Compliance Advisory: Manufacturers and Importers May Be Liable for Plumbing Products not Certified as “Lead Free”
Manufacturers and importers who introduce into commerce plumbing products that are not certified as “lead free” may be subject to enforcement and penalties under the Safe Drinking Water Act (SDWA). Compliance is important for reducing the public’s exposure to lead from plumbing products and thereby lowering the amount of lead entering drinking water. This compliance advisory outlines suggested steps for manufacturers and importers to ensure compliance.
I. Introducing Uncertified Plumbing Products into Commerce for Potable Use is Prohibited under the SDWA
Section 1417 of the SDWA and its federal regulations established under the 2014 Lead Free Rule prohibit any person from introducing pipes, fittings, and fixtures (“plumbing products”) into commerce for potable use in the United States unless the products are certified as “lead free.” The certification requirements became enforceable on September 1, 2023. Under the rule there are limited exemptions to the “lead free” and certification requirements.
Two key definitions within the rule are “lead free” and “potable uses.”
- Lead free means not more than a weighted average of 0.25 percent lead when used with respect to the wetted surfaces of pipes, pipe fittings, plumbing fittings, and fixtures.
- Potable uses means “services or applications that provide water for human ingestion, such as for drinking, cooking, food preparation, dishwashing, teeth brushing, or maintaining oral hygiene.”
II. Noncompliance is Costly
Failure to comply with the Lead Free Rule may result in enforcement action and civil penalties. As of December 27, 2023, a person may be liable for a maximum civil penalty of $69,733 for each noncompliant plumbing product a manufacturer or importer introduces into commerce. See Section V below regarding the EPA’s audit and self-disclosure policies.
III. How to Ensure Compliance
The EPA suggests that manufacturers and importers verify whether their plumbing products are regulated under the SDWA Section 1417 and the Lead Free Rule or if their products are listed as exempt from the “lead free” requirement or the certification requirement. If their plumbing products are regulated, manufacturers and importers must ensure and certify that their plumbing products meet the necessary requirements before they are introduced into commerce in the United States.
A. Check the List of Exemptions
1. "Lead Free” Requirement Exemptions
There are limited exemptions from the SDWA “lead free” requirements for products not used for potable uses and for specifically named product classes:
- Plumbing products for non-potable uses: Pipes, pipe fittings, plumbing fittings, or fixtures that are used exclusively for non-potable services such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption.
- Specifically named product classes: The full list of exempt products is contained in the Lead Free Rule and includes toilets, bidets, urinals, fill valves, fire hydrants, and shower valves.
2. Certification Exemptions
There are three exemptions from the certification requirement. Manufacturers and importers do not need to certify the following products:
- Individual product components of assembled pipes, fittings, or fixtures if the entire product in its final assembled form is certified.
- A replacement for a previously installed “lead free” certified product if the weighted average lead content of wetted surface for the replacement part does not exceed the lead content of the original part.
- Dishwashers.
B. Check the Certification Requirements
Certifications must demonstrate that, with some exceptions, any pipe, pipe fitting, plumbing fitting, or fixture introduced into commerce meets the definition of “lead free” pursuant to the NSF/American National Standards Institute (ANSI) 372 standard.
- Manufacturers with 10 or more employees, must demonstrate compliance by obtaining third-party certification by an ANSI accredited third-party certification body.
- Importers entering products purchased from or manufactured by manufacturers with 10 or more employees, must demonstrate compliance by obtaining third-party certification by an ANSI accredited third-party certification body.
- Manufacturers with fewer than 10 employees, must demonstrate compliance either through third-party certification by an ANSI accredited certification body or through self-certification.
- Importers entering products purchased from or manufactured by manufacturers with fewer than 10 employees, must demonstrate compliance either through third-party certification by an ANSI accredited certification body or through self-certification.
- Manufacturers of all sizes may certify custom fabricated products either through third-party certification by an ANSI accredited certification body or through self-certification.
- Importers entering goods manufactured by or purchased from entities of all sizes, may certify custom fabricated products either through third-party certification by an ANSI accredited certification body or through self-certification.
C. Check the Certification Recordkeeping Requirements
Manufacturers or importers must maintain documentation to substantiate the certification for at least 5 years from the date of the last sale of the product by the manufacturer or importer.
For all products certified by an accredited third-party certification body, the manufacturer or importer must maintain documentation to substantiate certification which includes, at a minimum:
- Documentation of certification,
- Dates of certification, and
- Date of certification expiration.
For all self-certified products, a manufacturer or importer must maintain, at a primary place of business within the United States, a certification (termed a “certificate of conformity”) and sufficient documentation to confirm that products meet the “lead free” requirements. Sufficient documentation may include:
- Detailed schematic drawings of the products (indicating dimensions);
- Records of calculations of the weighted average lead content of the product;
- Documentation of the lead content of materials used in the manufacture of the product; or
- Documentation used in verifying the lead content of a plumbing device.
IV. Threats from Lead to Public Health
The Centers for Disease Control and Prevention (CDC) states that “no safe blood lead level in children has been identified.” Children’s bodies absorb more lead, and their brains and nervous systems are more sensitive to its damaging effects. Low levels of lead exposure in children have been linked to damage of the central and peripheral nervous system, learning disabilities, shorter stature, impaired hearing, and impaired formation and function of blood cells. Lead exposure not only threatens the health of children. Lead exposure in adults has been linked to reproductive problems, decreased kidney function, and cardiovascular effects, such as increased blood pressure and incidence hypertension.
The United States has made tremendous progress in lowering childhood blood lead levels. However, lead can still be introduced into drinking water by corrosion of plumbing products and components of public water systems (PWSs) (pipes, pipe and plumbing fittings, and fixtures, solder, and flux). Ensuring compliance with Lead Free Rule requirements will help reduce the amount of lead entering drinking water and thereby reduce the exposure of children and the overall public to lead from plumbing products.
V. Benefits of the EPA’s Self-Disclosure Policies
Regulated entities of any size who voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. Most violations can be disclosed and processed through the EPA’s “eDisclosure Portal” on the agency’s website.
Information about the EPA’s violation disclosure policies, including conditions for eligibility, are available from EPA’s Audit Policy web page.
Many states also offer incentives for self-policing. Please check with your appropriate state agency for more information.
VI. For More Information
This Compliance Advisory focuses on the certification requirements of manufacturers and importers of plumbing products. There are additional requirements in the SDWA Section 1417 and the Lead Free Rule that apply to manufacturers, importers, wholesalers, distributers, re-sellers, retailers, and any person who uses these plumbing products in the installation or repair of a PWS or a residential or nonresidential facility providing water for human consumption.
For further information about the SDWA and the Lead Free Rule, please visit:
- Use of Lead Free Pipes, Fittings, Fixtures, Solder, and Flux for Drinking Water web page, EPA
- Basic Information on Lead in Drinking Water web page, EPA
- How to Identify Lead Free Certification Marks for Pipes, Fittings, Fixtures, Solder and Flux used for Drinking Water How to Identify Lead Free Certification Marks for Pipes, Fittings, Fixtures, Solder and Flux used for Drinking Water
- Federal Register notices and presentations from public meetings about prohibitions on use of lead pipes, solder, and flux EPA
- Lead Free final rule published in the Federal Register
- Questions and Answers About the Final Lead Free Rule, EPA
- Docket folder EPA-HQ-OW-2015-0680 containing supporting documents for the Lead Free final rule, Regulations.gov
- Code of Federal Regulations codification of the Lead Free Rule (40 C.F.R. §§ 143.10 - 143.20)
- Enforcement of Drinking Water Regulations (42 U.S.C. Section 300g-3)
Disclaimer: This compliance advisory addresses select provisions of the EPA regulatory requirements using plain language. Nothing in this advisory is meant to replace or revise any the EPA regulatory provisions or any other part of the Code of Federal Regulations, the Federal Register, or the SDWA. This advisory shall not be relied upon by any regulated entity in defense of or in response to any enforcement actions brought against the entity by the EPA or any local regulating agency.