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Resources: Government Agencies

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COMPLIANCE AND REGULATORY GOVERNMENT AGENCIES

ADK Information Services provides a basic overview and website links to various government agencies with compliance or regulatory authority in their jurisdiction.  This information is of a general nature and summarized from public documents.  Any user interested in more detailed information about these agencies or their authorities should seek the advice of experienced professionals.


United States

Government Recall Clearinghouse

Recalls.gov

This is the federal government’s central Internet clearinghouse for recalls in the following categories: consumer products, motor vehicles, boats, food, medicine, cosmetics, and environmental products. Through this portal site, individual federal agency recalls are listed, sign-ups are available, and other safety related information is provided for all federal agencies that have responsibilities in the product safety area.



U.S. Consumer Product Safety Commission

www.cpsc.gov
This site provides information for consumers and businesses under the regulatory authority of the CPSC, as well as the general public. Businesses will find information about products under the authority of the Agency, questions and answers pertaining to various regulations, and other legislative and compliance information. Businesses are by law required to notify the Agency if they learn about a product hazard associated with their products. The CPSC has jurisdiction over more than 15,000 kinds of consumer products used in and around the home, in sports, recreation and schools including: appliances, clothing, electronic/electrical, furniture, household, children’s products, lighting/lighter, outdoor, sports/ exercise. 

U.S. Consumer Product Safety Commission Headquarters
Consumer Product Safety Commission
4330 East West Highway
Bethesda, MD 20814
General Information: (301) 504-7923 M-F
8:00 am - 4:30 pm ET
Fax: (301) 504-0124 and
(301) 504-0025
E-mail: info@cpsc.gov



National Highway Traffic Safety Administration

www.nhtsa.gov
NHTSA is part of the U.S. Department of Transportation and provides recall information that include vehicle and equipment campaigns. NHTSA has authority over motor vehicle products that experience a safety-related defect or do not comply with federal motor vehicle safety standards, including motor vehicles and related equipment, child safety seats, and tires.  The NHTSA website serves as a general information site for consumers and the general public, as well as offering guidance and regulatory information to companies. Technical documents, legislative analysis, and information about safety materials are among the subjects presented at their web site. 

NHTSA Headquarters
1200 New Jersey Avenue, SE
West Building
Washington, DC 20590
Toll-Free: 1-888-327-4236
Compliance office: 1-202-366-2832
TTY: 1-800-424-9153



U.S. Coast Guard

www.uscgboating.org
The U.S. Coast Guard’s Boating Safety Division focuses on reducing loss of life, injuries, and property damage that occur on U.S. waterways by promoting knowledge and skills of general boaters. The U.S. Coast Guard Product Assurance Branch operations include oversight of all laws and regulations affecting boat safety, and the investigation of consumer complaints about recreational boats and related equipment. The Coast Guard web site provides a recall data base and maintains a manufacturer’s identification code on all boats made or imported into the U.S. Their web site features safety tips, news, recalls, defects, and laws and regulations dealing with recreational boats and personal watercraft, boat manufacturer installed equipment, and boating safety issues. The related federal laws and regulations are available through this site, as well as state laws and a boat builder’s handbook that provides compliance and safety information to manufacturers.

U.S. Coast Guard Commanding Officer and Headquarters Staff
202-372-4000
Assistant Commandant for Marine Safety, Security, and Stewardship
202-372-1001
Office of Vessel Activity (Compliance)
202-372-1251



U.S. Food and Drug Administration

www.fda.gov

FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. It oversees farm and pet animal food products. It provides industry guidance in its areas of authority, and provides regulatory and legislative information. Each of its areas of authority is specialized and companies with products overseen by the FDA generally require expert advisers in their compliance area. The FDA maintains databases in most of its areas of responsibility, and standard protocols for reporting hazardous products to the agency.  The following departments at FDA are responsible for the safety and regulation of products.

The Center for Drug Evaluation and Research (CDER) is responsible for making sure safe and effective drugs are available to improve the health of people in the United States. As part of FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines, for example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered “drugs.”

Division of Drug Information (CDER)
10903 New Hampshire Avenue
Silver Spring, MD 209
druginfo@fda.gov/CDER
(888) 463-6332
(301) 796-3400


The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of FDA. The Center has over 800 employees, who range from support staff to highly specialized professionals-- such as chemists, microbiologists, toxicologists, food technologists, pathologists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathematicians, and sanitarians.

Outreach and Information Center (HFS-009)
Industry: industry@fda.gov
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
1-888-SAFEFOOD
1-888-723-3366


The Center for Device and Radiological Health (CDRH)
 
operates as part of FDA and is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. Its website contains useful information for educating industry on the relevant policies and regulations. CDRH is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and nonmedical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. Editor note: Over the next decade, the FDA web site points out that its staff will be responsible for monitoring and regulating medical technology innovations that will fundamentally transform the health care and delivery systems. Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information that FDA and device manufacturers receive about problems with medical devices.

CDRH-Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5429
Silver Spring, MD 20993
1-888-463-6332
301-796-7100


The Center for Biologics and Evaluation Research (CBER) is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products including vaccines, blood, and biologics are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
The Center for Biologics and Evaluation Research
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
(800) 835-4709
(301) 827-1800
ocod@fda.hhs.gov


The Center for Veterinary Medicine (CVM) within FDA regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)

Center for Veterinary Medicine
7519 Standish Place
HFV-12
Rockville, MD 20855
CVMHomeP@cvm.fda.gov
Office of Compliance
240-276-9200

FDA’s Cosmetic Industry Responsibility. The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition-- FDA’s Cosmetic Industry Responsibility whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action. FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law. Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective. FDA categorizes a firm’s action as a recall (as opposed to a market withdrawal) when it determines that the product hazard or defect represents a violation of the FD&C Act. Editor note: FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA’s written request. 

Outreach and Information Center (HFS-009) Industry:
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
industry@fda.gov
1-888-SAFEFOOD
1-888-723-3366



U.S. Department of Agriculture

www.fsis.usda.gov
The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring the nation’s commercial supply of meat, poultry, and egg products is safe and correctly labeled and packaged. At the FSIS web site there is information about product recalls, agency authority, and other legislative and regulatory information. The Department of Agriculture inspects and regulates meat, poultry and processed egg products produced in federally inspected plants. FSIS is responsible for ensuring that these products are safe, wholesome, and accurately labeled. All other food products are regulated by FDA.

Recall Management Division
1400 Independence Ave. SW
Room 3157S
Washington, D.C. 20250
(202) 690-6389
FAX: (202) 690-6388



Environmental Protection Agency

www.epa.gov
The Environmental Protection Agency (EPA) is responsible for the nation’s environmental science, research, education and assessment efforts. Since 1970, EPA has been working in a variety of different ways to promote a cleaner, healthier environment for the American people. Among the acts which the EPA administers or has some responsibility for administering is the Clean Air Act, Clean Water Act, Comprehensive Environmental Response, Compensation and Liability Act (Superfund), Endangered Species Act, Protection of Children from Environmental Health Risks and Safety Risks, Federal Insecticide, Pesticide, and Rodenticide Act, and Federal Food, Drug, and Cosmetic Act. Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes EPA to set tolerances, or maximum residue limits, for pesticide residues on foods. To make the safety finding, EPA considers, among other things: the toxicity of the pesticide and its break-down products; aggregate exposure to the pesticide in foods and from other sources of exposure; and any special risks posed to infants and children.

Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Ave. NW
Washington, DC 20004
Office of Compliance
(202) 564-2280



Canada

Health Canada

www.hc-sc.gc.ca
Health Canada is the Agency that has responsibility for researching, assessing, and collaborating in the management of the health risks and safety hazards associated with the products that Canadians use every day. Health Canada’s authority includes supporting the development of safety standards and guidelines, enforcing legislation through investigations, inspections, seizures and prosecutions, and testing and conducting research on consumer products. In addition, they provide importers, manufacturers and distributors with hazard and technical information. Health Canada publishes product advisories, warnings and recalls. Proactively, they help promote product safety and the responsible use of products.

Consumer and Clinical Radiation Protection Bureau
Health Canada
775 Brookfield Road
A.L. 6302C
Ottawa, Ontario
K1A 1
(613) 954-6699
ccrpb-pcrpcc@hc-sc.gc.ca



National Capital Region Consumer Product Safety Office

Product Safety Programme
Health Canada
MacDonald Building
123 Slater Street, 4th Floor A.L. 3504D
Ottawa, Ontario
K1A 0K9
(613) 952-1014
Toll-free: 1-866-662-0666 (calls will be
routed to closest regional office)



Cosmetics Program

Health Canada
MacDonald Building
123 Slater Street , 4th Floor A.L. 3504D
Ottawa , Ontario
K1A 0K9
(613) 946-6452
cosmetics@hc-sc.gc.ca



Pest Management Information Service

Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Ottawa, Ontario
Address Locator: 6606D2
K1A 0K9
E-mail: pmra_infoserv@hc-sc.gc.ca
613-736-3799
Toll-free: 1-800-267-6315
Fax: 613-736-3798



Canadian Electrical Authority

www.esasafe.com
The Electrical Safety Authority (ESA) is a stand-alone, financially self-sustaining not-for-profit corporation accountable to a Board of Directors and operating as an Administrative Authority under the Electricity Act 1998 and an Administrative Agreement with the Ministry of Consumer Services. ESA is responsible for public electrical safety in Ontario as designated by Ontario Regulation 89/99. ESA is accountable to the public through the Ministry of Consumer Services for meeting its legislative and contractual obligations in the delivery of its delegated regulatory mandate. At the same time, it is accountable to its regulated sectors for results, sound management, and efficiency. The ESA has published at its web site information about reporting obligations by business owners, contractors, and operators. The ESA’s reporting requirements include, among other factors, the obligation to report within forty-eight hours after occurrence of a serious electrical incident that includes death, critical injury, or any fire or explosion suspected of being electrical in origin. 

Telephone contact for reporting an incident:
Electrical Safety Authority
1-877-372-7233
If a workplace injury, report to the Ministry of Labour



Transport Canada

www.tc.gc.ca
Transport Canada promotes safe and secure transportation systems as well as environmental responsibility. It reports to Parliament and Canadians through the Minister of Transportation, Infrastructure and Communities. Transport Canada is responsible for safety and security activities related to aircraft services, civil aviation, marine safety, rail and road safety, transportation of dangerous goods, urban transit and emergency preparedness. It promotes safety though rulemaking, oversight and outreach. Transport Canada also works with partners in Canada and abroad to improve safety and manage security risks in all transportation modes. Transport Canada has responsibility for marine vessel manufacturing and safety, automobile safety, road and motor vehicle safety, and as well as oversight for other transportation functions. They are the responsible arm of Canadian government for issuing rules and regulations relating to safety in its various areas of authority.

Transport Canada
330 Sparks Street
Ottawa, ON K1A 0N5
Phone: 613-990-2309
Teletypewriter (TTY):1-888-675-6863
Fax: 613-954-4731 / 613-998-8620
Email: Questions@tc.gc.ca



Canadian Food Inspection Agency

www.inspection.gc.ca

The Canadian Food Inspection Agency (CFIA) is responsible for safeguarding Canada’s food supply as well as the plants and animals upon which safe and high-quality food depends. The CFIA delivers inspection and quarantine programs related to foods, plants and animals in 18 regions and 160 field offices across Canada. CFIA may inspect products that include agricultural inputs such as seeds, feeds and fertilizer as well as fresh foods that include meat, fish, eggs, grains, dairy products and fruits and vegetables. Prepared and package foods are also subject to inspection. CFIA enforces policies and standards set by Health Canada and verifies compliance with federal acts and regulations. In the event that a food emergency occurs, CFIA partners with Health Canada, provincial agencies and the food industry to operate an emergency response system. CFIA certifies food, plant and animal products that are exported around the world and also sets the policies and regulation for food and agricultural import inspections that are conducted and enforced by the Canada Border Services Agency. Imports are referred to the CFIA when follow up action is indicated.

Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9
1-800-4422342




European Union

The European Union sets policy for member states but has no enforcement authority, which remains with individual state members. Within the EU, the Directorate General for Health and Consumers works to promote product and food safety with other EU Institutions, national government and agencies, business groups, consumer and health groups, scientists, researchers, and experts.

Directorate General for Health and Consumers
http://ec.europa.eu/dgs/health_consumer/index_en.htm



Prosafe

www.prosafe.org
Within the product safety structure of the EU is a professional organization of safety enforcement authorities in Europe called PROSAFE. This group publishes a guide, Product Safety in Europe, that provides best practices for corrective actions that includes common guidelines for businesses in Europe.
Guide: http://ec.europa.eu/consumers/cons_safe/action_guide_en.pdf 
The Product Safety & Recall Directory
4579 Laclede Ave., #326
St. Louis, Missouri 63108
Telephone: 314-977-3617
Email: info@adkprg.com