From: Megaw, Peter [Peter.Megaw@Croda.com]
Sent: Wednesday, October 06, 2004 9:37 AM
To: Fda rulemaking feedback (fdadockets@oc.fda.gov)
Subject: Docket No. 2004N-0081 and 2004N-0257 comments. Request for clar ification concerning status of cows' milk derivatives in cosmetics

 

Dear Madam/Sir

 

We are aware of the two dockets above, concerning "Use of materials derived from cattle in human food and cosmetics" and "Recordkeeping Requirements for Human Food and cosmetics manufactured from, processed with, or otherwise containing, materials from cattle.

 

This comments seeks to request clarification of the status of derivatives of cattle milk from living cows with respect to the requirements of the documents. We seek clarification either by amendment of the text of the document, or by any alternative mechanism that allows us to supply customers for the products with an official FDA clarification of the status of the materials.

 

The problem

 

The two documents concern derivatives of material from cattle used in Human food and cosmetics. Cows' milk is a cattle material. No specific reference is made to milk as a cattle material in either document.

 

The low risk from milk and its derivatives is already well documented, and has notably been incorporated into the provisions of the European Union with respect to TSE risk of even pharmaceutical ingredients. A copy of the European Union guidelines for TSE risk reduction in Pharmaceuticals, including comments on low risk from milk is attached as an example. (cpmp-guidelines-october-2003-rev2.pdf).

 

However, in the absence of specific text excluding milk derivatives from scope we have already encountered problems with respect to information provision to our customers and customs authorities in the context of the Interim Final Rule and proposed Rule.

 

Specific problems in case milk derivatives are not excluded

 

Ideally we would like to see an amendment to the text, or alternative clarification, indicating that cows' milk derivatives from living cows are outside the scope of the requirements, since they self-evidently do not contain the specified risk materials (SRMs) and there are no viable mechanisms for transfer of such materials from living cows to milk under normal dairy conditions.

 

If such a general exclusion cannot be made then the following specific issues will need to be addressed.

 

(1)               Implementation date to determine applicability

 

The penultimate paragraph of section V "Issuance of an interim final rule, immediate effective date, and opportunity for public comment" of the interim final rule states:

 

            "This interim final rule applies to human food and cosmetics manufactured from, processed with, or that otherwise contain, material from cattle slaughtered on or after its effective date"

 

When milked cattle are of course still living.

I will give an example of the type of problem that could arise if milk derivatives are not excluded:

We manufacture a product based on the hydrolysate of commercial powdered sodium caseinate derived from the milk of Australian cows. (Australia has had no TSE infected animals for over 50 years).

We estimate that a large spray-dried batch of sodium caseinate may be derived from the milk of thousands of cows. Possibly up to 100 000 cows for one bulk spray-drying session.

We have stocks of materials dating from before 14 July 2004. However, some of the cows whose milk was used to produce the sodium caseinate may have been slaughtered after the 14th July 2004. Does the final rule therefore require that the Australian dairy industry keep sufficiently robust records to be able to trace the date of eventual slaughter of each specific cow with the use of the milk from each of its milkings - including milk produced from cows before 14th July 2004 which are still alive after 14 July 2004?

 

If record-keeping for living cattle milk is required we believe that the Recordkeeping costs assessment would need a major revision, as this goes well beyond "requires those establishments that process the carcasses or parts of carcassess of cattle maintain daily records", since all dairies would also be required to keep records.

 

This seems such an onerous requirement with such little potential additional benefit in risk reduction that we will reserve further comment on difficulties of implementation until confimation of inclusion or exclusion of products derived from milk  from the scope of these requirements  has been received.

 

 

I therefore look forward to receipt of a response to my request for clarification.

 

 

Thank you in advance

 

Best regards

 

 

 

 

 

Peter Megaw

 

Regulatory Affairs Manager Croda Chemicals Europe Ltd

 

Cowick Hall

Snaith

Goole

East Yorkshire

DN14 9AA

Great Britain

 

 

Peter.Megaw@croda.com