FDA Accepts Alternative Method for Premilking Teat Preparation
During the National Conference on Interstate Milk Shipments (NCIMS), May 3-8, 1997,
the voting delegates accepted a proposal to modify the provision in the
Pasteurized Milk Ordinance (PMO) which deals with premilking udder and teat preparation
(Item 13r; Milking -- Flanks, Udders, and Teats). Under the proposal, the requirement to
treat teats with a sanitizing solution prior to milking would be changed to a recommendation.
Technical Review Conducted
Any changes to the PMO are subject to concurrence by the Food and Drug Administration (FDA).
To aid in their decision, FDA conducted a technical review on the effects of udder preparation
on milk quality and udder health. In summarizing the review, FDA stated "Despite the wealth of
available studies on milking practices and udder health, there is a scarcity of comparative
literature on the effects of those udder preparation methods which do and do not include treating
teats with sanitizing solutions prior to milking". FDA went on to say that "Despite this
scarcity, it is clear that a portion of the information available supports the current requirement
that teats be sanitized prior to milking and a portion of the information supports the concept
that there can be acceptable alternatives to the current requirement." FDA said they were
"prepared to accept both premises equally".
Compromise Reached
Based on the technical review, FDA did not concur with the original proposal as written, which would
have removed the requirement that teats be treated with a sanitizing solution prior to milking.
However, FDA offered an alternative solution to the proposal which was accepted by the NCIMS
Executive Board on October 19, 1997. As reported in FDA memorandum IMS-a-40 dated October 24, 1997,
point number 4 in the "administrative procedures" section of item 13r in the PMO has been modified
to the following (added text underlined and in italics):
This item is deemed to be satisfied when:
1. Milking is done in a milking barn, stable or parlor.
2. Brushing is completed prior to milking.
3. Flanks, bellies, tails and udders are clipped as often as necessary to facilitate cleaning of these
areas and are free from dirt. The hair on the udders shall be of such length that it is not
incorporated with the teat in the inflation during milking.
4. Udders and teats of all milking cows are clean and dry before milking. Teats shall be cleaned,
treated with a sanitizing solution and dry just prior to milking; except that additional alternative
udder preparation methods may also be used once they have been evaluated by FDA and found acceptable.
5. Wet hand milking is prohibited.
Alternative Method Accepted
Based on a literature review, FDA has accepted an alternative to the requirement to treat teats
with a sanitizing solution prior to milking. In an October 24, 1997 memorandum (M-I-97-6) FDA stated:
"Sanitizing of the teats shall not be required if the udder is dry and the teats have been
thoroughly cleaned (not dry wiped) and dried (manually wiped dry) prior to milking. The determination
of what constitutes a dry udder and cleaned and dried teats shall be made by the regulatory agency".
FDA also noted that "additional alternative udder preparation methods may also be used once they
have been evaluated by FDA and found acceptable".
More Research Needed
According to FDA, well controlled research studies could likely identify additional acceptable
alternative udder preparation methods. The studies need to focus on comparing the effects of
udder preparation methods, under various climatic and management conditions, with and without
treating teats with sanitizing solution prior to milking. FDA will evaluate such studies upon
submission to determine whether they are acceptable alternatives. FDA encouraged individuals
interested in conducting such research to consult with the agency to review protocols for the
study.
NCIMS Information Available on the WWW
NCIMS memoranda, model documents (such as the PMO), and other information regarding the NCIMS
program are available through the FDA Prime Connection, an on-line resource library of
information on retail food protection, milk safety and seafood safety. The Prime Connection
can be accessed from the FDA Center for Food Safety and Applied Nutrition (CFSAN) web page at:
http://vm.cfsan.fda.gov/.
From the NMC Newsletter "Udder Topics", October 1997
