Details of CPSC's "15 Month" Draft Proposed Rule on CPSIA Testing and Labeling

CPSC posted the draft in advance of its April 15, 2010 Commission meeting to discuss the draft. A Commission vote on the draft is currently scheduled for April 21, 2010.

Draft Covers Many Important Aspects of the CPSIA

As the proposed rule would codify Consumer Product Safety Act (CPSA) section 14(a) and (d), as amended by section 102(b) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), it would cover many of the most important aspects of the CPSIA.

It would also propose certain requirements that may surprise the trade, including CPSC's interpretation that verification would be testing initiated by the manufacturer or importer and conducted by an alternate third-party lab to ensure that the original third-party test results were correct; that each manufacturing site would be required to have separate periodic test plans; the extensive recordkeeping requirements; etc.

Reasonable Testing Programs for Non-Children's Products

Under the CPSIA, domestic manufacturers and importers of non-children's products are required to issue general conformity certificates, based either on individual product tests or on a reasonable testing program, which certify that the product complies with all CPSC-enforced rules, bans, standards, or regulations applicable to it (and lists each such rule, ban, etc.)

The draft proposed rule would establish requirements for and define the elements of reasonable testing programs for non-children's products as follows:

A. Need High Degree of Assurance that Products Comply

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

B. Elements of Reasonable Testing Programs

Reasonable testing programs (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.

Certification tests. A 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 submitted for testing so as to provide a high degree of assurance that the tests accurately represent the product's compliance. Previously certified products that undergo certain material changes would have to be retested.

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 regardless of whether the product is identical in all material respects to that manufactured at each site.

Remedial action plan. A plan would be required that described 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. 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 all products manufactured after the remedial action has been taken comply.

Recordkeeping - manufacturers (or importers) of non-children's products would be required to maintain³ records of: (i) the general conformity certificate for each product; (ii) each product specification; (iii) each certification test and, if the manufacturer elected to have a CPSC-recognized third party conformity assessment body (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.

C. RTP Could Rely on Component Testing, If Certain Conditions Met

A manufacturer (or importer) would be able to substitute component part testing for finished product testing of a non-children's product under a reasonable testing program unless the rule, ban, standard or regulation applicable to the product requires testing of the entire product.

If the 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.

(Note that CPSC has posted a separate draft proposed rule on component part testing. See future issue of ITT for BP summary.)

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

Manufacturers (or importers) of non-children's product could use third-party labs to conduct certification under a reasonable testing program, 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 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.

Third-Party Testing for Children's Products

Under the CPSIA, domestic manufacturers and importers of children's products are required to issue a certificate, based on testing of samples of the product by a third-party lab, which certifies that the product complies with all applicable children's product safety rules (and lists each rule, ban, etc. to which the product is subject). The draft would lay out requirements related to this certification testing as follows:

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

Manufacturers (including 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 submitted to provide a high degree of assurance that the finished product complies.

C. Component Tests Allowed If Part Determines Entire Product's Compliance

Except where otherwise specified by a children's product safety rule, ban, etc. a manufacturer (or importer) could substitute component part testing for complete product testing if the component part, without the remainder of the finished product, were sufficient to determine compliance for the entire product. (Note that CPSC has posted a separate draft proposed rule on component part testing. See future issue of ITT for BP summary.)

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 manufacturer (or importer) would be required to investigate the reasons for the failure and take remedial action. A 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.)

E. Reasonable Testing Program Would be Voluntarily, Have Certain Benefits

Manufacturers (and importers) of children's products would not be required to establish a five part reasonable testing program for certification of 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.

Continued Compliance Testing for Children's Products

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 draft proposed rule would establish protocols and standards for this continued compliance testing as follows:

A. Periodic Compliance Testing

Manufacturers (and importers) of children's products would be required to periodically submit their products to a third-party lab for testing to ensure that children's products manufactured after the issuance of a children's product certification, or when the previous periodic testing was conducted, continue to comply with all applicable children's product safety rules.

Could be conducted as part of RTP or separately. Periodic testing could be conducted under a reasonable testing program voluntarily established by the manufacturer or importer or, in the absence of such a program, in the following manner:

Would need periodic test plan. Manufacturers (or importers) of children's products that have not implemented a reasonable testing program would be required to develop a periodic testing plan, with a separate plan for each manufacturing site.

The plan would have to 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.

Testing would be annual. Manufacturers (or importers) of children's products that have not implemented a reasonable testing program would be required to ensure at least annual periodic testing by a third-party lab.

Less testing if have reasonable testing program. Manufacturers (or importers) that have implemented a reasonable testing program for their children's products would be able to conduct periodic testing on a less frequent basis.

No testing for low volumes. A manufacturer (or importer) would not be required to conduct periodic testing until it produces 10,000 units of a product after the time a third-party lab tested the children's product for certification purposes or conducted periodic testing.

Samples would have to be selected randomly. Each 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.)

B. Material Change Compliance 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.

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

Would have to test material changes before certifying. If such a material change occurs, the 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.

Extent of testing. 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 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.

Verification Testing for Children's Products

The CPSIA requires verification that a children's product tested by a third-party lab complies with applicable children's product safety rules. The draft proposed rule would establish protocols and standards for this verification.

A. Children's Products Would be Sent to Another Lab for Verification Testing

Verification would mean testing that demonstrates that the test results from one third- party lab are consistent with the test results from another third-party lab for a particular children's product. Therefore, a manufacturer (or importer) would be required to send samples of a previously certified children's product or a children's product that has been subject to periodic testing to another third-party lab for verification.

B. Manufacturer/Importer Would be Responsible

Under the draft final, a manufacturer (or importer) would be responsible for verifying that the children's product, as tested by a third-party lab, complies with applicable children's product safety rules. (Note that many in the trade had previously interpreted verification as a process that would be conducted by CPSC, not the manufacturer or importer.)

C. Verification Testing Would be Recurring

Verification testing would occur on a recurring basis and be conducted at a frequent enough interval to provide a high degree of assurance that the children's product that had been certified previously continues to comply with the applicable children's product safety rules or that the periodic test for the children's product was performed correctly. Verification would not have to occur at the same time for all applicable children's product safety rules or be performed by the same alternate third-party lab.

D. Periodic Tests Could Support Verification Test if Alternate Lab Used

It is important to note that under the draft proposed rule, a manufacturer (or importer) could use periodic test results to support verification if an alternate third-party lab conducted the periodic test.

E. If Product Fails, Would Have to Investigate & Notify CPSC if Lab Erred

If the verifying third-party lab finds that a children's product fails a children's product safety standard, ban, etc., the manufacturer (or importer) would be required to investigate the cause(s) for the failure. If, after conducting its investigation, the manufacturer/importer concludes that a third-party lab (whether the one that conducted the initial certification tests, the one that conducted the periodic tests, or the one that conducted the verification tests) was in error, the manufacturer (or importer) would be required to notify CPSC.

Remedial Action for Failing Children's Products

Manufacturers (or importers) of children's products would be required to take remedial action after any failing test result (whether compliance, periodic, or verification 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 CPSC-recognized third-party lab were to result in a failure, the 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 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 can include, is not 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 Lab for Children's Products

Each manufacturer (or importer) of a children's product would be required to establish procedures to safeguard against the exercise of undue influence by a manufacturer/importer 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 to hide or exert undue influence over test results; etc.

Recordkeeping for Children's Products

A manufacturer (or importer) of a children's product subject to an applicable children's product safety rule, ban, standard, etc. would be required to maintain³ 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) results of third-party verification tests; (vi) the undue influence procedures, including training materials and training records; and (vii) all remedial actions taken following a failing test result.

Labeling for Certification Purposes (Non-Children's and Children's)

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.)

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.

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 03/22/10, 10032215, for BP summary of CPSC's draft proposed rule on the CPSIA definition of children's products.)

³Records (except for test records) would have to be maintained for as long as the product is being distributed in commerce plus 3 years. Test records would have to be maintained for 3 years. All records would have to be available in English.

(See ITT's Online Archives or 04/05/10 news, 10040510, for BP summary of CPSC posting this and other draft proposed rules to its website.)

CPSC ballot vote sheet and draft proposed rule (posted 04/02/10) available at http://www.cpsc.gov/library/foia/foia10/brief/prodcert1.pdf

CPSC briefing package prepared for the Commissioners available at http://www.cpsc.gov/library/foia/foia10/brief/prodcert2.pdf