4. Featured Panelist & Host
FSMA FRIDAYS
Eric Edmunds, JD
Director of Food Safety
● Brings a combination of legal, regulatory
and food industry experience to TAG and
FSMA Fridays
● Certified in HACCP, is a Registered
Environmental Health Specialist with
NEHA, a FSMA Preventive Controls
Qualified Individual for Human Food, and
a FSMA Produce Safety Rule Trainer
Aaron Bolshaw
VP Marketing
5. FSMA FRIDAYS
The Latest FSMA Updates
• FDA Partners with the California Department of Food and Agriculture, Western
Center for Food Safety, and California Agricultural Stakeholders to Enhance Food
Safety
• FDA Releases New Outbreak Investigation Table
• FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in
Ingredient List on Food Labels
Today’s Topics:
FDA Labeling
FDA Nutritional Labeling Updates
Bioengineered Disclosure Act
6. FSMA FRIDAYS
Compliance Dates
• July 26, 2018/January 1, 2020
• For businesses with $10 million or more in annual food sales
• July 26, 2019/January 1, 2021
7. FSMA FRIDAYS
Updates
• Mandatory declaration of ‘added sugars’
• Highlight calories and servings in label
• Update some daily values
• Required nutrient declarations
• Dietary Fiber
• Records requirements
8. FSMA FRIDAYS
Updates
• Changes to some Reference Amounts
Customarily Consumed (RACCS)
• Used to determine serving size
• Serving sizes
• Single serving packages
• Dual column labeling
9. FSMA FRIDAYS
• Vitamin D and Potassium are now required
• Vitamin D: Osteoporosis
• Potassium: High blood pressure, stroke, and heart disease
• Calcium and Iron are still required
• Vitamins A and C
Nutrients of Public Health Concern
14. FSMA FRIDAYS
• Based on what people actually consume and package size
• Reference Amounts Customarily Consumed (RACCS)
• Approximately 30 changed and 25 new submissions
• Used to determine serving size
Serving Size
15. FSMA FRIDAYS
• Examples of some RACCs
• Ice cream from 1/2 cup to 2/3 cup
• Yogurt from 8 ounces to 6 ounces
• Beverages from 8 ounces to 12
ounces
• Milk stayed at 8 ounces
• Cheeses unchanged
Serving Size
17. FSMA FRIDAYS
• Dual column label
• Required for package with 200%
- 300% of RACC
• Voluntary when package
contains more than 150%, but
less than 200% of RACC
Serving Size
18. FSMA FRIDAYS
• Implementation and Compliance
• January 1, 2020
• January 1, 2021 for small food
manufacturers
• Voluntary compliance
• December 31, 2021
• Mandatory compliance
• January 1, 2022
National Bioengineered Food Disclosure Act
19. FSMA FRIDAYS
• When is disclosure required?
• When a food is bioengineered or contains a bioengineered ingredient
• When food is subject to labeling requirements of:
• Food, Drug, and Cosmetic Act (FDCA)
• Federal Meat Inspection Act, Poultry Product Inspection Act, or
the Egg Products Inspection Act only if:
• Predominant ingredient would be subject to FDCA; or
• Predominant ingredient is broth, stock water, or similar solution and
second most predominant ingredient is subject to FDCA
National Bioengineered Food Disclosure Act
21. FSMA FRIDAYS
• Bioengineered Food means:
• A food that contains detectable genetic material that has been
modified through in vitro recombinant deoxyribonucleic acid (rDNA)
techniques for which the modification could not otherwise be
obtained through conventional breeding found in nature
National Bioengineered Food Disclosure Act
22. FSMA FRIDAYS
• Detectability
• Recordkeeping
• Source of food or refinement process
• Validated refining process
• Analytical testing standards or continuous testing
• Standards of performance for detectability testing
• Laboratory quality assurance protocols for validity
National Bioengineered Food Disclosure Act
23. FSMA FRIDAYS
• Exemptions
• Restaurants and similar retail establishments
• Very small food manufacturers (annual receipts less than $2.5
million)
• Food with no intentionally added BE/GMO ingredients
• Inadvertent or technical allowance for up to 5% of each ingredient
• Food derived from an animal when animal has consumed BE feed
• Food that is certified under National Organic Program
National Bioengineered Food Disclosure Act
25. FSMA FRIDAYS
• Disclosure
• On-package text
• Symbol
• Electronic or digital link
• “Scan here for more food information”
• Must be accompanied by a phone number
• Text message
• “Text [command word] to [number] for bioengineered food
information”
National Bioengineered Food Disclosure Act
26. FSMA FRIDAYS
• Two types of voluntary disclosures are allowed:
• Entities that are exempt
• May voluntarily disclose using any of the available options
• May include very small food manufacturers, restaurants, etc.
• Foods that do not contain detectable modified genetic material, but
are derived from bioengineering
• Only applies to highly refined ingredients in which modified
genetic material is no longer detectable
• CANNOT be used for animal fed bioengineered feed, soups
where meat is the first ingredient, or incidental additives.
National Bioengineered Food Disclosure Act
27. FSMA FRIDAYS
• Enforcement
• Agricultural Marketing Services (AMS)
request for records
• 5 business days to provide records
• AMS will provide 3 days notice when onsite
access to records is necessary
• Any interested person may file a written
statement or complaint with AMS
• AMS will determine if reasonable grounds
exist for investigation
National Bioengineered Food Disclosure Act