SDS Authoring SOW.pdf

STATEMENT OF WORK

Safety Data Sheet Authoring

1.0 Background

The United States Occupational Safety and Health Administration’s (OSHA) Hazard Communication Standard (HCS), 29 CFR 1910.1200, requires that chemical manufacturers classify the hazards of the chemical products they produce. Additionally, chemical manufacturers must provide information about the classified hazards of their chemical products to downstream users by developing and providing Safety Data Sheets (SDSs) and “shipped” container labels. The HCS provides specific requirements regarding the hazard classification process and the required content and format for SDSs and “shipped” container labels for “hazardous chemicals” (as defined in the HCS). The HCS chemical manufacturer requirements apply to “laboratories” (as defined in OSHA 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories) only when the hazardous chemicals will be shipped from the laboratory workplace.

The National Institute of Standards and Technology (NIST) is an agency of the US Department of Commerce. NIST is a physical science laboratory located primarily in Gaithersburg, MD and Boulder, CO. NIST’s mission is to promote US innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. Over 5,000 employees and associates work at NIST facilities.

In conducting NIST’s mission, numerous hazardous chemicals are manufactured and used at NIST workplaces. The majority of the hazardous chemicals manufactured or used at NIST workplaces are “laboratory use” (as defined in OSHA 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories). Occasionally, hazardous chemicals need to be shipped from a NIST workplace and therefore the HCS chemical manufacturer requirements regarding hazard classification, SDSs, and “shipped” container labels apply; for these chemicals, hazard classification must be performed, an SDS must be developed, and a “shipped” container label must be developed in accordance with the requirements of the HCS.

2.0 Objectives

The objective of this requirement is to provide hazard classification and SDS authoring services, on an as-needed basis, to any NIST Operating Unit (OU). The NIST Office of Safety, Health and Environment (OSHE) will be the central facilitator for SDS authoring and will manage this effort.

3.0 Scope

a. Hazard classification, performed in accordance with the requirements of the HCS. Efforts taken to reach a classification must be documented and submitted to NIST in a Classification Back-Up Document (Attachment A)

b. SDS authoring, performed in accordance with the requirements of the HCS.

c. Submission of draft SDS and a Classification Back-Up Document to NIST. Revising and finalizing of draft SDS based on NIST comments.

The total number of SDSs that will be required by NIST cannot be specified. A minimum of ten

(10) SDSs shall be requested for the first year of the contract, and the maximum number of SDS requests is estimated at 80 per year.

4.0 Contractor Minimum Qualifications

SDS Authors shall have a Bachelor’s Degree in toxicology, chemistry, biology or a related field and 2-yrs. experience authoring SDS’s.

An adequate staff of SDS Authors to prepare up to 5 SDS’s concurrently and comply with the standard or rush preparation times stated in Section 5.0 b is required.

5.0 Tasks

a. NIST will request SDS Authoring as needed for specific chemicals. Each request will include available information on each chemical provided to the Contractor in a standard form (Attachment B).

The Contractor and NIST’s Contracting Officer’s Representative (COR) will agree on the complexity of the SDS to be authored; the fixed unit price that will be applied to the SDS to be authored (see Table 5.1) and the schedule (see Table 5.2) for completion of the SDS to be authored.

• Standard preparation time for a draft SDS shall be 7 working days or less.

• Rush preparation time for a draft SDS shall be 3 working days or less.

b. The Contractor shall submit a draft SDS and a Classification Back-up Document to the COR in accordance with the agreed upon schedule.

c. NIST will review the draft SDS and, as needed, submit comments to the Contractor. If no revisions are required, the COR will accept the draft SDS as the final SDS.

d. The Contractor shall revise the draft SDS based on comments submitted to the Contractor by the COR and submit a final SDS to the COR.

e. The COR will either accept the final SDS, or if comments have not been sufficiently addressed in the revision of the draft SDS, reject the final SDS and request further revisions.

The final SDS will not be accepted by the COR until the comments submitted by NIST are sufficiently addressed. Payment will not be authorized until the COR has accepted the final

SDS.

6.0 Deliverables / Deliverables Schedule

Table 6.1 Contract Deliverables

Contract Line Item Number

(CLIN)

Deliverable Description

SDS01 Level 1 SDS (including a Classification Back-up Document)

Basic SDS. Pure Substance

SDS02 Level 2 SDS (including a Classification Back-up Document)

Complex SDS. Mixture containing two to five substances.

SDS03 Level 3 SDS (including a Classification Back-up Document)

More Complex SDS. Mixture containing Six to ten substances.

SDS04 Level 4 SDS (including a Classification Back-up Document)

Highly Complex SDS. Mixture containing greater than 10 substances.

SDS05 Addendum and/or update of existing SDS

Table 6.2 Delivery Schedule

Contractor Deliverable Description Media Submission Schedule

Government Tasks

Standard Turn- Around Not to Exceed

Draft Safety Data Sheet (SDS), Classification Back-up Document

Submission by e-mail

SDS in MS WORD format

7 working days after receipt of a request from NIST

NIST review of Draft SDS Comments submitted by e-mail to the Contractor in

MS WORD

3 working days following receipt of the Draft SDS

Submission of the Final SDS Submission by e-mail

SDS in MS WORD and PDF format

2 working days after receipt of any comments from NIST

NIST acceptance of the Final SDS or rejection and request for further revision based on previously submitted comments

Submission by e-mail

2 working days following receipt of the Final SDS

Rush Turn-Around Not to Exceed

Draft Safety Data Sheet (SDS), Classification Back-up Document

Submission by e-mail

SDS in MS WORD format

3 working days after receipt of a request from NIST

NIST review of Draft SDS Comments submitted by e-mail to the Contractor in

MS WORD

1 working day following receipt of the Draft SDS

Submission of the Final SDS Submission by e-mail

SDS in MS WORD and PDF format

1 working day after receipt of any comments from NIST

NIST acceptance of the Final SDS or rejection and request for further revision based on previously submitted comments

Submission by e-mail

1 working day following receipt of the Final SDS

7.0 Government-Furnished Property, Material, Equipment, or Information

NIST will provide available information for each chemical for which the Contractor is requested to prepare an SDS. The information will be provided on the SDS Request Form shown in Attachment A.

8.0 Place of Performance

Performance shall be at the Contractor’s facilities.

9.0 Period of Performance

The period of performance for this requirement shall be one year with four option years.

10.0 Attachments

Attachment A: Classification Back-up Document

Attachment B: SDS Request Form

Attachment A

Classification Back-Up Document

The following information shall be recorded with each SDS Prepared to document the hazard classification for each specific product

General:

1. Product Identifier.

2. Name of SDS Author

3. Date the classification was completed.

Classification Data:

For each Hazard Class:

1. Under the column named "Category" indicate the hazard class category, when applicable.

2. Under the column named "Classification Status", enter one of the following options:

a. "Conclusive - Sufficient to Classify" if there is appropriate high quality data, and based on that, it is concluded that the classification criteria are fulfilled;

b. "Conclusive - Insufficient to Classify" if a substance is tested with the appropriate high quality reflected in the study or where other high quality information is available, and based on that, it is concluded that the classification criteria are not fulfilled;

c. "Inconclusive" if there is data or other information which is not reliable (e.g. data of poor quality) or if you have several equivocal study results or information (In these cases, the available data/information cannot be regarded as a firm basis for classification.); or,

d. "Data Lacking" if there is not relevant data or other adequate and reliable information that can be compared with the classification criteria.

3. Under the column "Classification Data and Bibliographic Reference" summarize the data/findings that are the basis for the classification. Enter relevant data (e.g. LD 50 value) used for hazard classification or enter "No Applicable Information Was Found." if no information was found. Enter the bibliographic source of the data.

4. Under the column "Rationale for Hazard Classification" describe the how the data analysis resulted in the classification.

5. Under the column "Data Sources Consulted " list all data sources consulted in the hazard classification.

Classification Back-Up Document Save the classification data in a file named in the following format "Product Identifier_Year-Month-Day".

General:

Product Identifier:

SDS Author:

Date:

Classification Data:

Hazard Class Category Classification

Status Classification Data and Bibliographic Reference

Rationale for Hazard Classification Data Sources Consulted

Health Hazards Acute Toxicity (Oral) HCS2012-App. A Acute Toxicity (Dermal)

Acute Toxicity (Inhalation-Gases) Acute Toxicity (Inhalation-Vapors) Acute Toxicity (Inhalation-Dust and Mists) Skin Corrosion/Irritation Serious Eye Damage/Eye Irritation Respiratory Sensitization Skin Sensitization Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity Specific Target Organ Toxicity-Single Exposure Specific Target Organ Toxicity-Repeated or Prolonged Exposure Aspiration Hazard

Physical Hazards Explosives HCS2012-App B Flammable Gases

Flammable Aerosols Oxidizing Gases Gases Under Pressure Flammable Liquids Flammable Solids Self-Reactive Chemicals

Classification Data:

Hazard Class Category Classification

Status Classification Data and Bibliographic Reference

Rationale for Hazard Classification Data Sources Consulted

Pyrophoric Liquids Pyrophoric Solids Self-Heating Chemicals Chemicals Which, In Contact With Water, Emit Flammable Gases Oxidizing Liquids Oxidizing Solids Organic Peroxides Corrosive to Metals

Other Hazards: Combustible Dust HCS2012 Definitions Pyrophoric Gas

Simple Asphyxiant Hazards Not Otherwise Classified

Attachment B

SAFETY DATA SHEET (SDS) AUTHORING REQUEST FORM

(Prepared by Product Owner – fill in readily available information; all sections do not have to be complete)

Requestor Information

Requested by:

Date:

OU/Division Number:

Why is an SDS being generated?

(New Product, Change to Existing Product’s Formulation, or Change to Existing Product’s Information)

Do you require a container label?

Will the product be shipped internationally? Y/N (specify country if international)1

Requested Delivery Date for the Draft

SDS:

(Standard delivery of a first draft is 10 business days;

rush turnaround of a first draft is 3 business days):

Product Information Product Name/Identifier to appear on SDS (Include ®/™ when appropriate):

Product CAS#, if applicable:

Synonyms (e.g. common names, trade names):

Physical Description (e.g., single crystal, solid bound to substrate, liquid).

Provide picture, optional

Product Use (R&D only?) and intended users:

Name, Address and telephone numbers of the chemical manufacturer, importer, or other responsible party

Other Information:

1 The NIST SDS Authoring Service provides an SDS in English that complies with U.S. Hazard Communication requirements (OSHA 29CFR1910.1200). For products that will be shipped internationally, it is the responsibility of the product importer to ensure that applicable international Hazard Communication requirements (e.g., content, format, language…) of the importing country are met.

SDS Request Form, Page 2 of 4

For mixtures, list all constituent substances and mole/weight percentage or amount

Constituent Substance Names

Substance Synonym or common name

Trade Secret (Yes or No)

Substance

CAS

Number

Substance Concentration (Mole/Weight percentage)

Impurities or additives that may contribute to the product’s hazards

SDS Request Form, Page 3 of 4

Any Available Physical Data for the Product Physical State (solid, liquid, or gas)

Appearance (e.g., color, transparency)

Combustible Dust (Y/N) (Is there the potential for generation of combustible dust?)

Odor and Odor threshold pH

Melting point/freezing point

Initial boiling point and boiling range

Flash point

Evaporation rate

Flammability (solid, gas)

Upper/lower flammability or explosive limits

Vapor pressure and Vapor density

Relative density

Solubility(s)

Partition coefficient: n-octanol/water

Auto-ignition temperature

Decomposition temperature

Viscosity

Chemical Formula and Chemical Formula Weight

SDS Request Form, Page 4 of 4 Any Available Physical Data for the Product (continued)

Miscibility

Fat Solubility

Conductivity

Volatile Organic Compounds (VOCs)

Any Available Stability/Reactivity Information for the Product Reactivity

Explosive

Oxidizing

Chemical stability

Possibility of hazardous reactions

Conditions to avoid (e.g., static discharge, shock, or vibration)

Incompatible materials

Hazardous decomposition products

Any available handling/storage information for the Product Precautions for safe handling

Conditions for safe storage, including any incompatibilities

Accidental Release Measures (Containment/Cleanup/Evacuation):

Is Product considered Hazardous Waste?

Is Product regulated as a Dangerous Good or Controlled Substance?