US Product Registration

PHMSA Registration

Offerors and transporters of certain quantities and types of hazardous materials, including hazardous wastes, are required to file an annual registration statement with the U.S. Department of Transportation and to pay a fee (see Title 49 CFR Part 107, Subpart G (107.601 – 107.620). The fee provides funds for grants distributed to States and Indian tribes for hazardous materials emergency response planning and training and to certain professional organizations for training purposes. This program began in 1992 and is administered by the Associate Administrator for Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration (PHMSA).

Registrations are required for any person who offers for transportation or transports any shipment of any one of the following, by highway, rail, air, or water:

  • Radioactive materials (hazard class 7), in quantities exceeding thresholds that trigger highway route restrictions.
  • More than 25 kilograms of explosives (hazard divisions 1.1 – 1.3) by motor vehicle, rail, or freight container.
  • More than one liter per package of materials that PHMSA designates as extremely toxic by inhalation.
  • Hazardous materials in any package, container, or tank having a capacity of 3,500 gallons or more of liquid or gas, or more than 468 cubic feet of solid.
  • Any single class of hazardous materials, for which placarding is required, in any shipment of 5,000 pounds or more, except in bulk packaging.
  • Any hazardous materials in a quantity that requires placarding.

Source: https://phmsa.dot.gov/hazmat/outreach-training/registration-program

Pesticide Registration

The process of registering a pesticide is a scientific, legal, and administrative procedure through which we examine

  • the ingredients of the pesticide;
  • the particular site or crop where it is to be used;
  • the amount, frequency, and timing of its use; and
  • storage and disposal practices.

In evaluating a pesticide registration application, we assess a wide variety of potential human health and environmental effects associated with use of the product. The company that wants to produce the pesticide must provide data from studies  that comply with our testing guidelines.

We develop risk assessments that evaluate the potential for

  • Harm to humans, wildlife, fish, and plants, including endangered species and non-target organisms.
  • Contamination of surface water or ground water from leaching, runoff, and spray drift.

Potential human risks range from short-term toxicity to long-term effects such as cancer and reproductive system disorders.

We also evaluate and approve the language that appears on each pesticide label to ensure the directions for use and safety measures are appropriate to any potential risk. Following label directions is required by law and is necessary to ensure safe use.

Companies submit an application for a registration action, such as to register a new pesticide active ingredient, new product for an existing pesticide, or adding a new use to an existing product.

The company’s application typically includes:

  • Service fee(s) required by the Pesticide Registration Improvement Act (PRIA).
  • Forms describing the requested action.
  • The identity and quantity of all chemicals in the product.
  • Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable).
  • Proof that the product manufacturing process is reliable.
  • Labeling, including directions for use, contents, and appropriate warnings.
  • Evidence of meeting all legal and financial obligations.

We publish a notice of receipt in the Federal Register for each application for registration of a new product that contains a new pesticide active ingredient or that proposes a new use for an existing pesticide.

Applications are assigned to the appropriate pesticide division, where it is processed and tracked. A project manager is then assigned to: 

  • Complete a detailed review of the application
  • Assign and coordinate the appropriate scientific review
  • Implement priorities and timetable as set by PRIA
  • Coordinate administrative action
  • Communicate with applicant, otherwise known as the registrant, about the review

Source: https://www.epa.gov/pesticide-registration/about-pesticide-registration

FDA Registration and Listing

Animal and Veterinary

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.

Cosmetics

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

Drugs

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Food

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Medical Devices

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Radiation-Emitting Products

Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms industry is required to submit to FDA.

Tobacco Products

Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.

  • Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

FDA strongly encourages electronic submission. For electronic submission of such information, FDA utilizes the FDA Unified Registration and Listing System (FURLS)

Alternatively, you may use Form FDA 3741 for Establishment Registration and Product Listing. Persons with disabilities having problems accessing the above pdf file may call 1-877-CTP-1373 for assistance. 

Vaccines, Blood, Biologics

If you are an establishment that manufactures human cells, tissue, and cellular and tissue-based products (HCT/Ps), FDA regulations require you to register with the agency and list your HCT/Ps. “Manufacture” includes any or all steps involved in the recovery, processing, storage, labeling, packaging or distribution of HCT/Ps, and the screening or testing of the cell or tissue donor. See below for information on how to register with FDA:

FDA regulations require all blood establishments that collect, manufacture, prepare, store under controlled conditions for further distribution or process blood and blood products to register. See below for detailed information on blood establishment registration:

Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA. Domestic and foreign drug and biologics manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug and biologic products. This information helps the FDA maintain a catalog of all drugs and biologics in commercial distribution in the United States.