CHCC seminar - 2012

Is BPA a contaminant in Polycarbonate made product?
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Contaminant Reporting Exception
Manufacturing Control Program
Must be in place at the time of manufacturing Must know the amount of reporting chemicals in its children’s products Must include methods and procedures required to comply with federal
Medical devices
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Who is required to report?
Manufacturers of children's products.
a) Manufacturer with a US presence b) US company that marketed the children's product under its
Unintended by-products of chemical reactions during manufacturing
Trace impurities in feed-stock Incompletely reacted chemical mixtures Degradation products.
The purpose of this rule is to implement the reporting requirements of Washington Children’s Safe Product Act (CSPA) (RCW 70.240). Adopted on Jul 21st, 2011. Became effective Aug 21st, 2011.
Toy steam engines Bicycles and tricycles Video toys that can be connected
to a video screen
Chemistry sets Dietary supplements Food and drugs approved by FDA
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Definition
• "Contaminant" means trace amounts of chemicals that are incidental to
manufacturing.
• • • • •
No intended function in the product component.
of the presence, use, and amount of reporting chemicals in its children’s product components
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When must manufacturers begin to report?
It requires manufacturers of children’s products to report if their products contain certain CHCCs.
Collect information to help government and the public better understand the presence of CHCCs in children’s products.
Other widely estandards program
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Contaminant Reporting Exception
Due Diligence may include:
Use and enforcement of contract specifications Procedures to ensure the quality / purity of feedstock Use and enforcement of contract specifications for manufacturing process
serves an intended function in the product component.
• "Practical quantification limit (PQL)" means the lowest concentration
that can be reliably measured within specified limits of precision, accuracy, representativeness, completeness, and comparability during routine laboratory operating conditions.
regulations
May include recognized industry best manufacturing practices such as: International Standards Organization (ISO) requirements American Society for Testing and Materials (ASTM) standards
Consumer electronics
Interactive software BB guns, pellet guns, and air rifles
（Snow) Sporting equipment Roller skates Model rockets Athletic shoes with cleats or spikes Pocket knives and multi-tools
• Cause cancer, genetic damage, or reproductive harm (CMR); • Disrupt the endocrine system (内分泌干扰物); • Damage the nervous system (神经系统), immune system (免疫系统), or
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Chemical of High Concern to Children (CHCC)
CHCC will include:
• Harm the normal development of a fetus or child or cause other
developmental toxicity;
• TDCPP (CAS # 13674-87-8) is proposed
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Scope
Children’s products
Toys Children’s Cosmetics
Children’s Jewelry Children’s Clothing (including shoes) Child car seats Products intended to help a child with sucking or teething, to
• CHCC is a contaminant in a product component must be reported if
above 100 ppm.
• Reporting is not required if the manufacturer had in place a manufacturing
facilitate sleep, relaxation, or the feeding of a child
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Excluded
Batteries Slings and catapults Sets of darts with metallic points
control program and exercised due diligence to minimize the presence of the contaminant in the component.
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Definition
• "Intentionally added chemical" means a chemical in a product that
Washington Children’s Safe Product Act Reporting Rule, Chapter 173-334-WAC (CHCC)
Intertek Testing Services Shanghai Ltd. Nov. 2012
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What is Chapter 173-334 WAC?
Larger
Medium
> 250 million but ≤ 1 billion
> 100 million but ≤ 250 million
Due dates from adoption date of rule, values are in months.
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What category is my company?
Base on the manufacturer’s annual aggregate gross sales in US (for filing federal taxes) (ALL products) Categories Largest annual aggregate gross sales (USD) > 1 billion
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What conditions must be reported?