The Consumer Product Safety Improvement Act Of 2008: New Product Safety Requirements May Create Pitfalls For Product Manufacturers By David G. Klaber1 and Jared S. Hawk2 [Editor’s Note: David G. Klaber is a partner in the Pittsburgh office of K&L Gates. His practice reflects his broad interest and experience in civil litigation and commercial arbitration, with particular emphasis in products liability, construction, commercial contracts and defamation. Mr. Klaber may be reached at (412) 355-6498 or dave.klaber@klgates.com. Jared S. Hawk is an associate in the Pittsburgh office of K&L Gates. His practice is concentrated in litigation in a number of different areas, including complex commercial litigation and products liability. Mr. Hawk may be reached at (412) 355-6348 or jared.hawk@klgates.com. Copyright 2009 by David G. Klaber and Jared S. Hawk, K&L Gates LLP.] Published in LexisNexis® Mealey's™ Personal Injury Report, Volume 5, Issue #16, February 23, 2009 I. Introduction In response to a number of highly-publicized product recalls and overall concerns regarding the safety of imported products, Congress passed the Consumer Product Safety Improvement Act of 2008 (“CPSIA” or the “Act”), which was signed into law by President Bush on August 14, 2008.3 The CPSIA significantly expands the authority of the Consumer Product Safety Commission (“CPSC”) and creates extensive obligations for manufacturers of consumer products. This article provides a summary of the relevant provisions of the CPSIA and explains how such provisions may impact product manufacturers.4 Because the CPSC has historically identified over 15,000 products as “consumer products,” from children’s toys to household items to power tools to recreational vehicles, the new CPSIA has the potential to directly affect thousands of manufacturers, distributors, importers, and retailers throughout the world. II. Highlights Of The CPSIA Expansion Of The Consumer Product Safety Commission The CPSIA represents the greatest expansion of the CPSC since it was first established by Congress in 1972. The Act nearly doubles the appropriations directed to the CPSC’s budget, from $63 million in 2007 to $118.2 million in 2010 to $136.4 million by 2014, and directs the CPSC to employ at least 500 full-time employees by October 1, 2013,5 an increase of 25% over pre-CPSIA levels. The Act permits the CPSC to operate under a twoCommissioner quorum for a period of one year after the CPSIA’s enactment, after which the CPSC will be restored to five Commissioners.6 The Act also provides procedures for expedited rulemaking under various product safety statutes by eliminating the requirement that the CPSC issue an advanced notice of proposed rulemaking.7 The Act permits the CPSC to share relevant information with federal, state, local, and foreign government agencies.8 Significant Expansion Of CPSC Enforcement Authority The CPSIA not only expanded the CPSC’s size, but it also drastically increased the enforcement mechanisms available to the agency. Perhaps most significantly, the Act increases the civil penalties for violations of the Consumer Product Safety Act (“CPSA”), the Flammable Fabrics Act, and the Federal Hazardous Substances Act from $5,000 to $100,000 for each violation and from a maximum of $1.825 million to $15 million for a related series of violations.9 The Act increases the criminal penalties by permitting imprisonment of up to five years, fines, and/or forfeiture of assets associated with a violation.10 Additionally, the Act removes the requirement that directors, officers, and agents must have knowledge of notice of noncompliance with a consumer product safety rule or regulation from the CPSC in order to be criminally liable.11 The Act expands the circumstances under which a consumer product manufacturer must notify the CPSC of a product hazard to include products that fail to comply with any rule, regulation, standard, ban, or statute enforced by the CPSC.12 The Act also expands the CPSC’s recall authority to permit it to order manufacturers to (i) cease distribution of a recalled product, (ii) notify all persons involved in the product distribution chain to cease distribution of a recalled product, (iii) notify appropriate state and local public health officials, and (iv) provide notice of the recall on the manufacturer’s website and/or third party websites where the product is sold and to provide such notice in languages other than English on radio and television as determined by the CPSC.13 The Act also eliminates the prior right of a party recalling a product to elect whether to offer a repair, replacement, or refund for recalled products and, instead, permits the CPSC to require a repair, replacement, and/or refund as it determines to be in the public interest.14 The Act further requires the CPSC to establish a rule containing guidelines for the content of recall notices.15 The Act provides state attorneys general with the ability to sue on behalf of the residents of their state to seek, with appropriate advance notice to the CPSC, injunctive relief for violations of the CPSIA and related laws.16 The Act also establishes whistleblower protections for employees of manufacturers, private labelers, distributors, or retailers who report violations, testify, or otherwise provide assistance in a consumer product safety enforcement proceeding or object to or refuse to participate in any activity that the employee reasonably believes to be in violation of a product safety rule or regulation.17 The Act decreases the time for manufacturers to claim confidential treatment of documents subject to Freedom of Information Act requests from 30 days to 15 days.18 The Act further requires the CPSC to submit to Congress a detailed plan for establishing and maintaining a searchable database on the safety of consumer products that will be accessible to the public through the CPSC’s website.19 The database, which must be available no later than 18 months after the CPSC submits its plan to Congress, is required by the Act to include the following information: (i) reports of harm relating to the use of consumer products that are received by the CPSC from consumers, government agencies, health care professionals, child service providers, and public safety entities; (ii) information relating to voluntary corrective actions taken by the product manufacturer; and (iii) comments provided by the product manufacturer in response to the reports noted above.20 Because the Act requires the CPSC to publish reports of harm relating to the use of consumer products in the database not later than the 10th business day after transmitting such reports to the manufacturer,21 manufacturers will have to adopt fast-track methods to investigate, evaluate, and respond to such reports. The Act also contains provisions that require the CPSC to correct or refuse to publish materially inaccurate information in reports that are to be published in the database or information that is already contained in the database, thereby making timely comments from a manufacturer that identify and correct inaccurate information incredibly important.22 Increased Regulation Of Children’s Products The CPSIA contains many new regulations that apply mainly to children’s products, which are defined by reference to the CPSA as “consumer product[s] designed or intended primarily for children 12 years of age or younger.”23 The CPSA states that: In determining whether a consumer product is primarily intended for a child 12 years of age or younger, the following factors shall be considered: (A) A statement by the manufacturer about the intended use of such product, including a label on such product if such statement is reasonable. (B) Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger. (C) Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger. (D) The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.24 The CPSIA also regulates children’s toys, which are defined as “consumer product[s] designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.”25 The CPSIA also regulates child care articles, which are defined as “consumer product[s] designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.”26 Reductions Of Lead Content In Children’s Products And Lead Paint Subject to certain exceptions and exemptions,27 the CPSIA requires the gradual reduction of the amount of lead in children’s products over a three-year period from 600 parts per million (“ppm”) total lead content by weight for any part of the product by February 10, 2009 to 300 ppm by August 14, 2009 and, if determined to be technologically feasible, to 100 ppm by August 14, 2011.28 The Act directs that any children’s product that contains more lead than the above-stated limits shall be treated as a banned hazardous substance under the Federal Hazardous Substances Act.29 In addition, the Act provides that lead in paint and similar surface-coating materials must be reduced from 600 ppm to 90 ppm by August 14, 2009.30 The effects of the CPSIA’s lead ban will be felt by manufacturers of countless products. For instance, unless they receive an exemption under the statute, bicycle manufacturers may not be able to sell children’s bicycles due to the lead content in tire valves, despite the fact that it is highly unlikely that children will ever come into contact with the lead on the tire valves.31 Prohibition On Phthalates In Children’s Toys And Child Care Articles Effective February 10, 2009, the CPSIA prohibits the manufacture, sale, distribution, or importation of any children’s toy or child care article that contains more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP).32 Further, concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP) are also temporarily prohibited in children’s toys that can be placed in a child’s mouth (i.e., toys that contain one dimension that is smaller than 5 centimeters) and child care articles.33 General Conformity Certificates For Consumer Products The CPSIA also mandates that all products subject to a consumer product safety rule must include a general conformity certification that states that, based on a test of each product or a reasonable testing program, the product complies with all rules, bans, standards, or regulations applicable to the product under the CPSIA or any other act enforced by the CPSC.34 This general conformity certification requirement, which became effective on November 12, 2008, is not limited to children’s products but, instead, applies to all “product[s] which [are] subject to a consumer product safety rule under [the CPSIA] or similar rule, ban, standard, or regulation under any other Act enforced by the [CPSC].”35 Mandatory Third Party Testing Of Children’s Products The Act also requires manufacturers to submit samples of children’s products that are subject to a children’s product safety rule to an accredited third party laboratory to be tested for compliance with relevant children’s product safety rules. In order for the product to be sold, the manufacturer must issue a certificate that certifies that the children’s product complies with the relevant rules based on the assessment of the third party laboratory.36 The third party testing requirements of the CPSIA apply to any children’s products manufactured more than 90 days after the CPSC has established and published notice of the requirements for accreditation of third party laboratories for various types of children’s products.37 The Act provides a timeline in which the CPSC must publish notice of the requirements for accreditation of the third party laboratories.38 For instance, the CPSC published the accreditation procedure for lead paint on September 22, 2008.39 Therefore, third party testing for lead paint is required for children’s products manufactured on or after December 22, 2008. Tracking Labels For Children’s Products The CPSIA also dictates that after August 14, 2009, manufacturers of children’s products must place permanent, distinguishing tracking labels on each children’s product and its packaging that will (i) enable the manufacturer to ascertain the location and date of production of the product, cohort information (batch number, run number, etc.), and any other information determined by the manufacturer to facilitate ascertaining the specific source of the product and (ii) enable the ultimate purchaser to ascertain the manufacturer or private labeler, location and date of production of the product, and cohort information.40 Standards And Consumer Registration Of Durable Infant / Toddler Products The Act requires the CPSC to promulgate mandatory consumer product safety standards for twelve categories of durable infant or toddler products by August 14, 2009 and every six months thereafter until complete.41 The CPSIA defines durable infant or toddler product as “a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years [and] includes—(A) full-size cribs and nonfull-size cribs; (B) toddler beds; (C) high chairs, booster chairs, and hook-on chairs; (D) bath seats; (E) gates and other enclosures for confining a child; (F) play yards; (G) stationary activity centers; (H) infant carriers; (I) strollers; (J) walkers; (K) swings; and (L) bassinets and cradles.”42 Additionally, by August 14, 2009, the CPSC must promulgate a final consumer product safety rule requiring each manufacturer of a durable infant or toddler product to provide consumers with a postage-paid consumer registration form with each such product and to maintain a record of customer contact information for each registered product for at least six years, which shall be used to contact registrants only in the event of a product recall or safety alert.43 Labeling Requirement For Advertising Toys And Games The CPSIA also expands the warning requirements regarding choking hazards for children’s toys and games. Under the Act, the warnings required by the Federal Hazardous Substances Act must now be included in all Internet websites by December 12, 2008 and in all catalogs and printed materials by February 10, 2009 if those mediums provide a direct means for the purchase or order of the product for which a warning is required.44 Mandatory Toy Safety Standards The Act provides for the adoption of the previously voluntary ASTM International Standard F963-07 Consumer Safety Specifications for Toy Safety (“ASTM F963”) as a mandatory consumer product safety rule issued by the CPSC on February 10, 2009.45 By August 14, 2009, the CPSC is required to consult with representatives of consumer groups, product manufacturers, and independent child product engineers and experts in order to assess the effectiveness of ASTM F963.46 Within one year of completing its assessment, the CPSC is required to promulgate its own rules regarding toy safety.47 III. Impact On Product Manufacturers Increased scrutiny from the newly-expanded CPSC and recently-authorized state attorneys general, coupled with the extensive expansion of regulations related to consumer and children’s products under the CPSIA, will likely lead to increased enforcement actions and product recalls as well as significant civil and criminal penalties for manufacturers who do not comply with the dictates of the CPSIA or other consumer product safety rules or regulations. These significant changes to the product safety landscape will require considerable planning and action on the part of product manufacturers to ensure compliance. First and foremost, a product manufacturer should establish an internal environment devoted to product safety by implementing safety- focused design and manufacturing processes and instituting effective quality controls. Such an environment may incorporate standard testing procedures, complete recordkeeping and labeling practices regarding the design, manufacture, and distribution of all products, and straightforward product warnings and instructions to the ultimate consumer. A product manufacturer may also consider establishing a multi-disciplinary product safety/product recall team that consists of the following individuals: product manager, chief engineer, quality control manager, public relations officer, and attorney. Such a safety team can implement and/or review product safety evaluation procedures, product recall plans, and procedures for review of potential product safety concerns. Such a team may also meet regularly to review public and internal data regarding product safety issues and to develop criteria for reporting, recalling, and complying with other obligations under the CPSIA. Because the CPSC tends to aggressively second-guess manufacturers regarding reporting requirements, any company that collects data on incidents and product failure without analysis for reportability may be taking an unnecessary risk. If a potential product recall is indicated, the team discussed above may be called upon to evaluate the need for a recall in conjunction with management, and, if a recall is required, to implement such a recall in conjunction with the requisite governmental agency, if any. If a product recall is required, a separate cost account should be considered and used exclusively for the tracking of all direct costs related to the recall. In addition, all actions taken in conjunction with the recall, such as notices sent to suppliers, customers, users, and government agencies, and responses thereto, should be memorialized in writing to eliminate confusion in potential third-party claims for reimbursement, inquiries from government agencies, and product liability claims by users and their families. Moreover, any applicable insurance coverage should be determined and any carriers should be put on notice of suitable claims. A manufacturer may also wish to review its current purchase agreements and, where appropriate, seek provisions in new purchase agreements with suppliers so that they (i) comply with the relevant product safety rules, (ii) conduct regular testing of their products, (iii) identify their responsibilities with regard to reporting and recalls, (iv) agree to indemnify the manufacturer in the event of a violation of a product safety rule or a recall, and (v) name the manufacturer as an additional insured in the supplier’s insurance policies. Further, a manufacturer may also wish to consider or revisit standard operating procedures to ensure compliance with relevant product safety rules, both internally and for its suppliers. Whenever appropriate, a manufacturer may wish to retain a third party laboratory accredited by the CPSC in accordance with the CPSIA and establish a standard testing program for its products. To the extent that it has not already done so, a manufacturer should also evaluate possible product liability and product recall insurance policies to ensure that it is adequately protected against the increased liability that it will likely face as a result of the CPSIA. With regard to the searchable product safety database discussed in Section II above, a manufacturer may wish to develop internal procedures to allow, as necessary, for prompt monitoring, investigation, and response to product complaints. As always, care should be given to the accuracy of information reported to the CPSC and/or published in the proposed database to avoid misperceptions later if the safety of the company’s products is falsely called into question. Once the CPSC has developed its policies to ensure accuracy in the database, and to permit necessary corrections to the database, a manufacturer must take full advantage of the openings offered by the CPSC regarding correction of inaccurate information; otherwise, a manufacturer runs the risk of global misinformation as to the quality of its products. IV. Conclusion The CPSIA presents many new and challenging issues for product manufacturers. Because the CPSIA has tasked the CPSC with significant rulemaking duties, many of which will take effect over the next several years, a manufacturer must constantly monitor the CPSC’s activities to ensure that it is in compliance with the new rules and regulations that may affect its products. By instituting a top-to-bottom culture of safety that embraces all aspects of product design, manufacture, sale, and distribution, a manufacturer will be ahead of the curve in complying with the mandates of the CPSIA and, at the same time, providing safe and reliable products to the individuals that the CPSC has been charged with protecting. Endnotes 1. Partner, K&L Gates LLP. dave.klaber@klgates.com. Mr. Klaber may be reached at 412-355-6498 or 2. Associate, K&L Gates LLP. jared.hawk@klgates.com. 3. Consumer Product Safety Improvement Act of 2008, Pub. L. No. 110-314, 122 Stat. 3016 [hereinafter CPSIA]. 4. This article provides a summary of the highlights of the CPSIA and is not intended to be, and should not be read as, a comprehensive discussion of all of the provisions of the CPSIA. A manufacturer should review the CPSIA in its entirety to determine which provisions may apply to it products. Additionally, this article is for informational purposes only and does not contain or convey legal advice. The information contained herein should not be used or relied upon in regard to any particular facts or circumstances without first consulting an attorney. Any specific questions may be addressed to the authors for their consideration. 5. CPSIA § 201(a), 122 Stat. 3038-39 (to be codified at 15 U.S.C. § 2081) Shepardize; CPSIA § 202(c)(1), 122 Stat. 3039-40 (to be codified at 15 U.S.C. § 2053). Shepardize 6. CPSIA § 202, 122 Stat. 3039-40 (to be codified at 15 U.S.C. § 2053). Shepardize 7. CPSIA § 204, 122 Stat. 3040-43 (to be codified at 15 U.S.C. §§ 2054 Shepardize(a)(3), 2058). 8. CPSIA § 207, 122 Stat. 3044-46 (to be codified at 15 U.S.C. § 2078). Shepardize Mr. Hawk may be reached at 412-355-6348 or 9. CPSIA § 217(a), 122 Stat. 3058 (to be codified at 15 U.S.C. §§ 1194 Shepardize(e)(1), 1264(c)(1), 2069(a)(1)). The increases to the civil penalties noted above will take effect on the date on which the CPSC issues a final regulation providing its interpretation of penalty factors or August 14, 2009, whichever is earlier. CPSIA § 217(a)(4), 122 Stat. 3058 (to be codified at 15 U.S.C. § 1194). Shepardize 10. CPSIA § 217(c)(1), 122 Stat. 3060 (to be codified at 15 U.S.C. §§ 1196 Shepardize, 1264(a), 2070(a)); CPSIA § 217(d), 122 Stat. 3060 (to be codified at 15 U.S.C. § 2070 Shepardize(b)). 11. CPSIA § 217(c)(2), 122 Stat. 3060 (to be codified at 15 U.S.C. § 2070). Shepardize 12. CPSIA § 214(a)(1)-(2), 122 Stat. 3052-53 (to be codified at 15 U.S.C. § 2064). Shepardize 13. CPSIA § 214(a)(3)(D)-(E), 122 Stat. 3053 (to be codified at 15 U.S.C. § 2064). Shepardize 14. CPSIA § 214(b), 122 Stat. 3054-55 (to be codified at 15 U.S.C. § 2064 Shepardize(d)). 15. CPSIA § 214(c), 122 Stat. 3055 (to be codified at 15 U.S.C. § 3064). Shepardize 16. CPSIA § 218, 122 Stat. 3060-62 (to be codified at 15 U.S.C. §§ 1477 Shepardize, 2073). Depending upon the political agenda of the particular state attorneys general, this provision could prove to be significant. 17. CPSIA § 219, 122 Stat. 3062-65 (to be codified at 15 U.S.C. § 2087). Shepardize 18. CPSIA § 211, 122 Stat. 3047-48 (to be codified at 15 U.S.C. § 2055). Shepardize 19. CPSIA § 212(a), 122 Stat. 3048-52 (to be codified at 15 U.S.C. § 2055 Shepardize(a)). 20. Id. 21. Id. 22. Id. 23. Consumer Product Safety Act, § 3(a)(2), 15 U.S.C. § 2052 Shepardize(a)(2) (2006). 24. Id. 25. CPSIA § 108(e)(1)(B), 122 Stat. 3038 (to be codified at 15 U.S.C. § 2057 Shepardize(c)). 26. CPSIA § 108(e)(1)(C), 122 Stat. 3038 (to be codified at 15 U.S.C. § 2057 Shepardize(c)). 27. See, e.g., Children’s Products Containing Lead; Exemptions for Certain Electronic Devices; Interim Final Rule, 74 Fed. Reg. 6,990 (Feb. 12, 2009) (example of exemption for certain electronic devices). 28. CPSIA §§ 101(a)(2)(A)-(C), 122 Stat. 3017-18 (to be codified at 15 U.S.C. § 1278 Shepardize(a)). 29. CPSIA § 101(a)(1), 122 Stat. 3017 (to be codified at 15 U.S.C. § 1278 Shepardize(a)). 30. CPSIA § 101(f), 122 Stat. 3020-21 (to be codified at 15 U.S.C. § 1278 Shepardize(a)). 31. Lindsey Layton & Annys Shin, Toy Makers Assail Costs of New Law, WASHINGTON POST, December 21, 2008, at A03, available at http://www.washingtonpost.com/wpdyn/content/article/2008/12/20/AR2008122001878.html. 32. CPSIA § 108(a), 122 Stat. 3036 (to be codified at 15 U.S.C. § 2057 Shepardize(c)). On February 5, 2009, the United States District Court for the Southern District of New York overturned the General Counsel of the CPSC’s November 17, 2008 advisory opinion that the phthalate prohibitions apply only to children’s toys and child care articles manufactured after February 10, 2009. See Natural Resources Defense Council, Inc. v. U.S. Consumer Product Safety Commission, No. 08-cv-10507-PGG, 2009 U.S. Dist. LEXIS 8265 Shepardize (S.D.N.Y. February 5, 2009). As a result, effective February 10, 2009, the CPSIA’s phthalate prohibitions apply to existing inventory as well as to products manufactured after that date. 33. CPSIA § 108(b)(1), 122 Stat. 3036-37 (to be codified at 15 U.S.C. § 2057 Shepardize(c)). 34. CPSIA § 102(a)(1), 122 Stat. 3022 (to be codified at 15 U.S.C. § 2063 Shepardize(a)). 35. Id. 36. CPSIA § 102(a)(2), 122 Stat. 3022-24 (to be codified at 15 U.S.C. § 2063 Shepardize(a)(2)). 37. Id. 38. Id. 39. Third Party Testing for Certain Children’s Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies To Assess Conformity With Part 1303 of Title 16, Code of Federal Regulations, 73 Fed. Reg. 54,564 (Sept. 22, 2008). 40. CPSIA § 103(a), 122 Stat. 3028 (to be codified at 15 U.S.C. §§ 3063 Shepardize(a), 3063(c)). 41. CPSIA § 104(b), 122 Stat. 3028-31 (to be codified at 15 U.S.C. § 2056 Shepardize(a)). 42. CPSIA § 104(f), 122 Stat. 3031 (to be codified at 15 U.S.C. § 2056 Shepardize(a)). 43. CPSIA § 104(d), 122 Stat. 3029 (to be codified at 15 U.S.C. § 2056 Shepardize(a)). 44. CPSIA § 105, 122 Stat. 3031-33 (to be codified at 15 U.S.C. § 1278). Shepardize 45. CPSIA § 106(a), 122 Stat. 3033 (to be codified at 15 U.S.C. § 2056 Shepardize(b)). 46. CPSIA § 106(b)(1), 122 Stat. 3033 (to be codified at 15 U.S.C. § 2056 Shepardize(b)). 47. CPSIA § 106(b)(2), 122 Stat. 3033 (to be codified at 15 U.S.C. § 2056 Shepardize(b)).