Rachel Edelstein - DC IFTdcift.org/wp-content/uploads/2012/12/Rachel-Edelstein.pdf · HACCP-Based Inspection Models Project or HIMP –Market hog slaughter establishments that do

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FSIS Policy Update

Food Policy Impact

February 11, 2019

Rachel EdelsteinDeputy Assistant Administrator, Office of Policy and

Program Development

Food Safety and Inspection Service (FSIS)

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Topics• 2018 Fall Regulatory Agenda Highlights• Inspection Modernization Efforts

• New Swine Slaughter Inspection System (NSIS)• HACCP for Egg Products

• Salmonella Performance Standards for Beef• Expansion of non-O157 STEC Testing for Raw

Beef Products• Campylobacter Performance Standards in Raw

Poultry• Labeling Updates

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Fall 2018 Regulatory Agenda Highlights

For information about regulations under development, visit: http://www.reginfo.gov


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RulemakingModernization of Swine Slaughter Inspection Proposed Rule:

Final Rule:2/01/184/00/19

Egg Products Inspection Regulations Proposed Rule:Final Rule:

2/13/185/00/19

Eliminating Unnecessary Requirements for Hog Carcass Cleaning

Proposed Rule:Final Rule:

5/16/182/7/19

Allowing Pet Food and Other Uninspected Articles to be Prepared in an Official Establishment Outside

the Hours of Operation Under Inspection


7/31/1812/00/2018

Eliminating the Requirement That Livestock Carcasses be Marked "U.S. Inspected and Passed"

at the Time of Inspection When Carcasses Are to be Further Processed Within the Same Establishment


7/31/182/00/19

Elimination of Dual Weight Labeling Requirements for Certain Meat and Poultry Products

Proposed Rule: 10/00/18

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Rulemaking

Changes to Accreditation of Non-Federal Laboratories for Analytical Testing of Meat, Poultry, and Processed Egg Products

Proposed Rule: TBD

Publication Method for Lists of Foreign Countries Eligible to Export Meat, Poultry, and Egg Products to the United States

Proposed Rule: TBD

Eligibility of the People’s Republic of China (PRC) for the Importation into the United States of Poultry Products from Birds Slaughtered in the PRC


3/28/16TBD

Eligibility of Honduras to Export Poultry Products to the United States


4/13/16TBD

Eligibility of the Republic of Poland to Export Poultry Products to the United States


4/20/16TBD

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Rulemaking

Eligibility of the PRC to Export Siluriformes Fish and Fish Products to the United States


9/19/2018TBD

Eligibility of the Socialist Republic of Vietnam to Export Siluriformes Fish and Fish Products to the

United States


9/19/2018TBD

Eligibility of Thailand to Export Siluriformes Fish and Fish Products to the United States


9/19/2018TBD

To Establish a Uniform Time Period Requirement and Clarify Related Procedures for Filing Appeals of

Agency Inspection Actions

Proposed Rule: 4/00/2019

Modernization of Swine Slaughter Inspection

Proposed Rule


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Modernization of Swine Slaughter Inspection

• On February 1, 2018, FSIS published the proposed rule “Modernization of Swine Slaughter Inspection” (83 FR 4780)– Comment period closed May 2, 2018

• Proposed new voluntary inspection system for market hog slaughter establishments, the New Swine Slaughter Inspection System (NSIS), informed by the Agency’s experiences under the HACCP-Based Inspection Models Project or HIMP– Market hog slaughter establishments that do not choose to

operate under the NSIS may continue to operate under traditional inspection

• The Agency also proposed several changes to the regulations that would affect all establishments that slaughter any swine, regardless of the inspection system under which they operate or the age, size, or class of swine

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Modernization of Swine Slaughter Inspection• FSIS received over 83,000 comments from trade associations, pork processors,

consumer groups, worker safety advocates, labor unions, animal welfare groups, foreign countries, and individual consumers.

• Comments from members of industry:• Proposal’s requirement to immediately denature carcasses that have been

sorted and won’t be presented for slaughter is burdensome• FSIS should enforce proposed RTC standard further down the processing

chain than proposed or immediately before packaging

• Establishments should be allowed to use discretion when deciding, on a lot-by-lot basis, whether to incise mandibular lymph nodes or palpate viscera

• Proposal’s requirement for pre-operational environmental sampling is unnecessary and lacks support

• Sampling frequency for all establishments should be based on the number of head slaughtered

• Received many comments from individuals, unions, worker safety advocates concerned that removing line speed caps could have a negative effect on worker safety, food safety, and animal welfare

• Fall 2018 Regulatory Agenda indicates the final rule will publish April 2019.

Proposed Rule to Amend Egg Products

Inspection Regulations


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FSIS has Proposed to Require Egg Products Plants to:• Develop and implement:

– HACCP Systems (9 CFR Part 417)– Sanitation Standard Operating Procedures (Sanitation SOPs) (9 CFR Part

416)– Meet sanitation performance standards in (9 CFR Part 416)

• Convert prescriptive, command-and-control requirements to performance standards to provide industry more flexibility and the ability to innovate– Plant sanitation, construction of rooms, doors, windows, plumbing and

sewage disposal• Remove the prescriptive pasteurization regulations, replace with a new

regulation specifying that egg products must be produced to be edible without additional preparation to achieve food safety; require that egg products be produced such that finished product has no detectable pathogens

• Reinterpret “continuous” inspection• In the Fall 2018 Regulatory Agenda, FSIS estimated that the final HACCP for

Egg Products rule would publish in May 201912

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Salmonella Performance Standards for Beef

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Background: Performance Standards • Since 1996, FSIS has employed Salmonella performance standards for

pathogens in raw meat and poultry products:– Reduce the food safety hazards posed by harmful bacteria on raw

meat and poultry products, thereby reducing illnesses– Encourage continual improvement of process control by industry,

and– Encourage appropriate microbial testing by industry

• FSIS conducts verification sampling to assess whether establishments are meeting performance standards

• In 1996, Salmonella performance standards codified for establishments producing selected classes of raw meat products, including ground beef, and carcasses of steers and heifers and cows and bulls.

• FSIS is not presently assessing if beef establishments against the 1996 Salmonella performance standards because the data used to establish these standards is outdated. 14


Controlling Salmonella in Ground BeefWe continue to have Salmonella foodborne outbreaks associated with ground beef.

• 2016/2017: 106 Salmonella Newport illnesses in 21 states were linked to ground beef. One person died and 42 people were hospitalized.

• 2018/2019: Multi-state illness outbreak from beef products contaminated with Salmonella Newport. To date, the outbreak has resulted in 333 illnessesand 91 hospitalizations in 28 States.

– October 4, 2018, ~ 6.5 million pounds of raw beef products, including ground beef were recalled from one establishment that has been directly linked to this outbreak; December 4, 2018, recall expanded to include an additional ~ 5.2 million pounds of raw beef products.

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Salmonella Performance Standards

• To address continued outbreaks, in FY2019, FSIS intends update its standard for ground beef and establish a new standard for beef manufacturing trimmings.

• FSIS anticipates the new performance standards will lead establishments producing raw ground beef and beef manufacturing trimmings to strengthen their Salmonella control measures.

• FSIS will consider comments received on the notice before announcing final standards in the FR and implementing them.

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Expanding Non-O157:H7 Sampling/Testing in Raw Beef

Products


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Expansion of Non-O157 STEC Testing

• In 2011, FSIS announced that raw non-intact beef products or beef products intended for non-intact use are adulterated if contaminated with non-O157 serogroups O26, O45, O102, O111, O121, and O145- (21 U.S.C. 601(m)(3)) (76 FR 58159)

• FSIS began verification testing for non-O157 STEC in beef manufacturing trimmings (BMT) June 2012- (77 FR 9889; Feb. 21, 2012)

• FSIS has announced in sampling plans its intention to expand non-O157 STEC testing to include raw ground beef components other than BMT

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Rationale for Expansion of Non-O157:H7 (STEC) Testing

• Summer of 2018, there was an outbreak of E. coli O26; raw ground chuck was the probable source of the reported illnesses; 18 case-patients confirmed ill across four states; six people were hospitalized, and 1 died.

• FSIS presently only tests BMT for non-O157STEC in addition to E. coli O157:H7– FSIS evaluated its beef manufacturing trimmings test results and found

that positives for E. coli O157:H7 and non-O157 STEC are not typically found in the same sample.

– FSIS verification results do not support using E. coli O157:H7 as an indicator organism for non-O157 STEC. Rather, the results indicate a need for FSIS to conduct additional verification testing of products for non-O157 STEC.

• In light of the recent O26 outbreak, and our BMT data analysis indicating the need to be look for both E.coli O157;H7 and non-O157 STEC in raw beef products, FSIS is considering expanding its non-O157 STEC testing to all raw beef products that we currently test for E. coli O157:H7, including other ground beef components and bench trim use in the production of raw ground beef and raw ground beef. 19

Update:Campylobacter

Performance Standards for Raw Poultry


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Campylobacter Performance Standards: Next Steps

• In August 2018, FSIS initiated testing all raw poultry samples using the enrichment method

• Procedures and frequency of sample collection remain the same

• In August, 2018 FSIS also announced that after collecting sufficient data, it intends to revise Campylobacter performance standards for raw poultry products based on the enrichment method and intends to propose and request comments on these revised standards in the Federal Register

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Update: Campylobacter Performance Standards

• Agency has sufficient data now - generated using the enrichment method - to establish new Campylobacterperformance standards for comminuted turkey products and comminuted chicken products.

• Agency also continues to make progress on establishing new Campylobacter performance standards for chicken carcasses, turkey carcasses, and chicken parts. We have over 6 months of data generated using the enrichment method for these product classes; we typically generate new performance standards based on 9-12 months of data.

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Animal Production Raising Claims Guidance

§ FSIS published new guidance in September 2016 titled, “Documentation Needed to Substantiate Animal Raising Claims for Label Submissions”

§ Provided clarification on the types of documentation needed to support specific raising claims (e.g., diet and breed)

§ Comment period closed on December 15, 2016. Over 4000 comments received

§ FSIS is in the process of evaluating all comments and will publish the guidance in final this year

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Examples of claims covered in the guidance

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Non-Genetically Engineered Claims

§ FSIS has approved labels that state the products meet the standards of a third-party certifier regarding the use of feed containing ingredients that are not genetically engineered, e.g. “This pasture raised beef is fed a vegetarian diet that was produced in compliance with the Non GMO Project standard for avoidance of genetically engineered ingredients.”

§ FSIS published a compliance policy guide titled, “Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products”

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/claims-guidance/procedures-nongenetically-

engineered-statement

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Nutrition Labeling

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§ Proposed rule published in the FR January 19, 2017.

§ Proposal very similar to FDA final followed same process for RACC analysis

§ Provided updated Daily Reference Values (DRVs)

§ Reference Daily Intake (RDI) values are based on current dietary recommendations from consensus reports

§ Proposed combine meat and poultry regulations in new 9 CFR Part 413


Nutrition Labeling

• Some proposed changes to the nutrition facts panel format:– Switched order and placement of servings

per container– Bolded serving size and Calories– Increased font size for Calories– Updated Daily Reference Values (DRV’s)

which the %DV is based on– Includes Xg Added Sugars with %DV– Trans Fat is mandatory– Vitamin D and Potassium are mandatory– Vitamin A and Vitamin C are voluntary– New footnote– Some packages will require 2 columns

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Nutrition Labeling

§ Until a final rule for FSIS is published, product labels may continue to use the current/original nutrition regulations in 9 CFR

§ In the interim, FSIS labeling may Voluntarily use the new FDA format

§ Companies should obtain one LPDS sketch for each specific format then same panel may be added to other labeling with generic approval per 9 CFR 412.2

§ FSIS Federal Register Notice (11/16/2016): Nutrition Facts Label Compliance https://www.fsis.usda.gov/wps/wcm/connect/815c1ec3-0779-42e5-b5ec-b85494392efb/2016-0030.html?MOD=AJPERES

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Thank You For Your Attention!

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Questions?

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/claims-guidance/procedures-nongenetically-engineered-statement

https://www.fsis.usda.gov/wps/wcm/connect/815c1ec3-0779-42e5-b5ec-b85494392efb/2016-0030.html?MOD=AJPERES

Documents

Rachel Edelstein - DC IFTdcift.org/wp-content/uploads/2012/12/Rachel-Edelstein.pdf · HACCP-Based Inspection Models Project or HIMP –Market hog slaughter establishments that do