Washington Regulatory Update

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1 Washington Regulatory Update February 25, 2018 Mark Dopp Senior Vice President, Regulatory and Scientific Affairs, and General Counsel

2 Topics Alternative Proteins Evaluations of Red and Processed Meats Labeling

3 ALTERNATIVE PROTEINS

4 Alternative Proteins Regulating plant and animal based protein products FMIA/PPIA bestow primary jurisdiction regarding meat and poultry to FSIS FDCA provides primary jurisdiction non-meat and poultry to FDA Plant based products at FDA.

5 Animal Based Proteins The definition of meat part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (and bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels with normal accompany the muscle tissue and that are not separated from it in the process of dressing.

6 Animal Based Proteins Meat food product Any article capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, except those exempted from definition as a meat food product by the Administrator Meat byproduct Any part capable of use as human food, other than meat, which has been derived from one or more cattle, sheep, swine, or goats.

7 Animal Based Proteins Some Key Issues - If it s meat (et al), does FSIS have jurisdiction under the FMIA (PPIA)? - Must the original material (stem cell) come from an animal subject to and passed ante-mortem inspection? - Does the product need to be produced in a federally-inspected facility? - If FSIS, labels need approval but what is it called and is some kind of disclosure needed? - Is the product bioengineered as defined in the GMO law? - How will FSIS respond to USCA petition?

8 Animal Based Proteins How are the new plant and animal based proteins regulated to ensure a level playing field?

9 EVALUATIONS OF RED AND PROCESSED MEATS

10 International Agency for Research on Cancer: Red and Processed Meat Monograph What is IARC? - Agency of the World Health Organization - Monograph Program Hazard vs Risk Assessments - Could something ever happen? vs. What is the risk of it happening? 2015 Abstract - Summary of findings send to Lancet 2018 Monograph - Full, detailed paper to publish on IARC site

11 IARC Red and Processed Meat Conclusions

12 Monograph = Hazard Assessment Hazard assessment: A meteor could fall from the sky and hit you today. Risk assessment: The risk of a meteor falling from the sky and hitting you today is X. Processed meats and tobacco in same category. IARC facing Congressional scrutiny.

13 World Cancer Research Fund Ten year report expected in 2018 American Institute for Cancer Research = North American affiliate

14 World Cancer Research Fund Same Report, Different Messages

15 Request for Information: Consumption of red meat: cancer and noncancer health hazard evaluations. Consumption of processed meat: cancer and non-cancer health hazard evaluations. Consumption of meat cooked at high temperatures: cancer and non-cancer health hazard evaluations.

16 Proposition 65 Authoritative Body reports Triggers listing Warning label Federal preemption Bounty hunter provision California Senate resolution

17 Labeling

18 Country of Origin Labeling Litigation in the U.S. District Court in Washington - R-CALF and Cattle Producers of Washington challenging FSIS policy that a meat or meat food product processed in a federally inspected establishment is a Product of the U.S. - Seek to reinstate mandatory country of origin labeling, at least for imported meat citing Tariff Act as the basis for the claim Bill requiring retail labeling via placards failed in Colorado, still breathing in Wyoming

19 NATURAL

20 He ran out of time New Swine Slaughter Inspection Cattle? City, County, State activity e.g., San Francisco antibiotics Meat tax? 2020 Dietary Guidelines

21 Questions?

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