# FAMILY OF MATERIALS EXAMPLE #1 **- API 5**  **STEP PROCESS (1)** 



## R - 1 R - 1 R - 1 R - 5

R - 5 R - 5 C1 A. B. C. EQUIPMENT **Chemistry Step**  **Presence of** 

**HAPs /UHAPs**  A Ta ble 1

HAP B NA C HAP **Isolated drum storage**

**(2) Isolated drum storage** 

**Isolated drum storage**  

## R - 1 R - 1 C1

R - 9 R - 5 C1 D1 1 D1 1 

## D. E. D HAP E HAP **Notes:** (1) Intermediates A, B, C, D and final product E are totally d ifferent chemicals made from totally d ifferent raw materials. (2) Material mu st be isolated prior to next step because of process safety concerns **Question:** Given that intermediates A, B, C and D are isolated in drums, are they (and final product E) in the same Family of Materials? **Isolated drum storage** 

Attachment A

# FAMILY OF MATERIALS EXAMPLE #2

A. B. EQUIPMENT **Process Presence**  **of HAPs /UHAPs**  

## A Ta ble 1 HAP generated (HAP used for cleaning) 

## B NA

(HAP used only for 

## R- 1 R- 1 C1

R - 5 R - 5 C1 D11
D11 (HAP used only for cleaning) Process A and Process B use the same CMPU Process A uses raw material X and a solvent (water) to make product Z Process B uses raw material X and raw material Y and a solvent (IP A) to make product W Product A generates a T

able 1 HAP as a byproduct Product B does not generate a T able 1 HAP

, but uses a HAP for equipment cleaning These products have similar end uses, but different applications. Attachment A

## Process A 

# FAMILY OF MATERIALS EXAMPLE #2

Ta ble 1 HAP + HAP (Cleaning) 

## N R 1 

## O + Initiator #1 

## N R 1 

## O
N + Water



## Note: No T

able 1 HAPin Process B Process B N 1



## N R 1 

## O + R2 

## N R3 

## O
N 2 

## + HAP (Cleaning) Initiator #2 IP A

Attachment A

# FAMILY OF MATERIALS **– EXAMPLE #3** 

• The company packages and sells a variety of specialty polyolefins. A large number of customers buy the polyolefins, many wanting a slightly different molecular weight, degree of saturation, solvent, etc.

• Emission profiles differ somewhat because (i) addition times for Reactant A Reactant A Solvent A or Solvent B
Polyolefin (HAP) control molecular weight, (ii) Solvent

A may produce Ta ble 1 HAP emissions while Solvent B does not, etc. Product C, Product D, etc. Product Z

Attachment A

## FOM EXAMPLE #4 - Pharmaceutical Production Raw M aterial X 1 

## + Raw

M aterial Y 1 

## Phrma A

MeCl 2 

## MeOH Raw M aterial X2 

## + Raw

M aterial Y2 

## Phrma B

MeOH Notes: 1. The same CMPU is used to make Phrma A and Phrma B 2. Pharmaceutical products Phrma A and Phrma B have different pharmacological properties or treat different medical conditions or diseases. They are both regulated as 2 distinct products and processes under FDA regulations. Questions: 1. Are the Pharmaceutical products Phrma A and Phrma B in the same family of Materials? 2. Wh at criteria should be used to answer the above question? 3. Given that Phrma A and Phrma B are somewhat different compounds (including, for example, the case where they are isomers) but have clearly different pharmacological properties or treat different medical conditions or diseases, would they belong to the same Family of Materials?
Attachment A

# FOM & Deminimis Cut-of f Example #5 – Biological Active Pharmaceutical Production

• A batch process uses 30 lbs/yr T able 1 metal HAPand approximately 30 lbs/yr of a non -Ta ble 1 metal HAP • Material from this process is isolated in drums until it is formulated and packaged into injectable syringes at the same facility • The formulation process does not involve any HAPs • The definition of a CMPU implies that the formulation/packaging process is not part of the initial batch process and therefore is not regulated by CMAS • FOM implies the opposite • If the above processes were located at a major source, the formulation/packaging process would not be regulated by the Pharma MACT because that rule does not contain the FOM language • EP A has created a contradictory and confusing situation by incorporating both “family of materials” and “isolated intermediate” language into the CMAS rule
Attachment A