A. Consumer Products
Any consumer product offered for importation will be refused admission if it (a) fails to comply with an applicable product safety standard or regulation or with a specified labelling or certification requirement, or (b) is determined to present a substantial product hazard. These requirements are administered by the CPSC.
In order to improve consumer product safety compliance rates, the CPSC strongly recommends that manufacturers fully comply with both CPSC mandatory standards and private sector voluntary standards. Although private sector standards are conceived as voluntary requirements, products that fail to comply with them are nonetheless regarded as substandard in design and may be considered to present a "substantial product hazard"for that reason alone. Any product that presents a substantial product hazard will be refused entry into the US and, if the product is already in circulation, subject to a CPSC recall.
Manufacturers should also take advantage of certification programmes where available. Several products are already subject to mandatory certification, including architectural glazing, matchbooks, bicycle helmets, walk-behind power lawn mowers, cigarette lighters, multi-purpose lighters, bunk beds and mattress sets. In the absence of certification, the CPSC recommends that representative samples be tested by a laboratory accredited to the ISO/IEC 17025 standard by a recognised accreditation body. Manufacturers should also ensure that the selected testing laboratory is technically competent to test for the specific product safety standards. There are many advantages to having a product certified, including the identification of all applicable product standards and the enhancement of mechanisms for quality control through factory inspections, pre-market production sample testing and post-market testing.
Consumer product safety became a priority issue in 2007 following a number of well-publicised toy recalls in the US. To address mounting public concerns, the US Congress was expected to approve tougher safety requirements for consumer products in 2008. Some of the measures under consideration included requiring independent third-party certification of compliance by children's products with federal consumer product safety standards, requiring the labelling of children's products with tracking information, adopting more stringent requirements regarding lead content in children's products, requiring manufacturers of certain durable nursery products to provide postage-paid registration cards, imposing tougher penalties for product safety violations, streamlining product safety rulemaking and recall procedures, and banning the use of certain phthalates in toys and childcare articles.
Several US states have also established restrictions on the sale of certain children's products. The state of California enacted legislation in October 2007 that bans the state-wide sale, manufacture, processing, and distribution of certain toys and childcare articles containing phthalates, effective from 1 January 2009. Specifically, toys and childcare articles may not contain di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) or benzyl butyl phthalate (BBP) in concentrations exceeding 0.1%, while toys and childcare articles that are intended for use by children under three years of age and can be placed in a child's mouth may not contain diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) or di-n-octyl phthalate (DnOP) in concentrations exceeding 0.1%. Toys are defined in the California legislation as "all products designed or intended by the manufacturer to be used by children when they play,"while childcare articles are defined as "all products designed or intended by the manufacturer to facilitate sleep, relaxation, or the feeding of children, or to help children with sucking or teething."
According to the California legislation, manufacturers are required to use the least toxic alternative when replacing phthalates and may not use any of the following substances as a replacement: (a) substances rated by the Environmental Protection Agency (EPA) as A, B or C carcinogens; (b) substances listed as known or likely carcinogens, known to be human carcinogens, likely to be human carcinogens or suggestive of being human carcinogens, as described in the "List of Chemicals Evaluated for Carcinogenic Potential,"or known to the state to cause cancer as listed in the California Safe Drinking Water Act; or (c) reproductive toxicants that cause birth defects or reproductive or developmental harm as identified by the EPA or listed in the California Safe Drinking Water Act.
Several other states are considering similar restrictions on phthalates, and some are evaluating banning the sale of jewellery that does not comply with strict lead content requirements. California prohibited the retail sale of children's jewellery from 1 September 2007 and the sale of all other jewellery from 1 March 2008, unless that jewellery complies with certain requirements. Many US companies have already agreed to comply with these requirements as signatories to a 2006 consent judgment resulting from a Proposition 65 lawsuit filed by the California Attorney General's office.
In the State of Illinois, the Lead Poisoning Prevention Act prohibits the sale of toys, furniture, clothing, accessories, jewellery, decorative objects, edible items, candy, food, and dietary supplements made with lead-bearing substances and used by or intended to be chewable by children. The term "lead-bearing substance"means any item containing or coated with lead such that the lead content is more than 0.06% lead by total weight.
In addition, a number of US retailers and manufacturers have responded to consumer demands for safer products by adopting more stringent sourcing requirements for toys that are designed to meet or exceed federal standards. These requirements include adhering to tougher lead content and testing standards and phasing out the use of phthalates in toys.
In September 2007, the CPSC and mainland China's General Administration of Quality Supervision, Inspection and Quarantine reached a commitment to create and implement a comprehensive plan to eliminate the use of lead-containing paint in Chinese manufactured toys exported to the US and agreed to implement work plans to improve the safety of fireworks, toys, lighters and electrical products. As part of these work plans, the two agencies have committed to (a) increase inspections of products imported into the US, (b) expand their knowledge and understanding of product safety facts, (c) implement training activities for technical personnel and inspectors, including training on testing methodology, (d) exchange information on various topics and (e) create a method by which safety problems can be readily identified.
Additional Information
a) Toys and Children's Articles
Toys and other children's articles cannot be imported into the US if they fail to comply with applicable regulations issued under the Federal Hazardous Substances Act (FHSA). The regulations stipulate that toys intended for children under three years of age cannot have small parts that present a choking, aspiration or ingestion hazard to small children. The Child Safety Protection Act (an amendment to the FHSA) and its implementing regulations require warning labelling on toys for children who are at least three years of age but less than six years of age that present choking hazards from small parts. These regulations also cover balloons, small balls (small balls for children under age three are banned), and marbles. Electric toys, rattles, pacifiers and cribs are also subject to specific safety regulations. The CPSC's regulations contain tests used to define hazardous sharp edges and points on toys and other children's articles. Lawn darts are banned.
b) Lead in Paint
Paint and other similar surface-coating materials intended for consumer use are banned if they contain more than 0.06% lead. This ban also applies to paint used on furniture as well as toys or other articles intended for use by children. Such products cannot be admitted into the US. Although this ban applies to "surface coatings", the CPSC can take action under the FHSA against other lead containing products if the lead content results in a substantial risk of injury or illness.
c) Bicycles and Bicycle Helmets
Bicycles cannot be admitted into the US unless they comply with the FHSA regulations. Bicycle helmets cannot be admitted into the US unless they meet the safety standard for bicycle helmets and are accompanied by a certificate of compliance. The safety standard establishes strict performance and construction requirements for the brakes, wheels, steering system and frame. Bicycles require reflectors on the front, back, sides and pedals to make them visible at night; require elimination of uncovered sharp edges and jutting parts; and require brakes on bicycles with seat height of 22 inches or more.
d) Fireworks
FHSA regulations set labelling requirements and technical specifications for consumer fireworks. The regulations limit firecrackers and other ground devices to 50 mg of pyrotechnic composition (powder) designed to produce an audible effect. Firecrackers that exceed this limit, including cherry bombs, M 80s, silver salutes and other large firecrackers, are banned for consumer use. The regulations limit aerial fireworks devices to 130 mg (two grains) of pyrotechnic composition intended to produce an audible effect. Aerial devices with a higher audible effect are banned. This limit applies to many types of fireworks, including but not limited to rockets, aerial bombs, and firecrackers or other types of reports included in aerial devices such as multi-tube shells and aerial rockets. Kits and components intended to produce any of these are also subject to this limit. Large re-loadable mortar shell fireworks are banned, and large multiple tube mine and shell fireworks are subject to specific requirements to prevent
tip over. Fireworks not meeting any of the requirements of the FHSA cannot be imported into the US.
As of May 2007, a total of five states (Delaware, Massachusetts, New Jersey, New York and Rhode Island) banned all consumer fireworks, including those allowed by federal law. Arizona only allowed novelty fireworks as of that date, while Illinois, Iowa, Maine, Ohio and Vermont allowed only sparklers and/or other novelties.
e) Flammable Fabrics
Any article of wearing apparel, fabric or interior furnishing cannot be imported into the US if it fails to conform to an applicable flammability standard issued under the Flammable Fabrics Act. These standards cover general wearing apparel, children's sleepwear, mattresses (including futons), and carpets and rugs. Certain products can be imported into the US for the purpose of finishing or processing to render such products not so highly flammable as to be dangerous when worn by individuals, provided that the exporter states on the invoice or other paper relating to the shipment that it is being made for that purpose.
A new mandatory flammability standard for mattresses entered into force on 1 July 2007. The new standard addresses mattress fires ignited by open flame sources, including matches, candles, lighters and other related scenarios. Cigarette ignition continues to be regulated by a separate standard.
The CSPC also initiated a rulemaking process in March 2008 that could result in a new mandatory flammability standard for residential upholstered furniture.
f) Art Materials
Art materials cannot be imported into the US unless they meet the requirements of the Labeling of Hazardous Art Materials Act (LHAMA). The LHAMA requires that chronically hazardous art materials carry the warning labelling specified in industry standard ASTM D 4236. This standard also requires that art materials carry a label certifying that they have been reviewed by a toxicologist and identifying any known hazards.
g) Cigarette Lighters
Disposable and novelty cigarette lighters cannot be admitted into the US unless they meet a safety standard that requires them to be child-resistant. All non-refillable lighters, and refillable lighters whose customs value is less than US$2.25 (this value is adjusted every five years, if necessary) and that use gas as a fuel, are considered to be "disposable lighters"and are covered by the standard. Novelty lighters are lighters (using any type of fuel) that have entertaining audio or visual effects or that depict articles commonly recognised as intended for use by children under five years of age. Manufacturers must test lighters, keep records and report the results to the CPSC. A certificate of compliance must accompany each shipping unit of the product or otherwise be furnished to the distributor or retailer to whom the product is delivered by the manufacturer, private labeller or importer.
h) Multi-purpose Lighters
Multi-purpose lighters cannot be admitted into the US unless they meet a safety standard that requires them to be child-resistant. A multi-purpose lighter, also known as grill lighter, fireplace lighter, utility lighter, micro-torch, or gas match, is a flame-producing product that operates on fuel (less than 10 ounces), incorporates an ignition mechanism, and is used by consumers to ignite items such as candles, fuel for fireplaces, charcoal or gas-fired grills, camp fires, camp stoves, lanterns, fuel-fired appliances or devices, or pilot lights, or for uses such as soldering or brazing. All manufacturers and importers must test lighters, keep records and report the results to CPSC. A certificate of compliance must accompany each shipping unit of the product or be furnished in another fashion to the distributor or retailer to whom the manufacturer, private labeller or importer delivers the product.
i) Other Consumer Products Regulated by the CPSC
The CPSC has also issued safety standards and regulations that apply to the following.
- Architectural glazing
- Matchbooks
- CB base station antennas and TV antennas
- Walk behind power lawn mowers
- Swimming pool slides
- Cellulose insulation
- Automatic residential garage door operators
- Unstable refuse bins
- Flammable contact adhesives
- Patching compounds with asbestos
- Emberising materials with asbestos
- Household chemicals
- Refrigerator doors
- Bunk beds
- Poison Prevention Packaging Act (requires child resistant packaging of certain drugs, cosmetics and household chemicals)
A range of products and substances are banned under the FHSA, including, but not limited to the following.
- Mixtures that are intended primarily for application to interior masonry walls, floors, etc. as a water repellent treatment that are deemed to be extremely flammable.
- Carbon tetrachloride and mixtures containing it (including carbon tetrachloride and mixtures containing it used in fire extinguishers), excluding unavoidable manufacturing residues of carbon tetrachloride in other chemicals that under reasonably foreseeable conditions of use do not result in an atmospheric concentration of carbon tetrachloride greater than 10 parts per million.
- Liquid drain cleaners containing 10% or more by weight of sodium and/or potassium hydroxide and that are not packaged in child-resistant packaging.
- Products containing soluble cyanide salts, excluding unavoidable manufacturing residues of cyanide salts in other chemicals that under reasonable and foreseeable conditions of use will not result in a concentration of cyanide greater than 25 ppm.
- General use garments containing asbestos (other than garments having a bona fide application for personal protection against thermal injury and so constructed that the asbestos fibres will not become airborne under reasonably foreseeable conditions of use).
- Self-pressurised products intended or suitable for household use that contain vinyl chloride monomer as an ingredient or in the propellant.
- Candles made with metal-cored wicks, unless they comply with certain lead content and labelling conditions.
Products banned under the CPSA include certain extremely flammable contact adhesives and consumer patching compounds and artificial ashes and embers used in fireplaces containing free-form asbestos that can be inhaled.
j) Other Miscellaneous Merchandise
The importation of white or yellow phosphorous matches, pepper shells and switchblade knives is also prohibited.
B. Electronic Products
Radiation producing Products, Including Sonic Radiation
The Radiation Control for Health and Safety Act (RCHSA) establishes standards for electronic products in order to control radiation emitted by those products. Every manufacturer of an electronic product for which an applicable standard is in effect must furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards. Unless otherwise provided, the certification must be in the form of a label or tag permanently affixed to or inscribed on the product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags must be in English. Certification must be based on a test, in accordance with the standard, of the individual article to which it is attached or upon a testing programme that is in accordance with good manufacturing practices.
Some of the more relevant specific requirements established by the RCHSA are as follows.
- Television receivers. Radiation exposure rates produced by a television receiver must not exceed 0.5 milliroentgens per hour at a distance of five centimetres from any point on the external surface of the receiver.
- Cold-cathode discharge tubes. Radiation exposure rates produced by cold-cathode gas discharge tubes must not exceed 10 mR/hr at a distance of 30 centimetres from any point on the external surface of the tube.
- Microwave ovens. Microwave ovens must meet applicable requirements regarding power density and must have a minimum of two operative safety interlocks with certain characteristics.
There are also extensive regulations for diagnostic x-ray systems and their major components, radiographic equipment, fluoroscopic equipment, computed tomography equipment, cabinet x-ray systems, laser products, sunlamp products and ultraviolet lamps intended for use in sunlamp products, high-intensity mercury vapour discharge lamps, ultrasonic therapy products, CD players, CD-ROMs, cellular and cordless telephones, and other electronic products for which there are radiation performance standards.
C. Food, Drugs, Cosmetics and Medical Devices
a) Foods, Cosmetics, etc.
The importation into the US of food, drugs, medical devices and cosmetics is governed by the provisions of the FFDCA, which is administered by the FDA. These regulations prohibit the importation of articles that are adulterated or misbranded, including products that are defective, unsafe, filthy or produced under unsanitary conditions. The term "misbranded"includes statements, designs or pictures in labelling that are false or misleading or that fail to provide required information in labelling. The importation of pharmaceuticals that have not been approved by the FDA for admission into the US is also prohibited.
Imported products regulated by the FDA are subject to inspection at the time of entry. Shipments found not to comply with applicable laws and regulations are subject to refusal. They must be brought into compliance, destroyed, or re exported. At the discretion of the FDA, an importer may be permitted to bring a non-conforming importation into compliance if it is possible to do so. Any sorting, re-processing or re-labelling must be supervised by the FDA at the importer's expense.
Various imported foods such as confectionery, dairy products, poultry, eggs and egg products, meats, fruits, nuts and vegetables are also subject to the requirements of other agencies, as discussed in this guide. In addition, certain aquatic species may be subject to the requirements of the National Marine Fisheries Service of the DOC's National Oceanic and Atmospheric Administration.
The importation of alcoholic beverages is also subject to the specific requirements of the FDA. Persons wishing to import distilled spirits, wines containing at least 7% alcohol or malt beverages must first obtain an importer's basic permit from the Alcohol and Tobacco Tax and Trade Bureau.
Certain plant materials, when used for bottle jackets for wine or other liquids, are subject to special restrictions under the USDA's plant quarantine regulations. All bottle jackets made of dried or un-manufactured plant materials are subject to inspection upon arrival and are referred to the USDA.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires (a) domestic and foreign facilities to register with the FDA if they manufacture, pack, process, label or otherwise handle foods or beverages intended for consumption in the US, and (b) prior notice to be given before foods or beverages are imported or offered for import into the US. "Foods or beverages"include, but are not necessarily limited to, food ingredients, packaging, perishable foods, food components, dietary supplements, candies, infant formula, drinking water, alcoholic beverages and even animal foods. Only owners, operators in charge or designated US agents may register a facility with the FDA. Additional information on the bioterrorism regulations may be obtained on-line at http://www.fda.gov/oc/bioterrorism/bioact.html.
b) Biological Drugs
The requirements that regulate the manufacture and importation of biological products for human consumption are overseen by the FDA. Domestic and foreign manufacturers of such products must obtain a US licence for both the manufacturing establishment and the product intended to be produced or imported. Licensing information may be obtained from the FDA or on-line at www.fda.org.
The regulations for biological drugs for animals are administered by the USDA. The importation of viruses, serums, toxins and analogous products, and organisms and vectors for use in the treatment of domestic animals is prohibited unless the importer holds a permit from the USDA covering the specific product. These importations are also subject to special labelling requirements.
The importation of any drug or medicine designed to cause an unlawful abortion is prohibited unless otherwise authorised by the FDA.
c) Biological Materials and Vectors
The importation into the US for sale, trade or exchange of any virus, therapeutic serum, toxin, antitoxin, or analogous products, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), except materials to be used in research experiments, applicable to the prevention, treatment or cure of human diseases or injuries, is prohibited unless these products have been propagated or prepared at an establishment holding an un-suspended and un-revoked licence for such manufacturing issued by the Secretary, Department of Health and Human Services.
A permit from the CDC is required for shipments of any etiological agent or insect, animal or plant vector of human disease, or exotic living insect, animal or plant capable of being a vector of human disease. See http://www.cdc.gov/od/eaipp/ for additional information on obtaining a permit.
d) Narcotic Drugs and Derivatives
The importation of controlled substances, including narcotics, marijuana and other dangerous drugs, is prohibited except when imported in compliance with the regulations of the Department of Justice's Drug Enforcement Administration (DEA). Examples of prohibited controlled substances are amphetamines; barbiturates; coca leaves and derivatives such as cocaine; hallucinogenic substances such as LSD, mescaline, peyote, marijuana, and other forms of cannabis; opiates, including methadone; opium, including opium derivatives such as morphine and heroin; synthetic substitutes for narcotic drugs; and anabolic steroids.
e) Drug Paraphernalia
Items of drug paraphernalia are prohibited from importation or exportation. The term "drug paraphernalia"means any equipment, product or material of any kind that is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling or otherwise introducing into the human body a controlled substance whose possession is unlawful under the Controlled Substances Act.
Items of drug paraphernalia include, but are not limited to, the following: (1) metal, wooden, acrylic, glass, stone, plastic or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls; (2) water pipes; (3) carburetion tubes and devices; (4) smoking and carburetion masks; (5) roach clips, meaning objects used to hold burning material, such as a marijuana cigarette, that has become too small or too short to be held in the hand; (6) miniature spoons with level capacities of one tenth cubic centimetre or less; (7) chamber pipes; (8) carburettor pipes; (9) electric pipes; (10) air driven pipes; (11) chillums; (12) bongs; (13) ice pipes or chillers; (13) wired cigarette papers; and (14) cocaine freebase kits.
D. Motor Vehicles and Boats
a) Motor Vehicles
As a general rule, all imported motor vehicles less than 25 years old and items of motor vehicle equipment must comply with all applicable federal motor vehicle safety standards (FMVSS) in effect when these vehicles or items were manufactured. A CBP inspection at the time of entry will determine such compliance, which is verified by the original manufacturer's certification permanently affixed to the vehicle or merchandise. An entry declaration form, HS 7, must be filed when motor vehicles or items of motor vehicle equipment are entered. An HS 7 can be obtained from customs brokers, ports of entry or at www.nhtsa.dot.gov/cars/rules/import.
A vehicle without a certification label cannot be imported as a conforming vehicle. In this case, the importer must contract with a registered importer (RI) to modify the vehicle and post a DOT conformance bond in an amount equivalent to one and a half times the vehicle's dutiable value. This bond is in addition to the normal CBP entry bond. Copies of the DOT conformance bond and the contract with an RI must be attached to the HS-7 form. Furthermore, the vehicle model and model year must be determined to be eligible for importation.
Under the contract, the RI will modify the vehicle and certify that it conforms to all applicable FMVSS requirements. Before an RI can modify a vehicle, the DOT's National Highway Traffic Safety Administration (NHTSA) must have determined that the vehicle is eligible for importation based on its capability of being modified to conform to all applicable FMVSS. If no determination has been made, the RI must petition the NHTSA to determine whether the vehicle is eligible for importation. If the petitioned vehicle is not similar to one sold in the US, this process can be complex and costly. A list of vehicles that have been determined eligible for importation can be found on NHTSA's Web site at www.nhtsa.dot.gov/cars/rules/import.
Certain temporary importations may be exempt from the requirements for conformance if written approval is obtained in advance from both the DOT and the EPA. This includes vehicles brought in for research, demonstrations, investigation, studies, testing or competitive events. EPA form 3520 1 and DOT form HS 7 must be submitted to CBP at the time entry is made for such vehicles.
Modifications necessary to bring a nonconforming vehicle into conformity with the safety, bumper or vehicle emissions standards may require extensive engineering and be impractical or impossible, and the labour and materials may be unduly expensive.
Additional Information
b) Boat Standards and Restrictions
Imported boats and associated equipment are subject to US Coast Guard safety regulations or standards. Products subject to standards must have a compliance certification label affixed to them. Certain hulls also require a hull identification number to be affixed. A Coast Guard import declaration is required to be filed with entries of nonconforming boats. Additional information may be obtained on-line at http://www.uscgboating.org/regulations/regulations.htm.
Vessels that are foreign built or of foreign registry may be used in the US for pleasure purposes and in the foreign trade of the US. However, federal law prohibits the use of such vessels in the coastwise trade; i.e., the transportation of passengers or merchandise between points in the US, including carrying fishing parties for hire.