Anyone doing business in the U.S. market should understand two key concepts: market access and market acceptance.
Market access includes governmental technical regulations and the conformity assessment measures that the government requires to demonstrate compliance with these technical regulations.
Market acceptance includes the private sector standards and conformity assessment measures that U.S. retailers and consumers expect products to meet. These measures typically go above and beyond market access requirements.
Step One
The first step for a company doing business in the United States is to know whether their product is subject to any U.S. regulation. If the product is regulated, the company needs to determine which technical regulations are applicable to its products. This includes U.S. federal regulations, as well as relevant state and local level regulations. If a product fails to meet a market access requirement, it could be denied access to the U.S., or the manufacturer could be fined, imprisoned, or face other penalties imposed by the government.
Using the online U.S. Code of Federal Regulations (CFR), companies can search all current federal-level regulations (including technical regulations) by keyword, subject, or regulatory agency.
Individual states or local authorities may have additional technical requirements that apply to specific products above and beyond the federal requirements outlined in the CFR. Companies can search these requirements on the official websites of the states in which they are doing business.
Step Two
The second step is to know what the government requires to demonstrate that a particular product or service has met the relevant technical regulations. Known as mandatory conformity assessment, these requirements vary by product and by regulatory agency, and are generally outlined in technical regulations. Mandatory conformity assessment requirements can range from suppliers declaration of conformity (often referred to as “self certification”) to mandatory third-party testing, inspection, or certification.
Step Three
The third step is to understand the private sector standards that products sold and
services provided in the U.S.
market are expected to meet. Private
sector standards are technically “voluntary” in that they are not enforced by
the U.S. government. However, failure to meet relevant
private sector standards could result in lawsuits, or in the unwillingness of U.S. consumers
and retailers to distribute, buy, or sell a product or service.
Step Four
The fourth
step is to know what conformity assessment measures (e.g. self declaration, testing,
inspection, certification, etc.) may be required to demonstrate compliance with
relevant private sector standards. These requirements can vary by product and by individual organizations purchasing a
product.
For many companies, the individual client, importer, or trading partner will be the primary source of
information on the market access and market acceptance requirements that should
be followed for a particular product in a particular circumstance.
U.S. trade associations can also provide valuable information on the requirements for the U.S. market.
Companies that are unable to find the information they need through www.StandardsPortal.org, or that require a higher degree of certainty may rely on a variety of other useful sources to provide information on the market access and market acceptance requirements in the U.S., including Trade Associations, your national enquiry point to the World Trade Organization (WTO), and independent consultants.