regulatory roadmap for market vendors · 1) laboratory based nutritional analysis require a...
TRANSCRIPT
Regulatory
Roadmap for
Farmer’s
Market
VendorsFaith Critzer
Rules for All
Food
Manufacturers
to Play By
Good Manufacturing Practices
Manufactured in a sanitary environment adhering to Good Manufacturing Practices (GMPs)-21CFR Part 110
Process controls (proper cooking time and temperature)
Ingredient handling/storage
Pest control
Cleaning and sanitation
Sanitary equipment and utensil design
Allergen control
Personal hygiene
Good Manufacturing Practices
TDA currently working to adopt subpart B
of the Preventative Controls Regulation
21 CFR Part 117
GMP Training & Resources Cornell GMP Online Training
http://gmptraining.dyson.cornell.edu/
Very Comprehensive course
$50
UT Publications
Getting Started in a Food
Manufacturing Business in Tennessee
Adding Value to Agriculture Through
Commercial Food Processing
Enterprises
UTK FST Extension>Publications
Product Labeling The Four Must Haves
Product name
Manufacturers name and address
Or name, city and zip if listed in white pages
Net weight of product in English and Metric
units
e.g. ounces/pounds and gram weight
equivalent or milliliters/liters and fluid ounces
Complete list of ingredients in order of
predominance by weight
Allergens Food Allergen and Consumer Protection Act
January 1, 2006
Any of the “Big 8” allergens properly
identified in ingredient statement
Wheat
Soy
Milk
Eggs
Fish
Shellfish
Peanuts
Tree nuts (e.g. almonds, cashew, brazil nuts)
Statement after ingredients “Contains: ……”
Allergens
Advisory Labeling Statements
Advisory Labeling
“May contain ________”
“Made on shared equipment ______”
“Made in a facility that _______”
Product
Name
Name of
Distributor or
Manufacturer with
Street Address
Weight in
grams and
ounces
Did we miss anything?
Ingredients: apples,
honey, apple cider,
citric acid, salt, spices
Nutrition Facts Panels
Small Business Exemption
File notice with FDA
Sales of less than 100,000
units
AND <100 full-time
employees
Notice does not need to
be filed with FDA
Gross sales of less than
$500,000
Nutrition Facts Panels Two Methods
1) Laboratory Based Nutritional Analysis
Require a physical sample of the product
The samples are then prepped and analyzed in
the laboratory using various scientific instruments and techniques to yield data that is
specific and unique to the product.
Laboratory based nutritional analysis can be
used for virtually any food type.
Nutrition Facts Panels Two Methods
2) Nutritional Database Analysis
Requires the formula for the product
Detailed information about each ingredient and product processing information
No physical sample is required to be submitted
Database analysis can be used for products that have common ingredients.
Not recommended:
Products that have unique or exotic ingredients,
Products with ingredients for which there is no nutritional data available, or
Products that undergo extensive processing. This method can only be used for human foods.
Nutrition Facts Panels
Two Methods
1) Laboratory Based Nutritional Analysis
Approx $800-1,500
Refer to outside testing lab
2) Nutritional Database Analysis
$100-300
Online as well as outside testing labs
Acidified
Foods
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/cater while closed
Co-packer- another company manufacturer your product
Require minimum batch sizes
Build their own
Inspected and permitted as commercial food manufacturer
What are the additional
requirements for acidified
foods?
1) One time educational course
Better Process Control School
Educates manufactures of the acidified
food requirements
Microbiology- food safety
Process controls- cook time/temperature
Product measurements – pH
Records
What are the additional
requirements for acidified
foods?
1) One time educational course
2) Register your facility with FDA
Registering Your Facility
Form 2541
Just file one time for each location you
process
http://www.fda.gov/downloads/aboutFD
A/ReportsManualsForms/Forms/UCM07677
8.pdf
What are the additional
requirements for acidified
foods?
1) One time educational course
2) Register your facility with FDA
3) Work with a processing authority to
establish a scheduled process for each
product
Who is a Processing Authority?
Someone with expertise knowledge in
microbiology and thermal processing
Charge a fee per recipe to establish process
May need to come on site while you
manufacture to collect data
What are the additional
requirements for acidified
foods?
1) One time educational course
2) Register your facility with FDA
3) Work with a processing authority to
establish a scheduled process for each
product
4) File Scheduled Process with FDA
Filing a Scheduled Process
with FDA
FDA Form 2541a NOW 2541e
Specific to the product
Documents critical factors established by
processing authority
What are the additional
requirements for acidified
foods?
1) One time educational course
2) Register your facility with FDA
3) Work with a processing authority to establish a scheduled process for each product
4) File Scheduled Process with FDA
5) Keep accurate records documenting all critical factors each time you process
Examples of Records
Thermal processing records
Cook time, temperature
Finished product pH
Fill weights
Solid fill weight
Acidified Food Resources
Factsheet to assist acidified food
manufacturers
FDA Resources and Guidance
Documents
http://www.fda.gov/Food/GuidanceReg
ulation/FoodFacilityRegistration/AcidifiedL
ACFRegistration/ucm2007436.htm
http://www.fda.gov/Food/GuidanceReg
ulation/GuidanceDocumentsRegulatoryIn
formation/AcidifiedLACF/default.htm
Formulated
Acid Foods
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
DO NOT have additional requirements for
acidified foods
Can voluntarily submit 2541e to FDA for
review
Formulated Acid Foods
Materials
Factsheet to assist formulated acid food
manufacturers
Cottage
Food Laws
Cottage Food Industry Growing support for home-made products
Allows producers to add value to fruit and vegetable crops they raise
A start to your business- not the end game
Applies ONLY to non-potentially hazardous foods?
Varies from state to state
What are non-potentially
hazardous foods?
Good question!
These foods don’t support
the growth of bacteria that
can be harmful
Can I get a list of non-
potentially hazardous foods?
No!
Wide range of products
Fruit jams and jellies
Apple butters
Dried pumpkin and spinach pasta
Dried herbs
Contact me to determine if your product
fits into this category
Domestic Kitchen Rules
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."
Domestic Kitchen Products Must be properly labeled
Product name
Manufacturers name and address
Net weight of product in ounces/pounds and
gram weight equivalent
Complete list of ingredients in order of
predominance by weight
Warning label: “This Product was made in a
private home not licensed or inspected”
Any of the “Big 8” allergens properly
identified- wheat, soy, milk, eggs, fish,
shellfish, peanuts, tree nuts,
What are the benefits to being
inspected?
Can sell through multiple retail outlets
Some farmers markets sill require
inspected/permitted domestic kitchen
manufacturers
Do not have to display “warning sign and
include this information on label”
If not properly trained, you don’t know
what proper practices are
What is required if I get
inspected?
1) Adhere to modified Good Manufacturing
Practices (GMPs)
How are GMPs modified?
No pets, no pets, no pets
At least inside
No domestic duties
Childcare, cooking dinner
Separate refrigerator/ingredient storage
Cross contamination
Break resistant lighting- teflon coated bulbs
No requirement for separate handwashing sink
Can use home bathroom
What is required if I get
inspected?
1) Adhere to modified Good
Manufacturing Practices (GMPs)
2) One time passage of a course that
covers information pertinent to Domestic
Kitchen Manufacturers- offered both
online and in person
Domestic Kitchen Course
Online- extOL Certifications
$75
404 students since Feb. of 2013
https://extol.tennessee.edu/people/course/category.php?id=25
In person classes on demand- 10 people minimum
$100
8 hours
What is required if I get
inspected?
1) Adhere to modified Good
Manufacturing Practices (GMPs)
2) One time passage of a course that
covers information pertinent to Domestic
Kitchen Manufacturers- offered both
online and in person
3) Permitted and Inspected by the
Tennessee Department of Agriculture
Other Food
Types
Retail Meat Sales Animals processed, meat
packaged and labeled at USDA inspected facility
Transported in a secure
manner - freezer operated by
inverter is acceptable
No re-freezing of product –
refrigerated product
maintained at or below 41F
Retail Meat Sales Permit from
TDA
Retail Meat Sales Labeling Requirements
Product name.
Name and address of the place of business of the manufacturer,
packer or distributor (“packed for ___” or “distributed by ___” are
acceptable).
USDA mark of inspection/establishment number.
Net weight.
Safe handling instructions.
Ingredients (if more than a single ingredient product).
Price per pound (non-frozen, random weight packages only).
Total price (non-frozen, random weight packages only).
Optional
Code date or lot number. (Recommended not required.)
Special statement and claims. (Require approval by USDA.)
Retail Meat Sales
Poultry Producer/Grower Exemption
<20,000 birds/year
Exempt from inspection
May sell to consumer, hotel, retail stores, and restaurants/institutions
Labeling: The shipping containers, when distributed in intrastate commerce, (instead of all the required features of a label for inspected product) bear:
The processor’s name
The address
Net weight
The statement, Exempt P.L. 90-492
Safe handling instructions
Exemption Provisions The poultry is healthy when
slaughtered;
The slaughter and processing
are conducted under sanitary
standards, practices, and
procedures that produce
poultry products that are
sound, clean, and fit for
human food (not
adulterated);
The poultry is not misbranded
is identified as exempt
product and labeled;
Exemption Provisions
The business operates under only 1 exemption during
calendar year;
Product cannot bear the Official USDA mark of inspection;
and
Poultry products do not move in inter-state commerce.
The business slaughters and processes no more than
20,000 birds/carcasses in a calendar year under the
exemption.
Facility used to slaughter or process poultry is not used to slaughter or process another person’s poultry unless the
Administrator of FSIS grants an exemption [9 CFR 381.10
(b)(2)].
Dairy Products
Milk, cream and mixes
must be pasteurized in
properly operated and
designed equipment in a
licensed and permitted
dairy plant
EXCEPTIONS:
1. Raw milk hard cheese –
processed in dairy facility
– cheese aged 60 days
2. Ice cream made from
pasteurized mix, cheese
balls, cheese cake etc.
Eggs No permit/inspection required
<3,000 birds
Limit of 50 cases (30 doz per case) of unclassified eggs per year= 18,000 eggs >18,000 eggs must be graded
Must be from own flock- no distributors
Cleaned and sanitized
Unused containers
Must be labeled Unclassified
Name of producer
Eggs deemed adulterated may not be offered for sale
Store at or below 41ºF
Honey No permit/inspection
required
<150 gallons per year
Only sell product you produce
Must be labeled
Honey
Comb honey
Cut comb honey, Honey with comb, Chunk honey
Name, address, & net weight
Newly Defined Standard of
Identity
TCA – chapter 0080-04-12
Honey and any flavoring, spice or other added ingredient
Processed in such a way that a modification to honey occurs that materially changes the flavor, color, viscosity or other material characteristics
Must be distinguished in the food name from honey by declaration of the food additive or modification.
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 NutsFresh produce that has been cut,
shredded, sliced, chopped, torn, or
shelled Maintain cut produce at 41° F or less during
storage and display
Will need to be processed in a facility inspected
and permitted by TDA
Weights And Measures
"Fresh fruits and
vegetables may be sold by
either weight, count.
head/bunch, dry measure,
or a combination of
these methods of sale
as specified in NIST
Handbook 130".
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
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 or
Tennessee Department of
Agriculture
Consumer and Industry Services
Mike Brown– Outreach Coordinator
(615)837-5177
Will send packet for you to complete and
send back for their review
Inspector will inspect at least once a year
University of Tennessee
County Extension Office
Department of Food Science &
Technology
Faith Critzer
