RFI Chemical Risk Assesment.docx

United States Department of Agriculture Forest Service

Sources Sought National Technology and Development Center Fire Chemical Risk Assessment Services.

Description This Request for Information (RFI) is solely for information and planning purposes and shall not be construed as a solicitation or as an obligation on the part of the U.S. Department of Agriculture (USDA), Forest Service. The purpose of this RFI is to identify qualified sources capable of performing the work described herein. As a result of this RFI, the US Forest Service, Procurement & Property Services (PPS) may issue a Request for Proposal (RFP). The Government will not pay for, nor reimburse, any expenses incurred in responding to this RFI.

The PPS does not intend to notify respondents of the evaluation and will not share information made available; please ensure any sensitive or protected information submitted is marked as such.

The Forest Service reserves the right to terminate this request and change its requirements if needed and any material submitted becomes the property of the Forest Service and will not be returned.

Responding to this notice does not guarantee participation in any future activities.

Background The US Forest Service, National Technology & Development Program (NTDP), has a need to procure services for Chemical Profiling, Human Health Risk Assessments, and Ecological Risk Assessments on new candidate wildland fire chemicals for possible inclusion on the Forest Service Qualified Products List.

Scope The work to be performed includes but is not limited to:

1.Risk Assessment for Wildland Fire Chemicals These Risk Assessments look at two different areas of work; Human Health and Ecological Risk.

It is the outcome of these assessments that inform the environmental consultation with Fish and Wildlife Services and National Oceanic and Atmospheric Administration (NOAA) Fisheries. This is all in accordance with the National Environmental Impact Statement (EIS) and the Endangered Species Act. The US Forest Service is legally required to perform this testing and analysis to help protect public lands.

The processes used to determine hazard identification, hazard data, exposure assessments, acute toxicity, and individual ingredient assessments is how the USFS determines and characterizes risk. These methodologies have been developed using subject matter expertise to address risk to wildland firefighters, our public lands and ecosystems, wildlife, and the public. The finer details of these assessments have been included below for reference under the Methodology section below.

These evaluation processes and risk analysis thresholds have been developed in partnership with the current contractor. The continuity of this work is critical in being able to keep all methodologies and practices in conformance to current US Forest Service specifications; FS 5100-304d, FS 5100-306b, and FS 5100-307b.

2. Methods

a. Hazard Assessment The goal of the hazard analysis is to determine toxicity levels with which to quantify risk. There are two types of toxicity endpoints: noncarcinogenic effects and carcinogenic effects. For noncarcinogenic effects, it is generally assumed that there is a threshold level, and that doses lower than this threshold can be tolerated with little potential for adverse health effects. The U.S. EPA has determined threshold doses for many chemicals and refers to these as reference doses (RfDs). The RfD is an estimate of the highest possible daily dose of a chemical that will pose no appreciable risk of deleterious effects to a human during his or her lifetime. The uncertainty of the estimate usually spans about one order of magnitude (EPA 2020). The RfD is calculated using the lowest NOAEL from the species and study most relevant to humans, or the most sensitive species (the species that exhibited the lowest NOAEL overall). This NOAEL is divided by an uncertainty factor (usually 100) consisting of a factor of 10 to allow for the variation of response within the human population and a factor of 10 to allow for extrapolation to humans. Additional uncertainty factors may be applied to account for extrapolation from a shorter term study, overall inadequacy of data, or failure to determine a no-effect level. RfDs are expressed in units of mg/kg/day. EPA lists RfDs in its Integrated Risk Information System, a chemical risk database (EPA 2020). RfDs can also be calculated using the steps outlined in EPA's methodology, if none has been developed by EPA. RfDs are analogous to the acceptable daily intake levels identified by groups such as the World Health Organization.

For compounds that are known or likely human carcinogens, cancer slope factors that have been calculated by EPA or other appropriate sources are identified for use in these risk assessments.

Reference:

U.S. Environmental Protection Agency. 2020. Integrated Risk Information System. www.epa.gov/iris.

b. Toxicity Assessments For many chemicals, including the majority of those found in the fire-fighting products and the formulations themselves, long-term study data for estimating chronic RfDs are not available. Layton et al. (1987) developed a methodology for deriving acceptable daily intake levels for noncarcinogenic compounds for which chronic toxicity data are unavailable. This methodology uses acute toxicity data, specifically, LD50s. Acute and chronic toxicity values for many chemicals were correlated to identify a factor that allowed a reasonable estimate of a chronic NOAEL based on an LD50. The LD50 is multiplied by this factor, which ranges from 0.00005 to 0.001, to obtain an estimate of the chronic NOAEL. This is the methodology on which the hazard assessment for the fire-fighting product formulations is based, because only acute toxicity data are available for these mixtures. In addition, Layton et al. (1987) summarized research that identified a factor of 5 that distinguished NOAELs in subchronic studies from NOAELs in chronic studies. Because the exposures evaluated in this risk assessment are predicted to occur at most 120 days per year (airtanker base personnel), this additional factor was also used in estimating the RfDs. The estimated NOAEL was then divided by an uncertainty factor of 100, to account for the uncertainty associated with interspecies extrapolation from laboratory animals to humans, and interindividual variation in sensitivity among humans. The estimated RfD was determined as follows:

This calculation was applied to the acute toxicity data for each of the products assessed, to provide an estimate of an acceptable exposure level. The estimated RfDs are summarized in the product-specific attachments.

Reference:

Layton, D.W., B.J. Mallon, D.H. Rosenblatt, and M.J. Small. 1987. Deriving allowable daily intakes for systemic toxicants lacking chronic toxicity data. Regulatory Toxicology and Pharmacology 7:96-112.

Deliverables and Services The contractor shall provide all labor, materials, travel, and expertise necessary to provide the following reports and information on the above listed products.

1. Chemical Profiles - Chemical Data Gathering and Profiles.

a. The Forest Service will provide data on the contents of each new product (chemical and percent composition). The contractor shall review and organize existing reports and data from sources including standard private and governmental databases, the Forest Service, USGS studies, previous risk assessment reports, and other Forest Service-directed laboratory studies on the products.

b .Chemical profiles of candidate products shall include the following sections: Identification, Characteristics and Fate, Toxicity, Ecological Effects, and References.

c. As part of each chemical risk assessment, the contractor shall review any existing chemical profiles available on these specific chemicals and update any information deemed critical for the risk assessments.

d. Any recommended changes shall be incorporated into final profiles.

2. Human Health Risk Assessment - Human Health Risk Assessment.

a. Using the methodology in the current “Human Health Risk Assessment:

Wildland Fire-Fighting Chemicals”, (available at https://www.fs.fed.us/rm/fire/wfcs/wildland-fire-chemicals.php) and updating/supplementing the methodology as appropriate, the contractor shall evaluate the human health risks to firefighters and members of the public from the submitted wildland firefighting chemical products. The report shall be a complete risk assessment of the product, using current and consistent methodology for assessing risks.

b. The contractor shall prepare a draft confidential human health risk assessment and a non-confidential human health risk assessment for Forest Service review and comment. Any recommended changes shall be incorporated into a final confidential human health risk assessment and a final non-confidential human health risk assessment. The confidential Risk Assessments shall contain specific information on the individual ingredients contained in a formulation and how those ingredients might impact human health. Ingredient information is proprietary to the company and will not be available to the public. The confidential risk assessment shall be a stand-alone document containing information on that product only. The non-confidential Risk Assessments will only contain information on the product as a whole, without the ingredient lists.

*Note: Upon award, the contractor shall complete and submit Government-provided confidentiality non-disclosures and after which, will be provided formulation, safety information, and toxicity results necessary for deliverables herein.

3. Ecological Risk Assessment - Ecological Risk Assessment.

a. Using the methodology followed in the 2014 final report “Ecological Risk Assessment: Wildland Fire-Fighting Chemicals”, (available at https://www.fs.fed.us/rm/fire/wfcs/index.htm) and updating/supplementing the methodology as appropriate, the contractor shall evaluate the ecological risks to terrestrial and aquatic wildlife from the submitted wildland fire chemical products. The report shall be a complete risk assessment of the products, using current and consistent methodology for assessing risks.

b. The contractor shall prepare a draft confidential ecological risk assessment and a draft non-confidential ecological risk assessment for Forest Service review and comment. Any recommended changes shall be incorporated into a final confidential ecological risk assessment and a final non-confidential ecological risk assessment. The confidential risk assessments shall contain specific information on the individual ingredients contained in a formulation and how those ingredients might impact ecological health. Ingredient information is proprietary to the company and will not be available to the public. The confidential risk assessment shall be a stand-alone document and containing information on that product only. The non-confidential risk assessments will only contain information on the product as a whole, without the ingredient lists.

*Note: Upon award, the contractor shall complete and submit Government provided confidentiality non-disclosures and after which, will be provided formulation, safety information, and toxicity results necessary for deliverables herein.

c. The methodology and organizational format for the Human Health Risk Assessment and the Ecological Risk Assessment shall follow the same format referenced at https://www.fs.fed.us/rm/fire/wfcs/wildland-fire-chemicals.php. This format allows for the efficient addition of new products to the overall report without requiring an entire revision. Formatting can be Instructions to Prospective Offerors Offerors responding to this Request for Information must provide the following:

A capability statement outlining core capabilities, available technology, past performance, and other differentiators that would indicate ability to meet needs in the Scope and Deliverables sections. Response to this RFI shall be limited to ten (10) pages. The following information must be submitted with your comments:

similar. Specify any small business categories that you may qualify for (SB, 8a, WOSB, VOSB, etc).

PROVIDE ANY OTHER PERTINENT INFORMATION RELATING TO THIS RFI THAT WILL ASSIST THE GOVERNMENT IN ADJUSTING THE CURRENT SCOPE FOR A FOLLOW-ON SOLICITATION.

The information requested by this RFI shall be provided, via email, by 5:00 p.m. Eastern Time, March 21, 2022 to: marlee.okeefe@usda.gov. Include “SSChemicalRiskAssesment” in the subject line of the email.

The U.S. Forest Service intends to utilize the RFI responses/information to assist with the development of a solicitation to satisfy the needs of chemical risk assessments for the US Forest Service.

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