Regulatory Update: Food Safety and Nutrition

Transcription

1 Regulatory Update: Food Safety and Nutrition Ricardo Carvajal Hyman, Phelps & McNamara, P.C. North American Millers Association March 2015

2 Today s Agenda Ø FSMA Update Ø Biological and chemical hazards Ø Reportable foods Ø Gluten-free labeling Ø GMOs and FDA Ø 2015 Dietary Guidelines Ø Revamp of nutrition labeling 2

3 Ø Who s out: Commissioner Margaret Hamburg Ø Who s in: CFSAN Director Susan Mayne Chair, Chronic Disease Epidemiology, Yale School of Public Health CSPI Scientific Advisory Board Ø Who s still in: Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine 3

4 Status of FSMA Rules 4 Ø August 30, 2015 Preventive Controls for Human Food Preventive Controls for Animal Food Ø October 31, 2015 Foreign Supplier Verification Program Produce Safety Standards Accreditation of Third Party Auditors Ø March 31, 2016 Sanitary Transport of Food and Feed Ø May 31, 2016 Intentional Contamination

5 Who s going to pay for this? Ø In 2016 budget, FDA asks for $84M increase in budget authority $169M increase through proposed user fees (e.g., imports and facility registration) Ø 20% of foods program budget would be paid by fees 5

6 Without the requested $$$ Ø Delays in FSMA implementation Ø Inadequate staffing Ø Inadequate training of FDA and state inspectors Ø Unable to provide guidance and technical assistance to industry Ø Inadequate implementation of import safety system 6

7 The rules keep moving along Ø On 9/29/14, FDA issued proposed supplemental rules for: Preventive controls (human and animal food) Foreign supplier verification program (FSVP) Ø Some additional flexibility mostly additional obligations 7

8 Changes to Preventive Controls 8 Ø Surprise! (not) product testing and environmental monitoring requirements have been added Ø Product testing required to verify implementation and effectiveness of preventive controls, as appropriate Ø Environmental monitoring required if contamination of an RTE food with an environmental pathogen is a significant hazard

9 Also in 9 Ø supplier controls required if: hazard analysis identifies significant hazard for incoming ingredient hazard is controlled before receipt (in other words, by supplier) Ø choice* of verification activities onsite audit sampling testing Ø hazard analysis to include economic adulteration?

10 Small & very small businesses Ø Small businesses: < 500 employees 2 years to comply Ø VSBs: qualified facilities subject to modified requirements given 3 years to comply < $1M in total annual sales (human food) < $2.5M in total annual sales (animal food) 10

11 Changes to FSVP Ø Hazard analysis: more comprehensive evaluation of risks combines hazard analysis with compliance status review Nature of hazard Entity applying controls Supplier s food safety SOPs Supplier s compliance with U.S. food safety regulations Food safety performance history 11

12 Supplier verification 12 Ø Proposed rule included 2 options, one of which required on-site audits where there is a reasonable probability of SAHCODHA for hazard controlled by supplier Ø Supplemental rule provides more flexibility Determine verification measures based on food and supplier risks On-site audits required if SAHCODHA, unless you can show something else will work If have supplier verification as manufacturer, no need to duplicate

13 Biological hazards Ø No news is good news Ø FDA to designate high-risk foods additional recordkeeping requirements Ø Not on most recent regulatory agenda 13

14 Chemical hazards Ø Allergens cumin recall due to undeclared peanut Ø Agricultural cross-contact? Ø Economic adulteration? Ø Is advisory labeling a fix? 14

15 Pesticides Ø A food is adulterated if it bears or contains an unsafe pesticide residue Ø Unsafe = unapproved Ø Act prohibits residues, not use Ø In import context, zero tolerance 15

16 Reportable foods Ø Standard is reasonable probability of serious adverse health consequences or death Ø 24 hours to report unless narrow exception applies Ø Should determination be made in reference to hazard posed by finished food? 16

17 Gluten-free labeling claims Ø Final rule published in August 2013 Ø Compliance date of August 5, 2014 Ø Noisy roll-out Ø Total silence since then 17

18 Enforcement strategy? Ø Misbranding results where gluten is > or = 20 ppm Ø What is to be tested? Ø Highly consequential decision, for commerce and public health 18

19 GMOs and FDA Ø Still no credible challenge to safety of GMO foods Ø Some consumers claim right-to-know Ø Why FDA is sitting it out Ø Marketplace is moving on 19

20 2015 Dietary Guidelines Ø Dietary Guidelines Advisory Committee (DGAC) issued Scientific Report on February 23 Ø Public meeting on report is scheduled for March 24 Ø Members of the Dietary Guidelines Advisory Committee greatly exceeded their scope in developing recommendations Ø Agencies failed to keep the Committee focused on nutritional recommendations and away from areas such as sustainability and tax policy, which are outside of the Committee s purview. 20

21 Whole grains 21 Ø The 2010 Dietary Guidelines for Americans recommended that half of all grain intake should come from whole grains. The 2015 DGAC brings forward this recommendation and here we give rationale and results to support this decision. Ø The majority of the U.S. population has low intakes of key food groups that are important sources of the shortfall nutrients, including whole grains

22 Whole grains (cont d) Ø The overall body of evidence examined by the 2015 DGAC identifies that a healthy dietary pattern is higher in whole grains and low in refined grains. Ø Because the average intake levels of dietary fiber are half the recommended levels, achieving the recommendation requires selecting high-fiber cereals and whole grains Ø [A] major shift from refined to whole grains is needed in order to meet recommendations. 22

23 Revamp of nutrition facts Ø FDA harmonizing definition of dietary fiber with Institute of Medicine Ø Certain isolated and synthetic carbohydrates would qualify as dietary fiber only if FDA approves petition demonstrating physiological effect beneficial to human health E.g., ß-glucan and barley ß-fiber Ø Increase in DRV for fiber from 25g to 28g 23

24 24 QUESTIONS?