ORBuys S-44300-00001995 OHA-RFA-5171 Final Form Price Agreement Attachment 2 QEA Review Form~1.pdf

A. Manufacturer (or Trade Association) Submitting QEA:

Date Received by OHA:

PUBLIC HEALTH DIVISON

Center for Health Protection

[Section A for OHA use only]

Name:

B. Contractor Information:

Reviewer's Phone:

Firm Name:

Reviewer Name(s):

Reviewer’s Email:

Date Review Completed:

Directions for Contractor for Completion of Review Forms Please review this Quantitative Exposure Assessment (QEA) submitted in support of a Waiver per Oregon Administrative Rule (OAR) 333-016-3040(2)(a). If approved, specified children's products containing High Priority Chemicals of Concern for Children's Health at or above de minimis may continue to be sold in Oregon.

OAR 333-016-3050(5) requires that children's products on which a QEA is conducted be identified per OAR 333-016-3010(3)(a) through (c) at the brand name, product model level (hereafter, BNPM or children's product).

Contractors should cut-and-pasteΣ ƛƴǘƻ ŀƴ ŀǘǘŀŎƘƳŜƴǘΣ information identifying each BNPM in the QEAΦ In the attachment, each BNPM should be give a unique identifier that may subsequently referred to in the Contractor's reviews. This attachment should be sent to OHA along with the completed Review Form(s) for anQEA.

A QEA Review Form is on the next page. Manufacturers are allowed to aggregate responses for substantially similar BNPM per Item 6 in QEA Guidance. Therefore, /ontractors may evaluate such responses in ŀ ǎƛƴƎƭŜ wŜǾƛŜǿ CƻNJƳΦ Contractors should note, in the space at the bottom of the QEA below, those aggregated BNPMs likely to have HPCCCH concentrations that vary more than 10% from concentrations of the same HPCCCH in the group, thus not qualifying for aggregation.

CƛƴŀƭƭȅΣ It///I ŘNJƻLJπŘƻǿƴ ƭƛǎǘǎ ŀNJŜ ŀǘ ǘƘŜ ǘƻLJ ƻŦ the QEA Review Form. In the lists, /ƻƴǘNJŀŎǘƻNJǎ ǎƘƻdzƭŘ ǎŜƭŜŎǘ It///Iǎ ŘƛǎŎdzǎǎŜd in the QEA. Review Forms may be reproduced, as needed, ensure an evaluation of each BNPM and HPCCCH.

Questions? Please contact the Authority’s Toxic-Free Kids Program at toxicfreekids.program@state.or.us.

QEA Review Form - Ver 1.0

Kate Brown, Governor

Attachment 2 - Quantitative Exposure Assessment (QEA) Review Form (per OAR 333-016-3050)

SAMPLE

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=276970 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=276974

1. Does the description of the children's product provided adequately identify the product per OAR Adequate Inadequate 333-016-3010(3)? [Please see #3 in QEA Guidance.]

If adequate, what information is needed to change this conclusion?

2. STEP A - Do the exposure scenario(s) provided adequately describe how, if at all, the HPCCCH in the BNPM could reasonably be anticipated to enter a child’s body through a completed exposure pathway because of leachability and bioavailability from the BNPM? [Please see #4 in QEA Guidance.]

• If inadequate, briefly describe below identified deficiencies below.

QEA Review: List Brand name, Product Model (BNPM)

Summary Report for:

QEA Review Form - Ver 1.0 3

Items 1-4 below described in QEA Guidance

3. STEP B - First Option - For each completed exposure pathway stated above, does the information submitted on the leachability and bioavailability of HPCCCH from a product adequately satisfy requirements of OAR 333-016-3050(2)(b)?

Reminder: per OAR 333-016-3050(6), to be approved a QEA for a BNPM must demonstrate that HPCCCCH concentrations measured in the appropriate media be less than or equal to the PQL of the HPCCCH established in OAR 333-016-2035(2) in effect for the biennial notice period for which the QEA is requested. [The Authority will

• If inadequate, briefly describe below identified deficiencies below.

Adequate Inadequate

4. STEP B - Second Option - Per OAR 333-016-3050(2)(c), does the information submitted adequately satisfy requirements of OAR 333-016-3050(2)(c)? Adequate Inadequate

Adequate Inadequatee

• Does the information provided adequately respond to the requirements of 333-016-3050(2)(a)?

provide correct version of OAR 333-016-2035(2) to Contractor.]

• If inadequate, briefly describe below identified deficiencies below.

Check this box if this QEA contains an aggregation of BNPMs not likely to meet criteria for aggregation per #6 of QEA Guidance? If so, please list Unique Identifiers for such BNPMs in the space below:

SAMPLE