cows must be physically examined and found healthy within 1 year previous to the time of importation; (2) if the milk or cream is raw when imported, all cows must pass a tuberculin test within 1 year previous to the time of importation; (3) the dairy farm and each plant in which the milk or cream is processed or handled must be inspected and must meet certain sanitary requirements; (4) bacterial counts of raw milk, raw cream, pasteurized milk, and pasteurized cream at the time of importation must not exceed specified limits; and (5) the temperature of the milk or cream at time of importation must not exceed 50º F (10º C). Requests for permit applications may be made to the Food and Drug Administration, Office of Plant and Dairy Foods, Division of Dairy and Egg Safety. The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents in compliance with milk and cream products import requirements.
8. Arrival at Port of Entry
When a food shipment is offered for import into the United States, the shipment must be declared by the importer or broker/agent to the U.S. Customs and Border Protection office at the
port of entry by the filing of an “entry notice” and acquisition of a bond. Customs then will notify FDA staff of the presence of the shipment. FDA may inspect and sample the shipment to ensure its compliance with U.S. requirements. The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents in compliance with port of entry import requirements.
9. FDA Field Offices and Inspections
Inspections of FDA-regulated food shipments offered for import into the United States are carried out by inspectors with the agency’s Office of Regulatory Affairs. ORA offices are located throughout the United States at ports of entry. Local FDA/ORA office can also be a point of contact for importers with ports of entry within the region covered by a particular FDA/ORA office.
10. Good Manufacturing Practice (GMP)
The FD&C Act gives the Food and Drug Administration the authority to establish and impose reasonable sanitation standards on the production of food. FDA requires processors to impose Good Manufacturing Practices (GMP) concerning personnel, buildings and facilities, equipment and product process controls which may give manufacturers assurances that their food is safe and sanitary. Sanitation provisions of the Food, Drug and Cosmetic Act require that foods be produced in sanitary facilities which ensure food is protected from contamination at all stages of production. These regulations establish a minimum level of safety performance, which apply to all businesses. Such protection includes extermination and exclusion of rodents, inspection and sorting of raw materials, quick handling and proper storage, use of clean equipment, and supervision of personnel. The Bayne Law Group LLC is available to assist our valued clients by compliance Good Manufacturing Practices requirements.
1. General Procedure
Imported goods may not be entered into the U.S. legally until the shipment has arrived within the limits of the port of entry and delivery of the merchandise has been authorized by the U.S. Customs Service, U.S. Treasury Department. This is normally accomplished by filing the appropriate documents, either by the importer or by their agent. Customs entry papers may be presented before the merchandise arrives.
The Customs Service does not notify the importer of the arrival of a shipment. Notification is usually made by the carrier of the goods. The importer should make their own arrangements to be sure they or their agent is informed immediately so that the entry can be filed and delays in obtaining the goods are avoided. If documentation is not filed within 30 days of arrival the goods are sent to a general order warehouse to be held as unclaimed. The importer is responsible for storage charges which are incurred during the period the merchandise is being held in the warehouse. After one year it is sold.
Entry of goods is made at the first port of arrival unless other arrangements are made prior to shipment from the country of origin for in-bond shipment to a farther port or to a bonded warehouse. If the importer is not able to be there to prepare and file the entry, commercial brokers, known as customs brokers and licensed by the Customs Service, may act as the agent. Such brokers charge a fee for their services. A list of customs brokers may be obtained from a local customs office or the telephone directory.
2. Entry Documents Required by U.S. Customs
- Customs Entry form 3461
- Evidence of right to make entry, e.g. bill of lading
- A Commercial Invoice or Pro-Forma Invoice if a commercial invoice cannot be produced
- Packing List if appropriate
- Other necessary documents to determine merchandise admissibility
- A bond which is normally posted with Customs to cover any potential duties, taxes, and penalties the may accrue after release of the cargo
3. 10 Steps to Faster Customs Clearance
- Make sure that your invoices contain the information that would be shown on a well prepared packing list.
- Mark and number each package so that it can be identified with the corresponding marks and numbers appearing on your invoice.
- Show on your invoice a detailed description of each item of goods contained in each individual package.
- Mark your goods legibly and conspicuously with the name of the country of origin, unless they are specifically exempted from the country of origin marking requirements, and with such other marking as required by the marking laws of the United States. Exemptions and general marking requirements may apply.
- Comply with the provisions of any special laws of the United States which may apply to your goods, such as the laws relating to food, drugs, cosmetics, alcoholic beverages, and radioactive materials.
- Observe closely the instructions with respect to invoicing, packaging, marking, labeling, etc., sent you by your customer in the United States. He has probably made a careful check of the requirements which will have to be met when you arrive.
- Work with U.S. Customs in developing packing standards for your commodities.
- Establish sound security procedures at your facility and while transporting your goods for shipment. Do not allow narcotics smugglers the opportunity to introduce narcotics into your shipment.
- Consider shipping on a carrier participating in the Automated Manifest System.
- If you use a licensed customs broker to handle the transaction, consider using a firm that participates in the Automated Broker Interface (ABI).
4. Steps for Obtaining Food Import Permission
Step One: Facility Registration
Step Two: Prior Notice of Incoming Shipping
Step Three: Food Safety Certification
Step Four: Meeting Labeling Requirements
The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines ‘labeling’ as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term ‘accompanying’ is interpreted liberally to mean more than physical association with the food product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.
Statistics seem to indicate that labeling mistakes result in more than 22% of all detentions in the United States. The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents in compliance with the labeling requirements.
Meat Steps: Completing Meat and Meat Products Inspection
In the United States, The Food Safety and Inspection Service (FSIS) regulates meat, poultry and egg products. FSIS is the U.S. Department of Agriculture’s public health regulatory agency that protects consumers by ensuring that meat, poultry and egg products are safe, wholesome, and accurately labeled.
Unlike FDA’s inspection process, which relies solely on point-of-entry inspection, FSIS, on the other hand, works collaboratively with the importing establishment’s government and uses a multi-part process to verify that other countries’ regulatory systems for meat, poultry and egg products are equivalent to that of the U.S. and that products entering the U.S. are safe and wholesome. Also, instead of dealing directly with individual companies, FSIS coordinates with the government of the country before accepting meat, poultry or egg products for sale into U.S. commerce.
FSIS Import Application Process
- To import to the U.S., countries must first complete the FSIS eligibility application package. To ensure that this process goes smoothly, FSIS provides as much advice and guidance as needed to other governments concerning any portion of the process.
- When FSIS receives the completed application, it conducts an initial document analysis to compare the country’s inspection system sanitary measures with the ones that are applied in the U.S.
- After reviewing the entire application, FSIS decides whether the foreign food regulatory system for meat, poultry and egg products is equivalent to the FSIS regulatory process. Additionally, FSIS makes certain that the other country’s regulatory system provides the same level of public health protection that is attained in the U.S.
- If it is determined that both of these objectives are met then FSIS sends a multidisciplinary team of experts to that country to conduct an on-site audit of its entire meat, poultry or egg products regulatory system. This is done in order for FSIS to verify that the country has satisfactorily implemented all laws, regulations, and other inspection or certification requirements cited in the initial application.
- After the on-site audit has been successfully completed, FSIS will publish a proposed regulation, which proposes to add the country to FSIS’ list of eligible exporters. There is a period of time in which the Agency must collect public comments to this proposed regulation to help FSIS make a final decision as to whether the country can be eligible to export meat, poultry or egg products to the U.S.
- It is important to note that FSIS does not conduct food inspections in another country, nor does it certify individual foreign establishments for export to the U.S. After it is determined that a country has an equivalent food regulatory system, FSIS will rely on that system to carry out daily inspection and then re-inspect upon arrival at U.S. import stations.
- Any foreign establishment that desires to export to the U.S. must apply to its own government, and that country’s chief inspection official must certify to FSIS a list of all establishments in that country that meet FSIS’ import requirements.
The Bayne Law Group LLC is available to assist our valued clients by counseling and working with our clients’ U.S. agents in compliance with Federal Meat and Poultry Inspection requirements.
Dairy Steps: Obtaining Milk and Dairy Products Import Permit
The Federal Import Milk Act requires a Food and Drug Administration permit for milk and cream (including sweetened condensed milk) imported into the United States. Information regarding how to obtain a permit is discussed in the Import Milk Act, 21 USC 141-149.
Generally, milk, cream, ice cream, butter and many cheeses are subject to quota restrictions administered by both CBP and the Department of Agriculture. All dairy products are subject to Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) requirements. They are also subject to Food and Drug Administration (FDA) requirements. Milk and cream may not be imported without a permit from the FDA. The wrappers or cartons for these products must be printed with the country of origin.
Import licensing: This is one of the tools the U.S. Department of Agriculture (USDA) uses to administer the tariff-rate quota (TRQ) system for U.S. imports of dairy products.
Under these TRQs, a low tariff rate, called the low-tier rate, applies to imports up to a specified quantity. A higher tariff rate, called the high-tier rate, applies to any imports in excess of that amount. High-tier tariff rates were reduced by 15 percent over the 6 years since the Uruguay Round Agreement was implemented in 1995, while quantities subject to low-tier rates were increased gradually over that same period. TRQ rates and quantities vary by product.
For dairy products subject to TRQs, an import license from USDA’s Foreign Agricultural Service (FAS) is generally required to bring in items at the low-tier tariff rate. No license is required to import products at the high-tier rate; to import dairy products for an agency of the U.S. Government; or to bring in products for personal use, as long as net weight does not exceed 5 kilograms (11 pounds) in any one shipment. FAS issues licenses in late December each year for the following calendar year (January 1-December 31). The Bayne Law Group LLC is available to assist our valued clients in obtaining Milk and Dairy Products Import Permit.
Agricultural Foods Step: For perishable agricultural foods, comply with Good Agricultural Practices for Fresh Fruits and Vegetables including the rules of Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Importers must also undergo Good Agricultural Practices (GAP) and Good Handling Practices (GHP) audits by USDA.
GMP Step: Satisfy FDA Good Manufacturing Practice (GMP)
It is necessary to obtain certification for complying with the rules of FDA’s Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in order to assure that the food manufacturers’ products are safe and sanitary. The Bayne Law Group LLC is available to assist food producers satisfy the FDA GMP requirements.