OFFICE OF THE SECRETARY OF STATE  
BEV CLARNO  
SECRETARY OF STATE
JEFF MORGAN  
INTERIM DEPUTY SECRETARY OF STATE
ARCHIVES DIVISION  
STEPHANIE CLARK  
DIRECTOR
800 SUMMER STREET NE  
SALEM, OR 97310  
503-373-0701
NOTICE OF PROPOSED RULEMAKING
INCLUDING STATEMENT OF NEED & FISCAL IMPACT
CHAPTER 333
OREGON HEALTH AUTHORITYFILED
06/22/2020 12:57 PM
ARCHIVES DIVISION
SECRETARY OF STATE
PUBLIC HEALTH DIVISION
FILING CAPTION: Toxic Free Kids Act - Phase 3 Rulemaking
LAST DAY AND TIME TO OFFER COMMENT TO AGENCY: 07/23/2020   5:00 PM  
The Agency requests public comment on whether other options should be considered for achieving the rule's substantive goals while reducing negative economic 
impact of the rule on business.
CONTACT: Brittany Hall  
971-673-1217  
publichealth.rules@state.or.us800 NE Oregon St. Suite 930  
Portland,OR 97232Filed By:  
Brittany Hall  
Rules Coordinator
HEARING(S) 
Auxilary aids for persons with disabilities are available upon advance request. Notify the contact listed above.
DATE: 07/16/2020  
TIME: 9:00 AM  
OFFICER: Staff  
ADDRESS: CALL-IN ONLY  
Following direction from the Gov/CDC  
public meetings are via conference call  
Portland, OR 97232  
SPECIAL INSTRUCTIONS: 
Due to COVID-19 public meetings are 
being held via conference call.  To 
provide oral testimony during this 
hearing, please dial 1877848-7030, 
access code: 2030826# 
NEED FOR THE RULE(S):
SB 478 (Oregon Laws 2015, chapter 786) was passed by the Oregon Legislature during the 2015 legislative session. The 
law requires the Oregon Health Authority (Authority) to require manufacturers of children’s products to disclose high 
priority chemicals of concern for children’s health used in children’s products that are sold or offered for sale in Oregon. 
The law states that the Authority shall adopt a list of High Priority Chemicals of Concern for Children’s Health 
(HPCCCH); establish requirements for disclosure; and establish a process for manufacturers to apply for an exemption 
from the disclosure requirements, all of which have been established through past rulemaking. By January 1, 2022, 
manufacturers of three specific categories of children’s products (those for children under three years-old; “mouthable” 
items, per ORS 431A.253(8); and children’s cosmetics)  are to remove HPCCCH from product models in these 
categories or substitute them with a less-hazardous alternative or have a waiver of this requirement approved by the 
Authority. This rulemaking establishes rules for these statutory requirements so manufacturers may comply with their 
Page 1 of 50obligations under the law by the 2022 deadline. This rulemaking also modifies previously established rules to clarify 
them. 
 
 
Proposed changes to OAR chapter 333, division 16 include: 
 
 
A)	Repeal OAR 333-016-2000 List of High Priority Chemicals of Concern for Children's Health When Used in 
Children's Products: Purpose, Scope, and Effective Date which contains language appropriate for the initial 
implementation of the 2015 Toxic Free Kids Act. Five years later, it has been replaced by OAR 333-016-2001 Toxic 
Free Kids Act Program; Effective Date with language reflecting the law’s current implementation. 
 
 
B)	The amendment of OAR 333-016-2010 Definitions. Clarification of existing definitions and the establishment of 
new definitions to address the waiver application process. 
 
 
C)	The amendment of OAR 333-016-2020 Chemicals of High Concern to Children. Changes to spelling or chemical 
wording in any of the 68 HPCCCH in OAR 333-016-2020 is done only to harmonize them with that of their 
counterparts listed for Washington State’s Children’s Safe Products Act (CSPA). These amendments were done to assist 
those providing biennial notifications to the Authority, and to assist members of the public in their search for HPCCCH 
in children’s products. 
 
 
D)	 The amendment of OAR 333-016-2030 Modifications the List of High Priority Chemicals of Concern for Children’s 
Health. In two places, the name High Priority Chemicals of Concern for Children’s Health has been collapsed into 
acronym “HPCCCH.” 
 
 
E)	The amendment of OAR 333-016-2035 Exhibit A. Changes to spelling or chemical wording in any of the 68 HPCCCH 
in OAR 333-016-2035 Exhibit A is done only to harmonize them with that of their counterparts in Washington’s CSPA’s 
list. These amendments were done to assist those providing biennial notifications to the Authority and to assist 
members of the public in their search for HPCCCH in children’s products. 
 
 
F)	The repeal of OAR 333-016-2040 Purpose and Scope. Replaced by purpose and scope language in other sections of 
these rules. 
 
 
G)	The repeal of OAR 333-016-2050 Definitions. Replaced by 333-016-2010 Definitions. 
 
 
H)   The amendment of OAR 333-016-2060 Notification Requirements. Specifies the fee and clarifies the reporting 
deadlines for manufacturers to report products that contain High Priority Chemicals of Concern for Children’s Health 
(HPCCCH) to the Authority. Adds a requirement for manufacturers to provide an intended age category for products 
sold in Oregon. Clarifies requirement that trade associations, if reporting on behalf of their members, must provide the 
name and contact information for a representative of that member. In addition, trade associations must provide the 
Page 2 of 50specific product categories being reported for that member and pay the fees required for that member’s report. Adds a 
requirement that manufacturers report to the Authority using the Interstate Chemicals Clearinghouse High Priority 
Chemicals Data System or alternate data system designated by the Authority. 
 
 
I)	The amendment of OAR 333-016-2070 Exemptions from Notification Requirements. Requires trade associations 
requesting an exemption from notification requirements on a manufacturer's behalf to provide the company name and 
contact information for the manufacturer. Clarifies the information needed by the Authority to evaluate whether or not 
the measures listed in the manufacturing control program will control the HPCCCH as a contaminant. Establishes a 
deadline for requesting an exemption for a particular reporting period. Specifies the information that must be submitted 
as part of an exemption request and specifies the process for making amendments to exemptions that have already 
been approved by the Authority. 
 
 
J) The amendment of OAR 333-016-2080 Fees. Specifies the application fees for requesting a waiver from the 
requirement to remove or substitute a high priority chemical of concern for children’s health. The fee for an exemption 
request is $1,500. There is also a $200 per hour fee for outside consultants to review the documents sent in support of 
the applications. [Both fees were approved by the Oregon Legislature as part of House Bill 5027 in 2017.]  Establishes a 
process and timeline for the review of waiver applications, the approval/disapproval process and the process to provide 
a revised waiver request. 
 
 
(K) The repeal of OAR 333-016-2090 Enforcement and Civil Penalties. Replaced by OAR 333-016-3080 Enforcement 
and Civil Penalties 
 
 
Proposed additions to OAR chapter 333, division 16 include: 
 
 
A)	 Adopt OAR 333-016-2001 Toxic Free Kids Act Program; Effective Date to state that the purpose of these rules is to 
implement the Toxic Free Kids Act established by the 2015 Oregon Legislature as well as the intention of the rules. 
 
 
B)	 The adoption of OAR 333-016-2065 Formal Communications Regarding Toxic Free Kids. Requires that formal 
communication to/from manufacturers or trade associations and the Authority on requests in these rules use the 
Program email. 
 
 
C)	The adoption of OAR 333-016-3010 Removal or Substitution of High Priority Chemical. Specifies the three 
categories of children’s products for which removal, substitution, or procurement of a waiver approved by the Authority 
is required, and respective due dates. Specifies the procedure that manufacturers must follow if removing a HPCCCH 
from a product or ceasing to manufacture the product (in lieu of substitution, waiver procurement). Specifies the 
process by which manufacturers with 25 or fewer employees may request a two-year extension of the date specified in 
ORS 431A.260(1) to meet the requirements of the rules. 
 
 
D)	The adoption of OAR 333-016-3015 Exemptions from Removal or Substitution Requirements. Specifies four 
Page 3 of 50categories through which manufacturers can request an exemption from having to have a specific product comply with 
ORS 431A.260(1), and the process needed to apply for such exemptions. 
 
 
E)	The adoption of OAR 333-016-3020 Requirements for Chemical Substitution. Specifies the definition of children’s 
product for this rule and that of OAR 333-016-3040. Specifies that a Hazard Assessment must be provided when 
substituting a less-hazardous chemical for a HPCCCH in a children’s product. Provides the methods that should be used 
to identify children’s products for which a Hazard Assessment is being done. Specifies the process and timelines by 
which the Authority and those requesting a Hazard Assessment must abide by for submitting and reviewing a Hazard 
Assessment. 
 
 
F)	The adoption of OAR 333-016-3030 Hazard Assessments for Substitute Chemicals. Specifies that manufacturers 
are to have their substitute chemicals assessed by a Licensed GreenScreen Profiler using GreenScreen® for Safer 
Chemicals Hazard Assessment Guidance. Details the standards under which the Authority will approve chemicals 
proposed to replace a HPCCCH. States the Authority’s determination that GreenScreen Guidance is a scientifically-
based, data-driven methodology. Provides the possibility of the use of an alternative methodology for a Hazard 
Assessment as wells as the criteria, process and timeline that should be used to submit the alternative process to the 
Authority for approval. 
 
 
G)	The adoption of OAR 333-016-3040 Waiver from Removal or Substitution Requirement. Specifies the application 
process and timelines by which the Authority and those requesting such a Waiver must abide by for submitting and 
reviewing Waiver documents. Specifies a manufacturer’s responsibilities if the Authority disapproves a revised waiver 
request or an initial waiver (if the manufacturer does not submit a revised version). 
 
 
H)	The adoption of OAR 333-016-3050 Quantitative Exposure Assessment. Specifies the standards and required 
content of this type of document which may be submitted as part of a request that ORS 431A.260(1) and its rules be 
waived for specified children’s product(s). 
 
 
I)	The adoption of OAR 333-016-3060 Alternatives Assessment. Specifies the standards and required content of this 
type of document which may be submitted as part of a request that ORS 431A.260(1) and its rules be waived for 
specified children’s product(s). 
 
 
J)	The adoption of OAR 333-016-3070 Trade Secrets. Specifies what manufacturers must do if they believe the 
information they are submitting is a trade secret as well as what the Authority will do if it receives a public records 
request for such records. 
 
 
K)	The adoption of OAR 333-016-3080 Enforcement and Civil Penalties. Specifies the civil penalties for violations of 
the proposed rules, the process and timeline the Authority must follow to both determine and assess those penalties, 
and what manufacturers may do to remedy those violations. 
DOCUMENTS RELIED UPON, AND WHERE THEY ARE AVAILABLE:
Page 4 of 50SB 478 (Oregon Law 2015, chapter 786): 
https://olis.leg.state.or.us/liz/2015R1/Downloads/MeasureDocument/SB478/Enrolled 
 
 
Oregon Toxic Free Kids Act, ORS 431A.250 – 431A.280: https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html 
 
 
OAR chapter 333, division 16:  https://secure.sos.state.or.us/oard/displayDivisionRules.action?selectedDivision=1231 
 
 
State of Washington, Department of Ecology, Children’s Safe Products Act Reporting Rule and guidance documents. 
http://apps.leg.wa.gov/wac/default.aspx?cite=173-334-090  and 
https://fortress.wa.gov/ecy/publications/documents/1704040.pdf 
https://fortress.wa.gov/ecy/publications/documents/1704021.pdf 
 
 
GreenScreen® for Safer Chemicals Hazard Assessment Guidance 
https://www.greenscreenchemicals.org/images/ee_images/uploads/resources/GreenScreen_Guidance_v1_4_2018_01_Final.pdf
FISCAL AND ECONOMIC IMPACT:
A)	 The adoption of OAR 333-016-2001 is not anticipated to have a fiscal impact on manufacturers or Oregon 
consumers. 
 
 
B)	The amendments to OAR 333-016-2010 Definitions are not anticipated to have a fiscal impact on manufacturers or 
Oregon consumers. 
 
 
C)	The amendments to OAR 333-016-2020 Chemicals of High Concern to Children s are not anticipated to have a 
fiscal impact on manufacturers or Oregon consumers. 
 
 
D)	The amendments to OAR 333-016-2035 Exhibit A are not anticipated to have a fiscal impact on manufacturers or 
Oregon consumers 
 
 
E)	The amendments to OAR 333-016-2060 Notification Requirements were made to clarify the reporting deadlines 
and specify what information is required to be submitted in the biennial notice required of manufacturers, and do not 
place additional 
burdens on manufacturers. The information requested of manufacturers was previously part of reporting guidance 
issued by 
the Authority. The changes are not anticipated to have a fiscal impact. 
 
 
F)	The amendments to OAR 333-016-2070 Exemptions from Notification Requirements clarify what information is 
required to be submitted to the Authority as part of an exemption request. These changes are not anticipated to have a 
fiscal impact. 
Page 5 of 50 
 
G)	The amendments to OAR 333-016-2080 Fees address the application and review fees for a waiver from the 
requirement to remove or substitute a HPCCCH from a product sold or offered for sale in Oregon. Fees are needed to 
review documents sent in support of requests for exemption from removal and substitution requirements. 
Manufacturers are not required to apply for a waiver or make a request for exemption, but those that do are required to 
pay these fees. A waiver request must include an Alternatives Assessment or a Quantitative Exposure Analysis, which 
will have associated cost to produce. It is not possible to estimate the cost of such an analysis due to the highly specific 
nature of each chemical and product. However, small businesses with 25 or fewer employees may apply for a two-year 
extension to meet the requirements of the removal or substitution requirements of OAR 333-016-3010. 
Manufacturers of children’s products with annual worldwide gross sales of less than $5 million are exempt from these 
requirements. 
 
 
H)	The amendments to OAR 333-016-2090 Enforcement and Civil Penalties explains the enforcement process that the 
Authority will take when a manufacturer sells a product in Oregon that contains a chemical listed under OAR 333-016-
2020 (Chemicals of High Concern to Children) and did not receive an exemption or waiver from the Authority. 
Manufacturers that do not follow the requirements of ORS 431A.250 through ORS 431A.280 may face a fiscal impact 
through the imposition of civil penalties. 
 
 
I)	  The adoption of OAR 333-016-3010 Removal or Substitution of High Priority Chemical. Because the Authority is 
unaware of any efforts by other states or jurisdictions to implement similar statutory provisions requiring the 
substitution of a chemical with a less hazardous alternative, comparison costs are not available. Manufacturers that are 
required to remove or substitute a HPCCCH will experience a fiscal impact, as they will be required to reformulate 
children’s products that contain the HPCCCH. It is not possible to estimate the cost of such a process due to both the 
lack of comparison costs and the highly specific nature of each chemical, the product model, and the chemical’s role in 
that product. 
 
 
J)	The adoption of OAR 333-016-3015 Exemptions from Removal or Substitution Requirements. Specifies four 
categories through which manufacturers can request an exemption from having to have a specific product comply with 
ORS 431A.260(1). Manufacturers are not required to seek these exemptions. Manufacturers that produce children’s 
products with HPCCCH that wish to seek an exemption from the removal or substitution requirements will bear the 
associated costs of producing the required reports and any associated fees. The application fee is $1,500 and the review 
fee is $200 per hour. It is not possible to estimate the cost of producing such an analysis due to the lack of comparison 
costs and highly specific nature of each chemical, the product model, and the chemical’s role in that product. 
 
 
K)	The adoption of OAR 333-016-3020 Requirements for Chemical Substitution. Manufacturers that produce 
children’s products with HPCCCH that wish to seek approval for a substitute chemical will bear the associated costs of 
producing the required reports and any associated fees. The application fee is $1,500 and the review fee is $200 per 
hour. Other than the estimate noted below for a GreenScreen assessment of a new chemical, it’s not possible to 
estimate the cost of producing such reports due to the lack of comparison costs and the highly specific nature of each 
chemical, the product model, and the chemical’s role in that product. 
 
 
Page 6 of 50L)	The adoption of OAR 333-016-3030 Hazard Assessments for Substitute Chemicals. Specifies that manufacturers 
are to have their substitute chemicals assessed by a Licensed GreenScreen Profiler using GreenScreen® for Safer 
Chemicals Hazard Assessment Guidance. There are both financial costs and benefits to this rule. At least 15% of 
HPCCCH’s have a current GreenScreen assessment that is in the public domain. These may be used without cost to a 
manufacturer for these purposes. On average, GreenScreen assessments on new chemicals are estimated to range from 
$2,000 to $10,000. However, GreenScreen evaluations of potential substitute chemicals, if paid for by manufacturers, 
are the property of those manufacturers. GreenScreen evaluations may be used for commercial purposes, subject to the 
GreenScreen licensure agreement. Associated costs will be borne by manufacturers. 
 
 
M)	The adoption of OAR 333-016-3040 Waiver from Removal or Substitution Requirement. Manufacturer that 
produce children’s products with HPCCCH that wish to seek a waiver from the removal or substitution requirements 
will bear the associated costs of producing the required reports and any associated fees. The application fee is $1,500 
and the review fee is $200 per hour.  It is not possible to estimate the cost of producing such reports due to due to the 
lack of comparison costs and the highly specific nature of each chemical, the product model, and the chemical’s role in 
that product. 
 
 
N)	The adoption of OAR 333-016-3050 Quantitative Exposure Assessment. It is not possible to estimate the cost of 
producing a quantitative exposure assessment due to the lack of comparison costs and the highly specific nature of each 
chemical, the product model, and the chemical’s role in that product. Manufacturers that request a waiver will be 
required to produce a quantitative exposure analysis, which will result in a cost to the manufacturer. 
 
 
O)	 The adoption of OAR 333-016-3060 Alternatives Assessment. It is not possible to estimate the cost of an 
alternatives assessment due to the lack of comparison costs and the highly specific nature of each chemical, the product 
model, and the chemical’s role in that product. 
 
 
P)	The adoption of OAR 333-016-3070 Trade Secrets. This is not expected to have a fiscal impact on manufacturers. 
 
 
Q)	The adoption of OAR 333-016-3080 Enforcement and Civil Penalties. Manufacturers found to be in violation of 
Oregon law may face civil penalties. These civil penalties may not exceed $2,500 for the first violation or $5,000 for the 
second and each subsequent violation. Those found in violation may avoid the penalties if they cure or address the 
violation within 90 days of the date of the notice of violation. There may be a fiscal impact to manufacturers who are 
unable to sell children’s products found to be in violation by the Authority of ORS 431A.260 or 431A.263, or relevant 
OARs. Additional costs to manufacturers may result from efforts necessary to identify such products and communicate 
that they can’t be sold in Oregon to business partners. It is not possible to estimate the total loss in profit for 
manufacturers of children’s products that can no longer be sold in Oregon given the variety of products, prices and 
manufacturers. 
COST OF COMPLIANCE: 
(1) Identify any state agencies, units of local government, and members of the public likely to be economically affected by the 
rule(s). (2) Effect on Small Businesses: (a) Estimate the number and type of small businesses subject to the rule(s); (b) Describe the 
expected reporting, recordkeeping and administrative activities and cost required to comply with the rule(s); (c) Estimate the cost 
of professional services, equipment supplies, labor and increased administration required to comply with the rule(s).
Page 7 of 50(1) A) The amendments to OAR 333-016-2010 Definitions is not anticipated to have a cost of compliance impact on 
state agencies, local governments or the public. 
 
 
B) The amendment of OAR 333-016-2060 Notification Requirements specifies the fees required for submitting an 
exemption request from the notification requirements of children’s products sold or offered for sale in Oregon that 
contain a HPCCCH listed under OAR 333-016-2020. It also specifies what manufacturers need to provide to the 
Authority as part of that exemption request. These changes will not result in a compliance cost for state or local 
government or the public. Fees are collected by the Toxic Free Kids Program and utilized to support program efforts. 
 
 
C) The amendment of OAR 333-016-2070 Exemptions from Notification Requirements clarifies what information is 
required to be submitted to the Authority as part of an exemption request. These changes will not result in a compliance 
cost for state or local government or the public. 
 
 
D) The amendment of OAR 333-016-2080 Fees addresses the application and review fee for requesting a waiver from 
the requirement to remove or substitute a HPCCCH from a product sold or offered for sale in Oregon. Manufacturers 
that request a waiver are required to pay these fees. These changes will not result in a compliance cost for state or local 
government or the public. Fees are collected by the Toxic Free Kids Program and utilized to support program efforts. 
 
 
E) The amendment of OAR 333-016-2090 Enforcement and Civil Penalties explains the enforcement process that the 
Authority will take when a manufacturer sells a product in Oregon that contains a HPCCCH listed under OAR 333-016-
2020 and did not receive an exemption or waiver from the Authority. These changes will not result in a compliance cost 
for local government or the public. The state anticipates legal costs associated with the civil penalty process. These 
costs are offset by the collection of civil penalties. 
 
 
F) The adoption of OAR 333-016-3010 Removal or Substitution of High Priority Chemical. This addition will not result 
in a compliance cost on state or local government or the public. 
 
 
G)	The adoption of OAR 333-016-3015 Exemptions from Removal or Substitution Requirements. This addition will not 
result in a compliance cost with state or local government or the public. 
 
 
H)	The adoption of OAR 333-016-3020 Requirements for Chemical Substitution. This addition will not result in a 
compliance cost on state or local government or the public. 
 
 
I)	The adoption of OAR 333-016-3030 Hazard Assessments for Substitute Chemicals. This addition will not result in 
compliance cost on state or local government or the public. 
 
 
J)	The adoption of OAR 333-016-3040 Waiver from Removal or Substitution Requirement This addition will not result 
in a compliance cost on state or local government or the public. 
Page 8 of 50 
 
K)	The adoption of OAR 333-016-3050 Quantitative Exposure Assessment. This addition will not result in a 
compliance cost on state or local government or the public. 
 
 
L)	The adoption of OAR 333-016-3060 Alternatives Assessment. This addition will not result in a 
compliance cost on state or local government or the public. 
 
 
M)	The adoption of OAR 333-016-3070 Trade Secrets. This addition will not result in a 
compliance cost on state or local government or the public. 
 
 
N)	The adoption of OAR 333-016-3080 Enforcement and Civil Penalties. This addition will not result in a 
compliance cost on state or local government or the public. 
 
 
(2)(a) ORS 431A.258 Disclosure by manufacturers (OAR 333-016-2060 through 3080) only pertains to companies that 
gross over $5,000,000 in worldwide gross sales per year who manufacture children’s products that contain HPCCCH. 
The term manufacturer includes an importer or domestic distributor. We are unable to estimate the number of 
manufacturers that would be considered a small business based on available information. 
 
 
(b) ORS 431A.258 Disclosure by manufacturers only pertains to companies that gross over $5,000,000 in worldwide 
gross sales per year who manufacture children’s products that contain HPCCCH. The term manufacturer includes an 
importer or domestic distributer. If a small business met these criteria, they would be responsible for providing notice, 
any associated fees and related recordkeeping to the Authority. There may be a fiscal impact to small business owners, 
as identified above, who are unable to sell, in Oregon, purchased children’s products determined to be in violation by the 
Authority of ORS 431A.260 or 431A.263, or relevant OARs. Additional costs to manufacturers and retailers may result 
from efforts necessary to identify such products and communicate that they can’t be sold in Oregon to business 
partners. 
 
 
(c) ORS 431A.258 Disclosure by manufacturers only pertains to companies that gross over $5,000,000 in worldwide 
gross sales per year who manufacture children’s products that contain HPCCCH. The term manufacturer includes an 
importer or domestic distributer. If a small business met these criteria and wanted to apply for a waiver from removing 
or substituting a HPCCCH in a children’s product, they would be responsible for paying the application and review fees, 
as well as providing an Alternatives Assessment or Quantitative Exposure Analysis. It is assumed that this type of 
analysis would require labor, supplies and increased administration costs, and may also include equipment. We are 
unable to estimate the costs to comply with the waiver application process due to the lack of comparison costs and the 
highly specific nature of each chemical, the product model, and the chemical’s role in that product. 
 
 
 
 
Page 9 of 50DESCRIBE HOW SMALL BUSINESSES WERE INVOLVED IN THE DEVELOPMENT OF THESE RULE(S):
Small business representatives and trade associations participated as Rule Advisory Committee members. 
WAS AN ADMINISTRATIVE RULE ADVISORY COMMITTEE CONSULTED?  YES
RULES PROPOSED:  
333-016-2000, 333-016-2001, 333-016-2010, 333-016-2020, 333-016-2030, 333-016-2035, 333-016-2040, 333-
016-2050, 333-016-2060, 333-016-2065, 333-016-2070, 333-016-2080, 333-016-2090, 333-016-3010, 333-016-
3015, 333-016-3020, 333-016-3030, 333-016-3040, 333-016-3050, 333-016-3060, 333-016-3070, 333-016-3080
REPEAL: 333-016-2000
RULE SUMMARY: Repeal OAR 333-016-2000 List of High Priority Chemicals of Concern for Children's Health When 
Used in Children's Products: Purpose, Scope, and Effective Date, which contains language appropriate for the initial 
implementation of the 2015 Toxic Free Kids Act. Five years later, it has been replaced by adoption of OAR 333-016-
2001 Toxic Free Kids Act Program; Effective Date with language reflecting the law’s current implementation. 
CHANGES TO RULE: 
333-016-2000  
List of High Priority Chemicals of Concern for Children's Health When Used in Children's Products: Purpose, 
Scope, and Effective Date  
(1) These rules establish the initial list of high priority chemicals of concern for children's health when used in 
children's products. The presence of a high priority chemical of concern in a children's product does not 
necessarily mean that the product is harmful to human health or that there is any violation of existing safety 
standards or laws. The information required to be reported in these rules will help fill a data gap that exists for 
both consumers and agencies.¶  
(2) A manufacturer of children's products sold or offered for sale in this state must provide biennial notice to the 
Oregon Health Authority, of all children's products that contain a high priority chemical listed in OAR 333-016-
2020.¶  
(3) A manufacturer's first report is due no later than January 1, 2018.  
Statutory/Other Authority: OL 2015, ch. 786, sec. 3  
Statutes/Other Implemented: OL 2015, ch. 786, sec. 3
Page 10 of 50ADOPT: 333-016-2001
RULE SUMMARY: Adopt OAR 333-016-2001 Toxic Free Kids Act Program; Effective Date to state that the purpose of 
these rules is to implement the Toxic Free Kids Act established by the 2015 Oregon Legislature as well as the intention 
of the rules.
CHANGES TO RULE: 
333-016-2001  
Toxic Free Kids Program; Effective Date  
(1) OAR 333-016-2001 to 333-016-3080 implement the Toxic Free Kids Act established by the Legislature in 
ORS 431A.253 to 431A.280. The presence of a high priority chemical of concern in a children's product does not 
necessarily mean that the product is harmful to human health or that there is any violation of existing safety 
standards or laws. The information required to be reported in these rules will help fill a data gap that exists for 
both consumers and agencies.¶  
(2) These rules apply to any children's product sold or offered for sale in Oregon by a manufacturer on or after 
January 1, 2017 that contains a high priority chemical listed in OAR 333-016-2020.  
Statutory/Other Authority: ORS 431A.253 - 431A.280, ORS 413.042  
Statutes/Other Implemented: ORS 431A.253 - 431A.280
 
Page 11 of 50AMEND: 333-016-2010
RULE SUMMARY: Amend OAR 333-016-2010 Definitions to clarify existing definitions and establish new definitions to 
address the waiver application process.
CHANGES TO RULE: 
333-016-2010  
Definitions ¶ 
 
(1) "Chemical" means:¶  
(a) A substance with a distinct molecular composition and the breakdown products of the substance that form 
through decomposition, degradation or metabolism.¶  
(b) A group of structurally related substances and the breakdown products of the substances that form through 
decomposition, degradation or metabolism.¶  
(2The following definitions apply to OAR 333-016-2001 to 333-016-3080.¶  
(1) "Alternatives Assessment" or "AA" as described in OAR 333-016-3060 means the evaluation of the possibility 
of replacing chemicals in products or processes with inherently safer alternatives in order to better protect human 
health.¶  
(2) "Analytical methods" means defined protocols for the analysis of the presence of a HPCCCH in a sample of a 
medium, including laboratory testing that can be described and is readily reproducible by another party.¶  
(3) "Bioavailability" means the extent to which a HPCCCH at or above the practical quantification limit for the 
chemical established in OAR 333-016-2035(2) Exhibit A in leachate or air may be absorbed by a child.¶  
(4) "Chemical" means:¶  
(a) A substance with a distinct molecular composition and the breakdown products of the substance that form 
through decomposition, degradation or metabolism.¶  
(b) A group of structurally related substances and the breakdown products of the substances that form through 
decomposition, degradation or metabolism.¶  
(5) "Chemical Abstracts Service Registry Number" means the number assigned for identification of a particular 
chemical by the Chemical Abstracts Service, a service of the American Chemical Society that indexes and compiles 
abstracts of worldwide chemical literature called Chemical Abstracts. ¶  
(6) "Child" means an individual under 12 years of age.¶  
(7) "Children's cosmetics" means products that are intended to be rubbed, poured, sprinkled or sprayed on, 
introduced into or otherwise applied to the human body or any part thereof for cleansing, moisturizing, 
beautifying, promoting attractiveness or altering the appearance. "Children's cosmetics" does not mean soap, 
dietary supplements or food and drugs approved by the United States Food and Drug Administration.¶  
(38)(a) "Children's product" means:¶  
(A) Any of the following products that are made for, marketed for use by or marketed to children under 12 years of 
age:¶  
(i) A product designed or intended by the manufacturer to facilitate sucking, teething, sleep, relaxation, feeding or 
drinking.¶  
(ii) Children's clothing and footwear.¶  
(iii) Car seats.¶  
(iv) Children's cosmetics.¶  
(v) Children's jewelry.¶  
(vi) Toys.¶  
(B) Any component part of a product specified in paragraph (A) of this subsection.¶  
(b) "Children's product" does not mean:¶  
(A) Athletic shoes with cleats or spikes.¶  
(B) Batteries.¶  
(C) BB guns, pellet guns and air rifles.¶  
Page 12 of 50(D) Bicycles and tricycles.¶  
(E) Chemistry sets.¶  
(F) Consumer electronic products, including personal computers, audio and video equipment, calculators, wireless 
telephones and game consoles, handheld devices that incorporate a video screen and are used to access 
interactive software, and the associated peripherals.¶  
(G) Interactive software intended for leisure and entertainment, such as computer games, and their storage media, 
such as compact discs.¶  
(H) Model rockets.¶  
(I) Pocketknives and multitools.¶  
(J) Roller skates.¶  
(K) Scooters.¶  
(L) Sets of darts with metallic points.¶  
(M) Slings and catapults.¶  
(N) Snow sporting equipment, including skis, poles, boots, snowboards, sleds and bindings.¶  
(O) Sporting equipment and accessories, including but not limited to bats, balls, gloves, sticks, pucks, pads, helmets 
and other protective equipment, weight training and exercise aids, protective eyewear, backpacks and tents, 
raingear, sport bags and luggage, and golf equipment.¶  
(P) Video toys that can be connected to a video screen and are operated at a nominal voltage exceeding 24 volts.¶  
(Q) Food and beverages and food and beverage packaging regulated by the United States Food and Drug 
Administration or the United States Department of Agriculture.¶  
(4) "These rules" mean OAR 333-016-2000 through 333-016-2030 9) "Component part" means a uniquely 
identifiable material or coating (including ink or dye) that is intended to be included as a part of a finished 
children's product, including, but not limited to:¶  
(a) Bio-based materials (animal or plant based);¶  
(b) Synthetic polymers (such as but not limited to synthetic rubber, plastics, and foams);¶  
(c) Metals (including alloys);¶  
(d) Glass, ceramic and siliceous material;¶  
(e) Surface coatings (such as but not limited to paints, plating, and waterproofing);¶  
(f) Homogenous mixtures (gels, creams, powders, liquids, adhesives, synthetic fragrances);¶  
(g) Inks/dyes/pigments; and¶  
(h) Textiles (synthetic fibers and blends).¶  
(10) "Contaminant" has the meaning given that term in ORS 431A.253.¶  
(11) "De minimis level" has the meaning given that term in ORS 431A.253.¶  
(12) "Essential use" means a function of a HPCCCH in a children's product considered critical for performance of a 
product. ¶  
(13) "Exposure scenarios" means the mechanisms by which children may be exposed to HPCCCHs found in a 
children's product.¶  
(14) "Hazard Assessment" or "HA" as described in OAR 333-016-3030 means an evaluation of whether a chemical 
or chemicals substituted for a HPCCCH in a children's product make that product less hazardous than it was when 
it contained the HPCCCH.¶  
(15) "HPCCCH" means high priority chemicals of concern to children's health.¶  
(16) "High priority chemicals of concern list" means the high priority chemicals of concern for children's health 
identified by the Authority in OAR 333-016-2020.¶  
(17) "Intentionally added chemical" has the meaning given that term in ORS 431A.253.¶  
(18) "Leachability" means the extent to which a HPCCCH is reasonably anticipated to migrate from a children's 
product through normal and reasonably foreseeable use and abuse of such product determined by measuring a 
HPCCCH at or above the practical quantification limit for the chemical established in OAR 333-016-2035(2) 
Exhibit A in media during simulated exposure scenarios.¶  
(19) "Manufacturer" has the meaning given that term in ORS 431A.253.¶  
Page 13 of 50(20) "Manufacturing control program" or "MCP" means a program implemented by the manufacturer or its 
suppliers to control the amount of a HPCCCH present as a contaminant at or above de minimis levels through the 
implementation of tools, processes and oversight that support effective chemicals management at all levels to 
include supply chain management, quality assurance and educational programs. Control includes the 
minimization, reduction or elimination of contaminants when possible.¶  
(21) "Mouthable" has the meaning given that term in ORS 431A.253.¶  
(22) "Non-essential use" means a function of a HPCCCH in a children's product that is not critical for the 
performance of a product but is included for other reasons such as market demand.¶  
(23) "Owner" for purposes of clarifying the definition of "manufacturer" means the person or entity, whether an 
importer or a distributor, that offers the children's product for sale in Oregon.¶  
(24) "Practical quantification limit" has the meaning given that term in ORS 431A.253.¶  
(25) "Product category" means the "brick" level of the GS1 Global Product Classification (GPC) standard, which 
identifies products that serve a common purpose, are of a similar form and material, and share the same set of 
category attributes. ¶  
(26) "Quantitative Exposure Assessment" or "QEA" means an assessment as described in OAR 333-016-3050 of 
whether a HPCCCH used in children's products is or is not reasonably anticipated to result in exposure based 
upon an analysis of leachability and bioavailability of the HPCCCH used in children's products.¶  
(27) "Reasonably foreseeable use and abuse" includes but is not limited to: non-incidental skin contact; 
swallowing; mouthing; inhalation of gaseous products emitted by a children's product; the aging of a children's 
product; and may include breaking during use by children. ¶  
(28) "Substitutable role" means a role for or presence of a HPCCCH that might be regarded as essential but where 
alternatives to the HPCCCH have been identified that have comparable functionality and performance making 
the use of the HPCCCH no longer essential.¶  
(29) "These rules" means OAR 333-016-2001 to 333-016-3080.¶  
(30) "Trade association" has the meaning given that term in ORS 431A.253 . 
Statutory/Other Authority: O L 2015, ch. 786, sec. 3 RS 413.042, ORS 431A.253 - 431A.280  
Statutes/Other Implemented: O L 2015, ch. 786, sec. 3 RS 431A.253 - 431A.280
 
Page 14 of 50AMEND: 333-016-2020
RULE SUMMARY: Amend OAR 333-016-2020 Chemicals of High Concern to Children to harmonize spelling or 
chemical wording in several of the 68 HPCCCH in OAR 333-016-2020 with that of their counterparts listed for 
Washington State’s Children’s Safe Products Act (CSPA). These modifications are done to assist those providing 
biennial notifications to the Authority, and to assist members of the public in their search for HPCCCH in children’s 
products.
CHANGES TO RULE: 
333-016-2020  
Chemicals of High Concern to Children ¶  
 
The following chemicals are designated as high priority chemicals of concern for children's health when used in 
children's products:¶  
(1) Formaldehyde (50-00-0).¶  
(2) Aniline (62-53-3).¶  
(3) N-Nitrosodimethylamine (62-75-9).¶  
(4) Benzene (71-43-2).¶  
(5) Vinyl chloride (75-01-4).¶  
(6) Acetaldehyde (75-07-0).¶  
(7) Methylene chloride (75-09-2).¶  
(8) Carbon disulfide (75-15-0).¶  
(9) Methyl ethyl ketone (78-93-3).¶  
(10) 1,1,2,2-Tetrachloroethane (79-34-5).¶  
(11) Tetrabromobisphenol A  (TBBPA)  (79-94-7).¶  
(12) Bisphenol A  (BPA)  (80-05-7).¶  
(13) Bisphenol S  (BPS)  (80-09-1).¶  
(14) Diethyl phthalate  (DEP)  (84-66-2).¶  
(15) Di -n-butyl phthalate  (DBP)  (84-74-2).¶  
(16) Di-n-hexyl phthalate  (DnHP)  (84-75-3).¶  
(17) Butyl benzyl phthalate (BBP) (85-68-7).¶  
(18) N-Nitrosodiphenylamine (86-30-6).¶  
(19) Hexachlorobutadiene  (HCDB)  (87-68-3).¶  
(20) Propyl paraben (94-13-3).¶  
(21) Butyl paraben (94-26-8).¶  
(22) 2-Aminotoluene (95-53-4).¶  
(23) 2,4-Diaminotoluene (95-80-7).¶  
(24) Methyl paraben (99-76-3).¶  
(25) p4-Hydroxybenzoic acid (99-96-7).¶  
(26) Ethylbenzene (100-41-4).¶  
(27) Styrene (100-42-5).¶  
(28) 4-Nonylphenol (104-40-5) ; 4-NP and its isomer mixtures including CAS 84852-15-3 and CAS 25154-52-3 .¶ 
(29) para 4-Chloroaniline (106-47-8).¶  
(30) Acrylonitrile (107-13-1).¶  
(31) Ethylene glycol (107-21-1).¶  
(32) Toluene (108-88-3).¶  
(33) Phenol (108-95-2).¶  
(34) 2-Methoxyethanol (109-86-4).¶  
(35) Ethylene glycol monoethyl e sther (110-80-5).¶  
(36) Triphenyl phosphate  (TPP)  (115-86-6).¶  
Page 15 of 50(37) Tris(2-chloroethyl) phosphate  (TCEP)  (115-96-8).¶  
(38) Di-2-ethylhexyl phthalate  (DEHP)  (117-81-7).¶  
(39) Di-n-octyl phthalate (DnOP) (117-84-0).¶  
(40) Hexachlorobenzene (118-74-1).¶  
(41) 3,3'-Dimethylbenzidine and Dyes Metabolized to 3,3'-Dimethylbenzidine (119-93-7).¶  
(42) Ethyl paraben (120-47-8).¶  
(43) 1,4-Dioxane (123-91-1).¶  
(44) Per Tetra chloroeth ylene (127-18-4).¶  
(45) Benzophenone-2 (Bp-2) ; 2,2',4,4'-Tetrahydroxybenzophenone (131-55-5).¶  
(46) 4-tert-Octylphenol; 4(1,1,3,3-Tetramethylbutyl) (131-55-5).¶  
(46) 4-tert-Octyl phenol (140-66-9).¶  
(47) Estragole (140-67-0).¶  
(48) 2-Ethylhexanoic acid (149-57-5).¶  
(49)  Benzene,  Pentachloro benzene  (608-93-5).¶  
(50) C.I. Solvent yellow 14 (842-07-9).¶  
(51) N-Methylpyrrolidone (872-50-4).¶  
(52) 2,2',3,3',4,4',5,5',6,6'- Decabromodiphenyl ether ; (BDE-209 ) (1163-19-5).¶  
(53) Perfluorooctane sulfonic acid and its salts; PFOS (1763-23-1).¶  
(54)  Phenol,  4-oOctyl phenol  (1806-26-4).¶  
(55) 2-Ethyl-hexyl-4-methoxycinnamate (5466-77-3).¶  
(56) Mercury (7439-97-6) and mercury compounds including methyl mercury (22967-92-6).¶  
(57) Antimony and Antimony compounds (7440-36-0).¶  
(58) Arsenic and Arsenic compounds (7440-38-2), including arsenic trioxide (1327-53-3) and dimethyl arsenic 
(75-60-5).¶  
(59) Cadmium and cadmium compounds (7440-43-9).¶  
(60) Cobalt and cobalt compounds (7440-48-4).¶  
(61) Tris(1-chloro-2-propyl) phosphate  (TCPP)  (13674-84-5).¶  
(62) Tris(1,3-dichloro-2-propyl) phosphate  (TDCPP)  (13674-87-8).¶  
(63) Butylated hydroxyanisole ; (BHA ) (25013-16-5).¶  
(64) Hexabromocyclododecane (25637-99-4).¶  
(65) Diisodecyl phthalate (DIDP) (26761-40-0).¶  
(66) Diisononyl phthalate  (unbranched)  (DINP) (28553-12-0).¶  
(67) Short-chain chlorinated paraffins  (SCCP)  (85535-84-8).¶  
(68) 2-ethylhexyl-2,3,4,5-tetrabromobenzoate  (TBB)  (183658-27-7).  
Statutory/Other Authority: ORS 413.042, ORS 431A.255  
Statutes/Other Implemented: ORS 431A.255
 
Page 16 of 50AMEND: 333-016-2030
RULE SUMMARY: Amend OAR 333-016-2030 Modifications to the List of High Priority Chemicals of Concern for 
Children’s Health in two places where the name High Priority Chemicals of Concern for Children’s Health is collapsed 
into acronym “HPCCCH.”
CHANGES TO RULE: 
333-016-2030  
Modifications to the List of High Priority Chemicals of Concern for Childrens Health ¶ 
 
(1) The Oregon Health Authority shall consider adding a chemical to the list of high priority chemicals of concern 
for children's health in OAR 333-016-2020 if that the chemical , on or after the effective date of these rules :¶ 
(a) Has been added to any of the following:¶  
(A) Washington's list of Chemicals of High Concern to Children (WAC 173-334-130);¶  
(B) Maine's list of Chemicals of High Concern (Maine law 38  1693-A(2));¶  
(C) Minnesota's list of Chemicals of High Concern (Minn. Stat. 2010 116.9401 - 116.9407);¶  
(D) Vermont's list of Chemicals of high concern to children (18 V.S.A. chapter 38A  1773);¶  
(b) Is currently or subsequently identified by the United States Environmental Protection Agency (USEPA) as 
being "carcinogenic to humans", or "likely to be carcinogenic to humans" through USEPA's Integrated Risk 
Information System;¶  
(c) Has been or is subsequently found to have a reference dose or reference concentration based on neurotoxicity 
through USEPA's Integrated Risk Information System;¶  
(d) Is currently or subsequently identified in monographs on the Potential Human Reproductive and 
Developmental Effects, United States Office of Health and Human Services National Toxicology Program, Office 
of Health Assessment and Translation as a reproductive or developmental toxicant; or¶  
(e) Is currently or subsequently identified by the Centers for Disease Control and Prevention in its National 
Report on Human Exposure to Environmental Chemicals.¶  
(2) The Authority shall also consider adding a chemical to the list of high priority chemicals of concern for 
children's health HPCCCHs  in OAR 333-016-2020 if that the chemical, on or after the effective date of these 
rules:¶  
(a) Is found to have the potential, as demonstrated by credible, peer-reviewed scientific evidence to:¶  
(A) Harm the normal development of a fetus or child or cause other developmental toxicity;¶  
(B) Act as a carcinogen;¶  
(C) Cause genetic damage or reproductive harm;¶  
(D) Disrupt the endocrine system;¶  
(E) Damage the nervous system, immune system or organs;¶  
(F) Cause other systemic toxicity;¶  
(G) Be a very persistent toxic substance by having a half-life greater than or equal to one of the following:¶  
(i) A half-life in soil or sediment of greater than one hundred eighty days.¶  
(ii) A half-life greater than or equal to sixty days in water or evidence of long-range transport; or¶  
(H) Be a very bioaccumulative toxic substance by having a bioconcentration factor or bioaccumulation factor 
greater than or equal to five thousand, or if neither are available, having a log Kow greater than 5.0; and¶  
(b) Has been found through:¶  
(A) Biomonitoring to be present in human blood, umbilical cord blood, breast milk, urine or other bodily tissues or 
fluids;¶  
(B) Sampling and analysis to be present in household dust, indoor air, drinking water or elsewhere in the home 
environment; or¶  
(C) Monitoring to be present in fish, wildlife or the natural environment.¶  
(3) The Oregon Health Authority may remove a chemical from the list if the Authority determines that:¶  
(a) The chemical is no longer being used in children's products; or¶  
Page 17 of 50(b) The chemical has been removed from any of the lists identified in subsection (1)(a) through (e) of this rule.¶  
(4) The list of high priority chemicals of concern for children's health HPCCCHs  in OAR 333-016-2020 may only be 
modified by following the Administrative Procedures Act rulemaking process.  
Statutory/Other Authority: O L 2015, ch. 786, sec. 3 RS 413.042, ORS 431A.255  
Statutes/Other Implemented: O L 2015, ch. 786, sec. 3 RS 431A.255
 
Page 18 of 50AMEND: 333-016-2035
RULE SUMMARY: Amend OAR 333-016-2035 Exhibit A to harmonize spelling or chemical wording in several of the 68 
HPCCCH in OAR 333-016-2035 Exhibit A with that of their counterparts listed for Washington State’s Children’s Safe 
Products Act (CSPA). These modifications are done to assist those providing biennial notifications to the Authority, and 
to assist members of the public in their search for HPCCCH in children’s products.
CHANGES TO RULE: 
333-016-2035  
Manufacturer Disclosure of High Priority Chemicals of Concern for Childrens Health Used in Childrens Products: 
Practical Quantification Limits ¶  
 
(1) The practical quantification limit for a chemical that is a contaminant is 100 parts per million.¶  
(2) The practical quantification limits for intentionally added chemicals are the limits established in Exhibit A, 
incorporated by reference.  
Statutory/Other Authority: ORS 413.042  
Statutes/Other Implemented: ORS 431A.253 - - 431A.280
RULE ATTACHMENTS DO NOT SHOW CHANGES. PLEASE CONTACT AGENCY REGARDING CHANGES.
 
Page 19 of 50Effective  TBD per filing w/ SOS   
OAR 333 -016-2035  
Exhibit A: Projected PQLs for the 68 high priority chemicals of concern in children’s products  
 
Chemical         CAS PQL 
(ppm)              Method  
1 Formaldehyde  50-00-0 5.0 8315  
2 Aniline  62-53-3 1.0 8270  
3 N-Nitrosodimethylamine  62-75-9 1.0 8270  
4 Benzene  71-43-2 1.0 8260  
5 Vinyl chloride  75-01-4 1.0 8260  
6 Acetaldehyde  75-07-0 1.0 8315  
7 Methylene chloride  75-09-2 1.0 8260  
8 Carbon disulfide  75-15-0 10.0  8260  
9 Methyl ethyl ketone  78-93-3 1.0 8260  
10 1,1,2,2 -Tetrachloroethane  79-34-5 1.0 8260  
11 Tetrabromobisphenol A  (TBBPA)  795-94-7 20.0  3540/GCMS  
12 Bisphenol A  (BPA)  80-05-7 20.0  8720  
13 Bisphenol S  (BPS ) 80-09-1 1.0 1694  
14 Diethyl phthalate  (DEP)  84-66-2 5.0 8720  
15 Di-n-butyl phthalate (DBP)  Dibutyl phthalate  84-74-2 5.0 8720  
16 Di-n-hexyl Phthalate  (DnHP)  84-75-3 5.0 8720  
17 Butyl benzyl phthalate (BBP)  85-68-7 5.0 8720  
18 N-Nitrosodiphenylamine  86-30-6 1.0 8720  
19 Hexachlorobutadiene  (HCDB)  87-68-3 30.0  8720  
20 Propyl paraben  94-13-3 30.0  HPLC  
21 Butyl paraben  94-26-8 30.0  HPLC  
22 2-Aminotoluene  95-53-4 1.0 8720  
23 2,4-Diaminotoluene  95-80-7 10.0  GC/MS  
24 Methyl paraben  99-76-3 30.0  HPLC  
25 p-Hydroxybenzoic acid 4-Hydroxybenzoic acid  99-96-7 10.0  HPLC  
26 Ethylbenzene  100-41-4 1.0 8260  
27 Styrene  100-42-5 1.0 8260  
   28 4-Nonylphenol 4-Nonylphenol ; 4-NP and its 
isomer mixtures including CAS 84852 -15-3 
and CAS 25154 -52-3 104-40-5           10.0                                                USGS 5 -B2 
29 4-Chloroaniline para -Chloroaniline  106-47-8 60.0  8720  
30 Acrylonitrile  107-13-1 1.0 8260  
31 Ethylene glycol  107-21-1 5.0 8015  
32 Toluene  108-88-3 1.0 8260  
33 Phenol  108-95-2 60.0  8270  
34 2-Methoxyethanol  109-86-4 10.0  8015  
35 Ethylene glycol monoethyl e ther  110-80-5 10.0  8015  
Page 20 of 50Effective  TBD per filing w/ SOS  Chemical  CAS          PQL 
      (ppm)  Method  
36 Triphenyl phosphate  (TPP)  115-86-6 50.0  8270  
37 Tris(2 -chloroethyl) phosphate  (TCEP) 115-96-8 50.0  8270  
38 Di-2-ethylhexyl phthalate  (DEHP)  117-81-7 20.0  8270  
39 Di-n-octyl phthalate (DnOP)  117-84-0 5.0 8270  
40 Hexachlorobenzene  118-74-1 30.0  8270  
41 3,3´-Dimethylbenzidine & Dyes Metabolized to same  
3,3'-Dimethylbenzidine and Dyes Metabolized to 3,3'-
Dimethylbenzidine 3,3'-Dimethylbenzidine and Dyes 
Metabolized to 3,3' -Dimethylbenzidine  119-93-7 10.0  8270  
42 Ethyl paraben  120-47-8 30.0  HPLC  
43 1,4-Dioxane  123-91-1 1.0 8720/many  
44 Perchloroethylene Tetrachloroethene  127-18-4 0.5 8260/many  
45 Benzophenone -2; 2,2’,4,4’ -
Tetrahydroxybenzophenone  (Bp-2) 131-55-5 20.0  GC-FID 
46 4-tert-Octylphenol   140-66-9 10.0  USGS 5 -B2 
47 Estragole   140-67-0 10.0  IFRA GCMS  
48 2-Ethylhexanoic Acid   149-57-5 1.0 Not given  
49 Benzene, Pentachlorobenzene Pentachlorobenzene   608-93-5 1.0 8270  
50 C.I. Solvent Yellow 14   842-07-9 1.0 LC/MS1 
51 N-Methylpyrrolidone  872-50-4 50.0  8015/8270  
52 2,2',3,3',4,4',5,5',6,6' -Decabromodiphenyl ether (BDE-
209) 1163 -19-5 10.0  8270  
53 Perfluorooctane  sulfonic acid and its 
salts Perfluorooctanyl sulphonic acid and its salts ; PFOS  1763 -23-1 1.0 EPA PFOA  
54 4-Octylphenol  Phenol, 4 -octyl phenol  1806 -26-4 10.0  USGS 5 -B2 
55 2-Ethyl -hexyl -4-methoxycinnamate   5466 -77-3 5.0 HPLC  
56 Mercury (7439 -97-6) & mercury compounds including  
methyl mercury   7439 -97-6 0.5 EPA2 
57 Antimony & Antimony compounds   7440 -36-0 1.0 EPA3 
58 Arsenic & Arsenic compounds including arsenic 
trioxide  
(1327 -53-3) and dimethyl arsenic (75 -60-5) 7440 -38-2 1.0 EPA3 
59 Cadmium & cadmium compounds  7440 -43-9 1.0 EPA3 
60 Cobalt & Cobalt compounds  7440 -48-4 1.0 EPA3 
61 Tris(1 -chloro -2-propyl) phosphate  (TCPP)   13674 -84-5 50.0  8270  
62 Tris(1,3 -dichloro -2-propyl) phosphate  (TDPP)  13674 -87-8 50.0  8270  
63 Butylated hydroxyanisole  (BHA )  25013 -16-5 10.0  USGS 5 -B2 
64 Hexabromocyclododecane  25637 -99-4 10.0  3540/GCMS  
65 Diisodecyl phthalate (DIDP)  26761 -40-0 50.0  8270  
66 Diisononyl phthalate (unbranched) (DINP)  28553 -12-0 50.0  8270  
    67 Short -chain chlorinated paraffins         85535 -84-8           50.0                        GCMS  
Page 21 of 50Effective  TBD per filing w/ SOS  68 2-ethylhexyl -2,3,4,5 -tetrabromobenzoate (TBB)  183658 -27-7 50.0  8270  
 
Page 22 of 50Effective  TBD per filing w/ SOS   
Page 23 of 50REPEAL: 333-016-2040
RULE SUMMARY: Repeal OAR 333-016-2040 Purpose and Scope. To be replaced in purpose and scope with similar 
language in other sections of these rules.
CHANGES TO RULE: 
333-016-2040  
Purpose and Scope  
OAR 333-016-2035 through 333-016-2090:¶  
(1) Require manufacturers of children's products to disclose high priority chemicals of concern for children's 
health used in children's products, unless the manufacturer is exempt;¶  
(2) Establish requirements for disclosure;¶  
(3) Establish a process for a manufacturer to apply for an exemption from the disclosure requirements;¶  
(4) Establish a fee schedule; and¶  
(5) Describe the Authority's civil penalty authority and enforcement process.  
Statutory/Other Authority: ORS 413.042  
Statutes/Other Implemented: ORS 431A.253-431A.280
 
Page 24 of 50REPEAL: 333-016-2050
RULE SUMMARY: Repeal OAR 333-016-2050 Definitions. That provision’s terms and definitions are embedded in OAR 
333-016-2010 Definitions.
CHANGES TO RULE: 
333-016-2050  
Definitions  
(1) "Authority" means the Oregon Health Authority.¶  
(2) "Chemical" has the meaning given that term in ORS 431A.253.¶  
(3) "Chemical Abstracts Service Registry Number" means the number assigned for identification of a particular 
chemical by the Chemical Abstracts Service, a service of the American Chemical Society that indexes and compiles 
abstracts of worldwide chemical literature called Chemical Abstracts.¶  
(4) "Child" means an individual under 12 years of age.¶  
(5) "Children's product" has the meaning given that term in ORS 431A.253.¶  
(6) "Component part" means a uniquely identifiable material or coating (including ink or dye) that is intended to be 
included as a part of a finished children's product, including, but not limited to:¶  
(a) Bio-based Materials (Animal or Plant based);¶  
(b) Synthetic Polymers (such as but not limited to synthetic rubber, plastics, and foams);¶  
(c) Metals (including alloys);¶  
(d) Glass, Ceramic and Siliceous material;¶  
(e) Surface coatings (such as but not limited to paints, plating, and waterproofing);¶  
(f) Homogenous Mixtures (gels, creams, powders, liquids, adhesives, synthetic fragrances);¶  
(g) Inks/Dyes/Pigments; and¶  
(h) Textiles (synthetic fibers and blends).¶  
(7) "Contaminant" has the meaning given that term in ORS 431A.253.¶  
(8) "De minimis level" has the meaning given that term in ORS 431A.253.¶  
(9) "HPCCCH" means high priority chemicals of concern to children's health.¶  
(10) "High priority chemicals of concern list" means the high priority chemicals of concern for children's health 
identified by the Authority in OAR 333-016-2020.¶  
(11) "Intentionally added chemical" has the meaning given that term in ORS 431A.253.¶  
(12) "Manufacturer" has the meaning given that term in ORS 431A.253¶  
(13) "Manufacturing control program" means a program implemented by the manufacturer or its suppliers to 
control the amount of a high priority chemical of concern in children's products present as a contaminant at or 
above de minimis through the implementation of tools, processes and oversight that support effective chemicals 
management at all levels to include supply chain management, quality assurance and educational programs. 
Control includes the minimization, reduction or elimination of contaminants when possible.¶  
(14) "Mouthable" has the meaning given that term in ORS 431A.253.¶  
(15) "Owner" for purposes of clarifying the definition of "manufacturer" means the first person or entity, whether 
an importer or a distributor, that first offers the children's product for sale in Oregon.¶  
(16) "Practical quantification limit" has the meaning given that term in ORS 431A.253.¶  
(17) "Product category" means the "brick" level of the GS1 Global Product Classification (GPC) standard, which 
identifies products that serve a common purpose, are of a similar form and material, and share the same set of 
category attributes.¶  
(18) "These rules" means OAR 333-016-2040 to 333-016-2100.¶  
(19) "Trade association" has the meaning given that term in ORS 431A.253.  
Statutory/Other Authority: ORS 413.042  
Statutes/Other Implemented: ORS 431A.253-431A.280
 
Page 25 of 50AMEND: 333-016-2060
RULE SUMMARY: Amend OAR 333-016-2060 Notification Requirements to specify the fees and clarify the reporting 
deadlines for manufacturers to report products that contain High Priority Chemicals of Concern for Children’s Health 
(HPCCCH) to the Authority. Establishes the requirement for manufacturers to provide an intended age category for 
products sold or offered for sale in Oregon. Clarifies requirement that trade associations, if reporting on behalf of their 
members, must provide the name and contact information for a representative of that member. In addition, establishes 
the requirement that trade associations, when reporting for member(s), must provide specific product categories being 
reported for that member and pay notification fees associated with that member’s report. Establishes that the number 
of products sold or offered for sale (reported as the number of units of such products) during a biennial notice period 
must be part of that manufacturer's biennial report. Establishes if a manufacturer has previously provided a biennial 
report to the Authority and only the number of products sold or offered for sale in Oregon has changed in the 
subsequent biennial notice period, that the manufacturer may inform the Authority, through email, that the previously 
reported data is still valid. They must still provide the number of products sold or offered for sale in the subsequent 
biennial notice period. Establishes the requirement that manufacturers reporting to the Authority must use the 
Interstate Chemicals Clearinghouse High Priority Chemicals Data System or alternate data system designated by the 
Authority. 
CHANGES TO RULE: 
333-016-2060  
Notification Requirements ¶  
 
(1) No later than January 1, 2018, and every other year thereafter, a manufacturer of a children's product sold or 
offered for sale in this state that contains a HPCCCH listed in OAR 333-016-2020 in an amount at or above a de 
minimis level must submit:¶  
(a) A notice to the Authority that contains all the information required in these rules, unless the manufacturer or 
product is exempt; and¶  
(b) A ny applicable fee  nonrefundable fee of $250 for the notification of each HPCCCH as specified  in OAR 333-
016-2080.¶  
(2) The first manufacturer's notice due on January 1, 2018, applies to children's products sold or offered for sale in 
this state between January 1, 2017 and December 31, 2017.¶  
(3) Future notices apply to children's products sold or offered for sale during Subsequent manufacturer reports are 
due on January 1st of even numbered years for  the previous two  -year biennial notice period. For example, for the 
reporting year 2020, a manufacturer must include children's products sold or offered for sale between January 1, 
2018, and December 31, 2019, that contain a HPCCCH listed in OAR 333-016-2020.¶  
(4) The notice required in section (1) of this rule must include the following:¶  
(a) The name and Chemical Abstracts Service Registry Number of the chemical contained in the children's 
product;¶  
(b) The product category of the children's product that contains the chemical;¶  
(c) A description of the function of the chemical in the children's product;¶  
(d) The amount of the chemical used in each unit of the children's product reported as a range rather than an exact 
amount;¶  
(e) The target age category for whom the children's product is intended, either ages 0-3, 3-12 or 0-12 years old.¶  
(f) The number of the children's product that contain the high priority chemical either sold or offered for sale in 
Oregon during the biennial notice period;  ¶ 
(fg) The name and address of the manufacturer, and the name, address and telephone number of the contact 
person for the manufacturer;  or¶ 
(gh) The name, address and contact information for the trade association submitting the notification on behalf of 
the affected industry; and¶  
Page 26 of 50(hi) Any other information that the manufacturer deems relevant to the appropriate use of the children's 
product.¶  
(5) The second biennial notice will cover the period of January 1, 2018 through December 31, 2019 No later than 
January 1, 2020, and every other year thereafter, notices to the Authority shall be submitted utilizing the 
Interstate Chemicals Clearinghouse's High Priority Chemicals Data System (HPCDS) or alternate data system 
designated by the Authority. A link to the data system will be made available on the Toxic Free Kids Program 
website: www.healthoregon.org/toxicfreekids. ¶  
(6) If a manufacturer, required to report under ORS 431A.258, is acquired by another business entity, merges into 
another business entity or separates into distinct business entities, the new controlling entity must submit the 
required biennial notices to the Authority .¶ 
(67) If a manufacturer has included a children's product in a notice required under these rules, and determines 
that there is no change to the information for the product except the number of products sold or offered for sale 
submitted to the Authority in the previous notice, the manufacturer may, in lieu of including the children's product 
again in a subsequent notice, submit a written statement, or if available, an electronic notification indicating that 
the previous reported data is still valid for that children's product.  The notification shall include the number of 
products sold or offered for sale during the biennial notice period. ¶ 
(78) A trade association may provide the notice required in these rules on behalf of a member manufacturer.  If a 
trade association reports on a member manufacturer's behalf, the trade association must specify which member 
or members the association is reporting on behalf of, including the name and contact information of a 
representative for each of those members, and must submit the fees for each member as required in OAR 333-
016-2080. ¶ 
(89) A trade association who fulfills the notice or exemption requirements of these rules on behalf of a member 
manufacturer will not be held liable for a violation or penalty as a result of the member manufacturer's 
noncompliance with the requirements of these rules.¶  
(910) A manufacturer may, during the notification process, submit to the Authority recommendations regarding 
technical, financial or logistical support considered necessary for the implementation of innovation and green 
chemistry solutions related to HPCCCH used in children's products.¶  
(101) Only one person or entity that falls within the definition of manufacturer is required to report with respect 
to a particular children's product. The Authority will hold the following primarily responsible for ensuring that it 
receives a complete, accurate, and timely notice for the children's product, in the following order:¶  
(a) Any person or entity that manufactured the children's product, unless it has no presence in the United States.¶  
(b) Any person or entity that distributed or made available for distribution the children's product, unless it has no 
presence in the United States.¶  
(c) The importer or owner of the children's product in the United States.¶  
(112) The Authority will enforce the reporting requirements in this rule against a manufacturer in the same order 
as the priority order for reporting in section (1 0) of this rule 1) of this rule. ¶  
(13) If a manufacturer has included a children's product in a notice required under these rules, and removes the 
HPCCCH from that children's product it shall, within 90 days of removal, submit a written statement, or if 
available, an electronic notification indicating the HPCCCH that was removed, whether another HPCCH was 
substituted and the date the removal was effective, unless the Authority has already been notified under OAR 
333-016-3010(1). Such notification will help the Authority avoid any unnecessary enforcement actions because of 
a failure to report or failure to comply with the other requirements of these rules . 
Statutory/Other Authority: ORS 413.042, 431A.258  
Statutes/Other Implemented: ORS 431A.258
 
Page 27 of 50ADOPT: 333-016-2065
RULE SUMMARY: Adopt OAR 333-016-2065 Formal Communications Regarding Toxic Free Kid. Specifies the email 
address that the Authority and manufacturers/trade associations shall use for formal communications regarding 
waivers, chemical substitution, chemical removal, or exemption requests, and their fees.
CHANGES TO RULE: 
333-016-2065  
Formal Communications Regarding Toxic Free Kids  
Formal communication between manufacturers or trade associations and the Authority relating to waiver, 
chemical substitution, chemical removal, or exemption requests, and their fees, shall be to and from 
ToxicFreeKids.Program@dhsoha.state.or.us.  
Statutory/Other Authority: ORS 413.042, ORS 431A.258  
Statutes/Other Implemented: ORS 431A.258
 
Page 28 of 50AMEND: 333-016-2070
RULE SUMMARY: Amend OAR 333-016-2070 Exemptions from Notification Requirement to clarify the need for trade 
associations requesting an exemption from notification requirements on a manufacturer's behalf provide the company 
name and contact information for the manufacturer. Clarifies the information needed by the Authority to evaluate 
whether or not the measures listed in the manufacturing control program will control the HPCCCH as a contaminant. 
Establishes a deadline for requesting an exemption for a particular reporting period. Specifies the information that must 
be submitted as part of an exemption request and specifies the process for making amendments to exemptions that 
have already been approved by the Authority.
CHANGES TO RULE: 
333-016-2070  
Exemptions from Notice Requirement ¶ 
 
(1) A manufacturer of children's products with annual worldwide gross sales of less than $5 million, as reported on 
the most recent tax return filed by the manufacturer before the notification required under OAR 333-016-2060, 
is exempt from all the requirements of these rules.¶  
(2) If, following the filing of the most recent tax return, a manufacturer's annual worldwide gross sales are $5 
million or more, the manufacturer must submit a notice as required under OAR 333-016-2060. The notice must be 
submitted during the next applicable reporting period or within 180 days of the filing, whichever is later.¶  
(3) A manufacturer or trade association may submit to the Authority a request for an exemption from these rules 
if the HPCCCH in a children's product is present only as a contaminant at or above the de minimis level, and a 
manufacturing control program  (MCP)  is in place. A request for an exemption must be accompanied by any 
applicable fees in OAR 333-016-2080.  ¶ 
(4a) IAn order to meet the standards for an exemption a manufacturing control program exemption request 
submitted by a trade association on behalf of its members must identify each member for which the exemption is 
being requested, including the name and contact information of a representative for each of those members. ¶  
(b) A request for an exemption from these rules by any entity must be received by the Authority before the last 
day (December 31st) of the two-year biennial notice period.¶  
(4) In order to meet the standards for an exemption an MCP  must be structured using at least one of the following 
categories:  ¶ 
(a) Manufacturing processes, for example polymerization of plastic resin, injection-molding of plastic, pad-transfer 
printing, silk screening;  ¶ 
(b) Materials or group of materials, for example multiple styrenic plastics;¶  
(c) Component parts;¶  
(d) A HPCCCH present as a contaminant at or above the de minimis level; or¶  
(e) Finished products.¶  
(5) In addition to the information provided in section (4) of this rule a manufacturer or a trade association must 
document in its exemption request the specific HPCCCH present as a contaminant at or above the de minimis 
level that the manufacturing control program MCP  is intended to address and the product categories where the 
HPCCCH are found.  MCPs submitted in support of an exemption request by a trade association on behalf of a 
member or members must include the product categories for which each member is seeking an exemption. ¶ 
(6) In order for the manufacturer to demonstrate that a  manufacturing control program n MCP  meets the 
minimum standards for an exemption, the manufacturing control program MCP  must meet generally-recognized 
industry best manufacturing practices and processes for the control of a HPCCCH, such as but not limited to:  ¶ 
(a) The most current and appropriate International Standards Organization (ISO) requirements for a specific 
manufacturing process or facility. The manufacturer must demonstrate how the ISO certification held by the 
manufacturer or supplier is controlling the contaminant in a component part or in the finished children's product ;.
¶ 
Page 29 of 50(b) Another established certification or standards manufacturing control program such as, but not limited to, Sony 
Corporations Green Partners Standards, the European ROHS (Restriction of Hazardous Substances in Electronic 
Parts),  and  EN  -71.¶  
(c) The most current American Society for Testing and Materials (ASTM) International standards that provide the 
recommended industry standards for materials used or produced in the manufacturing process;¶  
(d) Any proven alternative methodology that will enable the manufacturer to demonstrate:¶  
(A) That the methodology controls the contaminant to the lowest practicable levels in the finished children's 
product; and¶  
(B) That the alternative methodology is as or more effective at controlling the contaminant than the standards in 
subsections (a) through (c) of this section.¶  
(7) In addition to meeting one of the requirements of subsections (6)(a) through (d For any category described in 
section (4) of this rule a manufacturer must provide adequate evidence that the contaminant is being controlled, 
including but not limited to: ¶  
(a) Laboratory test reports from a third-party laboratory accredited to ISO 17025:2017 standards, and that is 
accredited for the method used to conduct the testing that shows the presence, if quantifiable, and the amount of 
a HPCCCH, including documentation that characterizes the test methodology. ¶  
(b) A supplier's certificate of analysis documenting the maximum levels of contaminant in any category described 
in section (4) of this rule for which the exemption is being requested. A certificate of analysis must include:¶  
(A) The name and address of the laboratory that performed the tests;¶  
(B) The name and description of the product or material being tested, including, if known, the batch number used 
by the original manufacturer;¶  
(C) The date of the batch's manufacture; ¶  
(D) A description of methodology employed to take samples from the batch to ensure that samples are 
representative of the product or material being tested;¶  
(E) A reference to the analytical laboratory test method used, including the data quality assurance criteria and 
reporting limits;¶  
(F) The results of all analytical laboratory tests performed on the batch for which the certificate is issued (in 
numerical form, where applicable) and a comparison with the established acceptance criteria (limits); ¶  
(G) The date or dates on which the test or tests were performed; and¶  
(H) The signature of an authorized representative of the laboratory, and the contact information for that 
individual.¶  
(c) Documentation demonstrating that the instituted control measures are able to control the contaminant, as 
appropriate for the category described in section (4) of this rule, including but not limited to, the quantification of 
the degree of contaminant control occurring because of contaminant control measures instituted.¶  
(8) In addition to meeting one of the requirements of section (6 ) of this rule a manufacture must document and 
describe, in its exemption request, whether the manufacturer's or the manufacturer's supplier's manufacturing 
control process, include any of the following:  ¶ 
(a) Procedures to ensure the quality and purity of feedstock, whether raw or recycled;¶  
(b) Contract specifications for manufacturing process parameters, for example material purity, drying and curing 
times when relevant to the presence of high priority chemicals in the finished children's product components;¶  
(c) Periodic testing for the presence and amount of HPCCCH in the finished children's product, including 
documentation of how tests were conducted and applicable lab results from an accredited third party 
laboratory;¶  
(d) Procedures and approaches to audit the methods used by contractors or suppliers to control a HPCCCP 
present as a contaminant in a children's product; and¶  
(ed) Education and outreach to members of a supply chain about the importance to the manufacturer of 
controlling the amount of HPCCCH in supplied materials through activities such as discussions with suppliers, oral 
presentations, written materials or webinars.¶  
(89) The Authority, upon receipt of an exemption request will date stamp the document. Once date stamped the 
Page 30 of 50Authority must approve or deny an exemption request within 180 days.¶  
(a) If the Authority does not approve or disapprove the exemption request within 180 days the manufacturing 
control program exemption is deemed approved.¶  
(b) If the Authority approves the exemption the Authority will notify the manufacturer of the approval, in 
writing.¶  
(c) If an exemption request is disapproved, the Authority will provide written notice to the manufacturer of the 
disapproval and the reason for the disapproval.¶  
(910) If the Authority disapproves an exemption request, the manufacturer may submit a revised exemption 
request for consideration within 180 days after the Authority's notice of disapproval.¶  
(101) If the exemption request is denied a second time, the manufacturer will have 90 days from the date of the 
written notification of disapproval to submit a notification in accordance with OAR 333-016-2060.¶  
(112) Resubmission of exemption requests in this rule is not allowed after the second disapproval.¶  
(13 ) At any time the Authority may request additional information from a manufacturer requesting an exemption
.¶ 
(12) If a manufacturer submits information to the Authority as part of its request for an exemption under this rule 
that the manufacturer believes is a trade secret, the manufacturer must mark the information "confidential - trad , 
and may specify the time period by which the manufacturer must provide the requested information¶  
(14) A manufacturer or trade association may request an amendment of an MCP previously approved by the 
Authority. A request must be made at least 30 days before the next biennial notice period. Such amendments are 
limited to the following:¶  
(a) The addition of product categories to an MCP provided that the HPCCCH in the manufacturing of products in 
these added categories is monitored and controlled, at all stages, with the specific mechanisms, tests and 
processes itemized in the approved MCP. ¶  
(b) Changes in the specific mechanisms, tests and processes identified in an approved MCP that ar e usecret." d to 
control an HPCCCH. ¶ 
(ac) If the Authority receives a publ The inclusion of additional members for specific product categories on an MCP 
approved by the Authority provided those members use all specif ic rmecords request for records related to a 
request for an exemption under this rule, it will review all documents submitted by the manufacturer to determine 
whether the documents contain trade secrets that would be exempt from disclosure under Oregon's Public 
Records Act, ORS 192.501(2).¶  
(b) For purposes of this section "trade secret" has the meaning given that term in ORS 192.501(2) hanisms, tests 
and processes itemized on the approved MCP for those product categories. ¶  
(15) The Authority may impose an MCP review fee under OAR 333-016-2080(1)(b)(B) for review of a request to 
amend an approved MCP.¶  
(16) Within 90 days the Authority will inform the holder of the approved exemption request if the proposed 
amendment to the MCP still meets the standards for exemption as described in these rules. ¶  
(17) Trade associations seeking to include additional members on an MCP approved by the Authority in 
accordance with subsection (14)(c) of this rule shall submit a new exemption request as specified in section (3) of 
this rule. A request for an exemption must be accompanied by any applicable fees in OAR 333-016-2080. A 
request to add a member manufacturer to an approved MCP must include the product categories for which each 
member manufacturer is seeking exemption from these rules. ¶  
(18) A trade association must notify the Authority within 90 days of the date it determines a manufacturer 
member listed on an approved MCP is no longer party to an approved MCP.¶  
(19) An approved MCP is only valid for the manufacturer that submitted it for approval. If a manufacture with an 
approved MCP merges with or is acquired by another business entity the new controlling entity must send a 
notice to the Authority within 90 days confirming that the specific mechanisms, tests and processes itemized in 
the previously approved MCP will continue to be utilized, or the exemption will be considered by the Authority to 
be invalid . 
Statutory/Other Authority: ORS 413.042, 431A.258, 431A.268  
Page 31 of 50Statutes/Other Implemented:  ORS  431A.258, 431A.268
 
Page 32 of 50AMEND: 333-016-2080
RULE SUMMARY: Amend OAR 333-016-2080 Fees to specify the non-refundable application fees for requesting a 
waiver from the requirement to remove or substitute a high priority chemical of concern for children’s health. Specifies 
that the non-refundable application fee for an exemption request is $1,500. There is also a $200 per hour fee for 
outside consultants to review the documents sent in support of the applications. Establishes a process and timeline for 
the payment of fees relating to waiver applications, hazard assessments, and exemption requests. 
CHANGES TO RULE: 
333-016-2080  
Fees ¶  
 
(1) The following fees are established:¶  
(1a) Notification. A nonrefundable fee of $250 for the notification of each HPCCCH reported to the Authority 
under OAR 333-016-2060(1).¶  
(2b) Exemption request  made under OAR 333-016-2070(3) or (14) :¶ 
(aA) A non-refundable fee of $1,500; and¶  
(bB) The fee for review of a Manufacturing Control Program is $200 per hour.¶  
(3) The Authority shall not review a Manufacturing Control Program unless the fees required under this rule are 
pai$200 per hour for review of an MCP.¶  
(c) Request for waiving requirement to remove or substitute chemicals:¶  
(A) A non-refundable fee of $1,500; and¶  
(B) $200 per hour for review of an Alternatives Assessment or a Quantitative Exposure Assessment.¶  
(d) Request to substitute chemicals:¶  
(A) A non-refundable fee of $1,500; and¶  
(B) $200 per hour for review of a Hazard Assessment conducted with an alternative methodology under OAR 
333-016-3030(6).¶  
(e) A non-refundable fee of $1,500 for a request to be exempt from removal or substitution requirements under 
OAR 333-016-3015.¶  
(2) The Authority will not accept an exemption request per OAR 333-016-2070(3) and (14) or OAR 333-016-
3015; a waiver to remove or substitute chemicals; a request to substitute chemicals; or a request to be exempt 
from removal or substitution requirements under OAR 333-016-3015 unless the non-refundable fee under this 
rule is submitted along with the request.¶  
(3) Prior to reviewing a request for a waiver, chemical substitution, exemption OAR 333-016-2070 and (14) or a 
Hazard Assessment conducted with an alternative methodology under OAR 333-016-3030(4), the Authority will 
send the applicant an estimate for the cost of the review. Unless the applicant informs the Authority in writing 
within seven business days of the date the fee estimate was sent, objecting to the estimate, the Authority will 
consider the estimate to be acceptable and will send an invoice to the applicant once the review of complete. ¶  
(4) If an applicant objects to the estimate in a timely manner the Authority will not review the request and the 
applicant may do one of the following:¶  
(a) Submit a second version of the initial request within 30 calendar days of the date the applicant submitted its 
objection to the Authority, in which case no additional application fee is required; or¶  
(b) Submit a new request and $1,500 non-refundable fee, if more than 30 days has passed since the applicant 
submitted its objection to the Authority; or¶  
(c) Comply with OAR 333-016-3010(3) or 333-016-2060.¶  
(5) If a second version of the initial request is submitted under subsection (4)(a) of this rule or if a new request is 
submitted under subsection (4)(b) of this rule, the Authority will provide a new estimate of the cost of the review. 
The Applicant will have seven calendar days to respon d by eithe  manufacturer and a request for exemption may 
be denied on the basis that the required fees were not paid r accepting or declining the estimate. If the estimate is 
declined, the Authority will consider the request for a waiver, chemical substitution, exemption, or Hazard 
Page 33 of 50Assessment conducted with an alternative methodology under OAR 333-016-3030(4) to be incomplete and the 
request will not be reviewed. The Authority will not accept a third version of the initial request or another 'new 
request.' ¶  
(6) If in the course of its review the Authority expects the actual number of hours to exceed the estimate by more 
than 15 percent the Authority will stop the review and send a new estimate to the applicant. Within seven 
business days from the date the new estimate was sent the applicant must do one of the following:¶  
(a) Accept the revised estimate by agreeing to pay for the new estimated amount; or ¶  
(b) Decline the new estimate and the Authority will consider the request for a waiver, chemical substitution, or 
exemption incomplete, and the request will not be reviewed. The Authority will invoice the Applicant for the 
actual hours spent on the review.¶  
(7) The process delineated in sections (3) through (6) of this rule also applies to revised requests for a waiver, 
chemical substitution, an exemption under OAR 333-016-2070(3) and (14), or a Hazard Assessment conducted 
with an alternative methodology under OAR 333-016-3030(4) .¶  
(8) An applicant must pay its review fees within 30 days of receipt of the invoice . 
Statutory/Other Authority: ORS 413.042, 431A.270  
Statutes/Other Implemented: ORS 431A.270
 
Page 34 of 50REPEAL: 333-016-2090
RULE SUMMARY: Repeal OAR 333-016-2090 Enforcement and Civil Penalties. Replacing with OAR 333-016-3080 
Enforcement and Civil Penalties.
CHANGES TO RULE: 
333-016-2090  
Enforcement and Civil Penalties ¶  
 
(1) The Authority may impose a civil penalty on a manufacturer for a violation of any provision of ORS 431A.258 
or these rules. A civil penalty may not exceed:¶  
(a) $2,500 for the first violation.¶  
(b) $5,000 for the second and each subsequent violation.¶  
(2) For purposes of assessing civil penalties under these rules a violation consists of a single course of conduct with 
regard to an entire children's product line that is sold or offered for sale in this state.¶  
(3)(a) If a manufacturer violates the notification requirement described in ORS 431A.258 the Authority shall 
provide the manufacturer with written notice informing the manufacturer of the violation and stating that the 
manufacturer may avoid a civil penalty for the violation by providing the proper notice required under ORS 
431A.258 within 90 days.¶  
(b) If the manufacturer fails to cure the violation within the first 90 days, the Authority may impose a civil penalty 
not to exceed $2,500.¶  
(c) For a continuing violation, each 90-day period that the violation continues after the preceding imposition of a 
civil penalty is considered a separate offense subject to a separate civil penalty not to exceed $5,000. The 
Authority is not required to provide the manufacturer with an opportunity to cure the continuing violation before 
imposing the separate civil penalty.¶  
(4) If the Authority has reason to believe that a children's product that contains a HPCCCH used in children's 
products is being sold or offered for sale in this state in violation of ORS 431A.258 the Authority may request that 
the manufacturer provide a statement of compliance on a form provided by the Authority. The manufacturer must 
submit the statement of compliance within 10 days after receipt of a request. To prove compliance with ORS 
431A.258 the manufacturer must provide:¶  
(a) Evidence that the children's product does not contain the HPCCCH used in children's products;¶  
(b) Evidence that the manufacturer has previously provided the Authority with notice as required by ORS 
431A.258 and these rules; or¶  
(c) Provide the Authority with notice as required by ORS 431A.258 and OAR 333-016-2060.¶  
(5) In imposing a penalty under these rules the Authority must consider the following factors:¶  
(a) The past history of the manufacturer in taking all feasible steps or following all feasible procedures necessary 
or appropriate to correct any violation.¶  
(b) Any prior violations of statutes, rules, orders or permits pertaining to HPCCCH used in children's products.¶  
(c) The gravity and magnitude of the violation.¶  
(d) Whether the violation was a sole event, repeated or continuous.¶  
(e) Whether the violation was a result of an unavoidable accident, negligence or an intentional act.¶  
(f) The violator's cooperativeness and efforts to correct the violation.¶  
(g) The economic and financial conditions of the manufacturer incurring a penalty.¶  
(h) The manufacturer's declaration that a HPCCCH used in a children's product is present only as a contaminant, 
and the manufacturer is able to provide evidence that a manufacturing control program for the contaminant that 
meets or exceeds the minimum requirements for a manufacturing control program in OAR 333-016-2070 was in 
place prior to the violation and that the manufacturer has exercised due diligence.¶  
(6) Civil penalties will be imposed in the manner provided in ORS 183.745.¶  
(7) The Authority will enforce the reporting requirements against a manufacturer in the same order as the priority 
order for reporting in OAR 333-016-2060(10).  
Page 35 of 50Statutory/Other Authority: ORS 431A.275, ORS 413.042  
Statutes/Other Implemented: ORS 431A.275
 
Page 36 of 50ADOPT: 333-016-3010
RULE SUMMARY: Adopt OAR 333-016-3010 Removal or Substitution of High Priority Chemical to specify the three 
categories of children’s products for which removal, substitution, or procurement of a waiver approved by the Authority 
is required, and respective due dates. Specifies the procedure that manufacturers must follow if removing a HPCCCH 
from a product or ceasing to manufacture the product (in lieu of substitution, waiver procurement). Specifies the 
process by which manufacturers with 25 or fewer employees may request a two-year extension of the date specified in 
ORS 431A.260(1) to meet the requirements of the rules.
CHANGES TO RULE: 
333-016-3010  
Removal or Substitution of High Priority Chemicals  
(1) On or before the date on which a manufacturer of a children's product submits the third biennial notice 
required under OAR 333-016-2060 for a HPCCCH that is present in a children's product, the manufacturer must 
remove or make a substitution, or seek a waiver under OAR 333-016-3040 if the HPCCCH is present in a 
children's product that is:¶  
(a) Mouthable;¶  
(b) A children's cosmetic; or¶  
(c) Made for, marketed for use by or marketed to children under three years of age.¶  
(2) A manufacturer with 25 or fewer employees may apply for a two-year extension of the date specified in ORS 
431A.260 to meet the requirements of these rules. To apply for an extension a manufacturer must submit a 
request for an extension. A request for an extension must: ¶  
(a) Be received by the Authority on or before the date on which the manufacturer of a children's product is 
obligated to submit the third biennial notice required under ORS 431A.260.¶  
(b) Include documentation that the manufacturer had an average of 25 or fewer employees on its payroll during 
the third biennial notice period and the number of employees currently employed by the manufacturer.¶  
(3) A manufacturer that has previously reported a HPCCCH to the Authority and later removes the HPCCCH 
from a children's product sold or offered for sale in Oregon and does not substitute another chemical or is no 
longer manufacturing such a product, must submit notice to the Authority that the manufacturer is no longer 
using the chemical or a substitute chemical or manufacturing the product. The notice must be submitted no later 
than the last day (December 31st) of the third biennial notice period. The notice shall include: ¶  
(a) The product category of the children's product; ¶  
(b) The brand names under which it is sold in Oregon and the model numbers of the children's product associated 
with those brand names. A manufacturer that intends to substitute a HPCCCH pursuant to ORS 431A.263 must 
comply with OAR 333-016-3030; and¶  
(c) Universal Product Code or Stock Keeping Unit codes, style codes or other mechanisms sufficient to identify 
product models sold in Oregon, which have been assigned by the manufacturer. ¶  
(4) From the date that the notice under section (3) of this rule is submitted, the manufacturer has 90 calendar days 
to:¶  
(a) Cease selling or offering for sale in Oregon the children's product; and ¶  
(b) Provide notice to all known distributers and retailers to whom the product was distributed that the product 
may no longer be sold or offered for sale in Oregon. To identify affected units of such children's products, the 
notice shall include Universal Product Code, Stock Keeping Unit codes, style codes or other mechanisms sufficient 
to identify the affected product models.¶  
(5) Units identified in this rule may no longer be sold or offered for sale in Oregon.¶  
(6) Manufacturers shall provide the Authority with the notice in subsection (4)(b) of this rule and a list of known 
distributers and retailers to whom notice was given.  
Statutory/Other Authority: ORS 413.042, ORS 431A.260, ORS 431A.268  
Statutes/Other Implemented: ORS 431A.260
Page 37 of 50 
Page 38 of 50ADOPT: 333-016-3015
RULE SUMMARY: Adopt OAR 333-016-3015 Exemptions from Removal or Substitution Requirements to specify four 
categories through which manufacturers can request an exemption from having to have a specific product comply with 
ORS 431A.260(1), and the process needed to apply for such exemptions. 
CHANGES TO RULE: 
333-016-3015  
Exemptions from Removal or Substitution Requirements  
(1) For purposes of this rule "children's product" is a children's product as defined in ORS 431A.253 that is:¶  
(a) Mouthable;¶  
(b) A children's cosmetic; or¶  
(c) Made for, marketed for use by or marketed to children under three years of age.¶  
(2) A manufacturer is exempt from meeting the requirement of removal or substitution of a HPCCCH in a 
children's product under ORS 431A.260 if one or more of the following is met: ¶  
(a) The children's product contains a HPCCCH used in children's products at levels that are at or below allowable 
levels for children's products as established by the Consumer Product Safety Improvement Act of 2008, P.L. 110-
314, 122 Stat. 3016, as in effect on July 27, 2015.¶  
(b) A manufacturer is in compliance with a federal consumer product safety standard adopted under federal law 
that establishes allowable levels for children's products of a high priority chemical of concern for children's health 
used in children's products.¶  
(c) The State of Washington has granted an exemption for the removal or substitution of a HPCCCH in the same 
children's product model for which the exemption is requested under OAR 333-016-3015.¶  
(d) A children's product has been tested under applicable EN-71 standards, by a laboratory with current 
accreditation to conduct such testing and found to be below the chemical migration limit of the EN-71 
requirement for the HPCCCH for which exemption is requested.¶  
(3) More than one product model may be submitted in a single exemption request. ¶  
(4) In order to be exempt under one or more of the categories in section (2) of this rule a manufacturer must 
submit an exemption request and the fees specified in OAR 333-016-2080(1)(e) and provide to the Authority 
written supporting documentation, including a certificate of conformity, if available, that clearly establishes that 
the children's product meets the applicable standards described in the applicable category including:¶  
(a) For an exemption request under subsection (2)(a) of this rule, the citation for the section of the Consumer 
Product Safety Improvement Act of 2008, P.L. 110-314, 122 Stat. 3016, in effect on July 27, 2015, naming the 
HPCCCH.¶  
(b) For an exemption request under subsection (2)(b) of this rule, a citation to the federal consumer product safety 
standard adopted under federal law that establishes an allowable level of a HPCCCH in children's products, 
specific to allowable levels of the HPCCCH in children's products. ¶  
(c) For an exemption request under subsection (2)(c) of this rule, a copy of the manufacturer's request for 
exemption under the applicable State of Washington law and the exemption approval from that state. ¶  
(d) For an exemption request under subsection (2)(d) of this rule, the technical dossier that a manufacturer is 
required to present to authorities enforcing the EN-71 standard that includes:¶  
(A) A citation of the EN-71 standard(s), current as of December 31, 2019, that is applicable to the HPCCCH for 
which an exemption is being sought; and ¶  
(B) A test report that identifies: ¶  
(i) The children's products being tested, as identified by Universal Product Code or Stock Keeping Unit codes, style 
codes or other information sufficient to identify them;¶  
(ii) The HPCCCH for which testing was conducted; and¶  
(iii) That the HPCCCH found to be migrating from the product, if at all, is below the chemical migration limit of the 
EN-71 requirement applicable to the HPCCCH for which exemption is being requested.¶  
(5) The specific children's products for which exemption is being sought under section (2) of this rule must be 
Page 39 of 50identified by manufacturers as specified in OAR 333-016-3010(3)(a) through (c).¶  
(6) This written documentation must be submitted in its entirely to the Authority on or before the date on which 
the manufacturer is required to submit the third biennial notice under ORS 431A.258 and OAR 333-016-2060.¶  
(7) The Authority will approve or disapprove an exemption request made under section (2) of this rule in writing 
within 180 days from receipt of all of the documentation required in the rule, explaining the basis of the approval 
or denial.¶  
(a) If the Authority does not approve or disapprove the exemption request made under section (2) of this rule 
within 180 days of its submission, the exemption is deemed approved.¶  
(b) If disapproved, a manufacturer may not resubmit an exemption request.¶  
(8) If a manufacturer is granted an exemption under subsection (2)(c) of this rule and subsequently the State of 
Washington withdraws the approval for the exemption, the manufacturer must immediately notify the Authority 
and come into compliance with ORS 431A.260 and these rules.  
Statutory/Other Authority: ORS 413.042, ORS 431A.260  
Statutes/Other Implemented: ORS 431A.260
 
Page 40 of 50ADOPT: 333-016-3020
RULE SUMMARY: Adopt 333-016-3020 Requirements for Chemical Substitution to specify the definition of children’s 
product for this rule and that of OAR 333-016-3040. Specifies that a Hazard Assessment must be provided when 
substituting a less-hazardous chemical for a HPCCCH in a children’s product. Provides the methods that should be used 
to identify children’s products for which a hazard assessment is being done. Specifies the process and timelines by which 
the Authority and those requesting a Hazard Assessment must abide by for submitting and reviewing a Hazard 
Assessment. 
CHANGES TO RULE: 
333-016-3020  
Requirements for Chemical Substitution  
(1) For purposes of this rule a "children's product" is a children's product as defined in OAR 333-016-3015(1) that 
is:¶  
(a) Mouthable;¶  
(b) A children's cosmetic; or¶  
(c) Made for, marketed for use by or marketed to children under three years of age.¶  
(2) When a manufacturer of a children's product that is sold or offered for sale in Oregon removes a HPCCCH as 
required in ORS 431.260 and intends to sell the product in Oregon with a substitute chemical, the manufacturer 
must provide or submit to the Authority no later than the last day (December 31st) of the third biennial notice 
period for the product:¶  
(a) A Hazard Assessment (HA) that meets the requirements in OAR 333-016-3030; and¶  
(b) The fees specified in OAR 333-016-2080.¶  
(3) The Authority must either approve or disapprove a HA within 180 days of the receipt of a HA and the 
information and fees required in section (2) of this rule.¶  
(4) During its review of the HA the Authority may request additional information from the manufacturer at any 
time and must specify the time period by which the manufacturer must provide the requested information.¶  
(5) If the Authority does not approve or disapprove the HA within 180 days from receipt of all of the information 
and fees required in section (2) of this rule the HA is deemed approved and the manufacturer may continue to sell 
or offer for sale in Oregon the children's product for which the manufacturer submitted a HA.¶  
(6) If the Authority approves a HA it will provide written notice to the manufacturer of the disapproval and the 
basis for the disapproval. ¶  
(7) If the Authority disapproves a HA the manufacturer may submit a revised HA within 180 days after the date of 
the Authority's notice of disapproval that meets the requirements of this rule. The payment of non-refundable 
fees in OAR 333-016-2080 is not required for a resubmitted HA. ¶  
(8) A revised HA is subject to the same requirements as an initial HA under this rule and the Authority will review 
and approve or disapprove a revised HA in the same manner as an initial HA. ¶  
(9) If the Authority disapproves an initial HA and no revised HA is submitted, the manufacturer has 90 calendar 
days to comply with OAR 333-016-3010(4) through (6).¶  
(10) The Authority will not consider any additional information it did not request that has been provided by a 
manufacturer and received by the Authority more than seven business days after the revised HA is submitted to 
the Authority.  
Statutory/Other Authority: ORS 413.042, ORS 431A.263  
Statutes/Other Implemented: ORS 431A.263
 
Page 41 of 50ADOPT: 333-016-3030
RULE SUMMARY: Adopt 333-016-3030 Hazard Assessments for Substitute Chemicals to specify that manufacturers 
are to have their substitute chemicals assessed by a Licensed GreenScreen Profiler using GreenScreen® for Safer 
Chemicals Hazard Assessment Guidance. Details the standards under which the Authority will approve chemicals 
proposed to replace a HPCCCH. States the Authority’s determination that GreenScreen Guidance is a scientifically-
based, data-driven methodology. Provides the possibility of the use of an alternative methodology for a Hazard 
Assessment as wells as the criteria, process and timeline that should be used to submit the alternative process to the 
Authority for approval.
CHANGES TO RULE: 
333-016-3030  
Hazard Assessment for Substitute Chemicals  
(1) A manufacturer must conduct a Hazard Assessment (HA) of the substitute chemical that includes:¶  
(a) A report:¶  
(A) By a Licensed GreenScreen Profiler using GreenScreen  for Safer Chemicals Hazard Assessment Guidance 
(GreenScreen methodology) that assesses the hazard level of the substitute chemical or chemicals; or¶  
(B) Using an Authority approved methodology as described in section (4) of this rule.¶  
(b) Information about each product model containing the HPCCCH and each final product model containing the 
substitute chemical that will enable the Authority to determine if the final children's product is inherently less 
hazardous than before. The information provided shall include but is not limited to:¶  
(A) A high-resolution image of the product model in JPEG or PDF form.¶  
(B) Identification of products on which a HA is conducted by manufacturers as specified in OAR 333-016-
3010(3)(a) through (c).¶  
(C) A complete list of the product model's components containing a HPCCCH at or above de minimis levels. For 
each component, the amount of HPCCCH in the component should be expressed as parts per million. The 
substitute chemical in each component of final product model should be expressed as parts per million. The 
HPCCCH and substitute chemical(s) shall be listed with their Chemical Abstract Numbers. ¶  
(2) The Authority will not approve a HA for a substitute chemical that has a high hazard level as determined by the 
GreenScreen methodology or Authority approved methodology for any of the following human health 
endpoints:¶  
(a) Reproductive toxicity;¶  
(b) Developmental toxicity;¶  
(c) Endocrine activity; or¶  
(d) Skin sensitization. ¶  
(3) For a HA submitted with an assessment from a Licensed GreenScreen Profiler:¶  
(a) A HPCCCH is considered by the Authority to be comparable to a chemical that has a GreenScreen Benchmark 
score of 1.¶  
(b) A substitute chemical is considered to be inherently less hazardous if it is assigned a GreenScreen Benchmark 
score of 2, 3 or 4, and is in compliance with section (2) of this rule. ¶  
(4) A manufacturer may request that the Authority approve an alternative methodology for conducting a HA that 
exists in the public domain and is equivalent to the GreenScreen Guidance methodology of this rule, including 
having an equivalent or stricter health hazard criteria for the human health endpoints described below:¶  
(a) Carcinogenicity;¶  
(b) Genotoxicity and mutagenicity;¶  
(c) Reproductive toxicity;¶  
(d) Developmental toxicity;¶  
(e) Endocrine activity;¶  
(f) Acute toxicity;¶  
Page 42 of 50(g) Systemic toxicity;¶  
(h) Neurotoxicity;¶  
(i) Skin sensitization;¶  
(j) Respiratory sensitization;¶  
(k) Skin irritation; or¶  
(l) Eye irritation.¶  
(5) Prior to conducting a HA using a methodology other than the GreenScreen methodology a manufacturer must 
submit detailed information about the methodology it proposes to use and a detailed analysis comparing the 
methodology to the GreenScreen Guidance methodology. ¶  
(a) Requests to use a HA methodology other than the GreenScreen methodology must be made at least 30 
business days before the date the manufacturer submits the Hazard Assessment.¶  
(b) The Authority will review the request and within 30 business days respond in writing to the manufacturer 
either approving or denying the request. ¶  
(6) The Authority will accept a HA that demonstrates through scientifically supported by objective data that the 
children's product and any substituted chemical is inherently less hazardous than before the substitution was 
made. ¶  
(7) For purposes of this rule and OAR 333-016-3060, the Authority: ¶  
(a) Finds that the GreenScreen methodology is scientifically supported by objective data;¶  
(b) Finds that an assessment by a licensed GreenScreen Profiler contains sufficient protocols and safeguards to 
ensure that the assessment is reliable; and¶  
(c) Will consider an assessment conducted by a licensed GreenScreen Profiler using the GreenScreen 
methodology that shows a children's product and any substitute chemical is inherently less hazardous than before 
the substitution was made, to be sufficient to approve a HA, assuming all other provisions of this rule and OAR 
333-016-3030 have been met.  
Statutory/Other Authority: ORS 413.042, ORS 431A.263, ORS 431A.265  
Statutes/Other Implemented: ORS 431A.263, ORS 431A.265
 
Page 43 of 50ADOPT: 333-016-3040
RULE SUMMARY: Adopt OAR 333-016-3040 Waiver from Removal or Substitution Requirement to specify the 
application process and timelines by which the Authority, and those requesting such a waiver must abide by for 
submitting and reviewing waiver documents. Specifies a manufacturer’s responsibilities if the Authority disapproves a 
revised waiver request or an initial waiver (if the manufacturer does not submit a revised version).
CHANGES TO RULE: 
333-016-3040  
Waiver from Removal or Substitution Requirement  
(1) For purposes of applying for a waiver from the removal or substitution requirement in ORS 431A.260 
"children's product" is a children's product that is:¶  
(a) Mouthable;¶  
(b) A children's cosmetic; or¶  
(c) Made for, marketed for use by or marketed to children under three years of age.¶  
(2) A manufacturer may request a waiver from the requirement to remove or substitute a chemical under ORS 
431A.260. An application for a waiver must include:¶  
(a) A Quantitative Exposure Assessment (QEA) that meets the requirements of OAR 333-016-3050; or ¶  
(b) An Alternatives Assessment (AA) that meets the requirements of OAR 333-016-3060.¶  
(3) An application for a waiver under this rule must be accompanied by the fees specified in OAR 333-016-2080 
and the following information:¶  
(a) The name, address, telephone number and other contact information for the manufacturer; and¶  
(b) The information required in OAR 333-016-2060(4)(a) through (i) for each children's product category or 
children's cosmetics for which a waiver is being requested, based on the information reported in the most recent 
Biennial Notice Period.¶  
(4) The Authority will not consider any additional information from the manufacturer it did not request, that is 
received by the Authority more than seven business days after a manufacturer submits a QEA, AA or an HA to the 
Authority. ¶  
(5) The Authority must either approve or disapprove a waiver request within 180 days of the receipt of a request 
and the fees required in sections (2) and (3) of this rule.¶  
(6) During its review of the waiver request the Authority may request additional information from the 
manufacturer that submitted the request at any time and must specify the time period by which the manufacturer 
must provide the requested information.¶  
(7) If the Authority does not approve or disapprove the waiver request within 180 days from receipt of the 
information and fees required in sections (2) and (3) of this rule the request is deemed approved and the 
manufacturer may continue to sell or offer for sale in Oregon the children's product for which the manufacturer 
submitted an AA or QEA.¶  
(8) If the Authority approves a waiver request the Authority will notify the manufacturer of the approval, in 
writing.¶  
(9) If the Authority disapproves a waiver request it will provide written notice to the manufacturer of the 
disapproval and the basis for the disapproval. ¶  
(10) If the Authority disapproves a waiver request the manufacturer may submit a revised waiver request that 
meets the requirements of this rule within 180 days after the date of the Authority's notice of disapproval. The 
payment of non-refundable fees in OAR 333-016-2080 is not required for a resubmitted waiver request. ¶  
(11) A revised waiver request is subject to the same requirements as an initial waiver request under this rule and 
the Authority will review and approve or disapprove a revised waiver request in the same manner as an initial 
request. ¶  
(12) If the Authority disapproves an initial or revised waiver request, or the Authority disapproves an initial 
request and the manufacturer does not submit a revised waiver request, the manufacturer has 90 calendar days to 
comply with OAR 333-016-3010(4) through (6). ¶  
Page 44 of 50(13) A manufacturer who has had an initial or revised waiver request disapproved who intends to remove the 
chemical or substitute a chemical may do so in compliance with these rules but may not sell or offer to sell the 
children's products unless and until the HPCCCH that is the subject of a the notice requirement in ORS 431A.258 
is removed and notice is given to the Authority or the Hazard Assessment for a substitute chemical has been 
approved by the Authority.¶  
(14) The Authority will disapprove any waiver request from a manufacturer that submits fraudulent information.  
Statutory/Other Authority: ORS 413.042, ORS 431A.263, ORS 431A.265  
Statutes/Other Implemented: ORS 431A.263, ORS 431A.265
 
Page 45 of 50ADOPT: 333-016-3050
RULE SUMMARY: Adopt OAR 333-016-3050 Quantitative Exposure Assessment to specify the standards and required 
content of this type of document which may be submitted as part of a request that ORS 431A.260(1) and its rules be 
waived for specified children’s product(s). 
 
 
CHANGES TO RULE: 
333-016-3050  
Quantitative Exposure Assessment  
(1) A Quantitative Exposure Assessment (QEA) must demonstrate that a HPCCCH in a children's product is not 
reasonably anticipated to result in exposure to a child based on an analysis of the leachability and bioavailability of 
the HPCCCH. ¶  
(2) A QEA may be done in two steps, as follows:¶  
(a) A description of exposure scenario(s) that demonstrate how, if at all, a HPCCCH in the children's product could 
reasonably be anticipated to be transferred to or into a child's body through a completed exposure pathway 
because of leachability and bioavailability of a HPCCCH from the children's product. Exposure scenarios must 
focus on the reasonably foreseeable use and abuse of the specified children's product. ¶  
(b) If the manufacturer determines that the exposure scenarios, through reasonably foreseeable use and abuse of 
the specified children's product, are reasonably anticipated to result in a completed exposure pathway to a child 
regardless of the amount of HPCCCH potentially transferred, the manufacturer shall submit information on the 
leachability and bioavailability of HPCCCH from a product, including measurements of the concentration of a 
HPCCCH in the simulated media such as saliva, sweat, or digestive fluid appropriate for the exposure scenarios, 
using analytical methods relevant to the chemical and the product. The manufacturer must also submit a copy of 
any analytical test results for the HPCCCH in each media tested that include:¶  
(A) The specific analytical methods or source of information utilized to determine the concentration of the 
HPCCCH in media relevant for each exposure pathway.¶  
(B) The detection limit for each HPCCCH for each analytical instrument used for the testing in each medium 
tested.¶  
(c) If a manufacturer determines that, based on exposure scenarios, a HPCCCH cannot reasonably be anticipated 
to be transferred to or into a child's body through a completed exposure pathway because of leachability and 
bioavailability and only conducts the first step of the QEA as described in subsection (2)(a) of this rule, the 
manufacturer shall provide a detailed report and analysis to the Authority that demonstrates to the Authority's 
satisfaction, that a child would not be exposed to a HPCCCH. ¶  
(3) A QEA must include citations from scientific literature for any assertion made. ¶  
(4) Laboratory analysis done for purposes of a QEA must be conducted by a laboratory accredited to ISO/IEC 
17025:2017 standards and the tests used in the QEA must fall within the scope of the laboratory's accreditation.¶  
(5) To enable accurate identification of children's products on which a QEA is conducted, such products must be 
identified by manufacturers as specified in OAR 333-016-3010(3)(a) through (c). ¶  
(6) In order to be approved a QEA must demonstrate that HPCCCH concentrations measured in the media are 
less than or equal to the Practical Quantification Limit of the HPCCCH established in OAR 333-016-2035(2), 
Exhibit A, incorporated by reference.¶  
(7) If the Authority determines that there are exposure scenarios for which a completed exposure pathway is 
possible through reasonably foreseeable use and abuse of the specified children's product, it will deny the QEA. 
The manufacturer may resubmit a revised request along with a completed QEA.  
Statutory/Other Authority: ORS 413.042, ORS 431A.265  
Statutes/Other Implemented: ORS 431A.265
 
Page 46 of 50ADOPT: 333-016-3060
RULE SUMMARY: Adopt OAR 333-016-3060 Alternatives Assessment to specify the standards and required content 
of this type of document which may be submitted as part of a request that ORS 431A.260(1) and its rules be waived for 
specified children’s product(s).
CHANGES TO RULE: 
333-016-3060  
Alternatives Assessment  
(1) An Alternatives Assessment (AA) must evaluate the possibility of replacing chemicals in products or processes 
with an inherently safer alternative, in order to better protect and enhance human health. ¶  
(2) A manufacturer must conduct an AA by doing a Hazard Assessment (HA), Quantitative Exposure Assessment 
(QEA), technical feasibility assessment, and financial feasibility assessment, starting with an HA, except as 
specified in section (3) of this rule. The three remaining assessments may be conducted in any order. For purposes 
of approving or disapproving a submitted AA, the Authority weighs the results of the modules, if needed, equally. 
¶ 
(3) If, after HA and technical feasibility assessments are conducted, an alternate chemical substitute or substitutes 
is not found to be technically feasible, the financial feasibility assessment is not required. ¶  
(4) The HA for purposes of an AA must be conducted in accordance with OAR 333-016-3030. ¶  
(5) The QEA for purposes of an AA must be conducted in accordance with OAR 333-016-3050.¶  
(6) To substantiate a claim that removal of a HPCCCH or substitution of a HPCCCH in a children's product with a 
less hazardous chemical is not technically feasible, a manufacturer must provide to the Authority the following for 
each HPCCCH in a children's product:¶  
(a) A detailed analysis of the role of each HPCCCH in the product specified by function, its application in the 
product (in a material, component, or manufacturing process) and whether the HPCCCH or function is non-
essential, substitutable or essential;¶  
(b) For HPCCCH roles labeled as substitutable or non-essential, an explanation with supporting evidence shall be 
provided that justifies retaining the HPCCCH in the children's product;¶  
(c) A detailed analysis of the role played by each HPCCCH in the product for the reliability, quality, useful life and 
acceptability to consumers of the product; and¶  
(d) After a HA is conducted, a detailed explanation of why it not technically feasible for any identified alternate 
chemical substitutes to fulfill the roles specified in subsections (a) through (c) of this section.¶  
(7) To substantiate a claim that removal or substitution of a HPCCCH is not financially feasible, a manufacturer 
must provide to the Authority a price comparison of the cost to produce the children's product with an alternative 
chemical to the current cost to produce the product. The comparison must include: ¶  
(a) Direct costs along the value-chain, such as product reformulation; ¶  
(b) Retooling;¶  
(c) Research or other capital investment costs;¶  
(d) An evaluation of adequate supply to meet demand; and¶  
(e) An evaluation of the potential reduction in price of the alternative chemical if the volume of the alternative 
chemical being purchased increases.  
Statutory/Other Authority: ORS 413.042, ORS 431A.263, ORS 431A.265  
Statutes/Other Implemented: ORS 431A.263, ORS 431A.265
 
Page 47 of 50ADOPT: 333-016-3070
RULE SUMMARY: Adopt OAR 333-016-3070 Trade Secrets to specify what manufacturers must do if they believe the 
information they are submitting is a trade secret as well as what the Authority will do if it receives a public records 
request for such records.
CHANGES TO RULE: 
333-016-3070  
Trade Secrets  
(1) If a manufacturer submits information to the Authority in order to comply with these rules that the 
manufacturer believes is a trade secret, the manufacturer must mark the information "confidential - trade 
secret."¶  
(2) If the Authority receives a public records request for information submitted by a manufacturer, it will review all 
documents submitted by the manufacturer to determine whether the documents contain trade secrets that would 
be exempt from disclosure under Oregon's Public Records Act, ORS 192.501.¶  
(3) For purposes of this rule "trade secret" has the meaning given that term in ORS 192.501.  
Statutory/Other Authority: ORS 192.501, ORS 413.042, ORS 431A.253 - 431A.280  
Statutes/Other Implemented: ORS 431A.253 - 431A.280
 
Page 48 of 50ADOPT: 333-016-3080
RULE SUMMARY: Adopt OAR 333-016-3080 Enforcement and Civil Penalties to specify the civil penalties for 
violations of the proposed rules, the process and timeline the Authority must follow to both determine and assess those 
penalties, and what manufacturers may do to remedy those violations. 
CHANGES TO RULE: 
333-016-3080  
Enforcement and Civil Penalties  
(1) The Authority may impose a civil penalty on a manufacturer for a violation of any provision of ORS 431A.258, 
431A.260 or 431A.263, or these rules. A civil penalty may not exceed:¶  
(a) $2,500 for the first violation.¶  
(b) $5,000 for the second and each subsequent violation.¶  
(2) For purposes of assessing civil penalties under these rules a violation consists of a single course of conduct with 
regard to an entire children's product line that is sold or offered for sale in Oregon.¶  
(3)(a) If a manufacturer violates the notification requirement described in ORS 431A.258 the Authority shall 
provide the manufacturer with written notice informing the manufacturer of the violation and stating that the 
manufacturer may avoid a civil penalty for the violation by providing the proper notice required under ORS 
431A.258 within 90 days.¶  
(b) If the manufacturer fails to cure the violation within the first 90 days, the Authority may impose a civil penalty 
not to exceed $2,500.¶  
(c) For a continuing violation, each 90-day period that the violation continues after the preceding imposition of a 
civil penalty is considered a separate offense subject to a separate civil penalty not to exceed $5,000. The 
Authority is not required to provide the manufacturer with an opportunity to cure the continuing violation before 
imposing the separate civil penalty.¶  
(4)(a) If a manufacturer continues to sell or offers for sale a product for which a chemical was required to be 
removed under ORS 431A.260, and the manufacturer does not have a pending or an approved waiver or hazard 
assessment request, the Authority shall provide the manufacturer with written notice informing the manufacturer 
of the violation. The notice shall state that the manufacturer may avoid a civil penalty by: ¶  
(A) Ceasing to sell or offer the product for sale; and¶  
(B) Contacting any known entities who are distributing or selling the product in Oregon, advising them that the 
product can no longer be sold in Oregon, and providing documentation of those notifications to the Authority in 
accordance with OAR 333-016-3010(4) through (6); or¶  
(C) Submitting proof to the Authority that it is not in violation as alleged in the notice. ¶  
(b) If the manufacturer does not submit proof that it is in compliance or fails to cure the violation within 90 days, 
the Authority may impose a civil penalty not to exceed $2,500.¶  
(c) For a continuing violation, each day that the violation continues after the preceding imposition of a civil penalty 
is considered a separate offense subject to a civil penalty not to exceed $5,000. The Authority is not required to 
provide the manufacturer with an opportunity to cure the continuing violation before imposing the separate civil 
penalty.¶  
(5) If the Authority has reason to believe that a children's product that contains a HPCCCH used in children's 
products is being sold or offered for sale in Oregon in violation of ORS 431A.258, 431A.260 or 431A.263 the 
Authority may request that the manufacturer provide a statement of compliance on a form provided by the 
Authority. The manufacturer must submit the statement of compliance within 30 days after receipt of a request. 
To prove compliance with ORS 431A.258, 431A.260 and 431A.263, the manufacturer must provide the Authority 
with proof that:¶  
(a) The children's product does not contain the HPCCCH at or above de minimis levels; or¶  
(b) The manufacturer has previously provided the Authority with notice as required by ORS 431A.258; or ¶  
(c) The manufacturer is providing notice as required by ORS 431A.258; or¶  
(d) The manufacturer or trade association has provided the Authority with an exemption request approved by the 
Page 49 of 50Authority under ORS 431A.260; or¶  
(e) The manufacturer possesses a hazard assessment for a substitution approved by the Authority for the 
HPCCCH and products in question under ORS 431A.263; or¶  
(f) The manufacturer possesses a waiver for the HPCCCH and products in question approved by the Authority 
under ORS 431A.265. ¶  
(6) Providing a notice under subsection (5)(c) of this rule does not exempt the manufacturer from compliance with 
the timelines for removal or substitution under ORS 431A.260, OAR 333-016-3015, ORS 431A.263, or OAR 333-
016-3030.¶  
(7) In imposing a penalty under these rules the Authority must consider the following factors:¶  
(a) The past history of the manufacturer in taking all feasible steps or following all feasible procedures necessary 
or appropriate to correct any violation.¶  
(b) Any prior violations of statutes, rules, orders or permits pertaining to HPCCCH used in children's products.¶  
(c) The gravity and magnitude of the violation.¶  
(d) Whether the violation was a sole event, repeated or continuous.¶  
(e) Whether the violation was a result of an unavoidable accident, negligence or an intentional act.¶  
(f) The violator's cooperativeness and efforts to correct the violation.¶  
(g) The economic and financial conditions of the manufacturer incurring a penalty.¶  
(h) The manufacturer's declaration that a HPCCCH used in a children's product is present only as a contaminant, 
and the manufacturer is able to provide evidence that a manufacturing control program for the contaminant that 
meets or exceeds the minimum requirements for a manufacturing control program in OAR 333-016-2070, which 
was approved by the Authority, was in place prior to the violation and that the manufacturer has exercised due 
diligence.¶  
(i) Civil penalties will be imposed in the manner provided in ORS 183.745.¶  
(8) The Authority will enforce the reporting requirements against a manufacturer in the same order as the priority 
order for reporting in OAR 333-016-2060(11).  
Statutory/Other Authority: ORS 413.042, ORS 431A.275  
Statutes/Other Implemented: ORS 431A.275
 
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