Update on CPSC Testing and Certification · PDF fileUpdate on CPSC Testing and ... Overview of...
Transcript of Update on CPSC Testing and Certification · PDF fileUpdate on CPSC Testing and ... Overview of...
ALSTON&BIRD LLP
Update on CPSC Testing and Certification Requirements
USA-ITA Webinar
March 19, 2013
Copyright © 2013 BJ Shannon All Rights Reserved
Preview
Overview of CPSIA
New rules Periodic testing of children’s
products
Draft amendments to testing and certification rule
Enforcement update
Q&A
CPSIA: An Overview
• Consumer Product
Safety Improvement
Act of 2008 - Amended the Consumer
Product Safety Act
- Amended by H.R. 2715
(2011)
• Response to: - Increasing recalls of unsafe
products
Especially toys from China
- Outdated statute
CPSIA: An Overview
• New substantive restrictions (e.g., lead, phthalates)
• New testing and certification requirements
- For all rules, bans, standards, and regulations enforced by CPSC
Not only for new substantive restrictions
Also for existing laws (e.g., Flammable Fabrics Act)
- General Conformity Certificate (GCC)/Children’s Product Certificate
(CPC) from the manufacturer (importer)
Based on a test of each product or a reasonable testing program
Testing of children’s products by CPSC accredited labs (third party testing)
• Tracking labels for children’s products
- Allow the ultimate purchaser to ascertain the manufacturer, date and
place of production, and cohort information
• Creation of the Publicly Available Consumer Product Safety
Information Database
Periodic Testing
• Governs reasonable testing of products for children age 12 or younger
- Initial certification
- Periodic testing
- Testing after material change
• Effective for all products manufactured after February 8, 2013
• 16 C.F.R. Part 1107
Initial Testing
• Test a sufficient number of samples to provide a high degree of assurance that the tests demonstrate that the products meets applicable rules
• Samples must be identical in all material respects
• Third party testing required
Initial Testing
• How many samples is sufficient?
- Will depend upon whether manufacturing process creates uniformity or variability of composition and quality
- High degree of assurance
Evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture
No quantifiable guidance
Flexibility to vary by industry, product, component part, manufacturer
Initial Testing
• If a sample fails, even if other samples pass, the manufacturer must investigate the reasons for the failure and take the necessary steps to address the reasons before the manufacturer can certify the product
- Unless specific regulations provide otherwise
Periodic Testing
• Third party testing
still required
• Select representative
samples - Document how number of
samples and sampling
procedure will provide a
basis for inferring
compliance of untested
products
- Test pursuant to a
Periodic Testing Plan
Periodic Testing
• Requirements for Periodic Testing Plans
- In writing
- Yield a high degree of assurance that products manufactured after issuance of a CPC and before the next periodic testing will be in compliance
- Specify
Tests to be conducted
Number of samples to be tested
Testing interval
Be specific to:
» The manufacturing site; and
» Each children’s product manufactured at that site
Periodic Testing
• Testing interval could be based on
- A fixed production interval
- A set number of units produced
- Another method chosen by the manufacturer based on the product and its manufacturing process
• But periodic testing must occur: - At least once per year
- Unless: Pursuant to a Production Testing
Plan (every 2 years)
Using a laboratory accredited to ISO/IEC 17025:2005(E): “General requirements for the competence of testing and calibration laboratories” (every 3 years)
Periodic Testing
• Factors for determining the testing interval
- Variability in test results
- Measurements close to thresholds
- Manufacturing processes that could affect compliance
Ex: Die that wears down over time
- Consumer complaints/warranty claims
- Introduction of new component parts
Periodic Testing
• Additional factors - Manufacture of a fixed
number of products
- Potential for serious injury/death resulting from noncompliance
- Volume of production
- Similarity to other children’s products with which the manufacturer is familiar and/or whether the product has many different component parts compared to other children’s products of a similar type
- Inability to determine noncompliance through visual inspection
Testing After Material Change
• Material change: A change in product design or manufacturing process, including the sourcing of component parts, which a manufacturer exercising due care knows, or should know, could affect the product’s ability to comply with applicable rules
- Due care: The degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances
Testing After Material Change
• Submit sufficient
samples to
reestablish the high
degree of assurance - Could be solely component
part testing
• Issue a new CPC
Additional Testing Requirements
• Safeguarding Against Undue Influence
- Written policy statement from company officials
- Training of appropriate staff
Signed statement attesting to participation in training
Required retraining if regulations change
- Must notify CPSC of any attempt to exercise undue influence
- Must instruct employees on confidential reporting to CPSC
Additional Testing Requirements
• Recordkeeping - Required records
Copy of CPC
Records of initial third party testing
» Site-specific
Periodic Testing Plan and test results
» Also production testing plan or ISO/IEC 17025:2005(E) records if applicable
Records documenting selection of representative samples and basis for inferring compliance
Material change records
Undue influence procedures and training records
Additional Testing Requirements
• Recordkeeping - Records retention
5 years from date of
creation
(Compare: 3 years for adult
products unless a specific
rule requires otherwise)
- Availability to CPSC
Electronic or hard copy
“Upon request”
» Translation of any non-
English records within 48
hours
Certification of Consumer Products
• Governs content,
form and availability
of GCCs and CPCs - For adult and children’s
products
• 16 C.F.R. Part 1110
• New: December 5,
2012 draft proposed
amendments
Availability of Certificates
• Accompany the shipment
• Be furnished to the retailer or distributor
• Currently no requirement to file certificate; must be available to CPSC
- When an imported product is available for inspection in the U.S.
- When a domestic product enters commerce
Content and Form of Certificates
• Current requirements - Identify the product
- Cite applicable rules
- Identify the manufacturer (importer) Name, mailing address, telephone
number
- Identify the individual maintaining records Name, mailing address, telephone
number, email
- Date and place of production Month and year
Country and city (unless manufacturer has two locations in same city)
- Date and place of testing Country and city
- Identification of third party labs
A New Certification Rule?
• Draft proposed rule released Dec. 5
• Vote scheduled for Jan. 16
- Postponed to complete Paperwork Reduction Act cost analysis
- In early Feb., CPSC said to expect action within “a few weeks”
• No substantive changes were expected . . .
• Public comment period after proposal
New Requirements: Availability
• Electronic filing of GCCs and CPCs
- With filing of CBP entry documents
- Mechanics of filing? CPSC is working with CBP
Also seeking industry input
Could be by document imaging or data elements (maybe even as part of 10+2 manifesting)
- Certificate must still be available immediately (within 24 hours) upon request by CPSC
• Who issues certificates - Foreign manufacturer or private
labeler for products directly received by consumers
- Private labeler of domestic products
New Requirements: Form/Content
• Attestation Requirement:
“I hereby certify that the finished product(s) or component part(s) covered by this certificate comply with the rules, bans, standards, and regulations stated herein, and that the information in this certificate is true and accurate to the best of my knowledge, information, and belief. I understand and acknowledge that it is a United States federal crime to knowingly and willfully make any materially false, fictitious, or fraudulent statements, representations, or omissions, on this certificate.”
New Requirements: Form/Content
• Designate as a finished product or component part certificate
- Most requirements also apply to component part certificates
• More detailed product identification
- Must include a model, style number, or other unique identifier and a description of the product UPC or GTIN optional
- Must describe the scope of products to which the certificate applies (e.g., start and end date, serial number range)
• Date of initial certification
• For electronic certificates not filed with CBP, “unique identifier” prominently displayed on the finished product, shipping carton, or invoice
New Requirements: Form/Content
• Additional contact information
- Factory’s street address
- Contact information (including email address) for all parties on whose testing the certificate depends
- Email address for manufacturer (importer)
- Street address of all testing labs
- Contact information for records custodian still required, but a link for electronic access to records is also permitted
New Requirements: Form/Content
• If a product is subject to more than one rule, and exempt from testing for some, but not all, rules, list all applicable regulations and state the exemption from testing
- Ex: A children’s product (not a toy) of untreated wood that is painted: CPC must list the lead in paint and lead content rules, and state the 16 C.F.R. 1500.91 exemption for lead content
- Ex: A child’s purse, made wholly of unadorned and untreated cotton fabric, exempt from testing under 16 C.F.R. 1500.91, need not be certified at all
- Ex: A children’s garment presumably must list testing exemptions for flammability and lead content
Enforcement Update
• CPSC is selecting imported products for inspection
• Certain product types may be targeted as inspection priorities
• For other products, avoid inspection triggers:
- Repetitive use of a foreign supplier that has been found in violation
- Incorrect manufacturer ID on entry documents
- Intellectual property issues
- Non-compliance with terms of a consent order
• Avoid inspection delays by: - Making certificates readily available
- Classifying products correctly
- Including detailed product information on invoices
- Ensuring third party labs are accredited
Enforcement Update
Enforcement Update
• CPSC anticipates that
electronic filing of
certificates as data
elements will help
target shipments for
inspection and track
accuracy of
certificates - Fewer inspections for low
risk shipments?
- Certificate errors no longer
just secondary offenses?
BJ Shannon
Alston & Bird LLP
950 F Street, N.W.
Washington, D.C. 20004
202 239 3344