BECOMING A WHOLESALE FOOD MANUFACTURER

BECOMING A WHOLESALE FOOD MANUFACTURER – EXPLANATION OF REQUIREMENTS


A Wholesale Food Manufacturing Establishment is defined in 50-57-102, Montana Codes Annotated (MCA) as a facility and the facility’s buildings or structures used to manufacture or prepare food for human consumption at wholesale. Please note that if the packaged food product you are proposing to produce for wholesale distribution is greater than 3% meat, licensing may be required by the Department of Livestock. Be sure to contact them at (406) 444-5202. For other packaged food, approval of the Food & Consumer Safety Section (FCSS) is required prior to licensing, and FCSS must issue the license.

In order to become a licensed wholesale food manufacturer, authorized to process and package food for public distribution, there are 5 steps a new applicant (person or corporation) must complete. They are shown below.

a) Apply for a license (including license fee and application form), and pay any plan review fee which may be required by the
county in which the facility is to be located.
b) Facility Plan -- Obtain approval of the plans and specifications prior to construction, including layout plans, water source,
sewage disposal, and other structural information. (See Part 1.)
c) Process Plan -- Obtain approval of product ingredients, processing information, packaging, storage, distribution, labeling etc.,
from FCSS. FDA standards are used for review. (See Part 2.)
d) Pass a preliminary inspection by the local health authority prior to commencing operations of food processing, packaging, sales or distribution.
e) Register with FDA—Beginning on December 12, 2003, all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption, must register with FDA. This can be easily accomplished by accessing the FDA website at www.fda.gov

The Montana Food Manufacturing Administrative Rules (ARM Title 37, Chapter 110, Subchapter 3) require that plans and specifications be submitted to FCSS and approved, prior to the construction of any food manufacturing establishment. You will also need to check with the local sanitarian. It is generally recommended that 2 copies of plans be submitted, one for the local health authority, and one for forwarding to FCSS. This includes building plans, food ingredients, processes used, containers, labels, and distribution plans. Additional copies of the building plans may be needed for State Building Codes Bureau, Liquor Division, or other state and local authorities.

If you already have a licensed food facility (a Bakery endorsement- F-4, or a Restaurant endorsement-F-1, for example), you may already process and package some types of food for onsite (retail) sale at your facility, but if you intend to wholesale the products for retail sale elsewhere, it is required that you obtain a separate food manufacturers license (13 or higher endorsement). The procedure is the same, except you do not need to submit facility construction plans. There is an additional license and fee required if you intend to operate both a retail and wholesale establishment on the same premises. Contact the county sanitarian for information.

This guide document is intended to assist new applicants in the process of obtaining approval of their proposal prior to the start of construction, as required by rule. Separate guides are available for Water Bottlers and Beverage Bottlers, this guide is intended for conventional food manufacturers. If you have questions or if you need a copy of the above noted administrative rule, or other documents, please contact the local sanitarian or call FCSS at 444-2408 or 444-5306. If you prefer, we will also respond to e-mail requests, at: hreid@mt.gov or you may visit our website at: www.dphhs.mt.gov