ORBuys S-44300-00001995 OHA-RFA-5171 Final Combined.pdf

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REQUEST FOR APPLICATION (RFA)

OregonBuys Number S-44300-00001995

OHA-RFA-5171

Review of Waiver and Hazard Assessment Requests1

The Oregon Health Authority (OHA) requests Applications from qualified individuals or organizations hereinafter “Applicants,” to provide review services of requests from manufacturers of children’s products who are subject to the Oregon Toxic-Free Kids Act.

Date of Issuance: February 08, 2022 Applications accepted through: See Section 10 Issuing Office: Oregon Health Authority

Office of Contracts and Procurement 635 Capitol Street NE, Suite 350 Salem, OR 97301

Sole Point of Contact: Danielle Pompe, Contract Specialist, OPBC

Telephone: (503) 947-5142 Fax: (503) 378-4324 Email: danielle.a.pompe@state.or.us mailto:dhs-oha.publicationrequest@state.or.us mailto:danielle.a.pompe@state.or.us

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 2 of 8

1. Background and Purpose

a. Background.

The Toxic-Free Kids (TFK) Act was passed during the 2015 legislative session under Senate Bill

478. Starting January 1, 2018 and every two years thereafter, manufacturers of children’s products sold or offered for sale in Oregon are to report the product categories for products containing High Priority Chemicals of Concern for Children's Health (HPCCCH) to the Oregon Health Authority’s (OHA) TFK Program.

On or before the date on which a manufacturer submits the third biennial notice for a product category, it must remove the HPCCCH found at or above de minimis levels from product models in three specific categories of children’s products. Per Oregon Administrative Rule (OAR) 333- 016-3010, these children’s products include: those made for, marketed for use by or marketed to children under three years of age; those that are “mouthable” items per Oregon Revised Statute (ORS) 431A.253(8); and children’s cosmetics.

In lieu of removing the chemical from the children’s product or stopping the sale of the product in Oregon, manufacturers may request the following:

• A Waiver: A manufacturer or trade association (Reporter) may request from OHA a waiver from removal requirements (OAR 333-016-3040). Either a Quantitative Exposure Assessment (QEA) (see OAR 333-016-3050) or Alternatives Assessment (AA) (see OAR 333-016-3060) must be conducted for specific product models/styles for which the waiver is being requested, and submitted with the waiver request.

• A Substitution: Reporters may also replace HPCCCH(s) with substitute chemicals approved by OHA that make the products less hazardous, per OAR 333-016-3020. The requirements for a Hazard Assessment (HA) of Substitute Chemicals are specified in OAR 333-016-3030. While OAR 333-016-3030(1) specifies that GreenScreen methodology is be used to assess hazard level of the substitute chemical or chemicals, Reporters may request OHA’s approval of an alternative methodology for conducting an HA. OAR 333-016-3030(4) through (6) specify requirements of alternative methodologies and timelines1.

Waiver and HPCCCH substitution requests must be submitted to OHA prior to a manufacturer’s third biennial notice of categories of children’s products containing HPCCCH(s). For example, Waiver and HPCCCH substitution requests for products sold or offered for sale in Oregon in 2020 and 2021 must be received before January 1, 2022.

Manufacturer must repeat compliance with one of these ‘removal/substitution/waiver’ options for future products unless the composition of a future product is substantially similar to that specified in an approved AA per OAR 333-016-3060(8) or QEA per OAR 333-016-3050(8).

OHA has determined that a QEA is an inherent part of any AA and so must be conducted for a proposed substitute chemical if the manufacturer chooses the AA option. This Request for Application (RFA) pertains to the evaluation of HAs conducted with an alternative methodology

1 Per OAR 333-016-3030(1)(a)(A), HAs are to be conducted a Licensed GreenScreen Profiler (LGSP) as arranged by a Reporter.

Reporters will send these HAs to OHA along with the other modules of an AA. Such HAs are to be treated “as is” by Contractors with the conclusions made by the LGSP not contested. Such HAs are sent with the other modules of an Alternatives Assessment to inform the Contractor's review of those modules. Reporters have the option of requesting use of an alternative HA methodology per OAR 333-016-3030(4) through (6). If OHA approves the alternative methodology, Reporters have the option to apply it to HPCCCHs and specific product models for purposes of a Hazard Assessment, per OAR 333-016-3030. Contractors will review submitted HAs conducted with an alternative methodology, approved per OAR 333-016-3030(4), either along with the other modules in an AA or as a stand-alone HA for the purposes of a Chemical Substitution per OAR 333-016-3020. OHA will provide the relevant criteria for alternative HA methodology and an appropriate review form to Contractors for this to be done. Approved alternative methodologies will be listed on TFK’s webpages: www.healthoregon.org/toxicfreekids.

http://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Pages/Toxic-Free-Kids.aspx https://olis.leg.state.or.us/liz/2015R1/Downloads/MeasureDocument/SB478 https://olis.leg.state.or.us/liz/2015R1/Downloads/MeasureDocument/SB478 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276960 https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Pages/Toxic-Free-Kids.aspx https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276960 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276970 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276970 https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276974 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276972 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276972 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276972 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276972 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276972 http://www.healthoregon.org/toxicfreekids

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 3 of 8 approved by OHA, as well as evaluations of QEAs and AAs. While Applicants are encouraged to apply for being able to review all three, Applicants may apply to review only one. Applicants are to indicate on the Application Form the modules for which they are applying to review.

Utilizing the OARs for QEA, AA, and an HA conducted with an alternative methodology approved by OHA and the definitions of these three items in OAR 333-016-2010; successful Applicants will complete an Review Form for each submission they agree to review at a rate of $200.00 per hour as outlined in OAR 333-016-2080. (OHA will not guarantee that any specific level of work or that overall funding will be authorized or required of the successful Applicants).

b. Purpose.

OHA does not have staff with the knowledge, expertise, or capacity to determine:

• Whether or not a submitted QEA demonstrates 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; or

• Whether or not the modules in an AA (QEA; Technical Feasibility; Financial Feasibility;

or a HA conducted with an alternative methodology per OAR 333-016-3030(4)) meet criteria specified for each in OAR; or

• Whether or not a HA, conducted with an approved alternative methodology per OAR 333-016-3030(4)),2 meets criteria of that alternative methodology.

2. Authority OHA issues this RFA under the authority of Oregon Revised Statute (ORS) 413.033, Oregon Administrative Rule (OAR) 125-247-0285, and Class Special Procurement No. 826-16.

3. Minimum Requirements Successful Applicants for this RFA (Contractor) will review AAs, QEAs and HAs completed with an approved alternative methodology per OAR 333-016-3030(4). Requirements are as follows:

a. Applicant must meet the “Responsible Proposer” requirements, identified in ORS 279B.110 and

OAR 137-047-0500, which includes the requirement to be registered as a business with the Oregon Business Registry. For information about and assistance with the Secretary of State’s Business Registration process, click on the following link:

http://sos.oregon.gov/business/Pages/register.aspx.

b. Applicant should have expertise in the modules for which they apply to review, as follows:

• Applicant should demonstrate an understanding that for the purposes of Oregon’s Toxic Free Kids Act the basis of a QEA is exposure, not risk. A QEA is used to determine whether a HPCCCH used in particular 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 product. [See OAR 333-016-2010 for definition of

QEA.]

• Applicant should demonstrate an understanding that an AA is an evaluation of the possibility of replacing chemicals in products or processes with inherently safer alternatives in order to better protect human health. [See OAR 333-016-2010 for definition of AA.]

2 OHA is unable to predict which alternative hazard assessment methodologies it will be asked to approve, per OAR 333-016-3030(4).

For purposes of applying for this RFA, Applicants are to demonstrate understanding of and experience with any hazard assessment methodology pertinent to OAR 333-016-3030 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=53685 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://www.oregonlegislature.gov/bills_laws/ors/ors279B.html http://arcweb.sos.state.or.us/pages/rules/oars_100/oar_137/137_047.html http://sos.oregon.gov/business/Pages/register.aspx https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 4 of 8

• Applicant should demonstrate an understanding that an HA, whether part of an AA or sent in support of a Chemical Substitution (OAR 333-016-3020), is to be 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.

• Applicant should provide a summary of what expertise the Applicant possesses to be qualified to review the modules for which they are applying to review. Examples might be licenses, certifications, types of education or experience as it may relate to the TFK Act.

c. Applicants must provide a written summary showing their understanding of Oregon’s 2015 TFK Act and its rules as they pertain to the specific modules supporting waiver requests. The specific modules and OARs are found at https://bit.ly/3k0RIIR in the Phase 3 subsection.

d. Applicants should demonstrate knowledge and/or past experience with developing and/or reviewing HAs, QEAs, AAs, chemical hazard assessment or similar product assessments.

Preference will be given to Applicants who can demonstrate past experience in assessing exposure from HPCCCHs from consumer products from these chemicals to children.

Applicants should provide no more than four (4) examples that demonstrate they have the skills and capacity to conduct or review QEAs, HAs or AAs. The examples provided must pertain to the module(s) the Applicant is applying to review and be within the last seven years to be considered.

Information identifying client and/or confidential business information with the examples should be redacted in the submission.

e. Applicants should demonstrate internal capacity for reviewing HAs, QEAs, AAs, chemical hazard assessment or similar product assessments. As described in Scope of Work (below), successful Applicants will fill out review forms provided by OHA that include responses to items/questions provided by OHA, including a recommendation whether or not OHA should approve a module

f. Contractor must have a system to track time and effort spent on assessing QEAs, AAs, and HA conducted with an alternative methodology per OAR 333-016-3030(4) through (6). The tracking system must be able to account for time spent to the quarter hour and the job titles of individuals doing the work. Contractor will provide OHA with a listing of total hours spent on a review as an attachment to the report with their recommendation/rationale.

g. Applicant must employ a system they will use to identify conflicts of interest. Provide a brief summary and/or sample of Applicant’s current system/process, or the one they will use, for identifying prior relationships, bias and actual conflicts of interests.

h. Contracts must have a system in place that ensures confidential business information will not be divulged. Applicants must employ a system that limits access to submitted documents to those staff (and their supervisors) who are directly reviewing the contents. Such a system must ensure that the contents of submitted documents will be on a ‘need to know’ basis. Provide a brief summary of the Applicant’s system/process for ensuring limited access to those individuals directly reviewing the contents of the submitted documents.

Quantitative Exposure Assessment (QEA) OAR 333-016-3050

Alternatives Assessment (AA) OAR 333-016-3060

Alternative Hazard Assessment methodologies OAR 333-016-3030(4) https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276972 http://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Pages/Toxic-Free-Kids.aspx http://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Pages/Toxic-Free-Kids.aspx https://bit.ly/3k0RIIR https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 5 of 8

4. Scope of Work Successful Applicants for this RFA will review AAs, QEAs, and HAs completed with an approved alternative methodology per OAR 333-016-3030(4) through (6). Requirements are as follows:

a. For an Alternatives Assessment:

An AA must evaluate the possibility of replacing HPCCCHs in products with an inherently safer alternative to better protect human health. This is done through the evaluation of candidate substitute chemical(s) to replace HPCCCH(s) in one or more children's products (specified per OAR 333-016-3010(1)(a) through (c)) for which a waiver is requested. For each product model or style submitted, Contractor is to ensure that the following has been completed in accordance with the relevant OARs:

1) For an AA, the Reporter is to start by conducting a Hazard Assessments (HA) of candidate chemical(s) that may replace a HPCCCH in a specific product(s). Per OAR 333-016-3030(1)(a), HAs are to be done using GreenScreen methodology unless OHA approves an alternative methodology per OAR 333-016-3030(4) through (6). If an approved alternative methodology is utilized, OHA will provide it to Contractor for their use. Following an HA, assessments for one or more substitute chemicals must include the following modules; a QEA (OAR 333-016-3050); an assessment of technical feasibility (OAR 333-016-3060(6)); and an assessment of financial feasibility (OAR 333-016- 3060(7), except per OAR 333-016-3060(3).

2) In assessing the four AA modules and any supporting documentation, Contractor is to determine if each meets criteria of its respective section or subsection (OAR listed above) and recommend a pass/fail outcome for each section, describing any deficiencies for Reporters to consider.

b. For a Quantitative Exposure Analysis:

A QEA must demonstrate that a HPCCCH in a children's product (as specified per OAR 333- 016-3010(3)(a) through (c)) for which a waiver is being requested is not reasonably anticipated to result in a completed exposure pathway to a child because of leachability and bioavailability.

1) “Exposure scenarios” per OAR 333-016-2010 are to be provided by Reporters for each product, per OAR 333-016-3050(2)(a), for all of the possible exposure scenarios arising from “reasonably foreseeable use and abuse,” per OAR 333-016-2010, of the specified children’s product. If Contractor determines that there are additional relevant exposure scenarios not covered by the Reporter’s submitted QEA, Contractor is to provide these to

OHA.

2) Per OAR 333-016-3050(2)(b), Contractor will assess any completed exposure scenarios and supporting information provided by a Reporter, for each product. Contractor is to determine if scenario protocols, analytical methodology, and analytic test results submitted were appropriate for determining leachability and bioavailability of the HPCCCH from each product in the simulated media.

3) Per 333-016-3050(2)(c), if a Reporter determines that a HPCCCH cannot reasonably be anticipated to be transferred to a child’s body through a completed exposure pathway, they will submit a detailed report and analysis. Contractor is to evaluate these conclusions. If they disagree, they’re to briefly explain the basis for that disagreement.

When conducting Steps 1 through 3 above for an AA, QEA or HA conducted with an approved alternative methodology per OAR 333-016-3030(4), Contractor may “group” submitted documentation and data that are very similar. This is discussed in detail on p. 6 Guidance for a Quantitative Exposure Assessment (QEA) per OAR 333-016-3050. For example, have the same HPCCCH(s) (i.e., in proportion of a product); the same relevant routes of exposure; the https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276970 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276970 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276970 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Documents/Guidance%20for%20Quantitative%20Exposure%20Assessment%20per%20OAR%20333-016-3050%20ver1.1.pdf https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Documents/Guidance%20for%20Quantitative%20Exposure%20Assessment%20per%20OAR%20333-016-3050%20ver1.1.pdf

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 6 of 8 same relevant exposure scenarios and/or completed exposure pathways. Contractor may conduct Steps 1 through 3 on requests for those products as groups but must clearly specify which product models or styles submitted by the Reporter are included in each grouping.

c. For a Hazard Assessment Conducted with an Approved Alternative Methodology:

HAs of candidate chemical(s) may replace a HPCCCH in a specific product(s) are to be completed by Reporters. Per OAR 333-016-3030(1)(a), HAs are to be done using GreenScreen methodology unless OHA approves an alternative methodology per OAR 333-016-3030(4) through (6).

Contractor is to evaluate an HA conducted with approved alternative methodology to determine if the HA meets criteria of that alternative methodology. If an approved alternative methodology is utilized, OHA will provide it to Contractor for their use.

All services provided under any award as a result of this RFA shall adhere to and comply with the provisions set forth in Attachment 2-Form Price Agreement Sample (PA).

5. Sole Point of Contact (SPC) and Issuing Office Oregon Health Authority Office of Contracts and Procurement Danielle Pompe, Contract Specialist 635 Capitol Street NE, Suite 350 Salem, Oregon 97301 Telephone: (971) 374-3474 Facsimile: (503) 378-4324 E-mail: danielle.a.pompe@state.or.us All communications concerning this RFA document and the Application process must be directed by email to the SPC named above. Any oral communications will be considered unofficial and non-binding.

Information received in writing from the SPC is also considered official.

When appropriate, OC&P will issue revisions, substitutions, or clarifications as addenda to this RFA.

Changes/modifications to the RFA shall be recognized only if in the form of written addenda issued by OC&P. OC&P will not automatically mail copies of any addenda or answers but will publish addenda and questions and answers on the OregonBuys website at https://oregonbuys.gov/bso/. OregonBuys will be used to distribute all information regarding this RFA. To review complete RFA documentation please go to the OregonBuys website at https://oregonbuys.gov/bso/.

6. Applicant Assurances By submitting an Application in response to this RFA, Applicant certifies that the following statements are true:

a. Applicant does not discriminate in its employment practices with regard to race, creed, age, religious affiliation, sex, disability, sexual orientation or national origin, nor has Applicant nor will Applicant discriminate against a subcontractor in the awarding of a subcontract because the subcontractor is a minority, women or emerging small business enterprise certified under ORS

200.055 or a Disabled Veteran or a subcontractor that employs a Disabled Veteran, and

b. Information included in the Application shall remain valid for 90 days after the Application is submitted or until a PA is executed, whichever comes first, and

c. The statements contained in the Application are true and complete to the best of the Applicant’s knowledge and Applicant accepts as a condition of the PA, the obligation to comply with the applicable state and federal requirements, policies, standards, and regulations. The Applicant recognizes that this is a public document and open to public inspection, and

d. The Applicant acknowledges receipt of any Addenda to the RFA, and https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 mailto:danielle.a.pompe@state.or.us https://oregonbuys.gov/bso/ https://oregonbuys.gov/bso/

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 7 of 8

e. If the Applicant is awarded a PA as a result of this RFA, the Contractor will be required to complete, and will be bound by, a PA, Attachment 2-Form PA Sample or an Intergovernmental Agreement (sample available upon request).

7. Application Evaluation Applications must be complete at the time of submission. OHA will evaluate Applications as they are received, to determine whether each Applicant meets the minimum requirements. During the evaluation process, OHA reserves the right to obtain clarification from Applicants regarding their Application information. Only Applicants determined by OHA to be qualified to provide services pursuant to this RFA will be offered a PA.

Applicants shall be notified of the evaluation decision regarding their Application and, for successful Applicants, the timeline to be issued a PA.

8. Public Information All Applications are public information after the Application has been opened. Any person may request copies of public information. However, copies of Applications will not be released until the evaluation process has been completed. Requests for copies of public information must be submitted in writing.

Requestors will be charged according to the current OHA policies and rates for public records requests in effect at the time OHA receives the written request for public information. Fees, if applicable, must be received by OHA before the records will be delivered to the requestor.

9. Cost of Applications All costs incurred in preparing and submitting an application in response to this RFA are the responsibility of the Applicant and will not be reimbursed by OHA.

10. Closing Date for Submittal of Applications Applications will be received on an open and ongoing basis for five years. When OHA has determined that sufficient Applications have been received, or for any other reason that OHA determines, OHA will issue notice on the ORPIN website specifying a date after which Applications will no longer be received. Applications received after the date and time specified in that notice, shall be late and will not be evaluated.

APPLICATIONS MAY BE REVIEWED BY OHA AT ANY TIME AFTER RECEIPT.

Applicants are encouraged to submit Applications as soon as possible. PA’s may be issued at any time throughout the open Application period.

11. PA Document Terms and Conditions The final PA will be based on Form PA Sample (Attachment 2), and will include all exhibits and attachments identified in the PA. The terms and conditions included in the PA are not subject to negotiation.

12. Reservation of OC&P Rights OC&P reserves all rights regarding this procurement, including, without limitation, the right to:

a. Amend or cancel this procurement without liability if it is in the best interest of the State to do so;

b. Reject any and all Applications received by reason of this request upon finding that it is in the best interest of the State to do so;

c. Waive any minor informality with the provisions or procedures of this procurement, and to seek clarification from the Applicant, if required;

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171 Page 8 of 8

d. Reject any Application that fails to substantially comply with all prescribed procurement procedures and requirements;

e. Extend, amend or negotiate any PA’s that are a result of this procurement, in accordance with the terms and conditions of the Form PA document; and

f. Engage Contractor by selection or procurement for different or additional services independent of this RFA process or any Contract, Agreement or PA entered into pursuant hereto.

13. Contractual Obligation All Applicants who submit an application in response to this RFA understand and agree that OHA is not obligated thereby to enter into a Contract or Agreement with any Applicant and further, has absolutely no financial obligation to any Applicant.

14. Application Requirements

• Applications must be submitted using Attachment 1-Application Form attached to this RFA and must indicate which Module(s) Applicant is applying to review.

• Applicant must submit a separate Application for each site that has a different Employer Identification Number (EIN).

• Applicants must be registered with the Oregon Secretary of State as a business or note on the Application that Applicant is a Government Entity.

• Applicant must also meet the minimum insurance requirements as outlined in Exhibit C of the Form PA Sample (Attachment 2) or Applicant will meet those requirements prior to PA execution.

• Applications must be submitted to the Sole Point of Contact by email and must be clearly marked "APPLICATION FOR RFA OREGONBUYS NUMBER S-44300-00001995/OHA-

RFA-5171”.

15. Applicant Ranking Order and Work Order Contract Assignment Process In order to establish a clear process for assigning Work Order Contracts, OHA will begin reviewing Applications in the order in which they are received. As Applications are approved, OHA will issue PA to Applicants. Upon execution of a PA, Applicant will be assigned an identifier (a letter of the alphabet, starting with A) and be placed on an eligible list for work and be notified by email of their ranking order and where the Work Order Contract Assignments are in the process among the PA holders. A tracking sheet for assignments will be maintained by OHA’s Toxic-Free Kids Act Program. See Section 4, of the PA for further details regarding Work Order Contract Assignment.

OREGONBUYS NUMBER: S-44300-00001995

RFA OHA-5171

Attachment 1 – APPLICATION FORM

Applicants must meet all Requirements, as described in Request for Application (RFA):

RFA-OHA-5171

Applicants must comply with the RFA and submit this completed Application Form to be considered for an Agreement.

Applicant info for Quantitative Exposure Assessment, Hazard Assessment, or Alternatives Assessment Review Services

Individual/Organization Name:

Mailing Address:

City: State: County: Zip Code:

Phone:

Facsimile:

Website Address:

Type of Organization

Individual Agency/organization Other

Module(s) Applicant Is Applying to Review (check all that apply. See RFA page 3)

QEA AA HA per OAR 333-016-3030(4)

Responsible Proposer Requirements

Yes, Applicant is currently registered with the Oregon Secretary of State business registry.

No, Applicant is not currently registered with the Oregon Secretary of State business registry but will meet requirement prior to Agreement execution.

Applicant Examples

Yes, Applicant has attached no more than four (4) examples within the last seven years evidencing experience with the conduction or review of Quantitative Exposure Assessments, Hazard Assessments, or Alternatives Assessments or similar product assessments. These focus on one or more High Priority Chemicals of Concern for Children’s Health (HPCCCH) under the Oregon Toxic-Free Kids Act.

Yes, Applicant has provided a written summary showing evidence of their understanding of Oregon’s 2015 Toxic Free Kids Act, OHA’s Guidance for a Quantitative Exposure Assessment (QEA) per OAR 333-016-3050 and the Act’s rules as they relate to how HPCCCHs can leach from children’s products and become bioavailable to children under ‘reasonably foreseeable use and abuse of such products’(as that defined in OAR 333-016- 2010)possesses the 5 years of experience in assessing exposure to children and developing fetuses posed by these chemicals, particularly from consumer products. [Such rules are found at OAR 333-016-3030(4); OAR 333-016-3050; and OAR 333-016-3060.] https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Documents/Guidance%20for%20Quantitative%20Exposure%20Assessment%20per%20OAR%20333-016-3050%20ver1.1.pdf https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276959 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276973 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276975 https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276976

RFA OHA-5171

Attachment 1 – APPLICATION FORM

Yes, Applicant has provided a written summary or example of 5 years’ experience in assessing exposure by one or more of the HPCCCH chemicals to children and developing fetuses.

Yes, Applicant has provided a written summary or example of their current system/process or one they will use for identifying prior relationships, bias and actual conflicts of interest.

Yes, Applicant has provided a brief summary of Applicant’s current system/process (or one to be used) to track total hours spent on an MCP review broken down into the quarter hour along with job titles of individuals doing the work.

Yes, Applicant has provided a written summary of Applicants system/process for ensuring limited access to individuals directly reviewing the contents of the exemption request and accompanied MCP.

Yes, Applicant has provided a written summary of expertise that they possess that makes them qualified to perform the MCP review services.

Applicant Insurance

Commercial General Liability Insurance

Yes, we currently meet the CGL insurance requirement.

Do not currently meet CGL insurance requirements but will meet requirement prior to Contract execution.

Professional Liability Insurance

Yes, we currently meet the PLI insurance requirement.

Do not currently meet PLI insurance requirements but will meet requirement prior to Contract execution.

Applicant Contract Administrator

Name and Title:

Phone:

Email:

Signature:

Submit application by email to danielle.a.pompe@state.or.us . An email will be sent as confirmation of receipt.

Thank you, Danielle Pompe Oregon Health Authority Office of Contracts and Procurement 635 Capitol St. NE, Suite 350 Salem, Oregon 97301 Phone :971-374-3474 Fax : 503-978-4324 mailto:danielle.a.pompe@state.or.us

Agreement Number TBD

OREGONBUYS NUMBER S-44300-00001995

OHA-RFA-5171

Attachment 2-Form Price Agreement Sample

STATE OF OREGON

PRICE AGREEMENT

In compliance with the Americans with Disabilities Act, this document is available in alternate formats such as Braille, large print, audio recordings, Web-based communications and other electronic formats. To request an alternate format, please send an e-mail to dhs-oha.publicationrequest@state.or.us or call 503-378-3486 (voice) or 503-378-3523 (TTY) to arrange for the alternative format.

This Agreement is between the State of Oregon, acting by and through its Oregon Health Authority, hereinafter referred to as “OHA,” and

Contractor d.b.a. Facility or Assumed Name

Address Address

Attention: (required) Telephone: (required)

Fax: (optional) E-mail address: (required) hereinafter referred to as “Contractor.”

Work to be performed under this Agreement relates principally to OHA’s

Public Health Division Center for Health Protection and Environmental Public Health Section

800 NE Oregon St. Suite 640 Portland, OR 97232

Agreement Administrator: Brett Sherry or delegate Telephone: 971-673-0442 Facsimile: 971-673-0497

E-mail address: brett.w.sherry@state.or.us mailto:dhs-oha.publicationrequest@state.or.us mailto:brett.w.sherry@state.or.us

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171/dap Page 2 of 26 OHA PSK (reviewed by DOJ 1/3/2019) Updated: 3/2/2020

1. This Price Agreement is entered into by OHA and the Contractor for the purpose of identifying the form of Work Order Contract to be used, the general terms and conditions applicable to subsequent Work Order Contracts (“WOC”) entered into between OHA and Contractor pursuant to which Contractor will provide Review of Waiver and Hazard Assessment requests services to OHA, and the process through which the Work Order Contracts will be assigned and authorized.

This Agreement, by itself, is not a binding contract. There is no guarantee that any specific level of work or overall dollar amounts will be authorized for and required of Contractor. Rather, OHA and Contractor intend to enter into binding and enforceable Work Order Contracts for program needed services by execution of a Work Order Contract substantially in the form attached hereto as Attachment 1 that specifies the work to be performed and that makes the terms and conditions set forth in this Agreement applicable to the authorized Work Order Contract. Each executed Work Order Contract shall create a separate Agreement between the parties (consisting of the Work Order Contract together with the Price Agreement terms and conditions) enforceable in accordance with the terms thereof and independent of all other such Work Order Contracts.

2. Effective Date and Duration.

This Agreement shall become effective on the date this Agreement has been fully executed by every party and, when required, approved by Department of Justice or on [insert start date], whichever date is later. Unless extended or terminated earlier in accordance with its terms, this Agreement shall remain effective for a duration of 5 years from the date it is fully executed by all parties. Agreement termination shall not extinguish or prejudice OHA’s right to enforce this Agreement with respect to any default by Contractor that has not been cured.

3. Agreement Documents.

a. This Agreement consists of this document and includes the following listed exhibits which are incorporated into this Agreement:

(1) Exhibit A, Part 1: Statement of Work

(2) Exhibit A, Part 2: Payment and Financial Reporting

(3) Exhibit A, Part 3: Special Provisions

(4) Exhibit B: Standard Terms and Conditions

(5) Exhibit C: Insurance Requirements

(6) Attachment 1 Work Order Contract (WOC) Sample

(7) Attachment 2 Quantitative Exposure Assessment (QEA) Review Form

(8) Attachment 3 Alternative Assessment (AA) Review Form

(9) Attachment 4 Hazard Assessment (HA) Review Form There are no other contract documents unless specifically referenced and incorporated in this Agreement.

b. This Agreement and the documents listed in Section 2., “Agreement Documents”, Subsection a.

above, shall be in the following descending order of precedence: this Agreement less all exhibits, Exhibits B, A, and C.

4. Consideration.

a. The maximum, not-to-exceed compensation payable to Contractor are subject to the project-specific budget authorized by Work Order Contracts issued under this Price Agreement. OHA

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171/dap Page 3 of 26 will not pay Contractor any amount in excess of the not-to-exceed compensation authorized by each Work Order Contract for completing the Work and will not pay for Work performed before the date this Price Agreement becomes effective or after the termination or expiration of any individual Work Order Contract issued under this Price Agreement. If the maximum compensation of a Work Order Contract is increased by amendment of the Work Order Contract, the amendment must be fully effective before Contractor performs Work subject to the amendment.

b. Interim payments to Contractor shall be subject to ORS 293.462, and shall be made in accordance with the payment schedule and requirements in Exhibit A, Part 2., “Payment and Financial Reporting.”

c. OHA will only pay for completed Work under this Agreement. For purposes of this Agreement, “Work” means the tasks or services and deliverables accepted by OHA as described in Exhibit A, Part 1, “Statement of Work.”

5. Work Order Contract Assignment Process.

When Review of Waiver and Hazard Assessment Requests Services are required, OHA will assign a Contractor according to the process outlined in Exhibit A, Part 1 Statement of Work, Section 2.

OHA will negotiate the final Work Order Contract with the assigned Contractor.

6. Contractor or Subrecipient Determination. In accordance with the State Controller’s Oregon Accounting Manual, policy 30.40.00.104, OHA’s determination is that:

Contractor is a subrecipient Contractor is a contractor Not applicable Catalog of Federal Domestic Assistance (CFDA) #(s) of federal funds to be paid through this Agreement: N/A

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171/dap Page 4 of 26

7. Contractor Data and Certification.

a. Contractor Information. This information is requested pursuant to ORS 305.385.

PLEASE PRINT OR TYPE THE FOLLOWING INFORMATION

Contractor Name (exactly as filed with the IRS):

Street address:

City, state, zip code:

Email address:

Telephone: ( ) Fax: ( )

Is Contractor a nonresident alien, as defined in 26 U.S.C. § 7701(b)(1)?

(Check one box): YES NO Business Designation: (Check one box):

Professional Corporation Nonprofit Corporation Limited Partnership Limited Liability Company Limited Liability Partnership Sole Proprietorship Corporation Partnership Other

Contractor Proof of Insurance. Contractor shall provide the following information upon submission of the signed Agreement. All insurance listed herein and required by Exhibit C must be in effect prior to Agreement execution.

Professional Liability Insurance Company: ___________________________________________ Policy #: ______________________________________ Expiration Date: ________________ Commercial General Liability Insurance Company: ____________________________________ Policy #: ______________________________________ Expiration Date: ________________ Workers’ Compensation: Does Contractor have any subject workers, as defined in ORS 656.027? (Check one box): YES NO If YES, provide the following information:

Workers’ Compensation Insurance Company: ________________________________________ Policy #: ______________________________________ Expiration Date: ________________

b. Certification. Without limiting the generality of the foregoing, by signature on this Agreement, the undersigned hereby certifies under penalty of perjury that:

(1) Contractor is in compliance with all insurance requirements in Exhibit C of this

Agreement, and notwithstanding any provision to the contrary, Contractor shall deliver to the OHA Agreement Administrator (see page 1 of this Agreement) the required Certificate(s) of Insurance within 30 days of execution of this Agreement. By certifying compliance with all insurance as required by this Agreement, Contractor acknowledges it may be found in breach of the Agreement for failure to obtain required insurance.

Contractor may also be in breach of the Agreement for failure to provide Certificate(s) of Insurance as required and to maintain required coverage for the duration of the Agreement;

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171/dap Page 5 of 26

(2) Contractor acknowledges that the Oregon False Claims Act, ORS 180.750 to 180.785, applies to any “claim” (as defined by ORS 180.750) that is made by (or caused by) the Contractor and that pertains to this Agreement or to the project for which the Agreement work is being performed. Contractor certifies that no claim described in the previous sentence is or will be a “false claim” (as defined by ORS 180.750) or an act prohibited by ORS 180.755. Contractor further acknowledges that in addition to the remedies under this Agreement, if it makes (or causes to be made) a false claim or performs (or causes to be performed) an act prohibited under the Oregon False Claims Act, the Oregon Attorney General may enforce the liabilities and penalties provided by the Oregon False Claims Act against the Contractor;

(3) The undersigned is authorized to act on behalf of Contractor and represents and warrants that Contractor has complied with the tax laws of the State of Oregon and the applicable tax laws of any political subdivision of Oregon. Contractor shall, throughout the duration of this Agreement and any extensions, comply with all tax laws of this state and all applicable tax laws of any political subdivision of Oregon. For the purposes of this Section, “tax laws” includes: (i) All tax laws of Oregon, including but not limited to ORS 305.620 and ORS chapters 316, 317, and 318; (ii) Any tax provisions imposed by a political subdivision of Oregon that applied to Contractor, to Contractor’s property, operations, receipts, or income, or to Contractor’s performance of or compensation for any work performed by Contractor; (iii) Any tax provisions imposed by a political subdivision of Oregon that applied to Contractor, or to goods, services, or property, whether tangible or intangible, provided by Contractor; and (iv) Any rules, regulations, charter provisions, or ordinances that implemented or enforced any of the foregoing tax laws or provisions.

Contractor acknowledges that the Oregon Department of Administrative Services will report this Agreement to the Oregon Department of Revenue (DOR). The DOR may take any and all actions permitted by law relative to the collection of taxes due to the State of Oregon or a political subdivision, including: (i) garnishing the Contractor’s compensation under this Agreement; or (ii) exercising a right of setoff against Contractor’s compensation under this Agreement for any amounts that may be due and unpaid to the State of Oregon or its political subdivisions for which the DOR collects debts;

(4) The information shown in Section 5.a., “Contractor Information” above is Contractor’s true, accurate and correct information;

(5) To the best of the undersigned’s knowledge, Contractor has not discriminated against and will not discriminate against minority, women or emerging small business enterprises certified under ORS 200.055 in obtaining any required subcontracts;

(6) Contractor and Contractor’s employees and agents are not included on the list titled “Specially Designated Nationals” maintained by the Office of Foreign Assets Control of the United States Department of the Treasury and currently found at:

https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx;

(7) Contractor is not listed on the non-procurement portion of the General Service Administration’s “List of Parties Excluded from Federal procurement or Non-procurement Programs” currently found at: https://www.sam.gov/portal/public/SAM/;

(8) Contractor is not subject to backup withholding because:

(a) Contractor is exempt from backup withholding;

https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx https://www.sam.gov/portal/public/SAM/

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171/dap Page 6 of 26

(b) Contractor has not been notified by the IRS that Contractor is subject to backup withholding as a result of a failure to report all interest or dividends; or

(c) The IRS has notified Contractor that Contractor is no longer subject to backup withholding; and

(9) Contractor Federal Identification Number (FEIN) or Social Security Number (SSN) provided is true and accurate. If this information changes, Contractor shall provide OHA with the new FEIN or SSN within 10 days.

OREGONBUYS NUMBER S-44300-00001995/OHA-RFA-5171/dap Page 7 of 26

CONTRACTOR, BY EXECUTION OF THIS CONTRACT, HEREBY ACKNOWLEDGES THAT

CONTRACTOR HAS READ THIS CONTRACT, UNDERSTANDS IT, AND AGREES TO BE BOUND

BY ITS TERMS AND CONDITIONS.

CONTRACTOR: YOU WILL NOT BE PAID FOR SERVICES RENDERED PRIOR TO NECESSARY

STATE APPROVALS.

8. Signatures. This Agreement and any subsequent amendments may be executed in several counterparts, all of which when taken together shall constitute one agreement binding on all parties, notwithstanding that all parties are not signatories to the same counterpart. Each copy of the Agreement and any amendments so executed shall constitute an original.

Contractor Name By:

Authorized Signature Printed Name

Title Date State of Oregon, acting by and through its Oregon Health Authority By:

Authorized Signature Printed Name

Title Date Approved for Legal Sufficiency:

Not Required per OAR 137-045-0030(1)(a) unless a WOC exceeds $150,000 total

Department of Justice Date

OREGONBUYS NUMBER S-44300-00001995

OHA-RFA-5171

EXHIBIT A

Part 1 Statement of Work

The Contractor will provide QEA/AA/HA Review services for OHA’s Toxic-Free Kids Program as described below.

1. Background and Purpose

a. Background.

The Toxic-Free Kids (TFK) Act was passed during the 2015 legislative session as Senate Bill

478. [See Oregon Revised Statute (ORS) 431A.250-280.] Starting January 1, 2018 and every two years thereafter, manufacturers of children’s products sold or offered for sale in Oregon are to report the product categories for products containing High Priority Chemicals of Concern for Children's Health (HPCCCH) to the Oregon Health Authority’s (OHA) TFK Program.

On or before the date on which a manufacturer submits the third biennial notice for a product category, it must remove the HPCCCH found at or above de minimis levels from product models in three specific categories of children’s products. Per Oregon Administrative Rule (OAR) 333- 016-3010, these children’s products include: those made for, marketed for use by or marketed to children under three years of age; those that are “mouthable” items per ORS 431A.253(8); and children’s cosmetics.

In lieu of removing the chemical from the children’s product or stopping the sale of the product in Oregon, manufacturers may request the following:

• A Waiver: A manufacturer or trade association (Reporter) may request from OHA a waiver from removal requirements (OAR 333-016-3040). Either a Quantitative Exposure Assessment (QEA) (see OAR 333-016-3050) or Alternatives Assessment (AA) (see OAR 333-016-3060) must be conducted for specific product models/styles for which the waiver is being requested, and submitted with the waiver request.

• A Substitution: Reporters may also replace HPCCCH(s) with substitute chemicals approved by OHA that make the products less hazardous, per OAR 333-016-3020. The requirements for a Hazard Assessment (HA) of Substitute Chemicals are specified in OAR 333-016-3030.