delivron
02-10-2013, 07:13 AM
Recently comments have been made in various media and online sources that maple syrup was being proposed as “exempt” under the FSMA, which is correct, however it is important to clarify that the proposed Food Safety Modernization Act addresses new food safety regulations and does not affect the FDA’s 2003 requirement to register your Facility (Sugarhouse). Therefore, it is our understanding that if you produce and sell maple syrup or maple syrup products to consumers from your sugarhouse, farm or other outlets, you are required to register your sugarhouse with the FDA.
On the attached document is the notice and registration information sent out by the North American Maple Syrup Council to all its member states with a request for the local associations to notify their members of this clarification, and the registration requirement.
Statement from North American Maple Syrup Council to member organizations:
FDA Requirements for Registration of Maple Syrup Production Facilities
In 2003 the U.S. Food & Drug Administration (FDA) issued amendments to the food safety laws which
required domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal
consumption in the United States to register with FDA by December 12, 2003.
As of today under the FDA regulation maple syrup producers are required to register their facility if they
manufacture maple syrup from sap collected from trees they tap or from sap purchased from others.
FDA Registration is also required if the facility makes other maple products for human consumption and / or
sells maple syrup or maple syrup products to consumers from the sugarhouse, farm or other outlets.
According to the FDA’s website, failure to register “is a prohibited act under the FD&C Act. The Federal
government can bring a civil action against persons who commit a prohibited act, or it can bring a criminal
action in Federal court to prosecute persons who are responsible for the commission of a prohibited act, or
both”.
What is confusing the issue is that regulations being proposed under the Food Modernization Act of
2011 may exclude maple syrup. However, note that this exception is about excluding maple syrup from
the proposed new food safety regulations only. It does not exclude maple syrup producers from
registering their facility under the FDA guidelines.
Our association leadership suspects that this news may not be well received by some producers so please
understand that we do not make the regulations nor do we enforce them. We are simply passing on this
important information to you. It’s up to you to decide whether you qualify to register and we trust that you
will represent the best interests of your sugaring operation during that decision process.
New registrants must complete the FORM FDA 3537 (9/12) on line which is simple to fill out but
rather lengthy (10 pages). There is no cost to register if you register directly to the FDA.
Facilities that are presently registered must update their registration information on file with the FDA every
two (2) years. We understand the current deadline for filing updates is January 31, 2013 and if you do not
update your account by January 31st you will need to re-register your facility.
For more information you can visit:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm082703.htm#a
PRINT FORM FDA 3537 (9/12) - To help facilitate registration print a blank form from the link below:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM071977.pdf
REGISTER BY FAX or MAIL - Complete and MAIL or FAX the completed FORM FDA 3537 to:
U.S. FOOD AND DRUG ADMINISTRATION, HFS-681
5100 PAINT BRANCH PARKWAY
COLLEGE PARK, MD 20993
FAX to: 301-436-2804
REGISTER ONLINE - The FORM FDA 3537 can be completed online and your account / pin set up with your
user name and password at the FDA website. Please note that if you want a copy of the FORM FDA 3537 to
fill out manually before you go on-line (recommended) you can access and print a copy from the link above;
Access the FDA Website for new Registrations:
http://www.fda.gov/food/guidancecomplianceregulatoryinformation/registrationoffoodfacilities/default.htm Click on: LOGIN / CREATE AN ACCOUNT (top center of page)
(New Page) then scroll down to bottom left corner and under NEW USER, click CREATE AN ACCOUNT
Then select FOOD & DRUG FACILITY REGISTRATION, then select FOOD FACILITY REGISTRATION
Now create your account and continue with the registration process.
If you forget to do something it will let you know by not completing the page. You cannot skip
sections of the registration process.
Important Note: “Maple Syrup” is not specifically listed in Section 10a of the FDA Form 3537 therefore under
Category select No.17 – “Food Sweeteners” then under Type of Activity select “Manufacturer / Processor”
Notes:
There is no fee or charge to register if you do so directly on the FDA website or by fax or mail.
The online process will take a while especially if you do not have the information handy. It is best to
fill out a draft of the FORM FDA 3537 before beginning the registration process on line.
If you stop entry too long after starting the registration process the program will quit and will not
save anything you entered to that point and you will need to start the form all over again.
Once you have registered you must update your data on file with the FDA every two (2) years.
Suggest marking your calendar as they will not remind you. If you miss the update deadline you may
be required to re-register your facility.
Source for this information is New York Maple Producers Association and North American Maple Council and was received on Feb 9.
On the attached document is the notice and registration information sent out by the North American Maple Syrup Council to all its member states with a request for the local associations to notify their members of this clarification, and the registration requirement.
Statement from North American Maple Syrup Council to member organizations:
FDA Requirements for Registration of Maple Syrup Production Facilities
In 2003 the U.S. Food & Drug Administration (FDA) issued amendments to the food safety laws which
required domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal
consumption in the United States to register with FDA by December 12, 2003.
As of today under the FDA regulation maple syrup producers are required to register their facility if they
manufacture maple syrup from sap collected from trees they tap or from sap purchased from others.
FDA Registration is also required if the facility makes other maple products for human consumption and / or
sells maple syrup or maple syrup products to consumers from the sugarhouse, farm or other outlets.
According to the FDA’s website, failure to register “is a prohibited act under the FD&C Act. The Federal
government can bring a civil action against persons who commit a prohibited act, or it can bring a criminal
action in Federal court to prosecute persons who are responsible for the commission of a prohibited act, or
both”.
What is confusing the issue is that regulations being proposed under the Food Modernization Act of
2011 may exclude maple syrup. However, note that this exception is about excluding maple syrup from
the proposed new food safety regulations only. It does not exclude maple syrup producers from
registering their facility under the FDA guidelines.
Our association leadership suspects that this news may not be well received by some producers so please
understand that we do not make the regulations nor do we enforce them. We are simply passing on this
important information to you. It’s up to you to decide whether you qualify to register and we trust that you
will represent the best interests of your sugaring operation during that decision process.
New registrants must complete the FORM FDA 3537 (9/12) on line which is simple to fill out but
rather lengthy (10 pages). There is no cost to register if you register directly to the FDA.
Facilities that are presently registered must update their registration information on file with the FDA every
two (2) years. We understand the current deadline for filing updates is January 31, 2013 and if you do not
update your account by January 31st you will need to re-register your facility.
For more information you can visit:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm082703.htm#a
PRINT FORM FDA 3537 (9/12) - To help facilitate registration print a blank form from the link below:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM071977.pdf
REGISTER BY FAX or MAIL - Complete and MAIL or FAX the completed FORM FDA 3537 to:
U.S. FOOD AND DRUG ADMINISTRATION, HFS-681
5100 PAINT BRANCH PARKWAY
COLLEGE PARK, MD 20993
FAX to: 301-436-2804
REGISTER ONLINE - The FORM FDA 3537 can be completed online and your account / pin set up with your
user name and password at the FDA website. Please note that if you want a copy of the FORM FDA 3537 to
fill out manually before you go on-line (recommended) you can access and print a copy from the link above;
Access the FDA Website for new Registrations:
http://www.fda.gov/food/guidancecomplianceregulatoryinformation/registrationoffoodfacilities/default.htm Click on: LOGIN / CREATE AN ACCOUNT (top center of page)
(New Page) then scroll down to bottom left corner and under NEW USER, click CREATE AN ACCOUNT
Then select FOOD & DRUG FACILITY REGISTRATION, then select FOOD FACILITY REGISTRATION
Now create your account and continue with the registration process.
If you forget to do something it will let you know by not completing the page. You cannot skip
sections of the registration process.
Important Note: “Maple Syrup” is not specifically listed in Section 10a of the FDA Form 3537 therefore under
Category select No.17 – “Food Sweeteners” then under Type of Activity select “Manufacturer / Processor”
Notes:
There is no fee or charge to register if you do so directly on the FDA website or by fax or mail.
The online process will take a while especially if you do not have the information handy. It is best to
fill out a draft of the FORM FDA 3537 before beginning the registration process on line.
If you stop entry too long after starting the registration process the program will quit and will not
save anything you entered to that point and you will need to start the form all over again.
Once you have registered you must update your data on file with the FDA every two (2) years.
Suggest marking your calendar as they will not remind you. If you miss the update deadline you may
be required to re-register your facility.
Source for this information is New York Maple Producers Association and North American Maple Council and was received on Feb 9.