Indoor Environment_PWS_rev 8-17-23.pdf

PERFORMANCE WORK STATEMENT

Exposure Testing of Consumer Products used within Indoor Environments to Support

CPSC Exposure Assessments

1. Description of Services

The Contractor will provide all necessary personnel and services to the U.S. Consumer Product

Safety Commission to conduct exposure testing of consumer products used within indoor environments to support CPSC exposure assessments. These may include laboratory studies, field studies, or field studies with laboratory analyses.

There is a wide variety of exposure testing for consumer products described in this performance work statement. Shorter-term (<1 day to days) and higher-throughput (larger sample size) testing as well as longer-term (weeks) and lower-throughput (lower sample size) testing are described.

Contractors who have experience and technical capability for more than one, but not all, of the exposure testing described in this performance work statement are encouraged to apply. Prior to initiating exposure product testing, a task order describing the product testing plan will be issued and finalized to ensure feasibility and determine an agreed upon scope.

2. Background

There is a close interrelationship between the use of consumer products and levels of chemical substances found in the indoor air, indoor dust, and surfaces of indoor environments. The staff of the U.S. Consumer Product Safety Commission (CPSC) routinely assess the potential exposures to consumers from chemicals that may be used in consumer products. These assessments are typically based on available data from the peer reviewed open literature and from gray literature

(e.g., product manufacturer websites, safety data sheets, technical data sheets, and defaults from government and non-profit consumer and indoor environment indoor/consumer modeling guides). For certain chemical/product combinations, additional de-novo laboratory or field testing of chemical content, emissions, and/or migration can be performed to provide scenario-specific information to reduce uncertainty.

To facilitate these processes, CPSC staff is seeking a contractor to administer and conduct exposure testing of consumer products used within indoor environments to support CPSC’s exposure assessments.

All exposure testing of consumer products used within indoor environments includes a description of how the consumer product or consumer article is used within the indoor environment. For this purpose, CPSC staff are using OECD definitions of consumer products and articles provided below.

• Consumer products are consumable liquids, aerosols, semi-solids, or solids that are used a given number of times before they are depleted. Exposures are elevated for a shorter period of time during use(s), and lower when products are not being used. Product use is more likely to include direct contact and/or close proximity. Note, some products may be applied on the surface of articles for long-term use and exposures over time may not follow this general trend1 (OECD 2017).

• Consumer articles are generally solids, polymers, foams, metals, woods, which are always present within indoor environments for the duration of their useful life which may be several years. Articles may include appliances, home furnishings, or children’s products. Migration of additive chemicals from articles can result in exposure through ingestion of dust particles, mouthing of article surface, or skin contact. Volatile organic chemicals are more likely to be released as vapors from certain articles over time, while semi-volatile organic chemicals are more likely to be released through mass transfer/diffusion and partition to dust. For articles, it will also be important to collect information on which polymer type is used for plastic articles, perhaps the largest and most diverse article category2 (OECD 2017).

The exposure testing may include laboratory studies and/or field studies that provide data on the chemical content of consumer products, the emissions of chemical substances to surfaces, indoor air, or dust through mediated exposure pathways, or the migration of chemical substances to skin or saliva through direct contact exposure pathways.

Exposure testing of consumer products used in an indoor environment is not an exposure assessment, although it does generate or compile many of the required inputs for an assessment of exposure to people who use consumer products or articles.

For each project, the CPSC Contracting Officer’s Representative (COR) will provide an initial scope. This will include what is known about the chemical substance(s), consumer product(s), and indoor environment(s) of interest. This will also include an overview of available product testing approaches. Product testing plans will be developed with the contractor first as separate task orders before starting new task orders to generate new data. All projects will require provision of raw data and a summary data report. The Contractor’s reports will be organized in a logical manner and include a complete bibliography.

3. Objective

The CPSC’s objective is to ensure that CPSC staff reports, such as product testing reports, indoor environment and source characterization analyses, and exposure assessments are thorough, scientifically-defensible, and of the highest quality, and that scientific information and assessments are adequate to support CPSC programs and decision-making.

4. Contract Type

This is a firm-fixed price, indefinite delivery/indefinite quantity contract (IDIQ) that will include a one-year base period and four option years. The minimum guaranteed amount is 1 task order for the base year only.

1 https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)14&doclanguage=en 2 Ibid https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)14&doclanguage=en

Issuance of Task Orders:

Task orders will be issued against this IDIQ contract. The Government will send a written request for quotation for a proposed task to the Contractor. The Contractor shall submit a written proposal describing the technical approach for completing the work, a firm fixed price and price breakdown, substantiating hours and any other supporting information required by the request for quotation. Upon completion of negotiations for a task, the Government will issue a firm fixed priced task order. The Contractor is not authorized to commence work on a task until after a task order has been awarded with a CPSC Contracting Officer signature. Invoicing and billing instructions will be noted on each task order. The issuance of all task orders will be contingent upon the agency decision to fund the service.

5. Description of Work

5a: Product Testing Plan and Source Characterization:

The product testing plan defines the proposed experimental conditions, approaches, methods, equipment, and specifications that govern how the data will be generated. CPSC staff generally requires the use of existing methods or standards that govern how samples will be prepared, extracted, and analyzed. CPSC staff will not be supporting method development of new approaches or techniques. However, the contractor may refine existing methods or standards with a reasonable justification, after consultation with the CPSC COR. CPSC staff will not be supporting the purchase of new laboratory equipment. However, the contractor may share existing laboratory equipment with existing partners or refine existing laboratory equipment with reasonable justification after consultation with the CPSC COR.

CPSC staff considers evaluation and updates of existing standards a routine part of conducting product testing work to support indoor exposure assessments. When related to an ongoing call order, the CPSC COR may request contractor review and comment on existing standards if these standards are being revised. Examples of existing standards development organizations that publish information about how to conduct product testing include: ASTM, ANSI, ISO, and UL.

The contractor must be familiar with these standards.

A dedicated section of the product testing plan will include a short narrative (1-2 pages) on source characterization. This narrative will include a plan for determining the sample size based on the objectives of the project and then obtaining consumer products for testing. CPSC staff has broad jurisdictional authority over hundreds of different consumer product and consumer article categories. Thousands of chemical substances are used in these consumer products and articles.

It is not possible to test or to model all of these different combinations. Source characterization is an important first step of exposure assessment. Call orders may focus on one or more categories of interest. The contractor may be asked to purchase products or articles or CPSC staff may purchase or provide these products or articles. The specific consumer product or consumer article of interest will be researched and assigned to a use category3 prior to purchase. Variability within and across brand names of consumer product or consumer article use categories will be considered. The contractor will confirm that one or more chemicals of interest is present in the formulation of a consumer product or article prior to purchase, if feasible. Note, the contractor

3 https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)14&doclanguage=en https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)14&doclanguage=en will consult with CPSC staff to determine if a consumer product or consumer article of interest has already been purchased or is available in CPSC staff inventory prior to purchase.

5b. Conduct Product Testing and Complete Product Testing Report:

After the product testing plan is approved by the CPSC COR, the product testing and report can be requested in a follow-up task order subject to available funds. The product testing report is comprised of two parts. The first part is a supplemental file that merges raw data, laboratory reports, and sampling plans into one file. The second part is a summary report that interprets the results of the product testing.

The Contractor will be bound by the contractor’s affidavit of non-disclosure executed by the

Contractor and to have all employees or agents of the Contractor handling copies of the documents execute the employee/agent affidavit of non-disclosure prior to their receipt of the documents. During the period of performance, the work is to remain confidential among the

Contractor, subcontractors, and CPSC staff. Completed reports generally will be made public and will be posted on the CPSC website after the conclusion of the task order.

Authors of reports may not release or publish their reports without the permission and approval of the CPSC COR. Publications resulting from the report must be cleared in accordance with

CPSC procedures.

6. Specifications

6.a. Product Testing Plan and Source Characterization. The product testing plan will include a review of available methods that could address identified data needs. The product testing plan will provide a recommended approach or approaches. The recommendation will be accompanied by a rationale that provides a discussion of the pros and cons for the various approaches presented. The product testing plan will also include a source characterization narrative that defines the chemical substance(s), the consumer products or articles, and indoor environments of interest. More specifically, the source characterization will include

• chemical information such as measured or estimated physical properties,

• product information such as brand name, safety data sheet, and comparison to similar products or articles within a category, and

• formulation information that describes expected starting concentration of the chemical in the product based on publicly available reported information.

The product testing contractor(s) will maintain current laboratory accreditation(s) or use comparable good laboratory practices (GLP) as follows. The laboratories must be well stocked with existing, well-maintained equipment. Purchase or repair of existing equipment will not be supported under the contract. Laboratory equipment includes apparatus for sampling (large chamber, small chamber, microchamber, specialized chambers or equipment for contact exposures, etc.), extraction (hot plates, microwaves, grinders, cryomills, etc.,), and analysis (GC-

MS, LC-MS, DART-MS, Orbitrap, etc.,). This list of equipment is illustrative and not exhaustive. If different parts of the product testing are conducted in different locations, the overall product testing must be overseen by an accredited laboratory (or a lab who uses comparable GLP) who maintains chain of custody over product samples. If multiple entities conduct sampling and analysis, they may demonstrate that they have met these requirements across their team. The limit of detection and limit of quantification should be provided for all analytes tested under this contract.

The following types of product testing may be required:

1- Source Characterization

2- Emissions from aqueous/liquid covered surfaces to air

3- Short Term Emission Testing from Products to Indoor Environment (Emission rates and emission factors4)

4- Long-Term Emission Testing from Products to Indoor Environment (Partition and

Diffusion Coefficients)

5- Particulate Matter Formation Due to Mechanical Forces Applied to Product or Article

Surfaces

6- Transfer of Chemicals from Sources to Settled Dust

7- Photolysis under Simulated Indoor Lighting Conditions

8- Migration to Saliva (oral exposure)

9- Migration to Sweat and Skin (dermal exposure)

10- Migration of chemical from solid material to liquids

These procedures are described in detail in the following document: “EPA 2019. Indoor

Exposure Product Testing Protocols Version 2.0. Document# 740-S1-70025”

Additional parameters6 are of interest for determining emissions, fate, and transport of semi-volatile organic compounds in the indoor environment. Some of these parameters can be measured experimentally on their own or in combination. Other parameters can be estimated based on measured or estimated physical-chemical properties or other measured product testing information. Parameters of interest may include:

- y0: the gas-phase concentration immediately above the surface of a material

- C0: Initial concentration of the SVOC in the source material

- Kma Source material-air partition coefficient

- Ks: surface-air partition coefficient

- Kdust: dust-air partition coefficient

- Kp: particle-air partition coefficient

- Pdust,s: Concentration of SVOCs in the dust settled on the sink (non-source) surfaces (μg g-1)

- Pdust: Concentration of SVOCs in the dust settled on the source surface (μg g-1)

- Hm: Mass transfer coefficient for the surface of a source (m h-1)

- hm,s: Mass transfer coefficient for the sink (non-source) surface (m h-1)

- hm,d: Mass transfer coefficient at the surface of settled dust (m h-1)

4 Short-term emission can either be for products with an application phase such as spraying, pouring, or mixing where initial emissions are expected to rise to a peak before decaying over time (hours to days) or for products that are generally stable at the start of sampling where emissions are likely to be steady-state over time or gently rise or fall in response to environmental conditions such as temperature changes.

5 https://www.epa.gov/tsca-screening-tools/indoor-exposure-testing-product-protocols-version-20 6 https://pubs.acs.org/doi/abs/10.1021/acs.est.0c02329 https://www.epa.gov/tsca-screening-tools/indoor-exposure-testing-product-protocols-version-20 https://pubs.acs.org/doi/abs/10.1021/acs.est.0c02329

Additional considerations are required for combustion products such as appliances. While emissions from consumer products and articles are typically normalized by mass or surface area, emissions from combustion products are normalized by energy usage which is related to the mass of fuel used. Direct-reading instruments capable of detecting rapidly changing concentrations of chemicals in the air will likely be required for product testing that involves combustion appliances.

Finally, testing of consumer products or articles during use is also of interest. Methods may involve personal exposure monitoring through use of personal air sampler badges, active sampling of personal air or area air through sorbent tubes, wiping of skin surfaces before and after product use, characterizing transfer efficiencies between product surfaces, hands, and face/mouth, or documentation of how people interact with products by observing duration of contact and/or frequency of contact over time. Appropriate informed consent (such as IRB approval) should be obtained for all testing that involves human subjects. Testing should be observational in nature, characterizing the range of exposure that would normally be expected during product or article use. These methods are typically employed in industrial settings to assess exposures to workers in the workplace. However, these methods can also be used, under certain conditions, to assess personal exposures during use of consumer products or after contact with consumer articles. These procedures are described in detail through the American Industrial

Hygiene Association7. CPSC staff requires that this type of testing be overseen by certified industrial hygienists8 who may be assisted by additional technicians and analysts.

7. Government Furnished Materials

Some tasks will require the Government to provide to the Contractor reports, documents, or other information in order for the Contractor to deliver the work specified in the task order. Generally, such documents will be transmitted to the Contractor through email. Large files may need to be transmitted through a secured file-sharing service authorized by CPSC. If needed, files may be provided using physical media, such as thumb drives. CPSC staff may provide some consumer product or consumer article samples to the contractor so that they can be used for product testing.

8. Deliverables or Performance

All time frames are calendar days.

a. After a call order is awarded, the Contractor and CPSC staff will meet (in person or by teleconference) to kick off the task. As specified in individual call orders, the Contractor will provide a written project plan, and will meet periodically with CPSC staff (in person or by teleconference) during the period of performance of the work. The Contractor will submit to the

CPSC COR a draft report within the time frame specified by the schedule in the individual call order. The draft report will be e-mailed to the CPSC COR in a Microsoft Word file. Following receipt of the report by the COR, the Contractor will make appropriate changes and submit a draft final report within the time frame specified by the call order. The draft final report may be

7 https://www.aiha.org/get-involved/volunteer-groups/volunteer-committees-bodies-of-work/industrial-hygiene-hazard-identification-and-exposure-risk-assessment-by-market-segment 8 http://www.abih.org/about-abih/cih-caih https://www.aiha.org/get-involved/volunteer-groups/volunteer-committees-bodies-of-work/industrial-hygiene-hazard-identification-and-exposure-risk-assessment-by-market-segment https://www.aiha.org/get-involved/volunteer-groups/volunteer-committees-bodies-of-work/industrial-hygiene-hazard-identification-and-exposure-risk-assessment-by-market-segment http://www.abih.org/about-abih/cih-caih subject to peer review, as specified in the individual call order. Upon receipt of peer reviewer comments, the Contractor will make appropriate changes and submit a final report following the schedule specified in the call order.

b. Delivery Schedule

The following table provides the general delivery schedule. Each task order will specify the deliverables and schedule to be followed for that task.

Table 1: Schedule of Deliverables for a Product Testing Plan

Product Testing Plan Report Schedule

Item(s) Quantity Delivery or Performance

The CPSC COR and

Contractor will meet in person or by teleconference to discuss and initiate the call order

1 meeting To be specified in individual call order, within 7calendar days of call order start date

The COR will provide to the

Contractor any government furnished documents

To be specified in individual call order

To be specified in individual call order, generally within

7calendar days of call order start date

The COR and Contractor will meet in person or by teleconference to discuss the status of the call order

As appropriate To be specified in the individual call order, generally monthly

The Contractor will submit the draft product testing plan to the COR. The draft report includes the source characterization narrative and product testing plan.

1 draft report To be specified in individual call order, generally

90 calendar days after project initiation meeting or receipt of specified documents. 90 days is an estimate for a typical product testing plan.

Depending on the nature of the testing, this could be shorter or longer.

The COR will provide written comments on the draft report to the Contractor

1 set of comments on draft report

To be specified in individual call order, generally

14 calendar days after receipt of the draft report

The Contractor will revise the draft report as appropriate and will submit the final report to the COR

1 draft final report To be specified in individual call order, generally

30 calendar days after receipt of comments on the draft report. 30 days is an estimate for a typical product testing plan. Depending on the nature of the testing, this could be shorter or longer.

Inspection and Acceptance (if peer review not specified)

The final report will be reviewed by the COR and formally accepted

14 days after receipt of the final report

Table 2: Schedule of Deliverables for a Product Testing and Product Testing Report

Product Testing and Product Testing Report Schedule

Item(s) Quantity Delivery or Performance

The CPSC COR and

Contractor will meet in person or by teleconference to discuss and initiate the call order

1 meeting To be specified in individual call order, within 7 calendar days of call order start date

The COR will provide to the

Contractor any government furnished documents

To be specified in individual call order

To be specified in individual call order, generally within 7 calendar days of call order start date

The COR and Contractor will meet in person or by teleconference to discuss the status of the call order

As appropriate To be specified in the individual call order, generally monthly

The Contractor will submit the schedule based on the approved product testing plan to the COR and obtain products for testing.

1 draft report To be specified in individual call order, generally within 14 calendar days of call order start date

The COR will provide written comments on the sample size of obtained products and product testing schedule

1 set of comments on draft report

To be specified in individual call order, generally

7 calendar days after receipt of the draft report

The Contractor will complete the product testing, record the results, and store the data

Product Testing results

(includes both sampling and analysis)

To be specified in individual call order, generally

180 calendar days after project initiation meeting or receipt of specified documents. 180 days is an estimate for a typical product testing plan. Depending on the nature of the testing, this could be shorter (days to weeks) or longer.

The Contractor will complete document the results of the product testing in a draft product testing report

1 draft final report To be specified in individual call order, generally

90 calendar days after final analysis is completed

The COR will provide written comments on the draft report to the Contractor

1 set of comments on draft report

To be specified in individual call order, generally

14 calendar days after receipt of the draft report

Inspection and Acceptance (if peer review not specified)

The final report will be reviewed by the COR and formally accepted

14 days after receipt of the final report

9. Performance Assessment Plan

Successful performance will be measured by:

Performance Objectives Performance Thresholds

Reporting Requirements: Reports are submitted on time.

Reports are submitted in accordance with the delivery schedule 95% of the time.

Documentation Requirements: Documents are submitted on time and are accurate.

Documents are complete and accurate and require only minimal editing for grammatical errors. Documents are submitted in accordance with the delivery schedule 95% of the time.

Key Personnel: All key personnel must be knowledgeable and experienced.

Key personnel working on tasks must be knowledgeable and experienced in all aspects of the work assigned 100% of the time.

10. Place of Delivery

U.S. Consumer Product Safety Commission

Directorate for Health Sciences

5 Research Place

Rockville, MD 20850

The CPSC Contracting Officer’s Representative (COR) and e-mail address will be indicated on each individual call order. Each call order will note delivery instructions.

11. Inspection and Acceptance

Each call order will note specific time periods for inspection and acceptance. For example, the final report submitted to the U.S. Consumer Product Safety Commission will be reviewed within

14-21 days of receipt of the report for any additional questions and comments. If returned to the

Contractor as a result of the review, the Contractor will address and revise their report accordingly and return the final version to the COR within 14 days of receipt.