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Chemicals of
Concern are chemicals that exhibit a "hazard
trait". All information used in the evaluation
must now meet the definition of
"reliable information". A three-step sequence for prioritizing the
chemicals is now provided (instead of one
undifferentiated list of factors): |
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#1 |
Relative degree of threat: assessment based upon
physical chemical hazards and adverse public health,
ecological, air quality, water quality and/or soil
quality impacts |
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"Chemical and physical properties" has been divided
into physical chemical hazards (which are part of
the threat assessment) and physico-chemical
properties (which are part of the chemical ID and
description) |
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"Adverse public health impacts" has been reduced
from 26 items to 7 and no longer includes
bioaccumulation or electromagnetic radiation |
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"Environmental impacts" (not the same as
ecological impacts) has been divided into four
stand-alone categories: air quality,
water quality and soil quality (which are part of
the threat assessment) and environmental fate
properties (which are part of the chemical ID and
description) |
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"Release of heat, odor or radiation" is no longer an
adverse impact, with the exception that thermal pollution is
still considered an adverse water quality impact |
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#2 |
Potential for exposure: assessment based upon
evidence of human or environmental exposure, use in
household products, and quantity in CA stream of
commerce |
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#3 |
Other federal or state programs or international
trade agreements that regulate the chemical |
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Availability of DTSC resources will be a limiting
factor |
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Public comment periods must include "workshops" for
oral comments (instead of written comments only) |
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Similarly, the DTSC will prepare only one list of products
(instead of two) which will be known as
Priority Products. The term
"products under consideration" is no longer used.
The
initial Priority Products list must be finalized by December 31,
2012 (instead of December 1, 2013).
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Priority
Products are products that contain a Chemical of Concern. Until
January 1, 2016, only children's products,
personal care products or household cleaning products
will be considered. This is a major change in scope (albeit
temporary). |
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A two-step sequence for prioritizing products is now provided: |
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#1 |
Relative degree of threat:
assessment based upon likelihood of human or
environmental exposure |
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"Volume in stream of commerce" has been reduced from
7 items to 2 (statewide sales by volume and number
of units) |
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"Types and extent of consumer uses" now excludes
workers (but not customers, clients and general
public) who are exposed at a workplace |
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#2 |
Other federal or state programs or international
trade agreements that regulate the chemical |
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Availability of DTSC resources will be a limiting
factor |
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For each
Priority Product, the DTSC must now specify the Chemical of
Concern and the component(s) that
are the basis for the product listing and a de minimis
concentration for that component. |
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Manufacturers must still submit the "Priority Product
Notification" within 60 days of its listing as a
Priority Product (unless de minimis applies). |
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The
de minimis exemption for products
listed on the Priority Products List has been streamlined:
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The
default level is 0.1% by weight, except when this
conflicts with DTSC's "hazardous waste regulatory
threshold" set for the chemical; all other
regulatory thresholds have been deleted |
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A
de minimis level will be specified for all products (the DTSC may not issue a determination that it is not
allowed for a particular product) |
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De
minimis concentrations apply at the product level
for "formulated" products and at the component level
for "assembled" products (new) |
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De
minimis applies to the maximum total concentration
of all COCs that are the basis for the Priority
Product listing (new) |
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Manufacturers only need to submit a De Minimis
Exemption Notification (instead of submitting a
"request" that must be approved by the DTSC) |
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There is now only one type of
Alternatives Assessment (instead of two). The
terms "Tier I AA" and "Tier II
AA" are no longer used. |
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"Tier I AA" (required when a product containing a
Chemical of Concern is reformulated, redesigned or replaced with an alternative
product) has been deleted |
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"Tier II AA" (required when a product is listed as a
Priority Product) is now simply "AA" |
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AA
must only be performed for the component that is the
basis for the Priority Product listing (not the
entire product) |
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Manufacturers must still submit the "AA Work Plan" within
180 days of its listing as a Priority Product, with
the following exceptions: |
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If the COC
is removed from the Priority Product without adding
or increasing the concentration of another chemical,
submit the "Chemical Removal Notice" instead; only one notice
is required (instead of two); the
"Chemical Removal Intent" and
"Chemical Removal Confirmation" are no
longer used |
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If
the Priority Product is no longer placed in the
California stream of commerce, submit
"documentation" to the DTSC; the terms "Product
Removal Intent" and "Product Removal Confirmation"
are no longer used |
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If
the Priority Product does not exceed the de minimis
concentration, a "De Minimis Exemption Notification"
should have already been sent |
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AAs are no longer divided into "Tier II-A" or "Tier
II-B". Only one report is required (instead of two). AAs must
include five assessments of the COC and selected alternative(s): |
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1. |
Chemical Hazard Assessment
includes physical chemical hazards and adverse
public health, ecological, air quality, water
quality and soil quality impacts (these are the
factors used to prioritize chemicals); formerly Tier
II-A |
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2. |
Exposure Potential Assessment
includes chemical quantity info, exposure limitation
factors, consumer uses and environmental releases
(these are the factors used to prioritize products);
formerly Tier II-A |
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Also includes quantities used to manufacture the
product, but no longer includes concentration of COC
in the product |
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3. |
Multimedia Life Cycle
Evaluation includes materials/resource
consumption, air quality, water quality, soil
quality and waste/end-of-life impacts over the
entire life cycle of the product; however, it no
longer includes the release of heat, odor or
radiation; formerly Tier II-B |
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4. |
Product Function and
Performance Analysis is now a stand-alone
assessment (formerly part of Multimedia Life Cycle,
Tier II-B) |
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5. |
Economic Impact Analysis
is now a stand-alone assessment (formerly part of
Multimedia Life Cycle, Tier II-B); additions include
impact on jobs or businesses, costs of doing
business (other than operations and maintenance),
and cost of goods to consumers; however,
non-compliance liability has been deleted |
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Accreditation is no longer a
requirement for performing an AA; in fact, all mention of
accreditation has been deleted; the terms "qualified assessment
entity" and "lead assessor" are no longer used. |
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AAs may now be performed by a consortium, trade
association or public-private partnership with which
the manufacturer is affiliated |
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AAs must
still be reviewed by a "third-party verifier"
without an economic interest |
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Responsible entity now includes
only the "manufacturer" who produces the product and the
"retailer" who sells the product directly to the consumer. The
importer and the distributor are no longer listed as responsible
entities. |
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"Duty to comply" now lies principally with the
manufacturer; the retailer is required to comply
only when the manufacturer has been placed on the
Failure to Comply List |
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Information may also be requested directly from
chemical manufacturer, who can be placed on the
Failure to Respond List for not complying |
