Regulatory Considerations for

Tennessee Food Manufacturers

Farmer’s Markets

Mike Brown

Outreach Coordinator

Tennessee Department of Agriculture

Agencies

Federal

USDA

• Meat and Poultry

• Catfish

• Egg Products (eggs removed from shell)

FDA

• Seafood

• Shell Eggs

• Produce

• Manufactured foods

Agencies

State

Department of Agriculture

•Dairy

•Food

•Feed

•Weights & Measures

•Plant Certification

Department of Health

•Local Health Departments

Manufactured

Foods

Restaurant and

Catering Food

Establishments

Responsibilities(lead public health agency related to food

safety)

Retail Food Stores

Delis and In House Food Service

Dairy Farms

Dairy Container & Closure Manufacturers

Dairy Processing Plants

Beverage Bottling Plants

Food Manufacturers and Warehouses

Seafood

Custom Slaughter

TN Dept. of Agriculture

Retail Food Stores

6550 inspected by TDA

2950 by contract w/counties

5500 delis/in-house food service

Small mom and pop’s to superstores

TN Dept. of Agriculture

Dairy Farms

(stable to table/gate to plate)

379 Grade A dairy farms

3 goat dairy farms

3 sheep dairy farms (1 ships

frozen)

Most regulated entity in the

food industry

TN Dept. of Agriculture

Dairy Processing Plants

25 Dairy Processors

Frozen dessert

Cheese

Large Hispanic cheese manufacturer

Sour cream

Fluid milk

Yogurt (largest in US, in world w/expansion)

2 new plants - Unilever, Bongard

TN Dept. of Agriculture

Beverage Bottlers Soft Drinks

Beer

Water

Wineries

Distilleries

TN Dept. of Agriculture

Food Manufacturers and

Warehouses

1267 food manufacturers (doubled in last 6 yrs.)

511 warehouses

Small jam and jelly to 1,000,000 sq. ft. facility

185 FDA Contract Food Inspections

283 COOL audits

Approximately 149 Domestic Kitchens

Approximately 28,000 public health inspections per year

Approx. 4,000 food/dairy samples per yr.

TN Dept. of Agriculture

Reality

All processed foods must come from licensed and inspected facilities with the exception of:

Honey from honey producers that produce less than 150 gallons of their own honey

Eggs from people who sell less than 18,000 from their own flock every year

Domestic kitchens that “opt out” of inspection

A Question For You

Have you

purchased a

food from a

store shelf in

the last week

?

Food Safety Program Our primary role is to protect the public’s health

and while doing so potentially lessen the liability

of those persons that wish to produce a safe

food for the consuming public.

Original HACCP Plan

Domestic Kitchen Rules Supports cottage food industry

Non-potentially hazardous foods

Non-refrigerated baked goods, candies

and jams/jellies, etc.

In May 2012, law was passed which allows

manufacturers to opt-out of inspection

and permitting by the Tennessee

Department of Agriculture

Opting Out

Allows manufacturers to sell direct to

consumers

They must display an 8.5-by-11-inch sign

with 0.75-inch font at the place of sale

stating, "These food products were made

in a private home not licensed or

inspected."

Pertinent Items

Baked foods/jams/jellies/candies

Food safety course prerequisite

No pets/no pets/no pets/no domestic duties

Separate refrigerator/ingredient storage

Hand washing/food grade materials/cleaners

Labeling/lot numbers/packaging materials

Hair covering/Disease/Tobacco/Pest control

Acidified Foods

Foods with >10% by weight in

particulates that are low acid (pH >4.6)

Vegetables

Eggs

Nuts

Examples: salsa, pickles, chow-chow

Acidified Foods

Must adhere to GMPs as well as acidified

food regulations

Manufactured in commercial facility

Community kitchen - rent time

Rent time from a restaurant/caterer while

closed

Co-packer- another company

manufacturer your product

Require minimum batch sizes

Build their own

Better Process Control School

Must take a one-time class

Educates manufacturers of the acidified

food requirements

Microbiology- food safety

Process controls- cook time/temperature

Product measurements – pH

Records

Better Process Control School

University of Tennessee

Taught annually

Online Course- UC Davis

www.fruitandvegetable.ucdavis.edu/Cooperat

ive_Extension_Short_Courses/Better_Process_Co

ntrol_School_Online/

Formulated Acid Foods Foods with natural pH <4.6

Usually 3.3-3.5

Less than 10% by weight particulate

low acid foods

Most of our sauces and dressings fall

into this category

BBQ sauce, mayonnaise and

marinades

Formulated Acid Foods

Still recommend review of product

formulation and processing steps

Must adhere to GMPs

Manufactured in a commercial kitchen

Inspected and permitted by TDA

Fruit Juices

Manufacturing must take place in a commercial facility licensed and inspected

FDA Regulation required processing step to achieve a 5-log reduction or 99.999% of pertinent pathogens

Implement Hazard Analysis and Critical Control Point system in addition to GMPs

Beverage Bottlers

Soft Drinks

Teas

Fermented Beverages

Water

Beer

Wineries

Moonshine

Regulated by TDA

Poultry

Small processor

<20,000 birds/year

Exempt from full-time inspection

Subject to USDA sanitation standards

USDA Small and Very Small Plant Outreach:

http://www.fsis.usda.gov/science/small_very_s

mall_plant_outreach/index.asp#Compliance_

Assistance

Retail Meat Sales Animals processed at USDA inspected facility

Meat packaged and labeled at USDA facility

Labels must meet USDA regulations. -include name of product, complete address of individual offering meat for sale, net weight, price per pound, total price of product,

lot/code recommended

Storage in separate freezer in a secure area away from potential sources of contamination

$50 Retail meat sales permit through TDA

Posted where sales occur

Retail Meat Sales

Transported in a secure

manner - freezer

operated by inverter is

acceptable

No re-freezing of product

– refrigerated product

maintained under 41F.

Display packages

marked “For Display

Only” and not offered for

sale

Retail Meat Sales

Eggs No permit/inspection

required

<3,000 birds

Limit of 50 cases (30 dozen per case) of unclassified eggs per year

Must be from own flock- no distributors

Must be labeled

Unclassified

Name of producer

Eggs deemed adulterated may not be offered for sale.

Washing Eggs

Wash in a mild detergent

~10°F higher temp than egg

Dip in warm potable water

Dip in sanitizer (chlorine 50-

200ppm)

Honey No permit/inspection

required

<150 gallons per year

Only sell product they

produced

Must be labeled

Name, address, & net weight

“100% Pure Honey”

“Not Pure Honey”- Include

ingredient listing

Sorghum Molasses

Must be labeled

Name, address, & net weight

“100% Pure Sorghum Molasses”

“Not Pure Sorghum Molasses”- Include

ingredient listing

Inspected by TDA

Fresh Cut and Shelled Produce

or Nuts

Fresh produce that has been cut,

shredded, sliced, chopped, torn, or shelled

To reduce the risk of pathogen growth, maintain cut

produce at 41° F (5°C) or less during storage and

display

Routinely monitor the temperature of the product

and the equipment used to maintain product temperature

Will need to be processed in a facility inspected and

permitted by TDA

Weights And Measures Scales used for retail sale must meet appropriate

standards & inspected by TDA

Nat’l Type Evaluation Program (NTEP)

Annual TDA inspection & permit

fees - <2500 lbs. - $5.00 - >2500 lb.

- $75.00

Non-compliant scales must be

repaired by registered service

company – TDA has a list

Net Wt. only – lbs. ozs. & grams.

Questions – Bob Williams – 615-

837-5109

Thank you for your interest!

We’ve covered some of the basics for the

most common products entrepreneurs

develop for Farmer’s Markets

I’m only a call or email away

Mike Brown/Outreach Coordinator

(615)837-5177

Mike.f.brown@tn.gov

Tennessee Dept. of Agriculture

Consumer and Industry Services

1-800-628-2631

Food and Dairy Division

Shanna Lively, Food and Dairy

Administrator

shanna.lively@tn.gov

(615)837-5176

Questions From You