CPSC Issues Important CPSIA Proposed Rule on Testing and Labeling

(1) reasonable testing programs for non-children’s products;

(2) compliance testing to support initial certification of children’s products²;

(3) continuing testing of children's products on a periodic basis and whenever a material change occurs; and

(4) certification labeling.

CPSC is proposing that any final rule become effective 180 days after its publication. Comments on the proposed rule are due August 3, 2010.

CPSC has also issued a related proposed rule on component testing. (See future issue of ITT for BP summary.)

NON-CHILDREN’S PRODUCTS

Under the CPSIA, domestic manufacturers (if the product is domestic) and importers (if the product is imported) of non-children’s products are required to issue a general conformity certificate for each product, based either on individual tests of the product or on a reasonable testing program (RTP), which certifies that the product complies with all applicable CPSC-enforced rules, bans, standards, or regulations (and list each such rule, ban, etc.)

Reasonable Testing Programs

The proposed rule would establish requirements for and define the elements of RTPs for non-children’s products as follows:

A. Need High Degree of Assurance Products Comply

A domestic manufacturer (or importer) certifying a product pursuant to an RTP would need to ensure that the program provides a “high degree of assurance” that the consumer products covered by the program will comply with all applicable rules, bans, standards, or regulations.

A high degree of assurance would mean an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.

B. RTPs Would Have 5 Elements

RTPs would be required to consist of the following five elements:

Product specification. It would have to include a description of the consumer product (including a photograph or illustration, model names or numbers, a detailed bill of materials, a parts listing, raw material selection, sourcing requirements, etc.); a list of all rules, bans, standards or regulations to which the product is subject; a list of any certified components; etc. Each manufacturing site would need a separate product specification.

Certification tests. A domestic manufacturer (or importer) would have to conduct certification tests on a product before issuing a general conformity certificate for that product. The tests must demonstrate that the product complies with all applicable safety rules, bans, etc. Certification tests would be performed on samples that are identical to the finished product in all material respects. A sufficient number of samples would have to be tested so as to provide a high degree of assurance that the tests accurately represent the product's compliance.

Previously certified products that undergo material changes would have to be retested, if that change affects the product’s ability to comply.

Production testing plan. A plan would be required that described the tests that must be performed and the frequency at which they must be performed to provide a high degree of assurance that the products manufactured after certification continue to meet all the applicable safety rules, bans, standards, or regulations. A production testing plan could include recurring testing or the use of process management techniques designed to control potential variations in product manufacturing.

Each manufacturing site would be required to have a separate production testing plan.

Remedial action plan. A plan would be required that describes the steps to be taken whenever samples of a product or a component part fails a test or fails to comply with an applicable rule, ban, standard, or regulation. Domestic manufacturers (or importers) would have to take remedial action (e.g. changes to the manufacturing process, reworking the product) after any failing test result to ensure with a high degree of assurance that the products manufactured after the remedial action had been taken comply.

Recordkeeping -- domestic manufacturers (or importers) of non-children's products would be required to maintain records of: (i) the general conformity certificate for each product; (ii) each product specification; (iii) each certification test, including how each applicable rule was evaluated and, if the domestic manufacturer/importer chose to have a third-party lab test the product, identification of that lab; (iv) records to demonstrate compliance with the production testing plan requirement; (v) records of all remedial actions taken, including the specific action and date taken, etc.

Records (except for test records) would have to be maintained for as long as the product is in production (or imported) by the domestic manufacturer (or importer), plus five years. Test records would have to be maintained for 5 years. All records would have to be available in English and maintained in the U.S. (See proposed rule for details.)

C. RTP Could Use Component Testing, If Certain Conditions Met

Under an RTP, a domestic manufacturer (or importer) of a non-children’s product would be able to substitute component part testing for finished product testing pursuant to proposed 16 CFR Part 1109 (the new proposed rule on component testing) unless the rule, ban, standard or regulation applicable to the product requires testing of the entire product.

If the domestic manufacturer/importer were to rely on certification testing of component parts (rather than tests of the finished product), they would have to demonstrate how the combination of testing of component parts, portions of the finished product, and finished product samples demonstrate, with a high degree of assurance, compliance with all applicable rules, bans, standards, or regulations.

D. Use of Third-Party Labs in RTPs Would be Optional

Domestic manufacturers (or importers) of non-children's product could use CPSC-recognized third-party conformity assessment bodies (third-party labs) to conduct certification under an RTP, but would not be required to do so.

E. Remedial Action and Retesting Would be Required if Any Test Fails

If any certification test were to result in a failure, a domestic manufacturer (or importer) would not be able to certify a product until remedial action were taken, and the product manufactured after the remedial action passes certification testing.

CHILDREN’S PRODUCTS

Under the CPSIA, domestic manufacturers (if the product is domestic) and importers (if the product is imported) of children’s products are required to issue a certificate, referred to as a “Children’s Product Certificate” based on testing of sufficient samples of the product by a third-party lab³, which certifies that the product complies with all applicable children’s product safety rules (and list each rule, ban, etc. to which the product is subject).

Initial Compliance Testing

The proposed rule lays out the requirements related to this “initial” compliance testing to support children’s product certification as follows:

A. Samples Must be Identical in All Material Respects to Product

Domestic manufacturers (or importers) would be required to submit a sufficient number of samples of a children's product, or samples that are identical in all material respects to the children's product, to a third party lab for testing to support certification.

B. Number of Samples Submitted Should Provide High Degree of Assurance

The number of samples submitted would have to provide a high degree of assurance of compliance. For example, if the manufacturing process tends to result in variability in the composition or quality of children's products, more samples may need to be tested to provide a high degree of assurance that the finished product complies.

C. Could Use Component Testing, If Condition Met

Except where otherwise specified by a children's product safety rule, a domestic manufacturer (or importer) would be able to substitute component part testing for complete product testing pursuant to proposed 16 CFR Part 1109 (the new proposed rule on component testing) if the component part, without the remainder of the finished product, is sufficient to determine compliance for the entire product.

(Note that the proposed rule on component testing has different language. It states that for both non-children’s and children’s products, component testing would be allowed if testing of the component is required or sufficient to assess compliance, in whole or in part, of the consumer product with the applicable rule, ban, standard, or regulation (with any doubts resolved in favor of testing the entire product). See future issue of ITT for BP summary of the component rule.)

D. Any Sample Failure Would Need to be Investigated Before Certification

If a product sample were to fail certification testing by a third-party lab, even if other samples have passed the same certification test, the domestic manufacturer (or importer) would be required to investigate the reasons for the failure and take remedial action. A domestic manufacturer (or importer) would not be able to certify the children's product until they establish with a high degree of assurance that the finished product complies with all applicable children's product safety rules, bans, etc. (See remedial action section below.)

Voluntary Use of Reasonable Testing Programs

Domestic manufacturers (and importers) of children's products would not be required to establish a five part reasonable testing program for certification of its children’s products (as described above for non-children’s products). However, as noted in the continued compliance section below, there would be certain advantages to creating such a program for children’s products.

Issue of: Retailers Using Children’s Product Certificates without Add’l Testing

The preamble of the proposed rule includes a statement to address that fact that some retailers of children’s products are requiring products that have already been tested by a third-party lab to be tested again by a specific lab. CPSC emphasizes that retailers and sellers of children's products can rely on certificates provided by importers and domestic manufacturers, as long as those certificates are based on testing by a third-party lab. CPSC adds that retailers will not be subject to civil and criminal penalties for doing so unless they know that the consumer product does not conform. (Note that these statements are not included in the regulatory text.)

Issue of: Importers Using Foreign Manufacturer Certificates

There is also language in the preamble stating that importers would be allowed to base their Children's Product Certificate on a certificate provided by a foreign manufacturer, as long as that manufacturer has based its certificate on testing by a third-party lab.

(Note that there is nothing in the regulatory text that would codify this statement and CPSC sources could not clarify it. Also note that the related proposed rule on component testing seeks comments on the possibility of allowing importer certificates to be based on “subordinate” certificates by foreign manufacturers certifying that the entire product complies. See future issue of ITT for BP summary of the component rule.)

Continued Compliance Testing

The CPSIA also requires children’s products that have undergone initial certification to undergo continued compliance testing both on a periodic basis and whenever there has been a material change. The proposed rule would establish protocols and standards for this continued compliance testing as follows:

A. Periodic Testing

Domestic manufacturers (and importers) of children’s products would be required to have periodic testing performed by a third-party lab to ensure that children's products manufactured after the initial certification is issued, or when the previous periodic testing was conducted, continue to comply with all applicable children's product safety rules.

Could be part of RTP or periodic test plan. Periodic testing could be conducted under a reasonable testing program voluntarily established by the domestic manufacturer (or importer) or conducted following the requirements laid out in the proposed rule for periodic test plans.

Periodic test plan. Domestic manufacturers (or importers) of children’s products that have not implemented a RTP would be required to develop a periodic testing plan, with a separate plan for each manufacturing site. The plan would include: (i) the tests to be conducted, the intervals at which the tests will be conducted, the number of samples tested, and the basis for determining that the periodic testing plan provides a high degree of assurance that the product being tested continues to comply; and (ii) determination of an appropriate testing interval which could vary depending on the children's product safety rule, the degree of variability in test results, whether results tend to be close to the limit, the potential for injury, etc.

No testing for low volumes. A domestic manufacturer (or importer) would not be subject to the periodic testing requirements until it produces 10,000 units of a product. Such testing would be annual without an RTP or biannual with one, and would not depend on how often the manufacturer produces or imports every 10,000 units of the product.

Random samples. Each domestic manufacturer (or importer) would be required to select random samples for periodic testing by using a process that assigns each sample in the production population an equal probability of being selected. (The production population is the number of products manufactured or imported after the initial certification or last periodic testing of a children's product.)

Frequency. Domestic manufacturers (or importers) of children’s products that have not implemented a RTP would be required to ensure at least annual periodic testing by a third-party lab. Those that have implemented a RTP would only be required to ensure periodic testing by a third-party lab at least once every two years.

B. Material Change Testing

Under the CPSIA, children's products must be tested for compliance with children's product safety rules when there has been a material change in the product's design or manufacturing process, including the sourcing of component parts.

Changes that could affect compliance. A material change would be a change in the product design or manufacturing process, including the sourcing of component parts, that a domestic manufacturer (or importer) exercising due care⁴ knows or should know could affect the product's ability to comply with applicable children's product safety rules.

Test material changes before certifying. If such a material change occurs, the domestic manufacturer (or importer) would be required to submit a sufficient number of samples of the materially changed product for testing by a third-party lab before they could certify the children's product.

The extent of such testing would depend on the nature of the material change. If a material change is limited to a component of the finished children's product and does not affect the ability of the product to comply with other children's product safety rules, a domestic manufacturer (or importer) could issue a certificate based on the earlier third-party certification tests and on test results of the changed component part conducted by a third-party lab. However, due care must be exercised to ensure that reliance on anything other than retesting of the finished product after a material change would not allow a noncompliant children's product to be distributed in commerce.

Remedial Action for Failing Test Results

Domestic manufacturers (or importers) of children’s products would be required to take remedial action after any failing test result (whether compliance, periodic, or material testing) in order to ensure, with a high degree of assurance, that all children's products manufactured after the remedial action was taken comply with the applicable rules.

A. Would Have to Take Remedial Action and Retest Before Certifying

If any children’s product certification test by a third-party lab were to result in a failure, the domestic manufacturer (or importer) would not be able to certify the product until they had taken remedial action and the children’s product manufactured after the remedial action passes certification testing.

B. Remedial Action Could Include Redesign, Sourcing Changes, Etc.

Each domestic manufacturer (or importer) would be required to have a remedial action plan that contains procedures they will follow to investigate and address failing test results. Remedial action could include, but would not be limited to, redesign, changes in the manufacturing process, or changes in component part sourcing. For existing production, remedial action may include rework, repair, or scrapping of the children's product.

Protection Against Undue Influence Over Labs

Domestic manufacturers (or importer) of children’s products would be required to establish procedures to safeguard against the exercise of undue influence on a third-party lab. Among other things, these procedures must include (partial list): a written policy statement from company officials that the exercise of undue influence is not acceptable, and directing that appropriate staff receive annual training on avoiding undue influence; a requirement to notify CPSC immediately of any attempt by the manufacturer/importer to hide or exert undue influence over test results; etc.

Recordkeeping

A domestic manufacturer (or importer) of a children's product subject to an applicable children's product safety rule would be required to maintain⁵ records of: (i) the children's product certificate for each product; (ii) each third party certification test (with separate certification tests records for each manufacturing site); (iii) the periodic test plan and periodic test results for a children's product; (iv) descriptions of all material changes in product design, manufacturing process, and sourcing of component parts, and the certification tests run and the test values; (v) the undue influence procedures, including training materials and training records; and (vi) all remedial actions taken following a failing test result.

Records (except for test records) would have to be maintained for as long as the product is in production (or imported) by the domestic manufacturer or importer, plus 5 years. Test records would have to be maintained for 5 years. All records would have to be available in English and maintained in the U.S. (See proposed rule for details.)

CPSC May Conduct Its Own Verification, Investigate Discrepancies

The proposed rule states that CPSC is not imposing any verification obligations on domestic manufacturers (and importers) of children’s products at this time because CPSC intends to conduct verification on its own inherent authority while it gains more experience with the testing and certification requirements. (Note that CPSC had included extensive verification requirements in the draft version of this rule.⁴)

However, if CPSC finds that a children's product accompanied by a certificate of conformity does not pass the tests upon which the certification was based, it may initiate an investigation of the domestic manufacturer, third-party lab, and any other relevant party in the supply chain, to determine the cause of the discrepancy.

NON-CHILDREN’S and CHILDREN’S PRODUCTS

Labeling for Certification Purposes

Domestic manufacturers and private labelers of a consumer product (whether for children’s products or non-children’s products) who have certified that their product complies with all CPSC-enforced rules, bans, standards or regulations applicable to the product would be able to indicate, by a uniform label on or provided with the product, that the product complies by labeling it: Meets CPSC Safety Requirements.

(See draft for details on the label size and format.)

Testing and Certification Stay Remains in Place for Certain Products/Rules

Note that in February 2009, CPSC issued a one-year stay of enforcement of much of the CPSIA-required testing and certification discussed in this proposed rule, which it later voted to extend for certain products and product safety rules. However, for some products/safety rules, the testing and certification stay was lifted on February 10, 2010; for others, it will be lifted upon notice by CPSC; and still for others, such as for lead content, it will be lifted on a specific date, such as February 10, 2011 for lead content.

Note that CPSC did not stay underlying product compliance and did not stay all CPSIA testing and certification. For example, pre-CPSIA testing and certification was never stayed; neither was testing and certification for the ban on lead in paint and similar surface coatings; full-size and non-full size crib and pacifier standards; the small parts standard; and the lead content of children’s metal jewelry.

(See ITT’s Online Archives or 12/29/09 and 02/06/09 news, 09122920 and 09020610, for BP summaries of CPSC’s decision to lift the stay in stages and its announcement of the original stay.)

Commissioner Comments on Testing & Labeling Proposed Rule

CPSC has also posted the statements of Chairman Tenenbaum and Commissioners Nord and Northup on this proposed rule. Though the rule was unanimously approved by all five Commissioners, Tenenbaum and Northup's statements are more supportive than Nord's. (See link to statements below.)

Related Component Testing Proposed Rule

CPSC has simultaneously issued a related proposed rule on the conditions and requirements for testing component parts of consumer products to demonstrate, in whole or in part, compliance of a finished consumer product with applicable CPSC rules, bans, standards, and regulations in order to support a General Conformity Certificate for non-children’s products, a Children’s Product Certificate, continued testing requirements for children’s products, etc. (See future issue of ITT for BP summary.)

¹CPSC often refers to this as its “15 month” rule since it was meant to be issued 15 months after enactment of the CPSIA -- or by November 2009.CPSC states that the proposed rule would implement Consumer Product Safety Act (CPSA) sections 14(a) and (d), as amended by section 102(b) of the CPSIA.

²”Children’s products” under the CPSIA are consumer products designed or intended primarily for children 12 years old or younger. In determining whether a consumer product is primarily intended for such children, the CPSIA outlines certain factors to be considered, including a statement by the manufacturer about the intended use of the product, whether the product is represented in its packaging as such a product, etc. (See ITT’s Online Archives or 04/20/10, 10042020, for BP summary of CPSC’s proposed rule on the CPSIA definition of children’s products.)

³The CPSC site for 3rd-party test lab information, including list of accredited third-party labs is available at http://www.cpsc.gov/about/cpsia/labaccred.html

⁴Due care would mean the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances.

⁵Under the draft, verification would have meant testing initiated by the manufacturer or importer to demonstrate that the test results from one third-party lab were consistent with the test results from another third-party lab for a particular children's product.

(See ITT’s Online Archives or 04/09/10 and 05/06/10 news, 10040905 and 10050672, for BP summaries of the draft version of the proposed rule and changes made to during a May 5, 2010 Commission meeting.)

CPSC contact -- Randy Butturini (301) 504-7562

CPSC proposed rule on testing and labeling (D/N CPSC-2010-0038, FR Pub 05/20/10) available at http://edocket.access.gpo.gov/2010/pdf/2010-11365.pdf

CPSC proposed rule on component testing (D/N CPSC-2010-0037, FR Pub 05/20/10) available at http://edocket.access.gpo.gov/2010/pdf/2010-11370.pdf

CPSC Commissioner statements available at http://www.cpsc.gov/pr/statements.html