Form and Instructions for the current request.

Instructions for Completing and Submitting the Pasteurization Holding Time and Temperature Data Collection Form and Signature Page

We have developed and provided two forms to assist you with the submission of your data. Be sure to print clearly or type and use a separate form for each plant. Please read and complete each form according to the instructions below.

Signature Page

• Please read the form and sign. Your signature indicates your understanding of the following:

• Submission of the data is voluntary;

• Data may only be viewed by FDA/CFSAN unless additional release privileges are requested from you;

• You certify that this information is accurate to the best of your knowledge.

• Please provide one signature page per submission. For example, if you have completed two or three data collection forms and are submitting them by fax, you only need one signature page if you fax all the documents at the same time.

Pasteurization Holding Time and Temperature Data Collection

• Please include only IMS listed facilities.

• Please do not provide data on non-bovine (e.g., goat’s, sheep, etc) milk, cream and cream products, cultured milk and milk products, milk and milk products to be cultured, and vat pasteurized, ultra-pasteurized, or aseptically processed Grade “A” milk and milk products. Please record:

• The actual pasteurization holding times for each process used (in seconds);

• The actual operating/pasteurizing temperature used (in °F);

• The number of days milk is processed;

• The volume of fluid Grade “A” products processed on a daily basis (in gallons);

• The specific pasteurization unit(s) used within the facility (i.e., HTST #1 or #2, or HTST N or S, or HHST #1, or HHST #2).

• Please separate the data for each processing unit as indicated in Footnote 1 (FN1).

As you proceed, if you have any questions or concerns, please address these to the FDA Regional Milk Specialist responsible for your State.

Please submit the forms as you complete them. There is no need to collect them and submit them all together for the entire state. Please fax or email the individual data collection forms and signature page to:

Protected Critical Infrastructure Information (PCII) Program Office,

Attn: PCII Office, Fax #: 703-288-4058

We appreciate your help and support in this vital endeavor!

Signature Page

Pasteurization Holding Time and Temperature Data Collection

NOT FOR PUBLIC DISTRIBUTION

This information is voluntarily provided to the Federal Government in the expectation of protection from disclosure as provided by the provisions of the Critical Infrastructure Information Act of 2002.

The information contained herein shall be released solely to the Food and Drug Administration, Center for Food Safety and Applied Nutrition.

To the best of my knowledge, information, and belief, this information:

• Is not being submitted in lieu of independent compliance with a Federal legal requirement;

• Is not customarily in the public domain; and

• Is not required to be submitted to a Federal Government Agency.

I understand that any false representations may constitute a violation of 18 U.S.C. §1001 and are punishable by fine and imprisonment.

Signed: ___________________________________________________

Date: _______________

Contact Information (please print):

Name: _________________________________________________________________

Title: __________________________________________________________________

Mailing Address: ________________________________________________________

_______________________________________________________________________

Phone: ________________________________

Email: ____________________________________

Pasteurization Holding Time and Temperature Data Collection

NOT FOR PUBLIC DISTRIBUTION

 

Plant Code Number: _________________________ Date of Data Collection: ________________

State Program Manager: ________________________ _____________________ _________________

(Name) (Telephone) (E-mail)

Please indicate which of the following reasons would prevent your firm from raising your current milk pasteurization temperatures and/or times. Circle all that apply.

1. Our pasteurization temperatures/times meet or exceed the recommendations provided by the International Dairy Foods Association (IDFA).

2. We have concerns about the formation of off flavors/taste at higher temperatures/times.

3. There are economic constraints (e.g., energy, equipment) associated with raising temperatures/times.

4. We do not have enough information regarding the risk or benefits of raising temperatures/times.

5. We have in the past tried higher pasteurization temperatures/times with adverse consequences and we do not have any plans at the current time to increase them again.

Please feel free to elaborate on any of your responses

Unit Processed On^FN1: _____________

	Whole	Whole Flavored	2%	2% Flavored	1%	1% Flavored	Skim	Skim Flavored
Processing TemperatureFN2
TimeFN3
VolumeFN4
# of Days Processed

Unit Processed On^FN1: __________

	Whole	Whole Flavored	2%	2% Flavored	1%	1% Flavored	Skim	Skim Flavored
Processing TemperatureFN2
TimeFN3
VolumeFN4
# of Days Processed

Please do not provide data on non-bovine (e.g., goat’s, sheep, etc) milk, cream and cream products, cultured milk and milk products, milk and milk products to be cultured, and vat pasteurized, ultra-pasteurized, or aseptically processed Grade “A” milk and milk products.

FN 1 Unit Processed On: i.e., HTST #1 or #2 or HTST N or S or HHST #1 or HHST #2.

FN 2 Temperature: Record actual operating/processing temperature (°F).

FN 3 Time: Obtain from the most recent pasteurization equipment validation (seconds).

FN 4 Volume: On a daily average (gallons). If multiple flavored products per fat level are being produced, combine the product volumes to report only one daily volume for all these flavored products per fat level.

Public reporting burden for this collection of information is estimated to average 31 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing burden to:

Food and Drug Administration

Center for Food Safety and Applied Nutrition

5100 Paint Branch Parkway, HFS-007

College Park, Maryland 20740