Entity Material Regulatory Information

The Entity Material Regulatory Information form is available to support regulatory reporting, through custom reports, for materials that need to be reported at the entity level. For example, a chemical may have different hazard ratings depending on the environment where it is used. Specify physical and health hazards, hazard classes, exposure limits, and ratings associated with an entity material on the form. Since regulatory information can change over time, an effective date is required to track and maintain changes. When more than one version of regulatory information exists for a specific entity material, a Select Effective Date field is displayed below the Effective Date field. The information associated with the most recent effective date is always automatically displayed when the Entity Material Regulatory Information form is opened; however, you can select a previous effective date to review/edit the information for the chosen effective date.

Tip:  Refer to Regulatory Information to enter hazards, exposure limits, and ratings at a material level.

For additional instruction on entity material regulatory information, click the following links or use the scroll bar to scan the page.

To enter regulatory information for an entity material

Tip:  If you are accessing the Entity Material Regulatory Information form from the Enterprise Entity or Entity Materials form, click the Regulatory Information EDIT link for an existing material, and begin with step 4.

1. Click Data Entry > Essential Hierarchy > Entity Material Regulatory Information in the Navigation Tree to access the Entity Material Regulatory Information list.
   
   For Process Data Manager, a link to the form has been added to the Process Unit Hierarchy folder.

2. Click the New button to open the Entity Material Regulatory Information form.

3. Enter the Entity and entity Material.
   
   If the material has not been established as an Entity Material for the selected entity, click the Ellipsis button and add it.

4. Enter the Effective Date. The Calendar button is available to select a date.

5. Add information in the Hazards, Exposure limits, and Ratings sections.

6. Click the Save button on the form.

Specifying Entity Material Regulatory Information Hazards and Hazard Classes

In the Hazards section on the Entity Material Regulatory Information form, define any number of physical, health, and other hazards that apply to the entity material regulatory information record. For each hazard, you can document the governing body that publishes the hazard and a reference for assigning the hazard, such as a CFR (Code of Federal Regulations) publication in the United State. For example, you could document that OSHA publishes the chemical stressor Benzene as a carcinogenic health hazard, as referenced by 29 CFR 1910.1028.

Tip:  Hazards must be associated with the governing bodies that publish them in the Hazards section on the Governing Bodies form before you can assign hazards to the entity material regulatory information.

You can also document an entity material's SARA hazard classes in this section. If a material has certain SARA health hazards, such as immediate or delayed, or SARA physical hazards, such as fire, sudden release of pressure, or reactivity, click the corresponding check box.

To specify entity material regulatory information health and physical hazards

1. Open the Entity Material Regulatory Information form for the entity material and review the effective date. Enter a new Effective Date when applicable.
   
   The regulatory information for the most recent effective date is automatically displayed. When there is more than one effective date, the Select Effective Date field is displayed below the Effective Date field where you can select a different effective date.

2. Expand the Hazards section.

3. Click the check box for each of the SARA Hazard Classes that apply to the entity material.

4. Click Add Hazard to add a hazard for the entity material regulatory information. Otherwise, skip to step 9.

5. Select the Governing Body and Hazard from the list for each field.
   
   If the applicable value is not listed, click the Ellipsis button next to the field and add it.

6. Enter a Reference publication for the hazard, such as the CFR.

7. Click OK.
   
   The hazard is displayed as a line item. Edit existing hazard information using the buttons adjacent to the line item.

8. Repeat steps 4 through 7 to add other hazards.

9. Click the Save button on the form.

Entering Entity Material Regulatory Information Exposure Limits

In the Exposure Limits section on the Entity Material Regulatory Information form, you can enter the exposure limits that various governing bodies have set for a material. For example, the American Conference of Governmental Industrial Hygienists (ACGIH) has developed an exposure limit called TLV (Threshold Limit Value) where the TLV for isopropanol has been defined as 400 ppm.

When applicable, Industrial Hygiene module users can associate a sample type with the exposure limit and then make the exposure limit available for samples of the selected type on the Exposure Session Sample Results and Exposure Session TWAs forms.

Tip:  Before beginning, make sure a list of exposure limits has been established on the Exposure Limits form and the limits have been assigned to the appropriate regulatory body or agency on the Governing Bodies form.

To enter entity material regulatory information exposure limits

1. Open the Entity Material Regulatory Information form for the entity material and review the effective date. Enter a new Effective Date when applicable.
   
   The regulatory information for the most recent effective date is automatically displayed. When there is more than one effective date, the Select Effective Date field is displayed below the Effective Date field where you can select a different effective date.

2. Expand the Exposure Limits section.

3. Click Add Exposure Limit and select a Governing Body from the list.
   
   If the governing body is not listed, click the Ellipsis button and add it.

4. Select an Exposure Limit from the list. Just the exposure limits associated with the selected governing body are listed.
   
   If the appropriate limit is not listed, click the Ellipsis button and add it.

5. Enter the numeric Value for the exposure limit. This value must be greater than zero.

6. Select a Unit of measure from the list for the value entered.
   
   If the unit is not listed, click the Ellipsis button and add it.

7. Use the guidelines below to complete the remaining fields which are Industrial Hygiene module-specific. Otherwise, skip to step 8.

1. • Select a Sample Type from the list.

   • Select the Available for IH option to make the exposure limit available for sample results on the Exposure Session form.

   • Click Available for TWA to make the exposure limit available on the Exposure Session TWAs form.

   • Select Set as OEL to flag the exposure limit value as the default Occupational Exposure Limit for exposure assessment industrial hygiene statistical reporting.

   • Click Set as default for TWA to make the exposure limit a default when assigning the sample type associated with the limit to an exposure session sample. The Governing Body and Exposure Limit Type fields on the Chemical Stressor Results and Exposure Session TWAs forms will be automatically populated.

8. Click OK.
   
   The exposure limit is displayed as a line item. Edit existing exposure limits using the buttons adjacent to the line item.

9. Repeat steps 3 through 8 to add other exposure limits.

10. Click the Save button on the form.

Adding Entity Material Regulatory Information Ratings

In the Ratings section on the Entity Material Regulatory Information form, you can enter ratings for health, fire, and physical hazards that various governing bodies have set for the material. Rating information is commonly used on MSDSs or for internal reporting. Examples of organizations that rate materials are NFPA (National Fire Protection Association) and HMIS (Hazardous Material Information System). Material ratings can range from 0 to 4, with 0 being the lowest hazard indicator.

In the Special field, you can enter up to 10 characters that can be used to identify special problems or fire fighting techniques that may be needed to deal with the material in an emergency.  

To add entity material regulatory ratings

1. Open the Entity Material Regulatory Information form for the entity material and review the effective date. Enter a new Effective Date when applicable.
   
   The regulatory information for the most recent effective date is automatically displayed. When there is more than one effective date, the Select Effective Date field is displayed below the Effective Date field where you can select a different effective date.

2. Expand the Add Ratings section.

3. Click Add Rating and select a Governing Body from the list.
   
   If the appropriate value is not listed, click the Ellipsis button and add it.

4. Select the applicable rating from the lists for the Health, Fire, and Instability/Physical Hazard fields.

5. Enter any key rating information in the Special field (maximum 10 characters) and click OK.
   
   The rating information is displayed as a line item in the Ratings section. Edit existing ratings using the buttons adjacent to the line item.

6. Repeat steps 3 through 5 to add rating information for other governing bodies.

7. Click the Save button on the form.