Beveridge & Diamond
 

EPA Requires Manufacturers and Importers to Submit Studies on Cadmium in Consumer Products

Beveridge & Diamond, P.C., December 5, 2012

On December 3, 2012, EPA published a final rule requiring manufacturers (including importers) of cadmium or cadmium compounds, including as part of an article, that have been or are reasonably likely to be incorporated into consumer products to report unpublished health and safety studies under Toxic Substances Control Act (TSCA) section 8(d).[1]  In particular, any person that imports consumer products containing cadmium or cadmium compounds is subject to the rule.  The final rule becomes effective 30 days after publication, or January 2, 2013.  Reporting will be due 90 days after publication, or March 4, 2013.  The rule is part of a focus by EPA toward greater regulation of chemicals in articles.

EPA also plans to propose adding processors and distributors to this TSCA section 8(d) requirement through a later notice and comment rulemaking.

This is an immediate final rule with no opportunity for comment, since it was adopted using EPA’s section 8(d) model rule.[2]  However, information showing why the rule should be withdrawn may be submitted for 14 days after publication, or by December 17, 2012.  EPA may withdraw the reporting rule for good cause prior to the effective date.[3]

The rule is based on the addition of cadmium and cadmium compounds to the TSCA section 4(e) Priority Testing List by the Interagency Testing Committee in May 2012 and August 2011,[4] and on a 2010 petition to EPA and the Consumer Product Safety Commission (CPSC) to establish various rules regarding cadmium in children’s products.[5]  EPA and CPSC have expressed concerns regarding potential health effects of exposure to cadmium or cadmium compounds from consumer products, especially those used by or around children.  CPSC recently denied the portion of the petition requesting it to establish content limits for cadmium in children’s jewelry and toy jewelry, choosing instead to rely on two ASTM standards, including a mandatory cadmium content standard for children’s products.[6]

A number of aspects of EPA’s section 8(d) rule for cadmium are distinctly broad, particularly when compared to a narrower 2008 section 8(d) rule requiring submission of health and safety studies on lead and lead compounds in consumer products intended for children.[7]

Under the cadmium section 8(d) rule, any person manufacturing or importing any chemical, product, or article containing cadmium or cadmium compounds that have been or are reasonably likely to be incorporated into consumer products must submit to EPA health and safety studies known to or reasonably ascertainable by that person. A “consumer product” is defined in the rule to include “any product that is sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in or around residential areas.”  In contrast to the 2008 section 8(d) rule for lead, and despite EPA’s stated rationale focusing on potential health effects on children, the cadmium rule is not limited to consumer products intended for children.  The cadmium rule therefore reaches a far wider range of products, mixtures, and industry sectors.

Section 8(d) rules generally only apply to manufacturers in NAICS Codes 325 (chemical manufacturing and allied products) or 32411 (petroleum refineries).[8]  However, here EPA has applied this rule to all “persons that manufacture (including import) cadmium or cadmium compounds that have been, or are reasonably likely to be, incorporated into consumer products,” without regard to NAICS classification.  The rule thus extends to broad industry sectors including manufacturers of basic inorganic chemicals, inorganic dyes and pigments, basic organic chemical products, and primary and secondary smelters and refiners.

Under TSCA, an importer is considered a manufacturer.  This rule is unusual in its application to distributors and retailers that import consumer products containing cadmium or cadmium compounds.  The preamble notes that covered manufacturers (due to import) may include wholesalers of toy and hobby goods, discount department stores, and warehouse clubs and supercenters, among others.

The rule requires an adequate file search for any health and safety studies in the possession of an affected entity relating to cadmium or cadmium compounds and submission of those studies, unless exempted.[9]   With some exceptions,[10] copies of completed studies must be submitted, and any ongoing studies must be listed.[11]  The term “health and safety studies” is defined broadly.  It includes workplace exposure assessments, physical and chemical property assessments, and informal data gathering and reports, among others.[12]

This rule on cadmium and cadmium compounds in consumer products covers a broader range of studies than did the 2008 section 8(d) rule on lead and lead compounds in consumer products intended for children.  That rule only required submission of health and safety studies that related to the lead content of consumer products that are intended for use by children, or that assessed children’s exposure to lead from such products.  In the cadmium rule, EPA requires submission of any health and safety study on cadmium or cadmium compounds as provided in the model rule.  The preamble gives as examples of reportable health and safety studies those that:

  1. Relate to the cadmium content (either from cadmium or cadmium compounds) of consumer products (including the specific cadmium compound used in the products such as surface coatings and filler), data related to the product formulations, and function of the cadmium (e.g., stabilizer, colorant, etc.) in the products.
  2. Relate to the assessment of consumer exposure to cadmium from such products (including studies of bioavailability, description of the consumer use (e.g., paints used on plastics), physical form of the product containing cadmium, method of consumer product application (e.g., spray applied, etc.), number of potentially exposed consumers).
  3. Include data on cadmium migration from products (e.g., conducted using acid extraction or saline solution tests).
  4. Include bio-monitoring data on cadmium presence in tissues.
  5. Focus on route, duration, and frequency of exposure to cadmium in products.
  6.  Provide toxicity data on cadmium or cadmium compounds including in vitro, in vivo, epidemiological, computational, or other studies on effects of exposure to or use of the cadmium-containing product, material, or component.
  7. Discuss the function or use of cadmium or cadmium compounds in a product, material or component including typical concentration.
  8. Include data conducted in compliance with ASTM certification standards and studies focusing on the effects of the cadmium or cadmium compounds in consumer products on the health and safety of children.

The rule states with regard to purity that studies showing any measurable content of cadmium or cadmium compounds must be submitted.  The preamble notes that in particular that the rule applies to any study that shows “any measurable content of cadmium or cadmium compounds” in consumer products.

There is no de minimis amount or concentration of cadmium or cadmium compounds below which the section 8(d) rule would not apply.  Section 8(d) limits the scope of the rule to studies known to a person or “reasonably ascertainable by such person,” meaning that there is a knowledge threshold for the existence of unpublished health and safety studies.  There is no knowledge threshold specified for the presence of cadmium in imported products, however, potentially making the section 8(d) rule one of strict liability.  EPA has not fully explained when imported or manufactured cadmium or cadmium compounds are “reasonably likely to be incorporated into consumer products.”

The broad section 8(d) rule for cadmium and cadmium compounds continues a trend of increasing focus on studying and regulating chemicals in products.  Historically, EPA has usually exempted articles containing chemicals from otherwise applicable TSCA regulatory requirements.  EPA has recently issued a number of other rules without such exemptions, however, including proposed significant new use rules in March 2012 targeting polybrominated diphenyl ethers, hexabromocyclododecane, and certain benzidine-based chemicals, including when contained in articles.[13]  Regulation of chemicals in imported articles, in particular, poses challenges in the context of complex industry supply chains.

However, EPA has never included an exemption for chemicals in articles in the section 8(d) model rule.  In adopting the rule, EPA concluded that “the rule will not impose an excessive burden on the importers of articles,” noting that “most importers of articles do not have health and safety studies in their possession, nor do they normally conduct studies, so importers would have little to report.”[14]

For more information, please contact Mark N. Duvall, mduvall@bdlaw.com, 202-789-6090, or Alexandra M. Wyatt, awyatt@bdlaw.com, 202-789-6086.  For a PDF version of this alert, click here.


[1] EPA, Health and Safety Data Reporting: Addition of Certain Chemicals; Final Rule, 77 Fed. Reg. 71561 (Dec. 3, 2012), available at http://www.gpo.gov/fdsys/pkg/FR-2012-12-03/pdf/2012-28840.pdf.

[2] 40 C.F.R. § 716.105(b).

[3] 40 C.F.R. § 716.105(c).

[4] 77 Fed. Reg. 30855 (May 23, 2012); 76 Fed. Reg. 46173 (Aug. 1, 2011).

[5] EPA, Section 21 Petitions Filed with EPA Since September 2007: Cadmium in Consumer Products, Especially Toy Metal Jewelry, http://www.epa.gov/oppt/chemtest/pubs/petitions.html#petition7.

[6] See CPSC, Statement on the Commission’s Vote to Terminate the Petition to Regulate Cadmium Content (Oct. 3, 2012), available at http://www.cpsc.gov/pr/nord10032012.pdf.

[7] EPA, Health and Safety Data Reporting; Addition of Certain Chemicals, 73 Fed. Reg. 5109 (Jan. 29, 2008), available at http://www.gpo.gov/fdsys/pkg/FR-2008-01-29/pdf/E8-1546.pdf.

[8] 40 C.F.R. § 716.5(a).

[9] 40 C.F.R. § 716.25.

[10] 40 C.F.R. § 716.20.

[11] 40 C.F.R. §§ 716.30, 716.35.

[12] 40 C.F.R. § 716.3.

[13] See Beveridge & Diamond, P.C., “EPA Targets Articles Containing Action Plan Chemicals” (Mar. 21, 2012), http://www.bdlaw.com/news-1327.html.

[14] EPA, “General Comments on the Proposed Section 8(d) Rule” (n.d.), at 6.

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