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FDA Regulations for D/DBPs:
Disinfectants and Disinfection By-Products

On March 28, 2001, the U.S. Food and Drug Administration (FDA) published a Direct Final Rule for Disinfectants and Disinfection Byproducts (D/DBPs) in the Federal Register.

On July 5, 2001, the FDA confirmed the effective date of January 1, 2002 for the D/DBPs final rule. Therefore, bottled water "on the shelf" as of January 1, 2002 must be in compliance for D/DBPs regulations.

Basically, the FDA has stated that although bottled water on the shelf as of January 1, 2002 would be out of compliance if it does not comply with the bromate MCL, the FDA does not currently intend to take any action such as an off-the-shelf study.

However, if any other organization should decide to perform such a study, non-compliance could result in the need for a recall.

The rule establishes allowable levels for the following:

 
   
   
   
     
   

MCL (mg/l)

 
  Residential disinfectants:    
  Chloramine* 4.0  
  Chlorine* 4.0  
  Chlorine Dioxide* 0.8  
       
  Disinfection byproducts (DBPs)    
  Bromate 0.010  
  Chlorite 1.0  
  Haloecetic Acids (HAAs) 0.060  
     
 

* Awaiting FDA and state guidance regarding methodology, certification and frequency of testing requirements.

The rule also revised allowable levels for the DBPs Total Trihalomethanes (TTHMs) to an MCL of 0.080 mg/l.

Source Water Requirements

Only sources which are treated with chlorine-based disinfectants or ozone will require testing for DBPs and residual disinfectants. Bottlers using public water supply (PWS) sources and those receiving source water via disinfected tanker transport would be required to do this testing.

Frequency of Testing

For 2001, the IBWA is requiring quarterly bromate and bromide testing on all types of finished product water and quarterly bromide and chloride testing on all types of source water (including municipal sources).

As of January 1, 2002, the FDA will be requiring testing "at least" annually on all types of finished product water and chlorinated or ozonated sources for the D/DBPs. We are awaiting clarification on frequency of testing from the FDA.

Some states are expected to require quarterly bromate/bromide monitoring but we are still waiting for more information.

Sources of Contaminants

Bromate can be formed when bromide, a naturally occurring inorganic ion, is exposed to ozone.

THMs & HAAs are formed as a result of chlorine disinfections. They are formed when chlorine reacts with organic matter in the water. TTHMs is the sum (in mg/l) of the concentration of the trihalomethane compounds:

Trichloromethane (chloroform)    Dibromochloromethane
Tribromomethane (bromoform)   Bromodichloromethane

Chlorite is a disinfection by-product which is formed as chlorine dioxide decomposes.

 

 

 

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