Mike Mattheisen/DC/USEPA/US 

02/28/2008 08:54 AM	

	To

	Sarah.Owen@nema.org

	cc

	Joseph Nash/DC/USEPA/US@EPA

	Subject

	Fw: Final rule on lead/lead components and children's product
[EPA-HQ-OPPT-2007-0487]

		

Ms. Owen, there is no exemption in the rule or regulations for
components that are "inaccessible" to children.  "consumer use" and
"intended for use by children" are defined in 40 CFR 710.43.  

In addition, below are answers that EPA recently gave to questions
submitted by another correspondent that provide some additional
clarification and guidance.  

1. Persons who must submit include importers of lead and lead compounds
that are in, or part of, articles that are consumer products intended
for use by children.  The phrase “intended for use by children” is
defined in 40 CFR 710.43. 

2. Health and safety studies concerning the lead and lead compounds in
articles that are consumer products intended for use by children are
among those studies that must be submitted. The types of studies that
are reportable are described at 40 CFR 716.21(a)(8)(i).  The phrase
“intended for use by children” is defined in 40 CFR 710.43

3. As a general matter, all known health and safety studies of the types
described at 40 CFR 716.21(a)(8)(i) must be reported, regardless of
their date.  However, analyzed aggregations of monitoring data are not
subject to reporting under this rule if they were based on monitoring
data acquired more than 5 years before a substance was listed under 40
CFR 716.120. 40 CFR 716.20(a)(7).  In addition, 40 CFR 716.25 provides
that persons subject to this rule are not required to search their
records for reportable information dated before January 1, 1977, unless
specifically required to do so in a rule.  Health and safety studies
dated before January 1, 1977, must nevertheless be reported if they are
known.

4. The rule only requires the reporting of unpublished health and safety
studies (defined in 40 CFR 716.3) that relate to any measurable lead
content in, or that assess children’s exposure (including
bioavailability) to lead from, consumer products intended for use by
children (except for children’s metal jewelry as described by the
Consumer Product Safety Commission in 72 FR 920 (Jan. 9, 2007)).  That
is, the amendment at 716.21(a)(8) is intended to limit reporting to only
two subsets of all possible unpublished health and safety studies. 
Whether or not “product content” data constituted a health and
safety study would depend on the extent to which the information met the
considerations in 716.3.  For example, a simple, isolated list of
ingredients or an isolated analysis of product content would not likely
be considered a health and safety study, whereas an analysis of product
ingredients coupled with an evaluation of hazard or human or
environmental exposure or risks would likely be considered a health and
safety study.  Regulations governing studies to be reported and studies
not subject to reporting are found at 40 CFR 716.10 and 40 CFR 716.20,
respectively.  

Mike Mattheisen

Acting Branch Chief

Chemical Information and Testing Branch

Chemical Control Division

US EPA Office of Pollution Prevention and Toxics

202-564-3077

----- Forwarded by Joseph Nash/DC/USEPA/US on 02/19/2008 11:53 AM -----

"Owen, Sarah" <Sarah.Owen@nema.org> 

02/19/2008 10:51 AM	

	To

	Joseph Nash/DC/USEPA/US@EPA

	cc

	"Kohorst, Mark" <Mar_Kohorst@nema.org>

	Subject

	Final rule on lead/lead components and children's product
[EPA-HQ-OPPT-2007-0487]

Mr. Nash,

 

Thank you for taking my phone call this morning. Per our conversation, I
am seeking guidance on the applicability of the final rule to
manufacturers of products which may be components of children’s
products, but in most cases are inaccessible. 

 

For example, would the rule/reporting requirements apply to
manufacturers of wire and cable (containing lead), which may be included
in toys or other children’s products, but which would not be directly
accessible to the child using such product? How would a “children’s
product” be defined – could it include something such as a desk lamp
which, if it used an incandescent light bulb, would contain lead solder?


 

Generally, the manufacturers the National Electrical Manufacturers
Association (NEMA) represents do not manufacture products intended
specifically for children, but it is unclear reading the rule whether
manufacturers of products such as those listed above would get drawn
into the rule’s requirements. Any clarification you can provide would
be most helpful.

 

Thank you for your consideration and attention to this.

 

Sarah

 

Sarah A. Owen

Manager, Government Relations

National Electrical Manufacturers Association

1300 North 17th Street, Suite 1752

Rosslyn, VA 22209

(703) 841-3245

www.nema.org

 

