Agency Roles

Each of the Working Group Members represents an agency that has a responsibility in ensuring the safety of products imported into the United States.

Department of Health and Human Services

Food and Drug Administration

Description of Agency responsibility:

Biologics:  product licensing of human biologics, safety of the nation's blood supply and human tissues; research to establish product standards and develop improved testing methods

Cosmetics:  safety, labeling

Drugs:  product approvals, OTC and prescription drug labeling, drug manufacturing standards, drug safety

Foods:  labeling, safety of all food products (except meat, poultry, and processed egg products), bottled water

Medical Devices:  pre-market approval of new devices; manufacturing and performance standards, tracking reports of device malfunctioning and serious adverse reactions, and other safety activities, accrediting and inspecting mammography facilities

Radiation-Emitting Electronic Products:  radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps

Animal Products:  livestock feeds, pet foods, veterinary drugs and devices

Statutory Authority:

FDA accomplishes its mission by establishing and enforcing regulatory requirements authorized or mandated by the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 321 et seq.] and other public health laws (e.g., section 351 of the Public Health Service Act governing biological products [42 U.S.C. 262]).

FDA also has authority under the Public Health Service Act to prevent the transmission of communicable diseases [42 U.S.C. 264]. 

Specifically with regard to imports, the following provisions apply:

Section 801(a) of the FD&C Act   [21 U.S.C. 381(a)] authorizes examination of foods, drugs, cosmetics, and devices offered for entry into the United States and allows us to refuse admission based upon the “appearance” of a violation. Section 536 of the FD&C Act [21 U.S.C. 360mm] authorizes refusal of radiation emitting products which fail to comply with an applicable standard or the requirements of Section 534(h) of the FD&C Act [21 U.S.C. 360kk(h)].

Section 801(j) of the FD&C Act [21 U.S.C. 381(j)] authorizes FDA to request that CBP hold food at the port of entry for 24 hours if there is credible evidence or information that the food presents a threat of serious adverse health consequences or death and FDA needs more time to inspect, examine, or investigate.

Section 801(m) of the FD&C Act [21 U.S.C. 381(m)] requires that FDA receive, before arrival, notice of articles of food (which includes animal feed) imported or offered for import into the United States.  Section 801(m) also provides that if an article of food arrives at the port of arrival with inadequate prior notice (for example, no prior notice, inaccurate prior notice, or untimely prior notice), the food is subject to refusal of admission under section 801(m)(1) of the Act and may not be delivered to the importer, owner, or consignee.

Section 801(n) of the FD&C Act [21 U.S.C. 381(n)] authorizes refused food (other than food required to be destroyed) to be marked “UNITED STATES: REFUSED ENTRY”.

Section 306 of the FD&C Act [21 U.S.C. 335a] establishes debarment for persons convicted of a felony related to food importation and persons who engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death.

Section 402(h) of the FD&C Act [21 U.S.C. 342(h)] provides that food is adulterated if it is imported or offered for import and has been previously refused admission, unless the person re-offering the food establishes that the article is in compliance.

top of page

Department of Homeland Security 

As the Department committed to leading the unified national effort to secure America, the Department of Homeland Security (DHS) possesses a critical role in the mission to enhance the safety of products imported into the United States.  Within the interagency community, DHS exercises an interagency leadership role in all homeland security missions, including public health and the protection of food supply chain.  DHS has established partnerships and programs with the states, local and territorial governments, and the private sector to enhance our Nation’s protective posture across all of our critical infrastructures.  Furthermore, DHS, in partnership with the Department of Agriculture (USDA) and the Department of Health and Human Services (HHS), is charged with the successful implementation of Homeland Security Presidential Directive-9 (HSPD-9), Defense of United States Agriculture and Food, which establishes a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies.

Ultimately, DHS fulfills their role in the enhancement the safety of product imported into the United States through the coordination of their Departmental components that possess direct responsibilities in this mission area. 

As the component responsible for the coordination of all medical activities within the Department, the Office of Health Affairs (OHA) ensures appropriate preparation for and response to incidents having medical significance.  This coordination also extends to the combination of health data and environmental monitoring from other Department and Agencies to improve detection and response. 

Within DHS, the Directorate for National Protection and Programs (NPPD) works to advance the Department's risk-reduction mission. Reducing risk requires an integrated approach that encompasses both physical and virtual threats and their associated human elements.

The Directorate for Science and Technology (S&T) is the primary research and development arm of the Department.  It provides federal, state and local officials with the technology and capabilities to protect the homeland.

The Office of Policy is the primary policy formulation and coordination component for the Department of Homeland Security.  It provides a centralized, coordinated focus to the development of Department-wide, long-range planning to protect the United States. The Office of Intelligence and Analysis (I&A) is responsible for using information and intelligence from multiple sources to identify and assess current and future threats to the United States.

The Transportation Security Administration (TSA) protects the nation's transportation systems to ensure freedom of movement for people and commerce.

The United States Immigration and Customs Enforcement (ICE), the largest investigative arm of the Department of Homeland Security, is responsible for identifying and shutting down vulnerabilities in the nation’s border, economic, transportation and infrastructure security. 

The United States Coast Guard (USCG) protects the public, the environment, and U.S. economic interests—in the nation’s ports and waterways, along the coast, on international waters, or in any maritime region as required to support national security. 

The United States Customs and Border Protection (CBP) is responsible for protecting our nation’s borders in order to prevent terrorists and terrorist weapons from entering the United States, while facilitating the flow of legitimate trade and travel.

Although, each component plays a critically required role import safety, in particular CBP maintains its long-established responsibilities for protecting and facilitating international trade, protecting the nation's revenue by assessing and collecting duties, and taxes and fees incident to international traffic and trade. Further, by providing procedural guidance to the import community, CBP enhances and increases compliance with domestic and international customs laws and regulations. CBP thus helps importers assure that their shipments are free from terrorist or other malicious interference, tampering, or corruption of containers or commodities. 

 Today, CBP is the nation’s premiere border enforcement agency, and it accomplishes this new mandate in part by executing the responsibilities for which it has always been known: controlling, regulating, and facilitating the movement of carriers, people, and commodities between the United States and other nations; protecting the American consumer and the environment against the introduction of hazardous, toxic or noxious products and diseases that threatens our nation’s food supply infrastructure into the United States; protecting domestic industry and labor against unfair foreign competition; and detecting, interdicting, and investigating smuggling and other illegal practices aimed at illegally entering narcotics, drugs, contraband or other prohibited articles into the United States.

CBP is also responsible for detecting, interdicting, and investigating fraudulent activities intended to avoid the payment of duties, taxes and fees, or activities meant to evade the legal requirements of international traffic and trade; and for detecting, interdicting, and investigating illegal international trafficking in arms, munitions, currency, and acts of terrorism at U.S. ports of entry.

top of page

Role of the Department of Agriculture in Import Safety

The primary role in the U.S. Department of Agriculture for the safety of imports is played by the Food Safety and Inspection Service (FSIS) and by the Animal and Plant Health Inspection Service (APHIS).  Below is a summary of the roles played by these two agencies, as well as smaller role in imports played by the Grain Inspection Packers and Stockyards Administration (GIPSA) and the Agricultural Marketing Service (AMS).

Food Safety and Inspection Service

USDA's Food Safety and Inspection Service (FSIS) administer laws and regulations that ensure the safety of meat, poultry, and egg products imported into the United States. FSIS focuses on approval of countries to export to the United States based on a determination that they operate an inspection system that is equivalent to the U.S. system.  Equivalence is monitored on an on-going basis through on-site audits, re-inspection of products at ports of entry and surveillance activities targeted at non-compliance or avoidance of U.S. law, regulations, and procedures.

A total of 33 countries are currently eligible to ship meat, poultry, and/or egg products into the United States.  Of the countries that are eligible, 29 actually shipped product to the United States in 2006.  The 3.84 billion pounds of meat and poultry products imported into the United States in FY 2006 represents approximately five percent of domestic production. 

Before a country can begin shipping, FSIS conducts a comprehensive equivalence evaluation of its food regulatory system through document reviews and on-site audits.  All aspects of the inspection system are evaluated.  Once a country becomes eligible to export to the United States, it must certify specific establishments within the country that meet FSIS requirements, and only those plants are eligible to export.  FSIS continuously monitors the country’s equivalence through re-inspection of products at ports-of entry and annual audits by FSIS personnel to review documentation, certified establishments, laboratories and government controls. 

Every shipment of FSIS-regulated food that enters the United States is re-inspected to ensure it comes from a country with an equivalent inspection system and from an eligible establishment and is properly labeled and certified.  FSIS has an automated system that randomly selects approximately 10 to 14 percent of shipments of meat, poultry, and egg products for a more intensive examination, including product examinations, condition of container, and microbiological analyses for pathogens, as well as chemical residues.

As a response, in part, to the events surrounding Sept. 11, 2001, FSIS also employs 23 Import Surveillance Liaison Officers (ISLOs) who are responsible for identifying, tracking and detaining ineligible, illegal, and smuggled imported product.  These ISLOs coordinate with other agencies, such as the Department of Homeland Security's Customs and Border Protection, the Department of Agriculture's Animal and Plant Health Inspection Service, the Department of Health and Human Services' Food and Drug Administration, and the Interior Department's U.S. Fish and Wildlife Service.  FSIS also has Program Investigators nationwide who are trained to identify food that has illegally entered the country.  FSIS has an electronic tracking system to monitor and respond to the findings of the ISLOs and Program Investigators. 

In addition to the safeguards described above, FSIS has a number of food defense activities designed to protect against deliberate or unintentional contamination of the food supply.  For instance, the agency has performed vulnerability assessments of imported food and of illegally imported food.  As a follow-up to these vulnerability assessments, the agency has conducted workshops to increase awareness of food defense issues among our trading partners, including Canada, Mexico, the G-8 countries, and the Asian Pacific Economic Council.  Through the G-8 Working Group, FSIS is developing a joint exercise on responding to an intentional food contamination incident.

FSIS is in the process of developing Memoranda of Agreement with Customs and Border Protection (CBP) that will provide FSIS interface to the Automated Targeting System and the Automated Commercial Environment.  The agreement will allow key personnel from FSIS program areas to work closely with CBP personnel in monitoring shipments of meat, poultry and egg products imported into the United States.  Related to that, FSIS worked with CBP’s National Targeting Center to develop or criteria to assist in targeting shipments of FSIS-regulated products which may require heightened inspection by CBP and FSIS.  The criteria are updated on a regular basis.

FSIS is participating in a federal-wide initiative led by the Department of Homeland Security to electronically link all regulatory and inspection agencies to CBP’s import control system through the International Trade Data System.  The agency is receiving reports of Customs entry summary data that shows where and when CBP cleared meat, poultry, and egg products entry into the United States.  Access to these data has enabled FSIS to better target and control ineligible shipments.

Animal and Plant Health Inspection Service

Since its inception, USDA's Animal and Plant Health Inspection Service has focused on enhancing and refining its ability to collect information regarding the health of our Nation’s agricultural resources.  The information collected through these surveillance and monitoring channels, including off-shore pest and disease monitoring efforts; cooperative animal disease testing programs; and the established networks of laboratories that support domestic animal disease testing programs, has long served as the basis for APHIS' regulatory, policy and operational decisions.  Utilizing this information, APHIS routinely makes adjustments to the strong system of overlapping safeguards in place to guard against the entry of potentially damaging foreign agricultural pests and diseases.  

Generally speaking, these safeguarding systems are comprised of components such as overseas monitoring of disease events, import restrictions, domestic surveillance efforts, the measures we take to eradicate and control disease, and the regulation of slaughter practices to protect the food supply.  In a nutshell, by understanding the potential pest and disease threats to U.S. agriculture as they exist in other countries, we can take the necessary steps to keep the pests and diseases out of the country, while also looking for any signs of them within our borders.  Should surveillance detect one of these pests or diseases, we then mount an aggressive control and eradication program, while also closing the pathway responsible for the introduction.

APHIS regulates the importation of animals and animal-derived materials to ensure that exotic animal and poultry diseases are not introduced into the United States.  A USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials.  This includes dairy products (except butter and cheese), and meat products (e.g., meat pies, prepared foods) from countries with livestock diseases which do not exist in the United States.

APHIS operates the Smuggling Interdiction and Trade Compliance (SITC) Program to detect and prevent the unlawful entry and distribution of prohibited products that may harbor exotic disease. SITC officers focus their efforts at international ports of entry, agriculture weigh stations, warehouses, restaurants, retail markets and other commercial locations to detect prohibited products, including poultry and meat products.

Also, APHIS works closely with the Department of Homeland Security's Customs and Border Protection (CBP) to enforce importation regulations. USDA provides technical assistance and training for CBP’s Agricultural Quarantine and Inspection program, assisting it in enforcing USDA regulations and seizing any article in violation of those regulations.

Grain Inspection Packers and Stockyards Administration

USDA's Grain Inspection Packers and Stockyards Administration (GIPSA) facilitates the movement of US grain into the marketplace by providing farmers, grain handlers, processors, exporters and international buyers with information that accurately and consistently describes the quality and quantity of grain being bought and sold.  The agency establishes and maintains official US standards for grain; inspects and weighs all exported grain, oilseeds and related products for domestic and export; and provides the agriculture industry with a national inspection and weighing system.  It also monitors certain grain handling practices to prevent the deceptive use of the grading standards and official inspection and weighing results, and the degradation of grain quality through the introduction of foreign material, dockage, or other non-grain material to grain.  Regarding imports of grains, processed grain products, and/or animal feed, GIPSA has no regulatory inspection requirements, but can provide voluntary inspection services upon request.

Agricultural Marketing Service

USDA's Agricultural Marketing Service (AMS) reviews meat, poultry, and egg products for quality and condition, and provides grading and certification for those products.  In order to be eligible for an official USDA grade designation, each imported meat or poultry carcass or part must first be deemed to have originated from an establishment approved by FSIS for import into the United States.

The Agricultural Marketing Agreement Act of 1937 provides that when certain domestically produced fruit, vegetable, and specialty crops are regulated under a federal marketing order, imports of the commodity must meet the same or comparable grade, size, quality and maturity requirements.  AMS is charged with this enforcing this requirement.

Department of Commerce

The Department of Commerce (DOC) does not have any specific statutory or regulatory authority to monitor or inspect the safety of products imported into the United States.   However, DOC does have programs that impact indirectly on import safety.

DOC’s National Oceanic and Atmospheric Administration (NOAA) runs the National Seafood Inspection Program, which for a fee inspects and certifies that foreign seafood firms that ship product to the United States meet FDA’s Hazard Analysis and Critical Control Point (HACCP) requirements.  The Seafood Inspection Program currently has a contractual relationship with about 35 such foreign seafood firms.  The Program also provides a fee-based service that certifies the quality of individual seafood lots as meeting DOC Grade A standards.

DOC participates in numerous bilateral and multilateral dialogues and capacity building programs with our trading partners around the globe that focus on standards development, regulatory cooperation, and IPR enforcement, all of which can enhance the safety and quality of imported products.  DOC leads the economic initiatives of the Security and Prosperity Partnership of North America (SPP), and, in August 2007, President Bush, Mexican President Calderon, and Canadian Prime Minister Harper agreed that promoting the safety of imported products that enter North America would be an SPP priority.  DOC is active in similar economic dialogues with China, India, Brazil, the European Union, and Japan.  In addition, DOC plays a role in Codex Alimentarius and Asia Pacific Economic Council (APEC) multilateral meetings on food safety and standards.

DOC’s Coordinator for International Intellectual Property Enforcement, U.S. Patent and Trademark Office, and International Trade Administration actively combat counterfeit and pirated imports, many of which pose a safety hazard. 

Department of Justice

The Department of Justice enforces consumer health and safety laws by seeking criminal and civil penalties in court.  It also plays a key role in tracking importation of certain products and in interdicting illegal trafficking of such products.  

The Department enforces and defends the consumer protection programs of federal agencies, including the Food and Drug Administration, the Department of Agriculture, and the Consumer Product Safety Commission, and has responsibility for litigation under the principal federal consumer protection laws these agencies enforce.  As such, the Department is on the front lines of enforcing safety standards for imported products in cases referred from other agencies. 

Those agencies establish enforcement policies and set standards on importation.  Thus, the regulatory agencies responsible for overseeing the safety of imported products bring these matters to the Department to initiate criminal or civil actions when needed to protect the public or to deter additional violations.  Actions referred from client agencies may be brought by a United States Attorneys’ Office or the appropriate Litigating Division.

Through enforcement of the Controlled Substances Act (CSA), the Department’s Drug Enforcement Administration (DEA) regulates importation of pharmaceutical controlled substances and listed chemicals.  Listed chemicals are materials with legitimate industrial or other purposes but are also used in both the licit and illicit manufacture of controlled substances.  As required by the CSA, importers of controlled substances and list chemicals must obtain an annual registration with DEA to conduct such activities.  Registration of importers and other handlers of such substances helps to ensure the integrity of the supply chain and the closed system of distribution established by the CSA.  (Note: This process, however, does not ensure the safety and efficacy of the imported substance.)   

DEA collects information regarding imported controlled substances.  DEA regulations require companies that import controlled substances to obtain an import permit or declaration, notify DEA not later than 15 days prior to the importation, and supply the following information: the type material being imported; the proposed import date; the port of exportation to the United States; the port of entry; the name, address, and DEA registration number of the recipient; and the name, address of the consignor in the foreign country of exportation. 

With respect to listed chemicals, importations that meet or exceed threshold quantities are also subject to a requirement for authorization to import.  A 15-day advance notification is required for imports that have not received a waiver of regular customer status.  Import declarations include:  name; address; and phone number of the chemical importer, broker and consignee; name and description of the chemical being imported; the proposed import date; foreign port of exportation; and the first U.S. Customs Port of Entry.  In the instance where a waiver for notification has been obtained, the importer must submit quarterly reports to DEA containing the above information. 

DEA also serves a vital role in the interdiction of illegally imported controlled substances and listed chemicals and works closely with U.S. Customs and Border Protection (CBP) in that effort.  (CBP is charged with inspecting incoming shipments to ensure compliance with all federal laws, including the CSA.)  As with all provisions of the CSA and DEA regulations, those provisions governing importation of controlled substances and listed chemicals are designed to protect the health and safety of the American people.

The Department’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) enforces the Federal firearms laws, including the Gun Control Act of 1968, the National Firearms Act, and the import provisions of the Arms Export Control Act.  All of these statutes provide ATF with authority to regulate the importation of firearms and ammunition, and the Arms Export Control Act also provides ATF with authority to regulate the importation of certain military equipment, including military vehicles, military vessels, military aircraft, launch vehicles and missiles, and toxicological agents and radiological equipment. 

ATF also administers the Federal explosives laws, which provides ATF with the authority to regulate the importation and distribution of explosives materials.  The Gun Control Act and the Federal explosives laws require that marks of identification be placed on firearms and explosives so they can be traced at the request of law enforcement agencies.  These markings are essential in tracking products through the chain of distribution in the event they are illegally imported or involved in another violation of the law. 

The Federal firearms and explosives laws were enacted under the congressional power to regulate interstate and foreign commerce and, with one minor exception; do not provide the Attorney General with authority to regulate the safety of firearms, ammunition, or explosives.  The one exception is the “sporting purposes” test for firearms imported pursuant to one of the import provisions of the Gun Control Act.  In the case of imported handguns, the sporting purposes test has been interpreted by ATF to require consideration of certain safety features for imported handguns, including a loaded chamber indicator, a magazine safety, a grip safety, and a locked breech mechanism.

ATF is also charged with enforcement of several statutes relating to illegal trafficking in alcohol and tobacco.  First, the Contraband Cigarette Trafficking Act, 18 U.S.C. § 2341 et seq., makes it unlawful for any person knowingly to ship, transport, receive, possess, sell, distribute or purchase contraband cigarettes or smokeless tobacco.  Persons who import cigarettes in violation of the Act, i.e., importation in excess of 10,000 cigarettes or an equivalent amount of smokeless tobacco that do not bear evidence of the payment of State or local taxes in the locality where they are found, can be charged with a violation of section 2341.  This statute is frequently charged when counterfeit cigarettes are imported into the United States.  To the extent that the counterfeit cigarettes are adulterated, there could be safety issues presented to consumers in the United States. 

Similarly, ATF enforces 18 U.S.C. § 1952, as that statute relates to traveling in interstate commerce in aid of racketeering enterprises concerning liquor on which Federal excise tax has not been paid.  Again, to the extent that such untaxed liquor is adulterated, there could be safety issues presented to consumers in the United States. 

top of page

Department of Transportation

The U.S. Department of Transportation’s role regarding import safety entails:

• ensuring that motor vehicles, motor vehicle parts, rail cars and associated equipment comply with U.S. safety performance standards;
• inspecting hazardous materials for conformance with labeling, packaging and transport requirements;
• ensuring that those who construct our nation’s transportation infrastructure use materials that meet appropriate technical standards; and,
• Ensuring that the design and performance of the imported aviation products meet applicable U.S. standards.
  
  

National Highway Traffic Safety Administration (NHTSA)

Under the National Traffic and Motor Vehicle Safety Act of 1966, NHTSA issues the Federal motor vehicle safety standards (FMVSS), which establish minimum performance requirements for safety systems and components on motor vehicles and for certain items of motor vehicle equipment.   These requirements are applicable to all vehicles and vehicle-related equipment manufactured or imported for sale in the United States and certified or use on public roads and highways. 

To be imported, a motor vehicle must bear a label permanently affixed by its original manufacturer, certifying that the vehicle complies with all applicable FMVSS in effect on its date of manufacture.  A vehicle that has not been so certified can only be lawfully imported if NHTSA has decided that it is eligible for importation, based on the vehicle’s capability of being modified to conform to all applicable FMVSS, and it is imported by an importer specially registered with the agency (a “registered importer” or “RI”), or by a person who has a contract with an RI to modify the vehicle so that it complies with all applicable FMVSS following importation.  Relying on entry data furnished by U.S. Customs and Border Protection, NHTSA regulates the importation of these vehicles and assures that they are brought into conformity with applicable FMVSS by importers properly registered with the agency.

Unlike vehicles, equipment items that are subject to the FMVSS cannot be imported in a nonconforming state.  There is a flat prohibition upon the importation of equipment items subject to the FMVSS that are not certified to the applicable standard by their original manufacturer.  In most instances, the certification of an equipment item’s compliance is shown by the letters “DOT” affixed to the item in a prescribed location.  NHTSA surveys the market and tests imported equipment items to learn whether they comply with applicable standards.  In recent years, these efforts have focused on imported lighting equipment, motorcycle helmets, and tires.  Enforcement activities undertaken by NHTSA in this area have resulted in a number of safety recalls.

NHTSA’s Safety Defects Investigation program investigates, and where appropriate, seeks recalls of vehicles and vehicle equipment that pose an unreasonable safety risk.  Unlike, the compliance program, there are no Federal standards that define what constitutes a “safety-related defect.”   Rather, defects can include any defect in the performance, construction, or design of a vehicle, vehicle component or equipment that poses a threat to motor vehicle safety and that exists in a group of vehicles/equipment of the same design or manufacture.  Potential defects are identified through a number of sources, including consumer complaints and early warning reporting (EWR) data submitted by manufacturers pursuant to the requirements of the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act.  Defect investigations cover all motor vehicles and equipment items that are in use in the United States, regardless of the country of origin.  Since 2000, NHTSA has influenced, on average, the recall of 10.5 million vehicles and related equipment annually for safety-related defects.

Federal Highway Administration (FHWA)

FHWA requires that the materials used to construct or operate roadways (both domestic and imported) meet industry standards, but is not involved in the testing of these materials to determine whether or not the standards are met.  The materials come with a product specification sheet stating that the material meets an industry standard (e.g., Underwriter's Laboratory (UL) or American Society for Testing and Materials (ASTM) standards).   FHWA works with its constituency to maintain appropriate standards and promulgates regulations that incorporate these standards (Quality Assurance Procedures for Construction).  These standards also are specified in the contracts the States let for federal-aid road construction.  FHWA oversight of federal-aid highways includes ensuring that these specifications are properly noted in the contract and that the State verifies that materials used in the contract meet these specifications.  In its oversight role, if the FHWA determines that compliant materials are not used, FHWA asks the State for corrective action.  If the State does not take that action then FHWA can choose not to participate in the project.  The requirement for these material specifications works to ensure the safety of the transportation system. 

Pipeline and Hazardous Materials Safety Administration (PHMSA)

Under federal hazardous materials transportation law, PHMSA’s role is to protect the public, property, and environment from the risks inherent in the transportation of hazardous materials, and is authorized to establish and enforce standards for their safe and secure movement in interstate, intrastate, and foreign commerce.  PHMSA prescribes hazardous materials transportation requirements for risk classification, packaging, hazard communication, emergency response information, training of hazmat employees, handling, incident reporting and security planning.  Foreign shippers and carriers must comply with applicable requirements when sending materials into the U.S.

PHMSA participates in international standards-setting bodies such as the United Nations Committee of Experts on the Transportation of Dangerous Goods, the International Maritime Organization, and the International Civil Aviation Organization, in part to ensure acceptable standards for the international transport of hazardous materials. 

Regarding specific safety issues, the Hazardous Material Rules (HMR) require that toxic materials be stowed away from food products during transport, thus minimizing the risk of contamination to those products.  For the shipment of lithium batteries, the HMR require certain design testing, quantity limits and packaging, to minimize the risk that these materials will overheat or cause fire in transport.  PHMSA has evidence that substandard batteries are being imported into the U.S. and is coordinating with USCG and Customs and Borders to intercept imported shipments that do not meet U.S. transportation safety standards.  We have been taking similar action in the case of certain imported aerosol products. 

Federal Railroad Administration (FRA)

FRA’s responsibility for the safety of imports focuses on: (1) hazardous material (hazmat) transported by rail, and (2) imported railroad equipment and components.  FRA’s role is to enforce the hazardous material laws with respect to hazardous materials transportation by rail, which entails inspecting shipments to determine whether hazmat is in the correct container, whether that container is properly sealed and handled, whether the containers are properly placarded, and whether all of the required paperwork is in order.  With respect to imported rail cars and equipment, FRA’s role is to inspect them for compliance with railroad safety laws.  If FRA finds that a noncompliant rail car or equipment item, FRA requires that the product is either brought into compliance with the rail safety laws or prohibits its use.  FRA has addressed problems with mislabeled hazmat imported from the Far East and faulty wheel and axle assemblies under rail cars that were imported from Mexico.

Federal Motor Carrier Safety Administration (FMCSA)

FMCSA enforces the PHMSA regulations applicable to various kinds of cargo tank motor vehicles.  Cargo tank and cargo tank motor vehicle manufacturers must register with DOT, and provide a certificate stating that the completed vehicle conforms to one of the tank specifications in 49 CFR part 178 and the applicable American Society of Mechanical Engineers (ASME) Code.  Civil, and some cases criminal, penalties attach to the violations of DOT registration and manufacturing standards.  These standards apply to foreign as well as domestic manufacturers.  FMCSA ensures that all cargo tank manufacturers comply with the requirements. 

Federal Aviation Administration (FAA)

FAA certifies aircraft airworthiness to ensure the safety and environmental acceptability of civil aircraft registered in the United States.  FAA applies the same airworthiness standards to aircraft, aircraft engines, propellers, equipment, and parts imported to the U.S. as to those manufactured domestically.  FAA monitors safety compliance and when an unsafe condition is identified, FAA issues airworthiness directives to mandate corrective action.

FAA's procedures and practices are intended to ensure that:

• the design and performance of the imported product meets the applicable U.S. standards,
• the product to be operated or installed on an aircraft conforms to an FAA-approved design and is in a condition for safe operation, the foreign companies responsible and their civil aviation authority have adequate technical capability so that if safety issues arise in a product during its operation, they will be satisfactorily resolved in a timely manner.
  
  FAA requires U.S. manufacturers to maintain a quality control system for any product they produce so that each article meets the design requirements.  FAA conducts audits of U.S. manufacturers to ensure that they maintain robust quality control systems.  If the manufacturer imports parts and/or materials they must have sufficient controls in their quality control system to ensure the imported parts and materials meet the FAA-approved design specifications.  

 top of page

Department of the Treasury

Alcohol and Tobacco Tax and Trade Bureau -- Protecting the Public

Integrity of the Regulated Industries

A key goal in achieving TTB’s mission is keeping ineligible persons from entering the alcohol and tobacco industries.  The tobacco and alcohol industries have the potential to be highly lucrative through illicit activity in these commodities.  Therefore, it is important that the Bureau ensures that terrorists and organized crime are kept out of these industries.  The National Revenue Center receives over 4,000 original applications annually for various permits.  To properly process the applications and ensure that only eligible persons enter the industries, personnel and financial background investigations, and inspections of the premises to be used for the operations, are conducted.  All excise taxpayer original applications are sent to the field for full investigation.  For other original and amended applications, TTB has a point value system based on critical information contained in the applications.  The information is assigned a numerical risk factor, which is the basis for requiring a field investigation.

Integrity of the Product (Alcohol)

Consumer Complaints

TTB responds to and monitors consumer complaints regarding suspected contaminated or adulterated alcohol beverage products through investigation and laboratory analyses.  These complaints are tracked to identify potential patterns and appropriate follow-up actions.  Upon corroboration through analysis, the Bureau notifies the appropriate authorities and the complainant of the results.  Significant issues, such as tampering or contamination, are dealt with immediately in coordination with the Food and Drug Administration.

Product Safety

The Bureau performs laboratory analyses of alcohol beverage products and inspects facilities, production records, and other documents to ensure products comply with approved formulas and the standards of identity for each type of product.  The Bureau continues to develop new and better analytical methods and protocols that will help identify non-compliant and deceptive products.

Verification of Label Claims

TTB performs field inspections to ensure the accuracy of product label claims.  These inspections include on-site review of production and bottling records, including viticultural source documents, and laboratory analysis.

Label Fraud

The Bureau investigates leads or allegations involving questionable alcohol beverage labels or documents.  TTB ensures that alcohol beverage products are properly labeled as shown on the certificate of label approval or certificate of exemption from label approval.

Lab Viticultural and Varietal Authentication Program

The authentications program was initiated in 2002 to develop and evaluate analytical approaches to the varietal and viticultural authentication of wines.  Samples of wine from various regions of the United States were gathered and analyzed in order to establish characteristics that would enable TTB to identify products with regard to varietal designation and geographic origin.  Early results were very promising and research and evaluation of additional samples will follow.

Alcohol Beverage Sampling Program

In FY 2005, TTB collected alcohol beverage product samples for laboratory analyses directly from producers and importers.  While this year’s program is still on-going, to date it has been determined that 54% of the products selected and tested under this specific program are non-compliant due to labeling violations.  Some examples include products which are over and under with respect to proof and fill, are misclassified for tax purposes, are improperly identified, or which contain unauthorized substances.

Alcohol Beverage Formulas

The Bureau examines formulas for domestic wine, distilled spirits and malt beverages, and pre-import applications filed by alcohol importers in order to properly identify the product for consumers and for proper tax classifications and to ensure that the products are manufactured in accordance with Federal laws and regulations.

Alcohol Beverage Labels

Importers and domestic bottlers must obtain certificates of label approval or certificates of exemption from label approval (COLAs) for most alcoholic beverages prior to their introduction into interstate commerce.  TTB examines and acts on the COLAs to ensure that alcohol beverage products are labeled in accordance with Federal laws and regulations.  The program prevents consumer deception and ensures that the label provides the consumer with adequate information as to the identity and quality of the product.

In FY 2005, TTB processed more than 105,000 applications, with a 27 percent rejection rate.  There were a total of 92 alcohol integrity investigations conducted with 25 significant investigations resulting in label fraud, tax evasions and in some instances both label fraud and tax evasion.

International Trade Data System and Import Safety

The International Trade Data System (ITDS) is a single-window system for filing import and export documentation.  This means traders file only once, with the information shared among government agencies.  ITDS is a feature of Automated Commercial Environment (ACE), the new automated system for processing imports and exports that is being built by Customs and Border Protection (CBP).

Currently, traders file separately with many agencies, sometimes electronically or on paper.  ITDS will provide for all electronic filing with a database that can be searched and used for targeting.  ITDS is already partly operational and used by some agencies with an import safety mission.  For example, the USDA Food Safety Inspection Service (FSIS) has already achieved a 44-fold increase in removing unsafe or uncertified imported products from commerce through use of ITDS.

Full implementation is not expected to occur until 2011; however, some steps might be taken to accelerate implementation of ITDS features related to import safety.

Recommendations to Accelerate Implementation of ITDS Features Related to Import Safety

• Input more information currently reported to CBP by importers (entry/entry summary data) in the ACE Data Warehouse where it can be accessed by other agencies (Status: this is underway).
• Input more information currently reported to CBP by carriers (manifest data) in ACE Data Warehouse where it can be accessed by other agencies (Status: this is underway).
• Encourage agencies with an import safety mission to take full advantage of current ITDS capabilities and deepen their own engagement in ITDS development.
• Explore accelerating implementation of World Customs Organization Data Model messages (new international standard for customs reporting), which could provide a platform for electronic reporting of health and safety information in advance of the current production schedule (Status: early stages of evaluation)

top of page

U.S. Environmental Protection Agency

In accordance with EPA’s mission to protect human health and the environment, EPA establishes and enforces (or, in some cases, assists other agencies in enforcing) health and environmental standards under a number of statutory authorities.  EPA standards apply both to domestically produced and imported products.  EPA’s responsibilities and roles are identified under the following statutes: the Clean Air Act (CAA); the Resource Conservation and Recovery Act (RCRA); the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); and the Toxic Substances Control Act (TSCA).

Training
EPA shares its scientific expertise and regulatory standards to educate our trading partners to facilitate the trade of safe and compliant products and otherwise support the broader goal of protecting public health and the environment.  EPA is coordinating with Customs and Border Protection (CBP) to more effectively identify imports that violate U.S. standards.  EPA's Office of Enforcement and Compliance Assurance is working with environmental and law enforcement agencies in Canada and Mexico to determine how information about noncompliant or suspect imports can be shared appropriately between our countries.  EPA has also actively worked with domestic and foreign trade groups who may be impacted by noncompliant imports within their sector.

International Organizations

EPA works closely with the Organization for Economic Cooperation and Development, the United Nations, and other international organizations to establish international standards and to harmonize regulations, including in the area of improved manufacturing process to reduce instances of non-conforming imports.  In these and other international fora, EPA shares technical and scientific expertise and regulatory standards to educate our trading partners to facilitate harmonized requirements, pollution prevention, enforcement programs, and the trade in safer products.   One of the purposes of these efforts is to reduce imports from trading partners that fail to meet U.S. safety and environmental standards. 

top of page

U.S. Trade Representative

The Office of the U.S. Trade Representative's responsibility in enhancing the safety of imported products is three-fold.

1.  Ensuring that any safety-related import measures imposed by U.S. regulatory agencies comply with World Trade Organization rules, in order to defend the measures if challenged by other WTO Members.  This includes obligations to base SPS measures on science and an assessment of specific risks, not maintained without sufficient scientific information, and only applied to the extent necessary. Additional relevant WTO obligations require the United States to ensure that mandatory standards or testing requirements are no more trade-restrictive than necessary to fulfill legitimate objectives, such as health, safety, or consumer interests and to base any such measures on relevant international standards wherever possible.   

2.  Challenging foreign trade measures that may serve as unjustified barriers to trade and at the same time pose a threat to health or safety in the United States.  Examples of such trade measures include inadequate intellectual property protections and inadequate regulatory regimes which create incentives for counterfeit pharmaceuticals posing a human health risk.

3.  Challenging unjustified foreign trade barriers to U.S. products, particularly non-science-based SPS restrictions blocking US food and agriculture exports, and protectionist standards that create unnecessary obstacles to U.S. industrial products. 

The USTR exercises this responsibility in part through its leading role in the coordination of the interagency process of trade policy formulation, which includes its chairmanship of the Trade Policy Staff Committee and numerous subcommittees including a Technical Barriers to Trade subcommittee, a Sanitary and Phytosanitary Measures subcommittee, and a Trade and the Environment subcommittee, which meet regularly to take trade policy actions.

 top of page

U.S. Consumer Product Safety Commission

Summary of Role in Enhancing the Safety of Imported Consumer Products

Mission

The mission of the Consumer Product Safety Commission is to protect the public against unreasonable risks of injury associated with consumer products.  (Consumer products are generally all products intended for use by consumers except food, drugs, medical devices, cosmetics, tobacco products, motor vehicles, aircraft, boats and guns).  (Section 2(b) (1) of the Consumer Product Safety Act, 15 U.S.C. § 2051 (b) (1)).

Imported Products

Generally speaking, imports that fail to meet a mandatory (CPSC) product safety standard (of which there are fewer than 100) OR that present a “substantial product hazard” can be denied entry into the US:Sec. 17 [15 U.S.C. §2066]

(a)    Any consumer product offered for importation into the customs territory of the United States shall be refused admission into such customs territory if such product—

            (1) fails to comply with an applicable consumer product safety rule

            (4) has a product defect which constitutes a substantial product hazard

(a)    For purposes of this section, the term “substantial product hazard” means a product defect which (because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise) creates a substantial risk of injury to the public.

Mandatory vs. Voluntary Product Safety Standards

While a violation of a mandatory standard constitutes per se grounds for refusing admission of a product, violations of voluntary (or “consensus”) standards can give rise to a determination by the CPSC that the product constitutes a substantial product hazard.  However, for U.S. Customs and Border Protection to seize products that violate consensus standards, the determination must effectively be made before the products reach the port of entry, which is a rare instance.

FHSA Authority

The Federal Hazardous Substances Act also provides that:  “The Secretary of the Treasury shall cause destruction of any such hazardous substance refused admission unless such hazardous substance is exported within 90 days of the date of notice of such refusal or within such additional time as permitted by Treasury regulations.”15 U.S.C. § 1273(a) (These include:  any toy or other article intended for use by children that is or contains a hazardous substance is banned under the FHSA if a child can gain access to the substance.  In addition, the Commission has the authority to ban products it finds to be so hazardous that the labeling required by the act would be inadequate to protect the public.).

Note:  Under the Poison Prevention Packaging Act, the CPSC also has similar enforcement authorities with respect to child resistant packaging as does the FDA and EPA.