# Presentation: 370000

- PACs QA/Updating Plans

- Po-Yung Lu
- Oak Ridge National Laboratory
- May 8, 2008

## Outline

-   QA Activities Since SCAPA 2007
-   QA/Updating Plans for 2008 and Beyond

## QA Procedures

***TEEL derivation for new chemicals, input worksheet data entry instructions, DKC-06-0006, by Craig.**** *

- Verify chemical identification information.
- Verify existing concentration–limit data, such as PEL, REL, TLVs, and IDLH.
- Verify toxicity data source and extraction rules.
- Verify toxicity data and unit are entered correctly.
- Verify “Y” or “N” chemical notations:
-     	Y: Concentration dependent; causing acute health effects; strong, moderate irritants.
-     	N: Dose dependent (Concentration x Duration of Exposure); chronic health effects; mild irritants.
- Dialog with Dr. Craig for final resolutions and TAG consultations, if necessary.

## QA Activities Since SCAPA 2007 

-   QAed 393 chemicals.
-   Summary of “corrective actions”
- Eliminated one duplication
- Corrected CAS Reg. No.: 4
- Changed: PAC-0: 18
- 			  PAC-1: 19
- 			  PAC-2: 23
- 			  PAC-3: 18
- 	Total                     78

*Percent of errors:*
*78/393x4=4.9%*

*Comparable to historical data,  about **5%,**  performed by Rocky Petrocchi and **4.3%** by Po-Yung Lu.*

## QA/Updating PACs for 2008 and Beyond

-  2007: DOE directed TAG to develop plans for comprehensive QA/updating the entire PACs.

-  2008: DOE approved the updating plans.

-  Team members: Doug Craig, Rocky Petrocchi,       Jane-Ann Bol, Tabitha Thompson, John Wassom, and  Po-Yung Lu (Lead).

**Notes:**
PAC has three severity levels of  toxicity:, PAC-1, PAC-2, and PAC-3.  When one is exposed to a concentration above PAC-2,  one may have irreversible or other serious health effects that could impair the ability to take protective action.  This is the most important toxicity value for emergency planning and management; 
		PAC has three data sources.  Two sources were adapted from EPA’s Acute Exposure Guideline Levels and American Industrial Hygiene Association’s Emergency Response Planning Guidelines. The third source is Temporary Emergency Exposure Limit (TEEL) developed by the DOE SCAPA committee.  TEELs account for 90% of the PACs. TEELs are developed by request when neither an AEGL nor ERPG values are available. This is a good example model of sharing resources and collaboration.  
		PACs data are selected for inclusion by priority order when they are available: first AEGL, second ERPG and third TEEL. 
  	 Since the  first release in 1991 with 86 chemicals, PAC is now in Rev 23  and has about 3300 chemicals.
 PAC has been used beyond the DOE complex, including other federal agencies, industries, universities, and foreign countries. 

When one is exposed to PAC-1: one may experience mild, transient health effects; when one is exposed PAC-3:  may cause death. 

## Approaches on Comprehensive QA/Updating Plans 

-   QA/Updating by PAC data sources: AEGLs,
- ERPGs, and TEELs.

-   QA/Updating by PAC data categories:

-  Concentration Limits and Others:
- PEL, RELs, WEELs, TLVs, LOCs, IDLHs, LELs;  SAX  and NFPA hazard ratings.

-  Toxicity Data:
- LD50, LDlo, TDlo, LC50, LClo, and TClo.

-  Chemical-physical Properties & Others: data varied depending on source used.

## QA/Updating Schedules

-  One-time comprehensive concentration limits QA/updating for the entire PAC database to 2008 values; then annual update for new additions/revisions.   .

-  Annual update New AEGL (Final and Interim), and  ERPG values.

-  Scheduled toxicity data updates for the entire database.

## Scheduled QA/Update of Entire PACs Database: Toxicity Values

**Updating priority criteria**
- 1. EPHA chemicals from all DOE sites.
- 2. By “age” of preparation.
- 3. Extremely hazardous list-19 chemicals.
- 4. Special requests.

** ****Updating schedule (4 years to update the entire PACs)**
- 1. 2008: 750 chemicals.
- 2. 2009: 750.
- 3. 2010: 900.
- 4. 2011: 900.
- 5. Evaluate updating policy/frequency.

## Expected Goals

-   Make sure the concentration limits are current with the year (Projected release:10/08).
-   AEGLs and ERPGs should be current with new releases timely.
-   By 2012 the entire PAC database chemicals should be completely updated with “age” of toxicity data ranging from 1 to 5 years.

## Historical Events of QA/Updating PACs

-  Rev.1 (1991): First released with 86 chemicals by Craig *et al.*

-  Rev.17M: First QA conducted by Petrochi, 10% of 143/1434 chemicals.

-  Rev.18 -21: QA conducted by Petrochi, 10% of new chemicals, about 160/1600, with about 5% errors.

-  2006: First 100% QA conducted, 360 chemicals, by Lu with 4.3% errors.

-  2007: DOE directed TAG to develop plans for comprehensive QA/updating the entire PACs.

-  2008: DOE approved the updating plans.

**Notes:**
PAC has three severity levels of  toxicity:, PAC-1, PAC-2, and PAC-3.  When one is exposed to a concentration above PAC-2,  one may have irreversible or other serious health effects that could impair the ability to take protective action.  This is the most important toxicity value for emergency planning and management; 
		PAC has three data sources.  Two sources were adapted from EPA’s Acute Exposure Guideline Levels and American Industrial Hygiene Association’s Emergency Response Planning Guidelines. The third source is Temporary Emergency Exposure Limit (TEEL) developed by the DOE SCAPA committee.  TEELs account for 90% of the PACs. TEELs are developed by request when neither an AEGL nor ERPG values are available. This is a good example model of sharing resources and collaboration.  
		PACs data are selected for inclusion by priority order when they are available: first AEGL, second ERPG and third TEEL. 
  	 Since the  first release in 1991 with 86 chemicals, PAC is now in Rev 23  and has about 3300 chemicals.
 PAC has been used beyond the DOE complex, including other federal agencies, industries, universities, and foreign countries. 

When one is exposed to PAC-1: one may experience mild, transient health effects; when one is exposed PAC-3:  may cause death.